Title 21 Food and Drugs Parts 100 to 169

Revised as of April 1, 2017

Containing a codification of documents of general applicability and future effect

As of April 1, 2017

Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register

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Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the original documents published in the Federal Register (44 U.S.C. 1510). It is prohibited to use NARA’s official seal and the stylized Code of Federal Regulations logo on any republication of this material without the express, written permission of the Archivist of the United States or the Archivist’s designee. Any person using NARA’s official seals and logos in a manner inconsistent with the provisions of 36 CFR part 1200 is subject to the penalties specified in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix This is the Official U.S. Government edition of this publication and is herein identified to certify its authenticity. Use of the 0–16 ISBN prefix is for U.S. Government Publishing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Publishing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN.

U.S. GOVERNMENT PUBLISHING OFFICE U.S. Superintendent of Documents • Washington, DC 20402–0001 http://bookstore.gpo.gov Phone: toll-free (866) 512-1800; DC area (202) 512-1800

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Page Explanation ...... v

Title 21:

Chapter I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 3

Finding Aids:

Table of CFR Titles and Chapters ...... 737

Alphabetical List of Agencies Appearing in the CFR ...... 757

List of CFR Sections Affected ...... 767

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To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 100.1 refers to title 21, part 100, section 1.

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2017), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

VerDate Sep<11>2014 13:04 Jun 30, 2017 Jkt 241071 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Q:\21\21V2.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. PAST PROVISIONS OF THE CODE Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appropriate List of CFR Sections Affected (LSA). For the convenience of the reader, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949- 1963, 1964-1972, 1973-1985, and 1986-2000. ‘‘[RESERVED]’’ TERMINOLOGY The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ location at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that a portion of the CFR was left vacant and not accidentally dropped due to a printing or computer error. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material published in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.

VerDate Sep<11>2014 13:04 Jun 30, 2017 Jkt 241071 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Q:\21\21V2.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB An index to the text of ‘‘Title 3—The President’’ is carried within that volume. The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail [email protected]. SALES The Government Publishing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours a day. For payment by check, write to: US Government Publishing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers of the Presidents of the United States, Compilation of Presi- dential Documents and the Privacy Act Compilation are available in electronic format via www.ofr.gov. For more information, contact the GPO Customer Con- tact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512- 1800 (toll-free). E-mail, [email protected]. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.archives.gov/federal-register. The e-CFR is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments, produced by the Office of the Federal Register and the Government Publishing Office. It is available at www.ecfr.gov.

OLIVER A. POTTS, Director, Office of the Federal Register. April 1, 2017.

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Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299, 300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, containing parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart- ment of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Jus- tice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2017.

For this volume, Robert J. Sheehan, III was Chief Editor. The Code of Federal Regulations publication program is under the direction of John Hyrum Martinez, assisted by Stephen J. Frattini.

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(This book contains parts 100 to 169)

Part

CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 100

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(Parts 100 to 169)

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994, 59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24, 2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July 15, 2005, and 70 FR 67650, Nov. 8, 2005.

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

Part Page 100 General ...... 5 101 Food labeling...... 10 102 Common or usual name for nonstandardized foods 197 104 Nutritional quality guidelines for foods ...... 204 105 Foods for special dietary use ...... 208 106 Infant formula requirements pertaining to current good manufacturing practice, quality control procedures, quality factors, records and reports, and notifications ...... 210 107 Infant formula...... 237 108 Emergency permit control ...... 247 109 Unavoidable contaminants in food for human consumption and food-packaging material ...... 257 110 Current good manufacturing practice in manufacturing, packing, or holding human food ...... 263 111 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements ...... 273 112 Standards for the growing, harvesting, packing, and holding of produce for human consumption .. 303 113 Thermally processed low-acid foods packaged in hermetically sealed containers ...... 340 114 Acidified foods...... 375 115 Shell eggs...... 381

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Part Page 117 Current good manufacturing practice, hazard analysis, and risk–based preventive controls for human food ...... 384 118 Production, storage, and transportation of shell eggs ...... 424 119 Dietary supplements that present a significant or unreasonable risk ...... 435 120 Hazard Analysis and Critical Control Point (HACCP) systems ...... 435 121 Mitigation strategies to protect food against intentional adulteration ...... 444 123 Fish and fishery products ...... 452 129 Processing and bottling of bottled drinking water 460 130 Food standards: General ...... 465 131 Milk and cream ...... 472 133 Cheeses and related cheese products ...... 491 135 Frozen desserts...... 543 136 Bakery products...... 550 137 Cereal flours and related products ...... 554 139 Macaroni and noodle products ...... 569 145 Canned fruits...... 579 146 Canned fruit juices ...... 620 150 Fruit butters, jellies, preserves, and related products ...... 634 152 Fruit pies...... 639 155 Canned vegetables...... 641 156 Vegetable juices...... 663 158 Frozen vegetables...... 666 160 Eggs and egg products ...... 669 161 Fish and shellfish ...... 674 163 Cacao products...... 691 164 Tree nut and peanut products ...... 699 165 Beverages ...... 702 166 Margarine ...... 722 168 Sweeteners and table sirups ...... 724 169 Food dressings and flavorings ...... 729

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PART 100—GENERAL ticular need for information that is not met by the preemptive Federal require- Subpart A—State and Local Requirements ment. (b) Definitions. (1) Act means the Fed- Sec. eral Food, Drug, and Cosmetic Act (21 100.1 Petitions requesting exemption from U.S.C. 321 et seq.). preemption for State or local require- (2) Agency means the Food and Drug ments. Administration. 100.2 State enforcement of Federal regulations. (3) Commissioner means the Commis- sioner of Food and Drugs. Subparts B–E [Reserved] (4) State means a State as defined in section 201(a)(1) of the act (which in- Subpart F—Misbranding for Reasons Other cludes a territory of the United States, Than Labeling the District of Columbia, and Puerto Rico) or any political subdivision of a 100.100 Misleading containers. State having authority to issue food standards and food labeling regulations Subpart G—Specific Administrative Rulings having force of law. and Decisions (5) State requirement means any stat- 100.155 Salt and iodized salt. ute, standard, regulation, or other requirement that is issued by a State. AUTHORITY: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371. (c) Prerequisites for petitions for exemption from preemption. The Food and SOURCE: 42 FR 14306, Mar. 15, 1977, unless Drug Administration will consider a otherwise noted. petition for exemption from preemp- EDITORIAL NOTE: Nomenclature changes to tion on its merits only if the petition part 100 appear at 81 FR 49895, July 29, 2016. demonstrates that: (1) The State requirement was en- Subpart A—State and Local acted or was issued as a final rule by Requirements an authorized official of the State and is in effect or would be in effect but for § 100.1 Petitions requesting exemption the provisions of section 403A of the from preemption for State or local act. requirements. (2) The State requirement is subject (a) Scope and purpose. (1) This subpart to preemption under section 403A(a) of applies to the submission and consider- the act because of a statutory provi- ation of petitions under section 403A(b) sion listed in that section or because of of the Federal Food, Drug, and Cos- a Federal standard or other Federal metic Act (the act), by a State or a po- regulation that is in effect, or that has litical subdivision of a State, request- been published as a final rule with a ing exemption of a State requirement designated effective date, and that was from preemption under section 403A(a) issued under the authority of a statu- of the act. tory provision listed in that section. (2) Section 403A(b) of the act provides For the purposes of this subpart, all pe- that where a State requirement has titions seeking exemption from pre- been preempted under section 403A(a) emption under section 403A(a)(3) of the act, the State may petition the through (a)(5) of the act submitted be- agency for an exemption. The agency fore May 8, 1992, will be considered may grant the exemption, under such timely even though the applicable stat- conditions as it may prescribe by regu- utory provisions or regulations are not lation, if the agency finds that the yet in effect. State requirement will not cause any (3) The petitioner is an official of a food to be in violation of any applica- State having authority to act for, or on ble requirement under Federal law, behalf of, the Government in applying will not unduly burden interstate com- for an exemption of State requirements merce, and is designed to address a par- from preemption.

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(4) The State requirement is subject A. Action Requested to preemption under section 403A(a) of 1. Identify and give the exact wording of the act because it is not identical to the State requirement and give date it was the requirement of the preemptive Fed- enacted or issued in final form. eral statutory provision or regulation 2. Identify the specific standard or regula- including a standard of identity, qual- tion that is believed to preempt the State re- ity, and fill. ‘‘Not identical to’’ does quirement and the section and paragraph of not refer to the specific words in the the act that the standard or regulation im- requirement but instead means that plements. the State requirement directly or indi- B. Documentation of State Requirement rectly imposes obligations or contains provisions concerning the composition Provide a copy of the State requirement or labeling of food, or concerning a that is the subject of the application. Where food container, that: available, the application should also include (i) Are not imposed by or contained copies of any legislative history or back- in the applicable provision (including ground materials used in issuing the requirement, including hearing reports or studies any implementing regulation) of sec- concerning the development or consideration tion 401 or 403 of the act; or of the requirement. (ii) Differ from those specifically imposed by or contained in the applicable C. Statement of Grounds provision (including any implementing A petition for an exemption from preemp- regulation) of section 401 or 403 of the tion should contain the following: act. 1. An explanation of the State requirement (d) Form of petition. (1) All informa- and its rationale, and a comparison of State tion included in the petition should and Federal requirements to show dif- meet the general requirements of ferences. § 10.20(c) of this chapter. 2. An explanation of why compliance with (2) An original and one copy of the the State requirement would not cause a petition shall be submitted, or the peti- food to be in violation of any applicable re- tioner may submit an original and a quirement under Federal law. computer readable disk containing the 3. Information on the effect that granting the State petition will have on interstate petition. Contents of the disk should be commerce. The petition should contain in- in a standard format, such as ASCII formation on economic feasibility, i.e., format. (Petitioners interested in sub- whether the State and Federal requirements mitting a disk should contact the Cen- have significantly different effects on the ter for Food Safety and Applied Nutri- production and distribution of the food prod- tion for details.) uct; comparison of the costs of compliance as (3) Petitions for exemption from pre- shown by data or information on the actual emption for a State requirement shall or anticipated effect of the State and Fed- be submitted to the Division of Dock- eral requirements on the sale and price of ets Management in the following form: the food product in interstate commerce; and the effect of the State requirement on the (Date) llllllll availability of the food product to con- Division of Dockets Management, sumers. To the extent possible, the petition Food and Drug Administration, should include information showing that it Department of Health and Human Services, is practical and feasible for producers of food 5630 Fishers Lane, rm. 1061, products to comply with the State require- Rockville, MD 20852. ment. Such information may be submitted in the form of statements from affected persons PETITION REQUESTING EXEMPTION FROM indicating their ability to comply. PREEMPTION FOR STATE REQUIREMENT 4. Identification of a particular need for in- The undersigned submits this petition formation that the State requirement is de- under section 403A(b)of the Federal Food, signed to meet, which need is not met by Drug, and Cosmetic Act to request that the Federal law. The petition should describe the Food and Drug Administration exempt a conditions that require the State to petition State requirement from preemption. for an exemption, the information need that The undersigned has authority to act for, the State requirement fulfills, the inad- or on behalf of, the (identify State or political equacy of the Federal requirement in ad- subdivision of the State) because (document pe- dressing this need, and the geographical area titioner’s authority to submit petition on behalf or political subdivision in which such need of the State). exists.

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D. Environmental Impact writing of the filing and docket number The petition shall contain a claim for cat- of a petition. egorical exclusion under 21 CFR 25.24 or an (4) Any interested person may submit environmental assessment under 21 CFR written comments to the Division of 25.31. Dockets Management on a filed peti- E. Notification tion as provided in § 10.30(d) of this chapter. Provide name and address of person, (5) Within 90 days of the date of filing branch, department, or other instrumen- tality of the State government that should the agency will furnish a response to be notified of the Commissioner’s action con- the petitioner. The response will ei- cerning the petition. ther: (i) State that the agency has ten- F. Certification tatively determined that the petition The undersigned certifies, that, to the best merits the granting of an exemption, knowledge and belief of the undersigned, this and that it intends to publish in the petition includes all information and views FEDERAL REGISTER a proposal to grant on which the petition relies. the exemption through rulemaking; (Signature) llllllllllll (Name of petitioner) llllllll (ii) Deny the petition and state the (Mailing address) lllllllll reasons for such denial; or (Telephone number) llllllll (iii) Provide a tentative response in- (Information collection requirements in dicating why the agency has been un- this section were approved by the Office of able to reach a decision on the peti- Management and Budget (OMB) and assigned tion, e.g., because of other agency pri- OMB number 0910–0277) orities or a need for additional infor- (e) Submission of petition for exemption; mation. public disclosure. The availability for (g) If a State submitted a petition for public disclosure of a petition for ex- exemption of a State requirement from emption will be governed by the rules preemption under section 403A(a)(3) specified in § 10.20(j) of this chapter. through (a)(5) of the act before May 8, (f) Agency consideration of petitions. (1) 1992, that State requirement will not Unless otherwise specified in this sec- be subject to preemption until: tion, all relevant provisions and re- (1) November 8, 1992; or quirements of subpart B of part 10 of (2) Action on the petition, whichever this chapter, are applicable to State occurs later. petitions requesting exemption from Federal preemption under section [58 FR 2468, Jan. 6, 1993] 403A(b) of the act. (2) If a petition does not meet the § 100.2 State enforcement of Federal prerequisite requirements of paragraph regulations. (c) of this section, the agency will issue (a) Under section 307 of the Federal a letter to the petitioner denying the Food, Drug, and Cosmetic Act (the petition and stating in what respect act), a State may bring, in its own the petition does not meet these re- name and within its own jurisdiction, quirements. proceedings for the civil enforcement, (3) If a petition appears to meet the or to restrain violations, of sections prerequisite requirements in paragraph 401, 403(b), 403(c), 403(d), 403(e), 403(f), (c) of this section, it will be filed by the 403(g), 403(h), 403(i), 403(k), 403(q), or Division of Dockets Management, 403(r) of the act if the food that is the stamped with the date of filing, and as- subject of the proceedings is located in signed a docket number. The docket the State. number identifies the file established (b) No proceeding may be commenced by the Division of Dockets Manage- by a State under paragraph (a) of this ment for all submissions relating to section: the petition, as provided in this part. (1) Before 30 days after the State has Subsequent submissions relating to the given notice to the Food and Drug Ad- matter must refer to the docket num- ministration (FDA) that the State in- ber and will be filed in the docket file. tends to bring such proceeding. The Division of Dockets Management (2) Before 90 days after the State has will promptly notify the petitioner in given notice to FDA of such intent if

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FDA has, within such 30 days, com- H. Name of firm against which action is menced an informal or formal enforce- anticipated (if applicable). ment action pertaining to the food I. Type of enforcement action. which would be the subject of such pro- Yours very truly, ceeding. Reporting Agency (3) If FDA is diligently prosecuting a By llllll proceeding in court pertaining to such (Indicate authority) food, has settled such proceeding, or (e) The letter of notification should has settled the informal or formal en- be signed by a State official authorized forcement action pertaining to such by the State to institute the con- food. templated enforcement actions. (c) A State may intervene as a mat- (f) The letter of notification should ter of right, in any court proceeding be sent to the Division of Enforcement described in paragraph (b)(3) of this (HFS–605), Center for Food Safety and section. Applied Nutrition, Food and Drug Ad- (d) The notification that a State sub- ministration, 5001 Campus Dr., College mits in accordance with paragraph (b) Park, MD 20740, FAX number 202–205– of this section should include the fol- 4642. lowing information and be submitted in the following recommended format: (g) FDA will notify the State of the date in which its letter of notification (Date) llllllll was received by FDA, Center for Food Name of State agency llllll Safety and Applied Nutrition, Division Post office address llllll of Enforcement (HFS–605) (within 2 Street address llllll City, State, and ZIP code llllll working days after date of receipt). Name of product(s) covered by the notifica- This date will be the date of notification llllll tion for the purposes of paragraph (b) Reporting official, title, and telephone no. of this section. llllll (h) The Director, Division of Enforce- FAX No. llllll ment, Office of Field Programs, Center Agency contact (if different from reporting official), title, and telephone no. for Food Safety and Applied Nutrition, llllll FDA, will respond to the State’s notification within 30 days of the date of no- Director, tification by advising: Division of Enforcement (HFS–605), Center for Food Safety and Applied Nutri- (1) Whether FDA has commenced an tion, informal or formal enforcement action Food and Drug Administration, pertaining to the food that is the sub- 5001 Campus Dr., ject of the notification; or College Park, MD 20740. (2) Whether FDA is prosecuting a To Whom It May Concern: proceeding in court pertaining to such The undersigned, lll, submits this letter food, has settled such proceeding, or of notification pursuant to section 307(b)(1) has settled informal or formal enforce- of the Federal Food, Drug, and Cosmetic Act ment action pertaining to such food. (21 U.S.C. 337(b)(1)) with respect to llll. (name of products covered by the notifica- (i) Information contained in State tion and the enforcement action that is to be notification letters shall be exempt initiated) from public disclosure to the same ex- Attached hereto, and constituting a part of tent to which such information would this letter of notification are the following: be so exempt pursuant to §§ 20.61, 20.64, A. The name of the product. and 20.88 of this chapter. B. The type and size of each product container. (j) Definitions. (1) Informal enforcement C. Copy of the label and labeling of the actions include warning letters, recalls, product. detentions, or other administrative en- D. Manufacturing code (if applicable). forcement actions that pertain to the E. Name and address of firm believed to be food in question. responsible for violations. (2) Formal enforcement actions include F. Name and address of parent firm (if known). seizures, injunctions, or other civil ju- G. Reason for the anticipated State en- dicial enforcement actions that pertain forcement action (list specific violations, in- to the food in question. (Information cluding sections of the law violated). collection requirements in this section

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were approved by the Office of Manage- date required food labeling (excluding ment and Budget (OMB) and assigned any vignettes or other nonmandatory OMB control number 0910–0275.) designs or label information), discour- age pilfering, facilitate handling, or ac- [58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 66 FR 56035, Nov. 6, 2001] commodate tamper-resistant devices). (b) [Reserved] Subparts B–E [Reserved] [59 FR 537, Jan. 5, 1994] Subpart F—Misbranding for Subpart G—Specific Administra- Reasons Other Than Labeling tive Rulings and Decisions § 100.100 Misleading containers. § 100.155 Salt and iodized salt. In accordance with section 403(d) of (a) For the purposes of this section, the act, a food shall be deemed to be the term iodized salt or iodized table salt misbranded if its container is so made, is designated as the name of salt for formed, or filled as to be misleading. human food use to which iodide has (a) A container that does not allow been added in the form of cuprous io- the consumer to fully view its contents dide or potassium iodide permitted by shall be considered to be filled as to be §§ 184.1265 and 184.1634 of this chapter. misleading if it contains nonfunctional In the labeling of such products, all slack-fill. Slack-fill is the difference words in the name shall be equal in between the actual capacity of a con- prominence and type size. The state- tainer and the volume of product con- ment ‘‘This salt supplies iodide, a nec- tained therein. Nonfunctional slack-fill essary nutrient’’ shall appear on the is the empty space in a package that is label immediately following the name filled to less than its capacity for rea- and shall be in letters which are not sons other than: less in height than those required for (1) Protection of the contents of the the declaration of the net quantity of package; contents as specified in § 101.7 of this (2) The requirements of the machines chapter. used for enclosing the contents in such (b) Salt or table salt for human food package; use to which iodide has not been added (3) Unavoidable product settling dur- shall bear the statement, ‘‘This salt ing shipping and handling; does not supply iodide, a necessary nu- (4) The need for the package to per- trient.’’ This statement shall appear form a specific function (e.g., where immediately following the name of the packaging plays a role in the prepara- food and shall be in letters which are tion or consumption of a food), where not less in height than those required such function is inherent to the nature for the declaration of the net quantity of the food and is clearly commu- of contents as specified in § 101.7 of this nicated to consumers; chapter. (5) The fact that the product consists (c) Salt, table salt, iodized salt, or io- of a food packaged in a reusable con- dized table salt to which anticaking tainer where the container is part of agents have been added may bear in ad- the presentation of the food and has dition to the ingredient statement des- value which is both significant in pro- ignating the anticaking agent(s), a portion to the value of the product and label statement describing the charac- independent of its function to hold the teristics imparted by such agent(s) (for food, e.g., a gift product consisting of a example, ‘‘free flowing’’), providing food or foods combined with a con- such statement does not appear with tainer that is intended for further use greater prominence or in type size larg- after the food is consumed; or durable er than the statements which imme- commemorative or promotional pack- diately follow the name of the food as ages; or required by paragraphs (a) and (b) of (6) Inability to increase level of fill this section. or to further reduce the size of the (d) Individual serving-sized packages package (e.g., where some minimum containing less than 1⁄2 ounce and pack- package size is necessary to accommo- ages containing more than 21⁄2 pounds

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of a food described in this section shall 101.30 Percentage juice declaration for foods be exempt from declaration of the purporting to be beverages that contain statements which paragraphs (a) and fruit or vegetable juice. (b) of this section require immediately Subpart C—Specific Nutrition Labeling following the name of the food. Such Requirements and Guidelines exemption shall not apply to the outer container or wrapper of a multiunit re- 101.36 Nutrition labeling of dietary supple- tail package. ments. (e) All salt, table salt, iodized salt, or 101.42 Nutrition labeling of raw fruit, vege- iodized table salt in packages intended tables, and fish. for retail sale shipped in interstate 101.43 Substantial compliance of food retailers with the guidelines for the voluntary commerce 18 months after the date of nutrition labeling of raw fruit, vegeta- publication of this statement of policy bles, and fish. in the FEDERAL REGISTER, shall be la- 101.44 Identification of the 20 most fre- beled as prescribed by this section; and quently consumed raw fruit, vegetables, if not so labeled, the Food and Drug and fish in the United States. Administration will regard them as 101.45 Guidelines for the voluntary nutri- misbranded within the meaning of section labeling of raw fruit, vegetables, and fish. tions 403 (a) and (f) of the Federal Food, Drug, and Cosmetic Act. Subpart D—Specific Requirements for [42 FR 14306, Mar. 15, 1977, as amended at 48 Nutrient Content Claims FR 10811, Mar. 15, 1983; 49 FR 24119, June 12, 101.54 Nutrient content claims for ‘‘good 1984; 81 FR 59131, Aug. 29, 2016] source,’’ ‘‘high,’’ ‘‘more,’’ and ‘‘high potency.’’ PART 101—FOOD LABELING 101.56 Nutrient content claims for ‘‘light’’ or ‘‘lite.’’ Subpart A—General Provisions 101.60 Nutrient content claims for the calorie content of foods. Sec. 101.61 Nutrient content claims for the so- 101.1 Principal display panel of package dium content of foods. form food. 101.62 Nutrient content claims for fat, fatty 101.2 Information panel of package form acid, and cholesterol content of foods. food. 101.65 Implied nutrient content claims and 101.3 Identity labeling of food in packaged related label statements. form. 101.67 Use of nutrient content claims for 101.4 Food; designation of ingredients. butter. 101.5 Food; name and place of business of 101.69 Petitions for nutrient content claims. manufacturer, packer, or distributor. 101.7 Declaration of net quantity of con- Subpart E—Specific Requirements for tents. Health Claims 101.8 Vending machines. 101.9 Nutrition labeling of food. 101.70 Petitions for health claims. 101.10 Nutrition labeling of restaurant foods 101.71 Health claims: claims not authorized. whose labels or labeling bear nutrient 101.72 Health claims: calcium, vitamin D, content claims or health claims. and osteoporosis. 101.11 Nutrition labeling of standard menu 101.73 Health claims: dietary lipids and can- items in covered establishments. cer. 101.12 Reference amounts customarily con- 101.74 Health claims: sodium and hyper- sumed per eating occasion. tension. 101.13 Nutrient content claims—general 101.75 Health claims: dietary saturated fat principles. and cholesterol and risk of coronary 101.14 Health claims: general requirements. heart disease. 101.15 Food; prominence of required state- 101.76 Health claims: fiber-containing grain ments. products, fruits, and vegetables and can- 101.17 Food labeling warning, notice, and cer. safe handling statements. 101.77 Health claims: fruits, vegetables, and 101.18 Misbranding of food. grain products that contain fiber, particularly soluble fiber, and risk of coro- Subpart B—Specific Food Labeling nary heart disease. Requirements 101.78 Health claims: fruits and vegetables and cancer. 101.22 Foods; labeling of spices, flavorings, 101.79 Health claims: Folate and neural tube colorings and chemical preservatives. defects.

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101.80 Health claims: dietary noncariogenic modate all the mandatory label infor- carbohydrate sweeteners and dental car- mation required to be placed thereon ies. by this part with clarity and conspicu- 101.81 Health claims: Soluble fiber from cer- ousness and without obscuring design, tain foods and risk of coronary heart disease (CHD). vignettes, or crowding. Where packages 101.82 Health claims: Soy protein and risk bear alternate principal display panels, of coronary heart disease (CHD). information required to be placed on 101.83 Health claims: plant sterol/stanol the principal display panel shall be du- esters and risk of coronary heart disease plicated on each principal display (CHD). panel. For the purpose of obtaining uniform type size in declaring the Subpart F—Specific Requirements for De- quantity of contents for all packages of scriptive Claims That Are Neither Nutri- substantially the same size, the term ent Content Claims nor Health Claims area of the principal display panel means 101.91 Gluten-free labeling of food. the area of the side or surface that 101.93 Certain types of statements for die- bears the principal display panel, tary supplements. which area shall be: 101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’ ‘‘fresh fro- (a) In the case of a rectangular pack- zen,’’ ‘‘frozen fresh.’’ age where one entire side properly can Subpart G—Exemptions From Food be considered to be the principal dis- Labeling Requirements play panel side, the product of the height times the width of that side; 101.100 Food; exemptions from labeling. (b) In the case of a cylindrical or 101.108 Temporary exemptions for purposes nearly cylindrical container, 40 percent of conducting authorized food labeling of the product of the height of the con- experiments. tainer times the circumference; APPENDIX A TO PART 101—MONIER-WILLIAMS (c) In the case of any otherwise PROCEDURE (WITH MODIFICATIONS) FOR shaped container, 40 percent of the SULFITES IN FOOD, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD total surface of the container: Provided, AND DRUG ADMINISTRATION (NOVEMBER however, That where such container 1985) presents an obvious ‘‘principal display APPENDIX B TO PART 101—GRAPHIC ENHANCE- panel’’ such as the top of a triangular MENTS USED BY THE FDA or circular package of cheese, the area APPENDIX C TO PART 101—NUTRITION FACTS shall consist of the entire top surface. FOR RAW FRUITS AND VEGETABLES In determining the area of the prin- APPENDIX D TO PART 101—NUTRITION FACTS cipal display panel, exclude tops, bot- FOR COOKED FISH toms, flanges at tops and bottoms of AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 cans, and shoulders and necks of bot- U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, tles or jars. In the case of cylindrical 264, 271. or nearly cylindrical containers, infor- SOURCE: 42 FR 14308, Mar. 15, 1977, unless mation required by this part to appear otherwise noted. on the principal display panel shall ap- EDITORIAL NOTE: Nomenclature changes to pear within that 40 percent of the cir- part 101 appear at 63 FR 14035, Mar. 24, 1998, cumference which is most likely to be 66 FR 17358, Mar. 30, 2001, and 66 FR 56035, displayed, presented, shown, or exam- Nov. 6, 2001; 81 FR 49895, July 29, 2016. ined under customary conditions of display for retail sale. Subpart A—General Provisions § 101.2 Information panel of package § 101.1 Principal display panel of pack- form food. age form food. (a) The term information panel as it The term principal display panel as it applies to packaged food means that applies to food in package form and as part of the label immediately contig- used in this part, means the part of a uous and to the right of the principal label that is most likely to be dis- display panel as observed by an indi- played, presented, shown, or examined vidual facing the principal display under customary conditions of display panel with the following exceptions: for retail sale. The principal display (1) If the part of the label imme- panel shall be large enough to accom- diately contiguous and to the right of

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the principal display panel is too small product shall not be exempt from any to accommodate the necessary infor- requirement of this section other than mation or is otherwise unusable label the exemptions created by § 1.24(a)(5) space, e.g., folded flaps or can ends, the (ii) and (v) of this chapter and the label panel immediately contiguous and to shall bear all required information in the right of this part of the label may the specified minimum type size, ex- be used. cept the label will not be required to (2) If the package has one or more al- bear the information required by § 101.5 ternate principal display panels, the in- if this information appears on the bot- formation panel is immediately contig- tle closure or on the lid of the can in a uous and to the right of any principal type size not less than one-sixteenth display panel. inch in height, or if embossed on the (3) If the top of the container is the lid of the can in a type size not less principal display panel and the pack- than one-eighth inch in height. age has no alternate principal display (B) If the soft drink is packaged in a panel, the information panel is any bottle which does not bear a paper, panel adjacent to the principal display plastic foam jacket or foil label, or is panel. packaged in a reusable bottle bearing a (b) All information required to ap- label lithographed onto the surface of pear on the label of any package of the bottle: food under §§ 101.4, 101.5, 101.8, 101.9, (1) Neither the bottle nor the closure 101.13, 101.17, 101.36, subpart D of part is required to bear nutrition labeling in 101, and part 105 of this chapter shall compliance with § 101.9, except that any appear either on the principal display multiunit retail package in which it is panel or on the information panel, un- contained shall bear nutrition labeling less otherwise specified by regulations if required by § 101.9; and any vending in this chapter. machine in which it is contained shall (c) All information appearing on the bear nutrition labeling if nutrition la- principal display panel or the informa- beling is not present on the bottle or tion panel pursuant to this section closure, if required by § 101.9. shall appear prominently and conspicu- (2) All other information pursuant to ously, but in no case may the letters this section shall appear on the top of and/or numbers be less than one-six- the bottle closure prominently and teenth inch in height unless an exemp- conspicuously in letters and/or num- tion pursuant to paragraph (f) of this bers no less than one thirty-second section is established. The require- inch in height, except that if the infor- ments for conspicuousness and leg- mation required by § 101.5 is placed on ibility shall include the specifications the side of the closure in accordance of §§ 101.7(h)(1) and (2) and 101.15. with § 1.24(a)(5)(ii) of this chapter, such (1)(i) Soft drinks packaged in bottles information shall appear in letters and/ manufactured before October 31, 1975 or numbers no less than one-sixteenth shall be exempt from the requirements inch in height. prescribed by this section to the extent (3) Upon the petition of any inter- that information which is blown, ested person demonstrating that the lithographed, or formed onto the sur- bottle closure is too small to accom- face of the bottle is exempt from the modate this information, the Commis- size and placement requirements of sioner may by regulation establish an this section. alternative method of disseminating (ii) Soft drinks packaged in bottles such information. Information appear- shall be exempt from the size and ing on the closure shall appear in the placement requirements prescribed by following priority: this section if all of the following con- (i) The statement of ingredients. ditions are met: (ii) The name and address of the man- (A) If the soft drink is packaged in a ufacturer, packer, or distributor. bottle bearing a paper, plastic foam (iii) The statement of identity. jacket, or foil label, or is packaged in (2) Individual serving-size packages a nonreusable bottle bearing a label of food served with meals in res- lithographed onto the surface of the taurants, institutions, and on board bottle or is packaged in metal cans, the passenger carriers, and not intended

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for sale at retail, are exempt from on the container body in accordance type-size requirements of this para- with this section. graph, provided: (iii) The statement of ingredients re- (i) The package has a total area of 3 quired by § 101.4 shall not be required square inches or less available to bear on the lid if this information appears labeling; on the container body in accordance (ii) There is insufficient area on the with this section. Further, the state- package available to print all required ment of ingredients is not required on information in a type size of 1⁄16 inch in the container body if this information height; appears on the lid in accordance with (iii) The information required by this section. paragraph (b) of this section appears on (e) All information appearing on the the label in accordance with the provi- information panel pursuant to this sec- sions of this paragraph, except that the tion shall appear in one place without other intervening material. type size is not less than 1⁄32 inch in height. (f) If the label of any package of food (d)(1) Except as provided by is too small to accommodate all of the §§ 101.9(j)(13) and (j)(17) and 101.36(i)(2) information required by §§ 101.4, 101.5, and (i)(5), all information required to 101.8, 101.9, 101.13, 101.17, 101.36, subpart appear on the principal display panel D of part 101, and part 105 of this chap- or on the information panel under this ter, the Commissioner may establish section shall appear on the same panel by regulation an acceptable alternative method of disseminating such informa- unless there is insufficient space. In de- tion to the public, e.g., a type size termining the sufficiency of the avail- smaller than one-sixteenth inch in able space, except as provided by height, or labeling attached to or in- §§ 101.9(j)(17) and 101.36(i)(5), any vi- serted in the package or available at gnettes, designs, and other nonmanda- the point of purchase. A petition re- tory label information shall not be con- questing such a regulation, as an sidered. If there is insufficient space amendment to this paragraph, shall be for all of this information to appear on submitted under part 10 of this chap- a single panel, it may be divided be- ter. tween these two panels, except that the information required under any given [42 FR 14308, Mar. 15, 1977, as amended at 42 section or part shall all appear on the FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13, same panel. A food whose label is re- 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, quired to bear the ingredient state- Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993; ment on the principal display panel 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12, may bear all other information speci- 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, fied in paragraph (b) of this section on Mar. 27, 1998; 81 FR 59131, Aug. 29, 2016] the information panel. (2) Any food, not otherwise exempted § 101.3 Identity labeling of food in in this section, if packaged in a con- packaged form. tainer consisting of a separate lid and (a) The principal display panel of a body, and bearing nutrition labeling food in package form shall bear as one pursuant to § 101.9, and if the lid quali- of its principal features a statement of fies for and is designed to serve as a the identity of the commodity. principal display panel, shall be ex- (b) Such statement of identity shall empt from the placement requirements be in terms of: of this section in the following re- (1) The name now or hereafter speci- spects: fied in or required by any applicable (i) The name and place of business in- Federal law or regulation; or, in the formation required by § 101.5 shall not absence thereof, be required on the body of the con- (2) The common or usual name of the tainer if this information appears on food; or, in the absence thereof, the lid in accordance with this section. (3) An appropriately descriptive (ii) The nutrition information re- term, or when the nature of the food is quired by § 101.9 shall not be required obvious, a fanciful name commonly on the lid if this information appears used by the public for such food.

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(c) Where a food is marketed in var- (3) A food for which a common or ious optional forms (whole, slices, usual name is established by regulation diced, etc.), the particular form shall (e.g., in a standard of identity pursuant be considered to be a necessary part of to section 401 of the act, in a common the statement of identity and shall be or usual name regulation pursuant to declared in letters of a type size bear- part 102 of this chapter, or in a regula- ing a reasonable relation to the size of tion establishing a nutritional quality the letters forming the other compo- guideline pursuant to part 104 of this nents of the statement of identity; ex- chapter), and which complies with all cept that if the optional form is visible of the applicable requirements of such through the container or is depicted by regulation(s), shall not be deemed to be an appropriate vignette, the particular an imitation. form need not be included in the state- (4) Nutritional inferiority includes: ment. This specification does not affect (i) Any reduction in the content of an the required declarations of identity essential nutrient that is present in a under definitions and standards for measurable amount, but does not in- foods promulgated pursuant to section clude a reduction in the caloric or fat 401 of the act. content provided the food is labeled (d) This statement of identity shall pursuant to the provisions of § 101.9, be presented in bold type on the prin- and provided the labeling with respect cipal display panel, shall be in a size to any reduction in caloric content reasonably related to the most promi- complies with the provisions applicable nent printed matter on such panel, and to caloric content in part 105 of this shall be in lines generally parallel to chapter. the base on which the package rests as (ii) For the purpose of this section, a it is designed to be displayed. measurable amount of an essential nu- (e) Under the provisions of section trient in a food shall be considered to be 2 percent or more of the Daily Ref- 403(c) of the Federal Food, Drug, and erence Value (DRV) of protein listed Cosmetic Act, a food shall be deemed under § 101.9(c)(7)(iii) and of potassium to be misbranded if it is an imitation of listed under § 101.9(c)(9) per reference another food unless its label bears, in amount customarily consumed and 2 type of uniform size and prominence, percent or more of the Reference Daily the word ‘‘imitation’’ and, immediately Intake (RDI) of any vitamin or mineral thereafter, the name of the food imi- listed under § 101.9(c)(8)(iv) per ref- tated. erence amount customarily consumed, (1) A food shall be deemed to be an except that selenium, molybdenum, imitation and thus subject to the re- chromium, and chloride need not be quirements of section 403(c) of the act considered. if it is a substitute for and resembles (iii) If the Commissioner concludes another food but is nutritionally infe- that a food is a substitute for and re- rior to that food. sembles another food but is inferior to (2) A food that is a substitute for and the food imitated for reasons other resembles another food shall not be than those set forth in this paragraph, deemed to be an imitation provided it he may propose appropriate revisions meets each of the following require- to this regulation or he may propose a ments: separate regulation governing the par- (i) It is not nutritionally inferior to ticular food. the food for which it substitutes and (f) A label may be required to bear which it resembles. the percentage(s) of a characterizing (ii) Its label bears a common or usual ingredient(s) or information con- name that complies with the provisions cerning the presence or absence of an of § 102.5 of this chapter and that is not ingredient(s) or the need to add an in- false or misleading, or in the absence gredient(s) as part of the common or of an existing common or usual name, usual name of the food pursuant to an appropriately descriptive term that subpart B of part 102 of this chapter. is not false or misleading. The label (g) Dietary supplements shall be may, in addition, bear a fanciful name identified by the term ‘‘dietary supple- which is not false or misleading. ment’’ as a part of the statement of

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identity, except that the word ‘‘die- which has an established common or tary’’ may be deleted and replaced by usual name, conforms to a standard es- the name of the dietary ingredients in tablished pursuant to the Meat Inspec- the product (e.g., calcium supplement) tion or Poultry Products Inspection or an appropriately descriptive term Acts by the U.S. Department of Agri- indicating the type of dietary ingredi- culture, or conforms to a definition and ents that are in the product (e.g., herb- standard of identity established pursu- al supplement with vitamins). ant to section 401 of the Federal Food, [42 FR 14308, Mar. 15, 1977, as amended at 48 Drug, and Cosmetic Act, shall be des- FR 10811, Mar. 15, 1983; 58 FR 2227, Jan. 6, ignated in the statement of ingredients 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, on the label of such food by either of Sept. 23, 1997] the following alternatives: § 101.4 Food; designation of ingredi- (i) By declaring the established com- ents. mon or usual name of the ingredient followed by a parenthetical listing of (a)(1) Ingredients required to be de- all ingredients contained therein in declared on the label or labeling of a scending order of predominance except food, including foods that comply with standards of identity, except those in- that, if the ingredient is a food subject gredients exempted by § 101.100, shall be to a definition and standard of identity listed by common or usual name in de- established in subchapter B of this scending order of predominance by chapter that has specific labeling pro- weight on either the principal display visions for optional ingredients, op- panel or the information panel in ac- tional ingredients may be declared cordance with the provisions of § 101.2, within the parenthetical listing in ac- except that ingredients in dietary sup- cordance with those provisions. plements that are listed in the nutri- (ii) By incorporating into the state- tion label in accordance with § 101.36 ment of ingredients in descending order need not be repeated in the ingredient of predominance in the finished food, list. Paragraph (g) of this section de- the common or usual name of every scribes the ingredient list on dietary component of the ingredient without supplement products. listing the ingredient itself. (2) The descending order of predomi- (3) Skim milk, concentrated skim nance requirements of paragraph (a)(1) milk, reconstituted skim milk, and of this section do not apply to ingredi- nonfat dry milk may be declared as ents present in amounts of 2 percent or ‘‘skim milk’’ or ‘‘nonfat milk’’. less by weight when a listing of these (4) Milk, concentrated milk, reconsti- ingredients is placed at the end of the tuted milk, and dry whole milk may be ingredient statement following an ap- declared as ‘‘milk’’. propriate quantifying statement, e.g., (5) Bacterial cultures may be de- ‘‘Contains l percent or less of lll’’ clared by the word ‘‘cultured’’ followed or ‘‘Less than l percent of lll.’’ The by the name of the substrate, e.g., blank percentage within the quanti- ‘‘made from cultured skim milk or cul- fying statement shall be filled in with tured buttermilk’’. a threshold level of 2 percent, or, if de- (6) Sweetcream buttermilk, con- sired, 1.5 percent, 1.0 percent, or 0.5 centrated sweetcream buttermilk, re- percent, as appropriate. No ingredient constituted sweetcream buttermilk, to which the quantifying phrase applies and dried sweetcream buttermilk may may be present in an amount greater than the stated threshold. be declared as ‘‘buttermilk’’. (b) The name of an ingredient shall (7) Whey, concentrated whey, recon- be a specific name and not a collective stituted whey, and dried whey may be (generic) name, except that: declared as ‘‘whey’’. (1) Spices, flavorings, colorings and (8) Cream, reconstituted cream, dried chemical preservatives shall be de- cream, and plastic cream (sometimes clared according to the provisions of known as concentrated milk fat) may § 101.22. be declared as ‘‘cream’’. (2) An ingredient which itself con- (9) Butteroil and anhydrous butterfat tains two or more ingredients and may be declared as ‘‘butterfat’’.

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(10) Dried whole eggs, frozen whole tonseed, and palm oils)’’, rather than eggs, and liquid whole eggs may be de- preceding the name of each individual clared as ‘‘eggs’’. fat and/or oil; if the blend of fats and/ (11) Dried egg whites, frozen egg or oils is partially hydrogenated, the whites, and liquid egg whites may be term ‘‘partially hydrogenated’’ may be declared as ‘‘egg whites’’. used in the same manner. Fat and/or (12) Dried egg yolks, frozen egg yolks, oil ingredients not present in the prod- and liquid egg yolks may be declared as uct may be listed if they may some- ‘‘egg yolks’’. times be used in the product. Such in- (13) [Reserved] gredients shall be identified by words (14) Each individual fat and/or oil in- indicating that they may not be gredient of a food intended for human present, such as ‘‘or’’, ‘‘and/or’’, ‘‘con- consumption shall be declared by its tains one or more of the following:’’, specific common or usual name (e.g., e.g., ‘‘vegetable oil shortening (con- ‘‘beef fat’’, ‘‘cottonseed oil’’) in its tains one or more of the following: cot- order of predominance in the food ex- tonseed oil, palm oil, soybean oil)’’. No cept that blends of fats and/or oils may fat or oil ingredient shall be listed un- be designated in their order of pre- less actually present if the fats and/or dominance in the foods as ‘‘lll oils constitute the predominant ingre- shortening’’ or ‘‘blend of lll oils’’, dient of the product, as defined in this the blank to be filled in with the word paragraph (b)(14). ‘‘vegetable’’, ‘‘animal’’, ‘‘marine’’, with (15) When all the ingredients of a or without the terms ‘‘fat’’ or ‘‘oils’’, wheat flour are declared in an ingre- or combination of these, whichever is dient statement, the principal ingre- applicable if, immediately following dient of the flour shall be declared by the term, the common or usual name of each individual vegetable, animal, or the name(s) specified in §§ 137.105, marine fat or oil is given in paren- 137.200, 137.220 and 137.225 of this chap- theses, e.g., ‘‘vegetable oil shortening ter, i.e., the first ingredient designated (soybean and cottonseed oil)’’. For in the ingredient list of flour, or products that are blends of fats and/or bromated flour, or enriched flour, or oils and for foods in which fats and/or self-rising flour is ‘‘flour’’, ‘‘white oils constitute the predominant ingre- flour’’, ‘‘wheat flour’’, or ‘‘plain flour’’; dient, i.e., in which the combined the first ingredient designated in the weight of all fat and/or oil ingredients ingredient list of durum flour is equals or exceeds the weight of the ‘‘durum flour’’; the first ingredient des- most predominant ingredient that is ignated in the ingredient list of whole not a fat or oil, the listing of the com- wheat flour, or bromated whole wheat mon or usual names of such fats and/or flour is ‘‘whole wheat flour’’, ‘‘graham oils in parentheses shall be in descend- flour’’, or ‘‘entire wheat flour’’; and the ing order of predominance. In all other first ingredient designated in the ingre- foods in which a blend of fats and/or dient list of whole durum wheat flour oils is used as an ingredient, the listing is ‘‘whole durum wheat flour’’. of the common or usual names in pa- (16) Ingredients that act as leavening rentheses need not be in descending agents in food may be declared in the order of predominance if the manufac- ingredient statement by stating the turer, because of the use of varying specific common or usual name of each mixtures, is unable to adhere to a con- individual leavening agent in paren- stant pattern of fats and/or oils in the theses following the collective name product. If the fat or oil is completely ‘‘leavening’’, e.g., ‘‘leavening (baking hydrogenated, the name shall include soda, monocalcium phosphate, and cal- the term hydrogenated, or if partially cium carbonate)’’. The listing of the hydrogenated, the name shall include common or usual name of each indi- the term partially hydrogenated. If each vidual leavening agent in parentheses fat and/or oil in a blend or the blend is shall be in descending order of pre- completely hydrogenated, the term dominance: Except, That if the manu- ‘‘hydrogenated’’ may precede the facturer is unable to adhere to a con- term(s) describing the blend, e.g., ‘‘hy- stant pattern of leavening agents in drogenated vegetable oil (soybean, cot- the product, the listing of individual

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leavening agents need not be in de- (19) Ingredients that act as firming scending order of predominance. Leav- agents in food (e.g., salts of calcium ening agents not present in the product and other safe and suitable salts in may be listed if they are sometimes canned vegetables) may be declared in used in the product. Such ingredients the ingredient statement, in order of shall be identified by words indicating predominance appropriate for the total that they may not be present, such as of all firming agents in the food, by ‘‘or’’, ‘‘and/or’’, ‘‘contains one or more stating the specific common or usual of the following:’’. name of each individual firming agent (17) Ingredients that act as yeast nu- in descending order of predominance in trients in foods may be declared in the parentheses following the collective ingredient statement by stating the name ‘‘firming agents’’. If the manu- specific common or usual name of each facturer is unable to adhere to a con- individual yeast nutrient in paren- stant pattern of firming agents in the theses following the collective name food, the listing of the individual firm- ‘‘yeast nutrients’’, e.g., ‘‘yeast nutri- ing agents need not be in descending ents (calcium sulfate and ammonium order of predominance. Firming agents phosphate)’’. The listing of the com- not present in the product may be list- mon or usual name of each individual ed if they are sometimes used in the yeast nutrient in parentheses shall be product. Such ingredients shall be in descending order of predominance: identified by words indicating that Except, That if the manufacturer is un- they may not be present, such as ‘‘or’’, able to adhere to a constant pattern of ‘‘and/or’’, ‘‘contains one or more of the yeast nutrients in the product, the list- following:’’. ing of the common or usual names of (20) For purposes of ingredient label- individual yeast nutrients need not be ing, the term sugar shall refer to su- in descending order of predominance. crose, which is obtained from sugar Yeast nutrients not present in the cane or sugar beets in accordance with product may be listed if they are some- the provisions of § 184.1854 of this chap- times used in the product. Such ingre- ter. dients shall be identified by words indi- (21) [Reserved] cating that they may not be present, (22) Wax and resin ingredients on such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains fresh produce when such produce is one or more of the following:’’. held for retail sale, or when held for (18) Ingredients that act as dough other than retail sale by packers or re- conditioners may be declared in the in- packers shall be declared collectively gredient statement by stating the spe- by the phrase ‘‘coated with food-grade cific common or usual name of each in- animal-based wax, to maintain dividual dough conditioner in paren- freshness’’ or the phrase ‘‘coated with theses following the collective name food-grade vegetable-, petroleum-, ‘‘dough conditioner’’, e.g., ‘‘dough con- beeswax-, and/or shellac-based wax or ditioners (L-cysteine, ammonium sul- resin, to maintain freshness’’ as appro- fate)’’. The listing of the common or priate. The terms ‘‘food-grade’’ and ‘‘to usual name of each dough conditioner maintain freshness’’ are optional. The in parentheses shall be in descending term lac-resin may be substituted for order of predominance: Except, That if the term shellac. the manufacturer is unable to adhere (23) When processed seafood products to a constant pattern of dough condi- contain fish protein ingredients con- tioners in the product, the listing of sisting primarily of the myofibrillar the common or usual names of indi- protein fraction from one or more fish vidual dough conditioners need not be species and the manufacturer is unable in descending order of predominance. to adhere to a constant pattern of fish Dough conditioners not present in the species in the fish protein ingredient, product may be listed if they are some- because of seasonal or other limita- times used in the product. Such ingre- tions of species availability, the com- dients shall be identified by words indi- mon or usual name of each individual cating that they may not be present, fish species need not be listed in de- such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains scending order of predominance. Fish one or more of the following:’’. species not present in the fish protein

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ingredient may be listed if they are food, including foods that comply with sometimes used in the product. Such standards of identity, shall be listed ingredients must be identified by words prominently and conspicuously by indicating that they may not be common or usual name in the manner present, such as ‘‘or’’, ‘‘and/or’’, or prescribed by paragraph (b) of this sec- ‘‘contains one or more of the fol- tion. lowing:’’ Fish protein ingredients may (g) When present, the ingredient list be declared in the ingredient statement on dietary supplement products shall by stating the specific common or be located immediately below the nu- usual name of each fish species that trition label, or, if there is insufficient may be present in parentheses fol- space below the nutrition label, imme- lowing the collective name ‘‘fish pro- diately contiguous and to the right of tein’’, e.g., ‘‘fish protein (contains one the nutrition label and shall be pre- or more of the following: Pollock, cod, ceded by the word ‘‘Ingredients,’’ un- and/or pacific whiting)’’. less some ingredients (i.e., sources) are (c) When water is added to reconsti- identified within the nutrition label in tute, completely or partially, an ingre- accordance with § 101.36(d), in which dient permitted by paragraph (b) of case the ingredients listed outside the this section to be declared by a class nutrition label shall be in a list pre- name, the position of the ingredient ceded by the words ‘‘Other ingredi- class name in the ingredient statement ents.’’ Ingredients in dietary supple- shall be determined by the weight of ments that are not dietary ingredients the unreconstituted ingredient plus the or that do not contain dietary ingredi- weight of the quantity of water added ents, such as excipients, fillers, artifi- to reconstitute that ingredient, up to cial colors, artificial sweeteners, fla- the amount of water needed to recon- vors, or binders, shall be included in stitute the ingredient to single the ingredient list. strength. Any water added in excess of (h) The common or usual name of in- the amount of water needed to recon- gredients of dietary supplements that stitute the ingredient to single are botanicals (including fungi and strength shall be declared as ‘‘water’’ algae) shall be consistent with the in the ingredient statement. names standardized in Herbs of Com- (d) When foods characterized on the merce, 1992 edition, which is incor- label as ‘‘nondairy’’ contain a casein- porated by reference in accordance ate ingredient, the caseinate ingre- with 5 U.S.C. 552(a) and 1 CFR part 51. dient shall be followed by a parenthet- Copies may be obtained from the Amer- ical statement identifying its source. ican Herbal Products Association, 8484 For example, if the manufacturer uses Georgia Ave., suite 370, Silver Spring, the term ‘‘nondairy’’ on a creamer that MD 20910, 301-588-1171, FAX 301-588-1174, contains sodium caseinate, it shall in- e-mail: [email protected], or may be exclude a parenthetical term such as ‘‘a amined at the Food and Drug Adminis- milk derivative’’ after the listing of so- tration’s Main Library, 10903 New dium caseinate in the ingredient list. Hampshire Ave., Bldg. 2, Third Floor, (e) If the percentage of an ingredient Silver Spring, MD 20993, 301–796–2039, or is included in the statement of ingredi- at the National Archives and Records ents, it shall be shown in parentheses Administration (NARA). For informa- following the name of the ingredient tion on the availability of this mate- and expressed in terms of percent by rial at NARA, call 202–741–6030, or go weight. Percentage declarations shall to: http://www.archives.gov/ be expressed to the nearest 1 percent, federallregister/ except that where ingredients are codeloflfederallregulations/ present at levels of 2 percent or less, ibrllocations.html. The listing of these they may be grouped together and ex- names on the label shall be followed by pressed in accordance with the quanti- statements of: fying guidance set forth in paragraph (1) The part of the plant (e.g., root, (a)(2) of this section. leaves) from which the dietary ingre- (f) Except as provided in § 101.100, in- dient is derived (e.g., ‘‘Garlic bulb’’ or gredients that must be declared on la- ‘‘Garlic (bulb)’’), except that this des- beling because there is no label for the ignation is not required for algae. The

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name of the part of the plant shall be § 101.5 Food; name and place of busi- expressed in English (e.g., ‘‘flower’’ ness of manufacturer, packer, or rather than ‘‘flos’’); distributor. (2) The Latin binomial name of the (a) The label of a food in packaged plant, in parentheses, except that this form shall specify conspicuously the name is not required when it is avail- name and place of business of the man- able in the reference entitled: Herbs of ufacturer, packer, or distributor. Commerce for the common or usual (b) The requirement for declaration name listed on the label, and, when re- of the name of the manufacturer, pack- quired, the Latin binomial name may er, or distributor shall be deemed to be be listed before the part of the plant. satisfied, in the case of a corporation, Any name in Latin form shall be in ac- only by the actual corporate name, cordance with internationally accepted which may be preceded or followed by rules on nomenclature, such as those the name of the particular division of found in the International Code of Bo- the corporation. In the case of an indi- tanical Nomenclature and shall include vidual, partnership, or association, the the designation of the author or au- name under which the business is con- thors who published the Latin name, ducted shall be used. when a positive identification cannot (c) Where the food is not manufac- be made in its absence. The Inter- tured by the person whose name ap- national Code of Botanical Nomenclature pears on the label, the name shall be (Tokyo Code), 1994 edition, a publica- qualified by a phrase that reveals the tion of the International Association connection such person has with such for Plant Taxonomy, is incorporated by food; such as ‘‘Manufactured for reference in accordance with 5 U.S.C. lll’’, ‘‘Distributed by lll’’, or any 552(a) and 1 CFR part 51. Copies of the other wording that expresses the facts. International Code of Botanical Nomen- (d) The statement of the place of clature may be obtained from Koeltz business shall include the street ad- Scientific Books, D–61453 Konigstein, dress, city, State, and ZIP code; how- Germany, and University Bookstore, ever, the street address may be omitted Southern Illinois University, if it is shown in a current city direc- Carbondale, IL 62901–4422, 618–536–3321, tory or telephone directory. The re- FAX 618–453–5207, or may be examined quirement for inclusion of the ZIP code at the Food and Drug Administration’s shall apply only to consumer com- Main Library, 10903 New Hampshire modity labels developed or revised Ave., Bldg. 2, Third Floor, Silver after the effective date of this section. Spring, MD 20993, 301–796–2039, or at the In the case of nonconsumer packages, National Archives and Records Admin- the ZIP code shall appear either on the istration (NARA). For information on label or the labeling (including in- the availability of this material at voice). NARA, call 202–741–6030, or go to: http:// (e) If a person manufactures, packs, www.archives.gov/federallregister/ or distributes a food at a place other codeloflfederallregulations/ than his principal place of business, the ibrllocations.html. (3) On labels of single-ingredient die- label may state the principal place of tary supplements that do not include business in lieu of the actual place an ingredient list, the identification of where such food was manufactured or the Latin binomial name, when needed, packed or is to be distributed, unless and the part of the plant may be such statement would be misleading. prominently placed on the principal § 101.7 Declaration of net quantity of display panel or information panel, or contents. included in the nutrition label. (a) The principal display panel of a [42 FR 14308, Mar. 15, 1977, as amended at 43 food in package form shall bear a dec- FR 12858, Mar. 28, 1978; 43 FR 24519, June 6, laration of the net quantity of con- 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, tents. This shall be expressed in the Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997; terms of weight, measure, numerical 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. count, or a combination of numerical 30, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, count and weight or measure. The Mar. 31, 2003; 81 FR 5590, Feb. 3, 2016] statement shall be in terms of fluid

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measure if the food is liquid, or in sumer usage and trade custom of em- terms of weight if the food is solid, ploying different common fractions in semisolid, or viscous, or a mixture of the net quantity declaration of a par- solid and liquid; except that such state- ticular commodity, they may be em- ment may be in terms of dry measure ployed. A common fraction shall be re- if the food is a fresh fruit, fresh vege- duced to its lowest terms; a decimal table, or other dry commodity that is fraction shall not be carried out to customarily sold by dry measure. If more than two places. A statement there is a firmly established general that includes small fractions of an consumer usage and trade custom of ounce shall be deemed to permit small- declaring the contents of a liquid by er variations than one which does not weight, or a solid, semisolid, or viscous include such fractions. product by fluid measure, it may be (e) The declaration shall be located used. Whenever the Commissioner de- on the principal display panel of the termines that an existing practice of label, and with respect to packages declaring net quantity of contents by bearing alternate principal panels it weight, measure, numerical count, or a shall be duplicated on each principal combination in the case of a specific display panel. packaged food does not facilitate value (f) The declaration shall appear as a comparisons by consumers and offers distinct item on the principal display opportunity for consumer confusion, he panel, shall be separated (by at least a will by regulation designate the appro- space equal to the height of the let- priate term or terms to be used for tering used in the declaration) from such commodity. other printed label information appear- (b)(1) Statements of weight shall be ing above or below the declaration and in terms of avoirdupois pound and (by at least a space equal to twice the ounce. width of the letter ‘‘N’’ of the style of (2) Statements of fluid measure shall type used in the quantity of contents be in terms of the U.S. gallon of 231 statement) from other printed label in- cubic inches and quart, pint, and fluid formation appearing to the left or right ounce subdivisions thereof, and shall: of the declaration. It shall not include (i) In the case of frozen food that is any term qualifying a unit of weight, sold and consumed in a frozen state, measure, or count (such as ‘‘jumbo express the volume at the frozen tem- quart’’ and ‘‘full gallon’’) that tends to perature. exaggerate the amount of the food in (ii) In the case of refrigerated food the container. It shall be placed on the that is sold in the refrigerated state, principal display panel within the bot- express the volume at 40 °F (4 °C). tom 30 percent of the area of the label (iii) In the case of other foods, ex- panel in lines generally parallel to the press the volume at 68 °F (20 °C). base on which the package rests as it is (3) Statements of dry measure shall designed to be displayed: Provided, be in terms of the U.S. bushel of That on packages having a principal 2,150.42 cubic inches and peck, dry display panel of 5 square inches or less, quart, and dry pint subdivisions there- the requirement for placement within of. the bottom 30 percent of the area of the (c) When the declaration of quantity label panel shall not apply when the of contents by numerical count does declaration of net quantity of contents not give adequate information as to meets the other requirements of this the quantity of food in the package, it part. shall be combined with such statement (g) The declaration shall accurately of weight, measure, or size of the indi- reveal the quantity of food in the pack- vidual units of the foods as will provide age exclusive of wrappers and other such information. material packed therewith: Provided, (d) The declaration may contain That in the case of foods packed in con- common or decimal fractions. A com- tainers designed to deliver the food mon fraction shall be in terms of under pressure, the declaration shall halves, quarters, eighths, sixteenths, or state the net quantity of the contents thirty-seconds; except that if there ex- that will be expelled when the instruc- ists a firmly established general con- tions for use as shown on the container

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are followed. The propellant is included specified in paragraphs (h)(1) through in the net quantity declaration. (4) of this section shall be increased by (h) The declaration shall appear in one-sixteenth of an inch. conspicuous and easily legible boldface (j) On packages containing less than print or type in distinct contrast (by 4 pounds or 1 gallon and labeled in typography, layout, color, embossing, terms of weight or fluid measure: or molding) to other matter on the (1) The declaration shall be expressed package; except that a declaration of both in ounces, with identification by net quantity blown, embossed, or mold- weight or by liquid measure and, if ap- ed on a glass or plastic surface is per- plicable (1 pound or 1 pint or more) fol- missible when all label information is lowed in parentheses by a declaration so formed on the surface. Requirements in pounds for weight units, with any re- of conspicuousness and legibility shall mainder in terms of ounces or common include the specifications that: or decimal fractions of the pound (see (1) The ratio of height to width (of examples set forth in paragraphs (m) the letter) shall not exceed a differen- (1) and (2) of this section), or in the tial of 3 units to 1 unit (no more than case of liquid measure, in the largest 3 times as high as it is wide). whole units (quarts, quarts and pints, (2) Letter heights pertain to upper or pints, as appropriate) with any re- case or capital letters. When upper and mainder in terms of fluid ounces or lower case or all lower case letters are common or decimal fractions of the used, it is the lower case letter ‘‘o’’ or pint or quart (see examples in para- its equivalent that shall meet the min- graphs (m) (3) and (4) of this section). imum standards. (2) If the net quantity of contents (3) When fractions are used, each declaration appears on a random pack- component numeral shall meet one- age, that is a package which is one of half the minimum height standards. a lot, shipment, or delivery of packages (i) The declaration shall be in letters of the same consumer commodity with and numerals in a type size established varying weights and with no fixed in relationship to the area of the prin- weight pattern, it may, when the net cipal display panel of the package and weight exceeds 1 pound, be expressed in shall be uniform for all packages of terms of pounds and decimal fractions substantially the same size by com- of the pound carried out to not more plying with the following type speci- than two decimal places. When the net fications: weight does not exceed 1 pound, the (1) Not less than one-sixteenth inch declaration on the random package in height on packages the principal dis- may be in decimal fractions of the play panel of which has an area of 5 pound in lieu of ounces (see example in square inches or less. paragraph (m)(5) of this section). (2) Not less than one-eighth inch in (3) The declaration may appear in height on packages the principal dis- more than one line. The term ‘‘net play panel of which has an area of more weight’’ shall be used when stating the than 5 but not more than 25 square net quantity of contents in terms of inches. weight. Use of the terms ‘‘net’’ or ‘‘net (3) Not less than three-sixteenths contents’’ in terms of fluid measure or inch in height on packages the prin- numerical count is optional. It is suffi- cipal display panel of which has an cient to distinguish avoirdupois ounce area of more than 25 but not more than from fluid ounce through association of 100 square inches. terms; for example, ‘‘Net wt. 6 oz’’ or (4) Not less than one-fourth inch in ‘‘6 oz Net wt.’’ and ‘‘6 fl oz’’ or ‘‘Net height on packages the principal dis- contents 6 fl oz’’. play panel of which has an area of more (k) On packages containing 4 pounds than 100 square inches, except not less or 1 gallon or more and labeled in 1 than ⁄2 inch in height if the area is terms of weight or fluid measure, the more than 400 square inches. declaration shall be expressed in Where the declaration is blown, em- pounds for weight units with any re- bossed, or molded on a glass or plastic mainder in terms of ounces or common surface rather than by printing, typ- or decimal fraction of the pound, or in ing, or coloring, the lettering sizes the case of fluid measure, it shall be

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expressed in the largest whole unit weight plus numerical count, net con- (gallons followed by common or dec- tents plus dilution directions of a con- imal fraction of a gallon or by the next centrate, etc.) are not regarded as sup- smaller whole unit or units (quarts, or plemental net quantity statements and quarts and pints)) with any remainder may be located on the principal display in terms of fluid ounces or common or panel. decimal fractions of the pint or quart (p) A separate statement of the net (see paragraph (m)(6) of this section). quantity of contents in terms of the (l) [Reserved] metric system is not regarded as a sup- (m) Examples: plemental statement and an accurate (1) A declaration of 11⁄2 pounds weight statement of the net quantity of con- shall be expressed as ‘‘Net Wt. 24 oz (1 tents in terms of the metric system of lb 8 oz),’’ ‘‘Net Wt. 24 oz (11⁄2 lb),’’ or weight or measure may also appear on ‘‘Net Wt. 24 oz (1.5 lb)’’. the principal display panel or on other (2) A declaration of three-fourths panels. pound avoirdupois weight shall be ex- (q) The declaration of net quantity of pressed as ‘‘Net Wt. 12 oz’’. contents shall express an accurate (3) A declaration of 1 quart liquid statement of the quantity of contents measure shall be expressed as ‘‘Net 32 fl of the package. Reasonable variations oz (1 qt)’’. caused by loss or gain of moisture dur- (4) A declaration of 13⁄4 quarts liquid ing the course of good distribution measure shall be expressed as ‘‘Net practice or by unavoidable deviations contents 56 fluid ounces (1 quart 11⁄2 in good manufacturing practice will be pints)’’ or as ‘‘Net 56 fluid oz (1 qt 1 pt recognized. Variations from stated 8 oz)’’, but not in terms of quart and quantity of contents shall not be un- ounce such as ‘‘Net 56 fluid oz (1 quart reasonably large. 24 ounces)’’. (r) The declaration of net quantity of (5) On a random package, declaration contents on pickles and pickle prod- of three-fourths pound avoirdupois may ucts, including relishes but excluding be expressed as ‘‘Net Wt. .75 lb’’. one or two whole pickles in clear plas- 1 (6) A declaration of 2 ⁄2 gallons liquid tic bags which may be declared by measure shall be expressed as ‘‘Net 1 count, shall be expressed in terms of contents 2 ⁄2 gallons,’’ ‘‘Net contents 2.5 the U.S. gallon of 231 cubic inches and gallons,’’ or ‘‘Net contents 2 gallons 2 quart, pint, and fluid ounce subdivi- quarts’’ and not as ‘‘2 gallons 4 pints’’. sions thereof. (n) For quantities, the following ab- (s) On a multiunit retail package, a breviations and none other may be em- statement of the quantity of contents ployed (periods and plural forms are shall appear on the outside of the pack- optional): age and shall include the number of in- weight wt pint pt dividual units, the quantity of each in- ounce oz quart qt dividual unit, and, in parentheses, the pound lb fluid fl total quantity of contents of the multi- gallon gal unit package in terms of avoirdupois or (o) Nothing in this section shall pro- fluid ounces, except that such declara- hibit supplemental statements at location of total quantity need not be fol- tions other than the principal display lowed by an additional parenthetical panel(s) describing in nondeceptive declaration in terms of the largest terms the net quantity of contents; whole units and subdivisions thereof, Provided, that such supplemental state- as required by paragraph (j)(1) of this ments of net quantity of contents shall section. A multiunit retail package not include any term qualifying a unit may thus be properly labeled: ‘‘6–16 oz of weight, measure, or count that tends bottles—(96 fl oz)’’ or ‘‘3–16 oz cans— to exaggerate the amount of the food (net wt. 48 oz)’’. For the purposes of contained in the package; for example, this section, ‘‘multiunit retail pack- ‘‘jumbo quart’’ and ‘‘full gallon’’. Dual age’’ means a package containing two or combination declarations of net or more individually packaged units of quantity of contents as provided for in the identical commodity and in the paragraphs (a), (c), and (j) of this sec- same quantity, intended to be sold as tion (for example, a combination of net part of the multiunit retail package

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but capable of being individually sold (2) The product shall be labeled on in full compliance with all require- the outside of its shipping container ments of the regulations in this part. with the statement(s): Open multiunit retail packages that do (i) When the variation concerns net not obscure the number of units or pre- weight and/or drained weight or vol- vent examination of the labeling on ume, ‘‘Product Mislabeled. Actual net each of the individual units are not weight (drained weight or volume subject to this paragraph if the label- where appropriate) may be as low as ing of each individual unit complies l% below labeled quantity. This Prod- with the requirements of paragraphs (f) uct Not for Retail Distribution’’, the blank to be filled in with the maximum and (i) of this section. The provisions percentage variance between the la- of this section do not apply to that beled and actual weight or volume of butter or margarine covered by the ex- contents of the individual packages in emptions in § 1.24(a) (10) and (11) of this the shipping container, and chapter. (ii) When the variation is in regard to (t) Where the declaration of net a fill of container standard, ‘‘Product quantity of contents is in terms of net Mislabeled. Actual fill may be as low weight and/or drained weight or vol- as l% below standard of fill. This ume and does not accurately reflect Product Not for Retail Distribution’’. the actual quantity of the contents or (3) The statements required by para- the product falls below the applicable graphs (t)(2) (i) and (ii) of this section, standard of fill of container because of which may be consolidated where ap- equipment malfunction or otherwise propriate, shall appear prominently unintentional product variation, and and conspicuously as compared to the label conforms in all other respects other printed matter on the shipping to the requirements of this chapter (ex- container and in boldface print or type cept the requirement that food falling on a clear, contrasting background in below the applicable standard of fill of order to render them likely to be read container shall bear the general state- and understood by the purchaser under ment of substandard fill specified in ordinary conditions of purchase. § 130.14(b) of this chapter), the mis- [42 FR 14308, Mar. 15, 1977, as amended at 42 labeled food product, including any FR 15673, Mar. 22, 1977. Redesignated at 81 FR food product that fails to bear the gen- 59131, Aug. 29, 2016] eral statement of substandard fill specified in § 130.14(b) of this chapter, may § 101.8 Vending machines. be sold by the manufacturer or proc- (a) Definitions. The definitions of essor directly to institutions operated terms in section 201 of the Federal by Federal, State or local governments Food, Drug, and Cosmetic Act apply to (schools, prisons, hospitals, etc.): Pro- such terms when used in this section. vided, That: In addition, for the purposes of this (1) The purchaser shall sign a state- section: Authorized official of a vending ma- ment at the time of sale stating that chine operator means an owner, oper- he is aware that the product is mis- ator, agent in charge, or any other per- labeled to include acknowledgment of son authorized by a vending machine the nature and extent of the operator who is not otherwise subject mislabeling, (e.g., ‘‘Actual net weight to section 403(q)(5)(H)(viii) of the Fed- may be as low as l% below labeled eral Food, Drug, and Cosmetic Act (21 quantity’’) and that any subsequent U.S.C. 343(q)(5)(H)(viii)), to register the distribution by him of said product ex- vending machine operator with the cept for his own institutional use is un- Food and Drug Administration lawful. This statement shall be kept on (‘‘FDA’’) for purposes of paragraph (d) file at the principal place of business of of this section. the manufacturer or processor for 2 Vending machine means a self-service years subsequent to the date of ship- machine that, upon insertion of a coin, ment of the product and shall be avail- paper currency, token, card, or key, or able to the Food and Drug Administra- by optional manual operation, dis- tion upon request. penses servings of food in bulk or in

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packages, or prepared by the machine, The visible nutrition information must without the necessity of replenishing be clear and conspicuous and able to be the machine between each vending op- easily read on the article of food while eration. in the vending machine, in a type size Vending machine operator means a at least 50 percent of the size of the person(s) or entity that controls or di- largest printed matter on the label and rects the function of the vending ma- with sufficient color and contrasting chine, including deciding which arti- background to other print on the label cles of food are sold from the machine to permit the perspective purchaser to or the placement of the articles of food clearly distinguish the information. within the vending machine, and is (c) Requirements for calorie labeling for compensated for the control or direc- certain food sold from vending machines— tion of the function of the vending ma- (1) Applicability; covered vending machine. chine food. For the purposes of this sec- (b) Articles of food not covered. Arti- tion, the term ‘‘covered vending ma- cles of food sold from a vending machine food’’ means an article of food chine are not covered vending machine that is: food if: (i) Sold from a vending machine that (1) The prospective purchaser can does not permit the prospective pur- view: chaser to examine the Nutrition Facts (i) The calories, serving size, and label prior to purchase as provided in servings per container listed in the Nu- paragraph (b)(1) of this section or oth- trition Facts label on the vending ma- erwise provide visible nutrition infor- chine food without any obstruction. mation at the point of purchase as pro- The Nutrition Facts label must be in vided in paragraph (b)(2) of this sec- the format required in § 101.9(c) and (d). tion; and The Nutrition Facts label must be in a (ii) Sold from a vending machine size that permits the prospective pur- that: chaser to be able to easily read the nutrition information contained in the (A) Is operated by a person engaged Nutrition Facts label on the article of in the business of owning or operating food in the vending machine. Smaller 20 or more vending machines; or formats allowed for Nutrition Facts for (B) Is operated by a vending machine certain food labeling under FDA regu- operator that has voluntarily elected lation at § 101.9 are not considered to be to be subject to the requirements of a size that a prospective purchaser is this section by registering with FDA able to easily read; or under paragraph (d) of this section. (ii) The calories, serving size, and (2) Calorie declaration. (i) The number servings per container listed in a repro- of calories for a covered vending ma- duction of the Nutrition Facts label on chine food must be declared in the fol- the vending machine food, provided lowing manner: that the reproduction is a reproduction (A) To the nearest 5-calorie incre- of an actual Nutrition Facts label that ment up to and including 50 calories complies with § 101.9 for a vending ma- and 10-calorie increment above 50 cal- chine food, is presented in a size that ories, except that amounts less than 5 permits the prospective purchaser to be calories may be expressed as zero. able to easily read the nutrition infor- (B) The term ‘‘Calories’’ or ‘‘Cal’’ mation, and the calories, serving size, must appear adjacent to the caloric and servings per container are dis- content value for each food in the played by the vending machine before vending machine. the prospective purchaser makes his or (C) The calorie declaration for a her purchase; or packaged food must include the total (2) The prospective purchaser can calories present in the packaged food, otherwise view visible nutrition infor- regardless of whether the packaged mation, including, at a minimum the food contains a single serving or mul- total number of calories for the article tiple servings. The vending machine of food as sold at the point of purchase. operator may voluntarily disclose cal- This visible nutrition information ories per serving in addition to the must appear on the food label itself. total calories for the food.

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(D) If a covered vending machine food tation or name, or in close proximity is one where the prospective purchaser to the selection button. selects among options to produce a (E) For electronic vending machines final vended product (e.g., vended cof- (e.g., machines with digital or elec- fee, hot chocolate or tea with options tronic or liquid crystal display (LCD) for added sugar, sugar substitute, milk, displays), the calorie declaration must and cream), calories must be declared be displayed before the prospective per option or for the final vended prod- purchaser makes his or her purchase. ucts. (F) For vending machines with few (ii) Calorie declarations for covered choices, e.g., popcorn, the calorie dec- vending machine food must be clear laration may appear on the face of the and conspicuous and placed promi- machine so long as the declaration is nently in the following manner: prominent, not crowded by other label- (A) The calorie declarations may be ing on the machine, and the type size is placed on a sign in close proximity to no smaller than the name of the food the article of food or selection button, on the machine (not the label), selec- i.e., in, on, or adjacent to the vending tion number, or price of the food as dis- machine, but not necessarily attached played on the vending machine, which- to the vending machine, so long as the ever is smallest. calorie declaration is visible at the (d) Voluntary provision of calorie label- same time as the food, its name, price, ing for foods sold from vending ma- selection button, or selection number chines—(1) Applicability. A vending ma- is visible. The sign must give calorie chine operator that is not subject to declarations for those articles of food the requirements of section that are sold from that particular 403(q)(5)(H)(viii) of the Federal Food, vending machine. Drug, and Cosmetic Act may, through (B) When the calorie declaration is in its authorized official, voluntarily reg- or on the vending machine, the calorie ister with FDA to be subject to the re- declaration must be in a type size no quirements established in paragraph smaller than the name of the food on (c)(2) of this section. An authorized of- the machine (not the label), selection ficial of a vending machine operator number, or price of the food as dis- that voluntarily registers cannot be played on the vending machine, which- subject to any State or local nutrition ever is smallest, with the same promi- labeling requirements that are not nence, i.e., the same color, or in a color identical to the requirements in at least as conspicuous, as the color of 403(q)(5)(H) of the Federal Food, Drug, the name, if applicable, or price of the and Cosmetic Act. food or selection number, and the same (2) Who may register? A vending ma- contrasting background, or a back- chine operator that is not otherwise ground at least as contrasting as the subject to the requirements of section background used for the item it is in 403(q)(5)(H) of the Federal Food, Drug, closest proximity to, i.e., name, selec- and Cosmetic Act may register with tion number, or price of the food item FDA. as displayed on the machine. (3) What information is required? The (C) When the calorie declaration is vending machine operator must pro- on a sign adjacent to the vending ma- vide FDA with the following informa- chine, the calorie declaration must be tion: in a type size large enough to render it (i) The contact information (includ- likely to be read and understood by the ing name, address, phone number, prospective purchaser under customary email address), for the vending ma- conditions of purchase and use, and in chine operator; a type that is all black or one color on (ii) The address of the location of a white or other neutral background each vending machine owned or oper- that contrasts with the type color. ated by the vending machine operator (D) Where the vending machine only that is being registered; displays a picture or other representa- (iii) Preferred mailing address (if dif- tion or name of the food item, the cal- ferent from the vending machine oper- orie declaration must be in close prox- ator address), for purposes of receiving imity to the picture or other represen- correspondence; and

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(iv) Certification that the informa- ber, and mailing address or email ad- tion submitted is true and accurate, dress. that the person or firm submitting it is (2) The contact information must be authorized to do so, and that each reg- readable and may be placed on the face istered vending machine will be subject of the vending machine, or otherwise to the requirements of this section. must be placed with the calorie dec- (v) Information should be submitted larations as described in paragraph by email by typing complete informa- (c)(2)(ii) of this section (i.e., on the sign tion into the portable document format in, on, or adjacent to the vending ma- (PDF) form, saving it on the reg- chine). istrant’s computer, and sending it by (f) Signatures. Signatures obtained email to under paragraph (d) of this section that [email protected]. If meet the definition of electronic signa- email is not available, the registrant tures in § 11.3(b)(7) of this chapter are can either fill in the PDF form and exempt from the requirements of part print it out (or print out the blank 11 of this chapter. PDF and fill in the information by [79 FR 71291, Dec. 1, 2014] hand or typewriter), and either fax the completed form to 301–436–2804 or mail § 101.9 Nutrition labeling of food. it to FDA, CFSAN Menu and Vending (a) Nutrition information relating to Machine Labeling Registration, White food shall be provided for all products Oak Building 22, rm. 0209, 10903 New intended for human consumption and Hampshire Ave., Silver Spring, MD offered for sale unless an exemption is 20993. provided for the product in paragraph (vi) Authorized officials of a vending (j) of this section. machine operator who elect to be sub- (1) When food is in package form, the ject to the Federal requirements can required nutrition labeling information register by visiting http://www.fda.gov/ shall appear on the label in the format food/ingredientspackaginglabeling/ specified in this section. labelingnutrition/ucm217762.htm. FDA (2) When food is not in package form, has created a form that contains fields the required nutrition labeling infor- requesting the information in para- mation shall be displayed clearly at graph (d) of this section and made the the point of purchase (e.g., on a form available at this Web site. Reg- counter card, sign, tag affixed to the istrants must use this form to ensure product, or some other appropriate de- that complete information is sub- vice). Alternatively, the required infor- mitted. mation may be placed in a booklet, (vii) To keep the establishment’s reg- looseleaf binder, or other appropriate istration active, the authorized official format that is available at the point of of the vending machine operator must purchase. register every other year within 60 (3) Solicitation of requests for nutri- days prior to the expiration of the tion information by a statement ‘‘For vending machine operator’s current nutrition information write to registration with FDA. Registration lllllllllll ’’ on the label or will automatically expire if not rein the labeling or advertising for a newed. food, or providing such information in (e) Vending machine operator contact a direct written reply to a solicited or information. (1) A vending machine op- unsolicited request, does not subject erator that is subject to section the label or the labeling of a food ex- 403(q)(5)(H)(viii) of the Federal Food, empted under paragraph (j) of this sec- Drug, and Cosmetic Act or a vending tion to the requirements of this section machine operator that voluntarily reg- if the reply to the request conforms to isters to be subject to the requirements the requirements of this section. under paragraph (d) of this section (4) If any vitamin or mineral is added must provide its contact information to a food so that a single serving pro- for vending machines selling covered vides 50 percent or more of the Ref- vending machine food. The contact in- erence Daily Intake (RDI) for the age formation must list the vending ma- group for which the product is in- chine operator’s name, telephone num- tended, as specified in paragraph

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(c)(8)(iv) of this section, of any one of (i) For products in discrete units the added vitamins or minerals, unless (e.g., muffins, sliced products, such as such addition is permitted or required sliced bread, or individually packaged in other regulations, e.g., a standard of products within a multiserving pack- identity or nutritional quality guide- age) and for products which consist of line, or is otherwise exempted by the two or more foods packaged and pre- Commissioner, the food shall be consid- sented to be consumed together where ered a food for special dietary use with- the ingredient represented as the main in the meaning of § 105.3(a)(1)(iii) of ingredient is in discrete units (e.g., this chapter. pancakes and syrup), the serving size (b) Except as provided in § 101.9(h)(3), shall be declared as follows: all nutrient and food component quan- (A) If a unit weighs 50 percent or less tities shall be declared in relation to a of the reference amount, the serving serving as defined in this section. size shall be the number of whole units that most closely approximates the ref- (1) The term serving or serving size erence amount for the product cat- means an amount of food customarily egory; consumed per eating occasion by per- (B) If a unit weighs more than 50 persons 4 years of age or older which is ex- cent, but less than 67 percent of the pressed in a common household meas- reference amount, the manufacturer ure that is appropriate to the food. may declare one unit or two units as When the food is specially formulated the serving size; or processed for use by infants or by (C) If a unit weighs 67 percent or toddlers, a serving or serving size more, but less than 200 percent of the means an amount of food customarily reference amount, the serving size consumed per eating occasion by in- shall be one unit; fants up to 12 months of age or by chil- (D) If a unit weighs at least 200 per- dren 1 through 3 years of age, respec- cent and up to and including 300 per- tively. cent of the applicable reference (2) Except as provided in paragraphs amount, the serving size shall be the (b)(3), (b)(4), and (b)(6) of this section amount that approximates the ref- and for products that are intended for erence amount. In addition to pro- weight control and are available only viding a column within the Nutrition through a weight-control or weight- Facts label that lists the quantitative maintenance program, serving size de- amounts and percent Daily Values per clared on a product label shall be deter- serving size, the manufacturer shall mined from the ‘‘Reference Amounts provide a column within the Nutrition Customarily Consumed Per Eating Oc- Facts label that lists the quantitative casion * * * *’’ (reference amounts) amounts and percent Daily Values per that appear in § 101.12(b) using the pro- individual unit. The first column would cedures described below. For products be based on the serving size for the that are both intended for weight con- product and the second column would trol and available only through a be based on the individual unit. The ex- weight-control program, a manufac- emptions in paragraphs (b)(12)(i)(A), turer may determine the serving size (B), and (C) of this section apply to this that is consistent with the meal plan of provision. the program. Such products must bear (E) The serving size for maraschino a statement, ‘‘for sale only through the cherries shall be expressed as 1 cherry lll program’’ (fill in the blank with with the parenthetical metric measure the name of the appropriate weight- equal to the average weight of a me- control program, e.g., Smith’s Weight dium size cherry. Control), on the principal display (F) The serving size for products that panel. However, the reference amounts naturally vary in size (e.g., pickles, in § 101.12(b) shall be used for purposes shellfish, whole fish, and fillet of fish) of evaluating whether weight-control may be the amount in ounces that products that are available only most closely approximates the ref- through a weight-control program erence amount for the product cat- qualify for nutrient content claims or egory. Manufacturers shall adhere to health claims. the requirements in paragraph

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(b)(5)(vi) of this section for expressing products which consist of two or more the serving size in ounces. foods packaged and presented to be (G) For products which consist of two consumed together where the ingre- or more foods packaged and presented dient represented as the main ingre- to be consumed together where the in- dient is a bulk product (e.g., peanut gredient represented as the main ingre- butter and jelly), the serving size shall dient is in discrete units (e.g., pan- be the amount in household measure cakes and syrup), the serving size may that most closely approximates the ref- be the number of discrete units rep- erence amount for the product cat- resented as the main ingredient plus egory and may be the amount of the proportioned minor ingredients used to bulk product represented as the main make the reference amount for the ingredient plus proportioned minor in- combined product determined in gredients used to make the reference § 101.12(f). amount for the combined product de- (H) For packages containing several termined in § 101.12(f). individual single-serving containers, (3) The serving size for meal products each of which is labeled with all re- and main dish products as defined in quired information including nutrition § 101.13 (l) and (m) that comes in single- labeling as specified in § 101.9 (that is, serving containers as defined in para- are labeled appropriately for individual graph (b)(6) of this section shall be the sale as single-serving containers), the entire content (edible portion only) of serving size shall be 1 unit. the package. Serving size for meal (ii) For products in large discrete products and main dish products in units that are usually divided for con- multiserving containers shall be based sumption (e.g., cake, pie, pizza, melon, on the reference amount applicable to cabbage), for unprepared products the product in § 101.12(b) if the product where the entire contents of the pack- is listed in § 101.12(b). Serving size for age is used to prepare large discrete meal products and main dish products units that are usually divided for con- in multiserving containers that are not sumption (e.g., cake mix, pizza kit), listed in § 101.12(b) shall be based on the and for products which consist of two reference amount according to or more foods packaged and presented to be consumed together where the in- § 101.12(f). gredient represented as the main ingre- (4) A variety pack, such as a package dient is a large discrete unit usually di- containing several varieties of single- vided for consumption (e.g., prepared serving units as defined in paragraph cake packaged with a can of frosting), (b)(2)(i) of this section, and a product the serving size shall be the fractional having two or more compartments slice of the ready-to-eat product (e.g., with each compartment containing a 1⁄12 cake, 1⁄8 pie, 1⁄4 pizza, 1⁄4 melon, 1⁄6 different food, shall provide nutrition cabbage) that most closely approxi- information for each variety or food mates the reference amount for the per serving size that is derived from product category, and may be the frac- the reference amount in § 101.12(b) ap- tion of the package used to make the plicable for each variety or food and reference amount for the unprepared the procedures to convert the reference product determined in § 101.12(c) or the amount to serving size in paragraph fraction of the large discrete unit rep- (b)(2) of this section. resented as the main ingredient plus (5) For labeling purposes, the term proportioned minor ingredients used to common household measure or common make the reference amount for the household unit means cup, tablespoon, combined product determined in teaspoon, piece, slice, fraction (e.g., 1⁄4 § 101.12(f). In expressing the fractional pizza), ounce (oz), fluid ounce (fl oz), or slice, manufacturers shall use 1⁄2, 1⁄3, 1⁄4, other common household equipment 1⁄5, 1⁄6, or smaller fractions that can be used to package food products (e.g., jar, generated by further division by 2 or 3. tray). In expressing serving size in (iii) For nondiscrete bulk products household measures, except as speci- (e.g., breakfast cereal, flour, sugar, dry fied in paragraphs (b)(5)(iv), (b)(5)(v), mixes, concentrates, pancake mixes, (b)(5)(vi), and (b)(5)(vii) of this section, macaroni and cheese kits), and for the following rules shall be used:

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(i) Cups, tablespoons, or teaspoons an appropriate visual unit of measure, shall be used wherever possible and ap- as described in paragraph (b)(5)(iii) of propriate except for beverages. For this section (e.g., declared as separate beverages, a manufacturer may use components: ‘‘3 oz dry macaroni (84 g/ fluid ounces. Cups shall be expressed in about 2⁄3 cup)’’ and ‘‘1 oz dry cheese mix 1/4- or 1/3-cup increments. Tablespoons (28 g/about 2 tbsp);’’ declared as a com- shall be expressed as 1, 1 1/3, 1 1/2, 1 2/ posite value: ‘‘4 oz (112 g/about 2⁄3 cup 3, 2, or 3 tablespoons. Teaspoons shall macaroni and 2 tbsp dry cheese mix)’’). be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 (viii) For nutrition labeling purposes, teaspoons. a teaspoon means 5 milliliters (mL), a (ii) If cups, tablespoons or teaspoons tablespoon means 15 mL, a cup means are not applicable, units such as piece, 240 mL, 1 fl oz means 30 mL, and 1 oz in slice, tray, jar, and fraction shall be weight means 28 g. used. (ix) When a serving size, determined (iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not applica- from the reference amount in § 101.12(b) ble, ounces may be used with an appro- and the procedures described in this priate visual unit of measure such as a section, falls exactly half way between dimension of a piece, e.g., 1 oz (28 g/ two serving sizes, e.g., 2.5 tbsp, manu- about 1⁄2 pickle). Ounce measurements facturers shall round the serving size shall be expressed in 0.5 oz increments up to the next incremental size. most closely approximating the ref- (6) A product that is packaged and erence amount. sold individually that contains less (iv) A description of the individual than 200 percent of the applicable ref- container or package shall be used for erence amount must be considered to single serving containers and for indi- be a single-serving container, and the vidually packaged products within entire content of the product must be multiserving containers (e.g., can, box, labeled as one serving. In addition to package). A description of the indi- providing a column within the Nutri- vidual unit shall be used for other tion Facts label that lists the quan- products in discrete units (e.g., piece, titative amounts and percent Daily slice, cracker, bar). Values per serving, for a product that (v) For unprepared products where is packaged and sold individually that the entire contents of the package is contains more than 150 percent and less used to prepare large discrete units than 200 percent of the applicable ref- that are usually divided for consump- erence amount, the Nutrition Facts tion (e.g., cake mix, pizza kit), the label may voluntarily provide, to the fraction or portion of the package may left of the column that provides nutri- be used. tion information per container (i.e., per (vi) Ounces with an appropriate vis- serving), an additional column that ual unit of measure, as described in lists the quantitative amounts and per- paragraph (b)(5)(iii) of this section, cent Daily Values per common house- may be used for products that natu- hold measure that most closely ap- rally vary in size as provided for in paragraph (b)(2)(i)(G) of this section. proximates the reference amount. (vii) As provided for in § 101.9(h)(1), (7) A label statement regarding a for products that consist of two or serving shall be the serving size ex- more distinct ingredients or compo- pressed in common household measures nents packaged and presented to be as set forth in paragraphs (b)(2) consumed together (e.g. dry macaroni through (b)(6) of this section and shall and cheese mix, cake and muffin mixes be followed by the equivalent metric with separate ingredient packages, quantity in parenthesis (fluids in milli- pancakes and syrup), nutrition infor- liters and all other foods in grams) ex- mation may be declared for each com- cept for single-serving containers. ponent or as a composite. The serving (i) For a single-serving container, the size may be provided in accordance parenthetical metric quantity, which with the provisions of paragraphs will be presented as part of the net (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this weight statement on the principal dis- section, or alternatively in ounces with play panel, is not required except

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where nutrition information is re- ty and Applied Nutrition, Food and quired on a drained weight basis ac- Drug Administration, 5001 Campus Dr., cording to § 101.9(b)(9). However, if a College Park, MD 20740. manufacturer voluntarily provides the (8) Determination of the number of metric quantity on products that can servings per container shall be based be sold as single servings, then the nu- on the serving size of the product de- merical value provided as part of the termined by following the procedures serving size declaration must be iden- described in this section. tical to the metric quantity declara- (i) The number of servings shall be tion provided as part of the net quan- rounded to the nearest whole number tity of contents statement. except for the number of servings be- (ii) The gram or milliliter quantity tween 2 and 5 servings and random equivalent to the household measure weight products. The number of should be rounded to the nearest whole servings between 2 and 5 servings shall number except for quantities that are be rounded to the nearest 0.5 serving. less than 5 g (mL). The gram (mL) Rounding should be indicated by the quantity between 2 and 5 g (mL) should use of the term about (e.g., about 2 be rounded to the nearest 0.5 g (mL) servings, about 3.5 servings). and the g (mL) quantity less than 2 g (ii) When the serving size is required (mL) should be expressed in 0.1-g (mL) to be expressed on a drained solids increments. basis and the number of servings varies (iii) In addition, serving size may be because of a natural variation in unit declared in ounce and fluid ounce, in size (e.g., maraschino cherries, pick- parenthesis, following the metric les), the manufacturer may state the measure separated by a slash where typical number of servings per con- other common household measures are tainer (e.g., usually 5 servings). used as the primary unit for serving (iii) For random weight products, size, e.g., 1 slice (28 g/1 oz) for sliced manufacturers may declare ‘‘varied’’ bread. The ounce quantity equivalent for the number of servings per con- to the metric quantity should be ex- tainer provided the nutrition informa- pressed in 0.1 oz increments. tion is based on the reference amount (iv) If a manufacturer elects to use expressed in the appropriate household abbreviations for units, the following measure based on the hierarchy de- abbreviations shall be used: tbsp for ta- scribed in paragraph (b)(5) of this sec- blespoon, tsp for teaspoon, g for gram, tion. Random weight products are mL for milliliter, oz for ounce, and fl foods such as cheeses that are sold as oz for fluid ounce. random weights that vary in size, such (v) For products that only require that the net contents for different con- the addition of water or another ingre- tainers would vary. The manufacturer dient that contains insignificant may provide the typical number of amounts of nutrients in the amount servings in parentheses following the added and that are prepared in such a ‘‘varied’’ statement. way that there are no significant (iv) For packages containing several changes to the nutrient profile, the individual single-serving containers, amount of the finished product may be each of which is labeled with all re- declared in parentheses at the end of quired information including nutrition the serving size declaration (e.g., 1⁄2 cup labeling as specified in § 101.9 (that is, (120 mL) concentrated soup (makes 1 are labeled appropriately for individual cup prepared)). sale as single-serving containers), the (vi) To promote uniformity in label number of servings shall be the number serving sizes in household measures de- of individual packages within the total clared by different manufacturers, FDA package. has provided a guidance document enti- (v) For packages containing several tled, ‘‘Guidelines for Determining the individually packaged multiserving Gram Weight of the Household Meas- units, the number of servings shall be ure.’’ The guidance document can be determined by multiplying the number obtained from the Office of Nutritional of individual multiserving units in the Products, Labeling and Dietary Supple- total package by the number of ments (HFS–800), Center for Food Safe- servings in each individual unit.

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(9) The declaration of nutrient and Facts label that lists the quantitative food component content shall be on the amounts and percent Daily Values for basis of food as packaged or purchased the entire package, as well as a column with the exception of raw fish covered listing the quantitative amounts and under § 101.42 (see 101.44), packaged sin- percent Daily Values for a serving that gle-ingredient products that consist of is less than the entire package (i.e., the fish or game meat as provided for in serving size derived from the reference paragraph (j)(11) of this section, and of amount). The first column would be foods that are packed or canned in based on the serving size for the prod- water, brine, or oil but whose liquid uct and the second column would be packing medium is not customarily based on the entire contents of the consumed (e.g., canned fish, mara- package. schino cherries, pickled fruits, and (A) This provision does not apply to pickled vegetables). Declaration of nu- products that meet the requirements trient and food component content of to use the tabular format in paragraph raw fish shall follow the provisions in (j)(13)(ii)(A)(1) of this section or to § 101.45. Declaration of the nutrient and products that meet the requirements food component content of foods that to use the linear format in paragraph are packed in liquid which is not cus- (j)(13)(ii)(A)(2) of this section. tomarily consumed shall be based on (B) This provision does not apply to the drained solids. raw fruits, vegetables, and seafood for (10) Another column of figures may which voluntary nutrition labeling is be used to declare the nutrient and provided in the product labeling or ad- food component information: vertising or when claims are made (i) Per 100 g or 100 mL, or per 1 oz or about the product. 1 fl oz of the food as packaged or purchased; (C) This provision does not apply to (ii) Per one unit if the serving size of products that require further prepara- a product in discrete units is more tion and provide an additional column than 1 unit. of nutrition information under para- (iii) Per cup popped for popcorn in a graph (e) of this section, to products multiserving container. that are commonly consumed in com- (11) If a product is promoted on the bination with another food and provide label, labeling, or advertising for a use an additional column of nutrition in- that differs in quantity by twofold or formation under paragraph (e) of this greater from the use upon which the section, to products that provide an ad- reference amount in § 101.12(b) was ditional column of nutrition informa- based (e.g., liquid cream substitutes tion for two or more groups for which promoted for use with breakfast cere- RDIs are established (e.g., both infants als), the manufacturer shall provide a and children less than 4 years of age), second column of nutrition informa- to popcorn products that provide an ad- tion based on the amount customarily ditional column of nutrition informa- consumed in the promoted use, in addition per 1 cup popped popcorn, or to tion to the nutrition information per varied-weight products covered under serving derived from the reference paragraph (b)(8)(iii) of this section. amount in § 101.12(b), except that non- (ii) When a nutrient content claim or discrete bulk products that are used health claim is made on the label of a primarily as ingredients (e.g., flour, product that uses a dual column as re- sweeteners, shortenings, oils), or tradi- quired in paragraph (b)(2)(i)(D) or tionally used for multipurposes (e.g., (b)(12)(i) of this section, the claim must eggs, butter, margarine), and multipur- be followed by a statement that sets pose baking mixes are exempt from forth the basis on which the claim is this requirement. made, except that the statement is not (12)(i) Products that are packaged required for products when the nutri- and sold individually and that contain ent that is the subject of the claim at least 200 percent and up to and in- meets the criteria for the claim based cluding 300 percent of the applicable on the reference amount for the prod- reference amount must provide an ad- uct and the entire container or the ditional column within the Nutrition unit amount. When a nutrient content

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claim is made, the statement must ex- book No. 74 (slightly revised, 1973) pp. press that the claim refers to the 9–11; amount of the nutrient per serving (C) Using the general factors of 4, 4, (e.g., ‘‘good source of calcium per serv- and 9 calories per gram for protein, ing’’ or ‘‘per X [insert unit]lserving’’) total carbohydrate (less the amount of or per reference amount (e.g., ‘‘good non-digestible carbohydrates and sugar source of calcium per [insert reference alcohols), and total fat, respectively, as amount (e.g., per 8 ounces)]), as re- described in USDA Handbook No. 74 quired based on § 101.12(g). When a (slightly revised, 1973) pp. 9–11. A gen- health claim is made, the statement eral factor of 2 calories per gram for shall be ‘‘A serving of lounces of this soluble non-digestible carbohydrates product conforms to such a diet.’’ shall be used. The general factors for (c) The declaration of nutrition infor- caloric value of sugar alcohols provided mation on the label and in labeling of in paragraph (c)(1)(i)(F) of this section a food shall contain information about shall be used; the level of the following nutrients, ex- (D) Using data for specific food fac- cept for those nutrients whose inclu- tors for particular foods or ingredients sion, and the declaration of amounts, is approved by the Food and Drug Admin- voluntary as set forth in this para- istration (FDA) and provided in parts graph. No nutrients or food compo- 172 or 184 of this chapter, or by other nents other than those listed in this means, as appropriate; paragraph as either mandatory or vol- (E) Using bomb calorimetry data sub- untary may be included within the nu- tracting 1.25 calories per gram protein trition label. Except as provided for in to correct for incomplete digestibility, paragraphs (f) or (j) of this section, nu- as described in USDA Handbook No. 74 trient information shall be presented (slightly revised, 1973) p. 10; or using the nutrient names specified and (F) Using the following general fac- in the following order in the formats tors for caloric value of sugar alcohols: specified in paragraphs (d) or (e) of this Isomalt—2.0 calories per gram, section. lactitol—2.0 calories per gram, (1) ‘‘Calories, total,’’ ‘‘Total cal- xylitol—2.4 calories per gram, ories,’’ or ‘‘Calories’’: A statement of maltitol—2.1 calories per gram, sor- the caloric content per serving, ex- bitol—2.6 calories per gram, hydro- pressed to the nearest 5-calorie incre- genated starch hydrolysates—3.0 cal- ment up to and including 50 calories, ories per gram, mannitol—1.6 calories and 10-calorie increment above 50 cal- per gram, and erythritol—0 calories per ories, except that amounts less than 5 gram. calories may be expressed as zero. En- (ii) ‘‘Calories from saturated fat’’ or ergy content per serving may also be ‘‘Calories from saturated’’ (VOL- expressed in kilojoule units, added in UNTARY): A statement of the caloric parentheses immediately following the content derived from saturated fat as statement of the caloric content. defined in paragraph (c)(2)(i) of this (i) Caloric content may be calculated section in a serving may be declared by the following methods. Where either voluntarily, expressed to the nearest 5- specific or general food factors are calorie increment, up to and including used, the factors shall be applied to the 50 calories, and the nearest 10-calorie actual amount (i.e., before rounding) of increment above 50 calories, except food components (e.g., fat, carbo- that amounts less than 5 calories may hydrate, protein, or ingredients with be expressed as zero. This statement specific food factors) present per serv- shall be indented under the statement ing. of calories as provided in paragraph (A) Using specific Atwater factors (d)(5) of this section. (i.e., the Atwater method) given in (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A table 13, USDA Handbook No. 74 statement of the number of grams of (slightly revised, 1973), total fat in a serving defined as total (B) Using the general factors of 4, 4, lipid fatty acids and expressed as and 9 calories per gram for protein, triglycerides where fatty acids are ali- total carbohydrate, and total fat, re- phatic carboxylic acids consisting of a spectively, as described in USDA Hand- chain of alkyl groups and characterized

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by a terminal carboxyl group. Amounts (6) ‘‘Carbohydrate, total’’ or ‘‘Total shall be expressed to the nearest 0.5 (1⁄2) carbohydrate’’: A statement of the gram increment below 5 grams and to number of grams of total carbohydrate the nearest gram increment above 5 in a serving expressed to the nearest grams. If the serving contains less than gram, except that if a serving contains 0.5 gram, the content shall be expressed less than 1 gram, the statement ‘‘Con- as zero. tains less than 1 gram’’ or ‘‘less than 1 (3) ‘‘Cholesterol’’: A statement of the gram’’ may be used as an alternative, cholesterol content in a serving ex- or if the serving contains less than 0.5 pressed in milligrams to the nearest 5- gram, the content may be expressed as milligram increment, except that label zero. Total carbohydrate content shall declaration of cholesterol information be calculated by subtraction of the sum is not required for products that con- of the crude protein, total fat, mois- tain less than 2 milligrams cholesterol ture, and ash from the total weight of in a serving and make no claim about the food. This calculation method is fat, fatty acids, or cholesterol content, described in A. L. Merrill and B. K. or such products may state the choles- Watt, ‘‘Energy Value of Foods—Basis terol content as zero. Except as pro- and Derivation,’’ USDA Handbook 74 vided for in paragraph (f) of this sec- (slightly revised 1973) pp. 2 and 3, which tion, if cholesterol content is not re- is incorporated by reference in accord- quired and, as a result, not declared, ance with 5 U.S.C. 552(a) and 1 CFR the statement ‘‘Not a significant part 51 (the availability of this incorpo- source of cholesterol’’ shall be placed ration by reference is given in para- at the bottom of the table of nutrient graph (c)(1)(i)(A) of this section). values in the same type size. If the food (i) ‘‘Dietary fiber’’: A statement of contains 2 to 5 milligrams of choles- the number of grams of total dietary terol per serving, the content may be fiber in a serving, indented and ex- stated as ‘‘less than 5 milligrams.’’ pressed to the nearest gram, except (4) ‘‘Sodium’’: A statement of the that if a serving contains less than 1 number of milligrams of sodium in a gram, declaration of dietary fiber is specified serving of food expressed as not required or, alternatively, the zero when the serving contains less statement ‘‘Contains less than 1 gram’’ than 5 milligrams of sodium, to the or ‘‘less than 1 gram’’ may be used, and nearest 5-milligram increment when if the serving contains less than 0.5 the serving contains 5 to 140 milligram, the content may be expressed as grams of sodium, and to the nearest 10- zero. Dietary fiber is defined as non-di- milligram increment when the serving gestible soluble and insoluble carbo- contains greater than 140 milligrams. hydrates (with 3 or more monomeric (5) ‘‘Fluoride’’ (VOLUNTARY): A units), and lignin that are intrinsic and statement of the number of milligrams intact in plants; isolated or synthetic of fluoride in a specified serving of food non-digestible carbohydrates (with 3 or may be declared voluntarily, except more monomeric units) determined by that when a claim is made about fluo- FDA to have physiological effects that ride content, label declaration shall be are beneficial to human health. Except required. Fluoride content shall be ex- as provided for in paragraph (f) of this pressed as zero when the serving con- section, if dietary fiber content is not tains less than 0.1 milligrams of fluo- required, and as a result not declared, ride, to the nearest 0.1-milligram incre- the statement ‘‘Not a significant ment when the serving contains less source of dietary fiber’’ shall be placed than or equal to 0.8 milligrams of fluo- at the bottom of the table of nutrient ride, and the nearest 0.2 milligram-in- values in the same type size. The fol- crement when a serving contains more lowing isolated or synthetic non-di- than 0.8 milligrams of fluoride. Bottled gestible carbohydrate(s) have been de- water that bears a statement about termined by FDA to have physiological added fluoride, as permitted by effects that are beneficial to human § 101.13(q)(8), must bear nutrition label- health and, therefore, shall be included ing that complies with requirements in the calculation of the amount of die- for the simplified format in paragraph tary fiber: [beta]-glucan soluble fiber (f) of this section. (as described in § 101.81(c)(2)(ii)(A)),

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psyllium husk (as described in fiber and expressed to the nearest § 101.81(c)(2)(ii)(A)(6)), cellulose, guar gram, except that if a serving contains gum, pectin, locust bean gum, and less than 1 gram, the statement ‘‘Con- hydroxypropylmethylcellulose. The tains less than 1 gram’’ or ‘‘less than 1 manufacturer must make and keep gram’’ may be used as an alternative, records in accordance with paragraphs and if the serving contains less than 0.5 (g)(10) and (11) of this section to verify gram, the content may be expressed as the declared amount of dietary fiber in zero. the label and labeling of food when a (ii) ‘‘Total Sugars’’: A statement of mixture of dietary fiber, and added the number of grams of sugars in a non-digestible carbohydrate(s) that serving, except that the label declara- does not meet the definition of dietary tion of sugars content is not required fiber, is present in the food. for products that contain less than 1 (A) ‘‘Soluble fiber’’ (VOLUNTARY): gram of sugars in a serving if no claims A statement of the number of grams of are made about sweeteners, sugars, or soluble dietary fiber in a serving may sugar alcohol content. Except as probe declared voluntarily except that vided for in paragraph (f) of this sec- when a claim is made on the label or in tion, if a statement of the total sugars labeling about soluble fiber, label dec- content is not required and, as a result, laration shall be required. Soluble fiber not declared, the statement ‘‘Not a sig- must meet the definition of dietary nificant source of total sugars’’ shall fiber in this paragraph (c)(6)(i). The be placed at the bottom of the table of manufacturer must make and keep nutrient values in the same type size. records in accordance with paragraphs Total sugars shall be defined as the (g)(10) and (11) of this section to verify sum of all free mono- and disaccharides the declared amount of soluble fiber in (such as glucose, fructose, lactose, and the label and labeling of food when a sucrose). Total sugars content shall be mixture of soluble fiber and added non- indented and expressed to the nearest digestible carbohydrate(s) that does gram, except that if a serving contains not meet the definition of dietary fiber less than 1 gram, the statement ‘‘Con- is present in the food. Soluble fiber tains less than 1 gram’’ or ‘‘less than 1 content shall be indented under dietary gram’’ may be used as an alternative, fiber and expressed to the nearest and if the serving contains less than 0.5 gram, except that if a serving contains gram, the content may be expressed as less than 1 gram, the statement ‘‘Con- zero. tains less than 1 gram’’ or ‘‘less than 1 (iii) ‘‘Added Sugars’’: A statement of gram’’ may be used as an alternative, the number of grams of added sugars in and if the serving contains less than 0.5 a serving, except that label declaration gram, the content may be expressed as of added sugars content is not required zero.’’ for products that contain less than 1 (B) ‘‘Insoluble fiber’’ (VOLUNTARY): gram of added sugars in a serving if no A statement of the number of grams of claims are made about sweeteners, sug- insoluble dietary fiber in a serving may ars, added sugars, or sugar alcohol con- be declared voluntarily except that tent. If a statement of the added sugars when a claim is made on the label or in content is not required and, as a result, labeling about insoluble fiber, label not declared, the statement ‘‘Not a sig- declaration shall be required. Insoluble nificant source of added sugars’’ shall fiber must meet the definition of die- be placed at the bottom of the table of tary fiber in this paragraph (c)(6)(i). nutrient values in the same type size. The manufacturer must make and keep Added sugars are either added during records in accordance with paragraphs the processing of foods, or are pack- (g)(10) and (11) of this section to verify aged as such, and include sugars (free, the declared amount of insoluble fiber mono- and disaccharides), sugars from in the label and labeling of food when a syrups and honey, and sugars from con- mixture of insoluble and added non-di- centrated fruit or vegetable juices that gestible carbohydrate(s) that does not are in excess of what would be expected meet the definition of dietary fiber is from the same volume of 100 percent present in the food. Insoluble fiber con- fruit or vegetable juice of the same tent shall be indented under dietary type, except that fruit or vegetable

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juice concentrated from 100 percent present in the food. Sugar alcohol con- juices sold to consumers, fruit or vege- tent shall be indented and expressed to table juice concentrates used towards the nearest gram, except that if a serv- the total juice percentage label dec- ing contains less than 1 gram, the laration under § 101.30 or for Brix stand- statement ‘‘Contains less than 1 gram’’ ardization under § 102.33(g)(2) of this or ‘‘less than 1 gram’’ may be used as chapter, fruit juice concentrates which an alternative, and if the serving con- are used to formulate the fruit compo- tains less than 0.5 gram, the content nent of jellies, jams, or preserves in ac- may be expressed as zero. cordance with the standard of identi- (7) ‘‘Protein’’: A statement of the ties set forth in §§ 150.140 and 150.160 of number of grams of protein in a serv- this chapter, or the fruit component of ing, expressed to the nearest gram, ex- fruit spreads shall not be labeled as cept that if a serving contains less added sugars. Added sugars content than 1 gram, the statement ‘‘Contains shall be indented under Total Sugars less than 1 gram’’ or ‘‘less than 1 and shall be prefaced with the word gram’’ may be used as an alternative, ‘‘Includes’’ followed by the amount (in and if the serving contains less than 0.5 grams) ‘‘Added Sugars’’ (‘‘Includes ‘X’ gram, the content may be expressed as g Added Sugars’’). It shall be expressed zero. When the protein in foods rep- to the nearest gram, except that if a resented or purported to be for adults serving contains less than 1 gram, the and children 4 or more years of age has statement ‘‘Contains less than 1 gram’’ a protein quality value that is a pro- or ‘‘less than 1 gram’’ may be used as tein digestibility-corrected amino acid an alternative, and if the serving con- score of less than 20 expressed as a pertains less than 0.5 gram, the content cent, or when the protein in a food rep- may be expressed as zero. When a mix- resented or purported to be for children ture of naturally occurring and added greater than 1 but less than 4 years of sugars is present in the food, and for age has a protein quality value that is specific foods containing added sugars, a protein digestibility-corrected amino alone or in combination with naturally acid score of less than 40 expressed as a occurring sugars, where the added sug- percent, either of the following shall be ars are subject to fermentation and/or placed adjacent to the declaration of non-enzymatic browning, the manufac- protein content by weight: The state- turer must make and keep records in ment ‘‘not a significant source of pro- accordance with paragraphs (g)(10) and tein,’’ or a listing aligned under the (11) of this section to verify the de- column headed ‘‘Percent Daily Value’’ clared amount of added sugars in the of the corrected amount of protein per label and labeling of food. serving, as determined in paragraph (iv) ‘‘Sugar alcohol’’ (VOLUNTARY): (c)(7)(ii) of this section, calculated as a A statement of the number of grams of percentage of the Daily Reference sugar alcohols in a serving may be de- Value (DRV) or Reference Daily Intake clared voluntarily on the label, except (RDI), as appropriate, for protein and that when a claim is made on the label expressed as a Percent of Daily Value. or in labeling about sugar alcohol or When the protein quality in a food as total sugars, or added sugars when measured by the Protein Efficiency sugar alcohols are present in the food, Ratio (PER) is less than 40 percent of sugar alcohol content shall be declared. the reference standard (casein) for a For nutrition labeling purposes, sugar food represented or purported to be alcohols are defined as the sum of sac- specifically for infants through 12 charide derivatives in which a hydroxyl months, the statement ‘‘not a signifi- group replaces a ketone or aldehyde cant source of protein’’ shall be placed group and whose use in the food is list- adjacent to the declaration of protein ed by FDA (e.g., mannitol or xylitol) or content. Protein content may be cal- is generally recognized as safe (e.g., culated on the basis of the factor 6.25 sorbitol). In lieu of the term ‘‘sugar al- times the nitrogen content of the food cohol,’’ the name of the specific sugar as determined by the appropriate alcohol (e.g., ‘‘xylitol’’) present in the method of analysis as given in the ‘‘Of- food may be used in the nutrition label ficial Methods of Analysis of the AOAC provided that only one sugar alcohol is International,’’ except when official

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AOAC procedures described in this the relative protein value is above 1.00, paragraph (c)(7) require a specific fac- it shall be set at 1.00. tor other than 6.25, that specific factor (iii) For the purpose of labeling with shall be used. a percent of the DRV or RDI, a value of (i) A statement of the corrected 50 grams of protein shall be the DRV amount of protein per serving, as de- for adults and children 4 or more years termined in paragraph (c)(7)(ii) of this of age, a value of 11 grams of protein section, calculated as a percentage of shall be the RDI for infants through 12 the RDI or DRV for protein, as appro- months, a value of 13 grams shall be priate, and expressed as Percent of the DRV for children 1 through 3 years Daily Value, may be placed on the of age, and a value of 71 grams of pro- label, except that such a statement tein shall be the RDI for pregnant shall be given if a protein claim is women and lactating women. made for the product, or if the product (8) ‘‘Vitamins and minerals’’: The re- is represented or purported to be spe- quirements related to including a cifically for infants through 12 months statement of the amount per serving of or children 1 through 3 years of age. vitamins and minerals are described in When such a declaration is provided, it this paragraph (c)(8). (i) For purposes of declaration of per- should be placed on the label adjacent cent of Daily Value as provided for in to the statement of grams of protein paragraphs (d), (e), and (f) of this sec- and aligned under the column headed tion, foods represented or purported to ‘‘Percent Daily Value,’’ and expressed be specifically for infants through 12 to the nearest whole percent. However, months, children 1 through 3 years, the percentage of the RDI for protein pregnant women, and lactating women shall not be declared if the food is rep- shall use the RDIs that are specified resented or purported to be specifically for the intended group. For foods rep- for infants through 12 months and the resented or purported to be specifically protein quality value is less than 40 for both infants through 12 months of percent of the reference standard. age and children 1 through 3 years of (ii) The ‘‘corrected amount of protein age, the percent of Daily Value shall be (gram) per serving’’ for foods rep- presented by separate declarations ac- resented or purported for adults and cording to paragraph (e) of this section children 1 or more years of age is equal based on the RDI values for infants to the actual amount of protein (gram) through 12 months of age and children per serving multiplied by the amino 1 through 3 years of age. When such acid score corrected for protein digest- dual declaration is used on any label, it ibility. If the corrected score is above shall be included in all labeling, and 1.00, then it shall be set at 1.00. The equal prominence shall be given to protein digestibility-corrected amino both values in all such labeling. The acid score shall be determined by percent Daily Value based on the RDI methods given in sections 5.4.1, 7.2.1, values for pregnant women and lac- and 8.00 in ‘‘Report of the Joint FAO/ tating women shall be declared on food WHO Expert Consultation on Protein represented or purported to be specifi- Quality Evaluation,’’ except that when cally for pregnant women and lactating official AOAC procedures described in women. All other foods shall use the paragraph (c)(7) of this section require RDI for adults and children 4 or more a specific factor other than 6.25, that years of age. specific factor shall be used. For foods (ii) The declaration of vitamins and represented or purported to be specifi- minerals as a quantitative amount by cally for infants through 12 months, weight and percent of the RDI shall in- the corrected amount of protein clude vitamin D, calcium, iron, and po- (grams) per serving is equal to the ac- tassium in that order, for infants tual amount of protein (grams) per through 12 months, children 1 through serving multiplied by the relative pro- 3 years of age, pregnant women, lac- tein quality value. The relative protein tating women, and adults and children quality value shall be determined by 4 or more years of age. The declaration dividing the subject food protein PER of folic acid shall be included as a value by the PER value for casein. If quantitative amount by weight when

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added as a nutrient supplement or a percent level, and the nearest 10-per- claim is made about the nutrient. The cent increment above the 50-percent declaration of vitamins and minerals level. Quantitative amounts and per- in a food, as a quantitative amount by centages of vitamins and minerals weight and percent of the RDI, may in- present at less than 2 percent of the clude any of the other vitamins and RDI are not required to be declared in minerals listed in paragraph (c)(8)(iv) nutrition labeling but may be declared of this section. The declaration of vita- by a zero or by the use of an asterisk mins and minerals shall include any of (or other symbol) that refers to an- the other vitamins and minerals listed other asterisk (or symbol) that is in paragraph (c)(8)(iv) of this section as placed at the bottom of the table and a statement of the amount per serving that is followed by the statement of the vitamins and minerals as de- ‘‘Contains less than 2 percent of the scribed in this paragraph, calculated as Daily Value of this (these) nutrient a percent of the RDI and expressed as a (nutrients)’’ or ‘‘Contains <2 percent of percent of the Daily Value, when they the Daily Value of this (these) nutrient are added as a nutrient supplement, or (nutrients).’’ Alternatively, except as when a claim is made about them, un- provided for in paragraph (f) of this less otherwise stated as quantitative section, if vitamin D, calcium, iron, or amount by weight and percent of the potassium is present in amounts less Daily Value. Other vitamins and min- than 2 percent of the RDI, label dec- erals need not be declared if neither laration of the nutrient(s) is not re- the nutrient nor the component is oth- quired if the statement ‘‘Not a signifi- erwise referred to on the label or the cant source of—(listing the vitamins or labeling or advertising and the vita- minerals omitted)’’ is placed at the mins and minerals are: bottom of the table of nutrient values. (A) Required or permitted in a stand- Either statement shall be in the same ardized food (e.g., thiamin, riboflavin, type size as nutrients that are in- and niacin in enriched flour) and that dented. The quantitative amounts of standardized food is included as an in- vitamins and minerals, excluding so- gredient (i.e., component) in another dium, shall be the amount of the vita- food; or min or mineral included in one serving (B) Included in a food solely for tech- of the product, using the units of meas- nological purposes and declared only in urement and the levels of significance the ingredient statement. The declara- given in paragraph (c)(8)(iv) of this section may also include any of the other tion, except that zeros following dec- vitamins and minerals listed in para- imal points may be dropped, and addi- graph (c)(8)(iv) of this section when tional levels of significance may be they are naturally occurring in the used when the number of decimal food. The additional vitamins and min- places indicated is not sufficient to ex- erals shall be listed in the order estab- press lower amounts (e.g., the RDI for lished in paragraph (c)(8)(iv) of this zinc is given in whole milligrams, but section. the quantitative amount may be de- (iii) The percentages for vitamins clared in tenths of a milligram). and minerals shall be expressed to the (iv) The following RDIs, nomen- nearest 2-percent increment up to and clature, and units of measure are es- including the 10-percent level, the tablished for the following vitamins nearest 5-percent increment above 10 and minerals which are essential in percent and up to and including the 50- human nutrition:

RDI Pregnant Nutrient Unit of measure Adults and Infants 1 Children 1 ≥ women and children 4 through 12 through 3 lactating years months years women

Vitamin A ...... Micrograms RAE 2 (mcg) .... 900 500 300 1,300 Vitamin C ...... Milligrams (mg) ...... 90 50 15 120 Calcium ...... Milligrams (mg) ...... 1,300 260 700 1,300 Iron ...... Milligrams (mg) ...... 18 11 7 27 Vitamin D ...... Micrograms (mcg) 3 ...... 20 10 15 15

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RDI Pregnant Nutrient Unit of measure Adults and Infants 1 Children 1 ≥ women and children 4 through 12 through 3 lactating years months years women

Vitamin E ...... Milligrams (mg) 4 ...... 15 5 6 19 Vitamin K ...... Micrograms (mcg) ...... 120 2.5 30 90 Thiamin ...... Milligrams (mg)...... 1.2 0.3 0.5 1.4 Riboflavin ...... Milligrams (mg)...... 1.3 0.4 0.5 1.6 Niacin ...... Milligrams NE 5 (mg) ...... 16 4 6 18 Vitamin B6 ...... Milligrams (mg)...... 1.7 0.3 0.5 2.0 Folate 6 ...... Micrograms DFE 7 (mcg) .... 400 80 150 600 Vitamin B12 ...... Micrograms (mcg)...... 2.4 0.5 0.9 2.8 Biotin ...... Micrograms (mcg) ...... 30 6 8 35 Pantothenic acid ...... Milligrams (mg) ...... 5 1.8 2 7 Phosphorus ...... Milligrams (mg) ...... 1,250 275 460 1,250 Iodine ...... Micrograms (mcg) ...... 150 130 90 290 Magnesium ...... Milligrams (mg) ...... 420 75 80 400 Zinc ...... Milligrams (mg) ...... 11 3 3 13 Selenium ...... Micrograms (mcg) ...... 55 20 20 70 Copper ...... Milligrams (mg)...... 0.9 0.2 0.3 1.3 Manganese ...... Milligrams (mg)...... 2.3 0.6 1.2 2.6 Chromium ...... Micrograms (mcg) ...... 35 5.5 11 45 Molybdenum ...... Micrograms (mcg) ...... 45 3 17 50 Chloride ...... Milligrams (mg) ...... 2,300 570 1,500 2,300 Potassium ...... Milligrams (mg) ...... 4,700 700 3,000 5,100 Choline ...... Milligrams (mg) ...... 550 150 200 550 Protein ...... Grams (g) ...... N/A 11 N/A 8 71 1 RDIs are based on dietary reference intake recommendations for infants through 12 months of age. 2 RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental b-carotene, 12 micrograms b-carotene, or 24 micrograms a-carotene, or 24 micrograms b-cryptoxanthin. 3 The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg. 4 1 mg a-tocopherol (label claim) = 1 mg a-tocopherol = 1 mg RRR- a-tocopherol = 2 mg all rac-a-tocopherol . 5 NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 6 ‘‘Folate’’ and ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid. 7 DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid. 8 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women.

(v) The following synonyms may be tene may be declared voluntarily. added in parentheses immediately fol- When the vitamins and minerals are lowing the name of the nutrient or die- listed in a single column, the state- tary component: ment shall be indented under the infor- Calories—Energy mation on vitamin A. When vitamins Vitamin C—Ascorbic acid and minerals are arrayed horizontally, the statement of percent shall be pre- Thiamin—Vitamin B1 Riboflavin—Vitamin B sented in parenthesis following the dec- 2 laration of vitamin A and the percent (v) The following synonyms may be DV of vitamin A in the food (e.g., added in parentheses immediately fol- ‘‘Percent Daily Value: Vitamin A 50 (90 lowing the name of the nutrient or die- percent as beta-carotene)’’). When de- tary component: clared, the percentages shall be ex- Calories—Energy pressed in the same increments as are Vitamin C—Ascorbic acid provided for vitamins and minerals in Thiamin—Vitamin B1 paragraph (c)(8)(iii) of this section. Riboflavin—Vitamin B2 (vii) When the amount of folate is de- Folate—Folic acid or Folacin. clared in the labeling of a conventional Alternatively, folic acid or folacin may be food or a dietary supplement, the nu- listed without parentheses in place of trient name ‘‘folate’’ shall be listed for folate. products containing folate (natural (vi) A statement of the percent of vi- folate, and/or synthetic folate as a tamin A that is present as beta-caro- component of dietary supplement, such

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as calcium salt of L–5-MTHF), folic food, may be expressed as folate and acid, or a mixture of folate and folic the percent DV based on folate in mcg acid. The name of the synthetic form of DFE. When declared, folic acid must be the nutrient ‘‘folic acid’’, when added in parentheses, mcg of folic acid as or a claim is made about the nutrient, shown in paragraph (d)(12) of this sec- shall be included in parentheses after tion in the display that illustrates vol- this declaration with the amount of untary declaration of nutrition infor- folic acid. The declaration must be mation. folate in mcg DFE (when expressed as a (9) The following DRVs, nomen- quantitative amount by weight in a clature, and units of measure are es- conventional food or a dietary supplement) and the percent DV based on tablished for the following food compo- folate in mcg DFE, or for conventional nents:

Adults and Children 1 Pregnant ≥ Infants through women and Food component Unit of measure children 4 12 months through 3 lactating years years women

Fat ...... Grams (g) ...... 1 78 30 2 39 1 78 Saturated fat ...... Grams (g) ...... 1 20 N/A 2 10 1 20 Cholesterol ...... Milligrams (mg) ...... 300 N/A 300 300 Total carbohydrate ...... Grams (g) ...... 1 275 95 2 150 1 275 Sodium ...... Milligrams (mg) ...... 2,300 N/A 1,500 2,300 Dietary Fiber ...... Grams (g) ...... 1 28 N/A 2 14 1 28 Protein ...... Grams (g) ...... 1 50 N/A 2 13 N/A Added Sugars ...... Grams (g) ...... 1 50 N/A 2 25 1 50 1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women 2 Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

(d)(1) Nutrient information specified (ii) All information within the nutri- in paragraph (c) of this section shall be tion label shall utilize: presented on foods in the following for- (A) Except as provided for in para- mat, as shown in paragraph (d)(12) of graph (c)(2)(ii) of this section, a single this section, except on foods where the easy-to-read type style, tabular display is permitted as pro- (B) Upper and lower case letters, vided for in paragraph (d)(11) of this (C) At least one point leading (i.e., section, on which dual columns of nu- space between two lines of text) except trition information are declared as pro- that at least four points leading shall vided for in paragraph (e) of this sec- be utilized for the information required tion, on those food products on which by paragraphs (d)(7) and (d)(8) of this the simplified format is required to be section as shown in paragraph (d)(12), used as provided for in paragraph (f) of and this section, on foods for infants through 12 months of age and children (D) Letters should never touch. 1 through 3 years of age as provided for (iii) Information required in para- in paragraph (j)(5) of this section, and graphs (d)(7) and (8) of this section on foods in small or intermediate-sized shall be in type size no smaller than 8 packages as provided for in paragraph point. Information required in para- (j)(13) of this section. In the interest of graph (d)(5) of this section for the uniformity of presentation, FDA ‘‘Calories’’ declaration shall be high- strongly recommends that the nutri- lighted in bold or extra bold and shall tion information be presented using be in a type size no smaller than 16 the graphic specifications set forth in point except the type size for this in- appendix B to part 101. formation required in the tabular dis- (i) The nutrition information shall be plays as shown in paragraphs (d)(11), set off in a box by use of hairlines and (e)(6)(ii), and (j)(13)(ii)(A)(1) of this sec- shall be all black or one color type, tion and the linear display for small printed on a white or other neutral packages as shown in paragraph contrasting background whenever prac- (j)(13)(ii)(A)(2) of this section shall be tical. in a type size no smaller than 10 point.

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The numeric amount for the informa- (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and tion required in paragraph (d)(5) of this (j)(13)(ii)(A)(2) of this section, unless section shall also be highlighted in impractical, shall be set the full width bold or extra bold type and shall be in of the information provided under a type size no smaller than 22 point, ex- paragraph (d)(7) of this section, as cept the type size for this information shown in paragraph (d)(12) of this sec- required for the tabular display for tion. small packages as shown in paragraph (3) Information on servings per con- (j)(13)(ii)(A)(1) of this section, and for tainer and serving size shall imme- the linear display for small packages diately follow the heading as shown in as shown in paragraph (j)(13)(ii)(A)(2) of paragraph (d)(12) of this section. Such this section no smaller than 14 point. information shall include: The information required in paragraph (i) ‘‘ll servings per container’’: The (d)(9) of this section shall be in a type number of servings per container, ex- size no smaller than 6 point. When pro- cept that this statement is not re- vided, the information described in quired on single serving containers as paragraph (d)(10) of this section shall defined in paragraph (b)(6) of this sec- be in a type size no smaller than 6 tion or on other food containers when point. this information is stated in the net (iv) The headings required by para- quantity of contents declaration. The graphs (d)(2), (d)(3)(ii), (d)(4), and (d)(6) information required in this paragraph of this section (i.e., ‘‘Nutrition Facts,’’ shall be located immediately after the ‘‘Serving size,’’ ‘‘Amount per serving,’’ ‘‘Nutrition Facts’’ heading and shall be and ‘‘% Daily Value*’’), the names of in a type size no smaller than 10 point, all nutrients that are not indented according to requirements of paragraph except the type size for this informa- (c) of this section (i.e., ‘‘Calories,’’ tion shall be no smaller than 9 point in ‘‘Total Fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ the tabular display for small packages ‘‘Total Carbohydrate’’ and ‘‘Protein’’), as shown in paragraph (j)(13)(ii)(A)(1) of and the percentage amounts required this section and the linear display for by paragraph (d)(7)(ii) of this section small packages as shown in paragraph shall be highlighted in bold or extra (j)(13)(ii)(A)(2) of this section. For the bold type or other highlighting (reverse linear display for small packages as printing is not permitted as a form of shown in paragraph (j)(13)(ii)(A)(2) of highlighting) that prominently distin- this section, the actual number of guishes it from other information. No servings may be listed after the other information shall be highlighted. servings per container declaration. (v) A hairline rule that is centered (ii) ‘‘Serving size’’: A statement of between the lines of text shall separate the serving size as specified in para- ‘‘Nutrition Facts’’ from the servings graph (b)(7) of this section which shall per container statement required in immediately follow the ‘‘llservings paragraph (d)(3)(i) of this section and per container’’ declaration. The infor- shall separate each nutrient and its mation required in this paragraph shall corresponding percent Daily Value re- be highlighted in bold or extra bold and quired in paragraphs (d)(7)(i) and (ii) of be in a type size no smaller than 10 this section from the nutrient and per- point, except the type size shall be no cent Daily Value above and below it, as smaller than 9 point for this informa- shown in paragraph (d)(12) of this section in the tabular displays as shown in tion and in Appendix B to Part 101. paragraphs (d)(11) and (e)(6)(ii) of this (2) The information shall be pre- section, the tabular display for small sented under the identifying heading of packages as shown in paragraph ‘‘Nutrition Facts’’ which shall be set in (j)(13)(ii)(A)(1) of this section, and the a type size no smaller than all other linear display for small packages as print size in the nutrition label except shown in paragraph (j)(13)(ii)(A)(2) of for the numerical information for this section. The serving size amount ‘‘Calories’’ required in paragraph (d)(5) must be right justified if adequate of this section, and except for labels space is available. If the ‘‘Serving size’’ presented according to the format pro- declaration does not fit in the allo- vided for in paragraphs (d)(11), cated space a type size of no smaller

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than 8 point may be used on packages in paragraph (d)(6) of this section with of any size. the percent expressed to the nearest (4) A subheading ‘‘Amount per serv- whole percent for each nutrient de- ing’’ shall be separated from the serv- clared in the column described in para- ing size information by a bar as shown graph (d)(7)(i) of this section for which in paragraph (d)(12) of this section, ex- a DRV has been established, except cept this information is not required that the percent for protein may be for the dual column formats shown in omitted as provided in paragraph (c)(7) paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section. The percent shall be of this section. calculated by dividing either the (5) Information on calories shall im- amount declared on the label for each mediately follow the subheading nutrient or the actual amount of each ‘‘Amount per serving’’ and shall be de- nutrient (i.e., before rounding) by the clared in one line. If ‘‘Calories from DRV for the nutrient, except that the saturated fat’’ is declared, it shall be percent for protein shall be calculated indented under ‘‘Calories’’ and shall be as specified in paragraph (c)(7)(ii) of in a type size no smaller than 8 point. this section. The numerical value shall (6) The column heading ‘‘% Daily be followed by the symbol for percent Value,’’ followed by an asterisk (e.g., (i.e., %). ‘‘% Daily Value*’’), shall be separated (8) Nutrient information for vitamins from information on calories by a bar and minerals (except sodium) shall be as shown in paragraph (d)(12) of this separated from information on other section. The position of this column nutrients by a bar and may be arrayed heading shall allow for a list of nutri- vertically as shown in paragraph (d)(12) ent names and amounts as described in of this section (e.g., Vitamin D 2 mcg paragraph (d)(7) of this section to be to 10%, Calcium 260 mg 20%, Iron 8 mg the left of, and below, this column 45%, Potassium 235 mg 6%) or may be heading. The column headings ‘‘Per- listed horizontally. When listed hori- cent Daily Value,’’ ‘‘Percent DV,’’ or zontally in two columns, vitamin D ‘‘% DV’’ may be substituted for ‘‘% and calcium should be listed on the Daily Value.’’ first line and iron and potassium (7) Except as provided for in para- should be listed on the second line, as graph (j)(13)(ii)(A)(2) of this section, shown in paragraph (d)(12) of this sec- nutrient information for both manda- tion in the side-by-side display. When tory and any voluntary nutrients listed more than four vitamins and minerals in paragraph (c) of this section that are are declared voluntarily as shown in to be declared in the nutrition label, paragraph (d)(12) of this section in the except for folic acid in conventional label which illustrates the mandatory food and voluntarily declared vitamins plus voluntary provisions of paragraph and minerals expressed as a statement (d) of this section, they may be de- of the amount per serving calculated as clared vertically with percentages list- a percent of the RDI and expressed as a ed under the column headed ‘‘% Daily percent Daily Value, shall be declared Value.’’ as follows: (9) A footnote, preceded by an aster- (i) The name of each nutrient, as isk, shall be placed beneath the list of specified in paragraph (c) of this sec- vitamins and minerals and shall be sep- tion, shall be given in a column and arated from the list by a bar, except followed immediately by the quan- that the footnote may be omitted from titative amount by weight for that nu- foods that can use the terms ‘‘calorie trient appended with a ‘‘g’’ for grams, free,’’ ‘‘free of calories,’’ ‘‘without cal- ‘‘mg’’ for milligrams, or ‘‘mcg’’ for ories,’’ ‘‘trivial source of calories,’’ micrograms as shown in paragraph ‘‘negligible source of calories,’’ or ‘‘di- (d)(12) of this section. The symbol ‘‘<’’ etary insignificant source of calories’’ may be used in place of ‘‘less than.’’ on the label or in the labeling of foods (ii) A listing of the percent of the as defined in § 101.60(b). The first sen- DRV as established in paragraphs tence of the footnote: ‘‘The % Daily (c)(7)(iii) and (c)(9) of this section shall Value tells you how much a nutrient in be given in a column aligned under the a serving of food contributes to a daily heading ‘‘% Daily Value’’ established diet’’ may be used on foods that can

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use the terms ‘‘calorie free,’’ ‘‘free of paragraph (d)(9) may be moved to the calories,’’ ‘‘without calories,’’ ‘‘trivial right of the column required in para- source of calories,’’ ‘‘negligible source graph (d)(7)(ii) of this section and set of calories,’’ or ‘‘dietary insignificant off by a line that distinguishes it and source of calories’’ on the label or in sets it apart from the percent Daily the labeling of foods as defined in Value information. The caloric conver- § 101.60(b). The footnote shall state: sion information provided for in para- ‘‘*The % Daily Value tells you how graph (d)(10) of this section may be pre- much a nutrient in a serving of food sented beneath either side or along the contributes to a daily diet. 2,000 cal- full length of the nutrition label. ories a day is used for general nutrition (ii) If the space beneath the manda- advice.’’ If the food product is rep- tory declaration of potassium is not resented or purported to be for children adequate to accommodate any remain- 1 through 3 years of age, the second ing vitamins and minerals to be de- sentence of the footnote shall sub- clared or the information required in stitute ‘‘1,000 calories’’ for ‘‘2,000 cal- paragraph (d)(9) of this section, the re- ories.’’ maining information may be moved to (10) Caloric conversion information the right and set off by a line that dis- on a per gram basis for fat, carbo- tinguishes it and sets it apart from the hydrate, and protein may be presented nutrients and the percent DV informa- beneath the information required in tion given to the left. The caloric con- paragraph (d)(9) of this section, sepa- version information provided for in rated from that information by a hair- paragraph (d)(10) of this section may be line. This information may be pre- presented beneath either side or along sented horizontally as shown in para- the full length of the nutrition label. graph (d)(12) of this section (i.e., ‘‘Cal- (iii) If there is not sufficient contin- ories per gram: fat 9, carbohydrate 4, uous vertical space (i.e., approximately protein 4’’) or vertically in columns. 3 in) to accommodate the required (11)(i) If the space beneath the infor- components of the nutrition label up to mation on vitamins and minerals is not and including the mandatory declara- adequate to accommodate the information of potassium, the nutrition label tion required in paragraph (d)(9) of this may be presented in a tabular display section, the information required in as shown in the following sample label.

(12) The following sample labels illus- paragraph (d) of this section and the trate the mandatory provisions and side-by-side display. mandatory plus voluntary provisions of

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(13)(i) Nutrition labels on the outer imum extent possible, except that the label of packages of products that con- identity of each food shall be specified tain two or more separately packaged immediately to the right of the ‘‘Nu- foods that are intended to be eaten in- trition Facts’’ heading, and both the dividually (e.g., variety packs of cere- quantitative amount by weight (i.e., g/ als or snack foods) or of packages that mg/mcg amounts) and the percent are used interchangeably for the same Daily Value for each nutrient shall be type of food (e.g., round ice cream con- listed in separate columns under the tainers) may use an aggregate display. name of each food. The following sam- (ii) Aggregate displays shall comply ple label illustrates an aggregate dis- with the format requirements of para- play. graph (d) of this section to the max-

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(14) In accordance with § 101.15(c)(2), provided, equal prominence shall be when nutrition labeling must appear in given to both sets of values. Informa- a second language, the nutrition infor- tion shall be presented in a format con- mation may be presented in a separate sistent with paragraph (d) of this sec- nutrition label for each language or in tion, except that: one nutrition label with the informa- (1) Following the serving size infor- tion in the second language following mation there shall be two or more col- that in English. Numeric characters umn headings accurately describing that are identical in both languages the amount per serving size of the form need not be repeated (e.g., ‘‘Protein/ of the same food (e.g., ‘‘Per 1⁄4 cup mix’’ Proteinas 2 g’’). All required informa- and ‘‘Per prepared portion’’), the com- tion must be included in both lan- binations of food, the units, or the RDI guages. groups that are being declared as (e) Nutrition information may be pre- shown in paragraph (e)(5) of this sec- sented for two or more forms of the tion. same food (e.g., both ‘‘as purchased’’ (2) The quantitative information by and ‘‘as prepared’’) or for common com- weight as required in paragraph binations of food as provided for in (d)(7)(i) and the information required paragraph (h)(4) of this section, for dif- in paragraph (d)(7)(ii) of this section ferent units (e.g., slices of bread or per shall be presented for the form of the 100 grams) as provided for in paragraph product as packaged and for any other (b) of this section, or for two or more form of the product (e.g., ‘‘as prepared’’ groups for which RDIs are established or combined with another ingredient as (e.g., both infants through 12 months of shown in paragraph (e)(5) of this sec- age and children 1 through 3 years of tion). age) as shown in paragraph (e)(5) of (3) When the dual labeling is pre- this section. When such dual labeling is sented for two or more forms of the

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same food, for combinations of food, for separated from information on other different units, or for two or more nutrients by a bar and shall be arrayed groups for which RDIs are established, vertically in the following order: Vita- the quantitative information by weight min D, calcium, iron, potassium as and the percent Daily Value shall be shown in paragraph (e)(5) of this sec- presented in two columns and the col- tion. umns shall be separated by vertical (5) The following sample label illus- lines as shown in paragraph (e)(5) of trates the provisions of paragraph (e) this section. of this section: (4) Nutrient information for vitamins and minerals (except sodium) shall be

(6) When dual labeling is presented umns shall be separated by vertical for a food on a per serving basis and per lines as shown in the displays in para- container basis as required in paragraph (e)(6)(i) of this section. graph (b)(12)(i) of this section or on a (i) Nutrient information for vitamins per serving basis and per unit basis as and minerals shall be separated from required in paragraph (b)(2)(i)(D) of information on other nutrients by a this section, the quantitative informa- bar and shall be arrayed vertically in tion by weight as required in paragraph the following order: Vitamin D, cal- (d)(7)(i) and the percent Daily Value as cium, iron, and potassium as shown in required in paragraph (d)(7)(ii) shall be the following sample labels. presented in two columns, and the col-

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(ii) The following sample label illus- (b)(2)(i)(D) and (b)(12)(i) of this section trates the provisions of paragraphs for labels that use the tabular display.

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(f) The declaration of nutrition infor- (i) Total calories, total fat, total car- mation may be presented in the sim- bohydrate, protein, and sodium; plified format set forth herein when a (ii) Any other nutrients identified in food product contains insignificant paragraph (f) of this section that are amounts of eight or more of the fol- present in the food in more than insig- lowing: Calories, total fat, saturated nificant amounts; and fat, trans fat, cholesterol, sodium, total (iii) Any vitamins and minerals list- carbohydrate, dietary fiber, total sug- ed in paragraph (c)(8)(iv) of this section ars, added sugars, protein, vitamin D, when they are required to be added as calcium, iron, and potassium; except a nutrient supplement to foods for that for foods intended for infants which a standard of identity exists. through 12 months of age and children (iv) Any vitamins or minerals listed 1 through 3 years of age to which para- in paragraph (c)(8)(iv) of this section graph (j)(5)(i) of this section applies, voluntarily added to the food as nutri- nutrition information may be pre- ent supplements. sented in the simplified format when a (3) Other nutrients that are naturally food product contains insignificant present in the food in more than insig- amounts of six or more of the fol- nificant amounts may be voluntarily lowing: Calories, total fat, sodium, declared as part of the simplified for- total carbohydrate, dietary fiber, total mat. sugars, added sugars, protein, vitamin (4) If any nutrients are declared as D, calcium, iron, and potassium. provided in paragraphs (f)(2)(iii), (1) An ‘‘insignificant amount’’ shall (f)(2)(iv), or (f)(3) of this section as part be defined as that amount that allows of the simplified format or if any nutri- a declaration of zero in nutrition label- tion claims are made on the label or in ing, except that for total carbohydrate, labeling, the statement ‘‘Not a signifi- dietary fiber, and protein, it shall be an cant source of llll’’ (with the blank amount that allows a declaration of filled in with the name(s) of any nutri- ‘‘less than 1 gram.’’ ent(s) identified in paragraph (f) of this (2) The simplified format shall in- section that are present in insignifi- clude information on the following nu- cant amounts) shall be included at the trients: bottom of the nutrition label.

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(5) Except as provided for in para- the AOAC International,’’ or, if no graphs (j)(5) and (j)(13) of this section, AOAC method is available or appro- nutrient information declared in the priate, by other reliable and appro- simplified format shall be presented in priate analytical procedures. the same manner as specified in para- (3) Two classes of nutrients are de- graphs (d) or (e) of this section, except fined for purposes of compliance: that the footnote required in paragraph (i) Class I. Added nutrients in for- (d)(9) of this section is not required, tified or fabricated foods; and and an asterisk shall be placed at the (ii) Class II. Naturally occurring (in- bottom of the label followed by the digenous) nutrients. When a nutrient is statement ‘‘% DV = % Daily Value’’ naturally occurring (indigenous) in a when ‘‘Daily Value’’ is not spelled out food or an ingredient that is added to a in the heading, as shown in paragraph food, the total amount of such nutrient (f)(4). in the final food product is subject to (g) Compliance with this section class II requirements, except that when shall be determined as follows: an exogenous source of the nutrient is (1) A collection of primary containers also added to the final food product, or units of the same size, type, and the total amount of the nutrient in the style produced under conditions as final food product (indigenous and ex- nearly uniform as possible, designated ogenous) is subject to class I require- by a common container code or mark- ments. ing, or in the absence of any common (4) A food with a label declaration of container code or marking, a day’s pro- a vitamin, mineral, protein, total car- duction, constitutes a ‘‘lot.’’ bohydrate, dietary fiber, soluble fiber, (2) The sample for nutrient analysis insoluble fiber, polyunsaturated or shall consist of a composite of 12 sub- monounsaturated fat shall be deemed samples (consumer units), taken 1 from to be misbranded under section 403(a) each of 12 different randomly chosen of the Federal Food, Drug, and Cos- shipping cases, to be representative of metic Act (the act) unless it meets the a lot. Unless a particular method of following requirements: analysis is specified in paragraph (c) of (i) When a vitamin, mineral, protein, this section, composites shall be ana- or dietary fiber meets the definition of lyzed by appropriate methods as given a Class I nutrient, the nutrient content in the ‘‘Official Methods of Analysis of of the composite must be formulated to

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be at least equal to the value for that not be considered granted until the nutrient declared on the label. Center for Food Safety and Applied Nu- (ii) When a vitamin, mineral, protein, trition has agreed to all aspects of the total carbohydrate, polyunsaturated or database in writing. The approval will monounsaturated fat, or dietary fiber be granted where a clear need is pre- meets the definition of a Class II nutri- sented (e.g., raw produce and seafood). ent, the nutrient content of the com- Approvals will be in effect for a limited posite must be at least equal to 80 per- time, e.g., 10 years, and will be eligible cent of the value for that nutrient de- for renewal in the absence of signifi- clared on the label. Provided, That no cant changes in agricultural or indus- regulatory action will be based on a de- try practices. Approval requests shall termination of a nutrient value that be submitted in accordance with the falls below this level by a factor less provisions of § 10.30 of this chapter. than the variability generally recog- Guidance in the use of databases may nized for the analytical method used in be found in the ‘‘FDA Nutrition Label- that food at the level involved. ing Manual—A Guide for Developing (5) A food with a label declaration of and Using Data Bases,’’ available from calories, total sugars, added sugars the Office of Nutrition and Food Label- (when the only source of sugars in the ing (HFS–800), Center for Food Safety food is added sugars), total fat, satu- and Applied Nutrition, Food and Drug rated fat, trans fat, cholesterol, or so- Administration, 5001 Campus Dr., Col- dium shall be deemed to be misbranded lege Park, MD 20740 or by going to under section 403(a) of the act if the http://www.fda.gov. nutrient content of the composite is (9) When it is not technologically fea- greater than 20 percent in excess of the sible, or some other circumstance value for that nutrient declared on the makes it impracticable, for firms to label. Provided, That no regulatory ac- comply with the requirements of this tion will be based on a determination section (e.g., to develop adequate nutri- of a nutrient value that falls above this ent profiles to comply with the require- level by a factor less than the varia- ments of paragraph (c) of this section), bility generally recognized for the ana- FDA may permit alternative means of lytical method used in that food at the compliance or additional exemptions level involved. to deal with the situation. Firms in (6) Reasonable excesses of vitamins, need of such special allowances shall minerals, protein, total carbohydrate, make their request in writing to the dietary fiber, soluble fiber, insoluble Center for Food Safety and Applied Nu- fiber, sugar alcohols, polyunsaturated trition (HFS–800), Food and Drug Ad- or monounsaturated fat over labeled ministration, 5001 Campus Dr., College amounts are acceptable within current Park, MD 20740. good manufacturing practice. Reason- (10) The manufacturer must make able deficiencies of calories, total sug- and keep written records (e.g., analyses ars, added sugars, total fat, saturated of databases, recipes, formulations, in- fat, trans fat, cholesterol, or sodium formation from recipes or formula- under labeled amounts are acceptable tions, or batch records) to verify the within current good manufacturing declared amount of that nutrient on practice. the Nutrition Facts label as follows: (7) Compliance will be based on the (i) When a mixture of dietary fiber, metric measure specified in the label and added non-digestible carbo- statement of serving size. hydrate(s) that does not meet the defi- (8) Alternatively, compliance with nition of dietary fiber, is present in the the provisions set forth in paragraphs food, a manufacturer must make and (g)(1) through (6) of this section may be keep written records of the amount of provided by use of an FDA approved non-digestible carbohydrate(s) added to database that has been computed fol- the food that does not meet the defini- lowing FDA guideline procedures and tion of dietary fiber. where food samples have been handled (ii) When a mixture of soluble fiber in accordance with current good manu- and added non-digestible carbo- facturing practice to prevent nutrition hydrate(s) that does not meet the defi- loss. FDA approval of a database shall nition of dietary fiber is present in the

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food, a manufacturer must make and tion for why the amount of added sug- keep written records necessary to ars in a serving of the product is likely verify the amount of the non-digestible to have a significant reduction in carbohydrate(s) added to the food that added sugars compared to the amount does not meet the definition of dietary added prior to non-enzymatic browning fiber. and/or fermentation. A significant re- (iii) When a mixture of insoluble duction would be where reduction in fiber and added non-digestible carbo- added sugars after non-enzymatic hydrate(s) that does not meet the defi- browning and/or fermentation may be nition of dietary fiber is present in the significant enough to impact the label food, a manufacturer must make and declaration for added sugars by an keep written records necessary to amount that exceeds the reasonable de- verify the amount of the non-digestible ficiency acceptable within good manu- carbohydrate(s) added to the food that facturing practice under paragraph does not meet the definition of dietary (g)(6) of this section. In addition, the fiber. scientific data or other information (iv) When a mixture of naturally oc- must include the reason that the man- curring and added sugars is present in ufacturer is unable to determine a rea- the food, a manufacturer must make sonable approximation of the amount and keep written records of the amount of added sugars in a serving of their of added sugars added to the food dur- finished product and a description of ing the processing of the food, and if the process that they used to come to packaged as a separate ingredient, as that conclusion. packaged (whether as part of a package (vi) When a mixture of all rac-a-to- containing one or more ingredients or copherol and RRR-a-tocopherol is packaged as a single ingredient). present in a food, manufacturers must (v) When the amount of sugars added make and keep written records of the to food products is reduced through amount of all rac-a-tocopherol added to non-enzymatic browning and/or fer- the food and RRR-a-tocopherol in the mentation, manufacturers must: finished food. (A) Make and keep records of all rel- (vii) When a mixture of folate and evant scientific data and information folic acid is present in a food, manufac- relied upon by the manufacturer that turers must make and keep written demonstrates the amount of added sug- records of the amount of synthetic ars in the food after non-enzymatic folate and/or folic acid added to the browning and/or fermentation and a food and the amount of naturally-oc- narrative explaining why the data and curring folate in the finished food. information are sufficient to dem- (11) Records necessary to verify cer- onstrate the amount of added sugars tain nutrient declarations that are declared in the finished food, provided specified in paragraph (g)(10) of this the data and information used is spe- section must be kept for a period of at cific to the type of food that is subject least 2 years after introduction or de- to non-enzymatic browning and/or fer- livery for introduction of the food into mentation; or interstate commerce. Such records (B) Make and keep records of the must be provided to FDA upon request, amount of added sugars added to the during an inspection, for official review food before and during the processing and photocopying or other means of re- of the food, and if packaged as a sepa- production. Records required to verify rate ingredient, as packaged (whether information on the label may be kept as part of a package containing one or either as original records, true copies more ingredients or packaged as a sin- (such as photocopies, pictures, scanned gle ingredient) and in no event shall copies, microfilm, microfiche, or other the amount of added sugars declared accurate reproductions of the original exceed the amount of total sugars on records), or electronic records which the label; or must be kept in accordance with part (C) Submit a petition, under 21 CFR 11 of this chapter. These records must 10.30, to request an alternative means be accurate, indelible, and legible. of compliance. The petition must pro- Failure to make and keep the records vide scientific data or other informa- or provide the records to appropriate

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regulatory authorities, as required by age or in labeling within or attached to this paragraph (g)(11), would result in the outer package. the food being misbranded under sec- (ii) In the absence of a reference tion 403(a)(1) of the act. amount customarily consumed in (h) Products with separately pack- § 101.12(b) that is appropriate for the aged ingredients or foods, with assort- variety or assortment of foods in a gift ments of food, or to which other ingre- package, the following may be used as dients are added by the user may be la- the standard serving size for purposes beled as follows: of nutrition labeling of foods subject to (1) If a product consists of two or this paragraph: 1 ounce for solid foods; more separately packaged ingredients 2 fluid ounces for nonbeverage liquids enclosed in an outer container or of as- (e.g., syrups); 8 ounces for beverages sortments of the same type of food that consist of milk and fruit juices, (e.g., assorted nuts or candy mixtures) nectars and fruit drinks; and 12 fluid in the same retail package, nutrition ounces for other beverages. However, labeling shall be located on the outer the reference amounts customarily container or retail package (as the case consumed in § 101.12(b) shall be used for may be) to provide information for the purposes of evaluating whether indi- consumer at the point of purchase. vidual foods in a gift package qualify However, when two or more food prod- for nutrient content claims or health ucts are simply combined together in claims. such a manner that no outer container (iii) The number of servings per con- is used, or no outer label is available, tainer may be stated as ‘‘varied.’’ each product shall have its own nutri- (iv) Nutrition information may be tion information, e.g., two boxes taped provided per serving for individual together or two cans combined in a foods in the package, or, alternatively, clear plastic overwrap. When sepa- as a composite per serving for reasonable categories of foods in the package rately packaged ingredients or assort- having similar dietary uses and similar ments of the same type of food are insignificant nutritional characteristics. tended to be eaten at the same time, Reasonable categories of foods may be the nutrition information may be spec- used only if accepted by FDA. In deter- ified per serving for each component or mining whether a proposed category is as a composite value. reasonable, FDA will consider whether (2) If a product consists of two or the values of the characterizing nutri- more separately packaged foods that ents in the foods proposed to be in the are intended to be eaten individually category meet the compliance criteria and that are enclosed in an outer con- set forth in paragraphs (g)(3) through tainer (e.g., variety packs of cereals or (6) of this section. Proposals for such snack foods), the nutrition information categories may be submitted in writing shall: to the Office of Nutrition and Food La- (i) Be specified per serving for each beling (HFS–800), Center for Food Safe- food in a location that is clearly visible ty and Applied Nutrition, Food and to the consumer at the point of pur- Drug Administration, 5001 Campus Dr., chase; and College Park, MD 20740. (ii) Be presented in separate nutri- (v) If a food subject to paragraph tion labels or in one aggregate nutri- (j)(13) of this section because of its tion label with separate columns for small size is contained in a gift pack- the quantitative amount by weight and age, the food need not be included in the percent Daily Value for each food. the determination of nutrition infor- (3) If a package contains a variety of mation under paragraph (h) of this sec- foods, or an assortment of foods, and is tion if it is not specifically listed in a in a form intended to be used as a gift, promotional catalogue as being present the nutrition labeling shall be in the in the gift package, and: form required by paragraphs (a) (A) It is used in small quantities pri- through (f) of this section, but it may marily to enhance the appearance of be modified as follows: the gift package; or (i) Nutrition information may be pre- (B) It is included in the gift package sented on the label of the outer pack- as a free gift or promotional item.

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(4) If a food is commonly combined reasonable estimates must indicate with other ingredients or is cooked or that annual sales will not exceed the otherwise prepared before eating, and amounts specified. For foreign firms directions for such combination or that ship foods into the United States, preparations are provided, another col- the business activities to be included umn of figures may be used to declare shall be the total amount of food sales, nutrition information on the basis of as well as other sales to consumers, by the food as consumed in the format re- the firm in the United States. quired in paragraph (e) of this section; (2) Except as provided in § 101.11, food e.g., a dry ready-to-eat cereal may be products that are: described with the percent Daily Value (i) Served in restaurants, Provided, and the quantitative amounts for the That the food bears no nutrition claims cereal as sold (e.g., per ounce), and the or other nutrition information in any percent Daily Value and the quan- context on the label or in labeling or titative amounts for the cereal and milk as suggested in the label (e.g., per advertising. Claims or other nutrition information subject the food to the ounce of cereal and 1⁄2cup of vitamin D fortified skim milk); and a cake mix provisions of this section; may be labeled with the percent Daily (ii) Served in other establishments in Value and the quantitative amounts which food is served for immediate for the dry mix (per serving) and the human consumption (e.g., institutional percent Daily Value and the quan- food service establishments, such as titative amounts for the serving of the schools, hospitals, and cafeterias; final cake when prepared, as shown in transportation carriers, such as trains paragraph (e)(5) of this section: Pro- and airplanes; bakeries, delicatessens, vided, that, the type and quantity of and retail confectionery stores where the other ingredients to be added to there are facilities for immediate con- the product by the user and the specific sumption on the premises; food service method of cooking and other prepara- vendors, such as lunch wagons, ice tion shall be specified prominently on cream shops, mall cookie counters, the label. vending machines, and sidewalk carts (i) Except as provided in paragraphs where foods are generally consumed (j)(13) and (j)(17) of this section, the lo- immediately where purchased or while cation of nutrition information on a the consumer is walking away, includ- label shall be in compliance with ing similar foods sold from convenience § 101.2. stores; and food delivery systems or es- (j) The following foods are exempt tablishments where ready-to-eat foods from this section or are subject to spe- are delivered to homes or offices), Pro- cial labeling requirements: vided, That the food bears no nutrition (1)(i) Food offered for sale by a person claims or other nutrition information who makes direct sales to consumers in any context on the label or in label- (e.g., a retailer) who has annual gross ing or advertising, except as provided sales made or business done in sales to in § 101.8(c). Claims or other nutrition consumers that is not more than $500,000 or has annual gross sales made information, except as provided in or business done in sales of food to con- § 101.8(c), subject the food to the provi- sumers of not more than $50,000, Pro- sions of this section; vided, That the food bears no nutrition (iii) Sold only in such facilities, Pro- claims or other nutrition information vided, That the food bears no nutrition in any context on the label or in label- claims or other nutrition information ing or advertising. Claims or other nu- in any context on the label or in label- trition information subject the food to ing or advertising. Claims or other nu- the provisions of this section, § 101.10, trition information subject the food to or § 101.11, as applicable. the provisions of this section; (ii) For purposes of this paragraph, (iv) Used only in such facilities and calculation of the amount of sales shall not served to the consumer in the be based on the most recent 2-year av- package in which they are received erage of business activity. Where firms (e.g., foods that are not packaged in in- have been in business less than 2 years, dividual serving containers); or

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(v) Sold by a distributor who prin- information under paragraph (c) of this cipally sells food to such facilities: Pro- section, Provided, That the food bears vided, That: no nutrition claims or other nutrition (A) This exemption shall not be information in any context on the label available for those foods that are man- or in labeling or advertising. Claims or ufactured, processed, or repackaged by other nutrition information, except as that distributor for sale to any persons provided in § 101.8(c), subject the food other than restaurants or other estab- to the provisions of this section. An in- lishments that serve food for imme- significant amount of a nutrient or diate human consumption, and food component shall be that amount (B) The manufacturer of such prod- that allows a declaration of zero in nu- ucts is responsible for providing the trition labeling, except that for total nutrition information on the products carbohydrate, dietary fiber, and pro- if there is a reasonable possibility that tein, it shall be an amount that allows the product will be purchased directly a declaration of ‘‘less than 1 gram.’’ by consumers. Examples of foods that are exempt (3) Except as provided in § 101.11, food under this paragraph include coffee products that are: beans (whole or ground), tea leaves, (i) Of the type of food described in plain unsweetened instant coffee and paragraphs (j)(2)(i) and (j)(2)(ii) of this tea, condiment-type dehydrated vege- section, tables, flavor extracts, and food colors. (ii) Ready for human consumption, (5)(i) Foods, other than infant for- (iii) Offered for sale to consumers but mula, represented or purported to be not for immediate human consump- specifically for infants through 12 tion, months of age and children 1 through 3 (iv) Processed and prepared primarily years of age shall bear nutrition label- in a retail establishment, and ing. The nutrients declared for infants (v) Not offered for sale outside of through 12 months of age and children that establishment (e.g., ready-to-eat 1 through 3 years of age shall include foods that are processed and prepared calories, total fat, saturated fat, trans on-site and sold by independent deli- fat, cholesterol, sodium, total carbo- catessens, bakeries, or retail confec- hydrates, dietary fiber, total sugars, tionery stores where there are no fa- added sugars, protein, and the fol- cilities for immediate human consump- lowing vitamins and minerals: Vitamin tion; by in-store delicatessen, bakery, D, calcium, iron, and potassium. or candy departments; or at self-serv- (ii) Foods, other than infant formula, ice food bars such as salad bars), Pro- represented or purported to be specifi- vided, That the food bears no nutrition cally for infants through 12 months of claims or other nutrition information age shall bear nutrition labeling, ex- in any context on the label or in label- cept that: ing or advertising. Claims or other nu- (A) Such labeling shall not declare a trition information subject the food to percent Daily Value for saturated fat, the provisions of this section. trans fat, cholesterol, sodium, dietary (4) Except as provided in § 101.11, fiber, total sugars, or added sugars and foods that contain insignificant shall not include a footnote. amounts of all of the nutrients and (B) The following sample label illus- food components required to be in- trates the provisions of paragraph cluded in the declaration of nutrition (j)(5)(ii) of this section.

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(C)–(E) [Reserved] of food contributes to a daily diet. 1,000 (iii) Foods, other than infant for- calories a day is used for general nutri- mula, represented or purported to be tion advice.’’ specifically for children 1 through 3 (A) The following sample label illus- years of age shall include a footnote trates the provisions of paragraph that states: ‘‘*The % Daily Value tells (j)(5)(iii) of this section. you how much a nutrient in a serving

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(B) [Reserved] of therapeutic or chronic medical (6) Dietary supplements, except that needs, has limited or impaired capacity such foods shall be labeled in compli- to ingest, digest, absorb, or metabolize ance with § 101.36. ordinary foodstuffs or certain nutri- (7) Infant formula subject to section ents, or who has other special medi- 412 of the act, as amended, except that cally determined nutrient require- such foods shall be labeled in compli- ments, the dietary management of ance with part 107 of this chapter. which cannot be achieved by the modi- (8) Medical foods as defined in section fication of the normal diet alone; 5(b) of the Orphan Drug Act (21 U.S.C. (iii) It provides nutritional support 360ee(b)(3)). A medical food is a food specifically modified for the manage- which is formulated to be consumed or ment of the unique nutrient needs that administered enterally under the su- result from the specific disease or con- pervision of a physician and which is dition, as determined by medical eval- intended for the specific dietary man- uation; agement of a disease or condition for (iv) It is intended to be used under which distinctive nutritional require- medical supervision; and ments, based on recognized scientific (v) It is intended only for a patient principles, are established by medical receiving active and ongoing medical evaluation. A food is subject to this ex- supervision wherein the patient re- emption only if: quires medical care on a recurring (i) It is a specially formulated and basis for, among other things, instruc- processed product (as opposed to a nat- tions on the use of the medical food. urally occurring foodstuff used in its (9) Food products shipped in bulk natural state) for the partial or exclu- form that are not for distribution to sive feeding of a patient by means of consumers in such form and that are oral intake or enteral feeding by tube; for use solely in the manufacture of (ii) It is intended for the dietary other foods or that are to be processed, management of a patient who, because labeled, or repacked at a site other

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than where originally processed or quail, wild turkey, or ostrich) may pro- packed. vide required nutrition information on (10) Raw fruits, vegetables, and fish labeling in accordance with the provi- subject to section 403(q)(4) of the act, sions of paragraph (a)(2) of this section. except that the labeling of such foods (13)(i) Foods in small packages that should adhere to guidelines in § 101.45. have a total surface area available to This exemption is contingent on the bear labeling of less than 12 square food bearing no nutrition claims or inches, Provided, That the labels for other nutrition information in any these foods bear no nutrition claims or context on the label or in labeling or other nutrition information in any advertising. Claims or other nutrition context on the label or in labeling or information subject the food to nutri- advertising, except as provided in tion labeling in accordance with § 101.8(c). Claims or other nutrition in- § 101.45. The term fish includes fresh- formation, except as provided in water or marine fin fish, crustaceans, § 101.8(c), subject the food to the provi- and mollusks, including shellfish, am- sions of this section. phibians, and other forms of aquatic (ii) Foods in packages that have a animal life. total surface area available to bear la- (11) Packaged single-ingredient prod- beling of 40 or less square inches may ucts that consist of fish or game meat (i.e., animal products not covered modify the requirements of paragraphs under the Federal Meat Inspection Act (c) through (f) and (i) of this section by or the Poultry Products Inspection one or more of the following means: Act, such as flesh products from deer, (A) Presenting the required nutrition bison, rabbit, quail, wild turkey, or os- information in a tabular or, as pro- trich) subject to this section may provided below, linear (i.e., string) fashion vide required nutrition information for rather than in vertical columns if the a 3-ounce cooked edible portion (i.e., on product has a total surface area avail- an ‘‘as prepared’’ basis), except that: able to bear labeling of less than 12 (i) Such products that make claims square inches, or if the product has a that are based on values as packaged total surface area available to bear la- must provide nutrition information on beling of 40 or less square inches and an as packaged basis, and the package shape or size cannot ac- (ii) Nutrition information is not re- commodate a standard vertical column quired for custom processed fish or or tabular display on any label panel. game meats. Nutrition information may be given in (12) Game meats (i.e., animal prod- a linear fashion only if the label will ucts not covered under the Federal not accommodate a tabular display. Meat Inspection Act or the Poultry (1) The following sample label illus- Products Inspection Act, such as flesh trates the tabular display for small products from deer, bison, rabbit, packages.

(2) The following sample label illustrates the linear display.

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(B) Using any of the following abbre- beled For Retail Sale’’ in type size not viations: less than 1/16-inch in height, except Serving size—Serv size that this statement shall not be re- Servings per container—Servings quired when the inner unit containers Calories from saturated fat—Sat fat cal bear no labeling at all. The word ‘‘in- Saturated fat—Sat fat dividual’’ may be used in lieu of or im- Monounsaturated fat—Monounsat fat mediately preceding the word ‘‘Retail’’ Polyunsaturated fat—Polyunsat fat in the statement. Cholesterol—Cholest (16) Food products sold from bulk Total carbohydrate—Total carb. This containers: Provided, That nutrition in- abbreviation can also be used on formation required by this section be dual-column displays as shown in displayed to consumers either on the paragraphs (e)(5), (e)(6)(i), and labeling of the bulk container plainly (e)(6)(ii). in view or in accordance with the pro- Dietary fiber—Fiber visions of paragraph (a)(2) of this sec- Soluble fiber—Sol fiber tion. Insoluble fiber—Insol fiber (17) Foods in packages that have a Sugar alcohol—Sugar alc total surface area available to bear la- Vitamin—Vit beling greater than 40 square inches Potassium—Potas but whose principal display panel and Includes—Incl. This abbreviation can information panel do not provide suffi- also be used on dual-column displays cient space to accommodate all reas shown in paragraphs (e)(5), quired information may use any alter- (e)(6)(i), and (e)(6)(ii) of this section. nate panel that can be readily seen by (C) Presenting the required nutrition consumers for the nutrition label. The information on any label panel. space needed for vignettes, designs, and (14) Shell eggs packaged in a carton other nonmandatory label information that has a top lid designed to conform on the principal display panel may be to the shape of the eggs are exempt considered in determining the suffi- from outer carton label requirements ciency of available space on the prin- where the required nutrition informa- cipal display panel for the placement of tion is clearly presented immediately the nutrition label. Nonmandatory beneath the carton lid or in an insert label information on the information that can be clearly seen when the car- panel shall not be considered in deter- ton is opened. mining the sufficiency of available (15) The unit containers in a multi- space for the placement of the nutri- unit retail food package where: tion label. (i) The multiunit retail food package (18) Food products that are low-vol- labeling contains all nutrition infor- ume (that is, they meet the require- mation in accordance with the requirements for units sold in paragraphs ments of this section; (j)(18)(i) or (j)(18)(ii) of this section); (ii) The unit containers are securely that, except as provided in paragraph enclosed within and not intended to be (j)(18)(iv) of this section, are the sub- separated from the retail package ject of a claim for an exemption that under conditions of retail sale; and provides the information required (iii) Each unit container is labeled under paragraph (j)(18)(iv) of this sec- with the statement ‘‘This Unit Not La- tion, that is filed before the beginning

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of the time period for which the exemp- provisions of paragraphs (j)(18)(i) or tion is claimed, and that is filed by a (j)(18)(ii) of this section, such person person, whether it is the manufacturer, shall have 18 months from the date packer, or distributor, that qualifies to that the product was no longer quali- claim the exemption under the require- fied as a low-volume product of a small ments for average full-time equivalent business to comply with this section. employees in paragraphs (j)(18)(i) or (iv) A notice shall be filed with the (j)(18)(ii) of this section; and whose la- Office of Nutrition and Food Labeling bels, labeling, and advertising do not (HFS–800), Center for Food Safety and provide nutrition information or make Applied Nutrition, Food and Drug Ad- a nutrient content or health claim. ministration, 5001 Campus Dr., College (i) For food products first introduced Park, MD 20740 and contain the fol- into interstate commerce before May 8, lowing information, except that if the 1994, the product shall be exempt for person is not an importer and has fewer the period: than 10 full-time equivalent employees, (A) Between May 8, 1995, and May 7, that person does not have to file a no- 1996, if, for the period between May 8, tice for any food product with annual 1994, and May 7, 1995, the person claim- sales of fewer than 10,000 total units: ing the exemption employed fewer than (A) Name and address of person re- an average of 300 full-time equivalent questing exemption. This should in- employees and fewer than 400,000 units clude a telephone number or FAX num- of that product were sold in the United ber that can be used to contact the per- States; and son along with the name of a specific (B) Between May 8, 1996, and May 7, contact; 1997, if for the period between May 8, (B) Names of the food products (in- 1995, and May 7, 1996, the person claim- cluding the various brand names) for ing the exemption employed fewer than which exemption is claimed; an average of 200 full-time equivalent employees and fewer than 200,000 units (C) Name and address of the manufac- of that product were sold in the United turer, distributor, or importer of the States. food product for which an exemption is (ii) For all other food products, the claimed, if different than the person product shall be eligible for an exemp- that is claiming the exemption; tion for any 12-month period if, for the (D) The number of full-time equiva- preceding 12 months, the person claim- lent employees. Provide the average ing the exemption employed fewer than number of full-time equivalent individ- an average of 100 full-time equivalent uals employed by the person and its af- employees and fewer than 100,000 units filiates for the 12 months preceding the of that product were sold in the United period for which a small business ex- States, or in the case of a food product emption is claimed for a product. The that was not sold in the 12-month pe- average number of full-time equivalent riod preceding the period for which ex- employees is to be determined by divid- emption is claimed, fewer than 100,000 ing the total number of hours of salary units of such product are reasonably or wages paid to employees of the per- anticipated to be sold in the United son and its affiliates by the number of States during the period for which ex- hours of work in a year, 2,080 hours emption is claimed. (i.e., 40 hours × 52 weeks); (iii) If a person claims an exemption (E) Approximate total number of under paragraphs (j)(18)(i) or (j)(18)(ii) units of the food product sold by the of this section for a food product and person in the United States in the 12- then, during the period of such exemp- month period preceding that for which tion, the number of full-time equiva- a small business exemption is claimed. lent employees of such person exceeds Provide the approximate total number the appropriate number, or the number of units sold, or expected to be sold, in of food products sold in the United a 12-month period for each product for States exceeds the appropriate number, which an exemption is claimed. For or, if at the end of the period of such products that have been in production exemption, the food product no longer for 1 year or more prior to the period qualifies for an exemption under the for which exemption is claimed, the 12-

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month period is the period imme- or other entity that is not a corpora- diately preceding the period for which tion. an exemption is claimed. For other (D) Full-time equivalent employee products, the 12-month period is the pe- means all individuals employed by the riod for which an exemption is claimed; person claiming the exemption. This and number shall be determined by divid- (F) The notice shall be signed by a re- ing the total number of hours of salary sponsible individual for the person who or wages paid directly to employees of can certify the accuracy of the infor- the person and of all of its affiliates by mation presented in the notice. The in- the number of hours of work in a year, dividual shall certify that the informa- 2,080 hours (i.e., 40 hours × 52 weeks). tion contained in the notice is a com- (k) A food labeled under the provi- plete and accurate statement of the av- sions of this section shall be deemed to erage number of full-time equivalent be misbranded under sections 201(n) employees of this person and its affili- and 403(a) of the act if its label or la- ates and of the number of units of the beling represents, suggests, or implies: product for which an exemption is (1) That the food, because of the pres- claimed sold by the person. The indi- ence or absence of certain dietary prop- vidual shall also state that should the erties, is adequate or effective in the average number of full-time equivalent prevention, cure, mitigation, or treat- employees or the number of units of ment of any disease or symptom. Infor- food products sold in the United States mation about the relationship of a die- by the person exceed the applicable tary property to a disease or health-re- numbers for the time period for which lated condition may only be provided exemption is claimed, the person will in conformance with the requirements notify FDA of that fact and the date on of § 101.14 and part 101, subpart E. which the number of employees or the (2) That the lack of optimum nutri- number of products sold exceeded the tive quality of a food, by reason of the standard. soil on which that food was grown, is or may be responsible for an inadequacy (v) FDA may by regulation lower the or deficiency in the quality of the daily employee or units of food products re- diet. quirements of paragraph (j)(18)(ii) of (3) That the storage, transportation, this section for any food product first processing, or cooking of a food is or introduced into interstate commerce may be responsible for an inadequacy after May 8, 2002, if the agency deter- or deficiency in the quality of the daily mines that the cost of compliance with diet. such lower requirement will not place (4) That a natural vitamin in a food an undue burden on persons subject to is superior to an added or synthetic vi- it. tamin. (vi) For the purposes of this para- (l) The standards required in this sec- graph, the following definitions apply: tion are incorporated by reference into (A) Unit means the packaging or, if this section with the approval of the there is no packaging, the form in Director of the Federal Register under which a food product is offered for sale 5 U.S.C. 552(a) and 1 CFR part 51. All to consumers. approved material is available for in- (B) Food product means food in any spection at the Office of Nutrition and sized package which is manufactured Food Labeling (HFS–800), Center for by a single manufacturer or which Food Safety and Applied Nutrition, bears the same brand name, which Food and Drug Administration, 5001 bears the same statement of identity, Campus Dr., College Park, MD 20740, and which has similar preparation 240–402–2404 and is available from the methods. sources indicated below. It is also (C) Person means all domestic and available for inspection at the National foreign affiliates, as defined in 13 CFR Archives and Records Administration 121.401, of the corporation, in the case (NARA). For information on the avail- of a corporation, and all affiliates, as ability of this material at NARA, call defined in 13 CFR 121.401, of a firm or 202–741–6030, or go to: http:// other entity, when referring to a firm www.archives.gov/federallregister/

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codeloflfederallregulations/ part) or a health claim (as defined in ibrllocations.html. § 101.14 and permitted by a regulation (1) AOAC Reseller. Techstreet, 6300 in subpart E of this part) is made, ex- Interfirst Dr., Ann Arbor, MI 48108, Toll cept that information on the nutrient free in United States: 1–800–699–9277, amounts that are the basis for the Outside United States: 1–734–780–8000, claim (e.g., ‘‘low fat, this meal provides Fax: 1–734–780–2046, www.techstreet.com, less than 10 grams of fat’’) may serve [email protected]. as the functional equivalent of com- FDA does not endorse any particular plete nutrition information as de- reseller and notes that other resellers scribed in § 101.9. For the purposes of also may have the reference for sale. this section, restaurant food includes Consult FDA at 240–402–2404 for more two categories of food. It includes food information on additional resellers. which is served in restaurants or other (i) ‘‘Official Methods of Analysis of establishments in which food is served the AOAC INTERNATIONAL,’’ 19th for immediate human consumption or Edition, Volumes 1 and 2, 2012. which is sold for sale or use in such es- (ii) [Reserved] tablishments. It also includes food (2) Food and Agriculture Organiza- which is processed and prepared pri- tion of the United Nations/World marily in a retail establishment, which Health Organization (FAO/WHO), Pub- is ready for human consumption, which lications Division, Viale delle Terme di is of the type described in the previous Caracalla, 00100 Rome, Italy sentence, and which is offered for sale (i) FAO Food and Nutrition Paper to consumers but not for immediate 51,’’Report of the Joint FAO/WHO Ex- human consumption in such establish- pert Consultation on Protein Quality ment and which is not offered for sale Evaluation,’’ Rome, 1991. http:// outside such establishment. For stand- apps.who.int /iris/bitstream/ 10665/38133/1/ ard menu items that are offered for 9251030979leng.pdf. sale in covered establishments (as de- (ii) [Reserved] fined in § 101.11(a)), the information in (3) United States Department of Ag- the written nutrition information re- riculture (USDA), Agricultural Re- quired by § 101.11(b)(2)(ii)(A) will serve search Service, Washington, DC, Nutri- to meet the requirements of this sec- ent Data Laboratory, Bldg. 005 Room tion. Nutrient levels may be deter- 105 BARC-West, Beltsville, MD 20705, mined by nutrient databases, cook- 301–504–0630. http://www.ars.usda.gov/ books, or analyses or by other reason- News/docs.htm?docid=9447. able bases that provide assurance that (i) USDA Handbook No. 74, Energy the food or meal meets the nutrient re- Value of Foods—basis and derivation, quirements for the claim. Presentation by A. L. Merrill and B. K. Watt, (slight- of nutrition labeling may be in various ly revised, 1973) http://www.ars.usda.gov forms, including those provided in /SP2UserFiles/Place/80400525/Data/ § 101.45 and other reasonable means. Classics/ah74.pdf. [79 FR 71253, Dec. 1, 2014] (ii) [Reserved] [58 FR 2175, Jan. 6, 1993] § 101.11 Nutrition labeling of standard menu items in covered establish- EDITORIAL NOTE: For FEDERAL REGISTER ci- ments. tations affecting § 101.9, see the List of CFR (a) Definitions. The definitions of Sections Affected, which appears in the Finding Aids section of the printed volume terms in section 201 of the Federal and at www.fdsys.gov. Food, Drug, and Cosmetic Act apply to such terms when used in this section. § 101.10 Nutrition labeling of res- In addition, for purposes of this sec- taurant foods whose labels or label- tion: ing bear nutrient content claims or Authorized official of a restaurant or health claims. similar retail food establishment means Nutrition labeling in accordance with the owner, operator, agent in charge, § 101.9 shall be provided upon request or other person authorized by the for any restaurant food or meal for owner, operator, or agent in charge to which a nutrient content claim (as de- register the restaurant or similar refined in § 101.13 or in subpart D of this tail food establishment, which is not

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otherwise subject to section 403(q)(5)(H) descriptor ‘‘concession stand’’), the of the Federal Food, Drug, and Cos- name of the parent entity of the estab- metic Act, with FDA for the purposes lishment. When the term ‘‘name’’ re- of paragraph (d) of this section. fers to the name of the establishment Combination meal means a standard presented to the public under para- menu item that consists of more than graph (i) of this definition, the term one food item, for example a meal that ‘‘same’’ includes names that are slight includes a sandwich, a side dish, and a variations of each other, for example, drink. A combination meal may be rep- due to the region, location, or size (e.g., resented on the menu or menu board in ‘‘New York Ave. Burgers’’ and ‘‘Penn- narrative form, numerically, or pic- sylvania Ave. Burgers’’ or ‘‘ABC’’ and torially. Some combination meals may ‘‘ABC Express’’). include a variable menu item or be a Food on display means restaurant- variable menu item as defined in this type food that is visible to the cus- paragraph where the components may tomer before the customer makes a se- vary. For example, the side dish may lection, so long as there is not an ordi- vary among several options (e.g., fries, nary expectation of further preparation salad, or onion rings) or the drinks by the consumer before consumption. may vary (e.g., soft drinks, milk, or Food that is part of a customary market juice) and the customer selects which test means food that appears on a menu of these items will be included in the or menu board for less than 90 consecu- meal. tive days in order to test consumer ac- Covered establishment means a res- ceptance of the product. taurant or similar retail food establish- Location means a fixed position or ment that is a part of a chain with 20 site. or more locations doing business under Menu or menu board means the pri- the same name (regardless of the type mary writing of the covered establish- of ownership, e.g., individual fran- ment from which a customer makes an chises) and offering for sale substan- order selection, including, but not lim- tially the same menu items, as well as ited to, breakfast, lunch, and dinner a restaurant or similar retail food es- menus; dessert menus; beverage menus; tablishment that is registered to be children’s menus; other specialty covered under paragraph (d) of this sec- menus; electronic menus; and menus tion. on the Internet. Determining whether Custom order means a food order that a writing is or is part of the primary is prepared in a specific manner based writing of the covered establishment on an individual customer’s request, from which a customer makes an order which requires the covered establish- selection depends on a number of fac- ment to deviate from its usual prepara- tors, including whether the writing tion of a standard menu item, e.g., a lists the name of a standard menu item club sandwich without the bacon if the (or an image depicting the standard establishment usually includes bacon menu item) and the price of the stand- in its club sandwich. ard menu item, and whether the writ- Daily special means a menu item that ing can be used by a customer to make is prepared and offered for sale on a an order selection at the time the cus- particular day, that is not routinely tomer is viewing the writing. The listed on a menu or menu board or of- menus may be in different forms, e.g., fered by the covered establishment, booklets, pamphlets, or single sheets of and that is promoted by the covered es- paper. Menu boards include those in- tablishment as a special menu item for side a covered establishment as well as that particular day. drive-through menu boards at covered Doing business under the same name establishments. means sharing the same name. The Offering for sale substantially the same term ‘‘name’’ refers to either: menu items means offering for sale a (i) The name of the establishment significant proportion of menu items presented to the public; or that use the same general recipe and (ii) If there is no name of the estab- are prepared in substantially the same lishment presented to the public (e.g., way with substantially the same food an establishment with the generic components, even if the name of the

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menu item varies, (e.g., ‘‘Bay View Variable menu item means a standard Crab Cake’’ and ‘‘Ocean View Crab menu item that comes in different fla- Cake’’). ‘‘Menu items’’ in this defini- vors, varieties, or combinations, and is tion refers to food items that are listed listed as a single menu item. on a menu or menu board or that are (b) Requirements for nutrition labeling offered as self-service food or food on for food sold in covered establishments— display. Restaurants and similar retail (1) Applicability. (i) The labeling re- food establishments that are part of a quirements in this paragraph (b) apply chain can still be offering for sale sub- to standard menu items offered for sale stantially the same menu items if the in covered establishments. availability of some menu items varies (ii)(A) The labeling requirements in within the chain. Having the same this paragraph (b) do not apply to foods name may indicate, but does not nec- that are not standard menu items, in- essarily guarantee, that menu items cluding: are substantially the same. (1) Items such as condiments that are Restaurant or similar retail food estab- for general use, including those placed lishment means a retail establishment on the table or on or behind the that offers for sale restaurant-type counter; daily specials; temporary food, except if it is a school as defined menu items; custom orders; food that by 7 CFR 210.2 or 220.2. is part of a customary market test; and Restaurant-type food means food that (2) Self-service food and food on dis- is: play that is offered for sale for less (i) Usually eaten on the premises, while walking away, or soon after ar- than a total of 60 days per calendar riving at another location; and year or fewer than 90 consecutive days (ii) Either: in order to test consumer acceptance. (A) Served in restaurants or other es- (B) The labeling requirements of tablishments in which food is served paragraph (b)(2)(iii) of this section do for immediate human consumption or not apply to alcoholic beverages that which is sold for sale or use in such es- are foods on display and are not self- tablishments; or service foods. (B) Processed and prepared primarily (2) Nutrition information. (i) Except as in a retail establishment, ready for provided by paragraph (b)(2)(i)(A)(8) of human consumption, of the type de- this section, the following must be pro- scribed in paragraph (ii)(A) of this defi- vided on menus and menu boards: nition, and offered for sale to con- (A) The number of calories contained sumers but not for immediate human in each standard menu item listed on consumption in such establishment and the menu or menu board, as usually which is not offered for sale outside prepared and offered for sale. In the such establishment. case of multiple-serving standard menu Self-service food means restaurant- items, this means the calories declared type food that is available at a salad must be for the whole menu item listed bar, buffet line, cafeteria line, or simi- on the menu or menu board as usually lar self-service facility and that is prepared and offered for sale (e.g., served by the customers themselves. ‘‘pizza pie: 1600 cal’’); or per discrete Self-service food also includes self- serving unit as long as the discrete service beverages. serving unit (e.g., pizza slice) and total Standard menu item means a res- number of discrete serving units con- taurant-type food that is routinely in- tained in the menu item are declared cluded on a menu or menu board or on the menu or menu board, and the routinely offered as a self-service food menu item is usually prepared and of- or food on display. fered for sale divided in discrete serv- Temporary menu item means a food ing units (e.g., ‘‘pizza pie: 200 cal/slice, that appears on a menu or menu board 8 slices’’). The calories must be de- for less than a total of 60 days per cal- clared in the following manner: endar year. The 60 days includes the (1) The number of calories must be total of consecutive and non-consecu- listed adjacent to the name or the price tive days the item appears on the of the associated standard menu item, menu. in a type size no smaller than the type

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size of the name or the price of the as- amount listed represents the calorie sociated standard menu item, which- amounts for each individual flavor or ever is smaller, in the same color, or a variety. color at least as conspicuous as that (ii) When the menu or menu board used for the name of the associated does not list flavors or varieties for an standard menu item, and with the entire individual variable menu item, same contrasting background or a and only includes a general description background at least as contrasting as of the variable menu item (e.g., ‘‘soft that used for the name of the associ- drinks’’), the calories must be declared ated standard menu item. for each option with a slash between (2) To the nearest 5-calorie increment the two calorie declarations where only up to and including 50 calories and to two options are available (e.g., ‘‘150/250 the nearest 10-calorie increment above calories’’) or as a range in accordance 50 calories, except that amounts less with the requirements of paragraph than 5 calories may be expressed as (b)(2)(i)(A)(7) of this section where zero. more than two options are available (3) The term ‘‘Calories’’ or ‘‘Cal’’ must appear as a heading above a col- (e.g., ‘‘100–250 calories’’). umn listing the number of calories for (iii) When the menu or menu board each standard menu item or adjacent describes flavors or varieties for only to the number of calories for each part of an individual variable menu standard menu item. If the term ‘‘Cal- item (such as different types of cheese ories’’ or ‘‘Cal’’ appears as a heading offered in a grilled cheese sandwich above a column of calorie declarations, (e.g., ‘‘Grilled Cheese (Cheddar or the term must be in a type size no Swiss)’’), the calories must be declared smaller than the smallest type size of for each option with a slash between the name or price of any menu item on the two calorie declarations where only that menu or menu board in the same two options are available (e.g., ‘‘450/500 color or a color at least as conspicuous calories’’) or as a range in accordance as that used for that name or price and with the requirements of paragraph in the same contrasting background or (b)(2)(i)(A)(7) of this section where a background at least as contrasting as more than two options are available that used for that name or price. If the (e.g., ‘‘450–550 calories’’). term ‘‘Calories’’ or ‘‘Cal’’ appears adja- (5) Additional requirements that cent to the number of calories for the apply to a variable menu item that is standard menu item, the term ‘‘Cal- offered for sale with the option of add- ories’’ or ‘‘Cal’’ must appear in the ing toppings listed on the menu or same type size and in the same color menu board. When the menu or menu and contrasting background as the board lists toppings that can be added number of calories. to a menu item (such as pizza or ice (4) Additional requirements that cream): apply to each individual variable menu item: (i) The calories must be declared for (i) When the menu or menu board the basic preparation of the menu item lists flavors or varieties of an entire in- as listed (e.g., ‘‘small pizza pie,’’ ‘‘sin- dividual variable menu item (such as gle scoop ice cream’’). soft drinks, ice cream, doughnuts, dips, (ii) The calories must be separately and chicken that can be grilled or declared for each topping listed on the fried), the calories must be declared menu or menu board (e.g., pepperoni, separately for each listed flavor or va- sausage, green peppers, onions on pizza; riety. Where flavors or varieties have fudge, almonds, sprinkles on ice the same calorie amounts (after round- cream), specifying that the calories are ing in accordance with paragraph added to the calories contained in the (b)(2)(i)(A)(2) of this section), the cal- basic preparation of the menu item. orie declaration for such flavors or va- Where toppings have the same calorie rieties can be listed as a single calorie amounts (after rounding in accordance declaration adjacent to the flavors or with paragraph (b)(2)(i)(A)(2) of this varieties, provided that the calorie dec- section), the calorie declaration for laration specifies that the calorie such toppings can be listed as a single

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calorie declaration adjacent to the top- (iii) When the menu or menu board pings, provided that the calorie dec- includes a choice to increase or de- laration specifies that the calorie crease the size of a combination meal, amount listed represents the calorie the calorie difference must be declared amount for each individual topping. for the increased or decreased size with (iii) The calories for the basic prepa- a slash between two calorie declara- ration of the menu item must be de- tions (e.g., ‘‘Adds 100/150 calories,’’ clared for each size of the menu item. ‘‘Subtracts 100/150 calories’’) if the The calories for each topping listed on menu or menu board lists two options the menu or menu board must be de- for menu items in the combination clared for each size of the menu item, meal, or as a range in accordance with or declared using a slash between the the requirements of paragraph two calorie declarations for each top- (b)(2)(i)(A)(7) of this section (e.g., ping where only two sizes of the menu ‘‘Adds 100–250 calories,’’ ‘‘Subtracts item are available (e.g., ‘‘adds 150/250 100–250 calories’’) if the menu or menu cal’’) or as a range for each topping in board lists three or more options for accordance with the requirements of menu items in the combination meal. paragraph (b)(2)(i)(A)(7) of this section (iv) Where the menu or menu board where more than two sizes of the menu describes an opportunity for a con- item are available (e.g., ‘‘adds 100–250 sumer to combine standard menu items cal’’). If a slash between two calorie for a special price (e.g.,’’Combine Any declarations or a range of calorie dec- Sandwich with Any Soup or Any Salad larations is used, the menu or menu for $8.99’’), and the calories for each board must indicate that the variation standard menu item, including each in calories for each topping arises from size option as described in paragraph the size of the menu item to which the (b)(2)(i)(A)(6)(iii) of this section if appli- toppings are added. cable, available for the consumer to (iv) If the amount of the topping in- combine are declared elsewhere on the cluded on the basic preparation of the menu or menu board, the requirements menu item decreases based on the total of paragraphs (b)(2)(i)(A)(6)(i), (ii), and number of toppings ordered for the (iii) of this section do not apply. menu item (such as is sometimes the (7) Additional format requirements case with pizza toppings), the calories for declaring calories for an individual for each topping must be declared as variable menu item, a combination single values representing the calories meal, and toppings as a range, if appli- for each topping when added to a one- cable. Calories declared as a range topping menu item, specifying that the must be in the format ‘‘xx–yy,’’ where calorie declaration is for the topping ‘‘xx’’ is the caloric content of the low- when added to a one-topping menu est calorie variety, flavor, or combina- item. tion, and ‘‘yy’’ is the caloric content of (6) Additional requirements that the highest calorie variety, flavor, or apply to a combination meal. Except as combination. provided in paragraph (b)(2)(i)(A)(6)(iv) (8) Exception for a variable menu of this section: item that has no clearly identifiable (i) When the menu or menu board upper bound to the range of calories: If lists two options for menu items in a the variable menu item appears on the combination meal (e.g., a sandwich menu or menu board and is a self-serv- with a side salad or chips), the calories ice food or food on display, and there is must be declared for each option with a no clearly identifiable upper bound to slash between the two calorie declara- the range, e.g., all-you-can-eat buffet, tions (e.g., ‘‘350/450 calories’’). then the menu or menu board must in- (ii) When the menu or menu board clude a statement, adjacent to the lists three or more options for menu name or price of the item, referring items in a combination meal (e.g., a customers to the self-service facility sandwich with chips, a side salad, or for calorie information, e.g., ‘‘See buf- fruit), the calories must be declared as fet for calorie declarations.’’ This a range in accordance with the require- statement must appear in a type size ments of paragraph (b)(2)(i)(A)(7) of no smaller than the type size of the this section (e.g., ‘‘350–500 calories’’). name or price of the variable menu

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item, whichever is smaller, and in the the menu. On menu pages that also same color or a color at least as con- bear the statement required by para- spicuous as that used for that name or graph (b)(2)(i)(C) of this section, this price, with the same contrasting back- statement must appear immediately ground or a background at least as con- above, below, or beside the statement trasting as that used for that name or required by paragraph (b)(2)(i)(C) of price. this section. (9) Additional requirements that (3) For menu boards, this statement apply to beverages that are not self- must appear on the bottom of the service. For beverages that are not menu board, immediately above, below, self-service, calories must be declared or beside the statement required by based on the full volume of the cup paragraph (b)(2)(i)(C) of this section. served without ice, unless the covered (C) The following statement regard- establishment ordinarily dispenses and ing the availability of the additional offers for sale a standard beverage fill written nutrition information required (i.e., a fixed amount that is less than in paragraph (b)(2)(ii) of this section the full volume of the cup per cup size) must be on all forms of the menu or or dispenses a standard ice fill (i.e., a menu board: ‘‘Additional nutrition in- fixed amount of ice per cup size). If the formation available upon request.’’ covered establishment ordinarily dis- (1) This statement must be posted penses and offers for sale a standard prominently and in a clear and con- beverage fill or dispenses a standard spicuous manner in a type size no ice fill, the covered establishment smaller than the smallest type size of must declare calories based on such any calorie declaration appearing on standard beverage fill or standard ice the same menu or menu board and in fill. the same color or in a color at least as (B) The following statement designed conspicuous as that used for the caloric to enable consumers to understand, in declarations, and with the same con- the context of a total daily diet, the trasting background or a background significance of the calorie information provided on menus and menu boards: at least as contrasting as that used for ‘‘2,000 calories a day is used for general the caloric declarations. nutrition advice, but calorie needs (2) For menus, the statement must vary.’’ For menus and menu boards tar- appear on the bottom of the first page geted to children, the following options with menu items immediately above, may be used as a substitute for or in below, or beside the succinct statement addition to the succinct statement: required by paragraph (b)(2)(i)(B) of ‘‘1,200 to 1,400 calories a day is used for this section. general nutrition advice for children (3) For menu boards, the statement ages 4 to 8 years, but calorie needs must appear on the bottom of the vary.’’ or ‘‘1,200 to 1,400 calories a day menu board immediately above, below, is used for general nutrition advice for or beside the succinct statement re- children ages 4 to 8 years and 1,400 to quired by paragraph (b)(2)(i)(B) of this 2,000 calories a day for children ages 9 section. to 13 years, but calorie needs vary.’’ (ii) The following nutrition informa- (1) This statement must be posted tion for a standard menu item must be prominently and in a clear and con- available in written form on the prem- spicuous manner in a type size no ises of the covered establishment and smaller than the smallest type size of provided to the customer upon request. any calorie declaration appearing on This nutrition information must be the same menu or menu board and in presented in the order listed and using the same color or in a color at least as the measurements listed, except as pro- conspicuous as that used for the calorie vided in paragraph (b)(2)(ii)(B) of this declarations and with the same con- section. Rounding of these nutrients trasting background or a background must be in compliance with § 101.9(c). at least as contrasting as that used for The information must be presented in a the calorie declarations. clear and conspicuous manner, includ- (2) For menus, this statement must ing using a color, type size, and con- appear on the bottom of each page of trasting background that render the

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information likely to be read and un- quired to be declared in the written nu- derstood by the ordinary individual trient information and calories from under customary conditions of pur- fat that are present in insignificant chase and use. Covered establishments amounts) must be included at the bot- may use the abbreviations allowed for tom of the list of nutrients. Nutrition Facts for certain packaged (C) For variable menu items, the nu- foods in § 101.9(j)(13)(ii)(B): trition information listed in paragraph (A)(1) Total calories (cal); (b)(2)(ii)(A) of this section must be de- (2) Calories from fat (fat cal); clared as follows for each size offered (3) Total fat (g); for sale: (4) Saturated fat (g); (1) The nutrition information re- (5) Trans fat (g); quired in paragraph (b)(2)(ii)(A) of this (6) Cholesterol (mg); section must be declared for the basic (7) Sodium (mg); preparation of the item and, sepa- (8) Total carbohydrate (g); rately, for each topping, flavor, or vari- (9) Dietary fiber (g); able component. (10) Sugars (g); and (2) Additional format requirements (11) Protein (g). for toppings if the amount of the top- (B) If a standard menu item contains ping included on the basic preparation insignificant amounts of all the nutri- of the menu item decreases based on ents required to be disclosed in para- the total number of toppings ordered graph (b)(2)(ii)(A) of this section, the for the menu item (such as is some- establishment is not required to in- times the case with pizza toppings). clude nutrition information regarding The nutrients for such topping must be the standard menu item in the written declared as single values representing form. However, if the covered estab- the nutrients for each topping when lishment makes a nutrient content added to a one-topping menu item, claim or health claim, the establish- specifying that the nutrient declara- ment is required to provide nutrition tion is for the topping when added to a information on the nutrient that is the subject of the claim in accordance with one-topping menu item. § 101.10. For standard menu items that (3) If the calories and other nutrients contain insignificant amounts of six or are the same for different flavors, vari- more of the required nutrients, the dec- eties, and variable components of the laration of nutrition information re- combination meal, each variety, flavor, quired by paragraph (b)(2)(ii)(A) of this and variable component of the com- section may be presented in a sim- bination meal is not required to be list- plified format. ed separately. All items that have the (1) An insignificant amount is defined same nutrient values could be listed to- as that amount that allows a declara- gether with the nutrient values listed tion of zero in nutrition labeling, ex- only once. cept that for total carbohydrates, die- (D) The written nutrition informa- tary fiber, and protein, it must be an tion required in paragraph (b)(2)(ii)(A) amount that allows a declaration of of this section may be provided on a ‘‘less than one gram.’’ counter card, sign, poster, handout, (2) The simplified format must in- booklet, loose leaf binder, or electronic clude information, in a column, list, or device such as a computer, or in a table, on the following nutrients: menu, or in any other form that simi- (i) Total calories, total fat, total car- larly permits the written declaration bohydrates, protein, and sodium; and of the required nutrient content infor- (ii) Calories from fat, and any other mation for all standard menu items. If nutrients identified in paragraph the written nutrition information is (b)(2)(ii)(A) of this section that are not in a form that can be given to the present in more than insignificant customer upon request, it must be amounts. readily available in a manner and loca- (3) If the simplified format is used, tion on the premises that allows the the statement ‘‘Not a significant customer/consumer to review the writ- source of ll’’ (with the blank filled in ten nutrition information upon re- with the names of the nutrients request.

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(iii) The following must be provided (3) The calories must be declared in for a standard menu item that is self- the following manner: service or on display. (i) To the nearest 5-calorie increment (A) Calories per displayed food item up to and including 50 calories and to (e.g., a bagel, a slice of pizza, or a muf- the nearest 10-calorie increment above fin), or if the food is not offered for sale 50 calories except that amounts less in a discrete unit, calories per serving than 5 calories may be expressed as (e.g., scoop, cup), and the serving or zero. discrete unit used to determine the cal- (ii) If the calorie declaration is pro- orie content (e.g., ‘‘per scoop’’ or ‘‘per vided on a sign with the food’s name, muffin’’) on either: A sign adjacent to price, or both, the calorie declaration, and clearly associated with the cor- accompanied by the term ‘‘Calories’’ or responding food; (e.g., ‘‘150 calories per ‘‘Cal’’ and the amount of the serving or scoop); a sign attached to a sneeze displayed food item on which the cal- guard with the calorie declaration and ories declaration is based must be in a the serving or unit used to determine type size no smaller than the type size the calorie content above each specific of the name or price of the menu item food so that the consumer can clearly whichever is smaller, in the same associate the calorie declaration with color, or a color that is at least as con- the food, except that if it is not clear spicuous as that used for that name or to which food the calorie declaration price, using the same contrasting back- and serving or unit refers, then the ground or a background at least as con- sign must also include the name of the trasting as that used for that name or food, e.g., ‘‘Broccoli and cheese cas- price. If the calorie declaration is pro- serole—200 calories per scoop’’; or a vided on a sign that does not include single sign or placard listing the cal- the food’s name, price, or both, the calorie declaration for several food items orie declaration, accompanied by the along with the names of the food items, term ‘‘Calories’’ or ‘‘Cal’’ and the so long as the sign or placard is located amount of the serving or displayed food where a consumer can view the name, item on which the calorie declaration calorie declaration, and serving or unit is based must be clear and conspicuous. of a particular item while selecting (iii) For self-service beverages, cal- that item. orie declarations must be accompanied by the term ‘‘fluid ounces’’ and, if ap- (1) For purposes of paragraph plicable, the description of the cup size (b)(2)(iii)(A) of this section, ‘‘per dis- (e.g., ‘‘small,’’ ‘‘medium’’). played food item’’; means per each dis- (B) For food that is self-service or on crete unit offered for sale, for example, display and is identified by an indi- a bagel, a slice of pizza, or a muffin. vidual sign adjacent to the food itself (2) For purposes of paragraph where such sign meets the definition of (b)(2)(iii)(A) of this section, ‘‘per serv- a menu or menu board under paragraph ing’’ means, for each food: (a) of this section, the statement re- (i) Per serving instrument used to quired by paragraph (b)(2)(i)(B) of this dispense the food offered for sale, pro- section and the statement required by vided that the serving instrument dis- paragraph (b)(2)(i)(C) of this section. penses a uniform amount of the food These two statements may appear on (e.g., a scoop or ladle); the sign adjacent to the food itself; on (ii) If a serving instrument that dis- a separate, larger sign, in close prox- penses a uniform amount of food is not imity to the food that can be easily used to dispense the food, per each read as the consumer is making order common household measure (e.g., cup selections; or on a large menu board or tablespoon) offered for sale or per that can be easily read as the consumer unit of weight offered for sale, e.g., per is viewing the food. quarter pound or per 4 ounces; or (C) The nutrition information in (iii) Per total number of fluid ounces written form required by paragraph in the cup in which a self-service bev- (b)(2)(ii) of this section, except for erage is served and, if applicable, the packaged food insofar as it bears nutri- description of the cup size (e.g., ‘‘140 tion labeling information required by calories per 12 fluid ounces (small)’’). and in accordance with paragraph

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(b)(2)(ii) of this section and the pack- determine the nutrient values for the aged food, including its label, can be standard menu items; examined by a consumer before pur- (2) If the information in paragraph chasing the food. (c)(3)(i)(C)(1) of this section is not (c) Determination of nutrient content. available, certification attesting that (1) A covered establishment must have the database will provide accurate re- a reasonable basis for its nutrient dec- sults when used appropriately and that larations. Nutrient values may be de- the database was used in accordance termined by using nutrient databases with its instructions; (with or without computer software (D) A detailed listing (e.g., printout) programs), cookbooks, laboratory anal- of the nutrient values determined for yses, or other reasonable means, in- each standard menu item. cluding the use of Nutrition Facts on (E) Any other information pertinent labels on packaged foods that comply to the final nutrient values of the with the nutrition labeling require- standard menu item (e.g., information ments of section 403(q)(1) of the Fed- about what might cause slight vari- eral Food, Drug, and Cosmetic Act and ations in the nutrient profile such as § 101.9, FDA nutrient values for raw moisture variations); fruits and vegetables in Appendix C of (F) A statement signed and dated by this part, or FDA nutrient values for a responsible individual, employed at cooked fish in Appendix D of this part. the covered establishment or its cor- (2) Nutrient declarations for standard porate headquarters or parent entity, menu items must be accurate and con- who can certify that the information sistent with the specific basis used to contained in the nutrient analysis is determine nutrient values. A covered complete and accurate; and establishment must take reasonable steps to ensure that the method of (G) A statement signed and dated by a responsible individual employed at preparation (e.g., types and amounts of ingredients, cooking temperatures) and the covered establishment certifying amount of a standard menu item of- that the covered establishment has fered for sale adhere to the factors on taken reasonable steps to ensure that which its nutrient values were deter- the method of preparation (e.g., types mined. and amounts of ingredients in the rec- (3) A covered establishment must ipe, cooking temperatures) and amount provide to FDA, within a reasonable of a standard menu item offered for period of time upon request, informa- sale adhere to the factors on which its tion substantiating nutrient values in- nutrient values were determined. cluding the method and data used to (ii) For published cookbooks that derive these nutrient values. This in- contain nutritional information for formation must include the following: recipes in the cookbook: (i) For nutrient databases: (A) The name, author, and publisher (A) The name and version (including of the cookbook used; the date of the version) of the data- (B) If available, information provided base, and, as applicable, the name of by the cookbook or from the author or the applicable software company and publisher about how the nutrition in- any Web site address for the database. formation for the recipes was obtained; The name and version of a database (C) A copy of the recipe used to pre- would include the name and version of pare the standard menu item and a the computer software, if applicable; copy of the nutrition information for (B) The recipe or formula used as a that standard menu item as provided basis for the nutrient declarations; by the cookbook; and (C)(1) Information on: (D) A statement signed and dated by (i) The amount of each nutrient that a responsible individual employed at the specified amount of each ingredient the covered establishment certifying identified in the recipe contributes to that that the covered establishment the menu item; and has taken reasonable steps to ensure (ii) How the database was used in- that the method of preparation (e.g., cluding calculations or operations (e.g., types and amounts of ingredients in worksheets or computer printouts) to the recipe, cooking temperatures) and

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amount of a standard menu item of- the covered establishment certifying fered for sale adhere to the factors on that the covered establishment has which its nutrient values were deter- taken reasonable steps to ensure that mined. (Recipes may be divided as nec- the method of preparation (e.g., types essary to accommodate differences in and amounts of ingredients in the rec- the portion size derived from the recipe ipe, cooking temperatures) and amount and that are served as the standard of a standard menu item offered for menu item but no changes may be sale adhere to the factors on which its made to the proportion of ingredients nutrient values were determined. used.) (d) Voluntary registration to be subject (iii) For laboratory analyses: to the menu labeling requirements—(1) (A) A copy of the recipe for the Applicability. A restaurant or similar standard menu item used for the nutri- retail food establishment that is not ent analysis; part of a chain with 20 or more loca- (B) The name and address of the lab- tions doing business under the same oratory performing the analysis; name and offering for sale substan- (C) Copies of analytical worksheets, tially the same menu items may volun- including the analytical method, used tarily register to be subject to the re- to determine and verify nutrition in- quirements established in this section. formation; Restaurants and similar retail food es- (D) A statement signed and dated by tablishments that voluntarily register a responsible individual, employed at will no longer be subject to non-iden- the covered establishment or its cor- tical State or local nutrition labeling porate headquarters or parent entity, requirements. who can certify that the information (2) Who may register? The authorized contained in the nutrient analysis is official of a restaurant or similar retail complete and accurate; and food establishment as defined in para- (E) A statement signed and dated by graph (a) of this section, which is not a responsible individual employed at otherwise subject to paragraph (b) of the covered establishment certifying this section, may register with FDA. that the covered establishment has taken reasonable steps to ensure that (3) What information is required? Au- thorized officials for restaurants and the method of preparation (e.g., types and amounts of ingredients in the rec- similar retail food establishments ipe, cooking temperatures) and amount must provide FDA with the following of a standard menu item offered for information on Form FDA 3757: sale adhere to the factors on which its (i) The contact information (includ- nutrient values were determined. ing name, address, phone number, and (iv) For nutrition information pro- email address) for the authorized offi- vided by other reasonable means: cial; (A) A detailed description of the (ii) The contact information (includ- means used to determine the nutrition ing name, address, phone number, and information; email address) of each restaurant or (B) A recipe or formula used as a similar retail food establishment being basis for the nutrient determination; registered, as well as the name and (C) Any data derived in determining contact information for an official on- the nutrient values for the standard site, such as the owner or manager, for menu item, e.g., nutrition information each specific restaurant or similar re- about the ingredients used with the tail food establishment; source of the nutrient information; (iii) All trade names the restaurant (D) A statement signed and dated by or similar retail food establishment a responsible individual, employed at uses; the covered establishment or its cor- (iv) Preferred mailing address (if dif- porate headquarters or parent entity, ferent from location address for each who can certify that the information establishment) for purposes of receiv- contained in the nutrient analysis is ing correspondence; and complete and accurate; and (v) Certification that the information (E) A statement signed and dated by submitted is true and accurate, that a responsible individual employed at the person submitting it is authorized

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to do so, and that each registered res- not in conformity with paragraph (b) taurant or similar retail food establish- or (c) of this section. ment will be subject to the require- [79 FR 71253, Dec. 1, 2014] ments of section 403(q)(5)(H) of the Fed- eral Food, Drug, and Cosmetic Act and § 101.12 Reference amounts custom- this section. arily consumed per eating occasion. (4) How to register. Authorized officials of restaurants and similar retail (a) The general principles and factors food establishments who elect to be that the Food and Drug Administra- subject to requirements in section tion (FDA) considered in arriving at 403(q)(5)(H) of the Federal Food, Drug, the reference amounts customarily and Cosmetic Act can register by vis- consumed per eating occasion (ref- iting http://www.fda.gov/food/ erence amounts) which are set forth in ingredientspackaginglabeling/ paragraph (b) of this section, are that: labelingnutrition/ucm217762.htm. FDA (1) FDA calculated the reference has created a form (Form 3757) that amounts for persons 4 years of age or contains fields requesting the informa- older to reflect the amount of food cus- tion in paragraph (d)(3) of this section tomarily consumed per eating occasion and made the form available at this by persons in this population group. Web site. Registrants must use this These reference amounts are based on form to ensure that complete informa- data set forth in appropriate national tion is submitted. food consumption surveys. (i) Information should be submitted (2) FDA calculated the reference by email by typing complete informa- amounts for an infant or child under 4 tion into the form (PDF), saving it on years of age to reflect the amount of the registrant’s computer, and sending food customarily consumed per eating it by email to occasion by infants up to 12 months of [email protected]. age or by children 1 through 3 years of (ii) If email is not available, the reg- age, respectively. These reference istrant can either fill in the form (PDF) amounts are based on data set forth in and print it out (or print out the blank appropriate national food consumption PDF and fill in the information by surveys. Such reference amounts are to hand or typewriter), and either fax the be used only when the food is specially completed form to 301–436–2804 or mail formulated or processed for use by an it to FDA, CFSAN Menu and Vending infant or by a child under 4 years of Machine Registration, White Oak age. Building 22, Rm. 0209, 10903 New Hamp- (3) An appropriate national food con- shire Ave., Silver Spring, MD 20993. sumption survey includes a large sam- (5) When to renew the registration. To ple size representative of the demo- keep the establishment’s registration graphic and socioeconomic characteris- active, the authorized official of the tics of the relevant population group restaurant or similar retail food estab- and must be based on consumption lishment must register every other data under actual conditions of use. year within 60 days prior to the expira- (4) To determine the amount of food tion of the establishment’s current reg- customarily consumed per eating occa- istration with FDA. Registration will sion, FDA considered the mean, me- automatically expire if not renewed. dian, and mode of the consumed (e) Signatures. Signatures obtained amount per eating occasion. under paragraph (d) of this section that (5) When survey data were insuffi- meet the definition of electronic signa- cient, FDA took various other sources tures in § 11.3(b)(7) of this chapter are of information on serving sizes of food exempt from the requirements of part into consideration. These other sources 11 of this chapter. of information included: (f) Misbranding. A standard menu (i) Serving sizes used in dietary guid- item offered for sale in a covered estab- ance recommendations or rec- lishment shall be deemed misbranded ommended by other authoritative sys- under sections 201(n), 403(a), 403(f) and/ tems or organizations; or 403(q) of the Federal Food, Drug, and (ii) Serving sizes recommended in Cosmetic Act if its label or labeling is comments;

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(iii) Serving sizes used by manufac- (8) The reference amounts for prod- turers and grocers; and ucts that are consumed as an ingre- (iv) Serving sizes used by other coun- dient of other foods, but that may also tries. be consumed in the form in which they (6) Because they reflect the amount are purchased (e.g., butter), are based customarily consumed, the reference on use in the form purchased. amount and, in turn, the serving size (9) FDA sought to ensure that foods declared on the product label are based that have similar dietary usage, prod- on only the edible portion of food, and uct characteristics, and customarily not bone, seed, shell, or other inedible consumed amounts have a uniform ref- components. erence amount. (7) The reference amount is based on (b) The following reference amounts the major intended use of the food shall be used as the basis for deter- (e.g., milk as a beverage and not as an mining serving sizes for specific prod- addition to cereal). ucts:

TABLE 1—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: FOODS FOR INFANTS AND YOUNG CHILDREN 1 THROUGH 3 YEARS OF AGE 123

Product category Reference amount Label statement 4

Cereals, dry instant ...... 15 g ...... l cup (l g) Cereals, prepared, ready-to- 110 g ...... l cup(s) (l g) serve. Other cereal and grain prod- 7 g for infants and 20 g for l cup(s) (l g) for ready-to- ucts, dry ready-to-eat, e.g., young children (1 through 3 eat cereals; piece(s) (l g) ready-to-eat cereals, cook- years of age) for ready-to- for others ies, teething biscuits, and eat cereals; 7 g for all oth- toasts. ers. Dinners, deserts, fruits, vege- 15 g ...... l tbsp(s) (l g); l cup(s) tables or soups, dry mix. (l g) Dinners, desserts, fruits, vege- 110 g ...... l cup(s) (l g); cup(s) (l mL) tables or soups, ready-to- serve, junior type. Dinners, desserts, fruits, vege- 110 g ...... l cup(s) (l g); cup(s) (l mL) tables or soups, ready-to- serve, strained type. Dinners, stews or soups for 170 g ...... l cup(s) (l g); cup(s) (l mL) young children, ready-to- serve. Fruits for young children, 125 g ...... l cup(s) (l g) ready-to-serve. Vegetables for young children, 70 g ...... l cup(s) (l g) ready-to-serve. Eggs/egg yolks, ready-to serve 55 g ...... l cup(s) (l g) Juices all varieties ...... 120 mL ...... 4 fl oz (120 mL) 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. We further considered data from the National Health and Nutrition Examination Survey, 2003–2004, 2005–2006, and 2007–2008 conducted by the Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. 2 Unless otherwise noted in the reference amount column, the reference amounts are for the ready-to-serve or almost ready-to-serve form of the product (e.g., heat and serve, brown and serve). If not listed separately, the reference amount for the unprepared form (e.g., dry mixes, concentrates, dough, batter, fresh and frozen pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for consumption (e.g., cooked). 3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appropriate to their specific product using the procedures in 21 CFR 101.9(b).

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4 The label statements are meant to provide examples of serving size statements that may be used on the label, but the specific wording may be changed as appropriate for individual products. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and bar for frozen novelties).

TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123

Product category Reference amount Label statement 4

Bakery Products: Bagels, toaster pastries, 110 g ...... l piece(s) (l g) muffins (excluding English muffins). Biscuits, croissants, tor- 55 g ...... l piece(s) (l g) tillas, soft bread sticks, soft pretzels, corn bread, hush puppies, scones, crumpets, English muffins. Breads (excluding sweet 50 g ...... l piece(s) (l g) for sliced quick type), rolls. bread and distinct pieces (e.g., rolls); 2 oz (56 g/ l inch slice) for unsliced bread Bread sticks—see crackers. Toaster pastries—see bagels, toaster pastries, muffins (excluding English muffins). Brownies ...... 40 g ...... l piece(s) (l g) for distinct pieces; fractional slice (l g) for bulk Cakes, heavyweight 125 g ...... l piece(s) (l g) for distinct (cheese cake; pineapple pieces (e.g., sliced or indi- upside-down cake; fruit, vidually packaged prod- nut, and vegetable ucts); l fractional slice cakes with more than or (l g) for large discrete equal to 35 percent of units the finished weight as fruit, nuts, or vegetables or any of these combinations) 5. Cakes, mediumweight 80 g ...... l piece(s) (l g) for distinct (chemically leavened pieces (e.g., cupcake); cake with or without l fractional slice (l g) for icing or filling except large discrete units those classified as light weight cake; fruit, nut, and vegetable cake with less than 35 percent of the finished weight as fruit, nuts, or vegetables or any of these combinations; light weight cake with icing; Boston cream pie; cupcake; eclair; cream puff) 6. Cakes, lightweight (angel 55 g ...... l piece(s) (l g) for distinct food, chiffon, or sponge pieces (e.g., sliced or indi- cake without icing or fill- vidually packaged prod- ing) 7. ucts); l fractional slice (l g) for large discrete units

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Coffee cakes, crumb 55 g ...... l piece(s) (l g) for sliced cakes, doughnuts, Dan- bread and distinct pieces ish, sweet rolls, sweet (e.g., doughnut); 2 oz (56 g/ quick type breads. visual unit of measure) for bulk products (e.g., unsliced bread) Cookies ...... 30 g ...... l piece(s) (l g) Crackers that are usually 15 g ...... l piece(s) (l g) not used as snack, melba toast, hard bread sticks, ice cream cones 8. Crackers that are usually 30 g ...... l piece(s) (l g) used as snacks. Croutons ...... 7 g ...... l tbsp(s) (l g); l cup(s) (l g); l piece(s) (l g) for large pieces Eggroll, dumpling, wonton, 20 g ...... l sheet (l g); wrapper (l g) or potsticker wrappers. French toast, crepes, pan- 110 g prepaed for French l piece(s) (l g); l cup(s) cakes, variety mixes. toast, crepes, and pan- (l g) for dry mix cakes; 40 g dry mix for variety mixes. Grain-based bars with or 40 g ...... l piece(s) (l g) without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars. Ice cream cones—see crackers. Pies, cobblers, fruit crisps, 125 g ...... l piece(s) (l g) for distinct turnovers, other pastries. pieces; l fractional slice (l g) for large discrete units Pie crust, pie shells, pas- the allowable declaration clos- l fractional slice(s) (l g) for try sheets, (e.g., phyllo, est to an 8 square inch sur- large discrete units; puff pastry sheets). face area. l shells (l g); l fractional l sheet(s) (l g) for distinct pieces (e.g., Pastry sheet). Pizza crust ...... 55 g ...... l fractional slice (l g) Taco shells, hard ...... 30 g ...... l shell(s) (l g) Waffles ...... 85 g ...... l piece(s) (l g) Beverages: Carbonated and non- 360 mL ...... 12 fl oz (360 mL) carbonated beverages, wine coolers, water. Coffee or tea, flavored 360 mL prepared ...... 12 fl oz (360 mL) and sweetened. Cereals and Other Grain Prod- ucts: Breakfast cereals (hot ce- 1 cup prepared; 40 g plain dry l cup(s) (l g) real type), hominy grits. cereal; 55 g flavored, sweetened cereal. Breakfast cereals, ready- 15 g ...... l cup(s) (l g) to-eat, weighing less than 20 g per cup, e.g., plain puffed cereal grains.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Breakfast cereals, ready- 40 g ...... l cup(s) (l g) to-eat, weighing 20 g or more but less than 43 g per cup; high fiber cereals containing 28 g or more of fiber per 100 g. Breakfast cereals, ready- 60 g ...... l piece(s) (l g) for large dis- to-eat, weighing 43 g or tinct pieces (e.g., biscuit more per cup; biscuit type); l cup(s) (l g) for all types. others Bran or wheat germ ...... 15 g ...... l tbsp(s) (l g); l cup(s) (l g) Flours or cornmeal ...... 30 g ...... l tbsp(s) (l g); l cup(s) (l g) Grains, e.g., rice, barley, 140 g prepared; 45 g dry ...... l cup(s) (l g) plain. Pastas, plain ...... 140 g prepared; 55 g dry ...... l cup(s) (l g); l piece(s) (l g) for large pieces (e.g., large shells or lasagna noodles) or 2 oz (56 g/visual unit of measure) for dry bulk products (e.g., spaghetti) Pastas, dry, ready-to-eat, 25 g ...... l cup(s) (l g) e.g., fried canned chow mein noodles. Starches, e.g., cornstarch, 10 g ...... l tbsp (l g) potato starch, tapioca, etc. Stuffing ...... 100 g ...... l cup(s) (l g) Dairy Products and Sub- stitutes: Cheese, cottage ...... 110 g ...... l cup (l g) Cheese used primarily as 55 g ...... l cup (l g) ingredients, e.g., dry cottage cheese, ricotta cheese. Cheese, grated hard, e.g., 5 g ...... l tbsp (l g) Parmesan, Romano. Cheese, all others except 30 g ...... l piece(s) (l g) for distinct those listed as separate pieces; l tbsp(s) (l g) for categories—includes cream cheese and cheese cream cheese and spread; 1 oz (28 g/visual cheese spread. unit of measure) for bulk Cheese sauce—see sauce category. Cream or cream sub- 15 mL ...... 1 tbsp (15 mL) stitutes, fluid. Cream or cream sub- 2 g ...... l tsp (l g) stitutes, powder. Cream, half & half ...... 30 mL ...... 2 tbsp (30 mL) Eggnog ...... 120 mL ...... 1⁄2 cup (120 mL); 4 fl oz (120 mL) Milk, condensed, undiluted 30 mL ...... 2 tbsp (30 mL) Milk, evaporated, undi- 30 mL ...... 2 tbsp (30 mL) luted.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Milk, milk-substitute bev- 240 mL ...... 1 cup (240 mL); 8 fl oz (240 erages, milk-based mL) drinks, e.g., instant breakfast, meal replacement, cocoa, soy beverage. Shakes or shake sub- 240 mL ...... 1 cup (240 mL); 8 fl oz (240 stitutes, e.g., dairy mL) shake mixes, fruit frost mixes. Sour cream ...... 30 g ...... l tbsp (l g) Yogurt ...... 170 g ...... l cup (l g) Desserts: Ice cream, frozen yogurt, 2⁄3 cup—includes the volume 2⁄3 cup (l g), l piece(s) sherbet, frozen flavored for coatings and wafers. (l g) for individually and sweetened ice and wrapped or packaged prod- pops, frozen fruit juices: ucts all types bulk and novelties (e.g., bars, sandwiches, cones, cups). Sundae ...... 1 cup ...... 1 cup (l g) Custards, gelatin, or pud- 1⁄2 cup prepared; amount to l piece(s) (l g) for distinct ding. make 1⁄2 cup prepared unit (e.g., individually pack- when dry. aged products); 1⁄2 cup (l g) for bulk Dessert Toppings and Fillings: Cake frostings or icings .... 2 tbsp ...... l tbsp(s) (l g) Other dessert toppings, 2 tbsp ...... 2 tbsp (l g); 2 tbsp (30 mL) e.g., fruits, syrups, spreads, marshmallow cream, nuts, dairy and non-dairy whipped toppings. Pie fillings ...... 85 g ...... l cup(s) (l g) Egg and Egg Substitutes: Egg mixtures, e.g., egg 110 g ...... l piece(s) (l g) for discrete foo young, scrambled pieces; l cup(s) (l g) eggs, omelets. Eggs (all sizes) 8 ...... 50 g ...... 1 large, medium, etc. (l g) Egg whites, sugared eggs, An amount to make 1 large l cup(s) (l g); l cup(s) sugared egg yolks, and (50 g) egg. (l mL) egg substitutes (fresh, frozen, dried). Fats and Oils: Butter, margarine, oil, 1 tbsp ...... 1 tbsp (l g); 1 tbsp (15 mL) shortening. Butter replacement, pow- 2 g ...... l tsp(s) (l g) der. Dressings for salads ...... 30 g ...... l tbsp (l g); l tbsp (l mL) Mayonnaise, sandwich 15 g ...... l tbsp (l g) spreads, mayonnaise- type dressings. Spray types ...... 0.25 g ...... About l seconds spray (l g) Fish, Shellfish, Game Meats,9 and Meat or Poultry Sub- stitutes: Bacon substitutes, canned 15 g ...... l piece(s) (l g) for discrete anchovies,10 anchovy pieces; l tbsp(s) (l g) for pastes, caviar. others Dried, e.g., jerky ...... 30 g ...... l piece(s) (l g)

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Entrees with sauce, e.g., 140 g cooked ...... l cup(s) (l g); 5 oz (140 g/ fish with cream sauce, visual unit of measure) if shrimp with lobster not measurable by cup sauce. Entrees without sauce, 85 g cooked; 110 g l piece(s) (l g) for discrete e.g., plain or fried fish uncooked 11. pieces; l cup(s) (l g); and shellfish, fish and l oz (l g/visual unit of shellfish cake. measure) if not measurable by cup 12 Fish, shellfish, or game 85 g ...... l piece(s) (l g) for discrete meat 9, canned 10. pieces; l cup(s) (l g); 3 oz (85 g/l cup) for products that are difficult to measure the g weight of cup measure (e.g., tuna); 3 oz (85 g/l pieces) for products that naturally vary in size (e.g., sardines) Substitute for luncheon 55 g ...... l piece(s) (l g) for distinct meat, meat spreads, pieces (e.g., slices, links); Canadian bacon, sau- l cup(s) (l g); 2 oz (56 g/ sages, frankfurters, and visual unit of measure) for seafood. nondiscrete bulk product Smoked or pickled fish,10 55 g ...... l piece(s) (l g) for distinct shellfish, or game pieces (e.g., slices, links) or meat 9; fish or shellfish l cup(s) (l g); 2 oz (56 g/ spread. visual unit of measure) for nondiscrete bulk product Substitutes for bacon bits—see Miscellaneous. Fruits and Fruit Juices: Candied or pickled 10 ...... 30 g ...... l piece(s) (l g) Dehydrated fruits—see snack category. Dried ...... 40 g ...... l piece(s) (l g) for large pieces (e.g., dates, figs, prunes); l cup(s) (l g) for small pieces (e.g., raisins) Fruits for garnish or flavor, 4 g ...... 1 cherry (l g); l piece(s) e.g., maraschino cher- (l g) ries 10. Fruit relishes, e.g., cran- 70 g ...... l cup(s) (l g) berry sauce, cranberry relish. Fruits used primarily as in- 50 g ...... See footnote 12 gredients, avocado. Fruits used primarily as in- 50 g ...... l piece(s) (l g) for large gredients, others (cran- fruits; l cup(s) (l g) for berries, lemon, lime). small fruits measurable by cup12 Watermelon ...... 280 g ...... See footnote 12 All other fruits (except 140 g ...... l piece(s) (l g) for large those listed as separate pieces (e.g., strawberries, categories), fresh, prunes, apricots, etc.); canned or frozen. l cup(s) (l g) for small pieces (e.g., blueberries, raspberries, etc.) 12 Juices, nectars, fruit drinks 240 mL ...... 8 fl oz (240 mL) Juices used as ingredi- 5 mL ...... 1 tsp (5 mL) ents, e.g., lemon juice, lime juice.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Legumes: Tofu,10 tempeh ...... 85 g ...... l piece(s) (l g) for discrete pieces; 3 oz (84 g/visual unit of measure) for bulk products Beans, plain or in sauce .. 130 g for beans in sauce or l cup (l g) canned in liquid and refried beans prepared; 90 g for others prepared; 35 g dry. Miscellaneous: Baking powder, baking 0.6 g ...... l tsp (l g) soda, pectin. Baking decorations, e.g., 1 tsp or 4 g if not measurable l piece(s) (l g) for discrete colored sugars and by teaspoon. pieces; 1 tsp (l g) sprinkles for cookies, cake decorations. Batter mixes, bread 30 g ...... l tbsp(s) (l g); l cup(s) crumbs. (l g) Chewing gum 8 ...... 3 g ...... l piece(s) (l g) Cocoa powder, carob 1 tbsp ...... 1 tbsp (l g) powder, unsweetened. Cooking wine ...... 30 mL ...... 2 tbsp (30 mL) Dietary supplements ...... The maximum amount rec- l tablet(s), l capsules(s), ommended, as appropriate, l packet(s), l tsp(s) (l g), on the label for consump- etc. tion per eating occasion or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonful, etc. Meat, poultry, and fish Amount to make one ref- l tsp(s) (l g); l tbsp(s) coating mixes, dry; sea- erence amount of final dish. (l g) soning mixes, dry, e.g., chili seasoning mixes, pasta salad seasoning mixes. Milk, milk substitute, and Amount to make 240 mL drink l fl oz (l mL); l tsp (l g); fruit juice concentrates (without ice). tbsp (l g) (without alcohol) (e.g., drink mixers, frozen fruit juice concentrate, sweetened cocoa powder). Drink mixes (without alco- Amount to make 360 mL drink l fl oz (l mL); l tsp (l g); hol): All other types (without ice). l tbsp (l g) (e.g., flavored syrups and powdered drink mixes). Salad and potato toppers, 7 g ...... l tbsp(s) (l g) e.g., salad crunchies, salad crispins, substitutes for bacon bits. Salt, salt substitutes, sea- 1⁄4 tsp ...... 1⁄4 tsp (l g); l piece(s) (l g) soning salts (e.g., garlic for discrete pieces (e.g., in- salt). dividually packaged products)

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Seasoning oils and sea- 1 tbsp ...... 1 tbsp (l g) soning sauces (e.g., coconut concentrate, ses- ame oil, almond oil, chili oil, coconut oil, walnut oil). Seasoning pastes (e.g., 1 tsp ...... 1 tsp (l g) garlic paste, ginger paste, curry paste, chili paste, miso paste), fresh or frozen. Spices, herbs (other than 1⁄4 tsp or 0.5 g if not measur- 1⁄4 tsp (l g); l piece(s) (l g) dietary supplements). able by teaspoon. if not measurable by teaspoons (e.g., bay leaf) Mixed Dishes: Appetizers, hors 85 g, add 35 g for products l piece(s) (l g) d’oeuvres, mini mixed with gravy or sauce topping. dishes, e.g., mini bagel pizzas, breaded mozzarella sticks, egg rolls, dumplings, potstickers, wontons, mini quesadillas, mini quiches, mini sandwiches, mini pizza rolls, potato skins. Measurable with cup, e.g., 1 cup ...... 1 cup (l g) casseroles, hash, macaroni and cheese, pot pies, spaghetti with sauce, stews, etc. Not measurable with cup, 140 g, add 55 g for products l piece(s) (l g) for discrete e.g., burritos, enchi- with gravy or sauce topping, pieces; l fractional slice ladas, pizza, pizza rolls, e.g., enchilada with cheese (l g) for large discrete quiche, all types of sauce, crepe with white units sandwiches. sauce 13. Nuts and Seeds: Nuts, seeds and mixtures, 30 g ...... l piece(s) (l g) for large all types: Sliced, pieces (e.g., unshelled chopped, slivered, and nuts); l tbsp(s) (l g); whole. l cup(s) (l g) for small pieces (e.g., peanuts, sunflower seeds) Nut and seed butters, 2 tbsp ...... 2 tbsp (l g) pastes, or creams. Coconut, nut and seed 15 g ...... l tbsp(s) (l g); l cup (l g) flours. Potatoes and Sweet Potatoes/ Yams: French fries, hash browns, 70 g prepared; 85 g for frozen l piece(s) (l g) for large dis- skins, or pancakes. unprepared French fries. tinct pieces (e.g., patties, skins); 2.5 oz (70 g/ l pieces) for prepared fries; 3 oz (84 g/l pieces) for unprepared fries Mashed, candied, stuffed 140 g ...... l piece(s) (l g) for discrete or with sauce. pieces (e.g., stuffed potato); l cup(s) (l g) Plain, fresh, canned, or 110 g for fresh or frozen; 125 l piece(s) (l g) for discrete frozen. g for vacuum packed; 160 g pieces; l cup(s) (l g) for for canned in liquid. sliced or chopped products

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Salads: Gelatin salad ...... 120 g ...... l cup (l g) Pasta or potato salad ...... 140 g ...... l cup(s) (l g) All other salads, e.g., egg, 100 g ...... l cup(s) (l g) fish, shellfish, bean, fruit, or vegetable salads. Sauces, Dips, Gravies, and Condiments: Barbecue sauce, hollan- 2 tbsp ...... 2 tbsp (l g); 2 tbsp (30 mL) daise sauce, tartar sauce, tomato chili sauce, other sauces for dipping (e.g., mustard sauce, sweet and sour sauce), all dips (e.g., bean dips, dairy-based dips, salsa). Major main entree sauces, 125 g ...... l cup (l g); l cup (l mL) e.g., spaghetti sauce. Minor main entree sauces 1⁄4 cup ...... 1⁄4 cup (l g); 1⁄4 cup (60 mL) (e.g., pizza sauce, pesto sauce, Alfredo sauce), other sauces used as toppings (e.g., gravy, white sauce, cheese sauce), cocktail sauce. Major condiments, e.g., 1 tbsp ...... 1 tbsp (l g); 1 tbsp (15 mL) catsup, steak sauce, soy sauce, vinegar, teri- yaki sauce, marinades. Minor condiments, e.g., 1 tsp ...... 1 tsp (l g); 1 tsp (5 mL) horseradish, hot sauces, mustards, Worcester- shire sauce. Snacks: All varieties, chips, pret- 30 g ...... l cup (l g) for small pieces zels, popcorn, extruded (e.g., popcorn); l piece(s) snacks, fruit and vege- (l g) for large pieces (e.g., table-based snacks large pretzels; pressed (e.g., fruit chips), grain- dried fruit sheet); 1 oz (28g/ based snack mixes. visual unit of measure) for bulk products (e.g., potato chips) Soups: All varieties ...... 245 g ...... l cup (l g); l cup (l mL) Dry soup mixes, bouillon .. Amount to make 245 g ...... l cup (l g); l cup (l mL) Sugars and Sweets: Baking candies (e.g., 15 g ...... l piece(s) (l g) for large chips). pieces; l tbsp(s) (l g) for small pieces; 1⁄2 oz (14 g/ visual unit of measure) for bulk products After-dinner confection- 10 g ...... l piece(s) (l g) eries. Hard candies, breath 2 g ...... l piece(s) (l g) mints 8. Hard candies, roll-type, 5 g ...... l piece(s) (l g) mini-size in dispenser packages.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Hard candies, others; 15 mL for liquid candies; 15 g l piece(s) (l g) for large powdered candies, liq- for all others. pieces; l tbsp(s) (l g) for uid candies. ‘‘mini-size’’ candies measurable by tablespoon; l straw(s) (l g) for powdered candies; l wax bottle(s) (l mL) for liquid candies; 1⁄2 oz (14 g/visual unit of measure) for bulk products All other candies ...... 30 g ...... l piece(s) (l g); 1 oz (30 g/ visual unit of measure) for bulk products Confectioner’s sugar ...... 30 g ...... l cup (l g) Honey, jams, jellies, fruit 1 tbsp ...... 1 tbsp (l g); 1 tbsp (15 mL) butter, molasses, fruit pastes, fruit chutneys. Marshmallows ...... 30 g ...... l cup(s) (l g) for small pieces; l piece(s) (l g) for large pieces Sugar ...... 8 g ...... l tsp (l g); l piece(s) (l g) for discrete pieces (e.g., sugar cubes, individually packaged products) Sugar substitutes ...... An amount equivalent to one l tsp(s) (l g) for solids; reference amount for sugar l drop(s) (l g) for liquid; in sweetness. l piece(s) (l g) (e.g., individually packaged products) Syrups ...... 30 mL for all syrups ...... 2 tbsp (30 mL) Vegetables: Dried vegetables, dried to- 5 g, add 5 g for products l piece(s); 1⁄3 cup (l g) matoes, sun-dried toma- packaged in oil. toes, dried mushrooms, dried seaweed. Dried seaweed sheets ...... 3 g ...... l piece(s) (l g); l cup(s) (l g) Vegetables primarily used 4 g ...... l piece(s) (l g); l tbsp(s) for garnish or flavor (l g) for chopped products (e.g., pimento,10 parsley, fresh or dried). Fresh or canned chili pep- 30 g ...... l piece(s) (l g) 12; l tbsp(s) pers, jalapeno peppers, (l g); l cup(s) (l g) for other hot peppers, sliced or chopped products green onion. All other vegetables with- 85 g for fresh or frozen; 95 g l piece(s) (l g) for large out sauce: Fresh, for vacuum packed; 130 g pieces (e.g., Brussels canned, or frozen. for canned in liquid, cream- sprouts); l cup(s) (l g) for style corn, canned or small pieces (e.g., cut corn, stewed tomatoes, pumpkin, green peas); 3 oz (84 g/vis- or winter squash. ual unit of measure) if not measurable by cup All other vegetables with 110 g ...... l piece(s) (l g) for large sauce: Fresh, canned, pieces (e.g., Brussels or frozen. sprouts); l cup(s) (l g) for small pieces (e.g., cut corn, green peas); 4 oz (112 g/ visual unit of measure) if not measurable by cup Vegetable juice ...... 240 mL ...... 8 fl oz (240 mL) Olives 10 ...... 15 g ...... l piece(s) (l g); l tbsp(s) (l g) for sliced products

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 123—Continued

Product category Reference amount Label statement 4

Pickles and pickled vege- 30 g ...... 1 oz (28 g/visual unit of meas- tables, all types 10. ure) Pickle relishes ...... 15 g ...... l tbsp (l g) Sprouts, all types: Fresh 1/4 cup ...... 1⁄4 cup (l g) or canned. Vegetable pastes, e.g., to- 30 g ...... l tbsp (l g) mato paste. Vegetable sauces or pu- 60 g ...... l cup (l g); l cup (l mL) rees, e.g., tomato sauce, tomato puree. 1 These values represent the amount (edible portion) of food customarily consumed per eating occasion and were primarily derived from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture and updated with data from the National Health and Nutrition Examination Survey, 2003–2004, 2005–2006 and 2007– 2008 conducted by the Centers for Diseases Control and Prevention, in the Department of Health and Human Services. 2 Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or almost ready-to-serve form of the product (e.g., heat and serve, brown and serve). If not listed separately, the reference amount for the unprepared form (e.g., dry mixes, concentrates, dough, batter, fresh and frozen pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for consumption (e.g., cooked). 3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appropriate to their specific product using the procedures in 21 CFR 101.9(b). 4 The label statements are meant to provide examples of serving size statements that may be used on the label, but the specific wording may be changed as appropriate for individual products. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless specifically stated in the product category, reference amount, or label statement column that it is for these forms of the product. For products that require further preparation, manufacturers must determine the label statement following the rules in § 101.9(b) using the reference amount determined according to § 101.12(c). 5 Includes cakes that weigh 10 g or more per cubic inch. The serving size for fruitcake is 1 1⁄2 ounces. 6 Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch. 7 Includes cakes that weigh less than 4 g per cubic inch. 8 Label serving size for ice cream cones, eggs, and breath mints of all sizes will be 1 unit. Label serving size of all chewing gums that weigh more than the reference amount that can reasonably be consumed at a single-eating occasion will be 1 unit. 9 Animal products not covered under the Federal Meat Inspection Act or the Poultry Products Inspection Act, such as flesh products from deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc. 10 If packed or canned in liquid, the reference amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed (e.g., canned chopped clam in juice). 11 The reference amount for the uncooked form does not apply to raw fish in § 101.45 or to single-ingredient products that consist of fish or game meat as provided for in § 101.9(j)(11). 12 For raw fruit, vegetables, and fish, manufacturers should follow the label statement for the serving size specified in Appendices C and D to part 101 (21 CFR part 101) Code of Federal Regulations. 13 Pizza sauce is part of the pizza and is not considered to be sauce topping.

(c) If a product requires further prep- graph (b) of this section provides a ref- aration, e.g., cooking or the addition of erence amount for the product in the water or other ingredients, and if para- prepared form, but not the unprepared

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form, then the reference amount for (3) Density measurements of the reg- the unprepared product must be the ular and the aerated products shall be amount of the unprepared product re- conducted by the same trained oper- quired to make the reference amount ator using the same methodology (e.g., for the prepared product as established the same equipment, procedures, and in paragraph (b) of this section. techniques) under the same conditions. (d) The reference amount for an imi- (4) Density measurements shall be tation or substitute food or altered replicated a sufficient number of times food, such as a ‘‘low calorie’’ version, to ensure that the average of the meas- shall be the same as for the food for urements is representative of the true which it is offered as a substitute. differences in the densities of the reg- (e) If a food is modified by incor- ular and the ‘‘aerated’’ products. porating air (aerated), and thereby the (f) For products that have no ref- density of the food is lowered by 25 per- erence amount listed in paragraph (b) cent or more in weight than that of an of this section for the unprepared or appropriate reference regular food as the prepared form of the product and described in § 101.13(j)(1)(ii)(A), and the that consist of two or more foods pack- reference amount of the regular food is aged and presented to be consumed to- in grams, the manufacturer may deter- gether (e.g., peanut putter and jelly, mine the reference amount of the aer- cracker and cheese pack, pancakes and ated food by adjusting for the dif- syrup, cake and frosting), the reference ference in density of the aerated food amount for the combined product shall be determined using the following relative to the density of the appro- rules: priate reference food provided that the (1) The reference amount for the manufacturer will show FDA detailed combined product must be the ref- protocol and records of all data that erence amount, as established in para- were used to determine the density-ad- graph (b) of this section, for the ingre- justed reference amount for the aer- dient that is represented as the main ated food. The reference amount for ingredient (e.g., peanut butter, pan- the aerated food shall be rounded to cakes, cake) plus proportioned the nearest 5-g increment. Such prod- amounts of all minor ingredients. ucts shall bear a descriptive term indi- (2) If the reference amounts are in cating that extra air has been incor- compatible units, the weights or vol- porated (e.g., whipped, aerated). The umes must be summed (e.g., the ref- density-adjusted reference amounts de- erence amount for equal volumes of scribed in paragraph (b) of this section peanut butter and jelly for which pea- may not be used for cakes except for nut butter is represented as the main cheese cake. The differences in the den- ingredient would be 4 tablespoons sities of different types of cakes having (tbsp) (2 tbsp peanut butter plus 2 tbsp different degrees of air incorporation jelly)). If the reference amounts are in have already been taken into consider- incompatible units, all amounts must ation in determining the reference be converted to weights and summed, amounts for cakes in § 101.12(b). In de- e.g., the reference amount for pancakes termining the difference in density of and syrup would be 110 g (the reference the aerated and the regular food, the amount for pancakes) plus the weight manufacturer shall adhere to the fol- of the proportioned amount of syrup. lowing: (g) The reference amounts set forth (1) The regular and the aerated prod- in paragraphs (b) through (f) of this uct must be the same in size, shape, section shall be used in determining and volume. To compare the densities whether a product meets the criteria of products having nonsmooth surfaces for nutrient content claims, such as (e.g., waffles), manufacturers shall use ‘‘low calorie,’’ and for health claims. If a device or method that ensures that the serving size declared on the prod- the volumes of the regular and the aer- uct label differs from the reference ated products are the same. amount, and the product meets the cri- (2) Sample selections for the density teria for the claim only on the basis of measurements shall be done in accord- the reference amount, the claim shall ance with the provisions in § 101.9(g). be followed by a statement that sets

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forth the basis on which the claim is (10) The suggested reference amount made. That statement shall include the shall be expressed in metric units. Ref- reference amount as it appears in para- erence amounts for fluids shall be ex- graph (b) of this section followed, in pressed in milliliters. Reference parenthesis, by the amount in common amounts for other foods shall be ex- household measure if the reference pressed in grams except when common amount is expressed in measures other household units such as cups, table- than common household measures spoons, and teaspoons, are more appro- (e.g., for a beverage, ‘‘Very low sodium, priate or are more likely to promote 35 mg or less per 240 mL (8 fl oz)’’). uniformity in serving sizes declared on (h) The Commissioner of Food and product labels. For example, common Drugs, either on his or her own initia- household measures would be more ap- tive or in response to a petition sub- propriate if products within the same mitted pursuant to part 10 of this chap- category differ substantially in den- ter, may issue a proposal to establish sity, such as frozen desserts. or amend a reference amount in para- (i) In expressing the reference graph (b) of this section. A petition to amounts in milliliters, the following establish or amend a reference amount rules shall be followed: shall include: (A) For volumes greater than 30 mil- (1) Objective of the petition; liliters (mL), the volume shall be ex- (2) A description of the product; pressed in multiples of 30 mL. (3) A complete sample product label (B) For volumes less than 30 mL, the including nutrition label, using the for- volume shall be expressed in milliliters mat established by regulation; equivalent to a whole number of (4) A description of the form (e.g., dry teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL. mix, frozen dough) in which the prod- (ii) In expressing the reference uct will be marketed; amounts in grams, the following gen- (5) The intended dietary uses of the eral rules shall be followed: product with the major use identified (A) For quantities greater than 10 g, (e.g., milk as a beverage and chips as a the quantity shall be expressed in the snack); nearest 5-g increment. (6) If the intended use is primarily as (B) For quantities less than 10 g, an ingredient in other foods, list of exact gram weights shall be used. foods or food categories in which the (11) A petition to create a new sub- product will be used as an ingredient category of food with its own reference with information on the prioritization amount shall include the following ad- of the use; ditional information: (7) The population group for which (i) Data that demonstrate that the the product will be offered for use (e.g., new subcategory of food will be con- infants, children under 4 years of age); sumed in amounts that differ enough (8) The names of the most closely re- from the reference amount for the par- lated products (or in the case of foods ent category to warrant a separate ref- for special dietary use and imitation or erence amount. Data must include substitute foods, the names of the sample size; and the mean, standard de- products for which they are offered as viation, median, and modal consumed substitutes); amount per eating occasion for the pe- (9) The suggested reference amount titioned product and for other products (the amount of edible portion of food as in the category, excluding the peti- consumed, excluding bone, seed, shell, tioned product. All data must be de- or other inedible components) for the rived from the same survey data. population group for which the product (ii) Documentation supporting the is intended with full description of the difference in dietary usage and product methodology and procedures that were characteristics that affect the con- used to determine the suggested ref- sumption size that distinguishes the erence amount. In determining the ref- petitioned product from the rest of the erence amount, general principles and products in the category. factors in paragraph (a) of this section (12) A claim for categorical exclusion should be followed. under § 25.30 or § 25.32 of this chapter or

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an environmental assessment under made in accordance with this regula- § 25.40 of this chapter, and tion and with the applicable regula- (13) In conducting research to collect tions in subpart D of this part or in or process food consumption data in part 105 or part 107 of this chapter. support of the petition, the following (1) An expressed nutrient content general guidelines should be followed. claim is any direct statement about (i) Sampled population selected the level (or range) of a nutrient in the should be representative of the demo- food, e.g., ‘‘low sodium’’ or ‘‘contains graphic and socioeconomic characteris- 100 calories.’’ tics of the target population group for (2) An implied nutrient content claim which the food is intended. is any claim that: (ii) Sample size (i.e., number of eat- (i) Describes the food or an ingre- ers) should be large enough to give reli- dient therein in a manner that sug- able estimates for customarily con- gests that a nutrient is absent or sumed amounts. present in a certain amount (e.g., (iii) The study protocol should iden- ‘‘high in oat bran’’); or tify potential biases and describe how (ii) Suggests that the food, because of potential biases are controlled for or, if its nutrient content, may be useful in not possible to control, how they affect maintaining healthy dietary practices interpretation of results. and is made in association with an ex- (iv) The methodology used to collect plicit claim or statement about a nu- or process data should be fully docu- trient (e.g., ‘‘healthy, contains 3 grams mented and should include: study de- (g) of fat’’). sign, sampling procedures, materials (3) Except for claims regarding vita- used (e.g., questionnaire, and inter- mins and minerals described in para- viewer’s manual), procedures used to graph (q)(3) of this section, no nutrient collect or process data, methods or pro- content claims may be made on food cedures used to control for unbiased es- intended specifically for use by infants timates, and procedures used to correct and children less than 2 years of age for nonresponse. unless the claim is specifically pro- (14) A statement concerning the fea- vided for in parts 101, 105, or 107 of this sibility of convening associations, cor- chapter. porations, consumers, and other inter- (4) Reasonable variations in the spell- ested parties to engage in negotiated ing of the terms defined in part 101 and rulemaking to develop a proposed rule their synonyms are permitted provided consistent with the Negotiated Rule- these variations are not misleading making Act (5 U.S.C. 561). (e.g., ‘‘hi’’ or ‘‘lo’’). (5) For dietary supplements, claims [58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. for calories, fat, saturated fat, and cho- 15, 1993, as amended at 59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 29, lesterol may not be made on products 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, that meet the criteria in § 101.60(b)(1) or Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR (b)(2) for ‘‘calorie free’’ or ‘‘low cal- 56035, Nov. 6, 2001; 81 FR 34041, May 27, 2016] orie’’ claims, except, in the case of calorie claims, when an equivalent § 101.13 Nutrient content claims—gen- amount of a similar dietary supple- eral principles. ment (e.g., another protein supple- (a) This section and the regulations ment) that the labeled food resembles in subpart D of this part apply to foods and for which it substitutes, normally that are intended for human consump- exceeds the definition for ‘‘low calorie’’ tion and that are offered for sale, in- in § 101.60(b)(2). cluding conventional foods and dietary (c) Information that is required or supplements. permitted by § 101.9 or § 101.36, as appli- (b) A claim that expressly or implic- cable, to be declared in nutrition label- itly characterizes the level of a nutri- ing, and that appears as part of the nu- ent of the type required to be in nutri- trition label, is not a nutrient content tion labeling under § 101.9 or under claim and is not subject to the require- § 101.36 (that is, a nutrient content ments of this section. If such informa- claim) may not be made on the label or tion is declared elsewhere on the label in labeling of foods unless the claim is or in labeling, it is a nutrient content

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claim and is subject to the require- (f) A nutrient content claim shall be ments for nutrient content claims. in type size no larger than two times (d) A ‘‘substitute’’ food is one that the statement of identity and shall not may be used interchangeably with an- be unduly prominent in type style com- other food that it resembles, i.e., that pared to the statement of identity. it is organoleptically, physically, and (g) [Reserved] functionally (including shelf life) simi- (h)(1) If a food, except a meal product lar to, and that it is not nutritionally as defined in § 101.13(l), a main dish inferior to unless it is labeled as an product as defined in § 101.13(m), or food ‘‘imitation.’’ intended specifically for use by infants (1) If there is a difference in perform- and children less than 2 years of age, ance characteristics that materially contains more than 13.0 g of fat, 4.0 g of limits the use of the food, the food may saturated fat, 60 milligrams (mg) of still be considered a substitute if the cholesterol, or 480 mg of sodium per label includes a disclaimer adjacent to reference amount customarily con- the most prominent claim as defined in sumed, per labeled serving, or, for a paragraph (j)(2)(iii) of this section, in- food with a reference amount custom- forming the consumer of such dif- arily consumed of 30 g or less or 2 ta- ference (e.g., ‘‘not recommended for blespoons or less, per 50 g (for dehy- frying’’). drated foods that must be reconsti- (2) This disclaimer shall be in easily tuted before typical consumption with legible print or type and in a size no water or a diluent containing an insig- less than that required by § 101.7(i) for nificant amount, as defined in the net quantity of contents state- § 101.9(f)(1), of all nutrients per ref- ment, except where the size of the erence amount customarily consumed, claim is less than two times the re- the per 50 g criterion refers to the ‘‘as quired size of the net quantity of con- prepared’’ form), then that food must tents statement, in which case the dis- bear a statement disclosing that the claimer shall be no less than one-half nutrient exceeding the specified level the size of the claim but no smaller is present in the food as follows: ‘‘See than one-sixteenth of an inch, unless nutrition information for ll content’’ the package complies with § 101.2(c)(5), with the blank filled in with the iden- in which case the disclaimer may be in tity of the nutrient exceeding the spec- type of not less than one thirty-second ified level, e.g., ‘‘See nutrition infor- of an inch. mation for fat content.’’ (e)(1) Because the use of a ‘‘free’’ or (2) If a food is a meal product as de- ‘‘low’’ claim before the name of a food fined in § 101.13(l), and contains more implies that the food differs from other than 26 g of fat, 8.0 g of saturated fat, foods of the same type by virtue of its 120 mg of cholesterol, or 960 mg of so- having a lower amount of the nutrient, dium per labeled serving, then that only foods that have been specially food must disclose, in accordance with processed, altered, formulated, or re- the requirements as provided in para- formulated so as to lower the amount graph (h)(1) of this section, that the of the nutrient in the food, remove the nutrient exceeding the specified level nutrient from the food, or not include is present in the food. the nutrient in the food, may bear such (3) If a food is a main dish product as a claim (e.g., ‘‘low sodium potato defined in § 101.13(m), and contains chips’’). more than 19.5 g of fat, 6.0 g of satu- (2) Any claim for the absence of a nu- rated fat, 90 mg of cholesterol, or 720 trient in a food, or that a food is low in mg of sodium per labeled serving, then a nutrient when the food has not been that food must disclose, in accordance specially processed, altered, formu- with the requirements as provided in lated, or reformulated to qualify for paragraph (h)(1) of this section, that that claim shall indicate that the food the nutrient exceeding the specified inherently meets the criteria and shall level is present in the food. clearly refer to all foods of that type (4)(i) The disclosure statement ‘‘See and not merely to the particular brand nutrition information for ll content’’ to which the labeling attaches (e.g., shall be in easily legible boldface print ‘‘corn oil, a sodium-free food’’). or type, in distinct contrast to other

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printed or graphic matter, and in a size ‘‘low’’ in or a ‘‘good source’’ of the nu- no less than that required by § 101.7(i) trient, such as ‘‘only 200 mg sodium per for the net quantity of contents state- serving, not a low sodium food.’’ The ment, except where the size of the disclaimer must be in easily legible claim is less than two times the re- print or type and in a size no less than quired size of the net quantity of con- that required by § 101.7(i) for the net tents statement, in which case the dis- quantity of contents statement except closure statement shall be no less than where the size of the claim is less than one-half the size of the claim but no two times the required size of the net smaller than one-sixteenth of an inch, quantity of contents statement, in unless the package complies with which case the disclaimer shall be no § 101.2(c)(2), in which case the disclo- less than one-half the size of the claim sure statement may be in type of not but no smaller than one-sixteenth of an less than one thirty-second of an inch. inch unless the package complies with (ii) The disclosure statement shall be § 101.2(c)(5), in which case the dis- immediately adjacent to the nutrient claimer may be in type of not less less content claim and may have no inter- than one thirty-second of an inch, or vening material other than, if applica- (3) The statement does not in any ble, other information in the statement way implicitly characterize the level of of identity or any other information the nutrient in the food and it is not that is required to be presented with false or misleading in any respect (e.g., the claim under this section (e.g., see ‘‘100 calories’’ or ‘‘5 grams of fat’’), in paragraph (j)(2) of this section) or which case no disclaimer is required. under a regulation in subpart D of this (4) ‘‘Percent fat free’’ claims are not part (e.g., see §§ 101.54 and 101.62). If the authorized by this paragraph. Such nutrient content claim appears on claims shall comply with § 101.62(b)(6). more than one panel of the label, the (j) A food may bear a statement that disclosure statement shall be adjacent compares the level of a nutrient in the to the claim on each panel except for food with the level of a nutrient in a the panel that bears the nutrition information where it may be omitted. reference food. These statements shall (iii) If a single panel of a food label or be known as ‘‘relative claims’’ and in- labeling contains multiple nutrient clude ‘‘light,’’ ‘‘reduced,’’ ‘‘less’’ (or content claims or a single claim re- ‘‘fewer’’), and ‘‘more’’ claims. peated several times, a single disclo- (1) To bear a relative claim about the sure statement may be made. The level of a nutrient, the amount of that statement shall be adjacent to the nutrient in the food must be compared claim that is printed in the largest to an amount of nutrient in an appro- type on that panel. priate reference food as specified (i) Except as provided in § 101.9 or below. § 101.36, as applicable, or in paragraph (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and (q)(3) of this section, the label or label- ‘‘more’’ claims, the reference food may ing of a product may contain a state- be a dissimilar food within a product ment about the amount or percentage category that can generally be sub- of a nutrient if: stituted for one another in the diet (1) The use of the statement on the (e.g., potato chips as reference for pret- food implicitly characterizes the level zels, orange juice as a reference for vi- of the nutrient in the food and is con- tamin C tablets) or a similar food (e.g., sistent with a definition for a claim, as potato chips as reference for potato provided in subpart D of this part, for chips, one brand of multivitamin as the nutrient that the label addresses. reference for another brand of multi- Such a claim might be, ‘‘less than 3 g vitamin). of fat per serving;’’ (B) For ‘‘light,’’ ‘‘reduced,’’ ‘‘added,’’ (2) The use of the statement on the ‘‘extra,’’ ‘‘plus,’’ ‘‘fortified,’’ and ‘‘en- food implicitly characterizes the level riched’’ claims, the reference food shall of the nutrient in the food and is not be a similar food (e.g., potato chips as consistent with such a definition, but a reference for potato chips, one brand the label carries a disclaimer adjacent of multivitamin for another brand of to the statement that the food is not multivitamin), and

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(ii)(A) For ‘‘light’’ claims, the ref- (ii) This information shall be imme- erence food shall be representative of diately adjacent to the most prominent the type of food that includes the prod- claim. The type size shall be in accord- uct that bears the claim. The nutrient ance with paragraph (h)(4)(i) of this value for the reference food shall be section. representative of a broad base of foods (iii) The determination of which use of that type; e.g., a value in a rep- of the claim is in the most prominent resentative, valid data base; an average location on the label or labeling will be value determined from the top three made based on the following factors, national (or regional) brands, a market considered in order: basket norm; or, where its nutrient (A) A claim on the principal display value is representative of the food panel adjacent to the statement of type, a market leader. Firms using identity; such a reference nutrient value as a (B) A claim elsewhere on the prin- basis for a claim, are required to pro- cipal display panel; vide specific information upon which (C) A claim on the information panel; the nutrient value was derived, on re- or quest, to consumers and appropriate (D) A claim elsewhere on the label or regulatory officials. labeling. (B) For relative claims other than (iv) The label or labeling must also ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ bear: claims, the reference food may be the (A) Clear and concise quantitative in- same as that provided for ‘‘light’’ in formation comparing the amount of paragraph (j)(1)(ii)(A) of this section, the subject nutrient in the product per or it may be the manufacturer’s reg- labeled serving with that in the ref- ular product, or that of another manu- erence food; and facturer, that has been offered for sale (B) This statement shall appear adja- to the public on a regular basis for a cent to the most prominent claim or to substantial period of time in the same the nutrition label, except that if the geographic area by the same business nutrition label is on the information entity or by one entitled to use its panel, the quantitative information trade name. The nutrient values used may be located elsewhere on the infor- to determine the claim when com- mation panel in accordance with § 101.2. paring a single manufacturer’s product (3) A relative claim for decreased lev- to the labeled product shall be either els of a nutrient may not be made on the values declared in nutrition label- the label or in labeling of a food if the ing or the actual nutrient values, pro- nutrient content of the reference food vided that the resulting label is inter- meets the requirement for a ‘‘low’’ nally consistent to (i.e., that the val- claim for that nutrient (e.g., 3 g fat or ues stated in the nutrition informa- less). tion, the nutrient values in the accom- (k) The term ‘‘modified’’ may be used panying information and the declara- in the statement of identity of a food tion of the percentage of nutrient by that bears a relative claim that com- which the food has been modified are plies with the requirements of this consistent and will not cause consumer part, followed immediately by the confusion when compared), and that name of the nutrient whose content the actual modification is at least has been altered (e.g., ‘‘Modified fat equal to the percentage specified in the cheesecake’’). This statement of iden- definition of the claim. tity must be immediately followed by (2) For foods bearing relative claims: the comparative statement such as (i) The label or labeling must state ‘‘Contains 35 percent less fat than the identity of the reference food and lll.’’ The label or labeling must also the percentage (or fraction) of the bear the information required by para- amount of the nutrient in the reference graph (j)(2) of this section in the man- food by which the nutrient in the la- ner prescribed. beled food differs (e.g., ‘‘50 percent less (l) For purposes of making a claim, a fat than (reference food)’’ or ‘‘1/3 fewer ‘‘meal product shall be defined as a calories than (reference food)’’), food that:

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(1) Makes a major contribution to the cable, shall be provided for any food for total diet by: which a nutrient content claim is (i) Weighing at least 10 ounces (oz) made. per labeled serving; and (o) Except as provided in § 101.10, (ii) Containing not less than three 40- compliance with requirements for nu- g portions of food, or combinations of trient content claims in this section foods, from two or more of the fol- and in the regulations in subpart D of lowing four food groups, except as this part, will be determined using the noted in paragraph (l)(1)(ii)(E) of this analytical methodology prescribed for section. determining compliance with nutrition (A) Bread, cereal, rice, and pasta labeling in § 101.9. group; (p)(1) Unless otherwise specified, the (B) Fruits and vegetables group; reference amount customarily con- (C) Milk, yogurt, and cheese group; sumed set forth in § 101.12(b) through (f) (D) Meat, poultry, fish, dry beans, shall be used in determining whether a eggs, and nuts group; except that; product meets the criteria for a nutri- (E) These foods shall not be sauces ent content claim. If the serving size (except for foods in the above four food declared on the product label differs groups that are in the sauces), gravies, from the reference amount customarily condiments, relishes, pickles, olives, consumed, and the amount of the nu- jams, jellies, syrups, breadings or trient contained in the labeled serving garnishes; and does not meet the maximum or min- (2) Is represented as, or is in a form imum amount criterion in the defini- commonly understood to be, a break- tion for the descriptor for that nutri- fast, lunch, dinner, or meal. Such rep- ent, the claim shall be followed by the resentations may be made either by criteria for the claim as required by statements, photographs, or vignettes. § 101.12(g) (e.g., ‘‘very low sodium, 35 (m) For purposes of making a claim, mg or less per 240 milliliters (8 fl oz.)’’). a ‘‘main dish product’’ shall be defined (2) The criteria for the claim shall be as a food that: immediately adjacent to the most (1) Makes a major contribution to a prominent claim in easily legible print meal by or type and in a size in accordance with (i) Weighing at least 6 oz per labeled paragraph (h)(4)(i) of this section. serving; and (q) The following exemptions apply: (ii) Containing not less than 40 g of (1) Nutrient content claims that have food, or combinations of foods, from not been defined by regulation and that each of at least two of the following are contained in the brand name of a four food groups, except as noted in specific food product that was the paragraph (m)(1)(ii)(E) of this section. brand name in use on such food before (A) Bread, cereal, rice, and pasta October 25, 1989, may continue to be group; used as part of that brand name for (B) Fruits and vegetables group; such product, provided that they are (C) Milk, yogurt, and cheese group; not false or misleading under section (D) Meat, poultry, fish, dry beans, 403(a) of the Federal Food, Drug, and eggs, and nuts groups; except that: Cosmetic Act (the act). However, foods (E) These foods shall not be sauces bearing such claims must comply with (except for foods in the above four food section 403(f), (g), and (h) of the act; groups that are in the sauces) gravies, (2) A soft drink that used the term condiments, relishes, pickles, olives, diet as part of its brand name before jams, jellies, syrups, breadings, or October 25, 1989, and whose use of that garnishes; and term was in compliance with § 105.66 of (2) Is represented as, or is in a form this chapter as that regulation ap- commonly understood to be, a main peared in the Code of Federal Regula- dish (e.g, not a beverage or a dessert). tions on that date, may continue to use Such representations may be made ei- that term as part of its brand name, ther by statements, photographs, or vi- provided that its use of the term is not gnettes. false or misleading under section 403(a) (n) Nutrition labeling in accordance of the act. Such claims are exempt with § 101.9, § 101.10, or § 101.36, as appli- from the requirements of section

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403(r)(2) of the act (e.g., the disclosure fatty acids per capsule (80 mg) as in 100 statement also required by § 101.13(h)). mg of menhaden oil (40 mg)’’). Soft drinks marketed after October 25, (4) The requirements of this section 1989, may use the term ‘‘diet’’ provided do not apply to: they are in compliance with the cur- (i) Infant formulas subject to section rent § 105.66 of this chapter and the re- 412(h) of the act; and quirements of § 101.13. (ii) Medical foods defined by section (3)(i) A statement that describes the 5(b) of the Orphan Drug Act. percentage of a vitamin or mineral in (5) A nutrient content claim used on the food, including foods intended spe- food that is served in restaurants or cifically for use by infants and children other establishments in which food is less than 2 years of age, in relation to served for immediate human consump- a Reference Daily Intake (RDI) as de- tion or which is sold for sale or use in fined in § 101.9 may be made on the such establishments shall comply with label or in labeling of a food without a the requirements of this section and regulation authorizing such a claim for the appropriate definition in subpart D a specific vitamin or mineral unless of this part, except that: such claim is expressly prohibited by (i) Such claim is exempt from the re- regulation under section 403(r)(2)(A)(vi) quirements for disclosure statements of the act. in paragraph (h) of this section and (ii) Percentage claims for dietary §§ 101.54(d), 101.62(c), (d)(1)(ii)(D), supplements. Under section 403(r)(2)(F) (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and (d)(5)(ii)(C); and of the act, a statement that character- (ii) In lieu of analytical testing, com- izes the percentage level of a dietary pliance may be determined using a rea- ingredient for which a reference daily sonable basis for concluding that the intake (RDI) or daily reference value food that bears the claim meets the (DRV) has not been established may be definition for the claim. This reason- made on the label or in labeling of die- able basis may derive from recognized tary supplements without a regulation data bases for raw and processed foods, that specifically defines such a state- recipes, and other means to compute ment. All such claims shall be accom- nutrient levels in the foods or meals panied by any disclosure statement re- and may be used provided reasonable quired under paragraph (h) of this sec- steps are taken to ensure that the tion. method of preparation adheres to the (A) Simple percentage claims. When- factors on which the reasonable basis ever a statement is made that charac- was determined (e.g., types and terizes the percentage level of a die- amounts of ingredients, cooking tem- tary ingredient for which there is no peratures, etc.). Firms making claims RDI or DRV, the statement of the ac- on foods based on this reasonable basis tual amount of the dietary ingredient criterion are required to provide to ap- per serving shall be declared next to propriate regulatory officials on re- the percentage statement (e.g., ‘‘40 per- quest the specific information on which cent omega-3 fatty acids, 10 mg per their determination is based and rea- capsule’’). sonable assurance of operational adher- (B) Comparative percentage claims. ence to the preparation methods or Whenever a statement is made that other basis for the claim; and characterizes the percentage level of a (iii) A term or symbol that may in dietary ingredient for which there is no some contexts constitute a claim under RDI or DRV and the statement draws a this section may be used, provided that comparison to the amount of the die- the use of the term or symbol does not tary ingredient in a reference food, the characterize the level of a nutrient, reference food shall be clearly identi- and a statement that clearly explains fied, the amount of that food shall be the basis for the use of the term or identified, and the information on the symbol is prominently displayed and actual amount of the dietary ingre- does not characterize the level of a nu- dient in both foods shall be declared in trient. For example, a term such as accordance with paragraph (j)(2)(iv) of ‘‘lite fare’’ followed by an asterisk re- this section (e.g., ‘‘twice the omega-3 ferring to a note that makes clear that

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in this restaurant ‘‘lite fare’’ means food and a disease or health-related smaller portion sizes than normal; or condition. an item bearing a symbol referring to a (2) Substance means a specific food or note that makes clear that this item component of food, regardless of meets the criteria for the dietary guid- whether the food is in conventional ance established by a recognized die- food form or a dietary supplement that tary authority would not be considered includes vitamins, minerals, herbs, or a nutrient content claim under § 101.13. other similar nutritional substances. (6) Nutrient content claims that were (3) Nutritive value means a value in part of the common or usual names of sustaining human existence by such foods that were subject to a standard of processes as promoting growth, replac- identity on November 8, 1990, are not ing loss of essential nutrients, or pro- subject to the requirements of para- viding energy. graphs (b) and (h) of this section or to (4) Disqualifying nutrient levels means definitions in subpart D of this part. the levels of total fat, saturated fat, (7) Implied nutrient content claims cholesterol, or sodium in a food above may be used as part of a brand name, which the food will be disqualified from provided that the use of the claim has making a health claim. These levels been authorized by the Food and Drug are 13.0 grams (g) of fat, 4.0 g of satu- Administration. Petitions requesting rated fat, 60 milligrams (mg) of choles- approval of such a claim may be sub- terol, or 480 mg of sodium, per ref- mitted under § 101.69(o). erence amount customarily consumed, (8) The term fluoridated, fluoride per label serving size, and, only for added or with added fluoride may be foods with reference amounts custom- used on the label or in labeling of bot- arily consumed of 30 g or less or 2 ta- tled water that contains added fluo- blespoons or less, per 50 g. For dehy- ride. drated foods that must have water added to them prior to typical con- [58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, sumption, the per 50-g criterion refers Apr. 2, 1993, as amended at 58 FR 44030, Aug. to the as prepared form. Any one of the 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR levels, on a per reference amount cus- 11731, Mar. 22, 1996; 61 FR 40332, Aug. 2, 1996; tomarily consumed, a per label serving 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9, size or, when applicable, a per 50 g 1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, basis, will disqualify a food from mak- Mar. 27, 1998; 63 FR 26980, May 15, 1998; 81 FR ing a health claim unless an exception 59131, Aug. 29, 2016] is provided in subpart E of this part, except that: § 101.14 Health claims: general re- (i) The levels for a meal product as quirements. defined in § 101.13(l) are 26.0 g of fat, 8.0 (a) Definitions. For purposes of this g of saturated fat, 120 mg of choles- section, the following definitions terol, or 960 mg of sodium per label apply: serving size, and (1) Health claim means any claim (ii) The levels for a main dish product made on the label or in labeling of a as defined in § 101.13(m) are 19.5 g of fat, food, including a dietary supplement, 6.0 g of saturated fat, 90 mg of choles- that expressly or by implication, in- terol, or 720 mg of sodium per label cluding ‘‘third party’’ references, writ- serving size. ten statements (e.g., a brand name in- (5) Disease or health-related condition cluding a term such as ‘‘heart’’), sym- means damage to an organ, part, struc- bols (e.g., a heart symbol), or vi- ture, or system of the body such that it gnettes, characterizes the relationship does not function properly (e.g., cardio- of any substance to a disease or health- vascular disease), or a state of health related condition. Implied health leading to such dysfunctioning (e.g., claims include those statements, sym- hypertension); except that diseases re- bols, vignettes, or other forms of com- sulting from essential nutrient defi- munication that suggest, within the ciencies (e.g., scurvy, pellagra) are not context in which they are presented, included in this definition (claims per- that a relationship exists between the taining to such diseases are thereby presence or level of a substance in the not subject to § 101.14 or § 101.70).

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(b) Eligibility. For a substance to be (d) General health claim labeling re- eligible for a health claim: quirements. (1) When FDA determines (1) The substance must be associated that a health claim meets the validity with a disease or health-related condi- requirements of paragraph (c) of this tion for which the general U.S. popu- section, FDA will propose a regulation lation, or an identified U.S. population in subpart E of this part to authorize subgroup (e.g., the elderly) is at risk, the use of that claim. If the claim per- or, alternatively, the petition sub- tains to a substance not provided for in mitted by the proponent of the claim § 101.9 or § 101.36, FDA will propose otherwise explains the prevalence of amending that regulation to include the disease or health-related condition declaration of the substance. in the U.S. population and the rel- (2) When FDA has adopted a regula- evance of the claim in the context of tion in subpart E of this part providing the total daily diet and satisfies the for a health claim, firms may make other requirements of this section. claims based on the regulation in sub- (2) If the substance is to be consumed part E of this part, provided that: as a component of a conventional food (i) All label or labeling statements at decreased dietary levels, the sub- about the substance-disease relation- stance must be a nutrient listed in 21 ship that is the subject of the claim are U.S.C. 343(q)(1)(C) or (q)(1)(D), or one based on, and consistent with, the con- that the Food and Drug Administra- clusions set forth in the regulations in tion (FDA) has required to be included subpart E of this part; in the label or labeling under 21 U.S.C. (ii) The claim is limited to describing 343(q)(2)(A); or the value that ingestion (or reduced in- (3) If the substance is to be consumed gestion) of the substance, as part of a at other than decreased dietary levels: total dietary pattern, may have on a (i) The substance must, regardless of particular disease or health-related whether the food is a conventional food condition; or a dietary supplement, contribute (iii) The claim is complete, truthful, taste, aroma, or nutritive value, or any and not misleading. Where factors other technical effect listed in § 170.3(o) other than dietary intake of the sub- of this chapter, to the food and must stance affect the relationship between retain that attribute when consumed the substance and the disease or at levels that are necessary to justify a health-related condition, such factors claim; and may be required to be addressed in the (ii) The substance must be a food or claim by a specific regulation in sub- a food ingredient or a component of a part E of this part; food ingredient whose use at the levels (iv) All information required to be in- necessary to justify a claim has been cluded in the claim appears in one demonstrated by the proponent of the place without other intervening mate- claim, to FDA’s satisfaction, to be safe rial, except that the principal display and lawful under the applicable food panel of the label or labeling may bear safety provisions of the Federal Food, the reference statement, ‘‘See lll Drug, and Cosmetic Act. for information about the relationship (c) Validity requirement. FDA will pro- between lll and lll,’’ with the mulgate regulations authorizing a blanks filled in with the location of the health claim only when it determines, labeling containing the health claim, based on the totality of publicly avail- the name of the substance, and the dis- able scientific evidence (including evi- ease or health-related condition (e.g., dence from well-designed studies con- ‘‘See attached pamphlet for informa- ducted in a manner which is consistent tion about calcium and osteoporosis’’), with generally recognized scientific with the entire claim appearing else- procedures and principles), that there where on the other labeling, Provided is significant scientific agreement, that, where any graphic material (e.g., among experts qualified by scientific a heart symbol) constituting an ex- training and experience to evaluate plicit or implied health claim appears such claims, that the claim is sup- on the label or labeling, the reference ported by such evidence. statement or the complete claim shall

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appear in immediate proximity to such ing of l ounces of this product con- graphic material; forms to such a diet.’’). (v) The claim enables the public to (B) Where the food that bears the comprehend the information provided claim is sold in a restaurant or in other and to understand the relative signifi- establishments in which food that is cance of such information in the con- ready for immediate human consump- text of a total daily diet; and tion is sold, the food can meet the re- (vi) If the claim is about the effects quirements of paragraphs (d)(2)(vi) or of consuming the substance at de- (d)(2)(vii) of this section if the firm creased dietary levels, the level of the that sells the food has a reasonable substance in the food is sufficiently basis on which to believe that the food low to justify the claim. To meet this that bears the claim meets the require- requirement, if a definition for use of ments of paragraphs (d)(2)(vi) or the term low has been established for (d)(2)(vii) of this section and provides that substance under this part, the sub- that basis upon request. stance must be present at a level that (3) Nutrition labeling shall be pro- meets the requirements for use of that vided in the label or labeling of any term, unless a specific alternative level food for which a health claim is made has been established for the substance in accordance with § 101.9; for resin subpart E of this part. If no defini- taurant foods, in accordance with tion for ‘‘low’’ has been established, § 101.10; or for dietary supplements, in the level of the substance must meet accordance with § 101.36. the level established in the regulation (e) Prohibited health claims. No ex- authorizing the claim; or pressed or implied health claim may be (vii) If the claim is about the effects made on the label or in labeling for a of consuming the substance at other food, regardless of whether the food is than decreased dietary levels, the level in conventional food form or dietary of the substance is sufficiently high supplement form, unless: and in an appropriate form to justify the claim. To meet this requirement, if (1) The claim is specifically provided a definition for use of the term high for for in subpart E of this part; and that substance has been established (2) The claim conforms to all general under this part, the substance must be provisions of this section as well as to present at a level that meets the re- all specific provisions in the appro- quirements for use of that term, unless priate section of subpart E of this part; a specific alternative level has been es- (3) None of the disqualifying levels tablished for the substance in subpart identified in paragraph (a)(4) of this E of this part. If no definition for section is exceeded in the food, unless ‘‘high’’ has been established (e.g., specific alternative levels have been es- where the claim pertains to a food ei- tablished for the substance in subpart ther as a whole food or as an ingredient E of this part; or unless FDA has per- in another food), the claim must speci- mitted a claim despite the fact that a fy the daily dietary intake necessary disqualifying level of a nutrient is to achieve the claimed effect, as estab- present in the food based on a finding lished in the regulation authorizing the that such a claim will assist consumers claim; Provided That: in maintaining healthy dietary prac- (A) Where the food that bears the tices, and, in accordance with the regu- claim meets the requirements of para- lation in subpart E of this part that graphs (d)(2)(vi) or (d)(2)(vii) of this makes such a finding, the label bears a section based on its reference amount disclosure statement that complies customarily consumed, and the labeled with § 101.13(h), highlighting the nutri- serving size differs from that amount, ent that exceeds the disqualifying the claim shall be followed by a state- level; ment explaining that the claim is (4) Except as provided in paragraph based on the reference amount rather (e)(3) of this section, no substance is than the labeled serving size (e.g., present at an inappropriate level as de- ‘‘Diets low in sodium may reduce the termined in the specific provision au- risk of high blood pressure, a disease thorizing the claim in subpart E of this associated with many factors. A serv- part;

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(5) The label does not represent or prominent placing of such word, state- purport that the food is for infants and ment, or information; toddlers less than 2 years of age except (4) Insufficiency of label space (for if the claim is specifically provided for the prominent placing of such word, in subpart E of this part; and statement, or information) resulting (6) Except for dietary supplements or from the use of label space for any where provided for in other regulations word, statement, design, or device in part 101, subpart E, the food con- which is not required by or under au- tains 10 percent or more of the Ref- thority of the act to appear on the erence Daily Intake or the Daily Ref- label; erence Value for vitamin A, vitamin C, (5) Insufficiency of label space (for iron, calcium, protein, or fiber per ref- the prominent placing of such word, erence amount customarily consumed statement, or information) resulting prior to any nutrient addition. from the use of label space to give ma- (f) The requirements of this section terially greater conspicuousness to any do not apply to: other word, statement, or information, (1) Infant formulas subject to section or to any design or device; or 412(h) of the Federal Food, Drug, and (6) Smallness or style of type in Cosmetic Act, and which such word, statement, or infor- (2) Medical foods defined by section mation appears, insufficient back- 5(b) of the Orphan Drug Act. ground contrast, obscuring designs or (g) Applicability. The requirements of vignettes, or crowding with other writ- this section apply to foods intended for ten, printed, or graphic matter. human consumption that are offered (b) No exemption depending on insuf- for sale, regardless of whether the ficiency of label space, as prescribed in foods are in conventional food form or regulations promulgated under section dietary supplement form. 403 (e) or (i) of the act, shall apply if such insufficiency is caused by: [58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58 FR 44038, Aug. 18, 1993; (1) The use of label space for any 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, word, statement, design, or device 1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, which is not required by or under au- Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR thority of the act to appear on the 17358, Mar. 30, 2001] label; (2) The use of label space to give § 101.15 Food; prominence of required greater conspicuousness to any word, statements. statement, or other information than (a) A word, statement, or other infor- is required by section 403(f) of the act; mation required by or under authority or of the act to appear on the label may (3) The use of label space for any rep- lack that prominence and conspicuous- resentation in a foreign language. ness required by section 403(f) of the (c)(1) All words, statements, and act by reason (among other reasons) of: other information required by or under (1) The failure of such word, state- authority of the act to appear on the ment, or information to appear on the label or labeling shall appear thereon part or panel of the label which is pre- in the English language: Provided, how- sented or displayed under customary ever, That in the case of articles dis- conditions of purchase; tributed solely in the Commonwealth (2) The failure of such word, state- of Puerto Rico or in a Territory where ment, or information to appear on two the predominant language is one other or more parts or panels of the label, than English, the predominant lan- each of which has sufficient space guage may be substituted for English. therefor, and each of which is so de- (2) If the label contains any represen- signed as to render it likely to be, tation in a foreign language, all words, under customary conditions of pur- statements, and other information re- chase, the part or panel displayed; quired by or under authority of the act (3) The failure of the label to extend to appear on the label shall appear over the area of the container or pack- thereon in the foreign language: Pro- age available for such extension, so as vided, however, That individual serving- to provide sufficient label space for the size packages of foods containing no

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more than 11⁄2 avoirdupois ounces or no (2) The warning required by para- more than 11⁄2 fluid ounces served with graph (b)(1) of this section is not re- meals in restaurants, institutions, and quired for the following products: passenger carriers and not intended for (i) Products expelled in the form of a sale at retail are exempt from the re- foam or cream, which contain less than quirements of this paragraph (c)(2), if 10 percent propellant in the container. the only representation in the foreign (ii) Products in a container with a language(s) is the name of the food. physical barrier that prevents escape of the propellant at the time of use. (3) If any article of labeling (other (iii) Products of a net quantity of than a label) contains any representa- contents of less than 2 ounces that are tion in a foreign language, all words, designed to release a measured amount statements, and other information re- of product with each valve actuation. quired by or under authority of the act (iv) Products of a net quantity of to appear on the label or labeling shall contents of less than one-half ounce. appear on such article of labeling. (c) Food containing or manufactured with a chlorofluorocarbon or other ozone- § 101.17 Food labeling warning, notice, depleting substance. Labeling require- and safe handling statements. ments for foods that contain or are (a) Self-pressurized containers. (1) The manufactured with a label of a food packaged in a self-pres- chlorofluorocarbon or other ozone-de- surized container and intended to be pleting substance designated by the expelled from the package under pres- Environmental Protection Agency sure shall bear the following warning: (EPA) are set forth in 40 CFR part 82. (d) Protein products. (1) The label and WARNING—Avoid spraying in eyes. Con- labeling of any food product in liquid, tents under pressure. Do not puncture or in- powdered, tablet, capsule, or similar cinerate. Do not store at temperature above forms that derives more than 50 per- 120 °F. Keep out of reach of children. cent of its total caloric value from ei- (2) In the case of products intended ther whole protein, protein hydroly- for use by children, the phrase ‘‘except sates, amino acid mixtures, or a com- under adult supervision’’ may be added bination of these, and that is rep- at the end of the last sentence in the resented for use in reducing weight warning required by paragraph (a)(1) of shall bear the following warning: this section. WARNING: Very low calorie protein diets (3) In the case of products packaged (below 400 Calories per day) may cause seri- in glass containers, the word ‘‘break’’ ous illness or death. Do Not Use for Weight may be substituted for the word Reduction in Such Diets Without Medical ‘‘puncture’’ in the warning required by Supervision. Not for use by infants, children, or pregnant or nursing women. paragraph (a)(1) of this section. (4) The words ‘‘Avoid spraying in (2) Products described in paragraph eyes’’ may be deleted from the warning (d)(1) of this section are exempt from required by paragraph (a)(1) of this sec- the labeling requirements of that para- tion in the case of a product not ex- graph if the protein products are rep- pelled as a spray. resented as part of a nutritionally bal- (b) Self-pressurized containers with anced diet plan providing 400 or more Calories (kilocalories) per day and the halocarbon or hydrocarbon propellants. label or labeling of the product speci- (1) In addition to the warning required fies the diet plan in detail or provides by paragraph (a) of this section, the a brief description of that diet plan and label of a food packaged in a self-pres- adequate information describing where surized container in which the propel- the detailed diet plan may be obtained lant consists in whole or in part of a and the label and labeling bear the fol- halocarbon or a hydrocarbon shall bear lowing statement: the following warning: Notice: For weight reduction, use only as WARNING—Use only as directed. Inten- directed in the accompanying diet plan (the tional misuse by deliberately concentrating name and specific location in labeling of the and inhaling the contents can be harmful or diet plan may be included in this statement fatal. in place of ‘‘accompanying diet plan’’). Do

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not use in diets supplying less than 400 Cal- on the immediate container labeling in ories per day without medical supervision. a way that maximizes the likelihood (3) The label and labeling of food that the warning is intact until all of products represented or intended for the dosage units to which it applies are dietery (food) supplementation that de- used. rive more than 50 percent of their total (3) Where the immediate container is caloric value from either whole pro- not the retail package, the warning tein, protein hydrolysates, amino acid statement required by paragraph (e)(1) mixtures, or a combination of these, of this section shall also appear promi- that are represented specifically for nently and conspicuously on the infor- purposes other than weight reduction; mation panel of the retail package and that are not covered by the relabel. quirements of paragraph (d) (1) and (2) (4) The warning statement shall ap- of this section; shall bear the following pear on any labeling that contains statement: warnings. NOTICE: Use this product as a food supple- (5) The warning statement required ment only. Do not use for weight reduction. by paragraph (e)(1) of this section shall (4) The provisions of this paragraph be set off in a box by use of hairlines. are separate from and in addition to (f) Foods containing psyllium husk. (1) any labeling requirements promulgated Foods containing dry or incompletely by the Federal Trade Commission for hydrated psyllium husk, also known as protein supplements. psyllium seed husk, and bearing a (5) Protein products shipped in bulk health claim on the association be- form for use solely in the manufacture tween soluble fiber from psyllium husk of other foods and not for distribution and reduced risk of coronary heart dis- to consumers in such container are ex- ease, shall bear a label statement in- empt from the labeling requirements of forming consumers that the appro- this paragraph. priate use of such foods requires con- (6) The warning and notice state- sumption with adequate amounts of ments required by paragraphs (d) (1), fluids, alerting them of potential con- (2), and (3) of this section shall appear sequences of failing to follow usage prominently and conspicuously on the recommendations, and informing per- principal display panel of the package sons with swallowing difficulties to label and any other labeling. avoid consumption of the product (e.g., (e) Dietary supplements containing iron ‘‘NOTICE: This food should be eaten or iron salts. (1) The labeling of any die- with at least a full glass of liquid. Eat- tary supplement in solid oral dosage ing this product without enough liquid form (e.g., tablets or capsules) that may cause choking. Do not eat this contains iron or iron salts for use as an product if you have difficulty in swal- iron source shall bear the following lowing.’’). However, a product in con- statement: ventional food form may be exempt WARNING: Accidental overdose of iron- from this requirement if a viscous ad- containing products is a leading cause of hesive mass is not formed when the fatal poisoning in children under 6. Keep this food is exposed to fluids. product out of reach of children. In case of (2) The statement shall appear promi- accidental overdose, call a doctor or poison nently and conspicuously on the infor- control center immediately. mation panel or principal display panel (2)(i) The warning statement required of the package label and any other la- by paragraph (e)(1) of this section shall beling to render it likely to be read and appear prominently and conspicuously understood by the ordinary individual on the information panel of the imme- under customary conditions of pur- diate container label. chase and use. The statement shall be (ii) If a product is packaged in unit- preceded by the word ‘‘NOTICE’’ in dose packaging, and if the immediate capital letters. container bears labeling but not a (g) Juices that have not been specifi- label, the warning statement required cally processed to prevent, reduce, or by paragraph (e)(1) of this section shall eliminate the presence of pathogens. (1) appear prominently and conspicuously For purposes of this paragraph (g),

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‘‘juice’’ means the aqueous liquid ex- (A) A 5-log (i.e., 100,000-fold) reduc- pressed or extracted from one or more tion; or fruits or vegetables, purees of the edi- (B) A reduction that is equal to, or ble portions of one or more fruits or greater than, the criterion established vegetables, or any concentrate of such for process controls by any final regu- liquid or puree. lation requiring the application of Haz- (2) The label of: ard Analysis and Critical Control Point (i) Any juice that has not been proc- (HACCP) principles to the processing of essed in the manner described in para- juice. graph (g)(7) of this section; or (ii) For the purposes of this para- (ii) Any beverage containing juice graph (g), the ‘‘pertinent microorga- where neither the juice ingredient nor nism’’ is the most resistant microorga- the beverage has been processed in the nism of public health significance that manner described in paragraph (g)(7) of is likely to occur in the juice. this section, shall bear the following (h) Shell eggs. (1) The label of all shell warning statement: eggs, whether in intrastate or interstate commerce, shall bear the fol- WARNING: This product has not been pas- lowing statement: teurized and, therefore, may contain harmful bacteria that can cause serious illness in SAFE HANDLING INSTRUCTIONS: To children, the elderly, and persons with weak- prevent illness from bacteria: keep eggs re- ened immune systems. frigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly. (3) The warning statement required (2) The label statement required by by this paragraph (g) shall not apply to paragraph (h)(1) of this section shall juice that is not for distribution to re- appear prominently and conspicuously, tail consumers in the form shipped and with the words ‘‘SAFE HANDLING IN- that is for use solely in the manufac- STRUCTIONS’’ in bold type, on the ture of other foods or that is to be principal display panel, the informa- processed, labeled, or repacked at a tion panel, or on the inside of the lid of site other than originally processed, egg cartons. If this statement appears provided that for juice that has not on the inside of the lid, the words been processed in the manner described ‘‘Keep Refrigerated’’ must appear on in paragraph (g)(7) of this section, the the principal display panel or informa- lack of such processing is disclosed in tion panel. documents accompanying the juice, in (3) The label statement required by accordance with the practice of the paragraph (h)(1) of this section shall be trade. set off in a box by use of hairlines. (4) The warning statement required (4) Shell eggs that have been, before by paragraph (g)(2) of this section shall distribution to consumers, specifically appear prominently and conspicuously processed to destroy all viable Sal- on the information panel or on the monella shall be exempt from the re- principal display panel of the label of quirements of paragraph (h) of this sec- the container. tion. (5) The word ‘‘WARNING’’ shall be (5) The safe handling statement for capitalized and shall appear in bold shell eggs that are not for direct sale type. to consumers, e.g., those that are to be (6) The warning statement required repacked or labeled at a site other than by paragraph (g)(2) of this section, where originally processed, or are sold when on a label, shall be set off in a for use in food service establishments, box by use of hairlines. may be provided on cartons or in label- (7)(i) The requirements in this para- ing, e.g., invoices or bills of lading in graph (g) shall not apply to a juice that accordance with the practice of the has been processed in a manner that trade. will produce, at a minimum, a reduc- (6) Under sections 311 and 361 of the tion in the pertinent microorganism Public Health Service Act (PHS Act), for a period at least as long as the shelf any State or locality that is willing life of the product when stored under and able to assist the agency in the en- normal and moderate abuse conditions, forcement of paragraphs (h)(1) through of the following magnitude: (h)(5) of this section, and is authorized

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to inspect or regulate establishments with the required statement in para- handling packed shell eggs, may in its graph (h)(1) of this section before fur- own jurisdiction, enforce paragraphs ther distribution. If the person chooses (h)(1) through (h)(5) of this section not to relabel, the district office of the through inspections under paragraph FDA or, if applicable, the appropriate (h)(8) of this section and through ad- State or local agency may serve upon ministrative enforcement remedies the person a written order that such identified in paragraph (h)(7) of this eggs be diverted (from direct consumer section until FDA notifies the State or sale, e.g., to food service) under the su- locality in writing that such assistance pervision of an officer or employee of is no longer needed. When providing the issuing entity, for processing in ac- such assistance, a State or locality cordance with the EPIA (21 U.S.C. 1031 may follow the hearing procedures set et seq.) or destroyed by or under the su- out in paragraphs (h)(7)(ii)(C) through pervision of the issuing entity, within (h)(7)(ii)(D) of this section, sub- 10-working days from the date of re- stituting, where necessary, appropriate ceipt of the order. State or local officials for designated (B) Issuance of order. The order shall FDA officials or may utilize State or include the following information: local hearing procedures if such proce- (1) A statement that the shell eggs dures satisfy due process. identified in the order are subject to (7) This paragraph (h) is established relabeling, diversion for processing in under authority of both the Federal accordance with the EPIA, or destruc- Food, Drug, and Cosmetic Act (the act) tion; and the PHS Act. Under the act, the (2) A detailed description of the facts agency can enforce the food mis- that justify the issuance of the order; branding provisions under 21 U.S.C. 331, (3) The location of the eggs; 332, 333, and 334. However, 42 U.S.C. 264 (4) A statement that these eggs shall provides for the issuance of imple- not be sold, distributed, or otherwise menting enforcement regulations; disposed of or moved except as pro- therefore, FDA has established the fol- vided in paragraph (h)(7)(i)(E) of this lowing administrative enforcement section; procedures for the relabeling, diver- (5) Identification or description of sion, or destruction of shell eggs and the eggs; informal hearings under the PHS Act: (6) The order number; (i) Upon finding that any shell eggs are in violation of this section an au- (7) The date of the order; thorized FDA representative or State (8) The text of this entire section; or local representative in accordance (9) A statement that the order may with paragraph (h)(6) of this section be appealed by written appeal or by re- may order such eggs to be relabeled questing an informal hearing; under the supervision of said represent- (10) The name and phone number of ative, diverted, under the supervision the person issuing the order; and of said representative for processing in (11) The location and telephone num- accordance with the Egg Products In- ber of the responsible office or agency spection Act (EPIA) (21 U.S.C. 1031 et and the name of its director. seq.), or destroyed by or under the su- (C) Approval of director. An order, be- pervision of an officer or employee of fore issuance, shall be approved by the the FDA, or, if applicable, of the State director of the office or agency issuing or locality, in accordance with the fol- the order. If prior written approval is lowing procedures: not feasible, prior oral approval shall (A) Order for relabeling, diversion, or be obtained and confirmed by written destruction under the PHS Act. Any dis- memorandum as soon as possible. trict office of the FDA or any State or (D) Labeling or marking of shell eggs locality acting under paragraph (h)(6) under order. An FDA, State, or local of this section, upon finding shell eggs representative issuing an order under held in violation of this regulation, paragraph (h)(7)(i)(A) of this section may serve upon the person in whose shall label or mark the shell eggs with possession such eggs are found a writ- official tags that include the following ten order that such eggs be relabeled information:

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(1) A statement that the shell eggs proprietary interest in such shell eggs. are detained in accordance with regula- The appellant of an order shall state tions issued under section 361(a) of the the ownership or proprietary interest PHS Act (42 U.S.C. 264(a)). the appellant has in the shell eggs. (2) A statement that the shell eggs (B) Summary decision. A request for a shall not be sold, distributed or other- hearing may be denied, in whole or in wise disposed of or moved except, after part and at any time after a request for notifying the issuing entity in writing, a hearing has been submitted, if the Of- to: fice of Regulatory Affairs Program Di- (i) Relabel, divert them for proc- rector or another FDA official senior essing in accordance with the EPIA, or to an FDA District Director deter- destroy them, or mines that no genuine and substantial (ii) Move them to another location issue of fact has been raised by the ma- for holding pending appeal. terial submitted in connection with the (3) A statement that the violation of hearing or from matters officially no- the order or the removal or alteration ticed. If the presiding FDA official de- of the tag is punishable by fine or im- termines that a hearing is not justi- prisonment or both (section 368 of the fied, written notice of the determina- PHS Act, 42 U.S.C. 271). tion will be given to the parties ex- (4) The order number and the date of plaining the reason for denial. the order, and the name of the govern- (C) Informal hearing. Appearance by ment representative who issued the any appellant at the hearing may be by order. mail or in person, with or without (E) Sale or other disposition of shell counsel. The informal hearing shall be eggs under order. After service of the conducted by an Office of Regulatory order, the person in possession of the Affairs Program Director or another shell eggs that are the subject of the FDA official senior to an FDA District order shall not sell, distribute, or oth- Director, and a written summary of the erwise dispose of or move any eggs sub- proceedings shall be prepared by the ject to the order unless and until the presiding FDA official. notice is withdrawn after an appeal ex- (1) The presiding FDA official may cept, after notifying FDA’s district of- direct that the hearing be conducted in fice or, if applicable, the State or local any suitable manner permitted by law agency in writing, to: and this section. The presiding FDA of- (1) Relabel, divert, or destroy them ficial has the power to take such ac- as specified in paragraph (h)(7)(i) of tions and make such rulings as are nec- this section, or essary or appropriate to maintain (2) Move them to another location for order and to conduct an informal, fair, holding pending appeal. expeditious, and impartial hearing, and (ii) The person on whom the order for to enforce the requirements concerning relabeling, diversion, or destruction is the conduct of hearings. served may either comply with the (2) Employees of FDA will first give a order or appeal the order to an Office of full and complete statement of the ac- Regulatory Affairs Program Director. tion which is the subject of the hear- (A) Appeal of a detention order. Any ing, together with the information and appeal shall be submitted in writing to reasons supporting it, and may present the FDA District Director in whose dis- oral or written information relevant to trict the shell eggs are located within the hearing. The party requesting the 5-working days of the issuance of the hearing may then present oral or writ- order. If the appeal includes a request ten information relevant to the hear- for an informal hearing, the hearing ing. All parties may conduct reason- shall be held within 5-working days able examination of any person (except after the appeal is filed or, if requested for the presiding officer and counsel for by the appellant, at a later date, which the parties) who makes any statement shall not be later than 20-calendar days on the matter at the hearing. after the issuance of the order. The (3) The hearing shall be informal in order may also be appealed within the nature, and the rules of evidence do not same period of 5-working days by any apply. No motions or objections relat- other person having an ownership or ing to the admissibility of information

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and views will be made or considered, (F) No appeal. If there is no appeal of but any party may comment upon or the order and the person in possession rebut any information and views pre- of the shell eggs that are subject to the sented by another party. order fails to relabel, divert, or destroy (4) The party requesting the hearing them within 10-working days, or if the may have the hearing transcribed, at demand is affirmed by the presiding the party’s expense, in which case a FDA official after an appeal and the copy of the transcript is to be fur- person in possession of such eggs fails nished to FDA. Any transcript of the to relabel, divert, or destroy them hearing will be included with the pre- within 10-working days, the FDA dis- siding FDA official’s report of the hear- trict office, or, if applicable, the State ing. or local agency may designate an offi- (5) The presiding FDA official shall cer or employee to divert or destroy prepare a written report of the hearing. such eggs. It shall be unlawful to pre- All written material presented at the vent or to attempt to prevent such di- hearing will be attached to the report. version or destruction of the shell eggs Whenever time permits, the presiding by the designated officer or employee. FDA official may give the parties the (8) Persons engaged in handling or opportunity to review and comment on storing packed shell eggs for retail dis- the report of the hearing. tribution shall permit authorized rep- (6) The presiding FDA official shall resentatives of FDA to make at any include as part of the report of the reasonable time such inspection of the hearing a finding on the credibility of establishment in which shell eggs are witnesses (other than expert witnesses) being held, including inspection and whenever credibility is a material sampling of the labeling of such eggs as issue, and shall include a recommended may be necessary in the judgment of decision, with a statement of reasons. such representatives to determine com- (D) Written appeal. If the appellant pliance with the provisions of this sec- appeals the detention order but does tion. Inspections may be made with or not request a hearing, the presiding without notice and will ordinarily be FDA official shall render a decision on made during regular business hours. the appeal affirming or revoking the (9) No State or local governing entity detention within 5-working days after shall establish or continue in effect the receipt of the appeal. any law, rule, regulation, or other re- (E) Presiding FDA official’s decision. If, quirement requiring safe handling in- based on the evidence presented at the structions on unpasteurized shell eggs hearing or by the appellant in a writ- that are less stringent than those reten appeal, the presiding FDA official quired in paragraphs (h)(1) through finds that the shell eggs were held in (h)(5) of this section. violation of this section, he shall af- [42 FR 14308, Mar. 15, 1977] firm the order that they be relabeled, EDITORIAL NOTE: For FEDERAL REGISTER ci- diverted under the supervision of an of- tations affecting § 101.17, see the List of CFR ficer or employee of FDA for processing Sections Affected, which appears in the under the EPIA, or destroyed by or Finding Aids section of the printed volume under the supervision of an officer or and at www.fdsys.gov. employee of FDA; otherwise, the presiding FDA official shall issue a writ- § 101.18 Misbranding of food. ten notice that the prior order is with- (a) Among representations in the la- drawn. If the presiding FDA official af- beling of a food which render such food firms the order, he shall order that the misbranded is a false or misleading relabeling, diversion, or destruction be representation with respect to another accomplished within 10-working days food or a drug, device, or cosmetic. from the date of the issuance of his de- (b) The labeling of a food which con- cision. The presiding FDA official’s de- tains two or more ingredients may be cision shall be accompanied by a state- misleading by reason (among other rea- ment of the reasons for the decision. sons) of the designation of such food in The decision of the presiding FDA offi- such labeling by a name which includes cial shall constitute final agency ac- or suggests the name of one or more tion, reviewable in the courts. but not all such ingredients, even

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though the names of all such ingredi- onions, garlic and celery; whose signifi- ents are stated elsewhere in the label- cant function in food is seasoning rath- ing. er than nutritional; that is true to (c) Among representations in the la- name; and from which no portion of beling of a food which render such food any volatile oil or other flavoring prin- misbranded is any representation that ciple has been removed. Spices include expresses or implies a geographical ori- the spices listed in § 182.10 and part 184 gin of the food or any ingredient of the of this chapter, such as the following: food except when such representation Allspice, Anise, Basil, Bay leaves, Caraway is either: seed, Cardamon, Celery seed, Chervil, Cin- (1) A truthful representation of geo- namon, Cloves, Coriander, Cumin seed, Dill graphical origin. seed, Fennel seed, Fenugreek, Ginger, (2) A trademark or trade name pro- Horseradish, Mace, Marjoram, Mustard vided that as applied to the article in flour, Nutmeg, Oregano, Paprika, Parsley, question its use is not deceptively Pepper, black; Pepper, white; Pepper, red; misdescriptive. A trademark or trade Rosemary, Saffron, Sage, Savory, Star ani- seed, Tarragon, Thyme, Turmeric. name composed in whole or in part of geographical words shall not be consid- Paprika, turmeric, and saffron or other ered deceptively misdescriptive if it: spices which are also colors, shall be (i) Has been so long and exclusively declared as ‘‘spice and coloring’’ unless used by a manufacturer or distributor declared by their common or usual that it is generally understood by the name. consumer to mean the product of a par- (3) The term natural flavor or natural ticular manufacturer or distributor; or flavoring means the essential oil, oleo- (ii) Is so arbitrary or fanciful that it resin, essence or extractive, protein hy- is not generally understood by the con- drolysate, distillate, or any product of sumer to suggest geographic origin. roasting, heating or enzymolysis, (3) A part of the name required by ap- which contains the flavoring constitu- plicable Federal law or regulation. ents derived from a spice, fruit or fruit (4) A name whose market signifi- juice, vegetable or vegetable juice, edi- cance is generally understood by the ble yeast, herb, bark, bud, root, leaf or consumer to connote a particular class, similar plant material, meat, seafood, kind, type, or style of food rather than poultry, eggs, dairy products, or fer- to indicate geographical origin. mentation products thereof, whose significant function in food is flavoring Subpart B—Specific Food Labeling rather than nutritional. Natural fla- Requirements vors include the natural essence or extractives obtained from plants listed in § 101.22 Foods; labeling of spices, §§ 182.10, 182.20, 182.40, and 182.50 and flavorings, colorings and chemical part 184 of this chapter, and the sub- preservatives. stances listed in § 172.510 of this chap- (a)(1) The term artificial flavor or arti- ter. ficial flavoring means any substance, (4) The term artificial color or artificial the function of which is to impart fla- coloring means any ‘‘color additive’’ as vor, which is not derived from a spice, defined in § 70.3(f) of this chapter. fruit or fruit juice, vegetable or vege- (5) The term chemical preservative table juice, edible yeast, herb, bark, means any chemical that, when added bud, root, leaf or similar plant mate- to food, tends to prevent or retard de- rial, meat, fish, poultry, eggs, dairy terioration thereof, but does not in- products, or fermentation products clude common salt, sugars, vinegars, thereof. Artificial flavor includes the spices, or oils extracted from spices, substances listed in §§ 172.515(b) and substances added to food by direct ex- 182.60 of this chapter except where posure thereof to wood smoke, or these are derived from natural sources. chemicals applied for their insecticidal (2) The term spice means any aro- or herbicidal properties. matic vegetable substance in the (b) A food which is subject to the re- whole, broken, or ground form, except quirements of section 403(k) of the act for those substances which have been shall bear labeling, even though such traditionally regarded as foods, such as food is not in package form.

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(c) A statement of artificial fla- (2) If the flavor consists of two or voring, artificial coloring, or chemical more ingredients, the label either may preservative shall be placed on the food declare each ingredient by its common or on its container or wrapper, or on or usual name or may state ‘‘All flavor any two or all three of these, as may be ingredients contained in this product necessary to render such statement are approved for use in a regulation of likely to be read by the ordinary per- the Food and Drug Administration.’’ son under customary conditions of pur- Any flavor ingredient not contained in chase and use of such food. The specific one of these regulations, and any non- artificial color used in a food shall be flavor ingredient, shall be separately identified on the labeling when so re- listed on the label. quired by regulation in part 74 of this (3) In cases where the flavor contains chapter to assure safe conditions of use a solely natural flavor(s), the flavor for the color additive. shall be so labeled, e.g., ‘‘strawberry (d) A food shall be exempt from com- flavor’’, ‘‘banana flavor’’, or ‘‘natural pliance with the requirements of sec- strawberry flavor’’. In cases where the tion 403(k) of the act if it is not in flavor contains both a natural flavor package form and the units thereof are and an artificial flavor, the flavor shall so small that a statement of artificial be so labeled, e.g., ‘‘natural and artifi- flavoring, artificial coloring, or chem- cial strawberry flavor’’. In cases where ical preservative, as the case may be, the flavor contains a solely artificial cannot be placed on such units with flavor(s), the flavor shall be so labeled, such conspicuousness as to render it e.g., ‘‘artificial strawberry flavor’’. likely to be read by the ordinary indi- (h) The label of a food to which flavor vidual under customary conditions of is added shall declare the flavor in the purchase and use. statement of ingredients in the fol- (e) A food shall be exempt while held lowing way: for sale from the requirements of sec- (1) Spice, natural flavor, and artifi- tion 403(k) of the act (requiring label cial flavor may be declared as ‘‘spice’’, statement of any artificial flavoring, ‘‘natural flavor’’, or ‘‘artificial flavor’’, artificial coloring, or chemical preserv- or any combination thereof, as the case atives) if said food, having been re- may be. ceived in bulk containers at a retail es- (2) An incidental additive in a food, tablishment, is displayed to the pur- originating in a spice or flavor used in chaser with either (1) the labeling of the manufacture of the food, need not the bulk container plainly in view or be declared in the statement of ingredi- (2) a counter card, sign, or other appro- ents if it meets the requirements of priate device bearing prominently and § 101.100(a)(3). conspicuously the information required (3) Substances obtained by cutting, to be stated on the label pursuant to grinding, drying, pulping, or similar section 403(k). processing of tissues derived from fruit, (f) A fruit or vegetable shall be ex- vegetable, meat, fish, or poultry, e.g., empt from compliance with the re- powdered or granulated onions, garlic quirements of section 403(k) of the act powder, and celery powder, are com- with respect to a chemical preservative monly understood by consumers to be applied to the fruit or vegetable as a food rather than flavor and shall be de- pesticide chemical prior to harvest. clared by their common or usual name. (g) A flavor shall be labeled in the (4) Any salt (sodium chloride) used as following way when shipped to a food an ingredient in food shall be declared manufacturer or processor (but not a by its common or usual name ‘‘salt.’’ consumer) for use in the manufacture (5) Any monosodium glutamate used of a fabricated food, unless it is a fla- as an ingredient in food shall be de- vor for which a standard of identity clared by its common or usual name has been promulgated, in which case it ‘‘monosodium glutamate.’’ shall be labeled as provided in the (6) Any pyroligneous acid or other ar- standard: tificial smoke flavors used as an ingre- (1) If the flavor consists of one ingredient in a food may be declared as arti- dient, it shall be declared by its com- ficial flavor or artificial smoke flavor. mon or usual name. No representation may be made, either

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directly or implied, that a food fla- strawberry flavored shortcake,’’ or vored with pyroligneous acid or other ‘‘strawberry flavored shortcake’’. artificial smoke flavor has been (ii) If none of the natural flavor used smoked or has a true smoked flavor, or in the food is derived from the product that a seasoning sauce or similar prod- whose flavor is simulated, the food in uct containing pyroligneous acid or which the flavor is used shall be la- other artificial smoke flavor and used beled either with the flavor of the prod- to season or flavor other foods will re- uct from which the flavor is derived or sult in a smoked product or one having as ‘‘artificially flavored.’’ a true smoked flavor. (iii) If the food contains both a char- (7) Because protein hydrolysates acterizing flavor from the product function in foods as both flavorings and whose flavor is simulated and other flavor enhancers, no protein hydroly- natural flavor which simulates, resem- sate used in food for its effects on fla- bles or reinforces the characterizing vor may be declared simply as ‘‘fla- flavor, the food shall be labeled in ac- vor,’’ ‘‘natural flavor,’’ or ‘‘flavoring.’’ cordance with the introductory text The ingredient shall be declared by its and paragraph (i)(1)(i) of this section specific common or usual name as pro- and the name of the food shall be im- vided in § 102.22 of this chapter. mediately followed by the words ‘‘with (i) If the label, labeling, or adver- other natural flavor’’ in letters not less tising of a food makes any direct or in- than one-half the height of the letters direct representations with respect to used in the name of the characterizing the primary recognizable flavor(s), by flavor. word, vignette, e.g., depiction of a (2) If the food contains any artificial fruit, or other means, or if for any flavor which simulates, resembles or other reason the manufacturer or dis- reinforces the characterizing flavor, tributor of a food wishes to designate the name of the food on the principal the type of flavor in the food other display panel or panels of the label than through the statement of ingredi- shall be accompanied by the common ents, such flavor shall be considered the characterizing flavor and shall be or usual name(s) of the characterizing declared in the following way: flavor, in letters not less than one-half (1) If the food contains no artificial the height of the letters used in the flavor which simulates, resembles or name of the food and the name of the reinforces the characterizing flavor, characterizing flavor shall be accom- the name of the food on the principal panied by the word(s) ‘‘artificial’’ or display panel or panels of the label ‘‘artificially flavored’’, in letters not shall be accompanied by the common less than one-half the height of the let- or usual name of the characterizing fla- ters in the name of the characterizing vor, e.g., ‘‘vanilla’’, in letters not less flavor, e.g., ‘‘artificial vanilla’’, ‘‘arti- than one-half the height of the letters ficially flavored strawberry’’, or ‘‘grape used in the name of the food, except artificially flavored’’. that: (3) Wherever the name of the charac- (i) If the food is one that is com- terizing flavor appears on the label monly expected to contain a character- (other than in the statement of ingre- izing food ingredient, e.g., strawberries dients) so conspicuously as to be easily in ‘‘strawberry shortcake’’, and the seen under customary conditions of food contains natural flavor derived purchase, the words prescribed by this from such ingredient and an amount of paragraph shall immediately and con- characterizing ingredient insufficient spicuously precede or follow such to independently characterize the food, name, without any intervening writ- or the food contains no such ingre- ten, printed, or graphic matter, except: dient, the name of the characterizing (i) Where the characterizing flavor flavor may be immediately preceded by and a trademark or brand are pre- the word ‘‘natural’’ and shall be imme- sented together, other written, printed, diately followed by the word ‘‘fla- or graphic matter that is a part of or is vored’’ in letters not less than one-half associated with the trademark or the height of the letters in the name of brand may intervene if the required the characterizing flavor, e.g., ‘‘natural words are in such relationship with the

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trademark or brand as to be clearly re- antee or undertaking under section lated to the characterizing flavor; and 303(a) of the act. The defenses provided (ii) If the finished product contains under section 303(c)(2) of the act shall more than one flavor subject to the re- be applicable to the certifications pro- quirements of this paragraph, the vided for in this section. statements required by this paragraph (ii) Wherever possible, the Food and need appear only once in each state- Drug Administration shall verify the ment of characterizing flavors present accuracy of a reasonable number of in such food, e.g., ‘‘artificially flavored certifications made pursuant to this vanilla and strawberry’’. section, constituting a representative (iii) If the finished product contains sample of such certifications, and shall three or more distinguishable charac- not request all such certifications. terizing flavors, or a blend of flavors (iii) Where no person authorized to with no primary recognizable flavor, provide such information is reasonably the flavor may be declared by an appropriately descriptive generic term in available at the time of inspection, the lieu of naming each flavor, e.g., ‘‘arti- certifying party shall arrange to have ficially flavored fruit punch’’. such person and the relevant materials (4) A flavor supplier shall certify, in and records ready for verification as writing, that any flavor he supplies soon as practicable: Provided, That, which is designated as containing no whenever the Food and Drug Adminis- artificial flavor does not, to the best of tration has reason to believe that the his knowledge and belief, contain any supplier or user may utilize this period artificial flavor, and that he has added to alter inventories or records, such ad- no artificial flavor to it. The require- ditional time shall not be permitted. ment for such certification may be sat- Where such additional time is pro- isfied by a guarantee under section vided, the Food and Drug Administra- 303(c)(2) of the act which contains such tion may require the certifying party a specific statement. A flavor user to certify that relevant inventories shall be required to make such a writ- have not been materially disturbed and ten certification only where he adds to relevant records have not been altered or combines another flavor with a fla- or concealed during such period. vor which has been certified by a flavor (iv) The certifying party shall pro- supplier as containing no artificial fla- vide, to an officer or representative vor, but otherwise such user may rely duly designated by the Secretary, such upon the supplier’s certification and qualitative statement of the composi- need make no separate certification. tion of the flavor or product covered by All such certifications shall be re- the certification as may be reasonably tained by the certifying party through- expected to enable the Secretary’s rep- out the period in which the flavor is resentatives to determine which rel- supplied and for a minimum of three evant raw and finished materials and years thereafter, and shall be subject flavor ingredient records are reason- to the following conditions: ably necessary to verify the certifi- (i) The certifying party shall make such certifications available upon re- cations. The examination conducted by quest at all reasonable hours to any the Secretary’s representative shall be duly authorized office or employee of limited to inspection and review of in- the Food and Drug Administration or ventories and ingredient records for any other employee acting on behalf of those certifications which are to be the Secretary of Health and Human verified. Services. Such certifications are re- (v) Review of flavor ingredient garded by the Food and Drug Adminis- records shall be limited to the quali- tration as reports to the government tative formula and shall not include and as guarantees or other under- the quantitative formula. The person takings within the meaning of section verifying the certifications may make 301(h) of the act and subject the certi- only such notes as are necessary to en- fying party to the penalties for making able him to verify such certification. any false report to the government Only such notes or such flavor ingre- under 18 U.S.C. 1001 and any false guar- dient records as are necessary to verify

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such certification or to show a poten- be declared as ‘‘Artificial Color,’’ ‘‘Ar- tial or actual violation may be re- tificial Color Added,’’ or ‘‘Color Added’’ moved or transmitted from the certi- (or by an equally informative term fying party’s place of business: Pro- that makes clear that a color additive vided, That, where such removal or has been used in the food). Alter- transmittal is necessary for such pur- natively, such color additives may be poses the relevant records and notes declared as ‘‘Colored with shall be retained as separate docu- llllllll’’ or ‘‘llllllll ments in Food and Drug Administra- color,’’ the blank to be filled in with tion files, shall not be copied in other the name of the color additive listed in reports, and shall not be disclosed pub- the applicable regulation in part 73 of licly other than in a judicial pro- this chapter. ceeding brought pursuant to the act or (3) When a coloring has been added to 18 U.S.C. 1001. butter, cheese, or ice cream, it need (j) A food to which a chemical pre- not be declared in the ingredient list servative(s) is added shall, except when unless such declaration is required by a exempt pursuant to § 101.100 bear a regulation in part 73 or part 74 of this label declaration stating both the com- chapter to ensure safe conditions of use mon or usual name of the ingredient(s) for the color additive. Voluntary dec- and a separate description of its func- laration of all colorings added to but- tion, e.g., ‘‘preservative’’, ‘‘to retard ter, cheese, and ice cream, however, is spoilage’’, ‘‘a mold inhibitor’’, ‘‘to help recommended. protect flavor’’ or ‘‘to promote color retention’’. [42 FR 14308, Mar. 15, 1977, as amended at 44 (k) The label of a food to which any FR 3963, Jan. 19, 1979; 44 FR 37220, June 26, coloring has been added shall declare 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, the coloring in the statement of ingre- Jan. 6, 1993; 63 FR 14818, Mar. 27, 1998; 74 FR dients in the manner specified in para- 216, Jan. 5, 2009] graphs (k)(1) and (k)(2) of this section, except that colorings added to butter, § 101.30 Percentage juice declaration for foods purporting to be bev- cheese, and ice cream, if declared, may erages that contain fruit or vege- be declared in the manner specified in table juice. paragraph (k)(3) of this section, and colorings added to foods subject to (a) This section applies to any food §§ 105.62 and 105.65 of this chapter shall that purports to be a beverage that be declared in accordance with the re- contains any fruit or vegetable juice quirements of those sections. (i.e., the product’s advertising, label, or (1) A color additive or the lake of a labeling bears the name of, or variation color additive subject to certification on the name of, or makes any other di- under 721(c) of the act shall be declared rect or indirect representation with re- by the name of the color additive listed spect to, any fruit or vegetable juice), in the applicable regulation in part 74 or the label or labeling bears any vi- or part 82 of this chapter, except that gnette (i.e., depiction of a fruit or vege- it is not necessary to include the table) or other pictorial representation ‘‘FD&C’’ prefix or the term ‘‘No.’’ in of any fruit or vegetable, or the prod- the declaration, but the term ‘‘Lake’’ uct contains color and flavor that gives shall be included in the declaration of the beverage the appearance and taste the lake of the certified color additive of containing a fruit or vegetable juice. (e.g., Blue 1 Lake). Manufacturers may The beverage may be carbonated or parenthetically declare an appropriate noncarbonated, concentrated, full- alternative name of the certified color strength, diluted, or contain no juice. additive following its common or usual For example, a soft drink (soda) that name as specified in part 74 or part 82 does not represent or suggest by its of this chapter. physical characteristics, name, label- (2) Color additives not subject to cer- ing, ingredient statement, or adver- tification and not otherwise required tising that it contains fruit or vege- by applicable regulations in part 73 of table juice does not purport to contain this chapter to be declared by their re- juice and therefore does not require a spective common or usual names may percent juice declaration.

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(b)(1) If the beverage contains fruit or percentage declaration as described in vegetable juice, the percentage shall be paragraph (c) of this section and con- declared by the words ‘‘Contains l pertains no fruit or vegetable juice, but cent (or %) lll juice’’ or ‘‘l percent the labeling or color and flavor of the (or %) juice,’’ or a similar phrase, with beverage represents, suggests, or im- the first blank filled in with the per- plies that fruit or vegetable juice may centage expressed as a whole number be present (e.g., the product adver- not greater than the actual percentage tising or labeling bears the name, a of the juice and the second blank (if variation of the name, or a pictorial used) filled in with the name of the representation of any fruit or vege- particular fruit or vegetable (e.g., table, or the product contains color ‘‘Contains 50 percent apple juice’’ or and flavor that give the beverage the ‘‘50 percent juice’’). appearance and taste of containing a (2) If the beverage contains less than fruit or vegetable juice), then the label 1 percent juice, the total percentage shall declare ‘‘contains zero (0) percent juice shall be declared as ‘‘less than 1 (or %) juice’’. Alternatively, the label percent juice’’ or ‘‘less than 1 percent may declare ‘‘Containing (or contains) lll juice’’ with the blank filled in no lll juice’’, or ‘‘no lll juice’’, or with the name of the particular fruit or ‘‘does not contain lll juice’’, the vegetable. blank to be filled in with the name of (3) If the beverage contains 100 per- the fruits or vegetables represented, cent juice and also contains non-juice suggested, or implied, but if there is a ingredients that do not result in a dim- general suggestion that the product inution of the juice soluble solids or, in contains fruit or vegetable juice, such the case of expressed juice, in a change as the presence of fruit pulp, the blank in the volume, when the 100 percent shall be filled in with the word ‘‘fruit’’ juice declaration appears on a panel of or ‘‘vegetable’’ as applicable (e.g., the label that does not also bear the in- ‘‘contains no fruit juice’’, or ‘‘does not gredient statement, it must be accom- contain fruit juice’’). panied by the phrase ‘‘with added (e) If the beverage is sold in a pack- lll,’’ the blank filled in with a term age with an information panel as de- such as ‘‘ingredient(s),’’ ‘‘preserva- fined in § 101.2, the declaration of tive,’’ or ‘‘sweetener,’’ as appropriate amount of juice shall be prominently (e.g., ‘‘100% juice with added sweet- placed on the information panel in ener’’), except that when the presence lines generally parallel to other re- of the non-juice ingredient(s) is de- quired information, appearing: clared as a part of the statement of (1) Near the top of the information identity of the product, this phrase panel, with no other printed label in- need not accompany the 100 percent formation appearing above the state- juice declaration. ment except the brand name, product (c) If a beverage contains minor name, logo, or universal product code; amounts of juice for flavoring and is la- and beled with a flavor description using (2) In easily legible boldface print or terms such as ‘‘flavor’’, ‘‘flavored’’, or type in distinct contrast to other ‘‘flavoring’’ with a fruit or vegetable printed or graphic matter, in a height name and does not bear: not less than the largest type found on (1) The term ‘‘juice’’ on the label the information panel except that used other than in the ingredient statement; for the brand name, product name, or logo, universal product code, the title (2) An explicit vignette depicting the phrase ‘‘Nutrition Facts,’’ the declara- fruit or vegetable from which the flation of ‘‘Serving size,’’ ‘‘Calories’’ and vor derives, such as juice exuding from the numerical value for ‘‘Calories ap- a fruit or vegetable; or pearing in the nutrition information as (3) Specific physical resemblance to a required by § 101.9. juice or distinctive juice characteristic (f) The percentage juice declaration such as pulp then total percentage may also be placed on the principal dis- juice declaration is not required. play panel, provided that the declara- (d) If the beverage does not meet the tion is consistent with that presented criteria for exemption from total juice on the information panel.

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(g) If the beverage is sold in a pack- 100 age that does not bear an information Juice percent juice 1 panel as defined in § 101.2, the percentage juice declaration shall be placed on Tangerine ...... 311.8 the principal display panel, in type size Tomato ...... 5.0 Watermelon ...... 7.8 not less than that required for the dec- Youngberry ...... 10.0 laration of net quantity of contents 1 Indicates Brix value unless other value specified. statement in § 101.7(i), and be placed 2 Indicates anhydrous citrus acid percent by weight. near the name of the food. 3 Brix values determined by refractometer for citrus juices (h)(1) In enforcing these regulations, may be corrected for citric acid. the Food and Drug Administration will (2) If there is no Brix level specified calculate the labeled percentage of in paragraph (h)(1) of this section, the juice from concentrate found in a juice labeled percentage of that juice from or juice beverage using the minimum concentrate in a juice or juice beverage Brix levels listed below where single- will be calculated on the basis of the strength (100 percent) juice has at least soluble solids content of the single- the specified minimum Brix listed strength (unconcentrated) juice used to below: produce such concentrated juice. (i) Juices directly expressed from a 100 Juice percent fruit or vegetable (i.e., not con- juice 1 centrated and reconstituted) shall be considered to be 100 percent juice and Acerola ...... 6.0 Apple ...... 11.5 shall be declared as ‘‘100 percent juice.’’ Apricot ...... 11.7 (j) Calculations of the percentage of Banana ...... 22.0 juice in a juice blend or a diluted juice Blackberry ...... 10.0 Blueberry ...... 10.0 product made directly from expressed Boysenberry ...... 10.0 juice (i.e., not from concentrate) shall Cantaloupe Melon ...... 9.6 be based on the percentage of the ex- Carambola ...... 7.8 Carrot ...... 8.0 pressed juice in the product computed Casaba Melon ...... 7.5 on a volume/volume basis. Cashew (Caju) ...... 12.0 (k) If the product is a beverage that Celery ...... 3.1 Cherry, dark, sweet ...... 20.0 contains a juice whose color, taste, or Cherry, red, sour ...... 14.0 other organoleptic properties have Crabapple ...... 15.4 been modified to the extent that the Cranberry ...... 7.5 Currant (Black) ...... 11.0 original juice is no longer recognizable Currant (Red) ...... 10.5 at the time processing is complete, or Date ...... 18.5 if its nutrient profile has been dimin- Dewberry ...... 10.0 Elderberry ...... 11.0 ished to a level below the normal nutri- Fig ...... 18.2 ent range for the juice, then that juice Gooseberry ...... 8.3 to which such a major modification has Grape ...... 16.0 been made shall not be included in the Grapefruit ...... 310.0 Guanabana (soursop) ...... 16.0 total percentage juice declaration. Guava ...... 7.7 (l) A beverage required to bear a per- Honeydew melon ...... 9.6 centage juice declaration on its label, Kiwi ...... 15.4 Lemon ...... 2 4.5 that contains less than 100 percent Lime ...... 2 4.5 juice, shall not bear any other percent- Loganberry ...... 10.5 age declaration that describes the juice Mango ...... 13.0 Nectarine ...... 11.8 content of the beverage in its label or Orange ...... 311.8 in its labeling (e.g., ‘‘100 percent nat- Papaya ...... 11.5 ural’’ or ‘‘100 percent pure’’). However, Passion Fruit ...... 14.0 the label or labeling may bear percent- Peach ...... 10.5 Pear ...... 12.0 age statements clearly unrelated to Pineapple ...... 12.8 juice content (e.g., ‘‘provides 100 per- Plum ...... 14.3 cent of U.S. RDA of vitamin C’’). Pomegranate ...... 16.0 Prune ...... 18.5 (m) Products purporting to be bev- Quince ...... 13.3 erages that contain fruit or vegetable Raspberry (Black) ...... 11.1 juices are exempted from the provi- Raspberry (Red) ...... 9.2 Rhubarb ...... 5.7 sions of this section until May 8, 1994. Strawberry ...... 8.0 All products that are labeled on or

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after that date shall comply with this declared when they are present in a di- section. etary supplement in quantitative [58 FR 2925, Jan. 6, 1993, as amended at 58 FR amounts by weight that exceed the 44063, Aug. 18, 1993; 58 FR 49192, Sept. 22, 1993; amount that can be declared as zero in 81 FR 33994, May 27, 2016; 81 FR 59131, Aug. 29, nutrition labeling of foods in accord- 2016] ance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, Subpart C—Specific Nutrition La- monounsaturated fat, soluble fiber, in- beling Requirements and soluble fiber, and sugar alcohol may be Guidelines declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not SOURCE: 55 FR 60890, Nov. 27, 1991, unless otherwise noted. present, or that are present in amounts that can be declared as zero in § 101.36 Nutrition labeling of dietary § 101.9(c), shall not be declared (e.g., supplements. amounts corresponding to less than 2 (a) The label of a dietary supplement percent of the RDI for vitamins and that is offered for sale shall bear nutri- minerals). Protein shall not be de- tion labeling in accordance with this clared on labels of products that, other regulation unless an exemption is pro- than ingredients added solely for tech- vided for the product in paragraph (h) nological reasons, contain only indi- of this section. vidual amino acids. (b) The declaration of nutrition infor- (A) The names and the quantitative mation on the label and in labeling amounts by weight of each (b)(2)-die- shall contain the following informa- tary ingredient shall be presented tion, using the subheadings and the under the heading ‘‘Amount Per Serv- format specified in paragraph (e) of ing.’’ When the quantitative amounts this section. by weight are presented in a separate (1) Serving size. (i) The subheading column, the heading may be centered ‘‘Serving Size’’ shall be placed under over a column of quantitative the heading ‘‘Supplement Facts’’ and amounts, described by paragraph aligned on the left side of the nutrition (b)(2)(ii) of this section, if space per- label. The serving size shall be deter- mits. A heading consistent with the mined in accordance with §§ 101.9(b) and declaration of the serving size, such as 101.12(b), Table 2. Serving size for die- ‘‘Each Tablet Contains,’’ or ‘‘Amount tary supplements shall be expressed Per 2 Tablets’’ may be used in place of using a term that is appropriate for the the heading ‘‘Amount Per Serving.’’ form of the supplement, such as ‘‘tab- Other appropriate terms, such as caplets,’’ ‘‘capsules,’’ ‘‘packets,’’ or ‘‘tea- sule, packet, or teaspoonful, also may spoonfuls.’’ be used in place of the term ‘‘Serving.’’ (ii) The subheading ‘‘Servings Per Container’’ shall be placed under the (B) The names of dietary ingredients subheading ‘‘Serving Size’’ and aligned that are declared under paragraph on the left side of the nutrition label, (b)(2)(i) of this section shall be pre- except that this information need not sented in a column aligned on the left be provided when it is stated in the net side of the nutritional label in the quantity of contents declaration. order and manner of indentation speci- (2) Information on dietary ingredients fied in § 101.9(c), except that calcium that have a Reference Daily Intake (RDI) and iron shall follow choline, and so- or a Daily Reference Value (DRV) as es- dium and potassium shall follow chlo- tablished in § 101.9(c) and their subcompo- ride. This results in the following order nents (hereinafter referred to as ‘‘(b)(2)- for vitamins and minerals: Vitamin A, dietary ingredients’’). (i) The (b)(2)-die- vitamin C, vitamin D, vitamin E, vita- tary ingredients to be declared, that is, min K, thiamin, riboflavin, niacin, vi- total calories, total fat, saturated fat, tamin B6, folate and folic acid, vitamin trans fat, cholesterol, sodium, total B12, biotin, pantothenic acid, choline, carbohydrate, dietary fiber, total sug- calcium, iron, phosphorous, iodine, ars, added sugars, protein, vitamin D, magnesium, zinc, selenium, copper, calcium, iron, and potassium, shall be manganese, chromium, molybdenum,

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chloride, sodium, potassium, and fluo- sium, shall be the amount of the vita- ride. The (b)(2)-dietary ingredients min or mineral included in one serving shall be listed according to the nomen- of the product, using the units of meas- clature specified in § 101.9 or in para- urement and the levels of significance graph (b)(2)(i)(B)(2) of this section. given in § 101.9(c)(8)(iv), except that (1) When ‘‘Calories’’ are declared, zeros following decimal points may be they shall be listed first in the column dropped, and additional levels of sig- of names, beneath a light bar sepa- nificance may be used when the num- rating the heading ‘‘Amount Per Serv- ber of decimal places indicated is not ing’’ from the list of names. When sufficient to express lower amounts ‘‘Calories from saturated fat’’ are de- (e.g., the RDI for zinc is given in whole clared, they shall be indented under milligrams (mg), but the quantitative ‘‘Calories.’’ amount may be declared in tenths of a (2) The following synonyms may be mg). The amount of vitamin D may, added in parentheses immediately fol- but is not required to, be expressed in lowing the name of these (b)(2)-dietary IUs, in addition to the mandatory dec- ingredients: Vitamin C (ascorbic acid), laration in mcg. Any declaration of the thiamin (vitamin B1), riboflavin (vita- amount of vitamin D in IUs must ap- min B2), and calories (energy). Energy pear in parentheses after the declara- content per serving may be expressed tion of the amount of vitamin D in in kilojoule units, added in parentheses mcg. immediately following the statement (iii) The percent of the Daily Value of of caloric content. all dietary ingredients declared under (3) Beta-carotene may be declared as paragraph (b)(2)(i) of this section shall the percent of vitamin A that is be listed, except that the percent Daily present as beta-carotene, except that Value for protein, when present, shall the declaration is required when a be calculated using the corrected claim is made about beta-carotene. amount of protein as specified in When declared, the percent shall be de- § 101.9(c)(7)(ii); no percent of the Daily clared to the nearest whole percent, Value shall be given for subcomponents immediately adjacent to or beneath for which DRVs or RDIs have not been the name vitamin A (e.g., ‘‘Vitamin A established (e.g., total sugars). Addi- (90% as beta-carotene)’’). The amount tionally, the percentage of the RDI for of beta-carotene in terms of protein shall be omitted when a food is micrograms (mcg) may be included in purported to be for infants through 12 the parentheses following the percent months of age. statement (e.g., ‘‘Vitamin A (90% (810 (A) When information on the percent mcg) as beta-carotene)’’). of Daily Values is listed, this informa- (ii) The number of calories, if de- tion shall be presented in one column clared, and the quantitative amount by aligned under the heading of ‘‘% Daily weight per serving of each dietary in- Value’’ and to the right of the column gredient required to be listed under of amounts. The headings ‘‘% Daily paragraph (b)(2)(i) of this section shall Value (DV),’’ ‘‘% DV,’’ ‘‘Percent Daily be presented either in a separate col- Value,’’ or ‘‘Percent DV’’ may be sub- umn aligned to the right of the column stituted for ‘‘% Daily Value.’’ The of names or immediately following the heading ‘‘% Daily Value’’ shall be listing of names within the same col- placed on the same line as the heading umn. The quantitative amounts by ‘‘Amount Per Serving.’’ When the acro- weight shall represent the weight of nym ‘‘DV’’ is unexplained in the head- the dietary ingredient rather than the ing and a footnote is required under weight of the source of the dietary in- (b)(2)(iii)(D), (b)(2)(iii)(F), or (b)(3)(iv) gredient (e.g., the weight of calcium of this section, the footnote shall ex- rather than that of calcium carbonate). plain the acronym (e.g. ‘‘Daily Value (A) The amounts shall be expressed (DV) not established’’). in the increments specified in (B) The percent of Daily Value shall § 101.9(c)(1) through (7), which includes be calculated by dividing the quan- increments for sodium. titative amount by weight of each (B) The amounts of vitamins and (b)(2)-dietary ingredient by the RDI as minerals, excluding sodium and potas- established in § 101.9(c)(8)(iv) or the

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DRV as established in § 101.9(c)(9) for (E) The percent of Daily Value shall the specified dietary ingredient and be based on RDI or DRV values for multiplying by 100, except that the per- adults and children 4 or more years of cent of Daily Value for protein, when age, unless the product is represented present, shall be calculated as specified or purported to be specifically for in- in § 101.9(c)(7)(ii). The quantitative fants through 12 months of age, chil- amount by weight of each dietary in- dren 1 through 3 years of age, pregnant gredient in this calculation shall be the women, or lactating women, in which unrounded amount, except that for case the column heading shall clearly total fat, saturated fat, cholesterol, so- state the intended group. If the product dium, potassium, total carbohydrate, is for persons within more than one and dietary fiber, the quantitative group, the percent of Daily Value for amount by weight declared on the label each group shall be presented in sepa- (i.e, rounded amount) may be used. The rate columns as shown in paragraph numerical value shall be followed by (e)(11)(ii) of this section. the symbol for percent (i.e., %). (F) For declared subcomponents that (C) The percentages based on RDI’s have no DRVs or RDIs, a symbol (e.g., and on DRV’s shall be expressed to the an asterisk) shall be placed in the nearest whole percent, except that for ‘‘Percent Daily Value’’ column that dietary ingredients for which DRV’s shall refer to the same symbol that is have been established, ‘‘Less than 1%’’ placed at the bottom of the nutrition or ‘‘<1%’’ shall be used to declare the label, below the last heavy bar and in- ‘‘% Daily Value’’ when the quan- side the box, and followed by a state- titative amount of the dietary ingre- ment ‘‘Daily Value not established.’’ dient by weight is great enough to require that the dietary ingredient be (G) When calories or calories from listed, but the amount is so small that saturated fat are declared, the space the ‘‘% Daily Value’’ when rounded to under the ‘‘% DV’’ column shall be left the nearest percent is zero (e.g., a prod- blank for these items. When there are uct that contains 1 gram of total car- no other (b)(2)-dietary ingredients list- bohydrate would list the percent Daily ed for which a value must be declared Value as ‘‘Less than 1%’’ or ‘‘<1%’’). in the ‘‘% DV’’ column, the column (D) If the percent of Daily Value is may be omitted as shown in paragraph declared for total fat, saturated fat, (e)(11)(vii) of this section. When the ‘‘% total carbohydrate, dietary fiber, or DV’’ column is not required, but the di- protein, or added sugars, a symbol etary ingredients listed are subject to shall follow the value listed for those paragraph (b)(2)(iii)(F) of this section, nutrients that refers to the same sym- the symbol required in that paragraph bol that is placed at the bottom of the shall immediately follow the quan- nutrition label, below the bar required titative amount by weight for each die- under paragraph (e)(6) of this section tary ingredient listed under ‘‘Amount and inside the box, that is followed by Per Serving.’’ the statement ‘‘Percent Daily Values (3) Information on dietary ingredients are based on a 2,000 calorie diet.’’ If the for which RDI’s and DRV’s have not been product is represented or purported to established. (i) Dietary ingredients for be for use by children 1 through 3 years which FDA has not established RDI’s of age, and if the percent of Daily or DRV’s and that are not subject to Value is declared for total fat, total regulation under paragraph (b)(2) of carbohydrate, dietary fiber, or protein, this section (hereinafter referred to as or added sugars, a symbol shall follow ‘‘other dietary ingredients’’) shall be the value listed for those nutrients declared by their common or usual that refers to the same symbol that is name when they are present in a die- placed at the bottom of the nutrition tary supplement, in a column that is label, below the bar required under under the column of names described in paragraph (e)(6) of this section and in- paragraph (b)(2)(i)(B) of this section or, side the box, that is followed by the as long as the constituents of an other statement ‘‘Percent Daily Values are based on a 1,000 calorie diet.’’ dietary ingredient are not listed, in a

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linear display, under the heavy bar de- of this section may be listed indented scribed in paragraph (e)(6) of this sec- under the dietary ingredient and fol- tion, except that if no (b)(2)-dietary in- lowed by their quantitative amounts gredients are declared, other dietary by weight per serving, except that die- ingredients shall be declared directly tary ingredients described in paragraph beneath the heading ‘‘Amount Per (b)(2) of this section shall be listed in Serving’’ described in paragraph accordance with that section. When the (b)(2)(i)(A) of this section. constituents of a dietary ingredient de- (ii) The quantitative amount by scribed in paragraph (b)(3)(i) of this weight per serving of other dietary in- section are listed, all other dietary ingredients shall be presented in the gredients shall be declared in a col- same manner as the corresponding in- umn; however, the constituents them- formation required in paragraph selves may be declared in a column or (b)(2)(ii) of this section or, when a lin- in a linear display. ear display is used, shall be presented (iv) Other dietary ingredients shall immediately following the name of the bear a symbol (e.g., an asterisk) in the other dietary ingredient. The quan- column under the heading of ‘‘% Daily titative amount by weight shall be the Value’’ that refers to the same symbol weight of the other dietary ingredient placed at the bottom of the nutrition listed and not the weight of any com- label and followed by the statement ponent, or the source, of that dietary ‘‘Daily Value not established,’’ except ingredient. that when the heading ‘‘% Daily (A) These amounts shall be expressed Value’’ is not used, the symbol shall using metric measures in appropriate follow the quantitative amount by units. weight for each dietary ingredient list- (B) For any dietary ingredient that is ed. a liquid extract from which the solvent (c) A proprietary blend of dietary in- has not been removed, the quantity gredients shall be included in the list listed shall be the volume or weight of of dietary ingredients described in the total extract. Information on the paragraph (b)(3)(i) of this section and condition of the starting material shall identified by the term ‘‘Proprietary be indicated when it is fresh and may Blend’’ or other appropriately descrip- be indicated when it is dried. Informa- tive term or fanciful name and may be tion may be included on the concentra- highlighted by bold type. Except as tion of the dietary ingredient and the specified in this paragraph, all other solvent used, e.g., ‘‘fresh dandelion requirements for the listing of dietary root extract, x (y:z) in 70% ethanol,’’ ingredients in dietary supplements are where x is the number of milliliters applicable. (mL) or mg of the entire extract, y is (1) Dietary ingredients contained in the weight of the starting material and the proprietary blend that are listed z is the volume (mL) of solvent. Where under paragraph (b)(2) of this section the solvent has been partially removed shall be declared in accordance with (not to dryness), the final concentra- paragraph (b)(2) of this section. tion, when indicated, shall be stated (2) Dietary ingredients contained in (e.g., if the original extract was 1:5 and the proprietary blend that are listed 50 percent of the solvent was removed, under paragraph (b)(3) of this section then the final concentration shall be (i.e., ‘‘other dietary ingredients’’) shall stated as 1:2.5). Where the name of the be declared in descending order of pre- solvent used is not included in the nu- dominance by weight, in a column or trition label, it is required to be listed linear fashion, and indented under the in the ingredient statement in accord- term ‘‘Proprietary Blend’’ or other ap- ance with § 101.4(g). propriately descriptive term or fanciful (C) For a dietary ingredient that is name. an extract from which the solvent has (3) The quantitative amount by been removed, the weight of the ingre- weight specified for the proprietary dient shall be the weight of the dried blend shall be the total weight of all extract. other dietary ingredients contained in (iii) The constituents of a dietary in- the proprietary blend and shall be gredient described in paragraph (b)(3)(i) placed on the same line to the right of

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the term ‘‘Proprietary Blend’’ or other more are used to provide a single die- appropriately descriptive term or fan- tary ingredient, all of the sources shall ciful name underneath the column of be listed within the parentheses in de- amounts described in paragraph scending order by weight. (b)(2)(ii) of this section. A symbol (e.g., (3) Representations that the source asterisk), which refers to the same ingredient conforms to an official com- symbol placed at the bottom of the nu- pendium may be included either in the trition label that is followed by the nutrition label or in the ingredient list statement ‘‘Daily Value not estab- (e.g., ‘‘Calcium (as calcium carbonate lished,’’ shall be placed under the head- USP)’’). ing ‘‘% Daily Value,’’ if present, or im- (e) Except as provided for small and mediately following the quantitative intermediate sized packages under amount by weight for the proprietary paragraph (i)(2) of this section, infor- blend. mation other than the title, headings, (4) The sample label shown in para- and footnotes shall be in uniform type graph (e)(11)(v) of this section illus- size no smaller than 8 point. A font size trates one method of nutrition labeling at least two points greater shall be a proprietary blend of dietary ingredi- used for ‘‘Calories’’ and the heading ents. ‘‘Calories’’ and the actual number of (d) The source ingredient that sup- calories per serving shall be high- plies a dietary ingredient may be iden- lighted in bold or extra bold type. Type tified within the nutrition label in pa- size no smaller than 6 point may be rentheses immediately following or in- used for column headings (e.g., dented beneath the name of a dietary ‘‘Amount Per Serving’’ and ‘‘% Daily ingredient and preceded by the words Value’’) and for footnotes (e.g., ‘‘Per- ‘‘as’’ or ‘‘from’’, e.g., ‘‘Calcium (as cal- cent Daily Values are based on a 2,000 cium carbonate),’’ except that manner calorie diet). of presentation is unnecessary when (1) The title, ‘‘Supplement Facts,’’ the name of the dietary ingredient shall be set in a type size larger than (e.g., Oriental ginseng) or its synonym all other print size in the nutrition (e.g., ascorbic acid) is itself the source label and, unless impractical, shall be ingredient. When a source ingredient is set full width of the nutrition label. identified in parentheses within the nu- The title and all headings shall be trition label, or when the name of the bolded to distinguish them from other dietary ingredient or its synonym is information. the source ingredient, it shall not be (2) The nutrition information shall be required to be listed again in the ingre- enclosed in a box by using hairlines. dient statement that appears outside of (3) All information within the nutri- the nutrition label. When a source in- tion label shall utilize: gredient is not identified within the (i) A single easy-to-read type style, nutrition label, it shall be listed in an (ii) All black or one color type, print- ingredient statement in accordance ed on a white or other neutral con- with § 101.4(g), which shall appear out- trasting background whenever prac- side and immediately below the nutri- tical, tion label or, if there is insufficient (iii) Upper- and lowercase letters, ex- space below the nutrition label, imme- cept that all uppercase lettering may diately contiguous and to the right of be utilized for packages that have a the nutrition label. total surface area available to bear la- (1) Source ingredients shall be identi- beling of less than 12 square inches, fied in accordance with § 101.4 (i.e., (iv) At least one point leading (i.e., shall be listed by common or usual space between lines of text), and name, and the listing of botanicals (v) Letters that do not touch. shall specify the part of the plant from (4) Except as provided for small and which the ingredient is derived) regard- intermediate-sized packages under less of whether they are listed in an in- paragraph (i)(2) of this section, infor- gredient statement or in the nutrition mation other than the title, headings, label. and footnotes shall be in uniform type (2) When source ingredients are listed size no smaller than 8 point. Type size within the nutrition label, and two or no smaller than 6 point may be used for

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column headings (e.g., ‘‘Amount Per that a dietary supplement be consumed Serving’’ and ‘‘% Daily Value’’) and for more than once per day, the total footnotes (e.g., ‘‘Percent Daily Values quantitative amount by weight (or vol- are based on a 2,000 calorie diet’’). ume, if permitted) and the percent of (5) A hairline rule that is centered Daily Value of each dietary ingredient between the lines of text shall separate may be presented on a ‘‘per day’’ basis each dietary ingredient required in in addition to the ‘‘per serving’’ basis paragraph (b)(2) and (b)(3) of this sec- required by paragraphs (b)(2)(ii) and tion from the dietary ingredient above (b)(2)(iii) of this section for (b)(2)-die- and beneath it, as shown in paragraph tary ingredients and (b)(3)(ii) and (e)(10) of this section. (b)(3)(iv) of this section for other die- (6) A heavy bar shall be placed: tary ingredients. If ‘‘per day’’ informa- (i) Beneath the subheading ‘‘Servings tion is provided, it must be presented Per Container’’ except that if in additional columns to the right of ‘‘Servings Per Container’’ is not re- the ‘‘per serving’’ information and be quired and, as a result, not declared, clearly identified by appropriate head- the bar shall be placed beneath the subheading ‘‘Serving Size,’’ ings and/or be presented in a parenthet- (ii) Beneath the last dietary ingre- ical statement as part of the ‘‘Serving dient to be listed under paragraph Size’’ declaration. A sample illustra- (b)(2)(i) of this section, if any, and tion for ‘‘per day’’ information in a col- (iii) Beneath the last other dietary umn format is provided in paragraph ingredient to be listed under paragraph (e)(11)(viii) of this section. As illus- (b)(3) of this section, if any. trated, the additional ‘‘Per Day’’ col- (7) A light bar shall be placed be- umn heading is followed parentheti- neath the headings ‘‘Amount Per Serv- cally by the number of servings rec- ing’’ and ‘‘% Daily Value.’’ ommended per day in other parts of the (8) If the product contains two or label (e.g., ‘‘Per Day (3 Caplets)’’). more separately packaged dietary sup- When the parenthetical statement for- plements that differ from each other mat following the ‘‘Serving Size’’ dec- (e.g., the product has a packet of sup- laration is used as an alternative to plements to be taken in the morning the column format, the statement and a different packet to be taken in must provide no more than simple in- the afternoon), the quantitative structions regarding how to calculate amounts and percent of Daily Value the ‘‘per day’’ amount for the number may be presented as specified in this of servings per day recommended in paragraph in individual nutrition la- other parts of the label (e.g., ‘‘Serving bels or in one aggregate nutrition label Size: 1 Caplet (Multiply amounts by 3 as illustrated in paragraph (e)(11)(iii) of for total daily amount)’’). When the this section. parenthetical statement format fol- (9)(i) The quantitative amount by lowing the ‘‘Serving Size’’ declaration weight (or volume, if permitted) and is used in addition to the column for- the percent of Daily Value of each die- mat, the statement must provide no tary ingredient may be presented on a more than a simple declaration of the ‘‘per unit’’ basis in addition to the ‘‘per number of servings recommended in serving’’ basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section other parts of the label (e.g., ‘‘Serving for (b)(2)-dietary ingredients and Size: 1 Caplet (Total daily amount: 3 (b)(3)(ii) and (b)(3)(iv) of this section caplets per day)’’). for other dietary ingredients. If ‘‘per (10) In the interest of uniformity of unit’’ information is provided, it must presentation, FDA urges that the infor- be presented in additional columns to mation be presented using the graphic the right of the ‘‘per serving’’ informa- specifications set forth in appendix B tion and be clearly identified by appro- to part 101, as applicable. priate headings. (11) The following sample labels are (ii) Alternatively, if a recommenda- presented for the purpose of illustra- tion is made in other parts of the label tion:

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(12) If space is not adequate to list the right must be set off by a line that the required information as shown in distinguishes it and sets it apart from the sample labels in paragraph (e)(11) the dietary ingredients and percent of of this section, the list may be split Daily Value information given to the and continued to the right as long as left. The following sample label illus- the headings are repeated. The list to trates this display:

(f)(1) Compliance with this section the same inspection lot, whichever is will be determined in accordance with smaller, randomly selected to be rep- § 101.9(g)(1) through (g)(8), (g)(10), and resentative of the lot. The criteria on (g)(11), except that the sample for anal- class I and class II nutrients given in ysis shall consist of a composite of 12 § 101.9(g)(3) and (g)(4) also are applica- subsamples (consumer packages) or 10 ble to other dietary ingredients de- percent of the number of packages in scribed in paragraph (b)(3)(i) of this

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section. Reasonable excesses over la- ufacture of other dietary supplements beled amounts are acceptable within or that are to be processed, labeled, or current good manufacturing practice. repacked at a site other than where (2) When it is not technologically fea- originally processed or packed. sible, or some other circumstance (i)(1) Dietary supplements are subject makes it impracticable, for firms to to the special labeling provisions speci- comply with the requirements of this fied in § 101.9(j)(5)(i) for foods other section, FDA may permit alternative than infant formula, represented or means of compliance or additional ex- purported to be specifically for infants emptions to deal with the situation in through 12 months of age and children accordance with § 101.9(g)(9). Firms in 1 through 3 years of age. need of such special allowances shall (2) Section 101.9(j)(13) for foods in make their request in writing to the small or intermediate-sized packages, Office of Nutrition and Food Labeling except that: (HFS–800), Food and Drug Administra- (i) All information within the nutrition, 5001 Campus Dr., College Park, tion label on small-sized packages, MD 20740. which have a total surface area avail- (g) Except as provided in paragraphs able to labeling of less than 12 square (i)(2) and (i)(5) of this section, the loca- inches, shall be in type size no smaller tion of nutrition information on a label than 4.5 point; shall be in compliance with § 101.2. (ii) All information within the nutri- (h) Dietary supplements are subject tion label on intermediate-sized pack- to the exemptions specified as follows ages, which have from 12 to 40 square in: inches of surface area available to bear (1) Section 101.9(j)(1) for foods that labeling, shall be in type size no small- are offered for sale by a person who er than 6 point, except that type size makes direct sales to consumers (i.e., a no smaller than 4.5 point may be used retailer) who has annual gross sales or on packages that have less than 20 business done in sales to consumers square inches available for labeling and that is not more than $500,000 or has more than 8 dietary ingredients to be annual gross sales made or business listed and on packages that have 20 to done in sales of food to consumers of 40 square inches available for labeling not more than $50,000, and whose la- and more than 16 dietary ingredients to bels, labeling, and advertising do not be listed. provide nutrition information or make (iii) When the nutrition information a nutrient content or health claim; is presented on any panel under (2) Section 101.9(j)(18) for foods that § 101.9(j)(13)(ii)(D), the ingredient list are low-volume products (that is, they shall continue to be located imme- meet the requirements for units sold in diately below the nutrition label, or, if § 101.9(j)(18)(i) or (j)(18)(ii)); that, except there is insufficient space below the as provided in § 101.9(j)(18)(iv), are the nutrition label, immediately contig- subject of a claim for an exemption uous and to the right of the nutrition that provides the information required label as specified in § 101.4(g). under § 101.9(j)(18)(iv), that is filed be- (iv) When it is not possible for a fore the beginning of the time period small or intermediate-sized package for which the exemption is claimed, that is enclosed in an outer package to and that is filed by a person, whether it comply with these type size require- is the manufacturer, packer, or dis- ments, the type size of the nutrition tributor, that qualifies to claim the ex- label on the primary (inner) container emption under the requirements for av- may be as small as needed to accom- erage full-time equivalent employees modate all of the required label infor- in § 101.9(j)(18)(i) or (j)(18)(ii), and whose mation provided that the primary con- labels, labeling, and advertising do not tainer is securely enclosed in outer provide nutrition information or make packaging, the nutrition labeling on a nutrient content or health claim; the outer packaging meets the applica- (3) Section 101.9(j)(9) for foods ble type size requirements, and such shipped in bulk form that are not for outer packaging is not intended to be distribution to consumers in such form separated from the primary container and that are for use solely in the man- under conditions of retail sale.

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(v) Where there is not sufficient (d) By May 8, 1993, FDA will issue a space on a small or intermediate-sized report on actions taken by food retail- package for a nutrition label that ers to provide consumers with nutri- meets minimum type size requirements tion information for raw fruit, vegeta- of 4.5 points if hairlines are used in ac- bles, and fish under the guidelines es- cordance with paragraph (e)(5) of this tablished in § 101.45. section, the hairlines may be omitted (1) The report will include a deter- and replaced by a row of dots con- mination of whether there is substan- necting the columns containing the tial compliance, as defined in § 101.43, name of each dietary ingredient and with the guidelines. the quantitative amounts (by weight (2) In evaluating substantial compli- and as a percent of Daily Value). ance, FDA will consider only the 20 va- (3) Section 101.9(j)(15) for foods in rieties of raw fruit, vegetables, and fish multiunit food containers; most frequently consumed as identified (4) Section 101.9(j)(16) for foods sold in § 101.44. in bulk containers; and (e) If FDA finds that there is substan- (5) Section 101.9(j)(17) for foods in tial compliance with the guidelines for packages that have a total surface area the nutrition labeling of raw fruit and available to bear labeling greater than vegetables or of fish, the agency will so 40 square inches but whose principal state in the report, and the guidelines display panel and information panel do will remain in effect. FDA will reevalu- not provide sufficient space to accom- ate the market place for substantial modate all required label information, compliance every 2 years. except that the ingredient list shall (f) If FDA determines that there is continue to be located immediately not substantial compliance with the below the nutrition label, or, if there is guidelines for raw fruit and vegetables insufficient space below the nutrition or for raw fish, the agency will at that label, immediately contiguous and to time issue proposed regulations requir- the right of the nutrition label as spec- ing that any person who offers raw ified in § 101.4(g). fruit and vegetables or fish to con- (j) Dietary supplements shall be sub- sumers provide, in a manner prescribed ject to the misbranding provisions of by regulations, the nutrition informa- § 101.9(k). tion required by § 101.9. Final regula- [62 FR 49849, Sept. 23, 1997, as amended at 63 tions would have to be issued 6 months FR 30620, June 5, 1998; 66 FR 56035, Nov. 6, after issuance of proposed regulations, 2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, and they would become effective 6 Dec. 13, 2006; 81 FR 33994, May 27, 2016] months after the date of their promul- gation. § 101.42 Nutrition labeling of raw fruit, vegetables, and fish. § 101.43 Substantial compliance of (a) The Food and Drug Administra- food retailers with the guidelines tion (FDA) urges food retailers to pro- for the voluntary nutrition labeling vide nutrition information, as provided of raw fruit, vegetables, and fish. in § 101.9(c), for raw fruit, vegetables, (a) The Food and Drug Administra- and fish at the point-of-purchase. If re- tion (FDA) will judge a food retailer tailers choose to provide such informa- who sells raw agricultural commodities tion, they should do so in a manner or raw fish to be in compliance with that conforms to the guidelines in the guidelines in § 101.45 with respect to § 101.45. raw agricultural commodities if the re- (b) In § 101.44, FDA has listed the 20 tailer displays or provides nutrition la- varieties of raw fruit, vegetables, and beling for at least 90 percent of the raw fish that are most frequently consumed agricultural commodities listed in during a year and to which the guide- § 101.44 that it sells, and with respect to lines apply. raw fish if the retailer displays or pro- (c) FDA has also defined in § 101.43, vides nutrition labeling for at least 90 the circumstances that constitute sub- percent of the types of raw fish listed stantial compliance by food retailers in § 101.44 that it sells. To be in compli- with the guidelines. ance, the nutrition labeling shall:

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(1) Be presented in the store or other sockeye, chum/pink), scallops, shrimp, type of establishment in a manner that swordfish, tilapia, and tuna. is consistent with § 101.45(a)(1); [71 FR 42044, July 25, 2006] (2) Be presented in content and format that are consistent with § 101.45 § 101.45 Guidelines for the voluntary (a)(2), (a)(3), and (a)(4); and nutrition labeling of raw fruits, (3) Include data that have been pro- vegetables, and fish. vided by FDA in appendices C and D to (a) Nutrition labeling for raw fruits, part 101 of this chapter, except that the vegetables, and fish listed in § 101.44 information on potassium is voluntary. should be presented to the public in the (b) To determine whether there is following manner: substantial compliance by food retail- (1) Nutrition labeling information ers with the guidelines in § 101.45 for should be displayed at the point of pur- the voluntary nutrition labeling of raw chase by an appropriate means such as fruit and vegetables and of raw fish, by a label affixed to the food or FDA will select a representative sam- through labeling including shelf labels, ple of 2,000 stores, allocated by store signs, posters, brochures, notebooks, or type and size, for raw fruit and vegeta- leaflets that are readily available and bles and for raw fish. in close proximity to the foods. The nu- (c) FDA will find that there is sub- trition labeling information may also stantial compliance with the guide- be supplemented by a video, live dem- lines in § 101.45 if it finds based on para- onstration, or other media. graph (a) of this section that at least 60 (2) Serving sizes should be deter- percent of all stores that are evaluated mined, and nutrients declared, in ac- are in compliance. cordance with § 101.9 (b) and (c), respec- (d) FDA will evaluate substantial tively, except that the nutrition label- compliance separately for raw agricul- ing data should be based on the raw ed- tural commodities and for raw fish. ible portion for fruits and vegetables and on the cooked edible portion for [55 FR 60890, Nov. 27, 1991, as amended at 61 fish. The methods used to cook fish FR 42759, Aug. 16, 1996] should be those that do not add fat, § 101.44 What are the 20 most fre- breading, or seasoning (e.g., salt or quently consumed raw fruits, vege- spices). tables, and fish in the United (3) When nutrition labeling informa- States? tion is provided for more than one raw (a) The 20 most frequently consumed fruit, vegetable, or fish on signs, post- raw fruits are: Apple, avocado (Cali- ers, brochures, notebooks, or leaflets, fornia), banana, cantaloupe, grapefruit, it may be presented in charts with horizontal or vertical columns or as a grapes, honeydew melon, kiwifruit, compilation of individual nutrition la- lemon, lime, nectarine, orange, peach, bels. Nutrition labeling that is pre- pear, pineapple, plums, strawberries, sented in a linear display (see sweet cherries, tangerine, and water- § 101.9(j)(13)(ii)(A)(2)) will not be consid- melon. ered to be in compliance. The heading (b) The 20 most frequently consumed ‘‘Nutrition Facts’’ must be in a type raw vegetables are: Asparagus, bell size larger than all other print in the pepper, broccoli, carrot, cauliflower, nutrition label. The required informa- celery, cucumber, green (snap) beans, tion (i.e., headings, serving sizes, list of green cabbage, green onion, iceberg let- nutrients, quantitative amounts by tuce, leaf lettuce, mushrooms, onion, weight (except for vitamins and min- potato, radishes, summer squash, sweet erals), and percent of Daily Values corn, sweet potato, and tomato. (DV’s) (except for sugars and protein) (c) The 20 most frequently consumed must be clearly presented and of suffi- raw fish are: Blue crab, catfish, clams, cient type size and color contrast to be cod, flounder/sole, haddock, halibut, plainly legible, with numeric values for lobster, ocean perch, orange roughy, percent of DV highlighted in contrast oysters, pollock, rainbow trout, rock- to the quantitative amounts by weight fish, salmon (Atlantic/coho/Chinook/ and hairlines between all nutrients.

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(i) Declaration of the number of sumed raw fruits, vegetables, and fish servings per container need not be in- listed in § 101.44 shall be used to ensure cluded in the nutrition labeling of raw uniformity in declared values. FDA fruits, vegetables, and fish. will publish proposed updates of the 20 (ii) Except for the statement ‘‘Per- most frequently consumed raw fruits, cent Daily Values are based on a 2,000 vegetables, and fish and nutrition label calorie diet,’’ the footnote required in data for these foods (or a notice that § 101.9(d)(9) is not required. However, the data sets have not changed from when labeling is provided in brochures, the previous publication) at least every notebooks, leaflets, or similar types of 4 years in the FEDERAL REGISTER. materials, retailers are encouraged to (1) The agency encourages the sub- include the footnote. mission of data bases with new or addi- (iii) When retailers provide nutrition tional nutrient data for any of the labeling information for more than one most frequently consumed raw fruits, raw fruit or vegetable on signs or post- vegetables, and fish to the Office of Nu- ers or in brochures, notebooks, or leaf- tritional Products, Labeling and Die- lets, the listings for saturated fat, trans tary Supplements (HFS–800), Center for fat, and cholesterol may be omitted Food Safety and Applied Nutrition, from the charts or individual nutrition Food and Drug Administration, 5001 labels if a footnote states that most Campus Dr., College Park, MD 20740, fruits and vegetables provide negligible for review and evaluation. FDA may amounts of these nutrients, but that incorporate these data in the next revi- avocados contain 0.5 gram (g) of satu- sion of the nutrition labeling informa- rated fat per ounce (e.g., ‘‘Most fruits tion for the top 20 raw fruits, vegeta- and vegetables provide negligible bles, and fish. amounts of saturated fat, trans fat, and (i) Guidance in the development of cholesterol; avocados provide 0.5 g of data bases may be found in the ‘‘FDA saturated fat per ounce’’). The footnote Nutrition Labeling Manual: A Guide also may contain information about for Developing and Using Data Bases,’’ the polyunsaturated and available from the FDA Office of Food monounsaturated fat content of avoca- Labeling. dos. (ii) The submission to FDA should in- (iv) When retailers provide nutrition clude, but need not be limited to, infor- labeling information for more than one mation on the following: Source of the raw fish on signs or posters or in bro- data (names of investigators, name of chures, notebooks, or leaflets, the list- organization, place of analyses, dates ings for trans fat, dietary fiber, and of analyses), number of samples, sam- sugars may be omitted from the charts pling design, analytical methods, and or individual nutrition labels if the fol- statistical treatment of the data. Pro- lowing footnote is used, ‘‘Fish provide posed quantitative label declarations negligible amounts of trans fat, dietary may be included. The proposed values fiber, and sugars.’’ for declaration should be determined in (4) When nutrition labeling is pro- accordance with the ‘‘FDA Nutrition vided for individual raw fruits, vegeta- Labeling Manual: A Guide for Devel- bles, or fish on packages or on signs, oping and Using Data Bases.’’ posters, brochures, notebooks, or leaf- (2) [Reserved] lets, it should be displayed in accord- (c) Data bases of nutrient values for ance with § 101.9, except that the dec- raw fruits, vegetables, and fish that are laration of the number of servings per not among the 20 most frequently con- container need not be included. For in- sumed may be used to develop nutri- dividual labels provided by retailers on tion labeling values for these foods. signs and posters, the footnote required This includes data bases of nutrient in § 101.9(d)(9) may be shortened to values for specific varieties, species, or ‘‘Percent Daily Values are based on a cultivars of raw fruits, vegetables, and 2,000 calorie diet.’’ fish not specifically identified among (b) Nutrition label values provided by the 20 most frequently consumed. the Food and Drug Administration (1) The food names and descriptions (FDA) in Appendices C and D to part for the fruits, vegetables, and fish 101 for the 20 most frequently con- should clearly identify these foods as

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distinct from foods among the most § 101.54 Nutrient content claims for frequently consumed list for which ‘‘good source,’’ ‘‘high,’’ ‘‘more,’’ and FDA has provided data. ‘‘high potency.’’ (2) Guidance in the development of (a) General requirements. Except as data bases may be found in the ‘‘FDA provided in paragraph (e) of this sec- Nutrition Labeling Manual: A Guide tion, a claim about the level of a nutri- for Developing and Using Data Bases.’’ ent in a food in relation to the Ref- (3) Nutrition labeling values com- erence Daily Intake (RDI) established puted from data bases are subject to for that nutrient in § 101.9(c)(8)(iv) or the compliance provisions of § 101.9(g). Daily Reference Value (DRV) estab- (i) Compliance with the provisions of lished for that nutrient in § 101.9(c)(9), § 101.9(g) may be achieved by use of a (excluding total carbohydrates) may data base that has been developed fol- only be made on the label or in labeling lowing FDA guideline procedures and of the food if: approved by FDA. (1) The claim uses one of the terms (A) The submission to FDA for ap- defined in this section in accordance proval should include but need not be with the definition for that term; limited to information on the fol- (2) The claim is made in accordance lowing: Source of the data (names of with the general requirements for nu- investigators, name of organization, trient content claims in § 101.13; and place of analyses, dates of analyses), (3) The food for which the claim is number of samples, sampling design, made is labeled in accordance with analytical methods, statistical treat- § 101.9, § 101.10, or § 101.36, as applicable. ment of the data, and proposed quan- (b) ‘‘High’’ claims. (1) The terms titative label declarations. The values ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source for declaration should be determined in of’’ may be used on the label and in the accordance with the ‘‘FDA Nutrition labeling of foods, except meal products Labeling Manual: A Guide for Devel- as defined in § 101.13(l) and main dish oping and Using Databases.’’ products as defined in § 101.13(m), pro- (B) FDA approval of a data base and vided that the food contains 20 percent nutrition labeling values shall not be or more of the RDI or the DRV per ref- considered granted until the Center for erence amount customarily consumed. Food Safety and Applied Nutrition has (2) The terms defined in paragraph agreed to all aspects of the data base in (b)(1) of this section may be used on writing. Approvals will be in effect for the label and in the labeling of meal a limited time, e.g., 10 years, and will products as defined in § 101.13(l) and be eligible for renewal in the absence of significant changes in agricultural or main dish products as defined in industry practices (e.g., a change oc- § 101.13(m), provided that: curs in a predominant variety pro- (i) The product contains a food that duced). FDA will take steps to revoke meets the definition of ‘‘high’’ in para- its approval of the data base and nutri- graph (b)(1) of this section; and tion labeling values if FDA monitoring (ii) The label or labeling clearly iden- suggests that the data base or nutri- tifies the food that is the subject of the tion labeling values are no longer rep- claim (e.g., the serving of broccoli in resentative of the item sold in this this product is high in vitamin C). country. Approval requests shall be (c) ‘‘Good Source’’ claims. (1) The submitted in accordance with the pro- terms ‘‘good source,’’ ‘‘contains,’’ or vision of § 101.30 of this chapter. ‘‘provides’’ may be used on the label (ii) [Reserved] and in the labeling of foods, except meal products as defined in § 101.13(l) [61 FR 42760, Aug. 16, 1996, as amended at 66 and main dish products as defined in FR 56035, Nov. 6, 2001; 71 FR 42044, July 25, § 101.13(m), provided that the food con- 2006] tains 10 to 19 percent of the RDI or the DRV per reference amount customarily Subpart D—Specific Requirements consumed. for Nutrient Content Claims (2) The terms defined in paragraph (c)(1) of this section may be used on the SOURCE: 58 FR 2413, Jan. 6, 1993, unless oth- label and in the labeling of meal prod- erwise noted. ucts as defined in § 101.13(l) and main

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dish products as defined in 101.13(m), the nutrient is greater relative to the provided that: RDI or DRV are declared in immediate (i) The product contains a food that proximity to the most prominent such meets the definition of ‘‘good source’’ claim (e.g., ‘‘contains 10 percent more in paragraph (c)(1) of this section; and of the Daily Value for fiber than white (ii) The label or labeling clearly iden- bread’’); and tifies the food that is the subject of the (B) Quantitative information com- claim (e.g., the serving of sweet pota- paring the level of the nutrient in the toes in this product is a ‘‘good source’’ product per labeled serving with that of fiber). of the reference food that it replaces (d) ‘‘Fiber’’ claims. (1) If a nutrient (e.g., ‘‘Fiber content of white bread is 1 content claim is made with respect to gram (g) per serving; (this product) 3.5 the level of dietary fiber, that is, that g per serving’’) is declared adjacent to the product is high in fiber, a good the most prominent claim or to the nu- source of fiber, or that the food con- trition label, except that if the nutri- tains ‘‘more’’ fiber, and the food is not tion label is on the information panel, ‘‘low’’ in total fat as defined in the quantitative information may be § 101.62(b)(2) or, in the case of a meal located elsewhere on the information product, as defined in § 101.13(l), or panel in accordance with § 101.2. main dish product, as defined in (2) A relative claim using the terms § 101.13(m), is not ‘‘low’’ in total fat as ‘‘more,’’ ‘‘fortified,’’ ‘‘enriched,’’ defined in § 101.62(b)(3), then the label ‘‘added,’’ ‘‘extra,’’ and ‘‘plus’’ may be shall disclose the level of total fat per used on the label or in labeling to de- labeled serving. scribe the level of protein, vitamins, (2) The disclosure shall appear in im- minerals, dietary fiber or potassium, mediate proximity to such claim, be in except as limited in § 101.13(j)(1)(i), in a type size no less than one-half the meal products as defined in § 101.13(l) or size of the claim and precede any dis- main dish products as defined in closure statement required under § 101.13(m), provided that: § 101.13(h) (e.g., ‘‘contains [x amount] of total fat per serving. See nutrition in- (i) The food contains at least 10 per- formation for fat content’’). cent more of the RDI for vitamins or (e) ‘‘More’’ claims. (1) A relative claim minerals or of the DRV for protein, die- using the terms ‘‘more,’’ ‘‘fortified,’’ tary fiber, or potassium (expressed as a ‘‘enriched,’’ ‘‘added,’’ ‘‘extra,’’ and percent of the Daily Value) per 100 g of ‘‘plus’’ may be used on the label or in food than an appropriate reference labeling of foods to describe the level food. of protein, vitamins, minerals, dietary (ii) Where the claim is based on a nu- fiber, or potassium, except as limited trient that has been added to the food, by § 101.13(j)(1)(i) and except meal prod- that fortification is in accordance with ucts as defined in § 101.13(l) and main the policy on fortification of foods in dish products as defined in § 101.13(m), § 104.20 of this chapter; and provided that: (iii) As required in § 101.13(j)(2) for (i) The food contains at least 10 per- relative claims: cent more of the RDI for vitamins or (A) The identity of the reference food minerals or of the DRV for protein, die- and the percentage (or fraction) that tary fiber, or potassium (expressed as a the nutrient was increased relative to percent of the Daily Value) per ref- the RDI or DRV are declared in imme- erence amount customarily consumed diate proximity to the most prominent than an appropriate reference food; and such claim (e.g., ‘‘contains 10 percent (ii) Where the claim is based on a nu- more of the Daily Value for fiber per 3 trient that has been added to the food, oz than does ‘X brand of product’ ’’), that fortification is in accordance with and the policy on fortification of foods in (B) Quantitative information com- § 104.20 of this chapter; and paring the level of the nutrient in the (iii) As required in § 101.13(j)(2) for product per specified weight with that relative claims: of the reference food that it replaces (A) The identity of the reference food (e.g., ‘‘The fiber content of ‘X brand of and the percentage (or fraction) that product’ is 2 g per 3 oz. This product

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contains 4.5 g per 3 oz.’’) is declared ad- cellular processes that inactivate free jacent to the most prominent claim or radicals or prevent free radical-initi- to the nutrition label, except that if ated chemical reactions; the nutrition label is on the informa- (3) The level of each nutrient that is tion panel, the quantitative informa- the subject of the claim is sufficient to tion may be located elsewhere on the qualify for the § 101.54 (b), (c), or (e) information panel in accordance with claim (e.g., to bear the claim ’’high in § 101.2. antioxidant vitamin C,’’ the product (f) ‘‘High potency’’ claims. (1)(i) The must contain 20 percent or more of the term ‘‘high potency’’ may be used on RDI for vitamin C). Beta-carotene may the label or in the labeling of foods to be a subject of the claim when the level describe individual vitamins or min- of vitamin A present as beta-carotene erals that are present at 100 percent or in the food that bears the claim is suf- more of the RDI per reference amount ficient to qualify for the claim. For ex- customarily consumed. ample, for the claim ‘‘good source of (ii) When the term ‘‘high potency’’ is antioxidant beta-carotene,’’ 10 percent used to describe individual vitamins or or more of the RDI for vitamin A must minerals in a product that contains be present as beta-carotene per ref- other nutrients or dietary ingredients, erence amount customarily consumed; the label or labeling shall clearly iden- and tify which vitamin or mineral is de- (4) The names of the nutrients that scribed by the term ‘‘high potency’’ are the subject of the claim are in- (e.g., ‘‘Botanical ‘X’ with high potency cluded as part of the claim (e.g., ‘‘high vitamin E’’). in antioxidant vitamins C and E’’). Al- (2) The term ‘‘high potency’’ may be ternatively, when used as part of a nu- used on the label or in the labeling of trient content claim, the term ‘‘anti- a multiingredient food product to de- oxidant’’ or ‘‘antioxidants’’ (as in scribe the product if the product con- ‘‘high in antioxidants’’) may be linked tains 100 percent or more of the RDI for by a symbol (e.g., an asterisk) that re- at least two-thirds of the vitamins and fers to the same symbol that appears minerals that are listed in elsewhere on the same panel of a prod- § 101.9(c)(8)(iv) and that are present in the product at 2 percent or more of the uct label followed by the name or RDI (e.g., ‘‘High potency multivitamin, names of the nutrients with recognized multimineral dietary supplement tab- antioxidant activity. The list of nutri- lets’’). ents shall appear in letters of a type (3) Where compliance with para- size height no smaller than the larger graphs (f)(1)(i), (f)(1)(ii), or (f)(2) of this of one-half of the type size of the larg- 1 section is based on a nutrient that has est nutrient content claim or ⁄16 inch. been added to a food (other than a die- [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, tary supplement), that fortification 1993, as amended at 59 FR 394, Jan. 4, 1994; 59 shall be in accordance with the policy FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, on fortification of foods in § 104.20 of 1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339, this chapter. June 9, 1997; 62 FR 49867, 49880, Sept. 23, 1997; (g) Nutrient content claims using the 63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 30, term ‘‘antioxidant.’’ A nutrient content 2001] claim that characterizes the level of § 101.56 Nutrient content claims for antioxidant nutrients present in a food ‘‘light’’ or ‘‘lite.’’ may be used on the label or in the labeling of that food when: (a) General requirements. A claim (1) An RDI has been established for using the term light or lite to describe each of the nutrients; a food may only be made on the label (2) The nutrients that are the subject or in labeling of the food if: of the claim have recognized anti- (1) The claim uses one of the terms oxidant activity; that is, when there defined in this section in accordance exists scientific evidence that, fol- with the definition for that term; lowing absorption from the gastro- (2) The claim is made in accordance intestinal tract, the substance partici- with the general requirements for nu- pates in physiological, biochemical, or trient content claims in § 101.13; and

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(3) The food is labeled in accordance (4) A ‘‘light’’ claim may not be made with § 101.9 or § 101.10, where applicable. on a food for which the reference food (b) ‘‘Light’’ claims. The terms ‘‘light’’ meets the definition of ‘‘low fat’’ and or ‘‘lite’’ may be used on the label or in ‘‘low calorie.’’ the labeling of foods, except meal prod- (c)(1)(i) A product for which the ref- ucts as defined in § 101.13(l) and main erence food contains 40 calories or less dish products as defined in § 101.13(m), and 3 g fat or less per reference amount without further qualification, provided customarily consumed may use the that: term ‘‘light’’ or ‘‘lite’’ without further (1) If the food derives 50 percent or qualification if it is reduced by 50 per- more of its calories from fat, its fat cent or more in sodium content com- content is reduced by 50 percent or pared to the reference food; and more per reference amount custom- (ii) As required in § 101.13(j)(2) for rel- arily consumed compared to an appro- ative claims: priate reference food as specified in (A) The identity of the reference food § 101.13(j)(1); or and the percent (or fraction) that the (2) If the food derives less than 50 per- sodium was reduced shall be declared cent of its calories from fat: in immediate proximity to the most prominent such claim (e.g., 50 percent (i) The number of calories is reduced less sodium than our regular soy by at least one-third (331⁄3 percent) per sauce); and reference amount customarily con- (B) Quantitative information com- sumed compared to an appropriate ref- paring the level of sodium per labeled erence food; or serving size with that of the reference (ii) Its fat content is reduced by 50 food that it replaces (e.g., ‘‘lite soy percent or more per reference amount sauce 500 milligrams (mg) sodium per customarily consumed compared to the serving; regular soy sauce 1,000 mg per reference food that it resembles or for serving’’) is declared adjacent to the which it substitutes as specified in most prominent claim or to the nutri- § 101.13(j)(1); and tion label, except that if the nutrition (3) As required in § 101.13(j)(2) for rel- label is on the information panel, the ative claims: quantitative information may be lo- (i) The identity of the reference food cated elsewhere on the information and the percent (or fraction) that the panel in accordance with § 101.2. calories and the fat were reduced are (2)(i) A product for which the ref- declared in immediate proximity to the erence food contains more than 40 cal- most prominent such claim, (e.g., ‘‘1/3 ories or more than 3 g fat per reference fewer calories and 50 percent less fat amount customarily consumed may than our regular cheese cake’’); use the term ‘‘light in sodium’’ or ‘‘lite (ii) Quantitative information com- in sodium’’ if it is reduced by 50 per- paring the level of calories and fat con- cent or more in sodium content com- tent in the product per labeled serving pared to the reference food, provided size with that of the reference food that ‘‘light’’ or ‘‘lite’’ is presented in that it replaces (e.g., ‘‘lite cheese- immediate proximity with ‘‘in sodium’’ cake—200 calories, 4 grams (g) fat per and the entire term is presented in uni- serving; regular cheesecake—300 cal- form type size, style, color, and promi- ories, 8 g fat per serving’’) is declared nence; and adjacent to the most prominent claim (ii) As required in § 101.13(j)(2) for rel- or to the nutrition label, except that if ative claims: the nutrition label is on the informa- (A) The identity of the reference food tion panel, the quantitative informa- and the percent (or fraction) that the tion may be located elsewhere on the sodium was reduced shall be declared information panel in accordance with in immediate proximity to the most § 101.2; and prominent such claim (e.g., 50 percent (iii) If the labeled food contains less less sodium than our regular canned than 40 calories or less than 3 g fat per peas); and reference amount customarily con- (B) Quantitative information com- sumed, the percentage reduction for paring the level of sodium per labeled that nutrient need not be declared. serving size with that of the reference

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food that it replaces (e.g., ‘‘lite canned (2) The attribute (e.g., ‘‘color’’ or peas, 175 mg sodium per serving; reg- ‘‘texture’’) is in the same style, color, ular canned peas 350 mg per serving’’) and at least one-half the type size as is declared adjacent to the most promi- the word ‘‘light’’ and in immediate nent claim or to the nutrition label, proximity thereto. except that if the nutrition label is on (f) If a manufacturer can dem- the information panel, the quantitative onstrate that the word ‘‘light’’ has information may be located elsewhere been associated, through common use, on the information panel in accordance with a particular food to reflect a phys- with § 101.2. ical or organoleptic attribute (e.g., (iii) Except for meal products as delight brown sugar, light corn syrup, or fined in § 101.13(l) and main dish prod- light molasses) to the point where it ucts as defined in § 101.13(m), a ‘‘light has become part of the statement of in sodium’’ claim may not be made on identity, such use of the term ‘‘light’’ a food for which the reference food shall not be considered a nutrient con- meets the definition of ‘‘low in so- tent claim subject to the requirements dium’’. in this part. (d)(1) The terms ‘‘light’’ or ‘‘lite’’ (g) The term ‘‘lightly salted’’ may be may be used on the label or in the la- used on a product to which has been beling of a meal product as defined in added 50 percent less sodium than is § 101.13(l) and a main dish product as normally added to the reference food as defined in § 101.13(m), provided that: described in § 101.13(j)(1)(i)(B) and (i) The food meets the definition of: (j)(1)(ii)(B), provided that if the prod- (A) ‘‘Low in calories’’ as defined in uct is not ‘‘low in sodium’’ as defined § 101.60(b)(3); or in § 101.61(b)(4), the statement ‘‘not a (B) ‘‘Low in fat’’ as defined in low sodium food,’’ shall appear adja- § 101.62(b)(3); and cent to the nutrition label of the food (ii)(A) A statement appears on the bearing the claim, or, if the nutrition principal display panel that explains label is on the information panel, it whether ‘‘light’’ is used to mean ‘‘low may appear elsewhere on the informa- fat,’’ ‘‘low calories,’’ or both (e.g., tion panel in accordance with § 101.2 ‘‘Light Delight, a low fat meal’’); and and the information required to accom- (B) The accompanying statement is pany a relative claim shall appear on no less than one-half the type size of the label or labeling as specified in the ‘‘light’’ or ‘‘lite’’ claim. § 101.13(j)(2). (2)(i) The term ‘‘light in sodium’’ or [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, ‘‘lite in sodium’’ may be used on the 1993, as amended at 60 FR 17206, Apr. 5, 1995] label or in the labeling of a meal product as defined in § 101.13(l) and a main § 101.60 Nutrient content claims for dish product as defined in § 101.13(m), the calorie content of foods. provided that the food meets the defi- (a) General requirements. A claim nition of ‘‘low in sodium’’ as defined in about the calorie or sugar content of a § 101.61(b)(5)(i); and food may only be made on the label or (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- in the labeling of a food if: dium’’ are presented in uniform type (1) The claim uses one of the terms size, style, color, and prominence. defined in this section in accordance (e) Except as provided in paragraphs with the definition for that term; (b) through (d) of this section, the term (2) The claim is made in accordance ‘‘light’’ or ‘‘lite’’ may not be used to with the general requirements for nu- refer to a food that is not reduced in trient content claims in § 101.13; fat by 50 percent, or, if applicable, in (3) The food for which the claim is calories by 1⁄3 or, when properly quali- made is labeled in accordance with fied, in sodium by 50 percent unless: § 101.9, § 101.10, or § 101.36, as applicable; (1) It describes some physical or and organoleptic attribute of the food such (4) For dietary supplements, claims as texture or color and the information regarding calories may not be made on (e.g., ‘‘light in color’’ or ‘‘light in tex- products that meet the criteria in ture’’) so stated, clearly conveys the § 101.60(b)(1) or (b)(2) for ‘‘calorie free’’ nature of the product; and or ‘‘low calorie’’ claims except when an

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equivalent amount of a similar dietary particular brand to which the label at- supplement (e.g., another protein sup- taches (e.g., ‘‘celery, a low calorie plement) that the labeled food resem- food’’). bles and for which it substitutes, nor- (3) The terms defined in paragraph mally exceeds the definition for ‘‘low (b)(2) of this section may be used on calorie’’ in § 101.60(b)(2). the label or in labeling of meal prod- (b) Calorie content claims. (1) The ucts as defined in § 101.13(l) or main terms ‘‘calorie free,’’ ‘‘free of calories,’’ dish products as defined in § 101.13(m), ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- provided that: out calories,’’ ‘‘trivial source of cal- (i) The product contains 120 calories ories,’’ ‘‘negligible source of calories,’’ or less per 100 g; and or ‘‘dietarily insignificant source of (ii) If the product meets this condi- calories’’ may be used on the label or tion without the benefit of special in the labeling of foods, provided that: processing, alteration, formulation, or (i) The food contains less than 5 cal- reformulation to lower the calorie con- ories per reference amount customarily tent, it is labeled to clearly refer to all consumed and per labeled serving. foods of its type and not merely to the (ii) As required in § 101.13(e)(2), if the particular brand to which it attaches. food meets this condition without the (4) The terms ‘‘reduced calorie,’’ ‘‘re- benefit of special processing, alter- duced in calories,’’ ‘‘calorie reduced,’’ ation, formulation, or reformulation to ‘‘fewer calories,’’ ‘‘lower calorie,’’ or lower the caloric content, it is labeled ‘‘lower in calories’’ may be used on the to disclose that calories are not usually present in the food (e.g., ‘‘cider label or in the labeling of foods, except vinegar, a calorie free food’’). as limited by § 101.13(j)(1)(i) and except (2) The terms ‘‘low calorie,’’ ‘‘few cal- meal products as defined in § 101.13(l) ories,’’ ‘‘contains a small amount of and main dish products as defined in calories,’’ ‘‘low source of calories,’’ or § 101.13(m), provided that: ‘‘low in calories’’ may be used on the (i) The food contains at least 25 per- label or in labeling of foods, except cent fewer calories per reference meal products as defined in § 101.13(l) amount customarily consumed than an and main dish products as defined in appropriate reference food as described § 101.13(m), provided that: in § 101.13(j)(1); and (i)(A) The food has a reference (ii) As required in § 101.13(j)(2) for rel- amount customarily consumed greater ative claims: than 30 grams (g) or greater than 2 ta- (A) The identity of the reference food blespoons and does not provide more and the percent (or fraction) that the than 40 calories per reference amount calories differ between the two foods customarily consumed; or are declared in immediate proximity to (B) The food has a reference amount the most prominent such claim (e.g., customarily consumed of 30 g or less or reduced calorie cupcakes ‘‘331⁄3 percent 2 tablespoons or less and does not pro- fewer calories than regular cupcakes’’); vide more than 40 calories per ref- and erence amount customarily consumed (B) Quantitative information com- and, except for sugar substitutes, per 50 paring the level of the nutrient per la- g (for dehydrated foods that must be beled serving size with that of the ref- reconstituted before typical consump- erence food that it replaces (e.g., ‘‘Cal- tion with water or a diluent containing orie content has been reduced from 150 an insignificant amount, as defined in to 100 calories per serving.’’) is declared § 101.9(f)(1), of all nutrients per ref- adjacent to the most prominent claim erence amount customarily consumed, or to the nutrition label, except that if the per 50 g criterion refers to the ‘‘as the nutrition label is on the informa- prepared’’ form). tion panel, the quantitative informa- (ii) If a food meets these conditions tion may be located elsewhere on the without the benefit of special proc- information panel in accordance with essing, alteration, formulation, or re- § 101.2. formulation to vary the caloric con- (iii) Claims described in paragraph tent, it is labeled to clearly refer to all (b)(4) of this section may not be made foods of its type and not merely to the on the label or labeling of foods if the

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reference food meets the definition for sumed and per labeled serving or, in ‘‘low calorie.’’ the case of a meal product or main dish (5) The terms defined in paragraph product, less than 0.5 g of sugars per la- (b)(4) of this section may be used on beled serving; and the label or in the labeling of meal (ii) The food contains no ingredient products as defined in § 101.13(l) and that is a sugar or that is generally un- main dish products as defined in derstood by consumers to contain sug- § 101.13(m), provided that: ars unless the listing of the ingredient (i) The food contains at least 25 per- in the ingredient statement is followed cent fewer calories per 100 g of food by an asterisk that refers to the state- than an appropriate reference food as ment below the list of ingredients, described in § 101.13(j)(1); and which states ‘‘adds a trivial amount of (ii) As required in § 101.13(j)(2) for rel- sugar,’’ ‘‘adds a negligible amount of ative claims: sugar,’’ or ‘‘adds a dietarily insignifi- (A) The identity of the reference food cant amount of sugar;’’ and and the percent (or fraction) that the calories differ between the two foods (iii)(A) It is labeled ‘‘low calorie’’ or are declared in immediate proximity to ‘‘reduced calorie’’ or bears a relative the most prominent such claim (e.g., claim of special dietary usefulness la- Larry’s Reduced Calorie Lasagna, ‘‘25 beled in compliance with paragraphs percent fewer calories per oz (or 3 oz) (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- than our regular Lasagna’’); and tion, or, if a dietary supplement, it (B) Quantitative information com- meets the definition in paragraph (b)(2) paring the level of the nutrient in the of this section for ‘‘low calorie’’ but is product per specified weight with that prohibited by §§ 101.13(b)(5) and of the reference food that it replaces 101.60(a)(4) from bearing the claim; or (e.g., ‘‘Calorie content has been re- (B) Such term is immediately accom- duced from 108 calories per 3 oz to 83 panied, each time it is used, by either calories per 3 oz.’’) is declared adjacent the statement ‘‘not a reduced calorie to the most prominent claim or to the food,’’ ‘‘not a low calorie food,’’ or ‘‘not nutrition label, except that if the nu- for weight control.’’ trition label is on the information (2) The terms ‘‘no added sugar,’’ panel, the quantitative information ‘‘without added sugar,’’ or ‘‘no sugar may be located elsewhere on the infor- added’’ may be used only if: mation panel in accordance with § 101.2. (i) No amount of sugars, as defined in (iii) Claims described in paragraph § 101.9(c)(6)(ii), or any other ingredient (b)(5) of this section may not be made that contains sugars that functionally on the label or labeling of food if the substitute for added sugars is added reference food meets the definition for during processing or packaging; and ‘‘low calorie.’’ (ii) The product does not contain an (c) Sugar content claims—(1) Use of ingredient containing added sugars terms such as ‘‘sugar free,’’ ‘‘free of such as jam, jelly, or concentrated sugar,’’ ‘‘no sugar,’’ ‘‘zero sugar,’’ fruit juice; and ‘‘without sugar,’’ ‘‘sugarless,’’ ‘‘trivial (iii) The sugars content has not been source of sugar,’’ ‘‘negligible source of sugar,’’ or ‘‘dietarily insignificant source increased above the amount present in of sugar.’’ Consumers may reasonably the ingredients by some means such as be expected to regard terms that rep- the use of enzymes, except where the resent that the food contains no sugars intended functional effect of the proc- or sweeteners e.g., ‘‘sugar free,’’ or ‘‘no ess is not to increase the sugars con- sugar,’’ as indicating a product which tent of a food, and a functionally insig- is low in calories or significantly re- nificant increase in sugars results; and duced in calories. Consequently, except (iv) The food that it resembles and as provided in paragraph (c)(2) of this for which it substitutes normally con- section, a food may not be labeled with tains added sugars; and such terms unless: (v) The product bears a statement (i) The food contains less than 0.5 g of that the food is not ‘‘low calorie’’ or sugars, as defined in § 101.9(c)(6)(ii), per ‘‘calorie reduced’’ (unless the food reference amount customarily con- meets the requirements for a ‘‘low’’ or

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‘‘reduced calorie’’ food) and that di- label or in the labeling of a meal prod- rects consumers’ attention to the nu- uct as defined in § 101.13(l) and a main trition panel for further information dish product as defined in § 101.13(m), on sugar and calorie content. provided that: (3) Paragraph (c)(1) of this section (i) The food contains at least 25 per- shall not apply to a factual statement cent less sugars per 100 g of food than that a food, including foods intended an appropriate reference food as de- specifically for infants and children scribed in § 101.13(j)(1), and less than 2 years of age, is unsweetened (ii) As required in § 101.13(j)(2) for rel- or contains no added sweeteners in the ative claims: case of a food that contains apparent (A) The identity of the reference food substantial inherent sugar content, and the percent (or fraction) that the e.g., juices. sugars differ between the two foods are (4) The claims provided for in para- declared in immediate proximity to the graph (c)(1) and (c)(2) of this section most prominent such claim (e.g., re- may be used on labels or in labeling of duced sweet and sour shrimp dinner, dietary supplements of vitamins or ‘‘25 percent less sugar per 3 oz than our minerals that are intended specifically regular sweet and sour shrimp din- for use by infants and children less ner’’); and than 2 years of age. (B) Quantitative information com- (5) The terms ‘‘reduced sugar,’’ ‘‘re- paring the level of the nutrient in the duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less product per specified weight with that sugar,’’ ‘‘lower sugar’’ or ‘‘lower in of the reference food that it replaces sugar’’ may be used on the label or in (e.g., ‘‘Sugar content has been reduced labeling of foods, except meal products from 17 g per 3 oz to 13 g per 3 oz.’’) is as defined in § 101.13(l), main dish prod- declared adjacent to the most promi- ucts as defined in § 101.13(m), and die- nent claim or to the nutrition label, tary supplements of vitamins or min- except that if the nutrition label is on erals, provided that: the information panel, the quantitative (i) The food contains at least 25 per- information may be located elsewhere cent less sugar per reference amount on the information panel in accordance customarily consumed than an appro- with § 101.2. priate reference food as described in [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, § 101.13(j)(1); and 1993, as amended at 58 FR 44031, Aug. 18, 1993; (ii) As required in § 101.13(j)(2) for rel- 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, ative claims: 1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, (A) The identity of the reference food Sept. 23, 1997] and the percent (or fraction) that the sugar differs between the two foods are § 101.61 Nutrient content claims for declared in immediate proximity to the the sodium content of foods. most prominent such claim (e.g., (a) General requirements. A claim ‘‘these corn flakes contain 25 percent about the level of sodium or salt in a less sugar than our sugar coated corn food may only be made on the label or flakes’’); and in the labeling of the food if: (B) Quantitative information com- (1) The claim uses one of the terms paring the level of the sugar in the defined in this section in accordance product per labeled serving with that with the definition for that term; of the reference food that it replaces (2) The claim is made in accordance (e.g., ‘‘Sugar content has been lowered with the general requirements for nu- from 8 g to 6 g per serving.’’) is de- trient content claims in § 101.13; and clared adjacent to the most prominent (3) The food for which the claim is claim or to the nutrition label, except made is labeled in accordance with that if the nutrition label is on the in- § 101.9, § 101.10, or § 101.36, as applicable. formation panel, the quantitative in- (b) Sodium content claims. (1) The formation may be located elsewhere on terms ‘‘sodium free,’’ ‘‘free of sodium,’’ the information panel in accordance ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without with § 101.2. sodium,’’ ‘‘trivial source of sodium,’’ (6) The terms defined in paragraph ‘‘negligible source of sodium,’’ or ‘‘die- (c)(5) of this section may be used on the tary insignificant source of sodium’’

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may be used on the label or in the la- particular brand to which the label at- beling of foods, provided that: taches (e.g., ‘‘potatoes, a very low-so- (i) The food contains less than 5 mil- dium food’’). ligrams (mg) of sodium per reference (3) The terms defined in paragraph amount customarily consumed and per (b)(2) of this section may be used on labeled serving or, in the case of a meal the label or in labeling of meal prod- product or a main dish product, less ucts as defined in § 101.13(l) and main than 5 mg of sodium per labeled serv- dish products as defined in § 101.13(m), ing; and provided that: (ii) The food contains no ingredient (i) The product contains 35 mg or less that is sodium chloride or is generally of sodium per 100 g of product; and understood by consumers to contain (ii) If the product meets this condi- sodium, unless the listing of the ingre- tion without the benefit of special dient in the ingredient statement is processing, alteration, formulation, or followed by an asterisk that refers to reformulation to lower the sodium con- the statement below the list of ingredi- tent, it is labeled to clearly refer to all ents, which states: ‘‘Adds a trivial foods of its type and not merely to the amount of sodium,’’ ‘‘adds a negligible particular brand to which the label at- amount of sodium’’ or ‘‘adds a dietarily taches. insignificant amount of sodium;’’ and (4) The terms ‘‘low sodium,’’ or ‘‘low (iii) As required in § 101.13(e)(2) if the in sodium,’’ ‘‘little sodium,’’ ‘‘contains food meets these conditions without a small amount of sodium,’’ or ‘‘low the benefit of special processing, alter- source of sodium’’ may be used on the ation, formulation, or reformulation to label or in the labeling of foods, except lower the sodium content, it is labeled meal products as defined in § 101.13(l) to disclose that sodium is not usually and main dish products as defined in present in the food (e.g., ‘‘leaf lettuce, § 101.13(m), provided that: a sodium free food’’). (i)(A) The food has a reference (2) The terms ‘‘very low sodium,’’ or amount customarily consumed greater ‘‘very low in sodium,’’ may be used on than 30 g or greater than 2 tablespoons the label or in labeling of foods, except and contains 140 mg or less sodium per meal products as defined in § 101.13(l) reference amount customarily con- and main dish products as defined in sumed; or § 101.13(m), provided that: (B) The food has a reference amount (i)(A) The food has a reference customarily consumed of 30 g or less or amount customarily consumed greater 2 tablespoons or less and contains 140 than 30 grams (g) or greater than 2 ta- mg or less sodium per reference blespoons and contains 35 mg or less amount customarily consumed and per sodium per reference amount custom- 50 g (for dehydrated foods that must be arily consumed; or reconstituted before typical consump- (B) The food has a reference amount tion with water or a diluent containing customarily consumed of 30 g or less or an insignificant amount, as defined in 2 tablespoons or less and contains 35 § 101.9(f)(1), of all nutrients per ref- mg or less sodium per reference erence amount customarily consumed, amount customarily consumed and per the per 50-g criterion refers to the ‘‘as 50 g (for dehydrated foods that must be prepared’’ form); and reconstituted before typical consump- (ii) If the food meets these conditions tion with water or a diluent containing without the benefit of special proc- an insignificant amount, as defined in essing, alteration, formulation, or re- § 101.9(f)(1), of all nutrients per ref- formulation to vary the sodium con- erence amount customarily consumed, tent, it is labeled to clearly refer to all the per 50-g criterion refers to the ‘‘as foods of its type and not merely to the prepared’’ form); particular brand to which the label at- (ii) If the food meets these conditions taches (e.g., ‘‘fresh spinach, a low so- without the benefit of special proc- dium food’’); and essing, alteration, formulation, or re- (5) The terms defined in paragraph formulation to vary the sodium con- (b)(4) of this section may be used on tent, it is labeled to clearly refer to all the label or in labeling of meal prod- foods of its type and not merely to the ucts as defined in § 101.13(l) and main

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dish products as defined in § 101.13(m), (i) The food contains at least 25 per- provided that: cent less sodium per 100 g of food than (i) The product contains 140 mg or an appropriate reference food as de- less sodium per 100 g; and scribed in § 101.13(j)(1), and (ii) If the product meets these condi- (ii) As required in § 101.13(j)(2) for rel- tions without the benefit of special ative claims: processing, alteration, formulation, or (A) The identity of the reference food reformulation to lower the sodium con- and the percent (or fraction) that the tent, it is labeled to clearly refer to all sodium differs from the reference food foods of its type and not merely to the are declared in immediate proximity to particular brand to which the label at- the most prominent such claim (e.g., taches. reduced sodium eggplant parmigiana (6) The terms ‘‘reduced sodium,’’ dinner ‘‘30 percent less sodium per oz ‘‘reduced in sodium,’’ ‘‘sodium re- (or 3 oz) than our regular eggplant duced,’’ ‘‘less sodium,’’ ‘‘lower so- parmigiana dinner’’). dium,’’ or ‘‘lower in sodium’’ may be (B) Quantitative information com- used on the label or in labeling of paring the level of sodium in the prod- foods, except meal products as defined uct per specified weight with that of in § 101.13(l) and main dish products as the reference food that it replaces (e.g., defined in § 101.13(m), provided that: ‘‘Sodium content has been reduced (i) The food contains at least 25 per- from 217 mg per 3 oz to 150 mg per 3 cent less sodium per reference amount oz.’’) is declared adjacent to the most customarily consumed than an appro- prominent claim or to the nutrition priate reference food as described in label, except that if the nutrition label § 101.13(j)(1). is on the information panel, the quan- (ii) As required for § 101.13(j)(2) for titative information may be located relative claims: elsewhere on the information panel in (A) The identity of the reference food accordance with § 101.2. and the percent (or fraction) that the (iii) Claims described in paragraph sodium differs from the labeled food (b)(7) of this section may not be made are declared in immediate proximity to on the label or in the labeling of a food the most prominent such claim (e.g., if the nutrient content of the reference ‘‘reduced sodium lll, 50 percent less food meets the definition for ‘‘low so- sodium than regular lll’’); and dium.’’ (B) Quantitative information com- (c) The term ‘‘salt’’ is not synony- paring the level of the sodium in the mous with ‘‘sodium.’’ Salt refers to so- product per labeled serving with that dium chloride. However, references to of the reference food that it replaces salt content such as ‘‘unsalted,’’ ‘‘no (e.g., ‘‘Sodium content has been low- salt,’’ ‘‘no salt added’’ are potentially ered from 300 to 150 mg per serving.’’) is misleading. declared adjacent to the most promi- (1) The term ‘‘salt free’’ may be used nent claim or to the nutrition label, on the label or in labeling of foods only except that if the nutrition label is on if the food is ‘‘sodium free’’ as defined the information panel, the quantitative in paragraph (b)(1) of this section. information may be located elsewhere (2) The terms ‘‘unsalted,’’ ‘‘without on the information panel in accordance added salt,’’ and ‘‘no salt added’’ may with § 101.2. be used on the label or in labeling of (iii) Claims described in paragraph foods only if: (b)(6) of this section may not be made (i) No salt is added during processing; on the label or in the labeling of a food (ii) The food that it resembles and for if the nutrient content of the reference which it substitutes is normally proc- food meets the definition for ‘‘low so- essed with salt; and dium.’’ (iii) If the food is not sodium free, the (7) The terms defined in paragraph statement, ‘‘not a sodium free food’’ or (b)(6) of this section may be used on ‘‘not for control of sodium in the diet’’ the label or in the labeling of meal appears adjacent to the nutrition label products as defined in § 101.13(l) and of the food bearing the claim, or, if the main dish products as defined in nutrition label is on the information § 101.13(m), provided that: panel, it may appear elsewhere on the

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information panel in accordance with which states ‘‘adds a trivial amount of § 101.2. fat,’’ ‘‘adds a negligible amount of fat,’’ (3) Paragraph (c)(2) of this section or ‘‘adds a dietarily insignificant shall not apply to a factual statement amount of fat;’’ and that a food intended specifically for in- (iii) As required in § 101.13(e)(2), if the fants and children less than 2 years of food meets these conditions without age is unsalted, provided such state- the benefit of special processing, alter- ment refers to the taste of the food and ation, formulation, or reformulation to is not otherwise false and misleading. lower fat content, it is labeled to disclose that fat is not usually present in [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 FR 44032, Aug. 18, 1993; the food (e.g., ‘‘broccoli, a fat free 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, food’’). 1995] (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ ‘‘contains a small amount of fat,’’ ‘‘low § 101.62 Nutrient content claims for source of fat,’’ or ‘‘little fat’’ may be fat, fatty acid, and cholesterol con- used on the label or in labeling of tent of foods. foods, except meal products as defined (a) General requirements. A claim in § 101.13(l) and main dish products as about the level of fat, fatty acid, and defined in § 101.13(m), provided that: cholesterol in a food may only be made (i)(A) The food has a reference on the label or in the labeling of foods amount customarily consumed greater if: than 30 g or greater than 2 tablespoons (1) The claim uses one of the terms and contains 3 g or less of fat per ref- defined in this section in accordance erence amount customarily consumed; with the definition for that term; or (2) The claim is made in accordance (B) The food has a reference amount with the general requirements for nu- customarily consumed of 30 g or less or trient content claims in § 101.13; 2 tablespoons or less and contains 3 g (3) The food for which the claim is or less of fat per reference amount cus- made is labeled in accordance with tomarily consumed and per 50 g of food § 101.9, § 101.10, or § 101.36, as applicable; (for dehydrated foods that must be re- and constituted before typical consumption (4) For dietary supplements, claims with water or a diluent containing an for fat, saturated fat, and cholesterol insignificant amount, as defined in may not be made on products that § 101.9(f)(1), of all nutrients per ref- meet the criteria in § 101.60(b)(1) or erence amount customarily consumed, (b)(2) for ‘‘calorie free’’ or ‘‘low cal- the per 50-g criterion refers to the ‘‘as orie’’ claims. prepared’’ form); and (b) Fat content claims. (1) The terms (ii) If the food meets these conditions ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ without the benefit of special proc- ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘negligible essing, alteration, formulation, or resource of fat,’’ or ‘‘dietarily insignifi- formulation to lower fat content, it is cant source of fat’’ or, in the case of labeled to clearly refer to all foods of milk products, ‘‘skim’’ may be used on its type and not merely to the par- the label or in labeling of foods, pro- ticular brand to which the label at- vided that: taches (e.g., ‘‘frozen perch, a low fat (i) The food contains less than 0.5 food’’). gram (g) of fat per reference amount (3) The terms defined in paragraph customarily consumed and per labeled (b)(2) of this section may be used on serving or, in the case of a meal prod- the label or in labeling of meal product or main dish product, less than 0.5 ucts as defined in § 101.13(l) or main g of fat per labeled serving; and dish products as defined in § 101.13(m), (ii) The food contains no added ingre- provided that: dient that is a fat or is generally un- (i) The product contains 3 g or less of derstood by consumers to contain fat total fat per 100 g and not more than 30 unless the listing of the ingredient in percent of calories from fat; and the ingredient statement is followed by (ii) If the product meets these condi- an asterisk that refers to the state- tions without the benefit of special ment below the list of ingredients, processing, alteration, formulation, or

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reformulation to lower fat content, it most prominent such claim (e.g., re- is labeled to clearly refer to all foods of duced fat spinach souffle, ‘‘33 percent its type and not merely to the par- less fat per 3 oz than our regular spin- ticular brand to which the label at- ach souffle’’); and taches. (B) Quantitative information com- (4) The terms ‘‘reduced fat,’’ ‘‘re- paring the level of fat in the product duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ per specified weight with that of the ‘‘lower fat,’’ or ‘‘lower in fat’’ may be reference food that it replaces (e.g., used on the label or in the labeling of ‘‘Fat content has been reduced from 7.5 foods, except meal products as defined g per 3 oz to 5 g per 3 oz.’’) is declared in § 101.13(l) and main dish products as adjacent to the most prominent claim, defined in § 101.13(m), provided that: to the nutrition label, or, if the nutri- (i) The food contains at least 25 per- tion label is located on the information cent less fat per reference amount cus- panel, it may appear elsewhere on the tomarily consumed than an appro- information panel in accordance with priate reference food as described in § 101.2. § 101.13(j)(1); and (iii) Claims described in paragraph (ii) As required in § 101.13(j)(2) for rel- (b)(5) of this section may not be made ative claims: on the label or in the labeling of a food (A) The identity of the reference food if the nutrient content of the reference and the percent (or fraction) that the food meets the definition for ‘‘low fat.’’ fat differs between the two foods and (6) The term ‘‘l percent fat free’’ are declared in immediate proximity to may be used on the label or in the la- the most prominent such claim (e.g., beling of foods, provided that: ‘‘reduced fat—50 percent less fat than (i) The food meets the criteria for our regular brownies’’); and ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of (B) Quantitative information com- this section; paring the level of fat in the product (ii) The percent declared and the per labeled serving with that of the ref- words ‘‘fat free’’ are in uniform type erence food that it replaces (e.g., ‘‘Fat size; and content has been reduced from 8 g to 4 (iii) A ‘‘100 percent fat free’’ claim g per serving.’’) is declared adjacent to may be made only on foods that meet the most prominent claim or to the nu- the criteria for ‘‘fat free’’ in paragraph trition label, except that if the nutri- (b)(1) of this section, that contain less tion label is on the information panel, than 0.5 g of fat per 100 g, and that con- the quantitative information may be tain no added fat. located elsewhere on the information (c) Fatty acid content claims. The label panel in accordance with § 101.2. or labeling of foods that bear claims (iii) Claims described in paragraph with respect to the level of saturated (b)(4) of this section may not be made fat shall disclose the level of total fat on the label or in the labeling of a food and cholesterol in the food in imme- if the nutrient content of the reference diate proximity to such claim each food meets the definition for ‘‘low fat.’’ time the claim is made and in type (5) The terms defined in paragraph that shall be no less than one-half the (b)(4) of this section may be used on size of the type used for the claim with the label or in the labeling of meal respect to the level of saturated fat. products as defined in § 101.13(l) and Declaration of cholesterol content may main dish products as defined in be omitted when the food contains less § 101.13(m), provided that: than 2 milligrams (mg) of cholesterol (i) The food contains at least 25 per- per reference amount customarily con- cent less fat per 100 g of food than an sumed or in the case of a meal or main appropriate reference food as described dish product less than 2 mg of choles- in § 101.13(j)(1); and terol per labeled serving. Declaration (ii) As required in § 101.13(j)(2) for rel- of total fat may be omitted with the ative claims: term defined in paragraph (c)(1) of this (A) The identity of the reference food section when the food contains less and the percent (or fraction) that the than 0.5 g of total fat per reference fat differs between the two foods are amount customarily consumed or, in declared in immediate proximity to the the case of a meal product or a main

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dish product, when the product con- (i) The food contains 1 g or less of tains less than 0.5 g of total fat per la- saturated fatty acids per reference beled serving. The declaration of total amount customarily consumed and not fat may be omitted with the terms de- more than 15 percent of calories from fined in paragraphs (c)(2) through (c)(5) saturated fatty acids; and of this section when the food contains (ii) If a food meets these conditions 3 g or less of total fat per reference without benefit of special processing, amount customarily consumed or in alteration, formulation, or reformula- the case of a meal product or a main tion to lower saturated fat content, it dish product, when the product con- is labeled to clearly refer to all foods of tains 3 g or less of total fat per 100 g its type and not merely to the par- and not more than 30 percent calories ticular brand to which the label at- from fat. taches (e.g., ‘‘raspberries, a low satu- (1) The terms ‘‘saturated fat free,’’ rated fat food’’). ‘‘free of saturated fat,’’ ‘‘no saturated (3) The terms defined in paragraph fat,’’ ‘‘zero saturated fat,’’ ‘‘without (c)(2) of this section may be used on the saturated fat,’’ ‘‘trivial source of satu- label or in the labeling of meal prod- rated fat,’’ ‘‘negligible source of satu- ucts as defined in § 101.13(l) and main rated fat,’’ or ‘‘dietarily insignificant dish products as defined in § 101.13(m), source of saturated fat’’ may be used provided that: on the label or in the labeling of foods, (i) The product contains 1 g or less of provided that: saturated fatty acids per 100 g and less (i) The food contains less than 0.5 g of than 10 percent calories from saturated saturated fat and less than 0.5 g trans fat; and fatty acid per reference amount cus- (ii) If the product meets these condi- tomarily consumed and per labeled tions without the benefit of special serving, or in the case of a meal prod- processing, alteration, formulation, or uct or main dish product, less than 0.5 reformulation to lower saturated fat g of saturated fat and less than 0.5 g content, it is labeled to clearly refer to trans fatty acid per labeled serving; and all foods of its type and not merely to (ii) The food contains no ingredient the particular brand to which the label that is generally understood by con- attaches. sumers to contain saturated fat unless (4) The terms ‘‘reduced saturated the listing of the ingredient in the in- fat,’’ ‘‘reduced in saturated fat,’’ gredient statement is followed by an ‘‘saturated fat reduced,’’ ‘‘less satu- asterisk that refers to the statement rated fat,’’ ‘‘lower saturated fat,’’ or below the list of ingredients which ‘‘lower in saturated fat’’ may be used states, ‘‘adds a trivial amount of satu- on the label or in the labeling of foods, rated fat,’’ ‘‘adds a negligible amount except as limited by § 101.13(j)(1)(i) and of saturated fat,’’ or ‘‘adds a dietarily except meal products as defined in insignificant amount of saturated fat;’’ § 101.13(l) and main dish products as de- and fined in § 101.13(m), provided that: (iii) As required in § 101.13(e)(2), if the (i) The food contains at least 25 per- food meets these conditions without cent less saturated fat per reference the benefit of special processing, alter- amount customarily consumed than an ation, formulation, or reformulation to appropriate reference food as described lower saturated fat content, it is la- in § 101.13(j)(1); and beled to disclose that saturated fat is (ii) As required in § 101.13(j)(2) for rel- not usually present in the food. ative claims: (2) The terms ‘‘low in saturated fat,’’ (A) The identity of the reference food ‘‘low saturated fat,’’ ‘‘contains a small and the percent (or fraction) that the amount of saturated fat,’’ ‘‘low source saturated fat differs between the two of saturated fat,’’ or ‘‘a little saturated foods are declared in immediate prox- fat’’ may be used on the label or in the imity to the most prominent such labeling of foods, except meal products claim (e.g., ‘‘reduced saturated fat. as defined in § 101.13(l) and main dish Contains 50 percent less saturated fat products as defined in § 101.13(m), pro- than the national average for nondairy vided that: creamers’’); and

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(B) Quantitative information com- (d) Cholesterol content claims. (1) The paring the level of saturated fat in the terms ‘‘cholesterol free,’’ ‘‘free of cho- product per labeled serving with that lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without of the reference food that it replaces cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial (e.g., ‘‘Saturated fat reduced from 3 g source of cholesterol,’’ ‘‘negligible to 1.5 g per serving’’) is declared adja- source of cholesterol,’’ or ‘‘dietarily in- cent to the most prominent claim or to significant source of cholesterol’’ may the nutrition label, except that if the be used on the label or in the labeling nutrition label is on the information of foods, provided that: panel, the quantitative information (i) For foods that contain 13 g or less may be located elsewhere on the infor- of total fat per reference amount cus- mation panel in accordance with § 101.2. tomarily consumed, per labeled serv- (iii) Claims described in paragraph ing, and per 50 g if the reference (c)(4) of this section may not be made amount customarily consumed is 30 g on the label or in the labeling of a food or less or 2 tablespoons or less (for de- if the nutrient content of the reference hydrated foods that must be reconsti- food meets the definition for ‘‘low satu- tuted before typical consumption with rated fat.’’ water or a diluent containing an insig- (5) The terms defined in paragraph nificant amount, as defined in (c)(4) of this section may be used on the § 101.9(f)(1), of all nutrients per ref- label or in the labeling of meal prod- erence amount customarily consumed, ucts as defined in § 101.13(l) and main the per 50-g criterion refers to the ‘‘as dish products as defined in § 101.13(m), prepared’’ form), or, in the case of meal provided that: products, 26.0 g or less total fat per la- (i) The food contains at least 25 per- beled serving, or, in the case of main cent less saturated fat per 100 g of food dish products, 19.5 g or less total fat than an appropriate reference food as per labeled serving: described in § 101.13(j)(1), and (A) The food contains less than 2 mg (ii) As required in § 101.13(j)(2) for rel- of cholesterol per reference amount ative claims: customarily consumed and per labeling (A) The identity of the reference serving or, in the case of a meal prod- food, and the percent (or fraction) that uct or main dish product, less than 2 the fat differs between the two foods mg of cholesterol per labeled serving; are declared in immediate proximity to and the most prominent such claim (e.g., (B) The food contains no ingredient reduced saturated fat Macaroni and that is generally understood by con- Cheese, ‘‘33 percent less saturated fat per 3 oz than our regular Macaroni and sumers to contain cholesterol, unless Cheese’’). the listing of the ingredient in the ingredient statement is followed by an (B) Quantitative information comparing the level of saturated fat in the asterisk that refers to the statement product per specified weight with that below the list of ingredients, which of the reference food that it replaces states ‘‘adds a trivial amount of choles- (e.g., ‘‘Saturated fat content has been terol,’’ ‘‘adds a negligible amount of reduced from 2.5 g per 3 oz to 1.7 g per cholesterol,’’ or ‘‘adds a dietarily insig- 3 oz.’’) is declared adjacent to the most nificant amount of cholesterol;’’ and prominent claim or to the nutrition (C) The food contains 2 g or less of label, except that if the nutrition label saturated fatty acids per reference in on the information panel, the quan- amount customarily consumed or, in titative information may be located the case of a meal product or main dish elsewhere on the information panel in product, 2 g or less of saturated fatty accordance with § 101.2. acids per labeled serving; and (iii) Claims described in paragraph (D) As required in § 101.13(e)(2), if the (c)(5) of this section may not be made food contains less than 2 mg of choles- on the label or in the labeling of a food terol per reference amount customarily if the nutrient content of the reference consumed or in the case of a meal prod- food meets the definition for ‘‘low satu- uct or main dish product, less than 2 rated fat.’’ mg of cholesterol per labeled serving

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without the benefit of special proc- shall be made on each panel except for essing, alteration, formulation, or re- the panel that bears nutrition labeling. formulation to lower cholesterol con- If the claim appears more than once on tent, it is labeled to disclose that cho- a panel, the disclosure shall be made in lesterol is not usually present in the immediate proximity to the claim that food (e.g., ‘‘applesauce, a cholesterol- is printed in the largest type; and free food’’). (E) As required in § 101.13(e)(2), if the (ii) For food that contain more than food contains less than 2 mg of choles- 13 g of total fat per reference amount terol per reference amount customarily customarily consumed, per labeling consumed or in the case of a meal prod- serving, or per 50 g if the reference uct or main dish product less than 2 mg amount customarily consumed is 30 g of cholesterol per labeled serving with- or less or 2 tablespoons or less (for de- out the benefit of special processing, hydrated foods that must be reconsti- alteration, formulation, or reformula- tuted before typical consumption with tion to lower cholesterol content, it is water or a diluent containing an insig- labeled to disclose that cholesterol is nificant amount, as defined in not usually present in the food (e.g., § 101.9(f)(1), of all nutrients per ref- ‘‘canola oil, a cholesterol-free food, erence amount customarily consumed, contains 14 g of fat per serving’’); or the per 50-g criterion refers to the ‘‘as (F) If the food contains less than 2 prepared’’ form), or in the case of a mg of cholesterol per reference amount meal product, more than 26 g of total customarily consumed or in the case of fat per labeled serving, or, in the case a meal product or main dish product of a main dish product more than 19.5 g less than 2 mg of cholesterol per la- of total fat per labeled serving: beled serving only as a result of special (A) The food contains less than 2 mg processing, alteration, formulation, or of cholesterol per reference amount reformulation, the amount of choles- customarily consumed and per labeling terol is substantially less (i.e., meets serving or, in the case of a meal prod- requirements of paragraph (d)(4)(ii)(A) uct or main dish product, less than 2 of this section) than the food for which mg of cholesterol per labeled serving; it substitutes as specified in § 101.13(d) and that has a significant (e.g., 5 percent or (B) The food contains no ingredient more of a national or regional market) that is generally understood by con- market share. As required in sumers to contain cholesterol, unless § 101.13(j)(2) for relative claims: the listing of the ingredient in the in- (1) The identity of the reference food gredient statement is followed by an and the percent (or fraction) that the asterisk that refers to the statement cholesterol was reduced are declared in below the list of ingredients, which immediate proximity to the most states ‘‘adds a trivial amount of choles- prominent such claim (e.g., ‘‘cholesterol,’’ ‘‘adds a negligible amount of terol-free margarine, contains 100 per- cholesterol,’’ or ‘‘adds a dietarily insig- cent less cholesterol than butter’’); and nificant amount of cholesterol;’’ and (2) Quantitative information com- (C) The food contains 2 g or less of paring the level of cholesterol in the saturated fatty acids per reference product per labeled serving with that amount cutomarily consumed or, in of the reference food that it replaces the case of a meal product or main dish (e.g., ‘‘Contains no cholesterol com- product less than 2 g of saturated fatty pared with 30 mg cholesterol in one acids per labeled serving; and serving of butter. Contains 13 g of fat (D) The label or labeling discloses the per serving.’’) is declared adjacent to level of total fat in a serving (as de- the most prominent claim or to the nu- clared on the label) of the food. Such trition label, except that if the nutri- disclosure shall appear in immediate tion label is on the information panel, proximity to such claim preceding any the quantitative information may be disclosure statement required under located elsewhere on the information § 101.13(h) in type that shall be no less panel in accordance with § 101.2. than one-half the size of the type used (2) The terms ‘‘low in cholesterol,’’ for such claim. If the claim appears on ‘‘low cholesterol,’’ ‘‘contains a small more than one panel, the disclosure amount of cholesterol,’’ ‘‘low source of

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cholesterol,’’ or ‘‘little cholesterol’’ ation, formulation, or reformulation to may be used on the label or in the la- lower cholesterol content, it is labeled beling of foods, except meal products to clearly refer to all foods of that type as defined in § 101.13(l) and main dish and not merely to the particular brand products as defined in § 101.13(m), pro- to which the label attaches (e.g., ‘‘low vided that: fat cottage cheese, a low cholesterol (i) For foods that have a reference food’’). amount customarily consumed greater (iii) For foods that have a reference than 30 g or greater than 2 tablespoons amount customarily consumed greater and contain 13 g or less of total fat per than 30 g or greater than 2 tablespoons reference amount customarily con- and contain more than 13 g of total fat sumed and per labeled serving: per reference amount customarily con- (A) The food contains 20 mg or less of sumed or per labeled serving, cholesterol per reference amount cus- (A) The food contains 20 mg or less of tomarily consumed; cholesterol per reference amount cus- (B) The food contains 2 g or less of tomarily consumed; saturated fatty acids per reference (B) The food contains 2 g or less of amount customarily consumed; and saturated fatty acids per reference (C) As required in § 101.13(e)(2), if the amount customarily consumed; food meets these conditions without (C) The label or labeling discloses the the benefit of special processing, alter- level of total fat in a serving (as de- ation, formulation, or reformulation to clared on the label) of the food. Such lower cholesterol content, it is labeled to clearly refer to all foods of that type disclosure shall appear in immediate and not merely to the particular brand proximity to such claim preceding any to which the label attaches (e.g., ‘‘low disclosure statement required under fat cottage cheese, a low cholesterol § 101.13(h) in type that shall be no less food.’’). than one-half the size of the type used (ii) For foods that have a reference for such claim. If the claim appears on amount customarily consumed of 30 g more than one panel, the disclosure or less or 2 tablespoons or less and con- shall be made on each panel except for tain 13 g or less of total fat per ref- the panel that bears nutrition labeling. erence amount customarily consumed, If the claim is made more than once on per labeled serving, and per 50 g (for de- a panel, the disclosure shall be made in hydrated foods that must be reconsti- immediate proximity to the claim that tuted before typical consumption with is printed in the largest type; and water or a diluent containing an insig- (D) As required in § 101.13(e)(2), if the nificant amount, as defined in food meets these conditions without § 101.9(f)(1), of all nutrients per ref- the benefit of special processing, alter- erence amount customarily consumed, ation, formulation, or reformulation to the per 50-g criterion refers to the ‘‘as lower cholesterol content, it is labeled prepared’’ form); to clearly refer to all foods of that type (A) The food contains 20 mg or less of and not merely to the particular brand cholesterol per reference amount cus- to which the label attaches; or tomarily consumed and per 50 g (for de- (E) If the food contains 20 mg or less hydrated foods that must be reconsti- of cholesterol only as a result of spe- tuted before typical consumption with cial processing, alteration, formula- water or a diluent containing an insig- tion, or reformulation, the amount of nificant amount, as defined in cholesterol is substantially less (i.e., § 101.9(f)(1), of all nutrients per ref- meets requirements of paragraph erence amount customarily consumed, (d)(4)(ii)(A) of this section) than the the per 50-g criterion refers to the ‘‘as food for which it substitutes as speci- prepared’’ form); fied in § 101.13(d) that has a significant (B) The food contains 2 g or less of (e.g., 5 percent or more of a national or saturated fatty acids per reference regional market) market share. As re- amount customarily consumed; and quired in § 101.13(j)(2) for relative (C) As required in § 101.13(e)(2), if the claims: food meets these conditions without (1) The identity of the reference food the benefit of special processing, alter- and the percent (or fraction) that the

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cholesterol has been reduced are de- the panel that bears nutrition labeling. clared in immediate proximity to the If the claim is made more than once on most prominent such claim (e.g., ‘‘low- a panel, the disclosure shall be made in cholesterol peanut butter sandwich immediate proximity to the claim that crackers, contains 83 percent less cho- is printed in the largest type; and lesterol than our regular peanut butter (D) As required in § 101.13(e)(2), if the sandwich crackers’’); and food meets these conditions without (2) Quantitative information com- the benefit of special processing, alter- paring the level of cholesterol in the ation, formulation, or reformulation to product per labeled serving with that lower cholesterol content, it is labeled of the reference food that it replaces to clearly refer to all foods of that type (e.g., ‘‘Cholesterol lowered from 30 mg and not merely to the particular brand to 5 mg per serving; contains 13 g of fat to which the label attaches; or per serving.’’) is declared adjacent to (E) If the food contains 20 mg or less the most prominent claim or to the nu- of cholesterol only as a result of spe- trition label, except that if the nutri- cial processing, alteration, formulation label is on the information panel, tion, or reformulation, the amount of the quantitative information may be cholesterol is substantially less (i.e., located elsewhere on the information meets requirements of paragraph panel in accordance with § 101.2. (d)(4)(ii)(A) of this section) than the (iv) For foods that have a reference food for which it substitutes as speci- amount customarily consumed of 30 g fied in § 101.13(d) that has a significant or less or 2 tablespoons or less and con- (i.e., 5 percent or more of a national or tain more than 13 g of total fat per ref- regional market) market share. As re- erence amount customarily consumed, quired in § 101.13(j)(2) for relative per labeled serving, or per 50 g (for de- claims: hydrated foods that must be reconsti- (1) The identity of the reference food tuted before typical consumption with and the percent (or fraction) that the water or a diluent containing an insig- cholesterol has been reduced are de- nificant amount, as defined in clared in immediate proximity to the § 101.9(f)(1), of all nutrients per ref- most prominent such claim (e.g., ‘‘low- erence amount customarily consumed, cholesterol peanut butter sandwich the per 50-g criterion refers to the ‘‘as crackers, contains 83 percent less cho- prepared’’ form), lesterol than our regular peanut butter (A) The food contains 20 mg or less of sandwich crackers’’); and cholesterol per reference amount cus- (2) Quantitative information com- tomarily consumed and per 50 g (for de- paring the level of cholesterol in the hydrated foods that must be reconsti- product per labeled serving with that tuted before typical consumption with of the reference food that it replaces water or a diluent containing an insig- (e.g., ‘‘Cholesterol lowered from 30 mg nificant amount, as defined in to 5 mg per serving; contains 13 g of fat § 101.9(f)(1), of all nutrients per ref- per serving.’’) is declared adjacent to erence amount customarily consumed, the most prominent claim or to the nu- the per 50-g criterion refers to the ‘‘as trition label, except that if the nutri- prepared’’ form), tion label is on the information panel, (B) The food contains 2 g or less of the quantitative information may be saturated fatty acids per reference located elsewhere on the information amount customarily consumed; panel in accordance with § 101.2. (C) The label or labeling discloses the (3) The terms defined in paragraph level of total fat in a serving (as de- (d)(2) of this section may be used on clared on the label) of the food. Such the label and in labeling of meal prod- disclosure shall appear in immediate ucts as defined in § 101.13(l) or a main proximity to such claim preceding any dish product as defined in § 101.13(m) disclosure statement required under provided that the product meets the re- § 101.13(h) in type that shall be no less quirements of paragraph (d)(2) of this than one-half the size of the type used section except that the determination for such claim. If the claim appears on as to whether paragraph (d)(2)(i) or more than one panel, the disclosure (d)(2)(iii) of this section applies to the shall be made on each panel except for product will be made only on the basis

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of whether the meal product contains product per labeled serving with that 26 g or less of total fat per labeled serv- of the reference food that it replaces ing or the main dish product contain (e.g., ‘‘[labeled product] 50 mg choles- 19.5 g or less of total fat per labeled terol per serving; [reference product] 30 serving, the requirement in paragraphs mg cholesterol per serving’’) is de- (d)(2)(i)(A) and (d)(2)(iii)(A) of this sec- clared adjacent to the most prominent tion shall be limited to 20 mg of choles- claim or to the nutrition label, except terol per 100 g, and the requirement in that if the nutrition label is on the in- paragraphs (d)(2)(i)(B) and (d)(2)(iii)(B) formation panel, the quantitative in- of this section shall be modified to re- formation may be located elsewhere on quire that the food contain 2 g or less the information panel in accordance of saturated fat per 100 g rather than with § 101.2. per reference amount customarily con- (ii) For foods that contain more than sumed. 13 g of total fat per reference amount (4) The terms ‘‘reduced cholesterol,’’ customarily consumed, per labeled ‘‘reduced in cholesterol,’’ ‘‘cholesterol serving, or per 50 g if the reference reduced,’’ ‘‘less cholesterol,’’ ‘‘lower amount customarily consumed is 30 g cholesterol,’’ or ‘‘lower in cholesterol’’ or less or 2 tablespoons or less (for de- except as limited by § 101.13(j)(1)(i) may hydrated foods that must be reconsti- be used on the label or in labeling of tuted before typical consumption with foods or foods that substitute for those water or a diluent containing an insig- foods as specified in § 101.13(d), exclud- nificant amount, as defined in ing meal products as defined in § 101.9(f)(1), of all nutrients per ref- § 101.13(l) and main dish products as de- erence amount customarily consumed, fined in § 101.13(m), provided that: the per 50-g criterion refers to the ‘‘as (i) For foods that contain 13 g or less prepared’’ form): of total fat per reference amount cus- (A) The food has been specifically tomarily consumed, per labeled serv- formulated, altered, or processed to re- ing, and per 50 g if the reference duce its cholesterol by 25 percent or amount customarily consumed is 30 g more from the reference food it resem- or less or 2 tablespoons or less (for de- bles as defined in § 101.13(j)(1) and for hydrated foods that must be reconsti- which it substitutes as specified in tuted before typical consumption with § 101.13(d) that has a significant (i.e., 5 water or a diluent containing an insig- percent or more of a national or re- nificant amount, as defined in gional market) market share; § 101.9(f)(1), of all nutrients per reference amount customarily consumed, (B) The food contains 2 g or less of the per 50-g criterion refers to the ‘‘as saturated fatty acids per reference prepared’’ form): amount customarily consumed; (A) The food has been specifically (C) The label or labeling discloses the formulated, altered, or processed to re- level of total fat in a serving (as de- duce its cholesterol by 25 percent or clared on the label) of the food. Such more from the reference food it resem- disclosure shall appear in immediate bles as defined in § 101.13(j)(1) and for proximity to such claim preceding any which it substitutes as specified in disclosure statement required under § 101.13(d) that has a significant (i.e., 5 § 101.13(h) in type that shall be no less percent or more) market share; and than one-half the size of the type used (B) The food contains 2 g or less of for such claim. If the claim appears on saturated fatty acids per reference more than one panel, the disclosure amount customarily consumed; and shall be made on each panel except for (C) As required in § 101.13(j)(2) for rel- the panel that bears nutrition labeling. ative claims: If the claim is made more than once on (1) The identity of the reference food a panel, the disclosure shall be made in and the percent (or fraction) that the immediate proximity to the claim that cholesterol has been reduced are de- is printed in the largest type; and clared in immediate proximity to the (D) As required in § 101.13(j)(2) for rel- most prominent such claim; and ative claims: (2) Quantitative information com- (1) The identity of the reference food paring the level of cholesterol in the and the percent (or fraction) that the

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cholesterol has been reduced are de- (e.g., ‘‘Cholesterol content has been re- clared in immediate proximity to the duced from 35 mg per 3 oz to 25 mg per most prominent such claim (e.g., 25 3 oz.’’) is declared adjacent to the most percent less cholesterol than lll); prominent claim or to the nutrition and label, except that if the nutrition label (2) Quantitative information com- is on the information panel, the quan- paring the level of cholesterol in the titative information may be located product per labeled serving with that elsewhere on the information panel in of the reference food that it replaces accordance with § 101.2. (e.g., ‘‘Cholesterol lowered from 55 mg (ii) For meal products that contain to 30 mg per serving. Contains 13 g of more than 26.0 g of total fat per labeled fat per serving.’’) is declared adjacent serving or for main dish products that to the most prominent claim or to the contain more than 19.5 g of total fat nutrition label, except that if the nu- per labeled serving: trition label is on the information (A) The food has been specifically panel, the quantitative information formulated, altered, or processed to re- may be located elsewhere on the infor- duce its cholesterol by 25 percent or mation panel in accordance with § 101.2. more from the reference food it resem- (iii) Claims described in paragraph bles as defined in § 101.13(j)(1) and for (d)(4) of this section may not be made which it substitutes as specified in on the label or in labeling of a food if § 101.13(d) that has a significant (e.g., 5 the nutrient content of the reference percent or more of a national or re- food meets the definition for ‘‘low cho- gional market) market share. lesterol.’’ (B) The food contains 2 g or less of (5) The terms defined in paragraph saturated fatty acids per 100 g; (d)(4) of this section may be used on the label or in the labeling of meal (C) The label or labeling discloses the products as defined in § 101.13(l) and level of total fat in a serving (as de- main dish products as defined in clared on the label) of the food. Such § 101.13(m), provided that: disclosure shall appear in immediate (i) For meal products that contain proximity to such claim preceding any 26.0 g or less of total fat per labeled disclosure statement required under serving or for main dish products that § 101.13(h) in type that shall be no less contain 19.5 g or less of total fat per la- than one-half the size of the type used beled serving; for such claim. If the claim appears on (A) The food has been specifically more than one panel the disclosure formulated, altered, or processed to re- shall be made on each panel except for duce its cholesterol by 25 percent or the panel that bears nutrition labeling. more from the reference food it resem- If the claim is made more than once on bles as defined in § 101.13(j)(1) and for a panel, the disclosure shall be made in which it substitutes as specified in immediate proximity to the claim that § 101.13(d) that has a significant (e.g., 5 is printed in the largest type; and percent or more of a national or re- (D) As required in § 101.13(j)(2) for rel- gional market) market share; ative claims: (B) The food contains 2 g or less of (1) The identity of the reference food saturated fatty acids per 100 g; and and the percent (or fraction) that the (C) As required in § 101.13(j)(2) for rel- cholesterol has been reduced are de- ative claims: clared in immediate proximity to the (1) The identity of the reference food, most prominent such claim (e.g., 25 and the percent (or fraction) that the percent less cholesterol than lll); cholesterol has been reduced are de- and clared in immediate proximity to the (2) Quantitative information com- most prominent such claim (e.g., ‘‘25% paring the level of cholesterol in the less cholesterol per 3 oz than lll); product per specified weight with that and of the reference food that it replaces (2) Quantitative information com- (e.g., ‘‘Cholesterol lowered from 30 mg paring the level of cholesterol in the to 22 mg per 3 oz of product.’’) is de- product per specified weight with that clared adjacent to the most prominent of the reference food that it replaces claim or to the nutrition label, except

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that if the nutrition label is on the in- less than 95 mg of cholesterol per 100 g formation panel, the quantitative in- and per labeled serving. formation may be located elsewhere on (f) Misbranding. Any label or labeling the information panel in accordance containing any statement concerning with § 101.2. fat, fatty acids, or cholesterol that is (iii) Claims described in paragraph not in conformity with this section (d)(5) of this section may not be made shall be deemed to be misbranded on the label or in the labeling of a food under sections 201(n), 403(a), and 403(r) if the nutrient content of the reference of the Federal Food, Drug, and Cos- food meets the definition for ‘‘low cho- metic Act. lesterol.’’ [58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, (e) ‘‘Lean’’ and ‘‘extra lean’’ claims. (1) Apr. 2, 1993, as amended at 58 FR 44032, Aug. The term ‘‘lean’’ may be used on the 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394, label or in labeling of foods except Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR meal products as defined in § 101.13(l) 59001, Nov. 20, 1996; 63 FR 26980, May 15, 1998; and main dish products as defined in 72 FR 1459, Jan. 12, 2007] § 101.13(m) provided that the food is a seafood or game meat product and as § 101.65 Implied nutrient content packaged contains less than 10 g total claims and related label statements. fat, 4.5 g or less saturated fat, and less (a) General requirements. An implied than 95 mg cholesterol per reference nutrient content claim can only be amount customarily consumed and per made on the label and in labeling of the 100 g; food if: (2) The term defined in paragraph (1) The claim uses one of the terms (e)(1) of this section may be used on the described in this section in accordance label or in labeling of a mixed dish not with the definition for that term; measurable with a cup as defined in (2) The claim is made in accordance § 101.12(b) in table 2, provided that the with the general requirements for nu- food contains less than 8 g total fat, 3.5 trient content claims in § 101.13; and g or less saturated fat and less than 80 (3) The food for which the claim is mg cholesterol per reference amount made is labeled in accordance with customarily consumed; § 101.9, § 101.10, or § 101.36, as applicable. (3) The term defined in paragraph (b) Label statements that are not im- (e)(1) of this section may be used on the plied claims. Certain label statements label or in the labeling of meal prod- about the nature of a product are not ucts as defined in § 101.13(l) or main nutrient content claims unless such dish products as defined in § 101.13(m) statements are made in a context that provided that the food contains less would make them an implied claim than 10 g total fat, 4.5 g or less satu- under § 101.13(b)(2). The following types rated fat, and less than 95 mg choles- of label statements are generally not terol per 100 g and per labeled serving; implied nutrient content claims and, as (4) The term ‘‘extra lean’’ may be such, are not subject to the require- used on the label or in the labeling of ments of § 101.13 and this section: foods except meal products as defined (1) A claim that a specific ingredient in § 101.13(l) and main dish products as or food component is absent from a defined in § 101.13(m) provided that the product, provided that the purpose of food is a discrete seafood or game meat such claim is to facilitate avoidance of product and as packaged contains less the substances because of food allergies than 5 g total fat, less than 2 g satu- (see § 105.62 of this chapter), food intol- rated fat, and less than 95 mg choles- erance, religious beliefs, or dietary terol per reference amount customarily practices such as vegetarianism or consumed and per 100 g; and other nonnutrition related reason, e.g., (5) The term defined in paragraph ‘‘100 percent milk free;’’ (e)(4) of this section may be used on the (2) A claim about a substance that is label or in labeling of meal products as nonnutritive or that does not have a defined in § 101.13(l) and main dish prod- nutritive function, e.g., ‘‘contains no ucts as defined in § 101.13(m) provided preservatives,’’ ‘‘no artificial colors;’’ that the food contains less than 5 g of (3) A claim about the presence of an fat, less than 2 g of saturated fat, and ingredient that is perceived to add

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value to the product, e.g., ‘‘made with enough to qualify that food as a ‘‘good real butter,’’ ‘‘made with whole fruit,’’ source’’ of that nutrient, and the la- or ‘‘contains honey,’’ except that beled food, on a per serving basis, is an claims about the presence of ingredi- equivalent, good source of that nutrients other than vitamins or minerals ent (e.g., ‘‘as much fiber as an apple,’’ or that are represented as a source of ‘‘Contains the same amount of Vitamin vitamins and minerals are not allowed C as an 8 oz glass of orange juice.’’). on labels or in labeling of dietary sup- (3) Claims may be made that a food plements of vitamins and minerals that contains or is made with an ingredient are not in conventional food form. that is known to contain a particular (4) A statement of identity for a food nutrient, or is prepared in a way that in which an ingredient constitutes es- affects the content of a particular nu- sentially 100 percent of a food (e.g., trient in the food, if the finished food is ‘‘corn oil,’’ ‘‘oat bran,’’ ‘‘dietary sup- either ‘‘low’’ in or a ‘‘good source’’ of plement of vitamin C 60 mg tablet’’). the nutrient that is associated with the (5) A statement of identity that ingredient or type of preparation. If a names as a characterizing ingredient, more specific level is claimed (e.g., an ingredient associated with a nutri- ‘‘high in lll), that level of the nutrient benefit (e.g., ‘‘corn oil margarine,’’ ent must be present in the food. For ex- ‘‘oat bran muffins,’’ or ‘‘whole wheat ample, a claim that a food contains oat bagels’’), unless such claim is made in bran is a claim that it is a good source a context in which label or labeling of dietary fiber; that a food is made statements, symbols, vignettes, or only with vegetable oil is a claim that other forms of communication suggest it is low in saturated fat; and that a that a nutrient is absent or present in food contains no oil is a claim that it a certain amount; and is fat free. (6) A label statement made in compli- (d) General nutritional claims. (1) This ance with a specific provision of part paragraph covers labeling claims that 105 of this chapter, solely to note that are implied nutrient content claims be- a food has special dietary usefulness cause they: relative to a physical, physiological, (i) Suggest that a food because of its pathological, or other condition, where nutrient content may help consumers the claim identifies the special diet of maintain healthy dietary practices; which the food is intended to be a part. and (c) Particular implied nutrient content (ii) Are made in connection with an claims. (1) Claims about the food or an explicit or implicit claim or statement ingredient therein that suggest that a about a nutrient (e.g., ‘‘healthy, con- nutrient or an ingredient is absent or tains 3 grams of fat’’). present in a certain amount (e.g., (2) You may use the term ‘‘healthy’’ ‘‘high in oat bran’’) are implied nutri- or related terms (e.g., ‘‘health,’’ ent content claims and must comply ‘‘healthful,’’ ‘‘healthfully,’’ ‘‘health- with paragraph (a) of this section. fulness,’’ ‘‘healthier,’’ ‘‘healthiest,’’ (2) The phrases ‘‘contains the same ‘‘healthily,’’ and ‘‘healthiness’’) as an amount of [nutrient] as a [food]’’ and implied nutrient content claim on the ‘‘as much [nutrient] as a [food]’’ may label or in labeling of a food that is be used on the label or in the labeling useful in creating a diet that is con- of foods, provided that the amount of sistent with dietary recommendations the nutrient in the reference food is if:

(i) The food meets the following conditions for fat, saturated fat, cholesterol, and other nutrients:

If the food is... The fat level must The saturated fat The cholesterol level The food must con- be... level must be... must be... tain...

(A) A raw fruit or vegetable Low fat as defined Low saturated fat as The disclosure level N/A in § 101.62(b)(2) defined in for cholesterol § 101.62(c)(2) specified in § 101.13(h) or less

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The fat level must The saturated fat The cholesterol level The food must con- If the food is... be... level must be... must be... tain...

(B) A single-ingredient or a mix- Low fat as defined Low saturated fat as The disclosure level N/A ture of frozen or canned fruits in § 101.62(b)(2) defined in for cholesterol and vegetables1 § 101.62(c)(2) specified in § 101.13(h) or less

(C) An enriched cereal-grain Low fat as defined Low saturated fat as The disclosure level N/A product that conforms to a in § 101.62(b)(2) defined in for cholesterol standard of identity in part 136, § 101.62(c)(2) specified in 137 or 139 of this chapter § 101.13(h) or less

(D) A raw, single-ingredient sea- Less than 5 grams Less than 2 g satu- Less than 95 mg At least 10 percent food or game meat (g) total fat per rated fat per RA cholesterol per RA of the RDI3 or the RA2 and per 100 and per 100 g and per 100 g DRV4 per RA of g one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber

(E) A meal product as defined in Low fat as defined Low saturated fat as 90 mg or less cho- At least 10 percent § 101.13(l) or a main dish prod- in § 101.62(b)(3) defined in lesterol per LS5 of the RDI or DRV uct as defined in § 101.13(m) § 101.62(c)(3) per LS of two nutrients (for a main dish product) or of three nutrients (for a meal product) of: vitamin A, vitamin C, calcium, iron, protein, or fiber

(F) A food not specifically listed in Low fat as defined Low saturated fat as The disclosure level At least 10 percent this table in § 101.62(b)(2) defined in for cholesterol of the RDI or the § 101.62(c)(2) specified in DRV per RA of § 101.13(h) or less one or more of vitamin A, vitamin C, calcium, iron, protein or fiber 1 May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable. 2 RA means Reference Amount Customarily Consumed per Eating Occasion (§ 101.12(b)). 3 RDI means Reference Daily Intake (§ 101.9(c)(8)(iv)). 4 DRV means Daily Reference Value (§ 101.9(c)(9)). 5 LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (§ 101.9(b)).

(ii) The food meets the following con- (iv) If you add a nutrient to the food ditions for sodium: specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section If the food is... The sodium level must be... to meet the 10 percent requirement, (A) A food with a RA that is 480 mg or less sodium per that addition must be in accordance greater than 30 g or 2 ta- RA and per LS with the fortification policy for foods blespoons (tbsp.) in § 104.20 of this chapter. (B) A food with a RA that is 480 mg or less sodium per equal to or less than 30 g 50 g1 [58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, or 2 tbsp. 1993, as amended at 59 FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, (C) A meal product as defined 600 mg or less sodium per in § 101.13(l) or a main dish LS 1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, product as defined in Mar. 25, 1998; 70 FR 56848, Sept. 29, 2005] § 101.13(m) 1 For dehydrated food that is typically reconstituted with § 101.67 Use of nutrient content claims water or a liquid that contains insignificant amounts per RA of for butter. all nutrients (as defined in § 101.9(f)(1)), the 50 g refers to the ‘‘prepared’’ form of the product. (a) Claims may be made to charac- (iii) The food complies with the defi- terize the level of nutrients, including nition and declaration requirements in fat, in butter if: this part 101 for any specific nutrient (1) The claim complies with the re- content claim on the label or in label- quirements of § 101.13 and with the re- ing, and quirements of the regulations in this

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subpart that define the particular nu- with the requirements of § 101.13(d). trient content claim that is used and The modified product shall perform at how it is to be presented. In deter- least one of the principal functions of mining whether a claim is appropriate, butter substantially as well as butter the calculation of the percent fat reas produced under 21 U.S.C. 321a. duction in milkfat shall be based on (c)(1) Each of the ingredients used in the 80 percent milkfat requirement the food shall be declared on the label provided by the statutory standard for as required by the applicable sections butter (21 U.S.C. 321a); of this part. (2) The product contains cream or (2) Safe and suitable ingredients milk, including milk constituents (in- added to improve texture, prevent syn- cluding, but not limited to, whey, ca- eresis, add flavor, extend shelf life, im- sein, modified whey, and salts of ca- prove appearance, or add sweetness and sein), or both, with or without added water added to replace milkfat shall be salt, with or without safe and suitable identified with an asterisk in the ingre- colorings, with or without nutrients dient statement. The statement added to comply with paragraph (a)(3) ‘‘*Ingredients not in regular butter’’ of this section, and with or without shall immediately follow the ingre- safe and suitable bacterial cultures. dient statement in the same type size. The product may contain safe and suit- [58 FR 2455, Jan. 6, 1993] able ingredients to improve texture, prevent syneresis, add flavor, extend § 101.69 Petitions for nutrient content shelf life, improve appearance, and add claims. sweetness. The product may contain (a) This section pertains to petitions water to replace milkfat although the for claims, expressed or implied, that: amount of water in the product shall (1) Characterize the level of any nu- be less than the amount of cream, trient which is of the type required to milk, or milk constituents; be in the label or labeling of food by (3) The product is not nutritionally section 403(q)(1) or (q)(2) of the Federal inferior, as defined in § 101.3(e)(4), to Food, Drug, and Cosmetic Act (the butter as produced under 21 U.S.C. 321a; act); and and (2) That are not exempted under sec- (4) If the product would violate 21 tion 403(r)(5)(A) through (r)(5)(C) of the U.S.C. 321a but for the nutrient content act from the requirements for such claim that characterizes the level of claims in section 403(r)(2). nutrients, that claim shall be an ex- (b) Petitions included in this section plicit claim that is included as part of are: the common or usual name of the prod- (1) Petitions for a new (heretofore un- uct. authorized) nutrient content claim; (b) Deviations from the ingredient (2) Petitions for a synonymous term provisions of 21 U.S.C. 321a must be the (i.e., one that is consistent with a term minimum necessary to achieve similar defined by regulation) for character- performance characteristics as butter izing the level of a nutrient; and as produced under 21 U.S.C. 321a, or the (3) Petitions for the use of an implied food will be deemed to be adulterated claim in a brand name. under section 402(b) of the act. The per- (c) An original and one copy of the formance characteristics (e.g., physical petition to be filed under the provi- properties, organoleptic characteris- sions of section 403(r)(4) of the act shall tics, functional properties, shelf life) of be submitted, or the petitioner may the product shall be similar to butter submit an original and a computer as produced under 21 U.S.C. 321a. If readable disk containing the petition. there is a significant difference in per- Contents of the disk should be in a formance characteristics (that materi- standard format, such as ASCII format. ally limits the uses of the product com- Petitioners interested in submitting a pared to butter,) the label shall include disk should contact the Food and Drug a statement informing the consumer of Administration’s (FDA) Center for such difference (e.g., if appropriate, Food Safety and Applied Nutrition for ‘‘not recommended for baking pur- details. If any part of the material sub- poses’’). Such statement shall comply mitted is in a foreign language, it shall

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be accompanied by an accurate and 25.32 of this chapter or an environ- complete English translation. The peti- mental assessment under § 25.40 of this tion shall state the petitioner’s post of- chapter. fice address to which published notices (i) The data specified under the sev- as required by section 403 of the act eral lettered headings should be sub- may be sent. mitted on separate sheets or sets of (d) Pertinent information may be in- sheets, suitably identified. If such data corporated in, and will be considered as have already been submitted with an part of, a petition on the basis of spe- earlier application from the petitioner, cific reference to such information sub- the present petition may incorporate it mitted to and retained in the files of by specific reference to the earlier peti- FDA. However, any reference to unpub- tion. lished information furnished by a per- (j) The petition must be signed by the son other than the applicant will not petitioner or by his attorney or agent, be considered unless use of such infor- or (if a corporation) by an authorized mation is authorized (with the under- official. standing that such information may in (k) The petition shall include a state- whole or part be subject to release to ment signed by the person responsible the public) in a written statement for the petition, that to the best of his signed by the person who submitted it. knowledge, it is a representative and Any reference to published information balanced submission that includes un- should be accompanied by reprints or favorable information, as well as favor- photostatic copies of such references. able information, known to him perti- (e) If nonclinical laboratory studies nent to the evaluation of the petition. are included in a petition submitted (l) All applicable provisions of part under section 403(r)(4) of the act, the 10—Administrative Practices and Pro- petition shall include, with respect to cedures, may be used by FDA, the peti- each nonclinical study contained in the tioner or any outside party with re- petition, either a statement that the spect to any agency action on the peti- study has been, or will be, conducted in tion. compliance with the good laboratory (m)(1) Petitions for a new nutrient practice regulations as set forth in part content claim shall include the fol- 58 of this chapter or, if any such study lowing data and be submitted in the was not conducted in compliance with following form. such regulations, a brief statement of (Date) llllll the reason for the noncompliance. Name of petitioner llllll (f) If clinical investigations are in- Post office address llllll cluded in a petition submitted under Subject of the petition llllll section 403(r)(4) of the act, the petition Office of Nutritional Products, Labeling and shall include a statement regarding Dietary Supplements (HFS–800) Food and Drug Administration, each such clinical investigation relied Department of Health and Human Services, upon in the petition that the study ei- Washington, DC 20204. ther was conducted in compliance with To Whom It May Concern: the requirements for institutional re- The undersigned, llllllllllll view set forth in part 56 of this chapter submits this petition under section 403(r)(4) or was not subject to such require- of the Federal Food, Drug, and Cosmetic Act ments in accordance with § 56.104 or (the act) with respect to (statement of the claim and its proposed use). § 56.105 of this chapter, and that it was Attached hereto and constituting a part of conducted in compliance with the re- this petition, are the following: quirements for informed consent set A. A statement identifying the descriptive forth in part 50 of this chapter. term and the nutrient that the term is in- (g) The availability for public disclo- tended to characterize with respect to the sure of petitions submitted to the level of such nutrient. The statement should agency under this section will be gov- address why the use of the term as proposed erned by the rules specified in § 10.20(j) will not be misleading. The statement should provide examples of the nutrient content of this chapter. claim as it will be used on labels or labeling, (h) All petitions submitted under this as well as the types of foods on which the section shall include either a claim for claim will be used. The statement shall a categorical exclusion under § 25.30 or specify the level at which the nutrient must

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be present or what other conditions con- number will be assigned to the peti- cerning the food must be met for the use of tion), and the petitioner will subse- the term in labels or labeling to be appro- quently be notified of the agency’s de- priate, as well as any factors that would make the use of the term inappropriate. cision to file or deny the petition; or B. A detailed explanation, supported by (ii) That the petition is incomplete, any necessary data, of why use of the food e.g., it lacks any of the data required component characterized by the claim is of by this part, it presents such data in a importance in human nutrition by virtue of manner that is not readily understood, its presence or absence at the levels that or it has not been submitted in quadru- such claim would describe. This explanation shall also state what nutritional benefit to plicate, in which case the petition will the public will derive from use of the claim be denied, and the petitioner will be as proposed, and why such benefit is not notified as to what respect the petition available through the use of existing terms is incomplete. defined by regulation under section (3) Within 100 days of the date of re- 403(r)(2)(A)(i) of the act. If the claim is in- ceipt of the petition, FDA will notify tended for a specific group within the population, the analysis should specifically ad- the petitioner by letter that the peti- dress nutritional needs of such group, and tion has either been filed or denied. If should include scientific data sufficient for denied, the notification shall state the such purpose. reasons therefor. If filed, the date of C. Analytical data that shows the amount the notification letter becomes the of the nutrient that is the subject of the date of filing for the purposes of sec- claim and that is present in the types of foods for which the claim is intended. The tion 403(r)(4)(A)(i) of the act. If FDA assays should be performed on representative does not act within such 100 days, the samples using the AOAC INTERNATIONAL petition shall be deemed to be denied (AOAC International) methods where avail- unless an extension is mutually agreed able. If no AOAC International method is upon by the FDA and the petitioner. A available, the petitioner shall submit the petition that has been denied, or has assay method used, and data establishing the validity of the method for assaying the nu- been deemed to be denied, without fil- trient in the particular food. The validation ing shall not be made available to the data should include a statistical analysis of public. A filed petition shall be avail- the analytical and product variability. able to the public as provided under D. A detailed analysis of the potential ef- paragraph (g) of this section. fect of the use of the proposed claim on food (4) Within 90 days of the date of filing consumption and of any corresponding changes in nutrient intake. The latter item FDA will by letter of notification to shall specifically address the intake of nutri- the petitioner: ents that have beneficial and negative con- (i) Deny the petition; or sequences in the total diet. If the claim is in- (ii) Inform the petitioner that a pro- tended for a specific group within the popu- posed regulation to provide for the relation, the above analysis shall specifically quested use of the new term will be address the dietary practices of such group and shall include data sufficient to dem- published in the FEDERAL REGISTER. onstrate that the dietary analysis is rep- FDA will publish the proposal to resentative of such group. amend the regulations to provide for E. The petitioner is required to submit ei- the requested use of the nutrient con- ther a claim for categorical exclusion under tent claim in the FEDERAL REGISTER § 25.30 or § 25.32 of this chapter or an environ- within 90 days of the date of filing. The mental assessment under § 25.40 of this chapter. proposal will also announce the avail- Yours very truly, ability of the petition for public disclo- Petitioner llllll sure. By llllll (iii) If FDA does not act within 90 (Indicate authority) days of the date of filing, the petition (2) Within 15 days of receipt of the pe- shall be deemed to be denied unless an tition, the petitioner will be notified extension is mutually agreed upon by by letter of the date on which the peti- FDA and the petitioner. tion was received by the agency. Such (5) If FDA issues a proposal, the rule- notice will inform the petitioner: making shall be completed within 540 (i) That the petition is undergoing days of the date of receipt of the peti- agency review (in which case a docket tion.

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(n)(1) Petitions for a synonymous (2) Within 15 days of receipt of the pe- term shall include the following data tition the petitioner will be notified by and be submitted in the following form. letter of the date on which the petition was received. Such notice will inform (Date)llllll Name of petitioner llllll the petitioner: Post office address llllll (i) That the petition is undergoing Subject of the petition llllll agency review (in which case a docket Office of Nutritional Products, Labeling and number will be assigned to the peti- Dietary Supplements (HFS–800) tion) and the petitioner will subse- Food and Drug Administration, quently be notified of the agency’s de- Department of Health and Human Services, cision to grant the petitioner permis- Washington, DC 20204. To Whom It May Concern: sion to use the proposed term or to The undersigned, llllll submits this deny the petition; or petition under section 403(r)(4) of the Federal (ii) That the petition is incomplete, Food, Drug, and Cosmetic Act (the act) with e.g., it lacks any of the data required respect to (statement of the synonymous by this part, it presents such data in a term and its proposed use in a nutrient con- manner that is not readily understood, tent claim that is consistent with an exist- or it has not been submitted in quadru- ing term that has been defined under section 403(r)(2) of the act). plicate, in which case the petition will Attached hereto and constituting a part of be denied, and the petitioner will be this petition, are the following: notified as to what respect the petition A. A statement identifying the synony- is incomplete. mous descriptive term, the existing term de- (3) Within 90 days of the date of refined by a regulation under section ceipt of the petition that is accepted 403(r)(2)(A)(i) of the act with which the syn- for review (i.e., that has not been found onymous term is claimed to be consistent. to be incomplete and consequently de- The statement should address why the proposed synonymous term is consistent with nied, FDA will notify the petitioner by the term already defined by the agency, and letter of the agency’s decision to grant why the use of the synonymous term as pro- the petitioner permission to use the posed will not be misleading. The statement proposed term, with any conditions or should provide examples of the nutrient con- limitations on such use specified, or to tent claim as it will be used on labels or la- deny the petition, in which case the beling, as well as the types of foods on which letter shall state the reasons therefor. the claim will be used. The statement shall Failure of the petition to fully address specify whether any limitations not applicable to the use of the defined term are in- the requirements of this section shall tended to apply to the use of the synony- be grounds for denial of the petition. mous term. (4) As soon as practicable following B. A detailed explanation, supported by the agency’s decision to either grant or any necessary data, of why use of the pro- deny the petition, FDA will publish a posed term is requested, including an expla- notice in the FEDERAL REGISTER in- nation of whether the existing defined term forming the public of his decision. If is inadequate for the purpose of effectively the petition is granted the Food and characterizing the level of a nutrient. This item shall also state what nutritional ben- Drug Administration will list, the ap- efit to the public will derive from use of the proved synonymous term in the regula- claim as proposed, and why such benefit is tions listing terms permitted for use in not available through the use of existing nutrient content claims. term defined by regulation. If the claim is (o)(1) Petitions for the use of an im- intended for a specific group within the pop- plied nutrient content claim in a brand ulation, the analysis should specifically ad- name shall include the following data dress nutritional needs of such group, and and be submitted in the following form: should include scientific data sufficient for such purpose. (Date)llllll C. The petitioner is required to submit ei- Name of petitioner llllll ther a claim for categorical exclusion under Post office address llllll § 25.30 or § 25.32 of this chapter or an environ- Subject of the petition llllll mental assessment under § 25.40 of this chap- Office of Nutritional Products, Labeling and ter. Dietary Supplements (HFS–800), Yours very truly, Food and Drug Administration, Petitioner llllll Department of Health and Human Services, By llllll Washington, DC 20204. (Indicate authority) To Whom It May Concern:

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The undersigned, lllllllllll sub- plicate, in which case the petition will mits this petition under section 403(r)(4) of be denied, and the petitioner will be the Federal Food, Drug, and Cosmetic Act notified as to what respect the petition (the act) with respect to (statement of the is incomplete. implied nutrient content claim and its proposed use in a brand name). (3) FDA will publish a notice of the Attached hereto and constituting a part of petition in the FEDERAL REGISTER an- this petition, are the following: nouncing its availability to the public A. A statement identifying the implied nu- and seeking comment on the petition. trient content claim, the nutrient the claim The petition shall be available to the is intended to characterize, the cor- public to the extent provided under responding term for characterizing the level paragraph (g) of this section. The no- of such nutrient as defined by a regulation tice shall allow 30 days for comments. under section 403(r)(2)(A)(i) of the act, and the brand name of which the implied claim is (4) Within 100 days of the date of re- intended to be a part. The statement should ceipt of the petition that is accepted address why the use of the brandname as pro- for review (i.e., that has not been found posed will not be misleading. It should ad- to be incomplete and subsequently re- dress in particular what information is returned to the petitioner), FDA will: quired to accompany the claim or other ways (i) Notify the petitioner by letter of in which the claim meets the requirements the agency’s decision to grant the peti- of sections 201(n) and 403(a) of the act. The tioner permission to use the proposed statement should provide examples of the types of foods on which the brand name will brand name if such use is not mis- appear. It shall also include data showing leading, with any conditions or limita- that the actual level of the nutrient in the tions on such use specified; or food qualifies the food to bear the cor- (ii) Deny the petition, in which case responding term defined by regulation. the letter shall state the reasons there- Assay methods used to determine the level of for. Failure of the petition to fully ad- a nutrient should meet the requirements dress the requirements of this section stated under petition format item C in para- shall be grounds for denial of the peti- graph (k)(1) of this section. B. A detailed explanation, supported by tion. Should FDA not notify the peti- any necessary data, of why use of the pro- tioner of his decision on the petition posed brand name is requested. This item within 100 days, the petition shall be shall also state what nutritional benefit to considered to be granted. the public will derive from use of the brand (5) As soon as practicable following name as proposed. If the branded product is the granting of a petition, the Commis- intended for a specific group within the pop- sioner of Food and Drugs will publish a ulation, the analysis should specifically address nutritional needs of such group and notice in the FEDERAL REGISTER in- should include scientific data sufficient for forming the public of such fact. such purpose. [58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, C. The petitioner is required to submit ei- 1993, as amended at 58 FR 44033, Aug. 18, 1993; ther a claim for categorical exclusion under 62 FR 40598, July 29, 1997; 63 FR 26718, May 14, § 25.30 or § 25.32 of this chapter or an environ- 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, mental assessment under § 25.40 of this chap- Mar. 4, 2002; 69 FR 16481, Mar. 30, 2004] ter. Yours very truly, Petitioner llllll Subpart E—Specific Requirements By llllll for Health Claims (2) Within 15 days of receipt of the petition the petitioner will be notified by § 101.70 Petitions for health claims. letter of the date on which the petition (a) Any interested person may peti- was received. Such notice will inform tion the Food and Drug Administration the petitioner: (FDA) to issue a regulation regarding a (i) That the petition is undergoing health claim. An original and one copy agency review (in which case a docket of the petition shall be submitted, or number will be assigned to the peti- the petitioner may submit an original tion); or and a computer readable disk con- (ii) That the petition is incomplete, taining the petition. Contents of the e.g., it lacks any of the data required disk should be in a standard format, by this part, it presents such data in a such as ASCII format. (Petitioners in- manner that is not readily understood, terested in submitting a disk should or it has not been submitted in quadru- contact the Center for Food Safety and

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Applied Nutrition for details.) If any (2) Names and any information that part of the material submitted is in a would identify any third party involved foreign language, it shall be accom- with the report, such as a physician or panied by an accurate and complete hospital or other institution. English translation. The petition shall (f) Petitions for a health claim shall state the petitioner’s post office ad- include the following data and be sub- dress to which any correspondence re- mitted in the following form: quired by section 403 of the Federal Food, Drug, and Cosmetic Act may be (Date)llllll Name of petitioner sent. llllll Post office address llllll (b) Pertinent information may be in- Subject of the petition llllll corporated in, and will be considered as Food and Drug Administration, part of, a petition on the basis of spe- Office of Nutritional Products, Labeling and cific reference to such information sub- Dietary Supplements (HFS–800), mitted to and retained in the files of 5001 Campus Dr., FDA. Such information may include College Park, MD 20740, any findings, along with the basis of The undersigned, lllllllll submits the findings, of an outside panel with this petition pursuant to section 403(r)(4) or expertise in the subject area. Any ref- 403(r)(5)(D) of the Federal Food, Drug, and erence to published information shall Cosmetic Act with respect to (statement of be accompanied by reprints, or easily the substance and its health claim). Attached hereto, and constituting a part of readable copies of such information. this petition, are the following: (c) If nonclinical laboratory studies A. Preliminary requirements. A complete are included in a petition, the petition explanation of how the substance conforms shall include, with respect to each non- to the requirements of § 101.14(b) (21 CFR clinical study contained in the peti- 101.14(b)). For petitions where the subject tion, either a statement that the study substance is a food ingredient or a compo- has been conducted in compliance with nent of a food ingredient, the petitioner the good laboratory practice regula- should compile a comprehensive list of the tions as set forth in part 58 of this specific ingredients that will be added to the food to supply the substance in the food chapter, or, if any such study was not bearing the health claim. For each such in- conducted in compliance with such reg- gredient listed, the petitioner should state ulations, a brief statement of the rea- how the ingredient complies with the re- son for the noncompliance. quirements of § 101.14(b)(3)(ii), e.g., that its (d) If clinical or other human inves- use is generally recognized as safe (GRAS), tigations are included in a petition, the listed as a food additive, or authorized by a petition shall include a statement that prior sanction issued by the agency, and they were either conducted in compli- what the basis is for the GRAS claim, the food additive status, or prior sanctioned sta- ance with the requirements for institu- tus. tional review set forth in part 56 of this B. Summary of scientific data. The sum- chapter, or were not subject to such re- mary of scientific data provides the basis quirements in accordance with § 56.104 upon which authorizing a health claim can or § 56.105, and a statement that they be justified as providing the health benefit. were conducted in compliance with the The summary must establish that, based on requirements for informed consent set the totality of publicly available scientific forth in part 50 of this chapter. evidence (including evidence from well-designed studies conducted in a manner which (e) All data and information in a is consistent with generally recognized sci- health claim petition are available for entific procedures and principles), there is public disclosure after the notice of fil- significant scientific agreement among ex- ing of petition is issued to the peti- perts qualified by scientific training and ex- tioner, except that clinical investiga- perience to evaluate such claims, that the tion reports, adverse reaction reports, claim is supported by such evidence. product experience reports, consumer The summary shall state what public complaints, and other similar data and health benefit will derive from use of the information shall only be available claim as proposed. If the claim is intended for a specific group within the population, after deletion of: the summary shall specifically address nu- (1) Names and any information that tritional needs of such group and shall in- would identify the person using the clude scientific data showing how the claim product. is likely to assist in meeting such needs.

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The summary shall concentrate on the provided in section C of the petition. The findings of appropriate review articles, Na- model health claim shall include: tional Institutes of Health consensus devel- 1. A brief capsulized statement of the rel- opment conferences, and other appropriate evant conclusions of the summary, and resource materials. Issues addressed in the 2. A statement of how this substance helps summary shall include answers to such ques- the consumer to attain a total dietary pat- tions as: tern or goal associated with the health ben- 1. Is there an optimum level of the par- efit that is provided. ticular substance to be consumed beyond E. The petition shall include the following which no benefit would be expected? attachments: 2. Is there any level at which an adverse ef- 1. Copies of any computer literature fect from the substance or from foods con- searches done by the petitioner (e.g., taining the substance occurs for any seg- Medline). ment of the population? 2. Copies of articles cited in the literature 3. Are there certain populations that must searches and other information as follows: receive special consideration? a. All information relied upon for the sup- 4. What other nutritional or health factors port of the health claim, including copies of (both positive and negative) are important to publications or other information cited in review articles and used to perform meta-anal- consider when consuming the substance? yses. In addition, the summary of scientific data b. All information concerning adverse con- shall include a detailed analysis of the po- sequences to any segment of the population tential effect of the use of the proposed (e.g., sensitivity to the substance). claim on food consumption, specifically any c. All information pertaining to the U.S. change due to significant alterations in eat- population. ing habits and corresponding changes in nu- F. The petitioner is required to submit ei- trient intake resulting from such changes in ther a claim for categorical exclusion under food consumption. The latter item shall spe- § 25.30 or § 25.32 of this chapter or an environ- cifically address the effect on the intake of mental assessment under § 25.40 of this chap- nutrients that have beneficial and negative ter. consequences in the total diet. Yours very truly, If the claim is intended for a significant Petitioner llllll subpopulation within the general U.S. popu- By llllll lation, the analysis shall specifically address (Indicate authority) the dietary practices of such group, and shall include data sufficient to demonstrate that (g) The data specified under the sev- the dietary analysis is representative of such eral lettered headings should be subgroup (e.g., adolescents or the elderly). mitted on separate pages or sets of If appropriate, the petition shall explain pages, suitably identified. If such data the prevalence of the disease or health-re- have already been submitted with an lated condition in the U.S. population and earlier application from the petitioner the relevance of the claim in the context of or any other final petition, the present the total daily diet. petition may incorporate it by specific Also, the summary shall demonstrate that the substance that is the subject of the pro- reference to the earlier petition. posed claim conforms to the definition of the (h) The petition shall include a state- term ‘‘substance’’ in § 101.14(a)(2). ment signed by the person responsible C. Analytical data that show the amount for the petition that, to the best of his/ of the substance that is present in represent- her knowledge, it is a representative ative foods that would be candidates to bear and balanced submission that includes the claim should be obtained from represent- unfavorable information as well as fa- ative samples using methods from the AOAC vorable information, known to him/her INTERNATIONAL (AOAC), where available. If no AOAC method is available, the peti- to be pertinent to the evaluation of the tioner shall submit the assay method used proposed health claim. and data establishing the validity of the (i) The petition shall be signed by the method for assaying the substance in food. petitioner or by his/her attorney or The validation data should include a statis- agent, or (if a corporation) by an au- tical analysis of the analytical and product thorized official. variability. (j) Agency action on the petition. (1) D. Model health claim. One or more model Within 15 days of receipt of the peti- health claims that represent label state- tion, the petitioner will be notified by ments that may be used on a food label or in labeling for a food to characterize the rela- letter of the date on which the petition tionship between the substance in a food to was received. Such notice will inform a disease or health-related condition that is the petitioner that the petition is un- justified by the summary of scientific data dergoing agency review and that the

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petitioner will subsequently be notified (4)(i) Within 270 of the date of publi- of the agency’s decision to file for com- cation of the proposal, FDA will pub- prehensive review or deny the petition. lish a final rule that either authorizes (2) Within 100 days of the date of reuse of the health claim or explains why ceipt of the petition, FDA will notify the agency has decided not to author- the petitioner by letter that the peti- ize one. tion has either been filed for com- (ii) For cause, FDA may extend, no prehensive review or denied. The agen- more than twice, the period in which it cy will deny a petition without review- will publish a final rule; each such ex- ing the information contained in ‘‘B. tension will be for no more than 90 Summary of Scientific Data’’ if the in- days. FDA will publish a notice of each formation in ‘‘A. Preliminary Require- extension in the FEDERAL REGISTER. ments’’ is inadequate in explaining how The document will state the basis for the substance conforms to the require- the extension, the length of the exten- ments of § 101.14(b). If the petition is sion, and the date by which the final denied, the notification will state the rule will be published, which date shall reasons therefor, including justifica- be within 540 days of the date of receipt tion of the rejection of any report from of the petition. an authoritative scientific body of the U.S. Government. If filed, the date of [58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, the notification letter becomes the 1993, as amended at 59 FR 425, Jan. 4, 1994; 62 date of filing for the purposes of this FR 28232, May 22, 1997; 62 FR 40599, July 29, 1997; 63 FR 26719, May 14, 1998; 63 FR 40024, regulation. If FDA does not act within July 27, 1998; 66 FR 56035, Nov. 6, 2001] such 100 days, the petition shall be deemed to be denied unless an exten- § 101.71 Health claims: claims not au- sion is mutually agreed upon by FDA thorized. and the petitioner. A petition that has Health claims not authorized for been denied, or has been deemed to be foods in conventional food form or for denied, without filing will not be made dietary supplements of vitamins, min- available to the public. A filed petition will be available to the public to the erals, herbs, or other similar sub- extent provided under paragraph (e) of stances: this section. (a) Dietary fiber and cardiovascular (3) Within 90 days of the date of fil- disease. ing, FDA will by letter of notification (b) Zinc and immune function in the to the petitioner: elderly. (i) Deny the petition, or [58 FR 2534, Jan. 6, 1993, as amended at 58 FR (ii) Inform the petitioner that a pro- 2548, 2578, 2620, 2639, 2664, 2714, Jan. 6, 1993; 58 posed regulation to provide for the re- FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 1994; quested use of the health claim will be 65 FR 58918, Oct. 3, 2000] published in the FEDERAL REGISTER. If the petition is denied, the notification § 101.72 Health claims: calcium, vitamin D, and osteoporosis. will state the reasons therefor, including justification for the rejection of (a) Relationship between calcium, vita- any report from an authoritative sci- min D, and osteoporosis. An inadequate entific body of the U.S. Government. intake of calcium or calcium and vita- FDA will publish the proposal to min D contributes to low peak bone amend the regulations to provide for mass, which has been identified as one the requested use of the health claim of many risk factors in the develop- in the FEDERAL REGISTER within 90 ment of osteoporosis. Peak bone mass days of the date of filing. The proposal is the total quantity of bone present at will also announce the availability of maturity, and experts believe that it the petition for public review. has the greatest bearing on whether a (iii) If FDA does not act within 90 person will be at risk of developing days of the date of filing, the petition osteoporosis and related bone fractures shall be deemed to be denied unless an later in life. Another factor that influ- extension is mutually agreed upon by ences total bone mass and suscepti- FDA and the petitioner. bility to osteoporosis is the rate of

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bone loss after skeletal maturity. Vita- (c) Requirements. (1) All requirements min D is required for normal absorp- set forth in § 101.14 shall be met. tion of calcium and to prevent the oc- (2) Specific requirements—(i) Nature of currence of high serum parathyroid the claim. A health claim associating hormone (PTH) concentration, which calcium or, when appropriate, calcium stimulates mobilization of calcium and vitamin D with a reduced risk of from the skeleton and can lower bone osteoporosis may be made on the label mass. Calcium, along with vitamin D or labeling of a food described in para- and several other nutrients, is required graphs (c)(2)(ii) and (d)(1) of this sec- for normal bone mineralization. While tion, provided that: vitamin D is required for optimal bone (A) The claim makes clear the impor- mineralization, it is more effective tance of adequate calcium intake, or when calcium intake is adequate. An when appropriate, adequate calcium adequate intake of calcium and vita- and vitamin D intake, throughout life, min D is thought to exert a positive ef- in a healthful diet, are essential to re- fect during adolescence and early duce osteoporosis risk. The claim does adulthood in optimizing the amount of not imply that adequate calcium in- bone that is laid down. However, the take, or when appropriate, adequate upper limit of peak bone mass is ge- calcium and vitamin D intake, is the netically determined. The mechanism only recognized risk factor for the de- through which adequate intakes of cal- velopment of osteoporosis; (B) The claim does not attribute any cium and vitamin D and optimal peak degree of reduction in risk of bone mass reduce the risk of osteoporosis to maintaining an ade- osteoporosis is thought to be as fol- quate dietary calcium intake, or when lows. All persons lose bone with age. appropriate, an adequate dietary cal- Hence, those with higher bone mass at cium and vitamin D intake, through- maturity take longer to reach the out life. critically reduced mass at which bones (ii) Nature of the food. (A) The food can fracture easily. The rate of bone shall meet or exceed the requirements loss after skeletal maturity also influ- for a ‘‘high’’ level of calcium as defined ences the amount of bone present at in § 101.54(b); old age and can influence an individ- (B) The calcium content of the prod- ual’s risk of developing osteoporosis. uct shall be assimilable; Maintenance of adequate intakes of (C) Dietary supplements shall meet calcium and vitamin D later in life is the United States Pharmacopeia (USP) thought to be important in reducing standards for disintegration and dis- the rate of bone loss particularly in the solution applicable to their component elderly and in women during the first calcium salts, except that dietary sup- decade following menopause, but a sig- plements for which no USP standards nificant protective effect is also seen exist shall exhibit appropriate assimi- among men and younger women. lability under the conditions of use (b) Significance of calcium or calcium stated on the product label; and vitamin D. Adequate calcium in- (D) A food or total daily rec- take, or adequate calcium and vitamin ommended supplement intake shall not D intake, is not the only recognized contain more phosphorus than calcium risk factor in the development of on a weight per weight basis. osteoporosis, which is a multifactorial (d) Optional information. (1) The claim bone disease. Maintenance of adequate may include the term ‘‘vitamin D’’ if calcium and vitamin D intakes the food meets or exceeds the require- throughout life is necessary to achieve ments for a ‘‘high’’ level of vitamin D optimal peak bone mass and to reduce as defined in § 101.54(b); the risk of osteoporosis in later life. (2) The claim may include informa- However, vitamin D is most effective tion from paragraphs (a) and (b) of this in this regard when calcium intake is section. adequate. Increasing intake of calcium (3) The claim may make reference to has been shown to have beneficial ef- physical activity. fects on bone health independent of di- (4) The claim may include informa- etary vitamin D. tion on the number of people in the

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United States, including the number of § 101.73 Health claims: dietary lipids people in certain subpopulations in the and cancer. United States, who have osteoporosis (a) Relationship between fat and can- or low bone density. The sources of this cer. (1) Cancer is a constellation of information must be identified, and it more than 100 different diseases, each must be current information from the characterized by the uncontrolled National Center for Health Statistics, growth and spread of abnormal cells. the National Institutes of Health, or Cancer has many causes and stages in the National Osteoporosis Foundation. its development. Both genetic and en- (5) The claim may state that the role vironmental risk factors may affect of adequate calcium intake, or when the risk of cancer. Risk factors include appropriate, the role of adequate cal- a family history of a specific type of cium and vitamin D intake, through- cancer, cigarette smoking, alcohol con- out life is linked to reduced risk of sumption, overweight and obesity, ultraviolet or ionizing radiation, expo- osteoporosis through the mechanism of sure to cancer-causing chemicals, and optimizing peak bone mass during ado- dietary factors. lescence and early adulthood. The (2) Among dietary factors, the phrase ‘‘build and maintain good bone strongest positive association has been health’’ may be used to convey the con- found between total fat intake and risk cept of optimizing peak bone mass. The of some types of cancer. Based on the claim may also state that adequate in- totality of the publicly available sci- take of calcium, or when appropriate, entific evidence, there is significant adequate intake of calcium and vita- scientific agreement among experts, min D, is linked to reduced risk of qualified by training and experience to osteoporosis through the mechanism of evaluate such evidence, that diets high slowing the rate of bone loss for per- in total fat are associated with an in- sons with a family history of the dis- creased cancer risk. Research to date, ease, post-menopausal women, and el- although not conclusive, demonstrates derly men and women. that the total amount of fats, rather (e) Model health claims. The following than any specific type of fat, is posi- model health claims may be used in tively associated with cancer risk. The food labeling to describe the relation- mechanism by which total fat affects ship between calcium and osteoporosis: cancer has not yet been established. (3) A question that has been the sub- Adequate calcium throughout life, as ject of considerable research is whether part of a well-balanced diet, may re- the effect of fat on cancer is site-spe- duce the risk of osteoporosis. cific. Neither human nor animal stud- Adequate calcium as part of a healthful ies are consistent in the association of diet, along with physical activity, may fat intake with specific cancer sites. reduce the risk of osteoporosis in later (4) Another question that has been life. raised is whether the association of (f) Model additional health claims for total fat intake to cancer risk is independently associated with energy in- calcium and vitamin D. The following takes, or whether the association of fat model health claims may be used in with cancer risk is the result of the food labeling to describe the relation- higher energy (caloric) intake nor- ship between calcium, vitamin D, and mally associated with high fat intake. osteoporosis: FDA has concluded that evidence from Adequate calcium and vitamin D both animal and human studies indi- throughout life, as part of a well-bal- cates that total fat intake alone, inde- anced diet, may reduce the risk of pendent of energy intake, is associated osteoporosis. with cancer risk. Adequate calcium and vitamin D as (b) Significance of the relationship between fat intake and risk of cancer. (1) part of a healthful diet, along with Cancer is ranked as a leading cause of physical activity, may reduce the risk death in the United States. The overall of osteoporosis in later life. economic costs of cancer, including di- [73 FR 56486, Sept. 29, 2008] rect health care costs and losses due to

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morbidity and mortality, are very obesity, ultraviolet or ionizing radi- high. ation, exposure to cancer-causing (2) U.S. diets tend to be high in fat chemicals, and dietary factors. and high in calories. The average U.S. (2) The claim may include informa- diet is estimated to contain 36 to 37 tion from paragraphs (a) and (b) of this percent of calories from total fat. Cur- section which summarize the relation- rent dietary guidelines from the Fed- ship between dietary fat and cancer eral Government and other national and the significance of the relation- health professional organizations rec- ship. ommend that dietary fat intake be re- (3) The claim may indicate that it is duced to a level of 30 percent or less of consistent with ‘‘Nutrition and Your energy (calories) from total fat. In Health: Dietary Guidelines for Ameri- order to reduce intake of total fat, in- cans,’’ U.S. Department of Agriculture dividuals should choose diets which are (USDA) and Department of Health and high in vegetables, fruits, and grain Human Services (DHHS), Government products (particularly whole grain Printing Office. products), choose lean cuts of meats, (4) The claim may include informa- fish, and poultry, substitute low-fat tion on the number of people in the dairy products for higher fat products, United States who have cancer. The and use fats and oils sparingly. sources of this information must be (c) Requirements. (1) All requirements identified, and it must be current infor- set forth in § 101.14 shall be met. mation from the National Center for (2) Specific requirements—(i) Nature of Health Statistics, the National Insti- the claim. A health claim associating tutes of Health, or ‘‘Nutrition and Your diets low in fat with reduced risk of Health: Dietary Guidelines for Ameri- cancer may be made on the label or la- cans,’’ USDA and DHHS, Government beling of a food described in paragraph Printing Office. (c)(2)(ii) of this section, provided that: (e) Model health claims. The following (A) The claim states that diets low in model health claims may be used in fat ‘‘may’’ or ‘‘might’’ reduce the risk food labeling to describe the relation- of some cancers; ship between dietary fat and cancer: (B) In specifying the disease, the (1) Development of cancer depends on claim uses the following terms: ‘‘some many factors. A diet low in total fat types of cancer’’ or ‘‘some cancers’’; may reduce the risk of some cancers. (C) In specifying the nutrient, the (2) Eating a healthful diet low in fat claim uses the term ‘‘total fat’’ or may help reduce the risk of some types ‘‘fat’’; of cancers. Development of cancer is (D) The claim does not specify types associated with many factors, includ- of fat or fatty acid that may be related ing a family history of the disease, cig- to the risk of cancer; arette smoking, and what you eat. (E) The claim does not attribute any degree of cancer risk reduction to diets [58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, low in fat; and 1993] (F) The claim indicates that the development of cancer depends on many § 101.74 Health claims: sodium and hy- factors. pertension. (ii) Nature of the food. The food shall (a) Relationship between sodium and meet all of the nutrient content re- hypertension (high blood pressure). (1) quirements of § 101.62 for a ‘‘low fat’’ Hypertension, or high blood pressure, food; except that fish and game meats generally means a systolic blood pres- (i.e., deer, bison, rabbit, quail, wild tur- sure of greater than 140 millimeters of key, geese, ostrich) may meet the re- mercury (mm Hg) or a diastolic blood quirements for ‘‘extra lean’’ in § 101.62. pressure of greater than 90 mm Hg. (d) Optional information. (1) The claim Normotension, or normal blood pres- may identify one or more of the fol- sure, is a systolic blood pressure below lowing risk factors for development of 140 mm Hg and diastolic blood pressure cancer: Family history of a specific below 90 mm Hg. Sodium is specified type of cancer, cigarette smoking, al- here as the chemical entity or electro- cohol consumption, overweight and lyte ‘‘sodium’’ and is distinguished

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from sodium chloride, or salt, which is sodium intake would have a small but 39 percent sodium by weight. significant effect on reducing the aver- (2) The scientific evidence establishes age blood pressure, and, consequently, that diets high in sodium are associ- reducing mortality from coronary ated with a high prevalence of hyper- heart disease and stroke. tension or high blood pressure and with (4) Sodium is an essential nutrient, increases in blood pressure with age, and experts have recommended a safe and that diets low in sodium are asso- minimum level of 500 milligrams (mg) ciated with a low prevalence of hyper- sodium per day and an upper level of tension or high blood pressure and with 2,400 mg sodium per day, the FDA a low or no increase of blood pressure Daily Value for sodium. with age. (c) Requirements. (1) All requirements (b) Significance of sodium in relation to set forth in § 101.14 shall be met. high blood pressure. (1) High blood pres- (2) Specific requirements—(i) Nature of sure is a public health concern pri- the claim. A health claim associating marily because it is a major risk factor diets low in sodium with reduced risk for mortality from coronary heart dis- of high blood pressure may be made on ease and stroke. Early management of the label or labeling of a food described high blood pressure is a major public in paragraph (c)(2)(ii) of this section, health goal that can assist in reducing provided that: mortality associated with coronary (A) The claim states that diets low in heart disease and stroke. There is a sodium ‘‘may’’ or ‘‘might’’ reduce the continuum of mortality risk that in- risk of high blood pressure; creases as blood pressures rise. Individ- (B) In specifying the disease, the uals with high blood pressure are at claim uses the term ‘‘high blood pres- greatest risk, and individuals with sure’’; moderately high, high normal, and nor- (C) In specifying the nutrient, the mal blood pressure are at steadily de- claim uses the term ‘‘sodium’’; creasing risk. The scientific evidence (D) The claim does not attribute any indicates that reducing sodium intake degree of reduction in risk of high lowers blood pressure and associated blood pressure to diets low in sodium; risks in many but not all hypertensive and individuals. There is also evidence that (E) The claim indicates that develop- reducing sodium intake lowers blood ment of high blood pressure depends on pressure and associated risks in many many factors. but not all normotensive individuals as (ii) Nature of the food. The food shall well. meet all of the nutrient content re- (2) The populations at greatest risk quirements of § 101.61 for a ‘‘low so- for high blood pressure, and those most dium’’ food. likely to benefit from sodium reduc- (d) Optional information. (1) The claim tion, include those with family his- may identify one or more of the fol- tories of high blood pressure, the elder- lowing risk factors for development of ly, males because they develop hyper- high blood pressure in addition to die- tension earlier in life than females, and tary sodium consumption: Family his- black males and females. Although tory of high blood pressure, growing some population groups are at greater older, alcohol consumption, and excess risk than others, high blood-pressure is weight. a disease of public health concern for (2) The claim may include informa- all population groups. Sodium intake, tion from paragraphs (a) and (b) of this alcohol consumption, and obesity are section, which summarizes the rela- identified risk factors for high blood tionship between dietary sodium and pressure. high blood pressure and the signifi- (3) Sodium intakes exceed rec- cance of the relationship. ommended levels in almost every group (3) The claim may include informa- in the United States. One of the major tion on the number of people in the public health recommendations rel- United States who have high blood ative to high blood pressure is to de- pressure. The sources of this informa- crease consumption of salt. On a popu- tion must be identified, and it must be lation-wide basis, reducing the average current information from the National

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Center for Health Statistics, the Na- are major modifiable risk factors in tional Institutes of Health, or ‘‘Nutri- the development of coronary heart dis- tion and Your Health: Dietary Guide- ease. High coronary heart disease rates lines for Americans,’’ U.S. Department occur among people with high blood of Health and Human Services (DHHS) cholesterol levels of 240 milligrams/dec- and U.S. Department of Argiculture aliter (mg/dL) (6.21 millimoles per liter (USDA), Government Printing Office. (mmol/L)) or above and LDL-choles- (4) The claim may indicate that it is terol levels of 160 mg/dL (4.13 mmol/L) consistent with ‘‘Nutrition and Your or above. Borderline high risk blood Health: U.S. Dietary Guidelines for cholesterol levels range from 200 to 239 Americans, DHHS and USDA, Govern- mg/dL (5.17 to 6.18 mmol/L) and 130 to ment Printing Office. 159 mg/dL (3.36 to 4.11 mmol/L) of LDL- (5) In specifying the nutrient, the cholesterol. Dietary lipids (fats) in- claim may include the term ‘‘salt’’ in clude fatty acids and cholesterol. Total addition to the term ‘‘sodium.’’ fat, commonly referred to as fat, is (6) In specifying the disease, the composed of saturated fat (fatty acids claim may include the term ‘‘hyper- containing no double bonds), and tension’’ in addition to the term ‘‘high monounsaturated and polyunsaturated blood pressure.’’ fat (fatty acids containing one or more (7) The claim may state that individ- double bonds). uals with high blood pressure should (2) The scientific evidence establishes consult their physicians for medical that diets high in saturated fat and advice and treatment. If the claim de- cholesterol are associated with in- fines high or normal blood pressure, creased levels of blood total- and LDL- then the health claim must state that cholesterol and, thus, with increased individuals with high blood pressure risk of coronary heart disease. Diets should consult their physicians for low in saturated fat and cholesterol are medical advice and treatment. associated with decreased levels of (e) Model health claims. The following blood total- and LDL-cholesterol, and are model health claims that may be thus, with decreased risk of developing used in food labeling to describe the re- coronary heart disease. lationship between dietary sodium and (b) Significance of the relationship be- high blood pressure: tween dietary saturated fat and choles- (1) Diets low in sodium may reduce terol and risk of coronary heart disease. the risk of high blood pressure, a dis- (1) Coronary heart disease is a major ease associated with many factors. public health concern in the United (2) Development of hypertension or States, primarily because it accounts high blood pressure depends on many for more deaths than any other disease factors. [This product] can be part of a or group of diseases. Early manage- low sodium, low salt diet that might ment of risk factors for coronary heart reduce the risk of hypertension or high disease is a major public health goal blood pressure. that can assist in reducing risk of coro- [58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, nary heart disease. There is a con- 1993] tinuum of mortality risk from coronary heart disease that increases with § 101.75 Health claims: dietary satu- increasing levels of blood LDL-choles- rated fat and cholesterol and risk of terol. Individuals with high blood LDL- coronary heart disease. cholesterol are at greatest risk. A larg- (a) Relationship between dietary satu- er number of individuals with more rated fat and cholesterol and risk of coro- moderately elevated cholesterol also nary heart disease. (1) Cardiovascular have increased risk of coronary events; disease means diseases of the heart and such individuals comprise a substantial circulatory system. Coronary heart proportion of the adult U.S. popu- disease is the most common and seri- lation. The scientific evidence indi- ous form of cardiovascular disease and cates that reducing saturated fat and refers to diseases of the heart muscle cholesterol intakes lowers blood LDL- and supporting blood vessels. High cholesterol and risk of heart disease in blood total- and low density most individuals. There is also evi- lipoprotein (LDL)- cholesterol levels dence that reducing saturated fat and

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cholesterol intakes in persons with ‘‘low fat’’ food, unless it is a raw fruit blood cholesterol levels in the normal or vegetable; except that fish and game range also reduces risk of heart dis- meats (i.e., deer, bison, rabbit, quail, ease. wild turkey, geese, and ostrich) may (2) Other risk factors for coronary meet the requirements for ‘‘extra lean’’ heart disease include a family history in § 101.62. of heart disease, high blood pressure, (d) Optional information. (1) The claim diabetes, cigarette smoking, obesity may identify one or more of the fol- (body weight 30 percent greater than lowing risk factors in addition to satu- ideal body weight), and lack of regular rated fat and cholesterol about which physical exercise. there is general scientific agreement (3) Intakes of saturated fat exceed that they are major risk factors for recommended levels in many people in this disease: A family history of coro- the United States. Intakes of choles- nary heart disease, elevated blood total terol are, on average, at or above rec- and LDL-cholesterol, excess body ommended levels. One of the major weight, high blood pressure, cigarette public health recommendations rel- smoking, diabetes, and physical inac- ative to coronary heart disease risk is tivity. to consume less than 10 percent of cal- (2) The claim may indicate that the ories from saturated fat, and an aver- relationship of saturated fat and cho- age of 30 percent or less of total cal- lesterol to heart disease is through the ories from all fat. Recommended daily intermediate link of ‘‘blood choles- cholesterol intakes are 300 mg or less terol’’ or ‘‘blood total- and LDL choles- per day. terol.’’ (c) Requirements. (1) All requirements (3) The claim may include informa- set forth in § 101.14 shall be met, except tion from paragraphs (a) and (b) of this § 101.14(e)(6) with respect to a raw fruit section, which summarize the relation- or vegetable. ship between dietary saturated fat and (2) Specific requirements—(i) Nature of cholesterol and risk of coronary heart the claim. A health claim associating disease, and the significance of the re- diets low in saturated fat and choles- lationship. terol with reduced risk of coronary (4) In specifying the nutrients, the heart disease may be made on the label claim may include the term ‘‘total fat’’ or labeling of a food described in para- in addition to the terms ‘‘saturated graph (c)(2)(ii) of this section provided fat’’ and ‘‘cholesterol’’. that: (5) The claim may include informa- (A) The claim states that diets low in tion on the number of people in the saturated fat and cholesterol ‘‘may’’ or United States who have coronary heart ‘‘might’’ reduce the risk of heart dis- disease. The sources of this informa- ease; tion shall be identified, and it shall be (B) In specifying the disease, the current information from the National claim uses the terms ‘‘heart disease’’ Center for Health Statistics, the Na- or ‘‘coronary heart disease;’’ tional Institutes of Health, or ‘‘Nutri- (C) In specifying the nutrient, the tion and Your Health: Dietary Guide- claim uses the terms ‘‘saturated fat’’ lines for Americans,’’ U.S. Department and ‘‘cholesterol’’ and lists both; of Health and Human Services (DHHS) (D) The claim does not attribute any and U.S. Department of Agriculture degree of risk reduction for coronary (USDA), Government Printing Office. heart disease to diets low in dietary (6) The claim may indicate that it is saturated fat and cholesterol; and consistent with ‘‘Nutrition and Your (E) The claim states that coronary Health: Dietary Guidelines for Ameri- heart disease risk depends on many cans,’’ DHHS and USDA, Government factors. Printing Office. (ii) Nature of the food. (A) The food (7) The claim may state that individ- shall meet all of the nutrient content uals with elevated blood total- or LDL- requirements of § 101.62 for a ‘‘low satu- cholesterol should consult their physi- rated fat’’ and ‘‘low cholesterol’’ food. cians for medical advice and treat- (B) The food shall meet the nutrient ment. If the claim defines high or nor- content requirements of § 101.62 for a mal blood total- or LDL-cholesterol

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levels, then the claim shall state that growth and spread of abnormal cells. individuals with high blood cholesterol Cancer has many causes and stages in should consult their physicians for its development. Both genetic and en- medical advice and treatment. vironmental risk factors may affect (e) Model health claims.The following the risk of cancer. Risk factors include: are model health claims that may be A family history of a specific type of used in food labeling to describe the re- cancer, cigarette smoking, overweight lationship between dietary saturated and obesity, alcohol consumption, ul- fat and cholesterol and risk of heart traviolet or ionizing radiation, expo- disease: sure to cancer-causing chemicals, and (1) While many factors affect heart dietary factors. disease, diets low in saturated fat and (2) The scientific evidence establishes cholesterol may reduce the risk of this that diets low in fat and high in fiber- disease; containing grain products, fruits, and (2) Development of heart disease de- vegetables are associated with a re- pends upon many factors, but its risk duced risk of some types of cancer. Al- may be reduced by diets low in satu- though the specific role of total dietary rated fat and cholesterol and healthy fiber, fiber components, and the mul- lifestyles; tiple nutrients and other substances (3) Development of heart disease de- contained in these foods are not yet pends upon many factors, including a fully understood, many studies have family history of the disease, high shown that diets low in fat and high in blood LDL-cholesterol, diabetes, high fiber-containing foods are associated blood pressure, being overweight, ciga- with reduced risk of some types of can- rette smoking, lack of exercise, and cer. the type of dietary pattern. A healthful (b) Significance of the relationship be- diet low in saturated fat, total fat, and cholesterol, as part of a healthy life- tween consumption of diets low in fat and style, may lower blood cholesterol lev- high in fiber-containing grain products, els and may reduce the risk of heart fruits, and vegetables and risk of cancer. disease; (1) Cancer is ranked as a leading cause (4) Many factors, such as a family of death in the United States. The history of the disease, increased blood- overall economic costs of cancer, in- and LDL-cholesterol levels, high blood cluding direct health care costs and pressure, cigarette smoking, diabetes, losses due to morbidity and mortality, and being overweight, contribute to de- are very high. veloping heart disease. A diet low in (2) U.S. diets tend to be high in fat saturated fat, cholesterol, and total fat and low in grain products, fruits, and may help reduce the risk of heart dis- vegetables. Studies in various parts of ease; and the world indicate that populations (5) Diets low in saturated fat, choles- who habitually consume a diet high in terol, and total fat may reduce the risk plant foods have lower risks of some of heart disease. Heart disease is de- cancers. These diets generally are low pendent upon many factors, including in fat and rich in many nutrients, in- diet, a family history of the disease, cluding, but not limited to, dietary elevated blood LDL-cholesterol levels, fiber. Current dietary guidelines from and physical inactivity. Federal government agencies and nationally recognized health professional [58 FR 2757, Jan. 6, 1993, as amended at 81 FR 91722, Dec. 19, 2016] organizations recommend decreased consumption of fats (less than 30 per- § 101.76 Health claims: fiber-con- cent of calories), maintenance of desir- taining grain products, fruits, and able body weight, and increased con- vegetables and cancer. sumption of fruits and vegetables (five (a) Relationship between diets low in or more servings daily), and grain prod- fat and high in fiber-containing grain ucts (six or more servings daily). products, fruits, and vegetables and can- (c) Requirements. (1) All requirements cer risk. (1) Cancer is a constellation of set forth in § 101.14 shall be met. more than 100 different diseases, each (2) Specific requirements—(i) Nature of characterized by the uncontrolled the claim. A health claim associating

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diets low in fat and high in fiber-con- (3) The claim may indicate that it is taining grain products, fruits, and consistent with ‘‘Nutrition and Your vegetables with reduced risk of cancer Health: Dietary Guidelines for Ameri- may be made on the label or labeling of cans,’’ U.S. Department of Agriculture a food described in paragraph (c)(2)(ii) (USDA) and Department of Health and of this section, provided that: Human Services (DHHS), Government (A) The claim states that diets low in Printing Office. fat and high in fiber-containing grain (4) The claim may include informa- products, fruits, and vegetables ‘‘may’’ tion on the number of people in the or ‘‘might’’ reduce the risk of some United States who have cancer. The cancers; sources of this information must be (B) In specifying the disease, the identified, and it must be current infor- claim uses the following terms: ‘‘some mation from the National Center for types of cancer,’’ or ‘‘some cancers’’; Health Statistics, the National Insti- (C) The claim is limited to grain tutes of Health, or ‘‘Nutrition and Your products, fruits, and vegetables that Health: Dietary Guidelines for Ameri- contain dietary fiber; cans,’’ USDA and DHHS, Government Printing Office. (D) The claim indicates that develop- (e) Model health claims. The following ment of cancer depends on many fac- model health claims may be used in tors; food labeling to characterize the rela- (E) The claim does not attribute any tionship between diets low in fat and degree of cancer risk reduction to diets high in fiber-containing grain products, low in fat and high in fiber-containing fruits, and vegetables and cancer risk: grain products, fruits, and vegetables; (1) Low fat diets rich in fiber-con- (F) In specifying the dietary fiber taining grain products, fruits, and component of the labeled food, the vegetables may reduce the risk of some claim uses the term ‘‘fiber’’, ‘‘dietary types of cancer, a disease associated fiber’’ or ‘‘total dietary fiber’’; and with many factors. (G) The claim does not specify types (2) Development of cancer depends on of dietary fiber that may be related to many factors. Eating a diet low in fat risk of cancer. and high in grain products, fruits, and (ii) Nature of the food. (A) The food vegetables that contain dietary fiber shall be or shall contain a grain prod- may reduce your risk of some cancers. uct, fruit, or vegetable. [58 FR 2548, Jan. 6, 1993] (B) The food shall meet the nutrient content requirements of § 101.62 for a § 101.77 Health claims: fruits, vegeta- ‘‘low fat’’ food. bles, and grain products that con- (C) The food shall meet, without for- tain fiber, particularly soluble fiber, tification, the nutrient content re- and risk of coronary heart disease. quirements of § 101.54 for a ‘‘good (a) Relationship between diets low in source’’ of dietary fiber. saturated fat and cholesterol and high in (d) Optional information. (1) The claim fruits, vegetables, and grain products that may include information from para- contain fiber, particularly soluble fiber, graphs (a) and (b) of this section, which and risk of coronary heart disease. (1) summarize the relationship between Cardiovascular disease means diseases diets low in fat and high in fiber-con- of the heart and circulatory system. taining grain products, fruits, and Coronary heart disease is the most vegetables, and some types of cancer common and serious form of cardio- and the significance of the relation- vascular disease and refers to diseases ship. of the heart muscle and supporting (2) The claim may identify one or blood vessels. High blood total- and low more of the following risk factors for density lipoprotein (LDL)- cholesterol development of cancer: Family history levels are major modifiable risk factors of a specific type of cancer, cigarette in the development of coronary heart smoking, overweight and obesity, alco- disease. High coronary heart disease hol consumption, ultraviolet or ion- rates occur among people with high izing radiation, exposure to cancer blood cholesterol levels of 240 milli- causing chemicals, and dietary factors. grams per deciliter (mg/dL) (6.21

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(mmol/L)) or above and LDL-choles- (b) Significance of the relationship be- terol levels of 160 mg/dL (4.13 mmol/L) tween diets low in saturated fat and cho- or above. Borderline high risk blood lesterol, and high in fruits, vegetables, cholesterol levels range from 200 to 239 and grain products that contain fiber, mg/dL (5.17 to 6.18 mmol/L) and 130 to particularly soluble fiber, and risk of cor- 159 mg/dL (3.36 to 4.11 mmol/L) of LDL- onary heart disease. (1) Coronary heart cholesterol. Dietary lipids (fats) in- disease is a major public health conclude fatty acids and cholesterol. Total cern in the United States, primarily fat, commonly referred to as fat, is because it accounts for more deaths composed of saturated fat (fatty acids than any other disease or group of dis- containing no double bonds), and eases. Early management of risk fac- monounsaturated and polyunsaturated tors for coronary heart disease is a fat (fatty acids containing one or more major public health goal that can as- double bonds). sist in reducing risk of coronary heart (2) The scientific evidence establishes disease. There is a continuum of mor- that diets high in saturated fat and tality risk from coronary heart disease cholesterol are associated with in- that increases with increasing levels of creased levels of blood total- and LDL- blood LDL-cholesterol. Individuals cholesterol and, thus, with increased with high blood LDL-cholesterol are at risk of coronary heart disease. Diets greatest risk. A larger number of indi- low in saturated fat and cholesterol are viduals with more moderately elevated associated with decreased levels of cholesterol also have increased risk of blood total- and LDL-cholesterol, and coronary events; such individuals com- thus, with decreased risk of developing prise a substantial proportion of the coronary heart disease. adult U.S. population. The scientific (3) Populations with relatively low evidence indicates that reducing satu- blood cholesterol levels tend to have rated fat and cholesterol intakes low- dietary patterns that are not only low ers blood LDL-cholesterol and risk of in total fat, especially saturated fat heart disease in most individuals, in- and cholesterol, but are also relatively cluding persons with blood cholesterol high in fruits, vegetables, and grain levels in the normal range. Addition- products. Although the specific roles of ally, consuming diets high in fruits, these plant foods are not yet fully un- vegetables, and grain products, foods derstood, many studies have shown that contain soluble fiber, may be a that diets high in plant foods are asso- useful adjunct to a low saturated fat ciated with reduced risk of coronary and low cholesterol diet. heart disease. These studies correlate (2) Other risk factors for coronary diets rich in fruits, vegetables, and heart disease include a family history grain products and nutrients from of heart disease, high blood pressure, these diets, such as some types of fiber, diabetes, cigarette smoking, obesity with reduced coronary heart disease (body weight 30 percent greater than risk. Persons consuming these diets ideal body weight), and lack of regular frequently have high intakes of dietary physical exercise. fiber, particularly soluble fibers. Cur- (3) Intakes of saturated fat exceed rently, there is not scientific agree- recommended levels in many people in ment as to whether a particular type of the United States. Intakes of choles- soluble fiber is beneficial, or whether terol are, on average, at or above rec- the observed protective effects of ommended levels. Intakes of fiber-con- fruits, vegetables, and grain products taining fruits, vegetables, and grain against heart disease are due to other products are about half of rec- components, or a combination of com- ommended intake levels. One of the ponents, in these diets, including, but major public health recommendations not necessarily limited to, some types relative to coronary heart disease risk of soluble fiber, other fiber compo- is to consume less than 10 percent of nents, other characteristics of the com- calories from saturated fat, and an av- plex carbohydrate content of these erage of 30 percent or less of total cal- foods, other nutrients in these foods, or ories from all fat. Recommended daily displacement of saturated fat and cho- cholesterol intakes are 300 mg or less lesterol from the diet. per day. Recommended total dietary

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fiber intakes are about 25 grams (g) (B) The food shall meet the nutrient daily, of which about 25 percent (about content requirements of § 101.62 for a 6 g) should be soluble fiber. ‘‘low saturated fat,’’ ‘‘low cholesterol,’’ (4) Current dietary guidance rec- and ‘‘low fat’’ food. ommendations encourage decreased (C) The food contains, without for- consumption of dietary fat, especially tification, at least 0.6 g of soluble fiber saturated fat and cholesterol, and in- per reference amount customarily con- creased consumption of fiber-rich foods sumed; to help lower blood LDL-cholesterol (D) The content of soluble fiber shall levels. Results of numerous studies be declared in the nutrition informa- have shown that fiber-containing tion panel, consistent with fruits, vegetables, and grain products § 101.9(c)(6)(i)(A). can help lower blood LDL-cholesterol. (d) Optional information. (1) The claim (c) Requirements. (1) All requirements may identify one or more of the fol- set forth in § 101.14 shall be met. lowing risk factors for heart disease (2) Specific requirements—(i) Nature of about which there is general scientific the claim. A health claim associating agreement: A family history of coro- diets low in saturated fat and choles- nary heart disease, elevated blood-, terol and high in fruits, vegetables, and total- and LDL-cholesterol, excess grain products that contain fiber, par- body weight, high blood pressure, ciga- ticularly soluble fiber, with reduced rette smoking, diabetes, and physical risk of heart disease may be made on the label or labeling of a food described inactivity. in paragraph (c)(2)(ii) of this section, (2) The claim may indicate that the provided that: relationship of diets low in saturated (A) The claim states that diets low in fat and cholesterol, and high in fruits, saturated fat and cholesterol and high vegetables, and grain products that in fruits, vegetables, and grain prod- contain fiber to heart disease is ucts that contain fiber ‘‘may’’ or through the intermediate link of ‘‘might’’ reduce the risk of heart dis- ‘‘blood cholesterol’’ or ‘‘blood total- ease; and LDL-cholesterol.’’ (B) In specifying the disease, the (3) The claim may include informa- claim uses the following terms: ‘‘heart tion from paragraphs (a) and (b) of this disease’’ or ‘‘coronary heart disease;’’ section, which summarize the relation- (C) The claim is limited to those ship between diets low in saturated fat fruits, vegetables, and grains that con- and cholesterol and high in fruits, tain fiber; vegetables, and grain products that (D) In specifying the dietary fiber, contain fiber and coronary heart dis- the claim uses the term ‘‘fiber,’’ ‘‘die- ease, and the significance of the rela- tary fiber,’’ ‘‘some types of dietary tionship. fiber,’’ ‘‘some dietary fibers,’’ or ‘‘some (4) In specifying the nutrients, the fibers;’’ the term ‘‘soluble fiber’’ may claim may include the term ‘‘total fat’’ be used in addition to these terms; in addition to the terms ‘‘saturated (E) In specifying the fat component, fat’’ and ‘‘cholesterol.’’ the claim uses the terms ‘‘saturated (5) The claim may indicate that it is fat’’ and ‘‘cholesterol;’’ and consistent with ‘‘Nutrition and Your (F) The claim indicates that develop- Health: Dietary Guidelines for Ameri- ment of heart disease depends on many cans,’’ U.S. Department of Agriculture factors; and (USDA) and Department of Health and (G) The claim does not attribute any Human Services (DHHS), Government degree of risk reduction for coronary Printing Office (GPO). heart disease to diets low in saturated (6) The claim may state that individ- fat and cholesterol and high in fruits, uals with elevated blood total- and vegetables, and grain products that LDL-cholesterol should consult their contain fiber. physicians for medical advice and (ii) Nature of the food. (A) The food treatment. If the claim defines high or shall be or shall contain a fruit, vege- normal blood total- and LDL-choles- table, or grain product. terol levels, then the claim shall state

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that individuals with high blood cho- ciated with reduced risk of some types lesterol should consult their physicians of cancers. These studies correlate for medical advice and treatment. diets rich in fruits and vegetables and (7) The claim may include informa- nutrients from these diets, such as vi- tion on the number of people in the tamin C, vitamin A, and dietary fiber, United States who have heart disease. with reduced cancer risk. Persons con- The sources of this information shall suming these diets frequently have be identified, and it shall be current in- high intakes of these nutrients. Cur- formation from the National Center for rently, there is not scientific agree- Health Statistics, the National Insti- ment as to whether the observed pro- tutes of Health, or ‘‘Nutrition and Your tective effects of fruits and vegetables Health: Dietary Guidelines for Ameri- against cancer are due to a combina- cans,’’ USDA and DHHS, GPO. tion of the nutrient components of (e) Model health claims. The following diets rich in fruits and vegetables, in- model health claims may be used in cluding but not necessarily limited to food labeling to characterize the rela- dietary fiber, vitamin A (as beta-caro- tionship between diets low in saturated tene) and vitamin C, to displacement of fat and cholesterol and high in fruits, fat from such diets, or to intakes of vegetables, and grain products that other substances in these foods which contain soluble fiber: are not nutrients but may be protec- (1) Diets low in saturated fat and tive against cancer risk. cholesterol and rich in fruits, vegeta- (b) Significance of the relationship be- bles, and grain products that contain tween consumption of diets low in fat and some types of dietary fiber, particu- high in fruits and vegetables and risk of larly soluble fiber, may reduce the risk cancer. (1) Cancer is ranked as a leading of heart disease, a disease associated cause of death in the United States. with many factors. The overall economic costs of cancer, (2) Development of heart disease de- including direct health care costs and pends on many factors. Eating a diet losses due to morbidity and mortality, low in saturated fat and cholesterol are very high. and high in fruits, vegetables, and (2) U.S. diets tend to be high in fat grain products that contain fiber may and low in fruits and vegetables. Stud- lower blood cholesterol levels and re- ies in various parts of the world indi- duce your risk of heart disease. cate that populations who habitually [58 FR 2578, Jan. 6, 1993] consume a diet high in plant foods have lower risks of some cancers. These § 101.78 Health claims: fruits and vege- diets generally are low in fat and rich tables and cancer. in many nutrients, including, but not (a) Relationship between substances in limited to, dietary fiber, vitamin A (as diets low in fat and high in fruits and beta-carotene), and vitamin C. Current vegetables and cancer risk. (1) Cancer is dietary guidelines from Federal Gov- a constellation of more than 100 dif- ernment agencies and nationally recog- ferent diseases, each characterized by nized health professional organizations the uncontrolled growth and spread of recommend decreased consumption of abnormal cells. Cancer has many fats (less than 30 percent of calories), causes and stages in its development. maintenance of desirable body weight, Both genetic and environmental risk and increased consumption of fruits factors may affect the risk of cancer. and vegetables (5 or more servings Risk factors include a family history of daily), particularly those fruits and a specific type of cancer, cigarette vegetables which contain dietary fiber, smoking, alcohol consumption, over- vitamin A, and vitamin C. weight and obesity, ultraviolet or ion- (c) Requirements. (1) All requirements izing radiation, exposure to cancer- set forth in § 101.14 shall be met. causing chemicals, and dietary factors. (2) Specific requirements—(i) Nature of (2) Although the specific roles of the the claim. A health claim associating numerous potentially protective sub- substances in diets low in fat and high stances in plant foods are not yet unin fruits and vegetables with reduced derstood, many studies have shown risk of cancer may be made on the that diets high in plant foods are asso- label or labeling of a food described in

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paragraph (c)(2)(ii) of this section, pro- development of cancer: Family history vided that: of a specific type of cancer, cigarette (A) The claim states that diets low in smoking, alcohol consumption, over- fat and high in fruits and vegetables weight and obesity, ultraviolet or ion- ‘‘may’’ or ‘‘might’’ reduce the risk of izing radiation, exposure to cancer- some cancers; causing chemicals, and dietary factors. (B) In specifying the disease, the (3) The claim may use the word claim uses the following terms: ‘‘some ‘‘beta-carotene’’ in parentheses after types of cancer’’, or ‘‘some cancers’’; the term vitamin A, provided that the (C) The claim characterizes fruits vitamin A in the food bearing the and vegetables as foods that are low in claim is beta-carotene. fat and may contain vitamin A, vita- (4) The claim may indicate that it is min C, and dietary fiber; consistent with ‘‘Nutrition and Your (D) The claim characterizes the food Health: Dietary Guidelines for Ameri- bearing the claim as containing one or cans,’’ U.S. Department of Agriculture more of the following, for which the (USDA) and the Department of Health food is a good source under § 101.54: die- and Human Services (DHHS), Govern- tary fiber, vitamin A, or vitamin C; ment Printing Office. (E) The claim does not attribute any (5) The claim may include informa- degree of cancer risk reduction to diets tion on the number of people in the low in fat and high in fruits and vege- United States who have cancer. The tables; sources of this information must be (F) In specifying the fat component identified, and it must be current infor- of the labeled food, the claim uses the mation from the National Center for term ‘‘total fat’’ or ‘‘fat’’; Health Statistics, the National Insti- (G) The claim does not specify types tutes of Health, or ‘‘Nutrition and Your of fats or fatty acids that may be re- Health: Dietary Guidelines for Ameri- lated to risk of cancer; cans,’’ USDA and DHHS, Government (H) In specifying the dietary fiber Printing Office. component of the labeled food, the (e) Model health claims. The following claim uses the term ‘‘fiber’’, ‘‘dietary model health claims may be used in fiber’’, or ‘‘total dietary fiber’’; food labeling to characterize the rela- (I) The claim does not specify types tionship between substances in diets of dietary fiber that may be related to low in fat and high in fruits and vege- risk of cancer; and tables and cancer: (J) The claim indicates that develop- (1) Low fat diets rich in fruits and ment of cancer depends on many fac- vegetables (foods that are low in fat tors. and may contain dietary fiber, vitamin (ii) Nature of the food. (A) The food A, and vitamin C) may reduce the risk shall be or shall contain a fruit or veg- of some types of cancer, a disease asso- etable. ciated with many factors. Broccoli is (B) The food shall meet the nutrient high in vitamins A and C, and it is a content requirements of § 101.62 for a good source of dietary fiber. ‘‘low fat’’ food. (2) Development of cancer depends on (C) The food shall meet, without for- many factors. Eating a diet low in fat tification, the nutrient content re- and high in fruits and vegetables, foods quirements of § 101.54 for a ‘‘good that are low in fat and may contain vi- source’’ of at least one of the following: tamin A, vitamin C, and dietary fiber, vitamin A, vitamin C, or dietary fiber. may reduce your risk of some cancers. (d) Optional information. (1) The claim Oranges, a food low in fat, are a good may include information from para- source of fiber and vitamin C. graphs (a) and (b) of this section, which [58 FR 2639, Jan. 6, 1993] summarize the relationship between diets low in fat and high in fruits and § 101.79 Health claims: Folate and neu- vegetables and some types of cancer ral tube defects. and the significance of the relation- (a) Relationship between folate and ship. neural tube defects—(1) Definition. Neu- (2) The claim may identify one or ral tube defects are serious birth de- more of the following risk factors for fects of the brain or spinal cord that

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can result in infant mortality or seri- ily history of these defects. The avail- ous disability. The birth defects able evidence shows that diets ade- anencephaly and spina bifida are the quate in folate may reduce the risk of most common forms of neural tube de- neural tube defects but not of other fects and account for about 90 percent birth defects. of these defects. These defects result (2) Populations at risk. Prevalence from failure of closure of the covering rates for neural tube defects have been of the brain or spinal cord during early reported to vary with a wide range of embryonic development. Because the factors including genetics, geography, neural tube forms and closes during socioeconomic status, maternal birth early pregnancy, the defect may occur cohort, month of conception, race, nu- before a woman realizes that she is trition, and maternal health, including pregnant. maternal age and reproductive history. (2) Relationship. The available data Women with a close relative (i.e., sib- show that diets adequate in folate may ling, niece, nephew) with a neural tube reduce the risk of neural tube defects. The strongest evidence for this rela- defect, those with insulin-dependent di- tionship comes from an intervention abetes mellitus, and women with sei- study by the Medical Research Council zure disorders who are being treated of the United Kingdom that showed with valproic acid or carbamazepine that women at risk of recurrence of a are at significantly increased risk com- neural tube defect pregnancy who con- pared with women without these char- sumed a supplement containing 4 milli- acteristics. Rates for neural tube de- grams (mg)(4,000 micrograms (mcg)) fects vary within the United States, folic acid daily before conception and with lower rates observed on the west continuing into early pregnancy had a coast than on the east coast. reduced risk of having a child with a (3) Those who may benefit. Based on a neural tube defect. (Products con- synthesis of information from several taining this level of folic acid are studies, including those which used drugs). In addition, based on its review multivitamins containing folic acid at of a Hungarian intervention trial that a daily dose level of ≥400 mcg (≥0.4 mg), reported periconceptional use of a the Public Health Service has inferred multivitamin and multimineral prepa- that folate alone at levels of 400 mcg ration containing 800 mcg (0.8 mg) of (0.4 mg) per day may reduce the risk of folic acid, and its review of the obser- neural tube defects. The protective ef- vational studies that reported fect found in studies of lower dose periconceptional use of multivitamins folate measured by the reduction in containing 0 to 1,000 mcg of folic acid, neural tube defect incidence, ranges the Food and Drug Administration con- from none to substantial; a reasonable cluded that most of these studies had estimate of the expected reduction in results consistent with the conclusion the United States is 50 percent. It is ex- that folate, at levels attainable in pected that consumption of adequate usual diets, may reduce the risk of neu- folate will avert some, but not all, neural tube defects. ral tube defects. The underlying causes (b) Significance of folate—(1) Public of neural tube defects are not known. health concern. Neural tube defects occur in approximately 0.6 of 1,000 live Thus, it is not known what proportion births in the United States (i.e., ap- of neural tube defects will be averted proximately 6 of 10,000 live births; by adequate folate consumption. From about 2,500 cases among 4 million live the available evidence, the Public births annually). Neural tube defects Health Service estimates that there is are believed to be caused by many fac- the potential for averting 50 percent of tors. The single greatest risk factor for cases that now occur (i.e., about 1,250 a neural tube defect-affected pregnancy cases annually). However, until further is a personal or family history of a research is done, no firm estimate of pregnancy affected with a such a de- this proportion will be available. fect. However, about 90 percent of in- (c) Requirements. The label or labeling fants with a neural tube defect are of food may contain a folate/neural born to women who do not have a fam- tube defect health claim provided that:

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(1) General requirements. The health intake with respect to the DV. The safe claim for a food meets all of the gen- upper limit of daily intake value of eral requirements of § 101.14 for health 1,000 mcg (1 mg) may be included in pa- claims, except that a food may qualify rentheses. to bear the health claim if it meets the (G) The claim shall state that folate definition of the term ‘‘good source.’’ needs to be consumed as part of a (2) Specific requirements—(i) Nature of healthful diet. the claim—(A) Relationship. A health (ii) Nature of the food—(A) Require- claim that women who are capable of ments. The food shall meet or exceed becoming pregnant and who consume the requirements for a ‘‘good source’’ adequate amounts of folate daily dur- of folate as defined in § 101.54; ing their childbearing years may reduce their risk of having a pregnancy (B) Dietary supplements. Dietary sup- affected by spina bifida or other neural plements shall meet the United States tube defects may be made on the label Pharmacopeia (USP) standards for dis- or labeling of food provided that: integration and dissolution, except (B) Specifying the nutrient. In speci- that if there are no applicable USP fying the nutrient, the claim shall use standards, the folate in the dietary the terms ‘‘folate,’’ ‘‘folic acid,’’ supplement shall be shown to be bio- ‘‘folacin,’’ ‘‘folate, a B vitamin,’’ ‘‘folic available under the conditions of use acid, a B vitamin,’’ or ‘‘folacin, a B vi- stated on the product label. tamin.’’ (iii) Limitation. The claim shall not (C) Specifying the condition. In speci- be made on foods that contain more fying the health- related condition, the than 100 percent of the RDI for vitamin claim shall identify the birth defects as A as retinol or preformed vitamin A or ‘‘neural tube defects,’’ ‘‘birth defects vitamin D per serving or per unit. spina bifida or anencephaly,’’ ‘‘birth (iv) Nutrition labeling. The nutrition defects of the brain or spinal cord label shall include information about anencephaly or spina bifida,’’ ‘‘spina the amount of folate in the food. This bifida and anencephaly, birth defects of information shall be declared after the the brain or spinal cord,’’ ‘‘birth de- declaration for iron if only the levels of fects of the brain or spinal cord;’’ or vitamin A, vitamin C, calcium, and ‘‘brain or spinal cord birth defects.’’ (D) Multifactorial nature. The claim iron are provided, or in accordance shall not imply that folate intake is with § 101.9 (c)(8) and (c)(9) if other op- the only recognized risk factor for neu- tional vitamins or minerals are de- ral tube defects. clared. (E) Reduction in risk. The claim shall (3) Optional information—(i) Risk fac- not attribute any specific degree of re- tors. The claim may specifically iden- duction in risk of neural tube defects tify risk factors for neural tube de- from maintaining an adequate folate fects. Where such information is pro- intake throughout the childbearing vided, it may consist of statements years. The claim shall state that some from § 101.79(b)(1) or (b)(2) (e.g., Women women may reduce their risk of a neu- at increased risk include those with a ral tube defect pregnancy by maintain- personal history of a neural tube de- ing adequate intakes of folate during fect-affected pregnancy, those with a their childbearing years. Optional close relative (i.e., sibling, niece, neph- statements about population-based es- ew) with a neural tube defect; those timates of risk reduction may be made with insulin-dependent diabetes in accordance with paragraph (c)(3)(vi) mellitus; those with seizure disorders of this section. who are being treated with valproic (F) Safe upper limit of daily intake. acid or carbamazepine) or from other Claims on foods that contain more parts of this paragraph (c)(3)(i). than 100 percent of the Daily Value (DV) (400 mcg) when labeled for use by (ii) Relationship between folate and adults and children 4 or more years of neural tube defects. The claim may in- age, or 800 mcg when labeled for use by clude statements from paragraphs (a) pregnant or lactating women) shall and (b) of this section that summarize identify the safe upper limit of daily the relationship between folate and

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neural tube defects and the signifi- amounts of folate can be obtained from cance of the relationship except for in- diets rich in fruits, including citrus formation specifically prohibited from fruits and juices, vegetables, including the claim. dark green leafy vegetables, legumes, (iii) Personal history of a neural tube whole grain products, including breads, defect-affected pregnancy. The claim rice, and pasta, fortified cereals, or a may state that women with a history dietary supplement.’’ of a neural tube defect pregnancy (d) Model health claims. The following should consult their physicians or are examples of model health claims health care providers before becoming that may be used in food labeling to de- pregnant. If such a statement is pro- scribe the relationship between folate vided, the claim shall also state that and neural tube defects: all women should consult a health care (1) Examples 1 and 2. Model health provider when planning a pregnancy. claims appropriate for foods containing (iv) Daily value. The claim may iden- 100 percent or less of the DV for folate tify 100 percent of the DV (100% DV; 400 per serving or per unit (general popu- mcg) for folate as the target intake lation). The examples contain only the goal. required elements: (v) Prevalence. The claim may provide (i) Healthful diets with adequate estimates, expressed on an annual folate may reduce a woman’s risk of basis, of the number of neural tube de- having a child with a brain or spinal fect-affected births among live births cord birth defect. in the United States. Current esti- (ii) Adequate folate in healthful diets mates are provided in § 101.79(b)(1), and may reduce a woman’s risk of having a are approximately 6 of 10,000 live births child with a brain or spinal cord birth annually (i.e., about 2,500 cases among defect. 4 million live births annually). Data (2) Example 3. Model health claim ap- provided in § 101.79(b)(1) shall be used, propriate for foods containing 100 per- unless more current estimates from the cent or less of the DV for folate per U.S. Public Health Service are avail- serving or per unit. The example con- able, in which case the latter may be tains all required elements plus op- cited. tional information: Women who con- (vi) Reduction in risk. An estimate of sume healthful diets with adequate the reduction in the number of neural folate throughout their childbearing tube defect-affected births that might years may reduce their risk of having a occur in the United States if all women child with a birth defect of the brain or consumed adequate folate throughout spinal cord. Sources of folate include their childbearing years may be in- fruits, vegetables, whole grain prod- cluded in the claim. Information con- ucts, fortified cereals, and dietary sup- tained in paragraph (b)(3) of this sec- plements. tion may be used. If such an estimate (3) Example 4. Model health claim ap- (i.e., 50 percent) is provided, the esti- propriate for foods intended for use by mate shall be accompanied by addi- the general population and containing tional information that states that the more than 100 percent of the DV of estimate is population-based and that folate per serving or per unit: Women it does not reflect risk reduction that who consume healthful diets with ade- may be experienced by individual quate folate may reduce their risk of women. having a child with birth defects of the (vii) Diets adequate in folate. The brain or spinal cord. Folate intake claim may identify diets adequate in should not exceed 250% of the DV (1,000 folate by using phrases such as mcg). ‘‘Sources of folate include fruits, vege- [61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, tables, whole grain products, fortified 1996, as amended at 65 FR 58918, Oct. 3, 2000] cereals, and dietary supplements.’’ or ‘‘Adequate amounts of folate can be ob- § 101.80 Health claims: dietary tained from diets rich in fruits, dark noncariogenic carbohydrate sweet- green leafy vegetables, legumes, whole eners and dental caries. grain products, fortified cereals, or die- (a) Relationship between dietary carbo- tary supplements.’’ or ‘‘Adequate hydrates and dental caries. (1) Dental

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caries, or tooth decay, is a disease ly metabolized by bacteria to form caused by many factors. Both environ- some acid. The rate and amount of acid mental and genetic factors can affect production is significantly less than the development of dental caries. Risk that from sucrose and other ferment- factors include tooth enamel crystal able carbohydrates and does not cause structure and mineral content, plaque the loss of important minerals from quantity and quality, saliva quantity tooth enamel. and quality, individual immune re- (c) Requirements. (1) All requirements sponse, types and physical characteris- set forth in § 101.14 shall be met, except tics of foods consumed, eating behav- that noncariogenic carbohydrate iors, presence of acid producing oral sweetener-containing foods listed in bacteria, and cultural influences. paragraph (c)(2)(ii) of this section are (2) The relationship between con- exempt from § 101.14(e)(6). sumption of fermentable carbo- (2) Specific requirements—(i) Nature of hydrates, i.e., dietary sugars and the claim. A health claim relating starches, and tooth decay is well estab- noncariogenic carbohydrate sweet- lished. Sucrose, also known as sugar, is eners, compared to other carbo- one of the most, but not the only, hydrates, and the nonpromotion of den- cariogenic sugars in the diet. Bacteria tal caries may be made on the label or found in the mouth are able to metabo- labeling of a food described in para- lize most dietary carbohydrates, pro- graph (c)(2)(iii) of this section, producing acid and forming dental plaque. vided that: The more frequent and longer the expo- (A) The claim shall state that fre- sure of teeth to dietary sugars and quent between-meal consumption of starches, the greater the risk for tooth foods high in sugars and starches can decay. promote tooth decay. (3) Dental caries continues to affect a (B) The claim shall state that the large proportion of Americans. Al- noncariogenic carbohydrate sweetener though there has been a decline in the present in the food ‘‘does not pro- prevalence of dental caries among chil- mote,’’ ‘‘may reduce the risk of,’’ dren in the United States, the disease ‘‘useful [or is useful] in not pro- remains widespread throughout the moting,’’ or ‘‘expressly [or is expressly] population, imposing a substantial bur- for not promoting’’ dental caries. den on Americans. Recent Federal gov- (C) In specifying the nutrient, the ernment dietary guidelines recommend claim shall state ‘‘sugar alcohol,’’ that Americans choose diets that are ‘‘sugar alcohols,’’ or the name or moderate in sugars and avoid excessive names of the substances listed in para- snacking. Frequent between-meal graph (c)(2)(ii) of this section, e.g., snacks that are high in sugars and ‘‘sorbitol.’’ D-tagatose may be identi- starches may be more harmful to teeth fied as ‘‘tagatose.’’ than eating such foods at meals and (D) In specifying the disease, the then brushing. claim uses the following terms: ‘‘dental (4) Noncariogenic carbohydrate caries’’ or ‘‘tooth decay.’’ sweeteners, such as sugar alcohols, can (E) The claim shall not attribute any be used to replace dietary sugars, such degree of the reduction in risk of den- as sucrose and corn sweeteners, in tal caries to the use of the foods such as chewing gums and cer- noncariogenic carbohydrate sweetener- tain confectioneries. Noncariogenic containing food. carbohydrate sweeteners are signifi- (F) The claim shall not imply that cantly less cariogenic than dietary sug- consuming noncariogenic carbohydrate ars and other fermentable carbo- sweetener-containing foods is the only hydrates. recognized means of achieving a re- (b) Significance of the relationship be- duced risk of dental caries. tween noncariogenic carbohydrate sweet- (G) Packages with less than 15 square eners and dental caries. Noncariogenic inches of surface area available for la- carbohydrate sweeteners do not pro- beling are exempt from paragraphs (A) mote dental caries. The noncariogenic and (C) of this section. carbohydrate sweeteners listed in para- (H) When the substance that is the graph (c)(2)(ii) of this section are slow- subject of the claim is a noncariogenic

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sugar, the claim shall identify the sub- (d) Optional information. (1) The claim stance as a sugar that, unlike other may include information from para- sugars, does not promote the develop- graphs (a) and (b) of this section, which ment of dental caries. describe the relationship between diets (ii) Nature of the substance. Eligible containing noncariogenic carbohydrate noncariogenic carbohydrate sweeteners sweeteners and dental caries. are: (2) The claim may indicate that de- (A) The sugar alcohols xylitol, sor- velopment of dental caries depends on bitol, mannitol, maltitol, isomalt, many factors and may identify one or lactitol, hydrogenated starch hydroly- more of the following risk factors for sates, hydrogenated glucose syrups, dental caries: Frequent consumption of and erythritol, or a combination of fermentable carbohydrates, such as di- these. etary sugars and starches; presence of (B) The sugars D-tagatose and oral bacteria capable of fermenting isomaltulose. carbohydrates; length of time fermentable carbohydrates are in contact with (C) Sucralose. the teeth; lack of exposure to fluoride; (iii) Nature of the food. (A) The food individual susceptibility; socio- shall meet the requirement in economic and cultural factors; and § 101.60(c)(1)(i) with respect to sugars characteristics of tooth enamel, saliva, content, except that the food may con- and plaque. tain D-tagatose or isomaltulose. (3) The claim may indicate that oral (B) A food whose labeling includes a hygiene and proper dental care may health claim under this section shall help to reduce the risk of dental dis- contain one or more of the ease. noncariogenic carbohydrate sweeteners (4) The claim may indicate that a listed in paragraph (c)(2)(ii) of this sec- substance listed in paragraph (c)(2)(ii) tion. of this section serves as a sweetener. (C) When carbohydrates other than (e) Model health claim. The following those listed in paragraph (c)(2)(ii) of model health claims may be used in this section are present in the food, the food labeling to describe the relation- food shall not lower plaque pH below ship between noncariogenic carbo- 5.7 by bacterial fermentation either hydrate sweetener-containing foods during consumption or up to 30 min- and dental caries. utes after consumption, as measured (1) Examples of the full claim: by the indwelling plaque pH test found (i) Frequent eating of foods high in in ‘‘Identification of Low Caries Risk sugars and starches as between-meal Dietary Components,’’ dated 1983, by T. snacks can promote tooth decay. The N. Imfeld, in Volume 11, Monographs in sugar alcohol [name, optional] used to Oral Science, 1983. The Director of the sweeten this food may reduce the risk Office of the Federal Register has ap- of dental caries. proved the incorporation by reference (ii) Frequent between-meal consump- of this material in accordance with 5 tion of foods high in sugars and starch- U.S.C. 552(a) and 1 CFR part 51. You es promotes tooth decay. The sugar al- may obtain copies from Karger AG cohols in [name of food] do not pro- Publishing Co., P.O. Box, Ch–4009 mote tooth decay. Basel, Switzerland, or you may exam- (iii) Frequent eating of foods high in ine a copy at the Food and Drug Ad- sugars and starches as between-meal ministration’s Main Library, 10903 New snacks can promote tooth decay. Hampshire Ave., Bldg. 2, Third Floor, [Name of sugar from paragraph Silver Spring, MD 20993, 301–796–2039, or (c)(2)(ii)(B) of this section], the sugar at the National Archives and Records used to sweeten this food, unlike other Administration (NARA). For informa- sugars, may reduce the risk of dental tion on the availability of this mate- caries. rial at NARA, call 202–741–6030, or go (iv) Frequent between-meal consump- to: http://www.archives.gov/ tion of foods high in sugars and starch- federallregister/ es promotes tooth decay. [Name of codeloflfederallregulations/ sugar from paragraph (c)(2)(ii)(B) of ibrllocations.html. this section], the sugar in [name of

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food], unlike other sugars, does not blood total cholesterol and LDL-cho- promote tooth decay. lesterol levels. These populations also (v) Frequent eating of foods high in tend to have dietary patterns that are sugars and starches as between-meal not only low in total fat, especially snacks can promote tooth decay. saturated fat and cholesterol, but are Sucralose, the sweetening ingredient also relatively high in fiber-containing used to sweeten this food, unlike sug- fruits, vegetables, and grain products, ars, does not promote tooth decay. such as whole oat products. (2) Example of the shortened claim (3) Scientific evidence demonstrates for small packages: that diets low in saturated fat and cho- (i) Does not promote tooth decay. lesterol may reduce the risk of CHD. (ii) May reduce the risk of tooth Other evidence demonstrates that the decay. addition of soluble fiber from certain (iii) [Name of sugar from paragraph foods to a diet that is low in saturated (c)(2)(ii)(B) of this section] sugar does fat and cholesterol may also help to re- not promote tooth decay. duce the risk of CHD. (iv) [Name of sugar from paragraph (b) Significance of the relationship be- (c)(2)(ii)(B) of this section] sugar may tween diets that are low in saturated fat reduce the risk of tooth decay. and cholesterol and that include soluble fiber from certain foods and the risk of [61 FR 43446, Aug. 23, 1996, as amended at 62 CHD. (1) CHD is a major public health FR 63655, Dec. 2, 1997; 66 FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, concern in the United States. It ac- Mar. 29, 2006; 72 FR 52789, Sept. 17, 2007; 81 FR counts for more deaths than any other 5590, Feb. 3, 2016] disease or group of diseases. Early management of risk factors for CHD is § 101.81 Health claims: Soluble fiber a major public health goal that can as- from certain foods and risk of coro- sist in reducing risk of CHD. High nary heart disease (CHD). blood total and LDL-cholesterol are (a) Relationship between diets that are major modifiable risk factors in the de- low in saturated fat and cholesterol and velopment of CHD. that include soluble fiber from certain (2) Intakes of saturated fat exceed foods and the risk of CHD. (1) Cardio- recommended levels in the diets of vascular disease means diseases of the many people in the United States. One heart and circulatory system. Coro- of the major public health rec- nary heart disease (CHD) is one of the ommendations relative to CHD risk is most common and serious forms of car- to consume less than 10 percent of cal- diovascular disease and refers to dis- ories from saturated fat and an average eases of the heart muscle and sup- of 30 percent or less of total calories porting blood vessels. High blood total from all fat. Recommended daily cho- cholesterol and low density lipoprotein lesterol intakes are 300 milligrams (LDL)-cholesterol levels are associated (mg) or less per day. Scientific evi- with increased risk of developing coro- dence demonstrates that diets low in nary heart disease. High CHD rates saturated fat and cholesterol are asso- occur among people with high total ciated with lower blood total- and cholesterol levels of 240 milligrams per LDL-cholesterol levels. Soluble fiber deciliter (mg/dL) (6.21 (mmol/L)) or from certain foods, when included in a above and LDL-cholesterol levels of 160 low saturated fat and cholesterol diet, mg/dL (4.13 mmol/L) or above. Border- also helps to lower blood total- and line high risk total cholesterol levels LDL-cholesterol levels. range from 200 to 239 mg/dL (5.17 to 6.18 (c) Requirements. (1) All requirements mmol/L) and 130 to 159 mg/dL (3.36 to set forth in § 101.14 shall be met. The 4.11 mmol/L) of LDL-cholesterol. The label and labeling of foods containing scientific evidence establishes that psyllium husk shall be consistent with diets high in saturated fat and choles- the provisions of § 101.17(f). terol are associated with increased lev- (2) Specific requirements—(i) Nature of els of blood total- and LDL-cholesterol the claim. A health claim associating and, thus, with increased risk of CHD. diets that are low in saturated fat and (2) Populations with a low incidence cholesterol and that include soluble of CHD tend to have relatively low fiber from certain foods with reduced

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risk of heart disease may be made on glucan soluble fiber will be determined the label or labeling of a food described by method No. 992.28 from the ‘‘Official in paragraph (c)(2)(iii) of this section, Methods of Analysis of the AOAC provided that: INTERNATIONAL,’’ 16th ed. (1995), (A) The claim states that diets that which is incorporated by reference in are low in saturated fat and cholesterol accordance with 5 U.S.C. 552(a) and 1 and that include soluble fiber from cer- CFR part 51. Copies may be obtained tain foods ‘‘may’’ or ‘‘might’’ reduce from the AOAC INTERNATIONAL, 481 the risk of heart disease. North Frederick Ave., suite 500, Gai- (B) In specifying the disease, the thersburg, MD 20877, or may be exam- claim uses the following terms: ‘‘heart ined at the Food and Drug Administra- disease’’ or ‘‘coronary heart disease’’; tion’s Main Library, 10903 New Hamp- (C) In specifying the substance, the shire Ave., Bldg. 2, Third Floor, Silver claim uses the term ‘‘soluble fiber’’ Spring, MD 20993, 301–796–2039, or at the qualified by the name of the eligible National Archives and Records Admin- source of soluble fiber (provided in istration (NARA). For information on paragraph (c)(2)(ii)) of this section. Ad- the availability of this material at ditionally, the claim may use the name NARA, call 202–741–6030, or go to: http:// of the food product that contains the www.archives.gov/federallregister/ eligible source of soluble fiber; codeloflfederallregulations/ (D) In specifying the fat component, ibrllocations.html; the claim uses the terms ‘‘saturated (1) Oat bran. Oat bran is produced by fat’’ and ‘‘cholesterol’’; grinding clean oat groats or rolled oats (E) The claim does not attribute any and separating the resulting oat flour degree of risk reduction for CHD to by suitable means into fractions such diets that are low in saturated fat and that the oat bran fraction is not more cholesterol and that include soluble than 50 percent of the original starting fiber from the eligible food sources material and provides at least 5.5 per- from paragraph (c)(2)(ii) of this section; cent (dry weight basis (dwb)) b-glucan and soluble fiber and a total dietary fiber (F) The claim does not imply that content of 16 percent (dwb), and such consumption of diets that are low in that at least one-third of the total die- saturated fat and cholesterol and that tary fiber is soluble fiber; include soluble fiber from the eligible (2) Rolled oats. Rolled oats, also food sources from paragraph (c)(2)(ii) of known as oatmeal, produced from 100 this section is the only recognized percent dehulled, clean oat groats by means of achieving a reduced risk of steaming, cutting, rolling, and flaking, CHD. and provides at least 4 percent (dwb) of (G) The claim specifies the daily die- b-glucan soluble fiber and a total dietary intake of the soluble fiber source tary fiber content of at least 10 per- that is necessary to reduce the risk of cent. coronary heart disease and the con- (3) Whole oat flour. Whole oat flour is tribution one serving of the product produced from 100 percent dehulled, makes to the specified daily dietary in- clean oat groats by steaming and take level. Daily dietary intake levels grinding, such that there is no signifi- of soluble fiber sources listed in para- cant loss of oat bran in the final prod- graph (c)(2)(ii) of this section that have uct, and provides at least 4 percent been associated with reduced risk coro- (dwb) of b-glucan soluble fiber and a nary heart disease are: total dietary fiber content of at least (1) 3 g or more per day of b-glucan 10 percent (dwb). soluble fiber from either whole oats or (4) Oatrim. The soluble fraction of barley, or a combination of whole oats alpha-amylase hydrolyzed oat bran or and barley. whole oat flour, also known as oatrim. (2) 7 g or more per day of soluble fiber Oatrim is produced from either oat from psyllium seed husk. bran as defined in paragraph (ii) Nature of the substance—Eligible (c)(2)(ii)(A)(1) of this section or whole sources of soluble fiber. (A) Beta (b) oat flour as defined in paragraph glucan soluble fiber from the whole oat (c)(2)(ii)(A)(3) of this section by and barley sources listed below. b- solubilization of the starch in the 171

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starting material with an alpha-amy- the bran, germ, and endosperm. Sieved lase hydrolysis process, and then re- barley meal is an endosperm cell wall- moval by centrifugation of the insol- enriched fraction of ground barley sep- uble components consisting of a high arated from meal by sieving or by air portion of protein, lipid, insoluble die- classification. tary fiber, and the majority of the fla- (6) Barley betafiber. Barley betafiber vor and color components of the start- is the ethanol precipitated soluble frac- ing material. Oatrim shall have a beta- tion of cellulase and alpha-amylase glucan soluble fiber content up to 10 hydrolyzed whole grain barley. Barley percent (dwb) and not less than that of betafiber is produced by hydrolysis of the starting material (dwb). whole grain barley flour, as defined in (5) Whole grain barley and dry milled paragraph (c)(2)(ii)(A)(5) of this sec- barley. Dehulled and hull-less whole tion, with a cellulase and alpha-amy- grain barley with a b-glucan soluble lase enzyme preparation, to produce a fiber content of at least 4 percent (dwb) clear aqueous extract that contains and a total dietary fiber content of at mainly partially hydrolyzed beta- least 10 percent (dwb). Dry milled bar- glucan and substantially hydrolyzed ley grain products include barley bran, starch. The soluble, partially barley flakes, barley grits, pearl bar- hydrolyzed beta-glucan is separated ley, barley flour, barley meal, and from the insoluble material by cen- sieved barley meal that are produced trifugation, and after removal of the from clean, sound dehulled or hull-less insoluble material, the partially barley grain using standard dry milling hydrolyzed beta-glucan soluble fiber is techniques, which may include steam- separated from the other soluble coming or tempering, and that contain at pounds by precipitation with ethanol. least 4 percent (dwb) of b-glucan solu- The product is then dried, milled and ble fiber and at least 8 percent (dwb) of sifted. Barley betafiber shall have a total dietary fiber, except barley bran beta-glucan soluble fiber content of at and sieved barley meal for which the least 70 percent on a dry weight basis. minimum b-glucan soluble fiber con- (B)(1) Psyllium husk from the dried tent is 5.5 percent (dwb) and minimum seed coat (epidermis) of the seed of total dietary fiber content is 15 percent Plantago (P.) ovata, known as blond (dwb). Dehulled barley, hull-less bar- psyllium or Indian psyllium, P. indica, ley, barley bran, barley flakes, barley or P. psyllium. To qualify for this grits, pearl barley, and barley flour are claim, psyllium seed husk, also known as defined in the Barley Glossary as psyllium husk, shall have a purity of (AACC Method 55–99), published in Ap- no less than 95 percent, such that it proved Methods of the American Asso- contains 3 percent or less protein, 4.5 ciation of Cereal Chemists, 10th ed. percent or less of light extraneous mat- (2000), pp. 1 and 2, which is incor- ter, and 0.5 percent or less of heavy ex- porated by reference in accordance traneous matter, but in no case may with 5 U.S.C. 552(a) and 1 CFR part 51. the combined extraneous matter ex- Copies may be obtained from the Amer- ceed 4.9 percent, as determined by U.S. ican Association of Cereal Chemists, Pharmacopeia (USP) methods de- Inc., 3340 Pilot Knob Rd., St. Paul, Min- scribed in USP’s ‘‘The National For- nesota, 55121, or may be examined at mulary,’’ USP 23, NF 18, p. 1341, (1995), the Food and Drug Administration’s which is incorporated by reference in Main Library, 10903 New Hampshire accordance with 5 U.S.C. 552(a) and 1 Ave., Bldg. 2, Third Floor, Silver CFR part 51. Copies may be obtained Spring, MD 20993, 301–796–2039, or at the from the U.S. Pharmacopeial Conven- National Archives and Records Admin- tion, Inc., 12601 Twinbrook Pkwy., istration (NARA). For information on Rockville, MD 20852, or may be exam- the availability of this material at ined at the Food and Drug Administra- NARA, call 202–741–6030, or go to: http:// tion’s Main Library, 10903 New Hamp- www.archives.gov/federallregister/ shire Ave., Bldg. 2, Third Floor, Silver codeloflfederallregulations/ Spring, MD 20993, 301–796–2039, or at the ibrllocations.html. Barley meal is National Archives and Records Admin- unsifted, ground barley grain not sub- istration (NARA). For information on jected to any processing to separate the availability of this material at

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NARA, call 202–741–6030, or go to: http:// (B) The amount of soluble fiber shall www.archives.gov/federallregister/ be declared in the nutrition label, con- codeloflfederallregulations/ sistent with § 101.9(c)(6)(i)(A). ibrllocations.html; (C) The food shall meet the nutrient (2) FDA will determine the amount of content requirement in § 101.62 for a soluble fiber that is provided by psyl- ‘‘low saturated fat’’ and ‘‘low choles- lium husk by using a modification of terol’’ food; and the Association of Official Analytical (D) The food shall meet the nutrient Chemists’ International (AOAC’s) content requirement in § 101.62(b)(2) for method for soluble dietary fiber (991.43) a ‘‘low fat’’ food, unless the food ex- described by Lee et al., ‘‘Determination ceeds this requirement due to fat con- of Soluble and Insoluble Dietary Fiber tent derived from whole oat sources in Psyllium-containing Cereal Prod- listed in paragraph (c)(2)(ii)(A) of this ucts,’’ Journal of the AOAC Inter- section. national, 78 (No. 3):724–729, 1995, which (d) Optional information. (1) The claim is incorporated by reference in accord- may state that the development of ance with 5 U.S.C. 552(a) and 1 CFR heart disease depends on many factors part 51. Copies may be obtained from and may identify one or more of the the AOAC INTERNATIONAL, 481 North following risk factors for heart disease Frederick Ave., suite 500, Gaithersburg, about which there is general scientific MD 20877, or may be examined at the agreement: A family history of CHD; Food and Drug Administration’s Main elevated blood total and LDL-choles- Library, 10903 New Hampshire Ave., terol; excess body weight; high blood Bldg. 2, Third Floor, Silver Spring, MD pressure; cigarette smoking; diabetes; 20993, 301–796–2039 or at the National and physical inactivity. The claim may Archives and Records Administration also provide additional information (NARA). For information on the avail- about the benefits of exercise and man- ability of this material at NARA, call agement of body weight to help lower the risk of heart disease; 202–741–6030, or go to: http:// www.archives.gov/federallregister/ (2) The claim may state that the re- codeloflfederallregulations/ lationship between intake of diets that are low in saturated fat and cholesterol ibrllocations.html; and that include soluble fiber from the (iii) Nature of the food eligible to bear eligible food sources from paragraph the claim. (A) The food product shall in- (c)(2)(ii) of this section and reduced clude: risk of heart disease is through the in- (1) One or more of the whole oat or termediate link of ‘‘blood cholesterol’’ barley foods from paragraphs or ‘‘blood total- and LDL-cholesterol;’’ (c)(2)(ii)(A)(1), (2), (3), and (5) of this (3) The claim may include informa- section, and the whole oat or barley tion from paragraphs (a) and (b) of this foods shall contain at least 0.75 gram section, which summarize the relation- (g) of soluble fiber per reference ship between diets that are low in satu- amount customarily consumed of the rated fat and cholesterol and that in- food product; or clude soluble fiber from certain foods (2) The food containing the oatrim and coronary heart disease and the sig- from paragraph (c)(2)(ii)(A)(4) of this nificance of the relationship; section or the barley betafiber from (4) The claim may specify the name paragraph (c)(2)(ii)(A)(6) of this section of the eligible soluble fiber; shall contain at least 0.75 g of beta- (5) The claim may state that a diet glucan soluble fiber per reference low in saturated fat and cholesterol amount customarily consumed of the that includes soluble fiber from whole food product; or oats or barley is consistent with ‘‘Nu- (3) Psyllium husk that complies with trition and Your Health: Dietary paragraph (c)(2)(ii)(B) of this section, Guidelines for Americans,’’ U.S. De- and the psyllium food shall contain at partment of Agriculture (USDA) and least 1.7 g of soluble fiber per reference Department of Health and Human amount customarily consumed of the Services (DHHS), Government Printing food product; Office (GPO);

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(6) The claim may state that individ- § 101.82 Health claims: Soy protein and uals with elevated blood total- and risk of coronary heart disease LDL-cholesterol should consult their (CHD). physicians for medical advice and (a) Relationship between diets that are treatment. If the claim defines high or low in saturated fat and cholesterol and normal blood total- and LDL-choles- that include soy protein and the risk of terol levels, then the claim shall state CHD. (1) Cardiovascular disease means that individuals with high blood cho- diseases of the heart and circulatory lesterol should consult their physicians system. CHD is one of the most com- for medical advice and treatment; mon and serious forms of cardio- (7) The claim may include informa- vascular disease and refers to diseases tion on the number of people in the of the heart muscle and supporting United States who have heart disease. blood vessels. High blood total choles- The sources of this information shall terol and low density lipoprotein be identified, and it shall be current in- (LDL)-cholesterol levels are associated formation from the National Center for with increased risk of developing CHD. Health Statistics, the National Insti- High CHD rates occur among people tutes of Health, or ‘‘Nutrition and Your with high total cholesterol levels of 240 Health: Dietary Guidelines for Ameri- milligrams per deciliter (mg/dL) (6.21 cans,’’ USDA and DHHS, GPO. millimole per liter (mmol/L)) or above (e) Model health claim. The following and LDL-cholesterol levels of 160 mg/ model health claims may be used in dL (4.13 mmol/L) or above. Borderline food labeling to describe the relation- high risk total cholesterol levels range ship between diets that are low in satu- from 200 to 239 mg/dL (5.17 to 6.18 rated fat and cholesterol and that in- mmol/L) and 130 to 159 mg/dL (3.36 to clude soluble fiber from certain foods 4.11 mmol/L) of LDL-cholesterol. The and reduced risk of heart disease: scientific evidence establishes that (1) Soluble fiber from foods such as diets high in saturated fat and choles- [name of soluble fiber source from terol are associated with increased lev- paragraph (c)(2)(ii) of this section and, els of blood total and LDL-cholesterol if desired, the name of food product], as and, thus, with increased risk of CHD. part of a diet low in saturated fat and (2) Populations with a low incidence cholesterol, may reduce the risk of of CHD tend to have relatively low heart disease. A serving of [ name of blood total cholesterol and LDL-cho- food] supplies llll grams of the lesterol levels. These populations also [grams of soluble fiber specified in tend to have dietary patterns that are paragraph (c)(2)(i)(G) of this section] not only low in total fat, especially soluble fiber from [name of the soluble saturated fat and cholesterol, but are fiber source from paragraph (c)(2)(ii) of also relatively high in plant foods that this section] necessary per day to have contain dietary fiber and other compo- this effect. nents. (2) Diets low in saturated fat and (3) Scientific evidence demonstrates cholesterol that include [llll grams that diets low in saturated fat and cho- of soluble fiber specified in paragraph lesterol may reduce the risk of CHD. (c)(2)(i)(G) of this section] of soluble Other evidence demonstrates that the fiber per day from [name of soluble addition of soy protein to a diet that is fiber source from paragraph (c)(2)(ii) of low in saturated fat and cholesterol this section and, if desired, the name of may also help to reduce the risk of the food product] may reduce the risk CHD. of heart disease. One serving of [name (b) Significance of the relationship be- of food] provides llll grams of this tween diets that are low in saturated fat soluble fiber. and cholesterol and that include soy protein and the risk of CHD. (1) CHD is a [62 FR 3600, Jan. 23, 1997, as amended at 62 major public health concern in the FR 15344, Mar. 31, 1997; 63 FR 8119, Feb. 18, United States. It accounts for more 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782, Oct. 2, 2002; 68 FR 15355, Mar. 31, 2003; 70 FR deaths than any other disease or group 40880, July 15, 2005; 70 FR 76162, Dec. 23, 2005; of diseases. Early management of risk 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1, factors for CHD is a major public 2008; 81 FR 5590, Feb. 3, 2016] health goal that can assist in reducing

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risk of CHD. High blood total and LDL- serving of the product makes to the cholesterol are major modifiable risk specified daily dietary intake level. factors in the development of CHD. The daily dietary intake level of soy (2) Intakes of saturated fat exceed protein that has been associated with recommended levels in the diets of reduced risk of coronary heart disease many people in the United States. One is 25 grams (g) or more per day of soy of the major public health rec- protein. ommendations relative to CHD risk is (ii) Nature of the substance. (A) Soy to consume less than 10 percent of cal- protein from the legume seed Glycine ories from saturated fat and an average max. of 30 percent or less of total calories (B) FDA will assess qualifying levels from all fat. Recommended daily cho- of soy protein in the following fashion: lesterol intakes are 300 mg or less per FDA will measure total protein con- day. Scientific evidence demonstrates tent by the appropriate method of that diets low in saturated fat and cho- analysis given in the ‘‘Official Methods lesterol are associated with lower blood of Analysis of the AOAC Inter- total and LDL-cholesterol levels. Soy national,’’ as described at § 101.9(c)(7). protein, when included in a low satu- For products that contain no sources of rated fat and cholesterol diet, also protein other than soy, FDA will con- helps to lower blood total and LDL- sider the amount of soy protein as cholesterol levels. equivalent to the total protein content. (c) Requirements. (1) All requirements For products that contain a source or set forth in § 101.14 shall be met. sources of protein in addition to soy, (2) Specific requirements—(i) Nature of FDA will, using the measurement of the claim. A health claim associating total protein content, calculate the soy diets that are low in saturated fat and protein content based on the ratio of cholesterol and that include soy pro- soy protein ingredients to total protein tein with reduced risk of heart disease ingredients in the product. FDA will may be made on the label or labeling of base its calculation on information a food described in paragraph (c)(2)(iii) identified and supplied by manufactur- of this section, provided that: ers, such as nutrient data bases or (A) The claim states that diets that analyses, recipes or formulations, pur- are low in saturated fat and cholesterol chase orders for ingredients, or any and that include soy protein ‘‘may’’ or other information that reasonably sub- ‘‘might’’ reduce the risk of heart dis- stantiates the ratio of soy protein to ease; total protein. Manufacturers must (B) In specifying the disease, the claim uses the following terms: ‘‘heart maintain records sufficient to substan- disease’’ or ‘‘coronary heart disease’’; tiate the claim for as long as the prod- (C) In specifying the substance, the ucts are marketed and provide these claim uses the term ‘‘soy protein’’; records, on written request, to appro- (D) In specifying the fat component, priate regulatory officials. the claim uses the terms ‘‘saturated (iii) Nature of the food eligible to bear fat’’ and ‘‘cholesterol’’; the claim. (A) The food product shall (E) The claim does not attribute any contain at least 6.25 g of soy protein degree of risk reduction for CHD to per reference amount customarily con- diets that are low in saturated fat and sumed of the food product; cholesterol and that include soy pro- (B) The food shall meet the nutrient tein; content requirements in § 101.62 for a (F) The claim does not imply that ‘‘low saturated fat’’ and ‘‘low choles- consumption of diets that are low in terol’’ food; and saturated fat and cholesterol and that (C) The food shall meet the nutrient include soy protein is the only recog- content requirement in § 101.62 for a nized means of achieving a reduced ‘‘low fat’’ food, unless it consists of or risk of CHD; and is derived from whole soybeans and (G) The claim specifies the daily die- contains no fat in addition to the fat tary intake of soy protein that is nec- inherently present in the whole soy- essary to reduce the risk of coronary beans it contains or from which it is heart disease and the contribution one derived.

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(d) Optional information. (1) The claim (e) Model health claim. The following may state that the development of model health claims may be used in heart disease depends on many factors food labeling to describe the relation- and may identify one or more of the ship between diets that are low in satu- following risk factors for heart disease rated fat and cholesterol and that in- about which there is general scientific clude soy protein and reduced risk of agreement: A family history of CHD; heart disease: elevated blood total and LDL-choles- (1) 25 grams of soy protein a day, as terol; excess body weight; high blood part of a diet low in saturated fat and pressure; cigarette smoking; diabetes; cholesterol, may reduce the risk of and physical inactivity. The claim may heart disease. A serving of [name of also provide additional information food] supplies ll grams of soy pro- about the benefits of exercise and man- tein. agement of body weight to help lower (2) Diets low in saturated fat and the risk of heart disease; cholesterol that include 25 grams of (2) The claim may state that the re- soy protein a day may reduce the risk lationship between intake of diets that of heart disease. One serving of [name are low in saturated fat and cholesterol of food] provides ll grams of soy pro- and that include soy protein and re- tein. duced risk of heart disease is through [64 FR 57732, Oct. 26, 1999] the intermediate link of ‘‘blood cholesterol’’ or ‘‘blood total and LDL-choles- EFFECTIVE DATE NOTE: At 64 FR 57732, Oct. terol’’; 26, 1999, § 101.82 was added. Paragraph (3) The claim may include informa- (c)(2)(ii)(B) contains information collection and recordkeeping requirements and will not tion from paragraphs (a) and (b) of this become effective until approval has been section, which summarize the relation- given by the Office of Management and ship between diets that are low in satu- Budget. rated fat and cholesterol and that include soy protein and CHD and the sig- § 101.83 Health claims: plant sterol/ nificance of the relationship; stanol esters and risk of coronary (4) The claim may state that a diet heart disease (CHD). low in saturated fat and cholesterol (a) Relationship between diets that in- that includes soy protein is consistent clude plant sterol/stanol esters and the with ‘‘Nutrition and Your Health: Die- risk of CHD. (1) Cardiovascular disease tary Guidelines for Americans,’’ U.S. means diseases of the heart and cir- Department of Agriculture (USDA) and culatory system. Coronary heart dis- Department of Health and Human ease (CHD) is one of the most common Services (DHHS), Government Printing and serious forms of cardiovascular dis- Office (GPO); ease and refers to diseases of the heart (5) The claim may state that individ- muscle and supporting blood vessels. uals with elevated blood total and High blood total cholesterol and low LDL-cholesterol should consult their density lipoprotein (LDL) cholesterol physicians for medical advice and levels are associated with increased treatment. If the claim defines high or risk of developing coronary heart dis- normal blood total and LDL-choles- ease. High CHD rates occur among peo- terol levels, then the claim shall state ple with high total cholesterol levels of that individuals with high blood cho- 240 milligrams per deciliter (mg/dL) lesterol should consult their physicians (6.21 millimole per liter (mmol/l)) or for medical advice and treatment; above and LDL cholesterol levels of 160 (6) The claim may include informa- mg/dL (4.13 mmol/l) or above. Border- tion on the number of people in the line high risk blood cholesterol levels United States who have heart disease. range from 200 to 239 mg/dL (5.17 to 6.18 The sources of this information shall mmol/l) for total cholesterol, and 130 to be identified, and it shall be current in- 159 mg/dL (3.36 to 4.11 mmol/l) of LDL formation from the National Center for cholesterol. Health Statistics, the National Insti- (2) Populations with a low incidence tutes of Health, or ‘‘Nutrition and Your of CHD tend to have relatively low Health: Dietary Guidelines for Ameri- blood total cholesterol and LDL choles- cans,’’ USDA and DHHS, GPO; terol levels. These populations also

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tend to have dietary patterns that are sterol esters’’ or ‘‘vegetable oil stanol not only low in total fat, especially esters’’; saturated fat and cholesterol, but are (E) The claim does not attribute any also relatively high in plant foods that degree of risk reduction for CHD to contain dietary fiber and other compo- diets that include plant sterol/stanol nents. esters; (3) Scientific evidence demonstrates (F) The claim does not imply that that diets that include plant sterol/ consumption of diets that include plant stanol esters may reduce the risk of sterol/stanol esters is the only recog- CHD. nized means of achieving a reduced (b) Significance of the relationship be- risk of CHD; and tween diets that include plant sterol/ (G) The claim specifies the daily die- stanol esters and the risk of CHD. (1) tary intake of plant sterol or stanol CHD is a major public health concern esters that is necessary to reduce the in the United States. It accounts for risk of CHD and the contribution one more deaths than any other disease or serving of the product makes to the group of diseases. Early management specified daily dietary intake level. of risk factors for CHD is a major pub- Daily dietary intake levels of plant lic health goal that can assist in reduc- sterol and stanol esters that have been ing risk of CHD. High blood total and associated with reduced risk of are: LDL cholesterol are major modifiable (1) 1.3 g or more per day of plant ste- risk factors in the development of rol esters. CHD. (2) 3.4 g or more per day of plant stanol esters. (2) The scientific evidence establishes (H) The claim specifies that the daily that including plant sterol/stanol dietary intake of plant sterol or stanol esters in the diet helps to lower blood esters should be consumed in two total and LDL cholesterol levels. servings eaten at different times of the (c) —(1) All re- Requirements General. day with other foods. quirements set forth in § 101.14 shall be (ii) Nature of the substance—(A) Plant met, except § 101.14(a)(4) with respect to sterol esters. (1) Plant sterol esters pre- the disqualifying level for total fat per pared by esterifying a mixture of plant 50 grams (g) in dressings for salad and sterols from edible oils with food-grade spreads and § 101.14(e)(6) with respect to fatty acids. The plant sterol mixture dressings for salad. shall contain at least 80 percent beta- (2) Specific requirements—(i) Nature of sitosterol, campesterol, and stigmas- the claim. A health claim associating terol (combined weight). diets that include plant sterol/stanol (2) FDA will measure plant sterol esters with reduced risk of heart dis- esters by the method entitled ‘‘Deter- ease may be made on the label or label- mination of the Sterol Content in Mar- ing of a food described in paragraph garines, Halvarines, Dressings, Fat (c)(2)(iii) of this section, provided that: Blends and Sterol Fatty Acid Ester (A) The claim states that plant ste- Concentrates by Capillary Gas Chroma- rol/stanol esters should be consumed as tography,’’ developed by Unilever part of a diet low in saturated fat and United States, Inc., dated February 1, cholesterol; 2000. The method, which is incor- (B) The claim states that diets that porated by reference in accordance include plant sterol/stanol esters with 5 U.S.C. 552(a) and 1 CFR part 51, ‘‘may’’ or ‘‘might’’ reduce the risk of may be obtained from the Center for heart disease; Food Safety and Applied Nutrition, Of- (C) In specifying the disease, the fice of Nutrition, Labeling and Dietary claim uses the following terms: ‘‘heart Supplements, Nutrition Programs disease’’ or ‘‘coronary heart disease’’; Staff, 5001 Campus Dr., College Park, (D) In specifying the substance, the MD 20740, and may be examined at the claim uses the term ‘‘plant sterol Food and Drug Administration’s Main esters’’ or ‘‘plant stanol esters,’’ except Library, 10903 New Hampshire Ave., that if the sole source of the plant Bldg. 2, Third Floor, Silver Spring, MD sterols or stanols is vegetable oil, the 20993, 301–796–2039, or at the National claim may use the term ‘‘vegetable oil Archives and Records Administration

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(NARA). For information on the avail- of the food products eligible to bear the ability of this material at NARA, call health claim, specifically spreads, 202–741–6030, or go to: http:// dressings for salad, snack bars, and die- www.archives.gov/federallregister/ tary supplements in softgel form. codeloflfederallregulations/ (B) The food shall meet the nutrient ibrllocations.html. content requirements in § 101.62 for a (B) Plant stanol esters. (1) Plant stanol ‘‘low saturated fat’’ and ‘‘low choles- esters prepared by esterifying a mix- terol’’ food; and ture of plant stanols derived from edi- (C) The food must meet the limit for ble oils or byproducts of the kraft total fat in § 101.14(a)(4), except that paper pulping process with food-grade spreads and dressings for salad are not fatty acids. The plant stanol mixture required to meet the limit for total fat shall contain at least 80 percent per 50 g if the label of the food bears a sitostanol and campestanol (combined disclosure statement that complies weight). with § 101.13(h); and (2) FDA will measure plant stanol (D) The food must meet the min- esters by the following methods devel- imum nutrient contribution require- oped by McNeil Consumer Heathcare ment in § 101.14(e)(6) unless it is a dress- dated February 15, 2000: ‘‘Determina- ing for salad. tion of Stanols and Sterols in Benecol (d) Optional information. (1) The claim Tub Spread’’; ‘‘Determination of may state that the development of Stanols and Sterols in Benecol Dress- heart disease depends on many factors ing’’; ‘‘Determination of Stanols and and may identify one or more of the Sterols in Benecol Snack Bars’’; or following risk factors for heart disease ‘‘Determination of Stanols and Sterols about which there is general scientific in Benecol Softgels.’’ These methods agreement: A family history of CHD; are incorporated by reference in ac- elevated blood total and LDL choles- cordance with 5 U.S.C. 552(a) and 1 CFR terol; excess body weight; high blood part 51. Copies may be obtained from pressure; cigarette smoking; diabetes; the Center for Food Safety and Applied and physical inactivity. The claim may Nutrition, Office of Nutrition, Labeling also provide additional information and Dietary Supplements, Nutrition about the benefits of exercise and man- Programs Staff, 5001 Campus Dr., Col- agement of body weight to help lower lege Park, MD 20740, or may be exam- the risk of heart disease. ined at the Food and Drug Administra- (2) The claim may state that the re- tion’s Main Library, 10903 New Hamp- lationship between intake of diets that shire Ave., Bldg. 2, Third Floor, Silver include plant sterol/stanol esters and Spring, MD 20993, 301–796–2039, and at reduced risk of heart disease is through the National Archives and Records Ad- the intermediate link of ‘‘blood choles- ministration (NARA). For information terol’’ or ‘‘blood total and LDL choles- on the availability of this material at terol.’’ NARA, call 202–741–6030, or go to: http:// (3) The claim may include informa- www.archives.gov/federallregister/ tion from paragraphs (a) and (b) of this codeloflfederallregulations/ section, which summarize the relation- ibrllocations.html. ship between diets that include plant (iii) Nature of the food eligible to bear sterol/stanol esters and the risk of CHD the claim. (A) The food product shall and the significance of the relation- contain: ship. (1) At least 0.65 g of plant sterol (4) The claim may include informa- esters that comply with paragraph tion from the following paragraph on (c)(2)(ii)(A)(1) of this section per ref- the relationship between saturated fat erence amount customarily consumed and cholesterol in the diet and the risk of the food products eligible to bear the of CHD: The scientific evidence estab- health claim, specifically spreads and lishes that diets high in saturated fat dressings for salad, or and cholesterol are associated with in- (2) At least 1.7 g of plant stanol creased levels of blood total and LDL esters that comply with paragraph cholesterol and, thus, with increased (c)(2)(ii)(B)(1) of this section per ref- risk of CHD. Intakes of saturated fat erence amount customarily consumed exceed recommended levels in the diets

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of many people in the United States. lllgrams of vegetable oil sterol One of the major public health rec- esters. ommendations relative to CHD risk is (ii) Diets low in saturated fat and to consume less than 10 percent of cal- cholesterol that include two servings of ories from saturated fat and an average foods that provide a daily total of at of 30 percent or less of total calories least 1.3 g of vegetable oil sterol esters from all fat. Recommended daily cho- in two meals may reduce the risk of lesterol intakes are 300 mg or less per heart disease. A serving of [name of the day. Scientific evidence demonstrates food] supplies lllgrams of vegetable that diets low in saturated fat and cho- oil sterol esters. lesterol are associated with lower blood (2) For plant stanol esters: (i) Foods total and LDL cholesterol levels. containing at least 1.7 g per serving of (5) The claim may state that diets plant stanol esters, eaten twice a day that include plant sterol or stanol with meals for a total daily intake of esters and are low in saturated fat and at least 3.4 g, as part of a diet low in cholesterol are consistent with ‘‘Nu- saturated fat and cholesterol, may re- trition and Your Health: Dietary duce the risk of heart disease. A serv- Guidelines for Americans,’’ U.S. De- ing of [name of the food] supplies partment of Agriculture (USDA) and lllgrams of plant stanol esters. Department of Health and Human (ii) Diets low in saturated fat and Services (DHHS), Government Printing cholesterol that include two servings of Office (GPO). foods that provide a daily total of at (6) The claim may state that individ- least 3.4 g of vegetable oil stanol esters uals with elevated blood total and LDL in two meals may reduce the risk of cholesterol should consult their physi- heart disease. A serving of [name of the cians for medical advice and treat- food] supplies lllgrams of vegetable ment. If the claim defines high or nor- oil stanol esters. mal blood total and LDL cholesterol levels, then the claim shall state that [65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. individuals with high blood cholesterol 24, 2000, as amended at 66 FR 66742, Dec. 27, should consult their physicians for 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, medical advice and treatment. July 21, 2005] (7) The claim may include information on the number of people in the Subpart F—Specific Requirements United States who have heart disease. for Descriptive Claims That The sources of this information shall Are Neither Nutrient Content be identified, and it shall be current in- Claims nor Health Claims formation from the National Center for Health Statistics, the National Insti- § 101.91 Gluten-free labeling of food. tutes of Health, or ‘‘Nutrition and Your Health: Dietary Guidelines for Ameri- (a) Definitions. (1) The term ‘‘gluten- cans,’’ U.S. Department of Agriculture containing grain’’ means any one of (USDA) and Department of Health and the following grains or their crossbred Human Services (DHHS), Government hybrids (e.g., triticale, which is a cross Printing Office (GPO). between wheat and rye): (e) Model health claim. The following (i) Wheat, including any species be- model health claims may be used in longing to the genus Triticum; food labeling to describe the relation- (ii) Rye, including any species be- ship between diets that include plant longing to the genus Secale; or sterol or stanol esters and reduced risk (iii) Barley, including any species be- of heart disease: longing to the genus Hordeum. (1) For plant sterol esters: (i) Foods (2) The term ‘‘gluten’’ means the pro- containing at least 0.65 g per serving of teins that naturally occur in a gluten- plant sterol esters, eaten twice a day containing grain and that may cause with meals for a daily total intake of adverse health effects in persons with at least 1.3 g, as part of a diet low in celiac disease (e.g., prolamins and saturated fat and cholesterol, may re- glutelins). duce the risk of heart disease. A serv- (3) The labeling claim ‘‘gluten-free’’ ing of [name of the food] supplies means:

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(i) That the food bearing the claim in ppm gluten in a variety of food mat- its labeling: rices, including both raw and cooked or (A) Does not contain any one of the baked products. following: (d) Preemption. A State or political (1) An ingredient that is a gluten- subdivision of a State may not estab- containing grain (e.g., spelt wheat); lish or continue into effect any law, (2) An ingredient that is derived from rule, regulation, or other requirement a gluten-containing grain and that has that is different from the requirements not been processed to remove gluten in this section for the definition and (e.g., wheat flour); or use of the claim ‘‘gluten-free,’’ as well (3) An ingredient that is derived from as the claims ‘‘no gluten,’’ ‘‘free of glu- a gluten-containing grain and that has ten,’’ or ‘‘without gluten.’’ been processed to remove gluten (e.g., wheat starch), if the use of that ingre- [78 FR 47178, Aug. 5, 2013] dient results in the presence of 20 parts per million (ppm) or more gluten in the § 101.93 Certain types of statements food (i.e., 20 milligrams (mg) or more for dietary supplements. gluten per kilogram (kg) of food); or (a)(1) No later than 30 days after the (B) Inherently does not contain glu- first marketing of a dietary supple- ten; and ment that bears one of the statements (ii) Any unavoidable presence of glu- listed in section 403(r)(6) or the Federal ten in the food bearing the claim in its Food, Drug, and Cosmetic Act, the labeling is below 20 ppm gluten (i.e., manufacturer, packer, or distributor of below 20 mg gluten per kg of food). the dietary supplement shall notify the (b) Requirements. (1) A food that bears Office of Nutritional Products, Label- the claim ‘‘gluten-free’’ in its labeling ing and Dietary Supplements (HFS– and fails to meet the requirements of 810), Center for Food Safety and Ap- paragraph (a)(3) of this section will be plied Nutrition, Food and Drug Admin- deemed misbranded. istration, 5001 Campus Dr., College (2) A food that bears the claim ‘‘no Park, MD 20740, that it has included gluten,’’ ‘‘free of gluten,’’ or ‘‘without such a statement on the label or in the gluten’’ in its labeling and fails to labeling of its product. An original and meet the requirements of paragraph two copies of this notification shall be (a)(3) of this section will be deemed submitted. misbranded. (2) The notification shall include the (3) A food that bears the term following: ‘‘wheat’’ in the ingredient list or in a (i) The name and address of the man- separate ‘‘Contains wheat’’ statement ufacturer, packer, or distributor of the in its labeling, as required by 21 U.S.C. dietary supplement that bears the 343(w)(1)(A), and also bears the claim statement; ‘‘gluten-free’’ or a claim identified in paragraph (b)(2) of this section will be (ii) The text of the statement that is deemed misbranded unless the word being made; ‘‘wheat’’ in the ingredient list or in the (iii) The name of the dietary ingre- ‘‘Contains wheat’’ statement is fol- dient or supplement that is the subject lowed immediately by an asterisk (or of the statement, if not provided in the other symbol) that refers to another text of the statement; and asterisk (or other symbol) in close (iv) The name of the dietary supple- proximity to the ingredient statement ment (including brand name), if not that immediately precedes the fol- provided in response to paragraph lowing: ‘‘The wheat has been processed (a)(2)(iii) on whose label, or in whose to allow this food to meet the Food and labeling, the statement appears. Drug Administration (FDA) require- (3) The notice shall be signed by a re- ments for gluten-free foods.’’ sponsible individual or the person who (c) Compliance. When compliance with can certify the accuracy of the infor- paragraph (b) of this section is based mation presented and contained in the on an analysis of the food, FDA will notice. The individual shall certify use a scientifically valid method that that the information contained in the can reliably detect the presence of 20 notice is complete and accurate, and

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that the notifying firm has substan- this section, bear statements that de- tiation that the statement is truthful scribe the role of a nutrient or dietary and not misleading. ingredient intended to affect the struc- (b) Disclaimer. The requirements in ture or function in humans or that this section apply to the label or label- characterize the documented mecha- ing of dietary supplements where the nism by which a nutrient or dietary in- dietary supplement bears a statement gredient acts to maintain such struc- that is provided for by section 403(r)(6) ture or function, provided that such of the Federal Food, Drug, and Cos- statements are not disease claims metic Act (the act), and the manufac- under paragraph (g) of this section. If turer, packer, or distributor wishes to the label or labeling of a product mar- take advantage of the exemption to keted as a dietary supplement bears a section 201(g)(1)(C) of the act that is disease claim as defined in paragraph provided by compliance with section (g) of this section, the product will be 403(r)(6) of the act. subject to regulation as a drug unless (c) Text for disclaimer. (1) Where there the claim is an authorized health claim is one statement, the disclaimer shall for which the product qualifies. be placed in accordance with paragraph (g) Disease claims. (1) For purposes of (d) of this section and shall state: 21 U.S.C. 343(r)(6), a ‘‘disease’’ is dam- This statement has not been evaluated by age to an organ, part, structure, or sys- the Food and Drug Administration. This tem of the body such that it does not product is not intended to diagnose, treat, function properly (e.g., cardiovascular cure, or prevent any disease. disease), or a state of health leading to (2) Where there is more than one such such dysfunctioning (e.g., hyper- statement on the label or in the label- tension); except that diseases resulting ing, each statement shall bear the dis- from essential nutrient deficiencies claimer in accordance with paragraph (e.g., scurvy, pellagra) are not included (c)(1) of this section, or a plural dis- in this definition. claimer may be placed in accordance (2) FDA will find that a statement with paragraph (d) of this section and about a product claims to diagnose, shall state: mitigate, treat, cure, or prevent dis- These statements have not been eval- ease (other than a classical nutrient uated by the Food and Drug Adminis- deficiency disease) under 21 U.S.C. tration. This product is not intended to 343(r)(6) if it meets one or more of the diagnose, treat, cure, or prevent any criteria listed below. These criteria are disease. not intended to classify as disease (d) Placement. The disclaimer shall be claims statements that refer to the placed adjacent to the statement with ability of a product to maintain no intervening material or linked to healthy structure or function, unless the statement with a symbol (e.g., an the statement implies disease preven- asterisk) at the end of each such state- tion or treatment. In determining ment that refers to the same symbol whether a statement is a disease claim placed adjacent to the disclaimer speci- under these criteria, FDA will consider fied in paragraphs (c)(1) or (c)(2) of this the context in which the claim is pre- section. On product labels and in label- sented. A statement claims to diag- ing (e.g., pamphlets, catalogs), the dis- nose, mitigate, treat, cure, or prevent claimer shall appear on each panel or disease if it claims, explicitly or im- page where there such is a statement. plicitly, that the product: The disclaimer shall be set off in a box (i) Has an effect on a specific disease where it is not adjacent to the state- or class of diseases; ment in question. (ii) Has an effect on the char- (e) Typesize. The disclaimer in para- acteristic signs or symptoms of a spe- graph (c) of this section shall appear in cific disease or class of diseases, using boldface type in letters of a typesize no scientific or lay terminology; smaller than one-sixteenth inch. (iii) Has an effect on an abnormal (f) Permitted structure/function state- condition associated with a natural ments. Dietary supplement labels or la- state or process, if the abnormal condi- beling may, subject to the require- tion is uncommon or can cause signifi- ments in paragraphs (a) through (e) of cant or permanent harm;

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(iv) Has an effect on a disease or dis- of a food in conformity with the provi- eases through one or more of the fol- sions of this section. The requirements lowing factors: of the section pertain to any use of the (A) The name of the product; subject terms as described in para- (B) A statement about the formula- graphs (a) and (b) of this section that tion of the product, including a claim expressly or implicitly refers to the that the product contains an ingre- food on labels or labeling, including dient (other than an ingredient that is use in a brand name and use as a sen- an article included in the definition of sory modifier. However, the use of the ‘‘dietary supplement’’ under 21 U.S.C. term ‘‘fresh’’ on labels or labeling is 321(ff)(3)) that has been regulated by not subject to the requirements of FDA as a drug and is well known to paragraph (a) of this section if the consumers for its use or claimed use in term does not suggest or imply that a preventing or treating a disease; food is unprocessed or unpreserved. For (C) Citation of a publication or ref- example, the term ‘‘fresh’’ used to de- erence, if the citation refers to a dis- scribe pasteurized whole milk is not ease use, and if, in the context of the subject to paragraph (a) of this section labeling as a whole, the citation im- because the term does not imply that plies treatment or prevention of a dis- the food is unprocessed (consumers ease, e.g., through placement on the commonly understand that milk is immediate product label or packaging, nearly always pasteurized). However, inappropriate prominence, or lack of the term ‘‘fresh’’ to describe pasta relationship to the product’s express sauce that has been pasteurized or that claims; contains pasteurized ingredients would (D) Use of the term ‘‘disease’’ or be subject to paragraph (a) of this sec- ‘‘diseased,’’ except in general state- tion because the term implies that the ments about disease prevention that do food is not processed or preserved. Uses not refer explicitly or implicitly to a of fresh not subject to this regulation specific disease or class of diseases or will be governed by the provisions of to a specific product or ingredient; or 403(a) of the Federal Food, Drug, and (E) Use of pictures, vignettes, sym- Cosmetic Act (the act). bols, or other means; (a) The term ‘‘fresh,’’ when used on (v) Belongs to a class of products the label or in labeling of a food in a that is intended to diagnose, mitigate, manner that suggests or implies that treat, cure, or prevent a disease; the food is unprocessed, means that the (vi) Is a substitute for a product that food is in its raw state and has not is a therapy for a disease; been frozen or subjected to any form of (vii) Augments a particular therapy thermal processing or any other form or drug action that is intended to diag- of preservation, except as provided in nose, mitigate, treat, cure, or prevent a paragraph (c) of this section. disease or class of diseases; (b) The terms ‘‘fresh frozen’’ and (viii) Has a role in the body’s re- ‘‘frozen fresh,’’ when used on the label sponse to a disease or to a vector of or in labeling of a food, mean that the disease; food was quickly frozen while still (ix) Treats, prevents, or mitigates ad- fresh (i.e., the food had been recently verse events associated with a therapy harvested when frozen). Blanching of for a disease, if the adverse events con- the food before freezing will not pre- stitute diseases; or clude use of the term ‘‘fresh frozen’’ to (x) Otherwise suggests an effect on a describe the food. ‘‘Quickly frozen’’ disease or diseases. means frozen by a freezing system such [62 FR 49886, Sept. 23, 1997, as amended at 62 as blast-freezing (sub-zero Fahrenheit FR 49867, Sept. 23, 1997; 65 FR 1050, Jan. 6, temperature with fast moving air di- 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, rected at the food) that ensures the Nov. 6, 2001] food is frozen, even to the center of the food, quickly and that virtually no de- § 101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’ terioration has taken place. ‘‘fresh frozen,’’ ‘‘frozen fresh.’’ (c) Provisions and restrictions. (1) The The terms defined in this section following do not preclude the food from may be used on the label or in labeling use of the term ‘‘fresh:’’

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(i) The addition of approved waxes or and conspicuously, but in no case with coatings; lettering of less than one-fourth of an (ii) The post-harvest use of approved inch in height, the information re- pesticides; quired to be stated on the label pursu- (iii) The application of a mild chlo- ant to section 403(i)(2) of the Federal rine wash or mild acid wash on Food, Drug, and Cosmetic Act (the produce; or act). (iv) The treatment of raw foods with (3) Incidental additives that are ionizing radiation not to exceed the present in a food at insignificant levels maximum dose of 1 kiloGray in accord- and do not have any technical or func- ance with § 179.26 of this chapter. tional effect in that food. For the pur- (2) A food meeting the definition in poses of this paragraph (a)(3), inci- paragraph (a) of this section that is re- dental additives are: frigerated is not precluded from use of (i) Substances that have no technical ‘‘fresh’’ as provided by this section. or functional effect but are present in a food by reason of having been incor- [58 FR 2426, Jan. 6, 1993] porated into the food as an ingredient of another food, in which the substance Subpart G—Exemptions From did have a functional or technical ef- Food Labeling Requirements fect. (ii) Processing aids, which are as fol- § 101.100 Food; exemptions from label- lows: ing. (a) Substances that are added to a (a) The following foods are exempt food during the processing of such food from compliance with the require- but are removed in some manner from ments of section 403(i)(2) of the act (re- the food before it is packaged in its fin- quiring a declaration on the label of ished form. the common or usual name of each in- (b) Substances that are added to a gredient when the food is fabricated food during processing, are converted from two or more ingredients). into constituents normally present in (1) An assortment of different items the food, and do not significantly in- of food, when variations in the items crease the amount of the constitutents that make up different packages naturally found in the food. packed from such assortment normally (c) Substances that are added to a occur in good packing practice and food for their technical or functional when such variations result in vari- effect in the processing but are present ations in the ingredients in different in the finished food at insignificant packages, with respect to any ingre- levels and do not have any technical or dient that is not common to all pack- functional effect in that food. ages. Such exemption, however, shall (iii) Substances migrating to food be on the condition that the label shall from equipment or packaging or other- bear, in conjunction with the names of wise affecting food that are not food such ingredients as are common to all additives as defined in section 201(s) of packages, a statement (in terms that the act; or if they are food additives as are as informative as practicable and so defined, they are used in conformity that are not misleading) indicating by with regulations established pursuant name other ingredients which may be to section 409 of the act. present. (4) For the purposes of paragraph (2) A food having been received in (a)(3) of this section, any sulfiting bulk containers at a retail establish- agent (sulfur dioxide, sodium sulfite, ment, if displayed to the purchaser sodium bisulfite, potassium bisulfite, with either: sodium metabisulfite, and potassium (i) The labeling of the bulk container metabisulfite) that has been added to plainly in view, provided ingredient in- any food or to any ingredient in any formation appears prominently and food and that has no technical effect in conspicuously in lettering of not less that food will be considered to be than one-fourth of an inch in height; or present in an insignificant amount (ii) A counter card, sign, or other ap- only if no detectable amount of the propriate device bearing prominently agent is present in the finished food. A

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detectable amount of sulfiting agent is propriate device bearing prominently 10 parts per million or more of the sul- and conspicuously the common or fite in the finished food. Compliance usual name of the food, or if the com- with this paragraph will be determined mon or usual name of the food is clear- using sections 20.123–20.125, ‘‘Total Sul- ly revealed by its appearance. furous Acid,’’ in ‘‘Official Methods of (c) An open container (a container of Analysis of the Association of Official rigid or semirigid construction, which Analytical Chemists,’’ 14th Ed. (1984), is not closed by lid, wrapper, or other- which is incorporated by reference and wise other than by an uncolored trans- the refinements of the ‘‘Total Sulfu- parent wrapper which does not obscure rous Acid’’ procedure in the ‘‘Monier- the contents) of a fresh fruit or fresh Williams Procedure (with Modifica- vegetable, the quantity of contents of tions) for Sulfites in Foods,’’ which is which is not more than 1 dry quart, appendix A to part 101. A copy of sec- shall be exempt from the labeling re- tions 20.123–20–125 of the Official Meth- quirements of sections 403(e), (g)(2) ods of Analysis of the Association of (with respect to the name of the food Official Analytical Chemists’’ is avail- specified in the definition and stand- able from the AOAC INTER- ard), and (i)(1) of the act; but such ex- NATIONAL, 481 North Frederick Ave., emption shall be on the condition that suite 500, Gaithersburg, MD 20877, or if two or more such containers are en- available for inspection at the National closed in a crate or other shipping Archives and Records Administration package, such crate or package shall (NARA). For information on the avail- bear labeling showing the number of ability of this material at NARA, call such containers enclosed therein and 202–741–6030, or go to: http:// the quantity of the contents of each. www.archives.gov/federallregister/ (d) Except as provided by paragraphs codeloflfederallregulations/ (e) and (f) of this section, a shipment or ibrllocations.html. other delivery of a food which is, in ac- (b) A food repackaged in a retail es- cordance with the practice of the trade, tablishment is exempt from the fol- to be processed, labeled, or repacked in lowing provisions of the act if the con- substantial quantity at an establish- ditions specified are met. ment other than that where originally (1) Section 403(e)(1) of the act (requir- processed or packed, shall be exempt, ing a statement on the label of the during the time of introduction into name and place of business of the man- and movement in interstate commerce ufacturer, packer, or distributor). and the time of holding in such estab- (2) Section 403(g)(2) of the act (requir- lishment, from compliance with the la- ing the label of a food which purports beling requirements of section 403 (c), to be or is represented as one for which (e), (g), (h), (i), (k), and (q) of the act if: a definition and standard of identity (1) The person who introduced such has been prescribed to bear the name of shipment or delivery into interstate the food specified in the definition and commerce is the operator of the estab- standard and, insofar as may be re- lishment where such food is to be proc- quired by the regulation establishing essed, labeled, or repacked; or the standard the common names of the (2) In case such person is not such op- optional ingredients present in the erator, such shipment or delivery is food), if the food is displayed to the made to such establishment under a purchaser with its interstate labeling written agreement, signed by and con- clearly in view, or with a counter card, taining the post office addresses of sign, or other appropriate device bear- such person and such operator, and ing prominently and conspicuously the containing such specifications for the information required by these provi- processing, labeling, or repacking, as sions. the case may be, of such food in such (3) Section 403(i)(1) of the act (requir- establishment as will ensure, if such ing the label to bear the common or specifications are followed, that such usual name of the food), if the food is food will not be adulterated or mis- displayed to the purchaser with its branded within the meaning of the act interstate labeling clearly in view, or upon completion of such processing, la- with a counter card, sign, or other ap- beling, or repacking. Such person and

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such operator shall each keep a copy of such shipment or delivery, or any part such agreement until 2 years after the thereof, from such establishment be- final shipment or delivery of such food come void ab initio if the food com- from such establishment, and shall prising such shipment, delivery, or part make such copies available for inspec- is adulterated or misbranded within tion at any reasonable hour to any offi- the meaning of the act when so recer or employee of the Department who moved. requests them. (2) An exemption of a shipment or (3) The article is an egg product sub- other delivery of a food under para- ject to a standard of identity promul- graph (d) (2) or (3) of this section shall gated in part 160 of this chapter, is to become void ab initio with respect to be shipped under the conditions speci- the person who introduced such ship- fied in paragraph (d) (1) or (2) of this ment or delivery into interstate com- section and for the purpose of pasteur- merce upon refusal by such person to ization or other treatment as required make available for inspection a copy of in such standard, and each container of the agreement, as required by para- such egg product bears a conspicuous graph (d) (2) or (3) of this section. tag or label reading ‘‘Caution—This (3) An exemption of a shipment or egg product has not been pasteurized or other delivery of a food under para- otherwise treated to destroy viable graph (d) (2) or (3) of this section shall Salmonella microorganisms’’. In addi- expire: tion to safe and suitable bactericidal (i) At the beginning of the act of re- processes designed specifically for Sal- moving such shipment or delivery, or monella destruction in egg products, any part thereof, from such establish- the term ‘‘other treatment’’ in the first ment if the food constituting such sentence of this paragraph shall in- shipment, delivery, or part is adulter- clude use in acidic dressings in the ated or misbranded within the meaning processing of which the pH is not above of the act when so removed; or 4.1 and the acidity of the aqueous phase, expressed as acetic acid, is not (ii) Upon refusal by the operator of less than 1.4 percent, subject also to the establishment where such food is to the conditions that: be processed, labeled, or repacked, to (i) The agreement required in para- make available for inspection a copy of graph (d)(2) of this section shall also the agreement, as required by such state that the operator agrees to uti- paragraph. lize such unpasteurized egg products in (f) The word ‘‘processed’’ as used in the processing of acidic dressings ac- this paragraph shall include the hold- cording to the specifications for pH and ing of cheese in a suitable warehouse at acidity set forth in this paragraph, a temperature of not less than 35 °F for agrees not to deliver the acidic dress- the purpose of aging or curing to bring ing to a user until at least 72 hours the cheese into compliance with re- after such egg product is incorporated quirements of an applicable definition in such acidic dressing, and agrees to and standard of identity. The exemp- maintain for inspection adequate tions provided for in paragraph (d) of records covering such processing for 2 this section shall apply to cheese which years after such processing. is, in accordance with the practice of (ii) In addition to the caution state- the trade, shipped to a warehouse for ment referred to above, the container aging or curing, on condition that the of such egg product shall also bear the cheese is identified in the manner set statement ‘‘Unpasteurized lll for forth in one of the applicable following use in acidic dressings only’’, the blank paragraphs, and in such case the provi- being filled in with the applicable sions of paragraph (e) of this section name of the eggs or egg product. shall also apply: (e) Conditions affecting expiration of (1) In the case of varieties of cheese exemptions: for which definitions and standards of (1) An exemption of a shipment or identity require a period of aging other delivery of a food under para- whether or not they are made from graph (d) (1) or (3) of this section shall, pasteurized milk, each such cheese at the beginning of the act of removing shall bear on the cheese a legible mark

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showing the date at which the prelimi- ticular manufacturer’s product may re- nary manufacturing process has been sult in unfair competition through re- completed and at which date curing vealing a trade secret. Exemption from commences, and to each cheese, on its the label declaration of such a marker wrapper or immediate container, shall is granted, therefore, provided that the be affixed a removable tag bearing the following conditions are met: statement ‘‘Uncured lll cheese for (1) The person desiring to use the completion of curing and proper label- marker without label declaration of its ing’’, the blank being filled in with the presence has submitted to the Commis- applicable name of the variety of sioner of Food and Drugs full informa- cheese. In the case of swiss cheese, the tion concerning the proposed usage and date at which the preliminary manu- the reasons why he believes label dec- facturing process had been completed laration of the marker should be sub- and at which date curing commences is ject to this exemption; and the date on which the shaped curd is (2) The person requesting the exemp- removed from immersion in saturated tion has received from the Commis- salt solution as provided in the defini- sioner of Food and Drugs a finding that tion and standard of identity for swiss the marker is harmless and that the cheese, and such cheese shall bear a re- exemption has been granted. movable tag reading, ‘‘To be cured and (h) Wrapped fish fillets of nonuniform labeled as ‘swiss cheese,’ but if eyes do weight intended to be unpacked and not form, to be labeled as ‘swiss cheese marked with the correct weight at or for manufacturing’ ’’. before the point of retail sale in an es- (2) In the case of varieties of cheeses tablishment other than that where which when made from unpasteurized originally packed shall be exempt from milk are required to be aged for not the requirement of section 403(e)(2) of less than 60 days, each such cheese the act during introduction and move- shall bear a legible mark on the cheese ment in interstate commerce and while showing the date at which the prelimi- held for sale prior to weighing and nary manufacturing process has been marking: completed and at which date curing (1) Provided, That (i) The outside con- commences, and to each such cheese or tainer bears a label declaration of the its wrapper or immediate container total net weight; and shall be affixed a removable tag read- (ii) The individual packages bear a ing, ‘‘lll cheese made from conspicuous statement ‘‘To be weighed unpasteurized milk. For completion of at or before time of sale’’ and a correct curing and proper labeling’’, the blank statement setting forth the weight of being filled in with the applicable the wrapper; name of the variety of cheese. (2) Provided further, That it is the (3) In the case of cheddar cheese, practice of the retail establishment to washed curd cheese, colby cheese, weigh and mark the individual pack- granular cheese, and brick cheese made ages with a correct net-weight state- from unpasteurized milk, each such ment prior to or at the point of retail cheese shall bear a legible mark on the sale. A statement of the weight of the cheese showing the date at which the wrapper shall be set forth so as to be preliminary manufacturing process has readily read and understood, using been completed and at which date cur- such term as ‘‘wrapper tare—ounce’’, ing commences, and to each such the blank being filled in with the cor- cheese or its wrapper or immediate rect average weight of the wrapper container shall be affixed a removable used. tag reading ‘‘lll cheese made from (3) The act of delivering the wrapped unpasteurized milk. For completion of fish fillets during the retail sale with- curing and proper labeling, or for label- out the correct net-weight statement ing as lll cheese for manufac- shall be deemed an act which results in turing’’, the blank being filled in with the product’s being misbranded while the applicable name of the variety of held for sale. Nothing in this paragraph cheese. shall be construed as requiring net- (g) The label declaration of a harm- weight statements for wrapped fish fil- less marker used to identify a par- lets delivered into institutional trade

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provided the outside container bears (b) Any firm that intends to under- the required information. take a labeling experiment that re- (i) Wrapped clusters (consumer units) quires exemptions from certain re- of bananas of nonuniform weight in- quirements of §§ 101.9 and 105.66 of this tended to be unpacked from a master chapter should submit a written pro- carton or container and weighed at or posal containing a thorough discussion before the point of retail sale in an es- of each of the following information tablishment other than that where items that apply to the particular ex- originally packed shall be exempt from periment: the requirements of section 403(e)(2) of (1) A description of the labeling for- the act during introduction and move- mat to be tested; ment in interstate commerce and while (2) A statement of the criteria to be held for sale prior to weighing: used in the experiment for assigning (1) Provided, That (i) The master car- foods to categories, e.g., nutrient or ton or container bears a label declara- other values defining ‘‘low’’ and ‘‘re- tion of the total net weight; and duced’’; (ii) The individual packages bear a (3) A draft of the material to be used conspicuous statement ‘‘To be weighed in the store, e.g., shelf tags, booklets, at or before the time of sale’’ and a cor- posters, etc.; rect statement setting forth the weight (4) The dates on which the experi- of the wrapper; using such term as ment will begin and end and on which ‘‘wrapper tare l ounce’’, the blank a written report of analysis of the ex- being filled in with the correct average perimental data will be submitted to weight of the wrapper used; FDA, together with a commitment not (2) That it is the Provided further, to continue the experiment beyond the practice of the retail establishment to proposed ending date without FDA ap- weigh the individual packages either proval; prior to or at the time of retail sale. (5) The geographic area or areas in (3) The act of delivering the wrapped which the experiment is to be con- clusters (consumer units) during the ducted; retail sale without an accurate net weight statement or alternatively (6) The mechanism to measure the ef- without weighing at the time of sale fectiveness of the experiment; shall be deemed an act which results in (7) The method for conveying to con- the product’s being misbranded while sumers the required nutrition and held for sale. Nothing in this paragraph other labeling information that is ex- shall be construed as requiring net- empted from the label during the ex- weight statements for clusters (con- periment; sumer units) delivered into institu- (8) The method that will be or has tional trade, provided that the master been used to determine the actual nu- container or carton bears the required tritional characteristics of foods for information. which a claim is made; and (9) A statement of the sections of the [42 FR 14308, Mar. 15, 1977, as amended at 51 regulations for which an exemption is FR 25017, July 9, 1986; 58 FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. 30, 2001] sought. (c) The written proposal should be § 101.108 Temporary exemptions for sent to the Division of Dockets Man- purposes of conducting authorized agement (HFA–305), Food and Drug Ad- food labeling experiments. ministration, 5630 Fishers Lane, rm. (a) The food industry is encouraged 1061, Rockville, MD 20852. The proposal to experiment voluntarily, under con- should be clearly identified as a re- trolled conditions and in collaboration quest for a temporary exemption for with the Food and Drug Administra- purposes of conducting authorized food tion, with and other formats for pre- labeling experiments and submitted as senting nutrition and other related a citizen petition under § 10.30 of this food labeling information that is con- chapter. sistent with the current quantitative (d) Approval for food labeling experi- system in §§ 101.9 and 105.66 of this ments will be given by FDA in writing. chapter. Foods labeled in violation of existing

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regulations will be subject to regu- Fig. 2. The 3% hydrogen peroxide solution latory action unless an FDA-approved can be contained in a vessel, G, with an i.d. exemption to the specific regulation of ca. 2.5 cm and a depth of 18 cm. has been granted for that specific prod- Buret—A 10 ml buret (Fisher Cat. No. 03– 848–2A or equivalent) with overflow tube and uct. hose connections for an Ascarite tube or (e) Reporting requirements contained equivalent air scrubbing apparatus. This will in § 101.108(b) have been approved by permit the maintenance of a carbon dioxide- this Office of Management and Budget free atmosphere over the standardized 0.01N and assigned number 0910–0151. sodium hydroxide. Chilled Water Circulator—The condensor [48 FR 15240, Apr. 8, 1983, as amended at 59 must be chilled with a coolant, such as 20% FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31, methanol-water, maintained at 5 °C. A circu- 1997] lating pump equivalent to the Neslab Coolflow 33 is suitable. APPENDIX A TO PART 101—MONIER-WIL- LIAMS PROCEDURE (WITH MODIFICA- Reagents TIONS) FOR SULFITES IN FOOD, CEN- (a) Aqueous hydrochloric acid, 4N.—For each TER FOR FOOD SAFETY AND APPLIED analysis prepare 90 ml of hydrochloric acid NUTRITION, FOOD AND DRUG ADMIN- by adding 30 ml of concentrated hydrochloric ISTRATION (NOVEMBER 1985) acid (12N) to 60 ml of distilled water. (b) Methyl red indicator—Dissolve 250 mg of The AOAC official method for sulfites methyl red in 100 ml ethanol. (Official Methods of Analysis, 14th Edition, (c) Hydrogen peroxide solution, 3%—Dilute 20.123–20.125, AOAC INTERNATIONAL) has ACS reagent grade 30% hydrogen peroxide to been modified, in FDA laboratories, to facili- 3% with distilled water. Just prior to use, tate the determination of sulfites at or near add three drops of methyl red indicator and 10 ppm in food. Method instructions, includ- titrate to a yellow end-point using 0.01N so- ing modifications, are described below. dium hydroxide. If the end-point is exceeded Apparatus—The apparatus shown diagram- discard the solution and prepare another 3% matically (Figure 1) is designed to accom- H O solution. plish the selective transfer of sulfur dioxide 2 2 (d) Standardized titrant, 0.01N NaOH—Cer- from the sample in boiling aqueous hydro- tified reagent may be used (Fisher SO–5–284). chloric acid to a solution of 3% hydrogen It should be standardized with reference peroxide. This apparatus is easier to assem- standard potassium hydrogen phthalate. ble than the official apparatus and the back (e) Nitrogen—A source of high purity nitro- pressure inside the apparatus is limited to gen is required with a flow regulator that the unavoidable pressure due to the height of will maintain a flow of 200 cc per minute. To the 3% H O solution above the tip of the 2 2 guard against the presence of oxygen in the bubbler (F). Keeping the backpressure as low nitrogen, an oxygen scrubbing solution such as possible reduces the likelihood that sulfur as an alkaline pyrogallol trap may be used. dioxide will be lost through leaks. The apparatus should be assembled as Prepare pyrogallol trap as follows: shown in Fig. 1 with a thin film of stopcock 1. Add 4.5 g pyrogallol to the trap. grease on the sealing surfaces of all the 2. Purge trap with nitrogen for 2 to 3 min- joints except the joint between the sepa- utes. ratory funnel and the flask. Each joint 3. Prepare a KOH solution prepared by add- should be clamped together to ensure a coming 65g KOH to 85 ml distilled water (cau- plete seal throughout the analysis. The sepa- tion: heat). ratory funnel, B, should have a capacity of 4. Add the KOH solution to the trap while 100 ml or greater. An inlet adapter, A, with maintaining an atmosphere of nitrogen in a hose connector (Kontes K–183000 or equiva- the trap. lent) is required to provide a means of apply- Determination ing a head of pressure above the solution. (A pressure equalizing dropping funnel is not Assemble the apparatus as shown in Fig. 1. recommended because condensate, perhaps The flask C must be positioned in a heating with sulfur dioxide, is deposited in the funnel mantle that is controlled by a power regu- and the side arm.) The round bottom flask, lating device such as Variac or equivalent. C, is a 1000 ml flask with three 24/40 tapered Add 400 ml of distilled water to flask C. Close joints. The gas inlet tube, D, (Kontes K– the stopcock of separatory funnel, B, and add 179000 or equivalent) should be of sufficient 90 ml of 4N hydrochloric acid to the sepa- length to permit introduction of the nitro- ratory funnel. Begin the flow of nitrogen at gen within 2.5 cm of the bottom of the flask. a rate of 200±10 cc/min. The condenser cool- The Allihn condenser, E, (Kontes K–431000– ant flow must be initiated at this time. Add 2430 or equivalent) has a jacket length of 300 30 ml of 3% hydrogen peroxide, which has mm. The bubbler, F, was fabricated from been titrated to a yellow end-point with glass according to the dimensions given in 0.01N NaOH, to container G. After fifteen

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minutes the apparatus and the distilled equipped with a valve. Open the stopcock in water will be thoroughly de-oxygenated and B and permit the hydrochloric acid solution the apparatus is ready for sample introduc- to flow into flask C. Continue to maintain tion. sufficient pressure above the acid solution to Sample preparation (solids)—Transfer 50 g of force the solution into the flask C. The stop- food, or a quantity of food with a convenient cock may be closed, if necessary, to pump up quantity of SO2 (500 to 1500 mcg SO2), to a the pressure above the acid and then opened food processor or blender. Add 100 ml of 5% again. Close the stopcock before the last few ethanol in water and briefly grind the mix- milliliters drain out of the separatory fun- ture. Grinding or blending should be contin- nel, B, to guard against the escape of sulfur ued only until the food is chopped into pieces dioxide into the separatory funnel. small enough to pass through the 24/40 point Apply the power to the heating mantle. of flask C. Use a power setting which will cause 80 to 90 Sample preparation (liquids)—Mix 50 g of the drops per minute of condensate to return to sample, or a quantity with a convenient the flask from condenser, E. After 1.75 hours quantity of SO2 (500 to 1500 mcg SO2), with of boiling the contents of the 1000 ml flask 100 ml of 5% ethanol in water. and remove trap G. Sample introduction and distillation—Re- Titration.—Titrate the contents with 0.01N move the separatory funnel B, and quan- sodium hydroxide. Titrate with 0.01N NaOH titatively transfer the food sample in aque- to a yellow end-point that persists for at ous ethanol to flask C. Wipe the tapered least twenty seconds. Compute the sulfite joint clean with a laboratory tissue, apply content, expressed as micrograms sulfur di- stopcock grease to the outer joint of the oxide per gram of food (ppm) as follows: separatory funnel, and return the separatory ppm = (32.03 × V × N × 1000) ÷ Wt funnel, B, to tapered joint flask C. The nitro- B gen flow through the 3% hydrogen peroxide where 32.03 = milliequivalent weight of sulfur solution should resume as soon as the funnel, dioxide; VB = volume of sodium hydrox- B, is re-inserted into the appropriate joint in ide titrant of normality, N, required to flask C. Examine each joint to ensure that it reach endpoint; the factor, 1000, converts is sealed. milliequivalents to microequivalents and Apply a head pressure above the hydro- Wt = weight (g) of food sample intro- chloric acid solution in B with a rubber bulb duced into the 1000 ml flask.

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FIGURE 1. THE OPTIMIZED MONIER-WILLIAMS APPARATUS. COMPONENT IDENTIFICATION IS GIVEN IN TEXT.

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FIGURE 2. DIAGRAM OF BUBBLER (F IN FIGURE 1). LENGTHS ARE GIVEN IN MM.

[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]

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APPENDIX B TO PART 101—GRAPHIC ENHANCEMENTS USED BY THE FDA

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[58 FR 17332, Apr. 2, 1993, as amended at 68 FR 41506, July 11, 2003]

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APPENDIX C TO PART 101—NUTRITION FACTS FOR RAW FRUITS AND VEGETABLES

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[71 FR 47439, AUG. 17, 2006]

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APPENDIX D TO PART 101—NUTRITION FACTS FOR COOKED FISH

[71 FR 47439, AUG. 17, 2006]

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PART 102—COMMON OR USUAL (b) The common or usual name of a NAME FOR NONSTANDARDIZED food shall include the percentage(s) of FOODS any characterizing ingredient(s) or component(s) when the proportion of Subpart A—General Provisions such ingredient(s) or component(s) in the food has a material bearing on Sec. price or consumer acceptance or when 102.5 General principles. the labeling or the appearance of the 102.19 Petitions. food may otherwise create an erro- Subpart B—Requirements for Specific neous impression that such ingre- Nonstandardized Foods dient(s) or component(s) is present in an amount greater than is actually the 102.22 Protein hydrolysates. case. The following requirements shall 102.23 Peanut spreads. apply unless modified by a specific reg- 102.26 Frozen ‘‘heat and serve’’ dinners. ulation in subpart B of this part. 102.28 Foods packaged for use in the preparation of ‘‘main dishes’’ or ‘‘dinners.’’ (1) The percentage of a characterizing 102.33 Beverages that contain fruit or vege- ingredient or component shall be de- table juice. clared on the basis of its quantity in 102.37 Mixtures of edible fat or oil and olive the finished product (i.e., weight/ oil. weight in the case of solids, or volume/ 102.39 Onion rings made from diced onion. volume in the case of liquids). 102.41 Potato chips made from dried pota- (2) The percentage of a characterizing toes. 102.45 Fish sticks or portions made from ingredient or component shall be de- minced fish. clared by the words ‘‘containing (or 102.46 Pacific whiting. contains) l percent (or %) lll’’ or 102.47 Bonito. ‘‘l percent (or %) lll’’ with the first 102.49 Fried clams made from minced clams. blank filled in with the percentage ex- 102.50 Crabmeat. pressed as a whole number not greater 102.54 Seafood cocktails. than the actual percentage of the in- 102.55 Nonstandardized breaded composite gredient or component named and the shrimp units. 102.57 Greenland turbot (Reinhardtius second blank filled in with the common hippoglossoides). or usual name of the ingredient or component. The word ‘‘containing’’ (or AUTHORITY: 21 U.S.C. 321, 343, 371. ‘‘contains’’), when used, shall appear SOURCE: 42 FR 14322, Mar. 15, 1977, unless on a line immediately below the part of otherwise noted. the common or usual name of the food EDITORIAL NOTE: Nomenclature changes to required by paragraph (a) of this sec- part 102 appear at 81 FR 49895, July 29, 2016. tion. For each characterizing ingredient or component, the words ‘‘l per- Subpart A—General Provisions cent or %) lll’’ shall appear following or directly below the word § 102.5 General principles. ‘‘containing’’ (or contains), or directly (a) The common or usual name of a below the part of the common or usual food, which may be a coined term, shall name of the food required by paragraph accurately identify or describe, in as (a) of this section when the word ‘‘con- simple and direct terms as possible, the taining’’ (or contains) is not used, in basic nature of the food or its charac- easily legible boldface print or type in terizing properties or ingredients. The distinct contrast to other printed or name shall be uniform among all iden- graphic matter, and in a height not tical or similar products and may not less than the larger of the following al- be confusingly similar to the name of ternatives: any other food that is not reasonably (i) Not less than one-sixteenth inch encompassed within the same name. in height on packages having a prin- Each class or subclass of food shall be cipal display panel with an area of 5 given its own common or usual name square inches or less and not less than that states, in clear terms, what it is in one-eighth inch in height if the area of a way that distinguishes it from dif- the principal display panel is greater ferent foods. than 5 square inches; or

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(ii) Not less than one-half the height § 102.19 Petitions. of the largest type appearing in the (a) The Commissioner of Food and part of the common or usual name of Drugs, either on his own initiative or the food required by paragraph (a) of on behalf of any interested person who this section. has submitted a petition, may publish (c) The common or usual name of a a proposal to issue, amend, or revoke, food shall include a statement of the under this part, a regulation pre- presence or absence of any character- scribing a common or usual name for a izing ingredient(s) or component(s) food, pursuant to part 10 of this chap- and/or the need for the user to add any ter. characterizing ingredient(s) or compo- (b) If the principal display panel of a nent(s) when the presence or absence of food for which a common or usual such ingredient(s) or component(s) in name regulation is established is too the food has a material bearing on small to accommodate all mandatory price or consumer acceptance or when requirements, the Commissioner may the labeling or the appearance of the establish by regulation an acceptable food may otherwise create an erro- alternative, e.g., a smaller type size. A neous impression that such ingre- petition requesting such a regulation, dient(s) or component(s) is present which would amend the applicable reg- when it is not, and consumers may oth- ulation, shall be submitted pursuant to erwise be misled about the presence or part 10 of this chapter. absence of the ingredient(s) or component(s) in the food. The following re- [42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977] quirements shall apply unless modified by a specific regulation in subpart B of this part. Subpart B—Requirements for (1) The presence or absence of a char- Specific Nonstandardized Foods acterizing ingredient or component shall be declared by the words ‘‘con- § 102.22 Protein hydrolysates. taining (or contains) lll’’ or ‘‘con- The common or usual name of a pro- taining (or contains) no lll’’ or ‘‘no tein hydrolysate shall be specific to the lll’’ or ‘‘does not contain lll’’, ingredient and shall include the iden- with the blank being filled in with the tity of the food source from which the common or usual name of the ingre- protein was derived. dient or component. (a) ‘‘Hydrolyzed wheat gluten,’’ (2) The need for the user of a food to ‘‘hydrolyzed soy protein,’’ and add any characterizing ingredient(s) or ‘‘autolyzed yeast extract’’ are exam- component(s) shall be declared by an ples of acceptable names. ‘‘Hydrolyzed appropriate informative statement. casein’’ is also an example of an ac- (3) The statement(s) required under ceptable name, whereas ‘‘hydrolyzed paragraph (c)(1) and/or (2) of this sec- milk protein’’ is not an acceptable tion shall appear following or directly name for this ingredient because it is below the part of the common or usual not specific to the ingredient (hydroly- name of the food required by para- sates can be prepared from other milk graphs (a) and (b) of this section, in proteins). The names ‘‘hydrolyzed vege- easily legible boldface print or type in table protein’’ and ‘‘hydrolyzed protein’’ are not acceptable because they distinct contrast to other printed or do not identify the food source of the graphic matter, and in a height not protein. less than the larger of the alternatives (b) [Reserved] established under paragraphs (b)(2) (i) and (ii) of this section. [58 FR 2876, Jan. 6, 1993] (d) A common or usual name of a food may be established by common § 102.23 Peanut spreads. usage or by establishment of a regula- (a) The common or usual name of a tion in subpart B of this part, in part spreadable peanut product that does 104 of this chapter, in a standard of not conform to § 164.150 of this chapter, identity, or in other regulations in this and more than 10 percent of which con- chapter. sists of nonpeanut ingredients, shall

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consist of the term ‘‘peanut spread’’ suite 500, Gaithersburg, MD 20877, or and a statement of the percentage by may be examined at the National Ar- weight of peanuts in the product in the chives and Records Administration manner set forth in § 102.5(b), except (NARA). For information on the avail- that peanut percentages shall be based ability of this material at NARA, call on the amount of peanuts used to make 202–741–6030, or go to: http:// the finished food and shall be declared www.archives.gov/federallregister/ in 5-percent increments expressed as a codeloflfederallregulations/ multiple of 5, not to exceed the actual ibrllocations.html. percentage of peanuts in the products. (2) Biological quality of protein: (b) A spreadable peanut product that AOAC, 13th Ed. (1980), using the meth- is nutritionally inferior to peanut but- od described in sections 43.212–43.216, ter shall be labeled as an imitation of which is incorporated by reference. The peanut butter under § 101.3(e)(2) of this availability of this incorporation by chapter; a spreadable peanut product reference is given in paragraph (c)(1) of shall be considered nutritionally equiv- this section. alent to peanut butter if it meets all of (3) Niacin: AOAC, 13th Ed. (1980), the following conditions: using the method described in sections (1) Protein. (i) The protein content of 43.044–43.046, which is incorporated by the product is at least 24 percent by reference. The availability of this in- weight of the finished product, and the corporation by reference is given in overall biological quality of the pro- paragraph (c)(1) of this section. tein contained in the product is at (4) Vitamin B6: AOAC, 13th Ed. (1980), least 68 percent that of casein; or using the method described in sections (ii) The protein content of the prod- 43.188–43.193, which is incorporated by uct is at least 16.6 percent by weight of reference. The availability of this in- the finished product, and the overall corporation by reference is given in biological quality of the protein con- paragraph (c)(1) of this section. tained in the product is equal to or (5) Folic acid: Using the method de- greater than that of casein. scribed in U.S. Department of Agri- (2) Other nutrients. The product con- culture Handbook No. 29, modified by tains the following levels of nutrients use of ascorbate buffer as described by per 100 grams of product: Ford and Scott, Journal of Dairy Re- search, 35:85–90 (1968), which is incor- Amount Nutrient (milli- porated by reference. Copies are avail- grams) able from the Center for Food Safety and Applied Nutrition (HFS–800), Food Niacin ...... 15.3 Vitamin B6 ...... 0.33 and Drug Administration, 5001 Campus Folic acid ...... 0.08 Dr., College Park, MD 20740, or avail- Iron ...... 2.0 able for inspection at the National Ar- Zinc ...... 2.9 Magnesium ...... 173.0 chives and Records Administration Copper ...... 0.6 (NARA). For information on the availability of this material at NARA, call (c) Compliance with the require- 202–741–6030, or go to: http:// ments of paragraph (b) of this section www.archives.gov/federallregister/ shall be determined by methods de- codeloflfederallregulations/ scribed in the following references ex- ibrllocations.html. cept that in determining protein quan- (6) Iron: AOAC, 13th Ed. (1980), using tity in products with mixed protein the method described in sections 43.217– sources a nitrogen conversion factor of 43.219, which is incorporated by ref- 6.25 may be used. erence. The availability of this incor- (1) Protein quantity: ‘‘Official Meth- poration by reference is given in para- ods of Analysis of the Association of graph (c)(1) of this section. Official Analytical Chemists’’ (AOAC), (7) Zinc: AOAC, 13th Ed. (1980), using 13th Ed. (1980), using the method de- the method described in sections 25.150– scribed in section 27.007, which is incor- 25.153, which is incorporated by ref- porated by reference. Copies may be erence. The availability of this incor- obtained from the AOAC INTER- poration by reference is given in para- NATIONAL, 481 North Frederick Ave., graph (c)(1) of this section.

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(8) Copper: AOAC, 13th Ed. (1980), (e.g., onion soup, enriched white bread, using the method described in sections and artificially flavored vanilla pud- 25.038–25.043, which is incorporated by ding) in their order of descending pre- reference. The availability of this in- dominance by weight. This part of the corporation by reference is given in name shall be placed immediately fol- paragraph (c)(1) of this section. lowing or directly below the part speci- (9) Magnesium: AOAC, 13th Ed. (1980), fied in paragraph (b)(1) of this section using the method described in sections in the manner set forth in § 102.5(c)(3). 2.109–2.113, which is incorporated by The words ‘‘contains’’ or ‘‘containing’’ reference. The availability of this in- are optional. corporation by reference is given in (3) If the labeling implies that the paragraph (c)(1) of this section. package contains other foods and these foods are not present in the package, [42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19, 1982; 49 FR 5609, Feb. 14, e.g., if a vignette on the package de- 1984; 54 FR 24891, June 12, 1989; 61 FR 14479, picts a ‘‘serving suggestion’’ which in- Apr. 2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR cludes any foods not present in the 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001] package, the principal display panel shall bear a statement that such foods § 102.26 Frozen ‘‘heat and serve’’ din- are not present, in type size not less ners. than that specified in § 102.5(b)(2)(i). (a) A frozen ‘‘heat and serve’’ dinner: (1) Shall contain at least three com- § 102.28 Foods packaged for use in the ponents, one of which shall be a signifi- preparation of ‘‘main dishes’’ or cant source of protein and each of ‘‘dinners.’’ which shall consist of one or more of (a) The common or usual name of a the following: meat, poultry, fish, packaged food which is represented on cheese, eggs, vegetables, fruit, pota- the principal display panel by word or toes, rice, or other cereal based prod- vignette to be used in the preparation ucts (other than bread or rolls). of a ‘‘main dish’’, ‘‘dinner’’, or other (2) May also contain other servings of such food serving, and to which some food (e.g., soup, bread or rolls, bev- other important characterizing ingre- erage, dessert). dient(s) or component(s) not present in (b) The common or usual name of the the package must be added, consists of food consists of all of the following: all the following: (1) The phrase ‘‘frozen ‘heat and (1) The common or usual name of serve’ dinner,’’ except that the name of each important ingredient or compo- the predominant characterizing ingre- nent in the package, in descending dient or other appropriately descrip- order of predominance by weight (e.g., tive term may immediately precede ‘‘noodles and tomato sauce’’). the word ‘‘dinner’’ (e.g., ‘‘frozen chick- (2) An appropriate informative state- en dinner’’ or ‘‘frozen heat and serve ment identifying the food to be pre- beef dinner’’). The words ‘‘heat and pared by use of the package contents serve’’ are optional. The word ‘‘frozen’’ (e.g., ‘‘for preparation of chicken cas- is also optional, provided that the serole’’). words ‘‘Keep Frozen’’ or the equivalent (3) An appropriate informative state- are prominently and conspicuously ment that additional characterizing in- placed on the principal display panel in gredient(s) or component(s) must be type size not less than that specified in added and which names the additional § 102.5(b)(2)(i). characterizing ingredient(s) or compo- (2) The phrase ‘‘containing (or con- nent(s) (e.g., ‘‘you must add lll to tains) lll’’ the blank to be filled in complete the recipe,’’ the blank to be with an accurate description of each of filled in with the name(s) of the impor- the three or more dish components list- tant characterizing ingredient(s) or ed in paragraph (a)(1) of this section in component(s) that must be added). their order of descending predominance (b) The labeling required by para- by weight (e.g., ham, mashed potatoes, graph (a) of this section shall appear on and peas), followed by any of the other the principal display panel. servings specified in paragraph (a)(2) of (1) No word in the statement required this section contained in the package by paragraph (a)(2) of this section may

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appear on the principal display panel height of the largest type appearing in more conspicuously or in larger type such brand name or other designation. than the smallest and least conspicuous type employed on the panel § 102.33 Beverages that contain fruit for any word, phrase or statement or vegetable juice. within the scope of paragraph (a)(1) of (a) For a carbonated or noncarbon- this section. ated beverage that contains less than (2) Every word in the statement re- 100 percent and more than 0 percent quired by paragraph (a)(3) of this sec- fruit or vegetable juice, the common or tion shall appear on the principal dis- usual name shall be a descriptive name play panel in easily legible bold face that meets the requirements of print or type in distinct contrast to § 102.5(a) and, if the common or usual other printed or graphic matter, and in name uses the word ‘‘juice,’’ shall in- a height not less than the larger of the clude a qualifying term such as ‘‘bev- following alternatives: erage,’’ ‘‘cocktail,’’ or ‘‘drink’’ appro- (i) Not less than one-sixteenth inch priate to advise the consumer that the in height on packages having a prin- product is less than 100 percent juice cipal display panel with an area of 5 (e.g., ‘‘diluted grape juice beverage’’ or square inches or less and not less than ‘‘grape juice drink’’). one-eighth inch in height if the area of (b) If the product is a diluted mul- the principal display panel is greater tiple-juice beverage or blend of single- than 5 square inches; or strength juices and names, other than (ii) Not less than one-half the height in the ingredient statement, more than of the largest type appearing in the one juice, then the names of those part of the common or usual name of juices, except in the ingredient state- the food required by paragraphs (a) (1) ment, must be in descending order of and (2) of this section. predominance by volume unless the (c) Any vignette which shows any name specifically shows that the juice food or characterizing ingredient(s) or with the represented flavor is used as a component(s) not included in the pack- flavor (e.g., raspberry-flavored apple age shall be accompanied either by the and pear juice drink). In accordance statement required by paragraph (a)(3) with § 101.22(i)(1)(iii) of this chapter, of this section or by a separate state- the presence of added natural flavors is ment specifying the food or character- not required to be declared in the name izing ingredient(s) or component(s) of the beverage unless the declared shown in the vignette but not included juices alone do not characterize the in the package. product before the addition of the (d) If the statement specified in para- added flavors. graph (a)(2) of this section is used on (c) If a diluted multiple-juice bev- any panel in addition to the principal erage or blend of single-strength juices display panel as a product identifica- contains a juice that is named or im- tion statement, the complete common plied on the label or labeling other or usual name shall appear on such than in the ingredient statement (rep- panel in the manner specified in para- resented juice), and also contains a graph (b) of this section. juice other than the named or implied (e) When a brand name or other juice (nonrepresented juice), then the prominent product designation con- common or usual name for the product tains a word or words that includes or shall indicate that the represented suggests an important characterizing juice is not the only juice present (e.g., ingredient(s) or component(s) that ‘‘Apple blend; apple juice in a blend of must be added, or otherwise states or two other fruit juices.’’) implies that the package contains a (d) In a diluted multiple-juice bev- complete main dish, dinner, or other erage or blend of single-strength juices food serving, the part of the common where one or more, but not all, of the or usual name of the food required by juices are named on the label other paragraph (a)(3) of this section shall than in the ingredient statement, and appear in direct conjunction with such where the named juice is not the pre- brand name or other designation and in dominant juice, the common or usual type size not less than one-half the name for the product shall:

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(1) Indicate that the named juice is beled with the term ‘‘from con- present as a flavor or flavoring (e.g., centrate’’ or ‘‘reconstituted.’’ ‘‘Raspcranberry’’; raspberry and cran- [58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1, berry flavored juice drink); or 1993, as amended at 58 FR 44063, Aug. 18, 1993; (2) Include the amount of the named 62 FR 15343, Mar. 31, 1997] juice, declared in a 5- percent range (e.g., Raspcranberry; raspberry and § 102.37 Mixtures of edible fat or oil cranberry juice beverage, 10- to 15-per- and olive oil. cent cranberry juice and 3- to 8-percent The common or usual name of a mix- raspberry juice). The 5-percent range, ture of edible fats and oils containing when used, shall be declared in the less than 100 percent and more than 0 manner set forth in § 102.5(b)(2). percent olive oil shall be as follows: (e) The common or usual name of a (a) A descriptive name for the prod- juice that has been modified shall in- uct meeting the requirements of clude a description of the exact nature § 102.5(a), e.g., ‘‘cottonseed oil and olive of the modification (e.g., ‘‘acid-reduced oil’’ or another descriptive phrase, and cranberry juice,’’ ‘‘deflavored, de- (b) When the label bears any rep- colored grape juice’’). resentation, other than in the ingre- (f) If the product is a beverage that dient listing, of the presence of olive contains a juice whose color, taste, or oil in the mixture, the descriptive other organoleptic properties have name shall be followed by a statement been modified to the extent that the of the percentage of olive oil contained original juice is no longer recognizable in the product in the manner set forth at the time processing is complete, or in § 102.5(b)(2). if its nutrient profile has been dimin- § 102.39 Onion rings made from diced ished to a level below the normal nutri- onion. ent range for the juice, then the source (a) The common or usual name of the fruits or vegetables from which the food product that resembles and is of modified juice was derived may not be the same composition as onion rings, depicted on the label by vignette or except that it is composed of other pictorial representation. comminuted onions, shall be as follows: (g)(1) If one or more juices in a juice (1) When the product is composed of beverage is made from concentrate, the dehydrated onions, the name shall be name of the juice must include a term ‘‘onion rings made from dried diced on- indicating that fact, such as ‘‘from ions.’’ concentrate,’’ or ‘‘reconstituted.’’ Such (2) When the product is composed of terms must be included in the name of any form of onion other than dehy- each individual juice or it may be stat- drated, the name shall be ‘‘onion rings ed once adjacent to the product name made from diced onions.’’ so that it applies to all the juices, (e.g., (b) The words ‘‘made from dried diced ‘‘cherry juice (from concentrate) in a onions’’ or ‘‘made from diced onions’’ blend of two other juices’’ or ‘‘cherry shall immediately follow or appear on juice in a blend of 2 other juices (from a line(s) immediately below the words concentrate)’’). The term shall be in a ‘‘onion rings’’ in easily legible boldface type size no less than one-half the print or type in distinct contrast to height of the letters in the name of the other printed or graphic matter, and in juice. a height not less than the larger of the (2) If the juice is 100 percent single following alternatives: species juice consisting of juice di- (1) Not less than one-sixteenth inch rectly expressed from a fruit or vege- in height on packages having a prin- table whose Brix level has been raised cipal display panel with an area of 5 by the addition of juice concentrate square inches or less and not less than from the same fruit or vegetable, the one-eighth inch in height if the area of name of the juice need not include a the principal display panel is greater statement that the juice is from con- than 5 square inches; or centrate. However, if water is added to (2) Not less than one-half the height this 100 percent juice mixture to adjust of the largest type used in the words the Brix level, the product shall be la- ‘‘onion rings.’’

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§ 102.41 Potato chips made from dried § 102.46 Pacific whiting. potatoes. ‘‘Pacific whiting’’ or ‘‘North Pacific (a) The common or usual name of the whiting’’ is the common or usual name food product that resembles and is of of the food fish Merluccius productus. the same composition as potato chips, except that it is composed of dehy- [44 FR 45617, Aug. 3, 1979] drated potatoes (buds, flakes, granules, § 102.47 Bonito. or other form), shall be ‘‘potato chips made from dried potatoes.’’ ‘‘Bonito’’ or ‘‘bonito fish’’ is the com- (b) The words ‘‘made from dried pota- mon or usual name of the following toes’’ shall immediately follow or ap- food fishes: pear on a line(s) immediately below the Cybiosarda elegans (Whitely, 1935)—Leaping words ‘‘potato chips’’ in easily legible bonito boldface print or type in distinct con- Gymnosarda unicolor (Ruppell, 1838)— trast to other printed or graphic mat- Dogtooth tuna ter, and in a height not less than the Orcynopsis unicolor (Geoffroy St. Hilaire, larger of the following alternatives: 1817)—Plain bonito Sarda australis (Macleay, 1880)—Australian (1) Not less than one-sixteenth inch bonito in height on packages having a prin- Sarda chiliensis (Cuvier, 1831)—Eastern Pa- cipal display panel with an area of 5 cific bonito square inches or less and not less than Sarda orientalis (Temminck and Schlegel, one-eighth inch in height if the area of 1844)—Striped bonito the principal display panel is greater Sarda sarda (Bloch, 1793)—Atlantic bonito than 5 square inches; or [55 FR 45797, Oct. 31, 1990] (2) Not less than one-half the height of the largest type used in the words § 102.49 Fried clams made from ‘‘potato chips.’’ minced clams. (a) The common or usual name of the § 102.45 Fish sticks or portions made food product that resembles and is of from minced fish. the same composition as fried clams, (a) The common or usual name of the except that it is composed of food product that resembles and is of comminuted clams, shall be ‘‘fried the same composition as fish sticks or clams made from minced clams.’’ fish portions, except that it is com- (b) The words ‘‘made from minced posed of comminuted fish flesh, shall clams’’ shall immediately follow or ap- be ‘‘fish lll made from minced fish,’’ pear on a line(s) immediately below the the blank to be filled in with the word words ‘‘fried clams’’ and in easily leg- ‘‘sticks’’ or ‘‘portions’’ as the case may ible boldface print or type in distinct be. contrast to other printed or graphic (b) The words ‘‘made from minced matter, and in a height not less than fish’’ shall immediately follow or ap- the larger of the following alternatives: pear on a line(s) immediately below the (1) Not less than one-sixteenth inch words ‘‘fish lll’’ in easily legible in height on packages having a prin- boldface print or type in distinct con- cipal display panel with an area of 5 trast to other printed or graphic mat- square inches or less and not less than ter, and in a height not less than the one-eighth inch in height if the area of larger of the following alternatives: the principal display panel is greater (1) Not less than one-sixteenth inch than 5 square inches; or in height on packages having a prin- (2) Not less than one-half the height cipal display panel with an area of 5 of the largest type used in the words square inches or less and not less than ‘‘fried clams.’’ one-eighth inch in height if the area of the principal display panel is greater § 102.50 Crabmeat. than 5 square inches; or The common or usual name of crab- (2) Not less than one-half the height meat derived from each of the fol- of the largest type used in the words lowing designated species of crabs shall ‘‘fish lll.’’ be as follows:

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tion in easily legible boldface print or Scientific name of crab Common or usual name of crabmeat type in distinct contrast to other Chionoecetes opilio, Snow crabmeat. printed or graphic matter, and in a Chionoecetes tanneri, height not less than the larger of the Chionoecetes bairdii, and following alternatives: Chionoecetes angulatus Erimacrus isenbeckii Korean variety crabmeat or (1) Not less than one-sixteenth inch Kegani crabmeat. in height on packages having a prin- Lithodes aequispina Brown King crabmeat. cipal display panel with an area of 5 Paralithodes brevipes King crabmeat or Hanasaki crabmeat. square inches or less and no less than Paralithodes camtschaticus King crabmeat and one-eighth inch in height if the area of Paralithodes Platypus. the principal display panel is greater than 5 square inches; or [42 FR 14322, Mar. 15, 1977, as amended at 60 (2) Not less than one-half the height FR 34460, July 3, 1995] of the largest type used in the words ‘‘breaded shrimp sticks’’ or the other § 102.54 Seafood cocktails. comparable words required by this sec- The common or usual name of a sea- tion. food cocktail in package form fabricated with one or more seafood ingre- § 102.57 Greenland turbot dients shall be: (Reinhardtius hippoglossoides). (a) When the cocktail contains only ‘‘Greenland turbot’’ is the common one seafood ingredient, the name of the or usual name of the food fish seafood ingredient followed by the Reinhardtius hippoglossoides, a species word ‘‘cocktail’’ (e.g., shrimp cocktail, of Pleuronectidae right-eye flounders. crabmeat cocktail) and a statement of The term ‘‘halibut’’ may be associated the percentage by weight of that sea- only with Atlantic halibut food ingredient in the product in the (Hippoglossus hippoglossus) or Pacific manner set forth in § 102.5(b). halibut (Hippoglossus stenolepis). (b) When the cocktail contains more than one seafood ingredient, the term PART 104—NUTRITIONAL QUALITY ‘‘seafood cocktail’’ and a statement of the percentage by weight of each sea- GUIDELINES FOR FOODS food ingredient in the product in the manner set forth in § 102.5(b). Subpart A—General Provisions Sec. § 102.55 Nonstandardized breaded 104.5 General principles. composite shrimp units. (a) The common on usual name of the Subpart B—Fortification Policy food product that conforms to the definition and standard of identity de- 104.20 Statement of purpose. scribed by § 161.175(c)(6) of this chapter, Subpart C—Specific Nutritional Quality except that the food is made from Guidelines comminuted shrimp and is not in raw frozen form, shall be ‘‘lll made from 104.47 Frozen ‘‘heat and serve’’ dinner. minced shrimp,’’ the blank to be filled AUTHORITY: 21 U.S.C. 321, 343, 371(a). in with the words ‘‘breaded shrimp sticks’’ or ‘‘breaded shrimp cutlets’’ de- SOURCE: 42 FR 14327, Mar. 15, 1977, unless pending upon the shape of the product, otherwise noted. or if prepared in a shape other than that of sticks or cutlets ‘‘breaded Subpart A—General Provisions shrimp lll made from minced shrimp,’’ the blank to be filled by a § 104.5 General principles. word or phrase that accurately de- (a) A nutritional quality guideline scribes the shape and that is not mis- prescribes the minimum level or range leading. of nutrient composition (nutritional (b) The words ‘‘made from minced quality) appropriate for a given class of shrimp’’ shall immediately follow or food. appear on a line(s) immediately below (b) Labeling for a product which com- the other words required by this sec- plies with all of the requirements of

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the nutritional quality guideline estab- the guideline, shall be ineligible to lished for its class of food may state bear the guideline statement provided ‘‘This product provides nutrients in for in paragraph (b) of this section, and amounts appropriate for this class of such a product shall also be deemed to food as determined by the U.S. Govern- be misbranded under the act unless the ment,’’ except that the words ‘‘this label and all labeling bear the fol- product’’ are optional. This statement, lowing prominent and conspicuous if used, shall be printed on the prin- statement: ‘‘The addition of lll to cipal display panel, and may also be (or ‘‘The addition of lll at the level printed on the information panel, in contained in) this product has been de- letters not larger than twice the size of termined by the U.S. Government to be the minimum type required for the unnecessary and inappropriate and declaration of net quantity of contents does not increase the dietary value of by § 101.7 of this chapter. Labeling of the food,’’ the blank to be filled in with noncomplying products may not in- the common or usual name of the nu- clude any such statement or otherwise trient(s) involved. represent, suggest, or imply the prod- [42 FR 14327, Mar. 15, 1977, as amended at 63 uct as being, in whole or in part, in FR 14818, Mar. 27, 1998; 81 FR 59131, Aug. 29, compliance with a guideline. 2016] (c) A product bearing the statement provided for in paragraph (b) of this Subpart B—Fortification Policy section, in addition to meeting the requirements of the applicable nutri- § 104.20 Statement of purpose. tional quality guideline, shall comply (a) The fundamental objective of this with the following requirements: subpart is to establish a uniform set of (1) The label of the product shall bear principles that will serve as a model for the common or usual name of the food the rational addition of nutrients to in accordance with the provisions of foods. The achievement and mainte- the guideline and §§ 101.3 and 102.5(a) of nance of a desirable level of nutritional this chapter. quality in the nation’s food supply is (2) The label of the product shall bear an important public health objective. nutrition labeling in accordance with The addition of nutrients to specific §§ 101.2 and 101.9 of this chapter and all foods can be an effective way of main- other labeling required by applicable taining and improving the overall nu- sections of part 101 of this chapter. tritional quality of the food supply. (d) No claim or statement may be However, random fortification of foods made on the label or in labeling rep- could result in over- or underfortifica- resenting, suggesting, or implying any tion in consumer diets and create nu- nutritional or other differences be- trient imbalances in the food supply. It tween a product to which nutrient ad- could also result in deceptive or mis- dition has or has not been made in leading claims for certain foods. The order to meet the guideline, except Food and Drug Administration does that a nutrient addition shall be de- not encourage indiscriminate addition clared in the ingredient statement. of nutrients to foods, nor does it con- (e) Compliance with a nutrient level sider it appropriate to fortify fresh specified in a nutritional quality guide- produce; meat, poultry, or fish prod- line shall be determined by the proce- ucts; sugars; or snack foods such as dures and requirements established in candies and carbonated beverages. To § 101.9(g) of this chapter. preserve a balance of nutrients in the (f) A product within a class of food diet, manufacturers who elect to for- for which a nutritional quality guide- tify foods are urged to utilize these line has been established and to which principles when adding nutrients to has been added a discrete nutrient ei- food. It is reasonable to anticipate that ther for which no minimum nutrient the Reference Daily Intakes (RDI’s) as level or nutrient range or other allow- delineated in § 101.9 of this chapter and ance has been established as appro- in paragraph (d) of this section will be priate in the nutritional quality guide- amended from time to time to list ad- line, or at a level that exceeds any ditional nutrients and/or to change the maximum established as appropriate in levels of specific RDI’s as improved

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knowledge about human nutrient re- contribute nutrients are considered in quirements and allowances develops. determining restoration levels; and The policy set forth in this section is (4) The food is not the subject of any based on U.S. dietary practices and nu- other Federal regulation that requires tritional needs and may not be applica- or prohibits nutrient addition(s), or the ble in other countries. food has not been fortified in accord- (b) A nutrient(s) listed in paragraph ance with any other Federal regulation (d)(3) of this section may appropriately that permits voluntary nutrient addi- be added to a food to correct a dietary tions. insufficiency recognized by the sci- (d) A nutrient(s) listed in paragraph entific community to exist and known (d)(3) of this section may be added to a to result in nutritional deficiency dis- food in proportion to the total caloric ease if: content of the food, to balance the vi- (1) Sufficient information is available tamin, mineral, and protein content if: to identify the nutritional problem and (1) A normal serving of the food con- the affected population groups, and the tains at least 40 kilocalories (that is, 2 food is suitable to act as a vehicle for percent of a daily intake of 2,000 the added nutrients. Manufacturers kilocalories); contemplating using this principle are (2) The food is not the subject of any urged to contact the Food and Drug other Federal regulation for a food or Administration before implementing a class of food that requires, permits, or fortification plan based on this prin- prohibits nutrient additions; and ciple. (3) The food contains all of the fol- (2) The food is not the subject of any lowing nutrients per 100 calories based other Federal regulation for a food or on 2,000 calorie total intake as a daily class of food that requires, permits, or standard: prohibits nutrient additions. (Other DRV or Amount Federal regulations include, but are Nutrient Unit of measurement 1 per 100 RDI calories not limited to, standards of identity promulgated under section 401 of the Protein ...... grams (g) ...... 50 2 .5 Federal Food, Drug, and Cosmetic Act, Vitamin A ...... International Unit (IU) 5,000 250 Vitamin C ...... milligrams (mg) ...... 60 3 nutritional quality guidelines estab- Calcium ...... g ...... 1 0 .05 lished in subpart C of this part, and Iron ...... mg ...... 18 0 .9 common or usual name regulations es- Vitamin D ...... IU ...... 400 20 tablished in part 102 of this chapter.) Vitamin E ...... do ...... 30 1 .5 Thiamin ...... mg ...... 1 .5 0 .08 (c) A nutrient(s) listed in paragraph Riboflavin ...... do ...... 1 .7 0 .09 (d)(3) of this section may appropriately Niacin ...... do ...... 20 1 be added to a food to restore such nu- Vitamin B6 ...... do ...... 2.0 0.1 Folate ...... micrograms (μg) ...... 400 20 trient(s) to a level(s) representative of Vitamin B12 ...... do ...... 6 .0 0 .3 the food prior to storage, handling, and Biotin ...... mg ...... 0.3 0.015 processing, when: Pantothenic acid do ...... 10 0.5 Phosphorus ...... g ...... 1 .0 0 .05 (1) The nutrient is shown by adequate Magnesium ...... mg ...... 400 20 scientific documentation to have been Zinc ...... do ...... 15 0 .8 lost in storage, handling, or processing Iodine ...... μg ...... 150 7 .5 in a measurable amount equal to at Copper ...... mg ...... 2 .0 0 .1 Potassium ...... do ...... 3,500 175 least 2 percent of the Daily Reference Value (DRV) of protein and of potas- 1 RDI’s for adults and children 4 or more years of age. sium and 2 percent of the Reference (e) A nutrient(s) may appropriately Daily Intake (RDI) in a normal serving be added to a food that replaces tradi- of the food. tional food in the diet to avoid nutri- (2) Good manufacturing practices and tional inferiority in accordance with normal storage and handling proce- § 101.3(e)(2) of this chapter. dures cannot prevent the loss of such (f) Nutrient(s) may be added to foods nutrient(s), as permitted or required by applicable (3) All nutrients, including protein, regulations established elsewhere in iodine and vitamin D, that are lost in this chapter. a measurable amount are restored and (g) A nutrient added to a food is ap- all ingredients of the food product that propriate only when the nutrient:

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(1) Is stable in the food under cus- added pursuant to paragraph (e) of this tomary conditions of storage, distribu- section. tion, and use; [45 FR 6323, Jan. 25, 1980, as amended at 58 (2) Is physiologically available from FR 2228, Jan. 6, 1993] the food; (3) Is present at a level at which Subpart C—Specific Nutritional there is a reasonable assurance that consumption of the food containing the Quality Guidelines added nutrient will not result in an ex- § 104.47 Frozen ‘‘heat and serve’’ din- cessive intake of the nutrient, consid- ner. ering cumulative amounts from other sources in the diet; and (a) A product, for which a common or (4) Is suitable for its intended pur- usual name is established in § 102.26 of pose and is in compliance with applica- this chapter, in order to be eligible to ble provisions of the act and regula- bear the guideline statement set forth tions governing the safety of sub- at § 104.5(b), shall contain at least the stances in food. following three components: (h) Any claims or statements in the (1) One or more sources of protein de- labeling of food about the addition of a rived from meat, poultry, fish, cheese, vitamin, mineral, or protein to a food or eggs. shall be made only if the claim or (2) One or more vegetables or vege- statement is not false or misleading table mixtures other than potatoes, and otherwise complies with the act rice, or cereal-based product. and any applicable regulations. The (3) Potatoes, rice, or cereal-based following label claims are acceptable: product (other than bread or rolls) or (1) The labeling claim ‘‘fully restored another vegetable or vegetable mix- with vitamins and minerals’’ or ‘‘fully ture. restored with vitamins and minerals to (b) The three or more components the level of unprocessed lll’’ (the named in paragraph (a) of this section, blank to be filled in with the common including their sauces, gravies, or usual name of the food) may be used breading, etc.: to describe foods fortified in accord- (1) Shall contribute not less than the ance with the principles established in minimum levels of nutrients prescribed paragraph (c) of the section. in paragraph (d) of this section. (2) The labeling claim, ‘‘vitamins and (2) Shall be selected so that one or minerals (and ‘‘protein’’ when appro- more of the listed protein sources of priate) added are in proportion to ca- paragraph (a)(1) of this section, exclud- loric content’’ may be used to describe ing their sauces, gravies, breading, food fortified in accordance with the etc., shall provide not less than 70 per- principles established in paragraph (d) cent of the total protein supplied by of this section. the components named in paragraph (a) (3) When labeling claims are per- of this section. mitted, the term ‘‘enriched,’’ ‘‘for- (c) If it is necessary to add any nutri- tified,’’ ‘‘added,’’ or similar terms may ent(s) in order to meet the minimum be used interchangeably to indicate the nutrient levels prescribed in paragraph addition of one or more vitamins or (d) of this section, the addition of each minerals or protein to a food, unless an such nutrient may not result in a total applicable Federal regulation requires nutrient level exceeding 150 percent of the use of specific words or statements. the minimum level prescribed. Nutri- (i) It is inappropriate to make any ents used for such addition shall be bio- claim or statement on a label or in la- logically available in the final product. beling, other than in a listing of the (d) Minimum levels of nutrients for a nutrient ingredients as part of the in- frozen ‘‘heat and serve’’ dinner are as gredient statement, that any vitamin, follows: mineral, or protein has been added to a food to which nutrients have been

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Minimum levels for fro- (f) For the purposes of labeling, an zen ‘‘heat and serve’’ ‘‘average serving’’ shall be one entire dinner— frozen ‘‘heat and serve’’ dinner. For each 100 Cal- [42 FR 14327, Mar. 5, 1977] Nutrient ories (keal) For the of the total total com- compo- ponents nents specified in PART 105—FOODS FOR SPECIAL specified in par. (a) DIETARY USE par. (a)

Protein, grams ...... 4.60 16.0 Subpart A—General Provisions Vitamin A, IU ...... 150.00 520.0 Sec. Thiamine, mg ...... 05 .2 Riboflavin, mg ...... 06 .2 105.3 Definitions and interpretations. Niacin, mg ...... 99 3.4 Pantothenic acid, mg ...... 32 1.1 Subpart B—Label Statements Vitamin, B6, mg ...... 15 .5 105.62 Hypoallergenic foods. Vitamin, B ...... 33 1.1 1 105.65 Infant foods. Iron, mg ...... 62 2.2 105.66 Label statements relating to usefulness in reducing or maintaining body (1) A frozen ‘‘heat and serve’’ dinner weight. prepared from conventional food ingredients listed in paragraph (a) of this Subpart C [Reserved] section will also contain folic acid, magnesium, iodine, calcium, and zinc. Subpart D—Standards of Identity Minimum levels for these nutrients [Reserved] cannot be established at the present time but may be specified as additional AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 350, data are obtained. 371, 379e. (2) The minimum levels for panto- SOURCE: 42 FR 14328, Mar. 15, 1977, unless thenic acid, vitamin B–6, and vitamin otherwise noted. B–12 are tentative. Final levels will be established when sufficient data are Subpart A—General Provisions available. Until final levels are established, a product containing less than § 105.3 Definitions and interpretations. the tentative levels will not be deemed The definitions and interpretations to be misbranded when labeled in ac- of terms contained in section 201 of the cordance with § 104.5(b). Federal Food, Drug, and Cosmetic Act (3) When technologically practicable, (hereafter ‘‘the act’’) shall be applica- iodized salt shall be used or iodine ble with the following additions: shall be present at a level equivalent to (a)(1) The term special dietary uses, as that which would be present if iodized applied to food for man, means par- salt were used in the manufacture of ticular (as distinguished from general) the product. uses of food, as follows: (4) When technologically practicable, (i) Uses for supplying particular die- product components and ingredients tary needs which exist by reason of a shall be selected to obtain the desir- physical, physiological, pathological or able calcium to phosphorous ratio of other condition, including but not lim- 1:1. Technological addition of ited to the conditions of diseases, con- phosphates shall be minimized and valescence, pregnancy, lactation, aller- shall not exceed the amount necessary gic hypersensitivity to food, under- for the intended effect. weight, and overweight; (e) If the product includes servings of (ii) Uses for supplying particular die- food which are not prescribed by para- tary needs which exist by reason of graph (a) of this section (e.g., soup, age, including but not limited to the bread or rolls, beverage, or dessert), ages of infancy and childhood; their contribution shall not be consid- (iii) Uses for supplementing or for- ered in determining compliance with tifying the ordinary or usual diet with the nutrient levels established in para- any vitamin, mineral, or other dietary graph (d) of this section but shall be in- property. Any such particular use of a cluded in any nutrition labeling. food is a special dietary use, regardless

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of whether such food also purports to erals alone) purports to be or is rep- be or is represented for general use. resented for special dietary use for in- (2) The use of an artificial sweetener fants, the label shall bear, if such food in a food, except when specifically and is fabricated from two or more ingredi- solely used for achieving a physical ents, the common or usual name of characteristic in the food which cannot each ingredient, including spices, fla- be achieved with sugar or other nutri- voring, and coloring. tive sweetener, shall be considered a (b) If such food, or any ingredient use for regulation of the intake of cal- thereof, consists in whole or in part of ories and available carbohydrate, or for plant or animal matter and the name use in the diets of diabetics and is of such food or ingredient does not therefore a special dietary use. clearly reveal the specific plant or ani- (b)–(d) [Reserved] mal which is its source, such name (e) For the purposes of the regula- shall be so qualified as to reveal clear- tions in this part, the terms infant, ly the specific plant or animal that is child, and adult mean persons not more such source. than 12 months old, more than 12 months but less than 12 years old, and [42 FR 14328, Mar. 15, 1977, as amended at 47 12 years or more old, respectively. FR 947, Jan. 8, 1982; 49 FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985] [42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979; 44 FR 49665, Aug. 24, § 105.66 Label statements relating to 1979] usefulness in reducing or maintaining body weight. Subpart B—Label Statements (a) General requirements. Any food that purports to be or is represented § 105.62 Hypoallergenic foods. for special dietary use because of use- If a food purports to be or is rep- fulness in reducing or maintaining resented for special dietary use by rea- body weight shall bear: son of the decrease or absence of any (1) Nutrition labeling in conformity allergenic property or by reason of with § 101.9, or, where applicable, being offered as food suitable as a sub- § 101.36 of this chapter, unless exempt stitute for another food having an al- under that section; and lergenic property, the label shall bear: (2) A conspicuous statement of the (a) The common or usual name and basis upon which the food claims to be the quantity or proportion of each in- of special dietary usefulness. gredient (including spices, flavoring, (b) Nonnutritive ingredients. (1) Any and coloring) in case the food is fab- food subject to paragraph (a) of this ricated from two or more ingredients. section that achieves its special die- (b) A qualification of the name of the tary usefulness by use of a nonnutri- food, or the name of each ingredient tive ingredient (i.e., one not utilized in thereof in case the food is fabricated normal metabolism) shall bear on its from two or more ingredients, to reveal label a statement that it contains a clearly the specific plant or animal nonnutritive ingredient and the per- that is the source of such food or of centage by weight of the nonnutritive such ingredient, if such food or such in- ingredient. gredient consists in whole or in part of (2) A special dietary food may con- plant or animal matter and such name tain a nonnutritive sweetener or other does not reveal clearly the specific ingredient only if the ingredient is safe plant or animal that is such a source. for use in the food under the applicable (c) An informative statement of the law and regulations of this chapter. nature and effect of any treatment or Any food that achieves its special die- processing of the food or any ingre- tary usefulness in reducing or main- dient thereof, if the changed allergenic taining body weight through the use of property results from such treatment a nonnutritive sweetener shall bear on or processing. its label the statement required by paragraph (b)(1) of this section, but § 105.65 Infant foods. need not state the percentage by (a) If a food (other than a dietary weight of the nonnutritive sweetener. supplement of vitamins and/or min- If a nutritive sweetener(s) as well as

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nonnutritive sweetener(s) is added, the Subpart D—Standards of Identity statement shall indicate the presence [Reserved] of both types of sweetener, e.g., ‘‘Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).’’ PART 106—INFANT FORMULA RE- (c) ‘‘Low calorie’’ foods. A food pur- QUIREMENTS PERTAINING TO porting to be ‘‘low calorie’’ must com- CURRENT GOOD MANUFAC- ply with the criteria set forth for such TURING PRACTICE, QUALITY foods in § 101.60(b)(2) and (b)(3) of this CONTROL PROCEDURES, QUALITY chapter. FACTORS, RECORDS AND RE- (d) ‘‘Reduced calorie’’ foods and other PORTS, AND NOTIFICATIONS comparative calorie claims. A food purporting to be ‘‘reduced calorie’’ or oth- Subpart A—General Provisions erwise containing fewer calories than a reference food must comply with the Sec. criteria set forth for such food in 106.1 Status and applicability of the regula- § 101.60(b)(4) and (b)(5) of this chapter. tions in part 106. (e) Label terms suggesting usefulness as 106.3 Definitions. low calorie or reduced calorie foods. (1) Subpart B—Current Good Manufacturing Except as provided in paragraphs (e)(2) Practice and (e)(3) of this section, and in § 101.13(q)(2) of this chapter for soft 106.5 Current good manufacturing practice. drinks, a food may be labeled with 106.6 Production and in-process control sys- terms such as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘ar- tem. tificially sweetened,’’ or ‘‘sweetened 106.10 Controls to prevent adulteration by with nonnutritive sweetener’’ only if workers. the claim is not false and misleading, 106.20 Controls to prevent adulteration and the food is labeled ‘‘low calorie’’ or caused by facilities. 106.30 Controls to prevent adulteration ‘‘reduced calorie’’ or bears another caused by equipment or utensils. comparative calorie claim in compli- 106.35 Controls to prevent adulteration due ance with part 101 of this chapter and to automatic (mechanical or electronic) this section. equipment. (2) Paragraph (e)(1) of this section 106.40 Controls to prevent adulteration shall not apply to any use of such caused by ingredients, containers, and terms that is specifically authorized by closures. regulation governing a particular food, 106.50 Controls to prevent adulteration dur- or, unless otherwise restricted by regu- ing manufacturing. lation, to any use of the term ‘‘diet’’ 106.55 Controls to prevent adulteration from microorganisms. that clearly shows that the food is of- 106.60 Controls to prevent adulteration dur- fered solely for a dietary use other ing packaging and labeling of infant for- than regulating body weight, e.g., ‘‘for mula. low-sodium diets.’’ 106.70 Controls on the release of finished in- (3) Paragraph (e)(1) of this section fant formula. shall not apply to any use of such 106.80 Traceability. terms on a formulated meal replace- 106.90 Audits of current good manufacturing ment or other food that is represented practice. to be of special dietary use as a whole Subpart C—Quality Control Procedures meal, pending the issuance of a regulation governing the use of such terms on 106.91 General quality control. foods. 106.92 Audits of quality control procedures. (f) ‘‘Sugar free,’’ and ‘‘no added sugar.’’ Criteria for the use of the Subpart D—Conduct of Audits terms ‘‘sugar free’’ and ‘‘no added 106.94 Audit plans and procedures. sugar’’ are provided for in § 101.60(c) of this chapter. Subpart E—Quality Factors for Infant [58 FR 2430, Jan. 6, 1993] Formulas 106.96 Requirements for quality factors for Subpart C [Reserved] infant formulas. 210

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Subpart F—Records and Reports record requirements in subpart F of this part with respect to an infant for- 106.100 Records. mula, the formula will be deemed to be Subpart G—Registration, Submission, and adulterated under section 412(a)(2) of Notification Requirements the Federal Food, Drug, and Cosmetic Act. If an infant formula manufacturer 106.110 New infant formula registration. fails to comply with the good manufac- 106.120 New infant formula submission. 106.121 Quality factor assurances for infant turing practices or quality control pro- formulas. cedures record requirements in subpart 106.130 Verification submission. F of this part with respect to an infant 106.140 Submission concerning a change in formula, the infant formula will be infant formula that may adulterate the deemed to be adulterated under section product. 106.150 Notification of an adulterated or 412(a)(3) of the Federal Food, Drug, and misbranded infant formula. Cosmetic Act. The criteria set forth in 106.160 Incorporation by reference. subpart F of this part also implement AUTHORITY: 21 U.S.C. 321, 342, 350a, 371. record retention requirements under section 412(b)(4) of the Federal Food, SOURCE: 79 FR 8059, Feb. 10, 2014, unless Drug, and Cosmetic Act. Failure to otherwise noted. comply with any regulation in subpart EDITORIAL NOTE: Nomenclature changes to F of this part is a violation of section part 106 appear at 81 FR 49895, July 29, 2016. 301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)). Subpart A—General Provisions (d) The criteria set forth in subpart G § 106.1 Status and applicability of the of this part describe, in part, certain regulations in part 106. good manufacturing practices, quality control procedures, and quality factor (a) The criteria set forth in subparts B, C, and D of this part prescribe the records requirements under section steps that manufacturers shall take 412(b)(1) and (b)(2) of the Federal Food, under section 412(b)(2) and (b)(3) of the Drug and Cosmetic Act. If an infant Federal Food, Drug, and Cosmetic Act formula manufacturer fails to comply (21 U.S.C. 350a(b)(2) and (b)(3)) in proc- with such records requirements with essing infant formula. If the processing respect to an infant formula, the infant of the formula does not comply with formula will be deemed to be adulter- any regulation in subparts B, C, or D of ated under section 412(a)(2) or (a)(3) of this part, the formula will be deemed the Federal Food, Drug, and Cosmetic to be adulterated under section Act, as applicable. The criteria set 412(a)(3) of the Federal Food, Drug, and forth in subpart G of this part also de- Cosmetic Act. scribe the circumstances in which an (b) The criteria set forth in subpart E infant formula manufacturer is re- of this part prescribe the requirements quired to register with, submit to, or for quality factors that infant formula notify the Food and Drug Administra- shall meet under section 412(b)(1) of the tion, and the content of a registration, Federal Food, Drug, and Cosmetic Act. submission, or notification, under sec- If the formula fails to comply with any tion 412(c), (d), and (e) of the Federal regulation in subpart E of this part, it Food, Drug, and Cosmetic Act. Failure will be deemed to be adulterated under to comply with any regulation in sub- section 412(a)(2) of the Federal Food, part G of this part is a violation of sec- Drug, and Cosmetic Act. tion 301(s) of the Federal Food, Drug, (c) The criteria set forth in subpart F and Cosmetic Act. of this part prescribe records requirements for quality factors under section § 106.3 Definitions. 412(b)(1) of the Federal Food, Drug, and Cosmetic Act and for good manufac- The definitions in this section and turing practices and quality control the definitions contained in section 201 procedures, including distribution and of the Federal Food, Drug, and Cos- audit records, under section 412(b)(2). If metic Act (21 U.S.C. 321) shall apply to an infant formula manufacturer fails infant formula requirements in 21 CFR to comply with the quality factor parts 106 and 107 of this chapter.

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Eligible infant formula means an in- (4) Any infant formula manufactured fant formula that could be lawfully dis- on a new processing line or in a new tributed in the United States on De- plant; cember 8, 2014. (5) Any infant formula manufactured Final product stage means the point in containing a new constituent not listed the manufacturing process, before dis- in section 412(i) of the Federal Food, tribution of an infant formula, at Drug, and Cosmetic Act (21 U.S.C. which the infant formula is homo- 350a(i)), such as taurine or L-carnitine; geneous and is not subject to further (6) Any infant formula processed by a degradation due to processing. manufacturer on new equipment that utilizes a new technology or principle Indicator nutrient means a nutrient (e.g., from terminal sterilization to whose concentration is measured dur- aseptic processing); or ing the manufacture of an infant for- (7) An infant formula for which there mula to confirm complete addition and has been a fundamental change in the uniform distribution of a premix or type of packaging used (e.g., changing other substance of which the indicator from metal cans to plastic pouches). nutrient is a part. Manufacturer means a person who Infant means a person not more than prepares, reconstitutes, or otherwise 12 months of age. changes the physical or chemical char- Infant formula means a food which acteristics of an infant formula or purports to be or is represented for spe- packages or labels the product in a cial dietary use solely as a food for in- container for distribution. The term fants by reason of its simulation of ‘‘manufacturer’’ does not include a per- human milk or its suitability as a com- son who prepares, reconstitutes, or plete or partial substitute for human mixes infant formula exclusively for an milk. infant under his/her direct care or the In-process production aggregate means direct care of the institution employ- a combination of ingredients at any ing such person. point in the manufacturing process be- Microorganisms means yeasts, molds, fore packaging. bacteria, and viruses and includes, but Major change in an infant formula is not limited to, species having public means any new formulation, or any health significance. change of ingredients or processes New infant formula means: where experience or theory would pre- (1) An infant formula manufactured dict a possible significant adverse im- by a person that has not previously pact on levels of nutrients or bio- manufactured an infant formula, and availability of nutrients, or any change (2) An infant formula manufactured that causes an infant formula to differ by a person that has previously manu- fundamentally in processing or in com- factured infant formula and in which position from any previous formulation there is a major change in processing or formulation from a current or any produced by the manufacturer. Exam- previous formulation produced by such ples of infant formulas deemed to differ manufacturer, or which has not pre- fundamentally in processing or in com- viously been the subject of a submis- position include: sion under section 412(c) of the Federal (1) Any infant formula produced by a Food, Drug, and Cosmetic Act for the manufacturer who is entering the U.S. U.S. market. market; Nutrient means any vitamin, mineral, (2) Any infant formula powder proc- or other substance or ingredient that is essed and distributed by a manufac- required in accordance with the ‘‘Nu- turer who previously only produced liq- trients’’ table set out in section uids (or vice versa); 412(i)(1) of the Federal Food, Drug, and (3) Any infant formula having a sig- Cosmetic Act or by regulations issued nificant revision, addition, or substi- under section 412(i)(2) or that is identi- tution of a macronutrient (i.e., protein, fied as essential for infants by the Food fat, or carbohydrate), with which the and Nutrition Board of the Institute of manufacturer has not had previous ex- Medicine through its development of a perience; Dietary Reference Intake, or that has

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been identified as essential for infants to be used in, and the facilities or con- by the Food and Drug Administration trols that are to be used for, the manu- through a FEDERAL REGISTER publica- facture, processing, packing, or holding tion. of an infant formula. Compliance with Nutrient premix means a combination these provisions is necessary to ensure of ingredients containing two or more that such infant formula provides the nutrients received from a supplier or nutrients required under § 107.100 of prepared by an infant formula manu- this chapter and is manufactured in a facturer. manner designed to prevent its adulter- Production aggregate means a quan- ation. A liquid infant formula that is a tity of product, or, in the case of an in- thermally processed low-acid food fant formula produced by continuous packaged in a hermetically sealed con- process, a specific identified amount tainer is also subject to the regulations produced in a unit of time, that is in- in part 113 of this chapter, and an intended to have uniform composition, fant formula that is an acidified food, character, and quality, within specified as defined in § 114.3(b) of this chapter, is limits, and is produced according to a also subject to the regulations in part master manufacturing order. 114 of this chapter. Production unit means a specific quantity of an infant formula produced (b) The failure to comply with any during a single cycle of manufacture regulation in this subpart in the manu- that has uniform composition, char- facture, processing, packing, or holding acter, and quality, within specified of an infant formula shall render such limits. infant formula adulterated under sec- Production unit number or production tion 412(a)(3) of the Federal Food, aggregate number means any distinctive Drug, and Cosmetic Act (21 U.S.C. combination of letters, numbers, sym- 350a(a)(3)); the failure to comply with bols, or any combination of them, from any regulation in part 113 of this chap- which the complete history of the man- ter in the manufacture, processing, ufacture, processing, packing, holding, packing, or holding of a liquid infant and distribution of a production aggre- formula shall render such infant for- gate or a production unit of infant formula adulterated under section mula can be determined. 412(a)(3); and the failure to comply Quality factors means those factors with any regulation in part 114 of this necessary to demonstrate the safety of chapter in the manufacture, proc- the infant formula and the bio- essing, packing, or holding of an infant availability of its nutrients, as pre- formula that is an acidified food shall pared for market and when fed as the render such infant formula adulterated sole source of nutrition, to ensure the under section 412(a)(3). healthy growth of infants. Representative sample means a sample § 106.6 Production and in-process con- that consists of a number of units that trol system. are drawn based on rational criteria, (a) A manufacturer shall conform to such as random sampling, and intended the requirements of this subpart by im- to ensure that the sample accurately plementing a system of production and portrays the material being sampled. in-process controls. This production Shall is used to state mandatory re- and in-process control system shall quirements. cover all stages of processing, from the [79 FR 8059, Feb. 10, 2014, as amended at 79 receipt and acceptance of the raw ma- FR 33070, June 10, 2014] terials, ingredients, and components through the storage and distribution of Subpart B—Current Good the finished product and shall be de- Manufacturing Practice signed to ensure that all the requirements of this subpart are met. § 106.5 Current good manufacturing (b) The production and in-process practice. control system shall be set out in a (a) The regulations set forth in this written plan or set of procedures that subpart define the minimum current is designed to ensure that an infant good manufacturing practices that are formula is manufactured in a manner

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that will prevent adulteration of the terials, infant formula packaging, or infant formula. infant formula equipment or utensil (c) At any point, step, or stage in the contact surfaces shall practice good production process where control is personal hygiene to protect the infant necessary to prevent adulteration, a formula against contamination. Good manufacturer shall: personal hygiene includes: (1) Establish specifications to be met; (1) Wearing clean outer garments (2) Monitor the production and in- and, as necessary, protective apparel process control point, step, or stage; such as head, face, hand, and arm cov- (3) Establish a corrective action plan erings; and for use when a specification established (2) Washing hands thoroughly in a in accordance with paragraph (c)(1) of hand washing facility with soap and this section is not met; running water at a suitable tempera- (4) Review the results of the moni- ture before starting work, after each toring required by paragraph (c)(2) of absence from the work station, and at this section, and review and evaluate any other time when the hands may be- the public health significance of any come soiled or contaminated. deviation from specifications that have (c) Any person who reports that he or been established in accordance with she has, or appears by medical exam- paragraph (c)(1) of this section. For ination or supervisory observation to any specification established in accord- have, an illness, open lesion (including ance with paragraph (c)(1) of this sec- boils, sores, or infected wounds), or any tion that a manufacturer fails to meet, other source of microbial contamina- an individual qualified by education, tion that creates a reasonable possi- training, or experience shall conduct a bility that the safety of an infant for- documented review and shall make a mula may be adversely affected, shall material disposition decision to reject be excluded from direct contact with the affected article, to reprocess or ingredients, containers, closures, in- otherwise recondition the affected arti- process materials, equipment, utensils, cle, or to approve and release the arti- and infant formula product until the cle for use or distribution; and condition is corrected or determined by (5) Establish recordkeeping proce- competent medical personnel not to dures, in accordance with § 106.100(e)(3), jeopardize the safety of the infant for- that ensure that compliance with the mula. requirements of this section is documented. § 106.20 Controls to prevent adultera- (d) Any article that fails to meet a tion caused by facilities. specification established in accordance (a) Buildings used in the manufac- with paragraph (c)(1) of this section ture, processing, packing, or holding of shall be controlled under a quarantine infant formula shall be maintained in a system designed to prevent its use clean and sanitary condition and shall pending the completion of a docu- have space for the separation of incom- mented review and material disposi- patible operations, such as the han- tion decision. dling of raw materials, the manufacture of the product, and packaging and § 106.10 Controls to prevent adultera- labeling operations. tion by workers. (b) Separate areas or another system (a) A manufacturer shall employ suf- of separation, such as a computerized ficient personnel, qualified by edu- inventory control, a written card sys- cation, training, or experience, to per- tem, or an automated system of seg- form all operations, including all re- regation, shall be used for holding raw quired recordkeeping, in the manufac- materials, in-process materials, and ture, processing, packing, and holding final infant formula product at the fol- of each infant formula and to supervise lowing times: such operations to ensure that the op- (1) Pending release for use in infant erations are correctly and fully per- formula production or pending release formed. of the final product; (b) Personnel working directly with (2) After rejection for use in, or as, infant formula, infant formula raw ma- infant formula; and

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(3) After release for use in infant for- (3) A manufacturer shall conduct the mula production or after release of the tests required by paragraph (f)(2) of final product. this section with sufficient frequency (c) Lighting shall allow easy identi- to ensure that the water meets the fication of raw materials, packaging, EPA’s Primary Drinking Water Regu- labeling, in-process materials, and fin- lations but shall not conduct these ished products that have been released tests less frequently than annually for for use in infant formula production chemical contaminants, every 4 years and shall permit the easy reading of infor radiological contaminants, and struments and controls necessary in weekly for bacteriological contami- processing, packaging, and laboratory nants. analysis. Any lighting fixtures directly (4) A manufacturer shall make and over or adjacent to exposed raw mate- retain records, in accordance with rials, in-process materials, or bulk § 106.100(f)(1), of the frequency and re- (unpackaged) finished product shall be sults of testing of the water used in the protected to prevent glass from con- production of infant formula. taminating the product in the event of (g) There shall be no backflow from, breakage. or cross-connection between, piping (d) A manufacturer shall provide ade- systems that discharge waste water or quate ventilation or control equipment sewage and piping systems that carry to minimize odors and vapors (includ- water for infant formula manufac- ing steam and noxious fumes) in areas turing. where they may contaminate the in- (h) Only culinary steam shall be used fant formula; and shall minimize the at all direct infant formula product potential for contamination of raw ma- contact points. Culinary steam shall be terials, in-process materials, final in compliance with the 3–A Sanitary product infant formula, packing mate- Standards, No. 60903, which is incor- rials, and infant formula-contact sur- porated by reference at § 106.160. Boiler faces, through the use of appropriate water additives in the steam shall be measures, which may include the use of used in accordance with § 173.310 of this air filtration. chapter. (e) All rodenticides, insecticides, fun- (i) Each infant formula manufac- gicides, fumigating agents, and clean- turing site shall provide its employees ing and sanitizing agents shall be with readily accessible toilet facilities stored and used in a manner that pro- and hand washing facilities that in- tects against contamination of infant clude hot and cold water, soap or deter- formula. gent, single-service towels or air dryers (f) Potable water used in the manu- in toilet facilities. These facilities facture of infant formula shall meet shall be maintained in good repair and the standards prescribed in the Envi- in a sanitary condition at all times. ronmental Protection Agency’s (EPA’s) These facilities shall provide for proper Primary Drinking Water regulations in disposal of the sewage. Doors to the 40 CFR part 141, except that the water toilet facility shall not open into areas used in infant formula manufacturing where infant formula, ingredients, con- shall not be fluoridated or shall be tainers, or closures are processed, han- defluoridated to a level as low as pos- dled, or stored, except where alternate sible prior to use. means have been taken to protect (1) The water shall be supplied under against contamination. continuous positive pressure in a plumbing system that is free of defects [79 FR 8059, Feb. 10, 2014, as amended at 79 that could contaminate an infant for- FR 33070, June 10, 2014] mula. (2) A manufacturer shall test rep- § 106.30 Controls to prevent adultera- resentative samples of the potable tion caused by equipment or uten- water drawn at a point in the system sils. at which the water is in the same con- (a) A manufacturer shall ensure that dition that it will be when it is used in equipment and utensils used in the infant formula manufacturing. manufacture, processing, packing, or

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holding of an infant formula are of ap- manufacturer of the instrument or con- propriate design and are installed to fa- trol, or as otherwise deemed necessary cilitate their intended function and to ensure the accuracy of the instru- their cleaning and maintenance. ment or control. The known reference (b) A manufacturer shall ensure that standard shall be certified for accuracy equipment and utensils used in the at the intervals specified in writing by manufacture, processing, packing, or the manufacturer of the instrument or holding of an infant formula are con- control, or at routine intervals other- structed so that surfaces that contact wise deemed necessary to ensure the ingredients, in-process materials, or in- accuracy of the instrument or control. fant formula are made of nontoxic ma- A manufacturer shall make and retain terials and are not reactive or absorp- records of the calibration activities in tive. A manufacturer shall ensure that accordance with § 106.100(f)(2). such equipment and utensils are de- (2) Instruments and controls that signed to be easily cleanable and to cannot be adjusted to agree with the withstand the environment of their intended use and that all surfaces that reference standard shall be repaired or contact ingredients, in-process mate- replaced. rials, or infant formula are cleaned and (3) If calibration of an instrument sanitized, as necessary, and are main- shows a failure to meet a specification tained to protect infant formula from for a point where control is deemed being contaminated by any source. All necessary to prevent adulteration of sanitizing agents used on such equip- infant formula product, a written eval- ment and utensils that are regulated as uation of all affected product, and of pesticide chemicals under 21 U.S.C. any actions that need to be taken with 346a(a) shall comply with the Environ- respect to that product, shall be made, mental Protection Agency’s regula- in accordance with § 106.100(f)(2). tions established under such section, (e) The following provisions apply to and all other such sanitizers shall com- thermal processing and cold storage of ply with all applicable Food and Drug infant formulas: Administration laws and regulations. (1) Equipment and procedures for (c) A manufacturer shall ensure that thermal processing of infant formula any substance, such as a lubricant or a packaged in hermetically sealed con- coolant, that is required for operation tainers shall conform to the require- of infant formula manufacturing equip- ments in 21 CFR parts 108 and 113. ment and which would render the in- (2)(i) Except as provided in paragraph fant formula adulterated if such sub- (e)(2)(ii) of this section, a manufacturer stance were to come in contact with shall maintain all areas of cold storage the formula, does not come in contact at a temperature of 40 °F (4.4 °C) or with formula ingredients, containers, below. closures, in-process materials, or with infant formula product during the (ii) A manufacturer may maintain a manufacture of an infant formula. cold storage area for an in-process in- (d) A manufacturer shall ensure that fant formula or for a final infant for- each instrument used for measuring, mula at a temperature not to exceed 45 ° ° regulating, or controlling mixing time F (7.2 C) for a defined period of time and speed, temperature, pressure, mois- provided that the manufacturer has ture, water activity, or other param- scientific data and other information eter at any point, step, or stage where to demonstrate that the time and tem- control is necessary to prevent adulter- perature conditions of such storage are ation of an infant formula during proc- sufficient to ensure that there is no essing is accurate, easily read, properly significant growth of microorganisms maintained, and present in sufficient of public health significance during the number for its intended use. period of storage of the in-process or (1) The instruments and controls final infant formula product. shall be calibrated against a known ref- (3)(i) Cold storage compartments and erence standard at the time of or be- thermal processing equipment shall be fore first use and thereafter at routine equipped with easily readable, accurate intervals, as specified in writing by the temperature-indicating devices.

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(ii) A manufacturer shall ensure that (2) A manufacturer shall make and the temperature of each cold storage retain records on equipment cleaning, compartment is maintained by: sanitizing, and maintenance, in accord- (A) Monitoring the temperature of ance with § 106.100(f)(4). the cold storage compartment on a (g) A manufacturer shall ensure that temperature-indicating device and re- compressed air or other gases that are cording this temperature in a record mechanically introduced into infant with such frequency as is necessary to formula, that are used to clean any ensure that temperature control is equipment, or that come into contact maintained; with any other surface that contacts (B) Equipping the cold storage com- ingredients, in-process materials, or in- partment with one or more tempera- fant formula product are treated in ture-recording devices that will reflect, such a way that their use will not con- on a continuing basis, the true tem- taminate the infant formula with un- perature, within the compartment; lawful or other chemical, physical, or (C) Equipping the cold storage com- microbiological contaminants. When partment with a high temperature compressed gases are used at product alarm that has been validated to func- filling machines to replace air removed tion properly and recording the tem- from the headspace of containers, a perature in a record with such fre- manufacturer shall install, as close as quency as is necessary to ensure that practical to the end of the gas line that temperature control is maintained; or feeds gas into the space, a filter capa- (D) Equipping the cold storage com- ble of retaining particles 0.5 microm- partment with a maximum-indicating eter or smaller. thermometer that has been validated [79 FR 8059, Feb. 10, 2014, as amended at 79 to function properly and recording this FR 33071, June 10, 2014] temperature in a record with such frequency as is necessary to ensure that § 106.35 Controls to prevent adultera- temperature control is maintained. tion due to automatic (mechanical (iii) A manufacturer shall, in accord- or electronic) equipment. ance with § 106.100(f)(3), make and re- (a) For the purposes of this section: tain records of the temperatures re- (1) ‘‘Hardware’’ means all automatic corded in compliance with equipment, including mechanical and § 106.30(e)(3)(ii). electronic equipment (such as com- (4) When a manufacturer uses a tem- puters), that is used in production or perature-recording device for a cold quality control of infant formula. storage compartment, such device shall (2) ‘‘Software’’ means any programs, not read lower than the reference tem- procedures, rules, and associated docu- perature-indicating device. mentation used in the operation of a (5) A manufacturer shall monitor the system. temperature in thermal processing (3) ‘‘System’’ means a collection of equipment at points where tempera- components (including software and ture control is necessary to prevent hardware) organized to accomplish a adulteration. Such monitoring shall be specific function or set of functions in at such frequency as is required by reg- a specified environment. ulation or is necessary to ensure that (4) ‘‘Validation’’ means establishing temperature control is maintained. documented evidence that provides a (f) A manufacturer shall ensure that high degree of assurance that a system equipment and utensils used in the will consistently produce a product manufacture of infant formula are meeting its predetermined specifica- cleaned, sanitized, and maintained at tions and quality characteristics. Vali- regular intervals to prevent adultera- dation can be accomplished through tion of the infant formula. any suitable means, such as (1) An individual qualified by edu- verification studies or modeling. cation, training, or experience to con- (b) All systems shall be designed, in- duct such a review shall review all stalled, tested, and maintained in a cleaning, sanitizing, and maintenance manner that will ensure that they are to ensure that it has been satisfac- capable of performing their intended torily completed. function and of producing or analyzing

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infant formula in accordance with this safe (GRAS) for such use, or is author- subpart and subpart C of this part. ized by a prior sanction. (1) A manufacturer shall ensure, at (b) Infant formula containers and clo- any point, step, or stage where control sures shall not be reactive or absorp- is necessary to prevent adulteration of tive so as to affect the safety of the in- the infant formula, that all hardware is fant formula. The following substances routinely inspected and checked ac- may be used as packaging material cording to written procedures and that that comes in contact with an infant hardware that is capable of being cali- formula: brated is routinely calibrated accord- (1) A food additive that is the subject ing to written procedures. of a regulation issued under section (2) A manufacturer shall check and 409(c) of the Federal Food, Drug, and document the accuracy of input into, Cosmetic Act (21 U.S.C. 348(c)) and is and output generated by, any system used consistent with the conditions of used in the production or quality con- use of that regulation; trol of an infant formula to ensure that (2) A food contact substance that is the infant formula is not adulterated. the subject of an effective notification The degree and frequency of input/out- under section 409(h) of the Federal put verification shall be based on the Food, Drug, and Cosmetic Act and is complexity and reliability of the sys- used consistent with the conditions of tem and the level of risk associated use in that notification; with the safe operation of the system. (3) A manufacturer shall ensure that (3) A substance that is exempt from each system is validated prior to the regulation as a food additive under release for distribution of any infant § 170.39 of this chapter and its use con- formula manufactured using the sys- forms to the use identified in the ex- tem. emption letter; (4) A manufacturer shall ensure that (4) A substance that is generally rec- any system that is modified is revali- ognized as safe for use in or on infant dated following the modification and formula or for use in infant formula prior to the release for distribution of packaging; any infant formula manufactured using (5) A substance the use of which is the modified system. All modifications authorized by a prior sanction from the to software shall be made by a des- Food and Drug Administration or from ignated individual and shall be checked the U.S. Department of Agriculture; by the infant formula manufacturer to and ensure that infant formula that is pro- (6) A substance that is not a food ad- duced or analyzed using the modified ditive within the meaning of section software complies with this subpart 201(s) of the Federal Food, Drug, and and with subpart C of this part. Cosmetic Act (21 U.S.C. 321(s)) because (c) A manufacturer shall make and the substance is not reasonably ex- retain records, in accordance with pected to become a component of food § 106.100(f)(5), concerning mechanical or or otherwise affect the characteristics electronic equipment. of food. [79 FR 8059, Feb. 10, 2014, as amended at 79 (c) Ingredients, containers, and clo- FR 33071, June 10, 2014] sures used in the manufacture of infant formula shall be identified with a lot § 106.40 Controls to prevent adultera- number to be used in recording their tion caused by ingredients, con- disposition. tainers, and closures. (d) A manufacturer shall develop (a) The only substances that may be written specifications for ingredients, used in an infant formula are sub- containers, and closures used in manu- stances that are safe and suitable for facturing infant formula and shall de- use in infant formula under the appli- velop and follow written procedures to cable food safety provisions of the Fed- determine whether all ingredients, con- eral Food, Drug, and Cosmetic Act; tainers, and closures meet these speci- that is, a substance is used in accord- fications. When any specification is not ance with the Agency’s food additive met, an individual qualified by edu- regulations, is generally recognized as cation, training, or experience shall

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conduct a documented review, shall de- (f) If an ingredient, container, or clo- termine whether a failure to meet such sure that complies with a manufactur- a specification could result in an adul- er’s specifications, or that has been re- terated infant formula, and shall make leased for use following a material re- and document a material disposition view and disposition decision, is subse- decision to reject the ingredient, con- quently exposed to air, heat, or other tainer, or closure or the affected infant conditions that may adversely affect formula; to reprocess or otherwise re- it, or if a manufacturer reasonably be- condition the ingredient, container, or lieves that an ingredient, container, or closure or the affected infant formula; closure that complies with a manufac- or to approve and release the ingre- turer’s specifications, or that has been dient, container, or closure or the af- released for use following a material fected infant formula for use. review and disposition decision, has (e) Ingredients, containers, and clo- been exposed to air, heat, or other con- sures shall be stored in separate areas ditions that may adversely affect it, or separated by a system of segrega- the ingredient, container, or closure tion, such as a computerized inventory shall be quarantined under a system control, a written card system, or an designed to prevent its use in the man- automated system of segregation, ufacture of infant formula until an in- clearly designated for materials pend- dividual qualified by education, training release for use; materials released ing, or experience has conducted a doc- for use; or materials rejected for use in umented review and has made and doc- infant formula production. umented a material disposition deci- (1) Any lot of an ingredient, a con- sion to reject the ingredient, container, tainer, or a closure that does not meet or closure; to reprocess or otherwise re- the manufacturer’s specifications shall condition the ingredient, container, or be quarantined under a system de- closure; or to approve and release the signed to prevent its use in the manu- ingredient, container, or closure for facture of infant formula until an indi- use. vidual qualified by education, training, (1) Any ingredient, container, or clo- or experience has conducted a docu- sure that is reprocessed or otherwise mented review, has determined wheth- reconditioned shall be retested or reex- er such failure could result in an adul- amined and be the subject of a docu- terated infant formula, and has made mented review and material disposi- and documented a material disposition tion decision by an individual qualified decision to reject the ingredient, con- by education, training, or experience to tainer, closure, or the affected infant determine whether the ingredient, con- formula; to reprocess or otherwise re- tainer, or closure should be rejected, condition the ingredient, container, further reprocessed or otherwise fur- closure, or the affected infant formula; ther reconditioned, or approved and re- or to approve and release the ingre- leased for use. dient, container, closure, or the af- (2) Any rejected ingredient, con- fected infant formula for use. tainer, or closure shall be clearly iden- (2) Any ingredient, container, or clo- tified as having been rejected for use in sure that has been reprocessed or oth- infant formula manufacturing or proc- erwise reconditioned shall be the sub- essing operations and shall be con- ject of a documented review and mate- trolled under a quarantine system de- rial disposition decision by an indi- signed to prevent its use in infant for- vidual qualified by education, training, mula manufacturing or processing op- or experience to determine whether it erations. may be released for use. (3) Any ingredient, container, or clo- (3) A manufacturer shall not reproc- sure that has not been manufactured, ess or otherwise recondition an ingre- packaged, labeled, or held under condi- dient, container, or closure rejected be- tions to prevent adulteration under cause it is contaminated with micro- section 402(a)(1) through (a)(4) of the organisms of public health significance Federal Food, Drug, and Cosmetic Act or other contaminants, such as heavy (21 U.S.C. 342(a)(1) through (a)(4)) shall metals. not be approved and released for use.

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(g) A manufacturer shall make and that the formula is not contaminated retain records, in accordance with with microorganisms or other contami- § 106.100(f)(6), on the ingredients, con- nants. Such controls shall include: tainers, and closures used in the manu- (1) The mixing time; the speed, tem- facture of infant formula. perature, and flow rate of product; and other critical parameters necessary to § 106.50 Controls to prevent adultera- ensure the addition of required ingredi- tion during manufacturing. ents to, and the homogeneity of, the (a) A manufacturer shall prepare and formula; follow a written master manufacturing (2) The spray-drying process for pow- order that establishes controls and pro- dered infant formula, including the fil- cedures for the production of an infant tering of the intake air before heating, formula. to prevent microbial and other con- (1) The manufacturer shall make and tamination; retain records, in accordance with (3) The removal of air from the fin- § 106.100(e), that include complete infor- ished product to ensure that nutrient mation relating to the production and deterioration does not occur; control of the production aggregate. (4) Ensuring that each container of An individual qualified by education, finished product is properly sealed. training, or experience shall conduct Such controls shall involve use of es- an investigation of any deviations from tablished procedures, specifications, the master manufacturing order and and intervals of examination that are document any corrective action taken. designed by qualified individuals and (2) Changes made to the master man- are sufficient to: ufacturing order shall be reviewed and (i) Detect visible closure or seal de- approved by a responsible official and fects, and include an evaluation of the effect of (ii) Determine closure strength the change on the nutrient content and through destructive testing. A manu- the suitability of the formula for in- facturer of a liquid infant formula that fants. is a thermally processed low-acid food (b) A manufacturer shall establish packaged in a hermetically sealed con- controls to ensure that each raw or in- tainer shall perform such closure integ- process ingredient required by the mas- rity testing in accordance with ter manufacturing order is examined § 113.60(a) of this chapter. by one person and checked by a second (e) A manufacturer shall establish person or system. This checking shall controls that ensure that the equip- ensure that the correct ingredient is ment used at points where control is added during the manufacturing proc- deemed necessary to prevent adultera- ess, that the ingredient has been re- tion is monitored, so that personnel leased for use in infant formula, and will be alerted to malfunctions. that the correct weight or measure of (f) A manufacturer shall establish the ingredient is added to the produc- controls for in-process material as fol- tion unit. lows: (c) A manufacturer shall establish a (1) For any specification established system of identification for the con- in accordance with § 106.6(c)(1) that a tents of all compounding and storage manufacturer fails to meet for in-proc- containers, processing lines, and major ess material, an individual qualified by equipment used during the manufac- education, training, or experience shall ture of a production aggregate of an in- conduct a documented review and shall fant formula. The system shall permit make a material disposition decision the identification of the processing to reject the affected in-process mate- stage and the unique identification rial, to reprocess or otherwise recondi- number for the particular production tion the affected in-process material, unit or production aggregate of infant or to approve and release the affected formula. in-process material for use or distribu- (d) A manufacturer shall establish tion; controls to ensure that the nutrient (2) Pending a documented review and levels required by § 107.100 of this chap- material disposition decision, any inter are maintained in the formula, and process material that fails to meet any

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specification established in accordance (b) A manufacturer of liquid infant with § 106.6(c)(1) shall be clearly identi- formula shall comply, as appropriate, fied as such and shall be controlled with the procedures specified in part under a quarantine system designed to 113 of this chapter for thermally proc- prevent its use in manufacturing or essed low-acid foods packaged in her- processing operations until completion metically sealed containers and part of the documented review and material 114 of this chapter for acidified foods. disposition decision; (c) A manufacturer of powdered in- (3) Any in-process material that has fant formula shall test representative been reprocessed or otherwise recondi- samples of each production aggregate tioned shall be the subject of a docu- of powdered infant formula at the final mented review and material disposi- product stage, before distribution, to tion decision by an individual qualified ensure that each production aggregate by education, training, or experience to meets the microbiological quality determine whether it may be released standards in the table in paragraph (e) for use; and of this section. (4) Any rejected in-process material (d) A manufacturer shall make and shall be clearly identified as having retain records, in accordance with been rejected for use in infant formula § 106.100(e)(5)(ii) and (f)(7), on the test- and shall be controlled under a quar- ing of infant formulas for microorga- antine system designed to prevent its nisms. use in infant formula manufacturing or (e) A powdered infant formula that processing operations. contains any microorganism that exceeds the M value listed for that micro- [79 FR 8059, Feb. 10, 2014, as amended at 79 organism in the table in paragraph (e) FR 33071, June 10, 2014] of this section shall be deemed adulterated under sections 402(a)(1), 402(a)(4), § 106.55 Controls to prevent adultera- and 412(a)(3) of the Federal Food, Drug, tion from microorganisms. and Cosmetic Act (21 U.S.C. 350a(a)(3)). (a) A manufacturer of infant formula The Food and Drug Administration shall establish a system of process con- will determine compliance with the M trols covering all stages of processing values listed below using the latest edi- that is designed to ensure that infant tion of the Bacteriological Analytical formula does not become adulterated Manual (BAM) (http://www.fda.gov/Food/ due to the presence of microorganisms FoodScienceResearch/LaboratoryMethods/ in the formula or in the processing en- BacteriologicalAnalyticalManualBAM/de- vironment. fault.htm) (accessed April 8, 2013).

Microorganism n 1 Sample size M value

Cronobacter spp...... 30 10 g (grams) ...... 2 0. Salmonella spp...... 60 25 g...... 2 0. 1 Number of samples. 2 None detected.

§ 106.60 Controls to prevent adultera- tions of processing, storage, handling, tion during packaging and labeling distribution, and use. of infant formula. (c) Packaging used to hold multiple (a) A manufacturer shall examine containers of an infant formula prod- packaged and labeled infant formula uct shall be labeled as follows: during finishing operations to ensure (1) Where all containers are the same that all containers and packages in the infant formula product and all bear the production aggregate have the correct same code established under § 106.80, label, the correct use-by date, and the the packaging label shall include the correct code established under § 106.80. product name, the name of the manufacturer, distributor, or shipper, and (b) Labels shall be designed, printed, the code established under § 106.80. and applied so that the labels remain (2) Where the containers are not the legible and attached during the condi- same infant formula product or do not

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all bear the same code established fant formula that is reprocessed or oth- under § 106.80, the packaging label erwise reconditioned shall be the sub- shall: ject of a documented review and mate- (i) Include the product name of each rial disposition decision by an indi- product, the name of the manufacturer, vidual qualified by education, training, distributor, or shipper of each product, or experience to determine whether it the code established under § 106.80 for may be released for use or distribution. each product, and a ‘‘use by’’ date that (c) Any rejected infant formula shall is no later than the ‘‘use by’’ date of be clearly identified as having been re- the container exhibiting the closest jected for use and shall be controlled ‘‘use by’’ date applied to satisfy the re- under a quarantine system designed to quirement of § 107.20(c) of this chapter; prevent its release or distribution. or (d) A production aggregate of infant (ii) Include a unique identification formula, including a reprocessed or re- number assigned by the packager, pro- conditioned production aggregate, that vided that the distributor of the pack- does not meet the nutrient require- age maintains a record linked to such ments of section 412(i) of the Federal unique number that identifies the prod- Food, Drug, and Cosmetic Act (21 uct name of each product, the name of U.S.C. 350a(i)) or that has not been the manufacturer, distributor, or ship- manufactured, packaged, labeled, and per of each product, the code estab- held under conditions to prevent adul- lished under § 106.80 for each product, teration under sections 402(a)(1) and the ‘‘use by’’ date for each product through (a)(4) of the Federal Food, applied to satisfy the requirement of Drug, and Cosmetic Act (21 U.S.C. § 107.20(c) of this chapter. 342(a)(1) through (a)(4)) shall not be ap- § 106.70 Controls on the release of fin- proved and released for distribution. ished infant formula. § 106.80 Traceability. (a) A manufacturer shall control under a quarantine system designed to Each production aggregate of infant prevent use or distribution of each pro- formula shall be coded with a sequen- duction aggregate of infant formula tial number that identifies the product until it determines that the production and the establishment where the prod- aggregate meets all of the manufactur- uct was packed and that permits trac- er’s specifications, including those ing of all stages of manufacture of that adopted to meet the standards of production aggregate, including the § 106.55 on microbiological contamina- year, the days of the year, and the pe- tion and of § 106.91(a) on quality control riod during those days that the product procedures, or until the documented re- was packed, and the receipt and han- view of the failure to meet any of the dling of raw materials used. manufacturer’s specifications finds that the failure does not result in, or § 106.90 Audits of current good manufacturing practice. could not lead to, adulteration of the product. (a) A manufacturer of an infant for- (b) Any production aggregate of in- mula, or an agent of such manufac- fant formula that fails to meet any of turer, shall conduct regularly sched- the manufacturer’s specifications shall uled audits to determine whether the be quarantined under a system de- manufacturer has complied with the signed to prevent its use in the manu- current good manufacturing practice facture of infant formula or its dis- regulations in this subpart. Such au- tribution until an individual qualified dits shall be conducted at a frequency by education, training, or experience that is required to ensure compliance has conducted a documented review with such regulations. and has made and documented a mate- (b) The audits required by paragraph rial disposition decision to reject the (a) of this section shall be performed by infant formula; to reprocess or other- an individual or a team of individuals wise recondition the infant formula; or who, as a result of education, training, to approve and release the infant for- or experience, is knowledgeable in all mula. Any production aggregate of in- aspects of infant formula production

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and of the Agency’s regulations con- shall collect, from each manufacturing cerning current good manufacturing site and at the final product stage, a practice that such individual or team representative sample of the first pro- is responsible for auditing. This indi- duction aggregate of packaged, fin- vidual or team of individuals shall ished formula in each physical form have no direct responsibility for the (powder, ready-to-feed, or concentrate) matters that such individual or team is and evaluate the levels of all nutrients auditing and shall have no direct inter- required under § 107.100 of this chapter est in the outcome of the audit. and all other nutrients added by the manufacturer. The manufacturer shall Subpart C—Quality Control repeat such testing every 4 months Procedures thereafter throughout the shelf life of the product. § 106.91 General quality control. (ii) The Food and Drug Administra- (a) During manufacture, a manufac- tion will exempt the manufacturer turer shall test each production aggre- from the requirements of paragraph gate for nutrients as follows: (b)(1)(i) of this section if the manufac- (1) Each nutrient premix used in the turer of a new infant formula requests manufacture of an infant formula shall an exemption and provides analytical be tested for each nutrient (required data, as required under § 106.120(b)(7), under § 107.100 of this chapter or other- that demonstrates that the stability of wise added by the manufacturer) that the manufacturer is relying on the pre- the new infant formula will likely not mix to provide, to ensure that the pre- differ from the stability of formulas mix is in compliance with the manu- with similar composition, processing, facturer’s specifications; and packaging for which there are ex- (2) During the manufacturing proc- tensive stability data. A manufacturer ess, after the addition of the premix, or exempt from the requirements of para- at the final product stage but before graph (b)(1)(i) of this section would be distribution, each production aggre- required to test the first production ag- gate of infant formula shall be tested gregate according to the requirements for at least one indicator nutrient for of § 106.91(b)(2). each of the nutrient premixes used in (2) The manufacturer shall collect, the infant formula to confirm that the from each manufacturing site and at nutrients supplied by each of the pre- the final product stage, a representa- mixes are present, in the proper con- tive sample of each subsequent produc- centration, in the production aggregate tion aggregate of packaged, finished of infant formula. formula in each physical form (powder, (3) At the final product stage, before ready-to-feed, or concentrate) and distribution of an infant formula, each evaluate the levels of all nutrients reproduction aggregate shall be tested quired under § 107.100 of this chapter for vitamins A, C, E, and thiamin. and all other nutrients added by the (4) During the manufacturing process manufacturer. The manufacturer shall or at the final product stage, before repeat such testing at the end of the distribution, each production aggre- shelf life of the product. gate shall be tested for all nutrients required to be included in such formula (3) If the results of the testing re- under § 107.100 of this chapter for which quired by paragraph (b)(1) of this sec- testing is not conducted for compliance tion do not substantiate the shelf life with paragraphs (a)(1) or (a)(3) of this of the infant formula, the manufac- section and for any nutrient added by turer shall address, as appropriate, all the manufacturer for which testing is production aggregates of formula re- not conducted for compliance with leased and pending release for distribu- paragraph (a)(1) of this section. tion that are implicated by the testing (b) A manufacturer shall test each results, such as by conducting the test- production aggregate of finished prod- ing required by paragraph (b)(1) of this uct for nutrients as follows: section on a subsequently produced (1)(i) For an infant formula that is a production aggregate to substantiate new infant formula the manufacturer the shelf life of the infant formula or

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revising the use by date for such prod- ducted at a frequency that is required uct so that such date is substantiated to ensure compliance with the require- by the stability testing results. ments for quality control procedures. (4) If results of the testing required (b) The audits required by paragraph by paragraph (b)(2) of this section show (a) of this section shall be performed by that any required nutrient is not an individual or a team of individuals present in the production aggregate of who, as a result of education, training, infant formula at the level required by or experience, is knowledgeable in all § 107.100 of this chapter or that any nu- aspects of infant formula production trient added by the manufacturer is and of the regulations concerning qual- not present at the level declared on the ity control procedures that such indi- label of the production aggregate of in- vidual or team is responsible for audit- fant formula, the manufacturer shall: ing. This individual or team of individ- (i) Investigate the cause of such vari- uals shall have no direct responsibility ance in the level of any required or for the matters that such individual or added nutrient; team is auditing and shall have no di- (ii) Evaluate the significance, if any, rect interest in the outcome of the of the results for other production ag- audit. gregates of the same formula that have been released for distribution; Subpart D—Conduct of Audits (iii) Address, as appropriate, all production aggregates of formula released § 106.94 Audit plans and procedures. and pending release for distribution (a) A manufacturer shall develop and that are implicated by the testing re- follow a written audit plan that is sults; and available at the manufacturing facility (iv) Determine whether it is nec- for Food and Drug Administration in- essary to conduct the testing required spection. by paragraph (b)(1) of this section. (b) The audit plan shall include audit (5) The testing required by para- procedures that set out the methods graphs (b)(1) and (b)(2) of this section is the manufacturer uses to determine not required to evaluate the level of whether the facility is operating in ac- minerals present in the infant formula. cordance with current good manufac- (c) All quality control testing shall turing practice, with the quality con- be conducted using appropriate, sci- trol procedures that are necessary to entifically valid test methods. ensure that an infant formula provides (d) A manufacturer shall make and nutrients in accordance with sections retain quality control records in ac- 412(b) and (i) of the Federal Food, Drug, cordance with § 106.100(e)(5)(i). and Cosmetic Act, and in a manner de- [79 FR 8059, Feb. 10, 2014, as amended at 79 signed to prevent adulteration of the FR 33071, June 10, 2014] infant formula. (c) The audit procedures shall in- § 106.92 Audits of quality control pro- clude: cedures. (1) An evaluation of the production (a) A manufacturer of an infant for- and in-process control system estab- mula, or an agent of such a manufac- lished under § 106.6(b) by: turer, shall conduct regularly sched- (i) Observing the production of infant uled audits to determine whether the formula and comparing the observed manufacturer has complied with the process to the written production and requirements for quality control proce- in-process control plan required under dures that are necessary to ensure that § 106.6(b); an infant formula provides nutrients in (ii) Reviewing records of the moni- accordance with section 412(b) and (i) toring of points, steps, or stages where of the Federal Food, Drug, and Cos- control is deemed necessary to prevent metic Act (21 U.S.C. 350a(b) and (i)) and adulteration; and is manufactured in a manner designed (iii) Reviewing records of how devi- to prevent adulteration of the infant ations from any specification at points, formula under section 412(a)(1) and steps, or stages where control is (a)(3) of the Federal Food, Drug, and deemed necessary to prevent adultera- Cosmetic Act. Such audits shall be con- tion were handled; and

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(2) A review of a representative sam- rent control group or groups and a sci- ple of all records maintained in accord- entifically appropriate reference. ance with § 106.100(e) and (f). (c) The Food and Drug Administra- tion will exempt a manufacturer from Subpart E—Quality Factors for the requirements of paragraph (b) of Infant Formulas this section, if: (1) The manufacturer requests an ex- § 106.96 Requirements for quality fac- emption and provides assurances, as re- tors for infant formulas. quired under § 106.121(b), that the The regulations set forth in this sub- changes made by the manufacturer to part define the minimum requirements an existing infant formula are limited for quality factors for infant formulas: to changing the type of packaging of (a) An infant formula shall meet the an existing infant formula (e.g., chang- quality factor of normal physical ing from metal cans to plastic pouch- growth. es); or (b) A manufacturer of an infant for- (2) The manufacturer requests an ex- mula that is not an eligible infant for- emption and provides assurances, as re- mula shall demonstrate that a formula quired under § 106.121, which dem- supports normal physical growth in in- onstrate that: fants when fed as a sole source of nutri- (i) An alternative method or study tion by conducting, in accordance with design that is based on sound scientific good clinical practice, an adequate and principles is available to show that the well-controlled growth monitoring formula supports normal physical study of the infant formula that: growth in infants when the formula is (1) Is no less than 15 weeks in dura- fed as the sole source of nutrition; tion, enrolling infants no more than 2 weeks old at time of entry into the (ii) The change made by the manu- study; facturer to an existing formula does (2) Includes the collection and main- not affect the ability of the formula to tenance of data on formula intake and support normal physical growth; or anthropometric measures of physical (iii) The manufacturer markets a for- growth, including body weight, recum- mulation in more than one form (e.g., bent length, head circumference, aver- liquid and powdered forms) and the age daily weight increment, and aver- quality factor requirements are met by age daily recumbent length increment; the form of the formula that is proc- (3) Includes anthropometric measure- essed using the method that has the ments made at the beginning and end greatest potential for adversely affect- of the study, and at least four addi- ing nutrient content and bio- tional measurements made at inter- availability. mediate time points with three of the (d) A manufacturer of a new infant six total measurements made within formula that is not an eligible infant the first 4 weeks of the study and three formula shall, in accordance with measurements made at approximately § 106.100(p)(1), make and retain records 4-week intervals over the remaining 11 demonstrating that the formula meets weeks of the study; the quality factor of normal physical (4) Compares the anthropometric growth. data for the test group to a concurrent (e) An infant formula shall meet the control group or groups at each time quality factor of sufficient biological point and compares the anthropo- quality of protein. metric data for each infant (body weight for age, body length for age, (f) A manufacturer of an infant for- head circumference for age, and weight mula that is not an eligible infant for- for length) in the test group and the mula shall demonstrate that a formula control group to the 2009 CDC growth meets the quality factor of sufficient charts, which are incorporated by ref- biological quality of protein by estab- erence at § 106.160; and lishing the biological quality of the (5) Compares the data on formula in- protein in the infant formula when fed take of the test group with a concur- as the sole source of nutrition using an

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appropriate modification of the Pro- (i) The scientific evidence on such in- tein Efficiency Ratio (PER) rat bio- fant formula meets the requirements of assay described in the ‘‘Official Meth- paragraph (b) of this section that apply ods of Analysis of AOAC Inter- to infant formula that is not an eligi- national,’’ 18th ed., sections 45.3.04 and ble infant formula; 45.3.05, ‘‘AOAC Official Method 960.48 (ii) The scientific evidence on such Protein Efficiency Ratio Rat Bio- infant formula meets the following assay,’’ which is incorporated by ref- provisions: erence at § 106.160. The PER rat bio- (A) The evidence is an adequate and assay shall be conducted on a formula well-controlled growth study, con- and the results evaluated prior to the ducted in accordance with good clinical initiation of a growth monitoring practice, to determine whether an in- study of the formula that is required fant formula supports normal physical under paragraph (b) of this section. growth in infants when the formula is (g) The Food and Drug Administra- fed as the sole source of nutrition; tion will exempt a manufacturer from (B) The growth study is no less than the requirements of paragraph (f) of 4 months in duration, enrolling infants this section, if: no more than 1 month old at time of (1) The manufacturer requests an ex- entry into the study; emption and provides assurances as re- (C) The growth study collects from quired under § 106.121(g) that the the study subjects data on anthropo- changes made by the manufacturer to metric measures of physical growth, an existing infant formula are limited including body weight, recumbent to changing the type of packaging of length, head circumference, and aver- an existing infant formula (e.g., chang- age daily weight increment, and plots ing from metal cans to plastic pouch- the data on the following charts from es); or ‘‘Physical Growth: National Center for Health Statistics Percentiles’’ for body (2) The manufacturer requests an ex- weight, body length, and head circum- emption and provides assurances, as reference, which are incorporated by ref- quired under § 106.121(h), that dem- erence at § 106.160: onstrate that the change made by the (1) Figure 1. Length by age percent- manufacturer to an existing formula iles for girls aged birth–36 months (p. does not affect the bioavailability of 609); the protein. (2) Figure 2. Length by age percent- (3) The manufacturer requests an ex- iles for boys aged birth–36 months (p. emption and provides assurances, as re- 610); quired under § 106.121(i), that dem- (3) Figure 3. Weight by age percentiles onstrate that an alternative method to for girls aged birth–36 months (p. 611); the PER that is based on sound sci- (4) Figure 4. Weight by age percentiles entific principles is available to dem- for boys aged birth–36 months (p. 612); onstrate that the formula supports the (5) Figure 5. Head circumference by quality factor for the biological qual- age percentiles for girls aged birth–36 ity of the protein. months (p. 613); (h) A manufacturer of a new infant (6) Figure 6. Weight by length per- formula that is not an eligible infant centiles for girls aged birth–36 months formula shall, in accordance with (p. 613); § 106.100(q), make and retain records (7) Figure 7. Head circumference by demonstrating that the formula meets age percentiles for boys aged birth–36 the quality factor of sufficient biologi- months (p. 614); and cal quality of protein. (8) Figure 8. Weight by length per- (i) The following provisions for re- centiles for boys aged birth–36 months quirements for quality factors apply (p. 614); and only to an ‘‘eligible infant formula’’ as (D) The growth study collects an- defined in § 106.3: thropometric measurements at the be- (1) An eligible infant formula that ginning of the growth study, at 2 fulfills one or more of the following weeks, at 4 weeks, at least monthly criteria meets the quality factor of thereafter, and at the conclusion of the normal physical growth: study; or

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(iii) The scientific evidence on such in infants when fed as the sole source infant formula otherwise demonstrates of nutrition and shall make and retain, that such formula supports normal in accordance with § 106.100(q)(2), physical growth. records to demonstrate that that the (2) An eligible infant formula that protein in such infant formula is of suf- fulfills one or more of the following ficient biological quality. The records criteria meets the quality factor of suf- required by this paragraph shall in- ficient biological quality of the pro- clude all relevant scientific data and tein: information and a narrative expla- (i) The scientific evidence on such in- nation of why the data and information fant formula meets the requirements of demonstrate that the formula supports paragraph (f) of this section that apply normal physical growth and a nar- to infant formula that is not an eligi- rative explanation of why the data and ble infant formula; information demonstrate that the pro- (ii) The scientific evidence on such tein in such infant formula is of suffi- infant formula is a study that estab- cient biological quality. lishes the biological quality of the pro- [79 FR 8059, Feb. 10, 2014, as amended at 79 tein in an infant formula by dem- FR 33071, June 10, 2014] onstrating that the protein source supports adequate growth using the Pro- tein Efficiency Ratio (PER) rat bio- Subpart F—Records and Reports assay described in sections 45.3.04 and § 106.100 Records. 45.3.05 of the ‘‘Official Methods of Anal- ysis of the Association of Official Ana- (a) Every manufacturer of infant for- lytical Chemists,’’ 16th ed., which are mula shall maintain the records speci- incorporated by reference at § 106.160; fied in this regulation in order to per- or mit the Food and Drug Administration (iii) The scientific evidence on such to determine whether each manufac- infant formula otherwise demonstrates turer is in compliance with section 412 that the protein in such infant formula of the Federal Food, Drug, and Cos- is of sufficient biological quality. metic Act (21 U.S.C. 350a)). (3) The manufacturer of an eligible (b) The manufacturer shall maintain infant formula may, not later than No- all records that pertain to food-pack- vember 12, 2015, submit a petition to aging materials subject to § 174.5 of this the Food and Drug Administration chapter and that bear on whether such under § 10.30 of this chapter that: materials would cause an infant for- (i) Demonstrates that such formula mula to be adulterated within the fulfills one or more of the criteria in meaning of section 402(a)(2)(C) of the paragraph (i)(1) of this section; or Federal Food, Drug, and Cosmetic Act (ii) Demonstrates that such formula (21 U.S.C. 342(a)(2)(C)). fulfills one or more of the criteria in (c) The manufacturer shall maintain paragraph (i)(2) of this section. all records that pertain to nutrient (4) A petition filed under paragraph premix testing that it generates or re- (i)(3) of this section shall address only ceives. Such records shall include, but one infant formula formulation and are not limited to: shall contain all data and information (1) Any results of testing conducted relied upon by the manufacturer to to ensure that each nutrient premix is demonstrate that such formulation ful- in compliance with the premix certifi- fills one or more of the criteria in para- cate and guarantee and specifications graph (i)(1) or in paragraph (i)(2) of this that have been provided to the manu- section. A manufacturer may combine facturer by the premix supplier, includ- petitions submitted under paragraphs ing tests conducted when nutrients ex- (i)(3)(i) and (i)(3)(ii) of this section that ceed their expiration date or shelf life relate to the same formulation. (retest date). (5) The manufacturer of each eligible (2) All certificates and guarantees infant formula shall make and retain, given by premix suppliers concerning in accordance with § 106.100(p)(2), the nutrients required by section 412(i) records to demonstrate that such for- of the Federal Food, Drug, and Cos- mula supports normal physical growth metic Act and § 107.100 of this chapter.

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(d) The premix supplier shall main- the finishing operations to provide as- tain the results of all testing con- surance that the containers and pack- ducted to provide all certificates and ages have the correct label. guarantees concerning nutrient pre- (2) Any deviations from the master mixes for infant formulas. Such records manufacturing order and any correc- shall include but are not limited to: tive actions taken because of the devi- (1) The results of tests conducted to ations. determine the purity of each nutrient (3) Documentation, in accordance required by section 412(i) of the Federal with § 106.6(c), of the monitoring at any Food, Drug, and Cosmetic Act or point, step, or stage in the manufac- § 107.100 of this chapter and any other turer ’s production process where con- nutrient listed in the certificate and trol is deemed necessary to prevent guarantee; adulteration. These records shall in- (2) The weight of each nutrient clude: added; (i) A list of the specifications estab- (3) The results of any quantitative lished at each point, step, or stage in tests conducted to determine the the production process where control is amount of each nutrient certified or deemed necessary to prevent adultera- guaranteed; and tion, in accordance with § 106.6(c)(1), in- (4) The results of any quantitative cluding documentation of the scientific tests conducted to identify the nutri- basis for each specification; ent levels present when nutrient pre- (ii) The actual values obtained during mixes exceed their expiration date or the monitoring operation, any devi- shelf life (retest date). ations from established specifications, (e) For each production aggregate of and any corrective actions taken; and infant formula, a manufacturer shall (iii) Identification of the person mon- prepare and maintain records that in- itoring each point, step, or stage in the clude complete information relating to production process where control is the production and control of the pro- deemed necessary to prevent adultera- duction aggregate. These records shall tion. include: (4) The conclusions and followup, (1) The master manufacturing order. along with the identity of the indi- The master manufacturing order shall vidual qualified by education, training, include: or experience who investigated: (i) The significant steps in the pro- (i) Any deviation from the master duction of the production aggregate manufacturing order and any correc- and the date on which each significant tive actions taken; step occurred; (ii) A finding that a production ag- (ii) For a manufacturing facility that gregate or any of its ingredients failed has more than one set of equipment or to meet the infant formula manufac- more than one processing line, the turer’s specifications; and identity of equipment and processing (iii) A failure to meet any specifica- lines for which the manufacturer has tion at any point, step, or stage in the identified points, steps, or stages in the production process where control is production process where control is deemed necessary to prevent adultera- necessary to prevent adulteration; tion. (iii) The identity of each lot of ingre- (5) The results of all testing per- dients, containers, and closures used in formed on the production aggregate of producing the production aggregate of infant formula, including testing on formula; the in-process production aggregate, at (iv) The amount of each ingredient to the final product stage, and on finished be added to the production aggregate of product throughout the shelf life of the infant formula and a check product. The results recorded shall in- (verification) that the correct amount clude: was added; and (i) The results of all quality control (v) A copy of each infant formula testing conducted in accordance with label used on a finished production ag- § 106.91(a) and (b) to verify that each gregate of infant formula and the re- nutrient required by § 107.100 of this sults of examinations conducted during chapter is present in each production

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aggregate of infant formula at the tizing, and maintenance and the pro- level required by § 107.100 of this chap- duction aggregate number of each inter, and that all other nutrients added fant formula processed between equip- by the manufacturer are present at the ment startup and shutdown for clean- appropriate level. The record of the re- ing, sanitizing, and maintenance. The sults of the quality control testing person performing and checking the shall include: cleaning, sanitizing, and maintenance (A) A summary document identifying shall date and sign or initial the record the stages of the manufacturing proc- indicating that the work was per- ess at which the nutrient analysis for formed. each required nutrient is conducted as (5) Records, in accordance with required under § 106.91(a); and § 106.35(c), on all mechanical and elec- (B) A summary document on the sta- tronic equipment used in the produc- bility testing program conducted under tion or quality control of infant for- § 106.91(b), including the nutrients test- mula. These records shall include: ed and the frequency of nutrient test- (i) A list of all systems used with a ing throughout the shelf life of the description of the computer files and product. the defined capabilities and inherent (ii) For powdered infant formula, the limitations of each system; results of any testing conducted in ac- (ii) A copy of all software used; cordance with § 106.55(c) to verify com- (iii) Records that document installa- pliance with the microbiological qual- tion, calibration, testing or validation, ity standards in § 106.55(e). and maintenance of the systems used; (f) A manufacturer shall make and (iv) A list of all persons authorized to retain all records described in subparts create or modify software; B and C of this part, including: (v) Records that document modifica- (1) Records, in accordance with tions to software, including the iden- § 106.20(f)(4), of the frequency and re- tity of the person who modified the sults of testing of the water used in the software; production of infant formula; (vi) Records that document retesting (2) Records, in accordance with or revalidation of modified systems; § 106.30(d), of accuracy checks of instru- and ments and controls. A certification of (vii) A backup file of data entered accuracy of any known reference into a computer or related system. The standard used and a history of recer- backup file shall consist of a hard copy tification shall be maintained. At a or alternative system, such as dupli- minimum, such records shall specify cate electronic records, tapes, or the instrument or control being microfilm, designed to ensure that checked, the date of the accuracy backup data are exact and complete, check, the standard used, the calibra- and that they are secure from alter- tion method used, the results found, ation, inadvertent erasures, or loss. any actions taken if the instrument is found to be out of calibration, and the (6) Records, in accordance with initials or name of the individual per- § 106.40(g), on ingredients, containers, forming the test. If calibration of an and closures used in the manufacture instrument shows that a specification of infant formula. These records shall at a point, step, or stage in the produc- include: tion process where control is deemed (i) The identity and quantity of each necessary to prevent adulteration has lot of ingredients, containers, and clo- not been met, a written evaluation of sures; all affected product, and any actions (ii) The name of the supplier; that need to be taken with respect to (iii) The supplier’s lot numbers; that product, shall be made. (iv) The name and location of the (3) Records, in accordance with manufacturer of the ingredient, con- § 106.30(e)(3)(iii). tainer, or closure, if different from the (4) Records, in accordance with supplier; § 106.30(f), on equipment cleaning, sani- (v) The date of receipt; tizing, and maintenance that show the (vi) The receiving code as specified; date and time of such cleaning, sani- and

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(vii) The results of any test or exam- plaint’’ as any communication that ination (including retesting and reex- contains any allegation, written or amination) performed on the ingredi- oral, expressing dissatisfaction with a ents, containers, or closures and the product for any reason, including con- conclusions derived there from and the cerns about the possible existence of a disposition of all ingredients, con- hazard to health and about appearance, tainers, or closures. taste, odor, and quality. Correspond- (7) A full description of the method- ence about prices, package size or ology used to test powdered infant for- shape, or other matters that could not mula to verify compliance with the possibly reveal the existence of a haz- microbiological quality standards of ard to health shall not, for compliance § 106.55(c) and the methodology used to purposes, be considered a complaint do quality control testing, in accord- and therefore need not be made avail- ance with § 106.91(a). able to a Food and Drug Administra- (g) A manufacturer shall maintain all tion investigator. records pertaining to distribution of (2) When a complaint shows that a the infant formula, including records hazard to health possibly exists, the that show that formula produced for manufacturer shall conduct an inves- export only is exported. Such records tigation into the validity of the com- shall include all information and data plaint. Where such an investigation is necessary to effect and monitor recalls conducted, the manufacturer shall in- of the manufacturer’s infant formula clude in its file on the complaint the products in accordance with subpart E determination as to whether a hazard of part 107 of this chapter. to health exists and the basis for that (h) The manufacturer shall maintain determination. No investigation is nec- all records pertaining to the micro- essary when the manufacturer deter- biological quality and purity of raw mines that there is no possibility of a materials and finished powdered infant hazard to health. When no investiga- formula. tion is necessary, the manufacturer (i) [Reserved] shall include in the record the reason (j) The manufacturer shall make and that an investigation was found to be retain records pertaining to regularly unnecessary and the name of the re- scheduled audits, including the audit sponsible person making that deter- plans and procedures, the findings of mination. the audit, and a listing of any changes (3) When there is a reasonable possi- made in response to these findings. The bility of a causal relationship between manufacturer shall make readily avail- the consumption of an infant formula able for authorized inspection the audit and an infant’s death, the manufac- plans and procedures and a statement turer shall, within 15 days of receiving of assurance that the regularly sched- such information, conduct an inves- uled audits are being conducted. The tigation and notify the Agency as re- findings of the audit and any changes quired in § 106.150. made in response to these findings (4) The manufacturer shall maintain shall be maintained for the time period in designated files all records per- required under paragraph (n) of this taining to the complaints it receives. section, but need not be made available The manufacturer shall separate the to the Food and Drug Administration. files into two classes: (k) The manufacturer shall maintain (i) Those complaints that allege that procedures describing how all written the infant became ill from consuming and oral complaints regarding infant the product or required treatment by a formula will be handled. The manufac- physician or health care provider and turer shall follow these procedures and (ii) Those complaints that may in- shall include in them provisions for the volve a possible existence of a hazard review of any complaint involving an to health but do not refer to an infant infant formula and for determining the becoming ill or the need for treatment need for an investigation of the pos- by physician or a health care provider. sible existence of a hazard to health. (5) The manufacturer shall include in (1) For purposes of this section, every a complaint file the following informa- manufacturer shall interpret a ‘‘com- tion concerning the complaint:

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(i) The name of the infant formula; meeting the requirements of this para- (ii) The production aggregate num- graph. ber; (m) A manufacturer shall maintain (iii) The name of complainant; all records required under this part in (iv) A copy of the complaint or a a manner that ensures that both the memo of the telephone conversation or manufacturer and the Food and Drug meeting and all correspondence with Administration can be provided with the complainant; access to such records within 24 hours. (v) By reference or copy, all the asso- The manufacturer may maintain the ciated manufacturing records and com- records required under this part as plaint investigation records needed to original records, as true copies such as evaluate the complaint. When copies of photocopies, microfilm, microfiche, or such records are not maintained in the other accurate reproductions of the complaint file, they must be available original records, or as electronic within 24 hours when requested by a records. Where reduction techniques, Food and Drug Administration official. such as microfilming, are used, suit- (vi) All actions taken to followup on able reader and photocopying equip- the complaint; and ment shall be readily available. All (vii) All findings and evaluations of electronic records maintained under the complaint. this part shall comply with part 11 of (6) The manufacturer should main- this chapter. tain the files regarding infant formula (n) Production control, product test- complaints at the establishment where ing, testing results, complaints, and the infant formula was manufactured, distribution records necessary to verify processed, or packed. When the manu- compliance with parts 106, 107, 109, 110, facturer wishes to maintain all con- 113, and 117 of this chapter, or with sumer complaints for the entire firm at other appropriate regulations, shall be one location other than at the facility retained for 1 year after the expiration where an infant formula was manufac- of the shelf life of the infant formula or tured, processed, or packed, the manu- 3 years from the date of manufacture, facturer may do so as long as all whichever is greater. records required by this section are available within 24 hours of request for (o) The manufacturer shall maintain inspection at that facility. However, quality control records that contain all records of consumer complaints, insufficient information to permit a pub- cluding summaries, any reports, and lic health evaluation of any production any files, maintained at the manufac- aggregate of infant formula. turing facility or at any other facility (p) A manufacturer shall make and shall be made available to investiga- retain records that demonstrate that tors for review and copying upon re- the formula meets the quality factor of quest. normal physical growth. (l) The manufacturer shall make (1) For an infant formula that is not readily available for authorized inspec- an eligible infant formula, in accord- tion all records required under this ance with § 106.96(d), these records shall part or copies of such records. Records include: shall be available at any reasonable (i) Records demonstrating compli- time at the establishment where the ance with the requirements in activities described in such records oc- § 106.96(b), including records made in curred. (Infant formula complaint files compliance with § 106.121; or may be maintained at one facility, as (ii) Records demonstrating satisfac- provided in paragraph (k)(6) of this section of an applicable exemption under tion, if all required records are readily § 106.96(c), including records made in available at that facility.) These compliance with § 106.121. records or copies thereof shall be sub- (2) For an eligible infant formula, in ject to photocopying or other means of accordance with § 106.96(i)(5), these reproduction as part of such inspec- records shall include records dem- tion. Records that can be immediately onstrating that the formula fulfills one retrieved from another location by or more of the criteria listed in electronic means shall be considered as § 106.96(i)(1).

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(q) A manufacturer shall make and tion into interstate commerce, includ- retain records that demonstrate that a ing a new infant formula for export formula meets the quality factor of only, the manufacturer of the formula sufficient biological quality of protein. shall register with the Food and Drug (1) For an infant formula that is not Administration, Center for Food Safety an eligible infant formula, in accord- and Applied Nutrition, Office of Nutri- ance with § 106.96(h), these records shall tion, Labeling, and Dietary Supple- include: ments, Infant Formula and Medical (i) Records demonstrating compli- Foods Staff (HFS–850), 5001 Campus ance with the requirements in Dr., College Park, MD 20740–3835. § 106.96(f), including records made in (b) The new infant formula registra- compliance with § 106.121; or tion shall include: (ii) Records demonstrating satisfac- (1) The name of the new infant for- tion of an applicable exemption under mula; § 106.96(g), including records made in (2) The name of the manufacturer; compliance with § 106.121. (3) The street address of the place of (2) For an eligible infant formula, in business of the manufacturer; and accordance with § 106.96(i)(5), these (4) The name and street address of records shall include records dem- each establishment at which the manu- onstrating that the formula fulfills one facturer intends to manufacture such or more of the criteria listed in new infant formula. § 106.96(i)(2). (r) The failure to comply with the § 106.120 New infant formula submis- records requirements in this section sion. applicable to the quality factors shall (a) At least 90 days before a new in- render the formula adulterated under fant formula is introduced or delivered section 412(a)(2) of the Federal Food, for introduction into interstate com- Drug, and Cosmetic Act. The failure to merce, a manufacturer shall submit no- comply with the records requirements tice of its intent to do so to the Food in this section applicable to the good and Drug Administration at the ad- manufacturing practices and quality dress given in § 106.110(a). An original control procedures, including distribu- and two paper copies of such notice of tion and audit records requirements, intent shall be submitted, unless the with respect to an infant formula shall notice is submitted in conformance render the formula adulterated under with part 11 of this chapter, in which section 412(a)(3) of the Federal Food, case a single copy shall be sufficient. Drug, and Cosmetic Act. A failure to (b) The new infant formula submis- retain or make available records appli- sion shall include: cable to the quality factor require- (1) The name and description of the ments, quality control procedures, or physical form (e.g., powder, ready-to current good manufacturing practices feed, or concentrate) of the infant for- requirements in compliance with para- mula; graph (l), (m), or (n) of this section (2) An explanation of why the for- with respect to a formula shall render mula is a new infant formula; the formula adulterated under section (3) The quantitative formulation of 412(a)(2) or (a)(3) of the Federal Food, Drug, and Cosmetic Act, as applicable. each form of the infant formula that is the subject of the notice in units per [79 FR 8059, Feb. 10, 2014, as amended at 79 volume or units per weight for liquid FR 33072, June 10, 2014; 80 FR 56144, Sept. 17, formulas, specified either as sold or as 2015] fed, and units per dry weight for powdered formulas, and the weight of pow- Subpart G—Registration, Submis- der to be reconstituted with a specified sion, and Notification Require- volume of water, and, when applicable, ments a description of any reformulation of the infant formula, including a listing § 106.110 New infant formula registra- of each new or changed ingredient and tion. a discussion of the effect of such (a) Before a new infant formula may changes on the nutrient levels in the be introduced or delivered for introduc- formulation;

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(4) A description, when applicable, of is relying on to demonstrate that the any change in processing of the infant stability of the new infant formula will formula. Such description shall iden- likely not differ from the stability of tify the specific change in processing, formulas with similar composition, including side-by-side, detailed sche- processing, and packaging for which matic diagrams comparing the new there are extensive stability data. processing to the previous processing (c) For a new infant formula for ex- and processing times and tempera- port only, a manufacturer may submit, tures; in lieu of the information required (5) Assurance that the infant formula under paragraphs (b)(5) and (b)(6) of will not be marketed unless the for- this section, a statement certifying mula meets the requirements for qual- that the infant formula meets the spec- ity factors of section 412(b)(1) of the ifications of the foreign purchaser, the Federal Food, Drug, and Cosmetic Act infant formula does not conflict with (21 U.S.C. 350a(b)(1)) and the nutrient the laws of the country to which it is content requirements of section 412(i) intended for export, the infant formula of the Federal Food, Drug, and Cos- is labeled on the outside of the ship- metic Act. ping package to indicate that it is in- (i) Assurance that the formula meets tended for export only, and the infant the requirements for quality factors, formula will not be sold or offered for which are set forth in § 106.96, shall be sale in domestic commerce. Such man- provided by a submission that complies ufacturer shall also submit a state- with § 106.121; ment certifying that it has adequate (ii) Assurance that the formula com- controls in place to ensure that such plies with the nutrient content require- formula is actually exported. ments, which are set forth in § 107.100 of (d) The submission will not con- this chapter, shall be provided by a stitute notice under section 412 of the statement that the formula will not be Federal Food, Drug, and Cosmetic Act marketed unless it meets the nutrient unless it complies fully with paragraph requirements of § 107.100 of this chap- (b) of this section, as applicable, and ter, as demonstrated by testing re- the information that it contains is set quired under subpart C of this part; and forth in a manner that is readily un- (6) Assurance that the processing of derstandable. The Agency will notify the infant formula complies with sec- the manufacturer if the notice is not tion 412(b)(2) of the Federal Food, complete because it does not meet the Drug, and Cosmetic Act. Such assur- requirements in section 412(c) and (d) ance shall include: of the Federal Food, Drug, and Cos- (i) A statement that the formula will metic Act. be produced in accordance with sub- (e) If a new infant formula submis- parts B and C of this part; and sion contains all the information re- (ii) The basis on which each ingre- quired by paragraph (b) of this section, dient meets the requirements of as applicable, the Food and Drug Ad- § 106.40(a), e.g. that it is an approved ministration will acknowledge its re- food additive, that it is authorized by a ceipt and notify the manufacturer of prior sanction, or that it is generally the date of receipt. The date that the recognized as safe (GRAS) for its in- Agency receives a new infant formula tended use. Any claim that an ingre- submission that is complete is the fil- dient is GRAS shall be supported by a ing date for such submission. The man- citation to the Agency’s regulations or ufacturer shall not market the new in- by an explanation, including a list of fant formula before the date that is 90 published studies and a copy of those days after the filing date. If the infor- publications, for why, based on the mation in the submission does not pro- published studies, there is general rec- vide the assurances required under sec- ognition of the safety of the use of the tion 412(d)(1) of the Federal Food, ingredient in infant formula. Drug, and Cosmetic Act and the regula- (7) If the manufacturer is requesting tions of this chapter, the Food and an exemption under § 106.91(b)(1)(ii), the Drug Administration will so notify the manufacturer shall include the sci- manufacturer before the expiration of entific evidence that the manufacturer the 90th day.

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(f) If the manufacturer provides addi- (ii) Calculations of the statistical tional information in support of a new power of the study before study initi- infant formula submission, the Agency ation and at study completion. will determine whether the additional (4) A report on attrition and on all information is a substantive amend- occurrences of adverse events during ment to the new infant formula sub- the study, which shall include: mission. If the Agency determines that (i) Identification of the infant by sub- the new submission is a substantive ject number and feeding group and a amendment, the Food and Drug Admin- complete description of the adverse istration will assign the new infant for- event, including comparisons of the mula submission a new filing date. The frequency and nature of occurrence in Food and Drug Administration will ac- each feeding group and information on knowledge receipt of the additional in- the health of the infant during the formation and, when applicable, notify course of the study, including the oc- the manufacturer of the new filing currence and duration of any illness; date, which is the date of receipt by (ii) A clinical assessment by a health the Food and Drug Administration of care provider of the infant’s health the information that constitutes the during each suspected adverse event; substantive amendment to the new in- and fant formula submission. (iii) A list of all subjects who did not (g) Submissions relating to exempt complete the study, including the sub- infant formulas are subject to the pro- ject number and the reason that each visions of § 107.50 of this chapter. subject did not complete the study. [79 FR 8059, Feb. 10, 2014, as amended at 79 (b) If the manufacturer is requesting FR 33072, June 10, 2014] an exemption from the growth monitoring study requirements under § 106.121 Quality factor assurances for § 106.96(c)(1), the manufacturer shall in- infant formulas. clude a detailed description of the To provide assurance that an infant change made by the manufacturer to formula meets the requirements for an existing infant formula and an ex- quality factors set forth in § 106.96, the planation of why the change made by manufacturer shall submit the fol- the manufacturer to an existing infant lowing data and information: formula satisfies the criteria of (a) Unless the manufacturer of a new § 106.96(c)(1). infant formula can claim an exemption (c) If the manufacturer is requesting under § 106.96(c)(1) or (c)(2), the fol- an exemption under § 106.96(c)(2)(i), the lowing assurances shall be provided to manufacturer shall include a detailed ensure that the requirements of description of the alternative method § 106.96(a) and (b) have been met: or alternative study design, an expla- (1) An explanation, in narrative form, nation of why the method or study de- setting forth how requirements for sign is based on sound scientific prin- quality factors in § 106.96(b) have been ciples, and data that demonstrate that met; the formula supports normal physical (2) Records that contain the informa- growth in infants when the formula is tion required by § 106.96(b) to be col- fed as the sole source of nutrition. lected during the study for each infant (d) If the manufacturer is requesting enrolled in the study. The records shall an exemption under § 106.96(c)(2)(ii), the be identified by subject number, age, manufacturer shall include a detailed feeding group, gender, and study day of description of the change and an expla- collection. nation of why the change made by the (3) Data, which shall include: manufacturer to an existing infant for- (i) Statistical evaluation for all mula does not the affect the ability of measurements, including group means, the formula to support normal physical group standard deviations, and meas- growth. ures of statistical significance for all (e) If the manufacturer is requesting measurements for each feeding group an exemption under § 106.96(c)(2)(iii), at the beginning of the study and at the manufacturer shall include a de- every point where measurements were tailed description of the two formula- made throughout the study, and tions and an explanation of why the

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quality factor requirement of normal written submission to the Food and physical growth is met by the form of Drug Administration at the address the formula that is processed using the given in § 106.110(a) that the infant for- method that has the greatest potential mula complies with the requirements for adversely affecting nutrient con- of the Federal Food, Drug, and Cos- tent and bioavailability. metic Act and is not adulterated. (f) Unless the manufacturer of a new (b) The verification submission shall infant formula is requesting an exemp- include the following information: tion under § 106.96(g), the results of the (1) The name of the new infant for- Protein Efficiency Ratio bioassay shall mula; the filing date for the new infant be provided in accordance with formula submission, in accordance § 106.96(f). with § 106.120, for the subject formula; (g) If the manufacturer is requesting and the identification number assigned an exemption under § 106.96(g)(1), the by the Agency to the new infant for- manufacturer shall include a detailed mula submission: description of the change made by the (2) A statement that the infant for- manufacturer to an existing infant formula to be introduced into interstate mula and an explanation of why the commerce is the same as the infant for- change made by the manufacturer to mula that was the subject of the new an existing infant formula satisfies the infant formula notification and for criteria listed in § 106.96(g)(1). which the manufacturer provided as- (h) If the manufacturer is requesting surances in accordance with the re- an exemption under § 106.96(g)(2), the quirements of § 106.120; manufacturer shall include a detailed (3) A summary of test results of the description of the change and an expla- level of each nutrient required by nation of why the change made by the § 107.100 of this chapter and any nutri- manufacturer to an existing infant for- ent added by the manufacturer in the mula does not affect the bio- formula, presented in units per 100 availability of the protein. kilocalories at the final product stage. (i) If the manufacturer is requesting (4) A certification that the manufac- an exemption under § 106.96(g)(3), the turer has established current good manufacturer shall include a detailed manufacturing practices, including explanation of the alternative method, quality control procedures and in-proc- an explanation of why the method is ess controls, and testing required by based on sound scientific principles, current good manufacturing practice, and the data that demonstrate that the designed to prevent adulteration of quality factor for the biological qual- this formula in accordance with sub- ity of the protein has been met. parts B and C of this part. (j) A statement certifying that the (c) The submission shall not con- manufacturer has collected and consid- stitute written verification under sec- ered all information and data con- tion 412(d)(2) of the Federal Food, cerning the ability of the infant for- Drug, and Cosmetic Act (21 U.S.C. mula to meet the requirements for 350a(d)(2)) when any data prescribed in quality factors and that the manufac- paragraph (b) of this section are lack- turer is not aware of any information ing or are not set forth so as to be read- or data that would show that the for- ily understood. In such circumstances, mula does not meet the requirements the Agency will notify the manufac- for quality factors. turer that the notice is not adequate. [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014] § 106.140 Submission concerning a change in infant formula that may § 106.130 Verification submission. adulterate the product. (a) A manufacturer shall, after the (a) When a manufacturer makes a first production and before the intro- change in the formulation or proc- duction into interstate commerce of a essing of the formula that may affect new infant formula (except for a new whether the formula is adulterated infant formula that is for export only under section 412(a) of the Federal for which a submission is received in Food, Drug, and Cosmetic Act (21 compliance with § 106.120(c)), verify in a U.S.C. 350a(a)), the manufacturer shall,

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before the first processing of such for- ject to the control of the manufac- mula, make a submission to the Food turer: and Drug Administration at the ad- (1) May not provide the nutrients re- dress given in § 106.110(a). An original quired by section 412(i) of the Federal and two copies shall be submitted. Food, Drug, and Cosmetic Act (21 U.S.C (b) The submission shall include: 350d(i)) or by regulations issued under (1) The name and physical form of section 412(i)(2); or the infant formula (i.e., powder, ready- (2) May be otherwise adulterated or to-feed, or concentrate); misbranded. (2)(i) An explanation of why the (b) The notification made according change in formulation or processing to paragraph (a) of this section shall be may affect whether the formula is made by telephone, to the Director of adulterated; and the appropriate Food and Drug Admin- (ii) What steps will be taken to en- istration district office. After normal sure that, before the formula is intro- business hours (8 a.m. to 4:30 p.m.), the duced into interstate commerce, the Food and Drug Administration’s emer- formula will not be adulterated; and gency number, 1–866–300–4374 shall be (3) A statement that the submission used. The manufacturer shall promptly complies with § 106.120(b)(3), (b)(4), send written confirmation of the notifi- (b)(5), and (b)(6). When appropriate, a cation to the Food and Drug Adminis- statement to the effect that the infor- tration, Center for Food Safety and Ap- mation required by § 106.120(b)(3), (b)(4), plied Nutrition, Office of Compliance, (b)(5), or (b)(6) has been provided to the Division of Enforcement (HFS–605), Re- Agency previously and has not been af- call Coordinator, 5001 Campus Dr., Col- fected by the changes that are the sub- lege Park, MD 20740, and to the appro- ject of the current submission, to- priate Food and Drug Administration gether with the identification number district office. assigned by the Agency to the relevant infant formula submission, may be pro- § 106.160 Incorporation by reference. vided in lieu of such statement. (c) The submission shall not con- (a) Certain material is incorporated stitute notice under section 412 of the by reference into this part with the ap- Federal Food, Drug, and Cosmetic Act proval of the Director of the Federal unless it complies fully with paragraph Register under 5 U.S.C. 552(a) and 1 (b) of this section, and the information CFR part 51. To enforce any edition that it contains is set forth in a man- other than that specified in this sec- ner that is readily understandable. The tion, the Food and Drug Administra- Agency will notify the manufacturer if tion must publish notice of change in the notice is not adequate because it the FEDERAL REGISTER and the mate- does not meet the requirements of sec- rial must be available to the public. All tion 412(d)(3) of the Federal Food, approved material is available for in- Drug, and Cosmetic Act. spection at the Food and Drug Admin- istration library at 10903 New Hamp- § 106.150 Notification of an adulter- shire Ave., Building 2, Third Floor, Sil- ated or misbranded infant formula. ver Spring, MD 20993, 301–796–2039, and (a) A manufacturer shall promptly is available from the sources listed notify the Food and Drug Administra- below. This material is also available tion in accordance with paragraph (b) for inspection at the National Archives of this section when the manufacturer and Records Administration (NARA). has knowledge (that is, actual knowl- For information on the availability of edge that the manufacturer had, or the this material at NARA, call 202–741– knowledge which a reasonable person 6030 or go to: http://www.archives.gov/ would have had under like cir- federallregister/ cumstances or which would have been codeloflfederallregulations/ obtained upon the exercise of due care) ibrllocations.html. that reasonably supports the conclu- (b) 3–A Sanitary Standards, Inc., 6888 sion that an infant formula that has Elm St., Suite 2D, McLean, VA 22101– been processed by the manufacturer 3829, 703–790–0295, and may be ordered and that has left an establishment sub- online at http://www.3-a.org/:

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(1) 3–A Sanitary Standards, No. 609– PART 107—INFANT FORMULA 03: A Method of Producing Culinary Steam, adopted November 21, 2004, into Subpart A—General Provisions § 106.20(h). (2) [Reserved] Sec. (c) American Society for Nutrition, 107.1 Status and applicability of the regulations in part 107. 9650 Rockville Pike, Bethesda, MD 107.3 Definitions. 20814–3998, 301–634–7279, http:// www.nutrition.org: Subpart B—Labeling (1) Physical growth: National Center for Health Statistics percentiles, Hamill, 107.10 Nutrient information. P.V.V., T.A. Drizd, C.L. Johnson, R.B. 107.20 Directions for use. 107.30 Exemptions. Reed, A.F. Roche, and W.M. Moore, American Journal of Clinical Nutrition, Subpart C—Exempt Infant Formulas vol. 32, pp. 607–614, dated March 1979, into § 106.96(i)(1)(ii)(c). 107.50 Terms and conditions. (2) [Reserved] (d) AOAC International, 481 North Subpart D—Nutrient Requirements Frederick Ave., suite 500, Gaithersburg, 107.100 Nutrient specifications. MD 20877–2417, 301–924–7078: (1) Official Methods of Analysis of Subpart E—Infant Formula Recalls AOAC International, 16th ed., dated 107.200 Food and Drug Administration-re- 1995, into § 106.96(i)(2)(ii): quired recall. (i) Section 45.3.04, AOAC Official 107.210 Firm-initiated product removals. Method 960.48 Protein Efficiency Ratio 107.220 Scope and effect of infant formula Rat Bioassay, and recalls. (ii) Section 45.3.05, AOAC Official 107.230 Elements of an infant formula re- Method 982.30 Protein Efficiency Ratio call. Calculation Method. 107.240 Notification requirements. 107.250 Termination of an infant formula re- (2) Official Methods of Analysis of call. AOAC International, 18th ed., dated 107.260 Revision of an infant formula recall. 2005, into § 106.96(f): 107.270 Compliance with this subpart. (i) Section 45.3.04, AOAC Official 107.280 Records retention. Method 960.48 Protein Efficiency Ratio AUTHORITY: 21 U.S.C. 321, 343, 350a, 371. Rat Bioassay, and (ii) Section 45.3.05, AOAC Official SOURCE: 50 FR 1840, Jan. 14, 1985, unless Method 982.30 Protein Efficiency Ratio otherwise noted. Calculation Method. EDITORIAL NOTE: Nomenclature changes to (e) Centers for Disease Control and part 107 appear at 81 FR 49895, July 29, 2016. Prevention, 1600 Clifton Rd., Atlanta, GA 30333, 1–800–232–4636, http:// Subpart A—General Provisions www.cdc.gov/growthcharts/ wholcharts.htm. § 107.1 Status and applicability of the (1) Birth to 24 months: Boys Head cir- regulations in part 107. cumference-for-age and Weight-for- (a) The criteria in subpart B of this length percentiles, dated November 1, part describe the labeling requirements 2009, into § 106.96(b)(4). applicable to infant formula under sec- (2) Birth to 24 months: Boys Length- tion 403 of the Federal Food, Drug, and for-age and Weight-for-age percentiles, Cosmetic Act (21 U.S.C 343). Failure to dated November 1, 2009, into comply with any regulation in subpart § 106.96(b)(4). B of this part will render an infant for- (3) Birth to 24 months: Girls Head cir- mula misbranded under section 403 of cumference-for-age and Weight-for- the Federal Food, Drug, and Cosmetic length percentiles, dated November 1, Act. 2009, into § 106.96(b)(4). (b) The criteria in subpart C of this (4) Birth to 24 months: Girls Length- part describe the terms and conditions for-age and Weight-for-age percentiles, for the exemption of an infant formula dated November 1, 2009, into from the requirements of section 412(a), § 106.96(b)(4). (b), and (c) of the Federal Food, Drug,

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and Cosmetic Act (21 U.S.C. 350a(a), (b), shall bear in the order given, in the and (c)). Failure to comply with any units specified, and in tabular format, regulations in subpart C of this part the following information regarding will result in withdrawal of the exemp- the product as prepared in accordance tion given under section 412(h)(1) of the with label directions for infant con- Federal Food, Drug, and Cosmetic Act. sumption: (c) Subpart D of this part contains (1) A statement of the number of the nutrient requirements for infant fluid ounces supplying 100 kilocalories formula under section 412(i) of the Fed- (in case of food label statements, a eral Food, Drug, and Cosmetic Act. kilocalorie is represented by the word Failure to comply with any regulation ‘‘Calorie’’); and in subpart D of this part will render an (2) A statement of the amount, sup- infant formula adulterated under sec- plied by 100 kilocalories, of each of the tion 412(a)(1) of the Federal Food, following nutrients and of any other Drug, and Cosmetic Act. nutrient added by the manufacturer: (d) An exempt infant formula is subject to the provisions of § 107.50 and Nutrients Unit of measurement other applicable Food and Drug Admin- Protein ...... Grams istration food regulations. Fat ...... Do. Carbohydrate ...... Do. [79 FR 8074, Feb. 10, 2014] Water ...... Do. Linoleic acid ...... Milligrams § 107.3 Definitions. Vitamins The following definitions shall apply, in addition to the definitions contained Vitamin A ...... International Units in section 201 of the Federal Food, Vitamin D ...... Do. Vitamin E ...... Do. Drug, and Cosmetic Act (the act): Vitamin K ...... Micrograms Exempt formula. An exempt infant for- Thiamine (Vitamin B1) ...... Do. mula is an infant formula intended for Riboflavin (Vitamin B2) ...... Do. commercial or charitable distribution Vitamin B6 ...... Do. Vitamin B12 ...... Do. that is represented and labeled for use Niacin ...... Do. by infants who have inborn errors of Folic acid (Folacin) ...... Do. metabolism or low birth weight, or who Pantothenic acid ...... Do. Biotin ...... Do. otherwise have unusual medical or die- Vitamin C (Ascorbic acid) ...... Milligrams tary problems. Choline ...... Do. Manufacturer. A person who prepares, Inositol ...... Do. reconstitutes, or otherwise changes the Minerals physical or chemical characteristics of an infant formula or packages or labels Calcium ...... Milligrams the product in a container for distribu- Phosphorus ...... Do. Magnesium ...... Do. tion. The term ‘‘manufacturer’’ does Iron ...... Do. not include a person who prepares, re- Zinc ...... Do. constitutes, or mixes infant formula Manganese ...... Micrograms exclusively for an infant under his/her Copper ...... Do. Iodine ...... Do. direct care or the direct care of the in- Selenium ...... Do. stitution employing such person. Sodium ...... Milligrams References. References in this part to Potassium ...... Do. regulatory sections of the Code of Fed- Chloride ...... Do. eral Regulations are to chapter I of (b) In addition the following apply: title 21, unless otherwise noted. (1) Vitamin A content may also be [50 FR 48186, Nov. 22, 1985, as amended at 79 declared on the label in units of FR 8074, Feb. 10, 2014] microgram retinol equivalents, vitamin D content in units of micrograms Subpart B—Labeling cholecalciferol, vitamin E content in units of milligram alpha-tocopherol § 107.10 Nutrient information. equivalents, and sodium, potassium, (a) The labeling of infant formulas, and chloride content in units of as defined in section 201(z) of the Fed- millimoles, micromoles, or milli- eral Food, Drug, and Cosmetic Act, equivalents. When these declarations

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are made they shall appear in paren- this chapter, the product label shall theses immediately following the dec- bear: larations in International Units for vi- (a) Under the heading ‘‘Directions tamins A, D, and E, and immediately For Preparation and Use’’, directions following the declarations in milli- for: grams for sodium, potassium, and chlo- (1) Storage of infant formula before ride. and after the container has been (2) Biotin, choline, and inositol con- opened, including a statement indi- tent shall be declared except when they cating that prolonged storage at exces- are not added to milk-based infant for- sive temperatures should be avoided; mulas. (2) Agitating liquid infant formula (3) Each of the listed nutrients, and before opening the container, such as the caloric density, may also be de- ‘‘Shake Well Before Opening’’; clared on the label on other bases, such as per 100 milliliters or per liter, as (3) ‘‘Sterilization’’ of water, bottle, prepared for infant consumption. and nipples when necessary for pre- (4) One of the following statements paring infant formula for use; shall appear on the principal display (4) Dilution of infant formula, when panel, as appropriate: appropriate. Directions for powdered (i) The statement ‘‘Infant Formula infant formula shall contain the weight With Iron’’, or a similar statement, if and volume of powdered formula to be the product contains 1 milligram or reconstituted. more of iron in a quantity of product (b) In close proximity to the ‘‘Direc- that supplies 100 kilocalories when pre- tions for Preparation and Use’’ a picto- pared in accordance with label direc- gram depicting the major steps for tions for infant consumption. preparation of that infant formula, (ii) The statement ‘‘Additional Iron such as (for a concentrated formula): May Be Necessary’’, or a similar statement, if the product contains less than 1 milligram of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption. (5) Any additional vitamin may be declared at the bottom of the vitamin list and any additional minerals may be declared between iodine and sodium, provided that any additionally declared nutrient: (i) Has been identified as essential by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or has been identified as essential by the Food and Drug Administration through a FEDERAL REGISTER publication; and (ii) Is provided at a level considered in these publications as having biological significance, when these levels are known. [50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002; 79 FR 8074, Feb. 10, 2014; 80 FR 35840, June 23, 2015]

§ 107.20 Directions for use. In addition to the applicable labeling requirements in parts 101 and 105 of

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if the addition of water is necessary. The symbol shall be placed on a white background encircled by a dark border. (e) A warning statement beneath or in close proximity to the ‘‘Directions For Preparation and Use’’ that cautions against improper preparation or use of an infant formula, such as ‘‘THE HEALTH OF YOUR INFANT DE- PENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARA- TION AND USE’’. (f) A statement indicating that par- ents should consult their physicians about the use of infant formulas, such as ‘‘USE AS DIRECTED BY A PHYSI- CIAN’’. (c) A ‘‘Use by lll’’ date, the blank [50 FR 1840, Jan. 14, 1985, as amended at 67 to be filled in with the month and year FR 9585, Mar. 4, 2002] selected by the manufacturer, packer, or distributor of the infant formula on § 107.30 Exemptions. the basis of tests or other information When containers of ready-to-feed in- showing that the infant formula, until fant formula, to be sold at the retail that date, under the conditions of han- level, are contained within a multiunit dling, storage, preparation, and use package, the labels of the individual prescribed by label directions, will: (1) containers shall contain all of the label when consumed, contain not less than information required by section 403 of the quantity of each nutrient, as set the Federal Food, Drug, and Cosmetic forth on its label; and (2) otherwise be Act (the act), §§ 107.10 and 107.20, and all of an acceptable quality (e.g., pass appropriate sections of part 101 of this through an ordinary bottle nipple). chapter, except that the labels of the (d) The statement ‘‘Add Water’’ or individual containers contained within ‘‘Do Not Add Water’’, as appropriate, to the outer package shall be exempt appear on the principal display panel of from compliance with the require- concentrated or ready-to-feed infant ments of section 403 (e)(1) and (i)(2) of formulas. In close proximity to the the act; and §§ 107.10 (a) and (b)(2) and statement ‘‘Add Water’’, a symbol such 107.20 (b), (e), and (f), provided that (a) the multiunit package meets all the reas quirements of this part; (b) individual containers are securely enclosed within and are not intended to be separated

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from the retail package under condi- day before the first processing of the tions of retail sale; and (c) the label on infant formula for commercial or char- each individual container includes the itable distribution, whichever occurs statement ‘‘This Unit Not Intended For later, the label and other labeling of Individual Sale’’ in type size not less the infant formula, a complete quan- than one-sixteenth inch in height. The titative formulation for the infant for- word ‘‘Retail’’ may be used in lieu of or mula, and a detailed description of the immediately following the word ‘‘Indi- medical conditions for which the infant vidual’’ in the statement. formula is represented. FDA will review the information under paragraph Subpart C—Exempt Infant (d) of this section. Formulas (4) To retain the exempt status of an infant formula covered by this para- § 107.50 Terms and conditions. graph, when any change in ingredients (a) Terms and conditions. Section or processes that may result in an ad- 412(f)(1) of the act exempts from the reverse impact on levels of nutrients or quirements of section 412(a), (b), and availability of nutrients is instituted, (c)(1)(A) of the act infant formulas that the manufacturer shall submit to FDA are represented and labeled for use by at the address specified in paragraph an infant who has an inborn error of (e)(1) of this section, before the first metabolism or low brith weight or who processing of the infant formula, the otherwise has an unusual medical or label and other labeling of the infant dietary problem, if such formulas com- formula, a complete quantitative for- ply with regulations prescribed by the mulation for the infant formula, a de- Secretary. The regulations in this sub- tailed description of the reformulation part establish the terms and conditions and the rationale for the reformula- that a manufacturer must meet with tion, a complete description of the respect to such infant formulas. change in processing, and a detailed de- (b) Infant formulas generally available scription of the medical conditions for at the retail level. (1) These exempt in- which the infant formula is rep- fant formulas can generally be pur- resented. FDA will review that infor- chased from retail store shelves that mation under paragraph (d) of this sec- are readily available to the public. tion. Such formulas are also typically rep- (5) A manufacturer may deviate from resented and labeled for use to provide the requirements of paragraph (b)(2) of dietary management for diseases or this section only with respect to those conditions that are not clinically seri- specific requirements for which it sub- ous or life-threatening, even though mits to FDA, at the address specified such formulas may also be represented in paragraph (e)(1) of this section, the and labeled for use in clinically serious medical, nutritional, scientific, or or life-threatening disorders. technological rationale (including any (2) Except as provided in paragraphs appropriate animal or human clinical (b)(4) and (5) of this section, an infant studies). FDA will review that informa- formula manufacturer shall, with re- tion under paragraph (d) of this sec- spect to each formula covered by this tion. paragraph, comply with the nutrient (c) Infant formulas not generally avail- requirements of section 412(g) of the able at the retail level. (1) These exempt act or of regulations promulgated infant formulas are not generally found under section 412(a)(2) of the act, the on retail shelves for general consumer quality control procedure requirements purchase. Such formulas typically are of part 106, and the labeling require- prescribed by a physician, and must be ments of subpart B of this part. requested from a pharmacist or are dis- (3) To retain the exempt status of an tributed directly to institutions such infant formula covered by this para- as hospitals, clinics, and State or Fed- graph, the manufacturer shall submit eral agencies. Such formulas are also to the Food and Drug Administration generally represented and labeled sole- (FDA), at the address specified in para- ly to provide dietary management for graph (e)(1) of this section, on or before specific diseases or conditions that are May 21, 1986, or on or before the 90th clinically serious or life-threatening

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and generally are required for pro- or more specific infants on a physi- longed periods of time. Exempt infant cian’s request. formulas distributed directly to insti- (d) FDA review of exempt status. (1) tutions such as hospitals, clinics, and FDA’s Center for Food Safety and Ap- State or Federal agencies that are of plied Nutrition will review information the same formulation as those gen- submitted by infant formula manufac- erally available at the retail level are turers under paragraph (b) (3), (b) (4), subject to the requirements of para- or (c)(4) of this section. On the basis of graph (b) of this section rather than to such review and other information the requirements of this paragraph. available to the agency, the Center for (2) Except as provided for in para- Food Safety and Applied Nutrition graph (c)(5) of this section, an infant may impose additional conditions on, formula manufacturer shall, with re- or modify requirements for, the quality spect to each formula covered by this control procedures, nutrient specifica- paragraph, comply with the nutrient tions, or labeling of an infant formula, requirements of section 412(g) of the or withdraw a product’s exempt status. act or of regulations promulgated Such determinations will be made by under section 412(a)(2) of the act, and the Director of the Center for Food the labeling requirements of subpart B Safety and Applied Nutrition. of this part. (2)(i) If after completing its review of (3) Each manufacturer of an infant all information submitted, the Center formula covered by this paragraph for Food Safety and Applied Nutrition shall establish quality control proce- concludes that additional or modified dures designed to ensure that the in- quality control, nutrient, or labeling fant formula meets applicable nutrient requirements are needed, or that a requirements of this section, including product’s exempt status is withdrawn, any special nutritional characteristics the Center for Food Safety and Applied for the specific disorders or conditions Nutrition will so notify the manufac- for which the formula is represented turer and this notification will specify for use. Each manufacturer shall main- the reasons therefor. Upon receipt of tain records of such quality control this notification, the manufacturer has procedures sufficient to permit a public 10 working days to have the decision health evaluation of each manufac- reviewed under § 10.75 by the office of tured batch of infant formula and shall the Commissioner of Food and Drugs. permit any authorized FDA employee A determination by the Director of the at all reasonable times to have access Center for Food Safety and Applied Nu- to and to copy and verify the records trition that is not appealed becomes a referred to in this paragraph. final agency decision. (4) To retain the exempt status of an (ii) After a final decision by the Di- infant formula covered by this para- rector or by the office of the Commis- graph, the manufacturer shall submit sioner that a product’s exempt status the information required by paragraphs is withdrawn, the manufacturer shall (b)(3) and (4) of this section. comply with the nutrient requirements (5) A manufacturer may deviate from of section 412(g) of the act or of regula- the requirements of paragraph (c)(2) of tions promulgated under section this section only with respect to those 412(a)(2) of the act, the quality control specific requirements for which it sub- requirements of part 106, and the label- mits to FDA, at the address specified ing requirements of subpart B of this in paragraph (e)(1) of this section, the part. medical, nutritional, scientific, or (iii) The compliance date for the technological rationale (including any withdrawal of a product’s exempt sta- appropriate animal or human clinical tus or the imposition of additional or studies). FDA will review that informa- modified quality control, nutrient, or tion under paragaraph (d) of this sec- labeling requirements is 60 calendar tion. days after issuance of the final decision (6) The requirements of this section except as otherwise provided for rea- do not apply to an infant formula spe- sons stated in the decision. If the agen- cially and individually prepared for one cy determines that a health hazard

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may exist and so notifies the manufac- Center for Food Safety and Applied Nu- turer, withdrawal of a product’s ex- trition, Office of Nutrition, Labeling, empt status shall be effective on the and Dietary Supplements, Infant For- date of receipt of notification from the mula and Medical Foods Staff (HFS– Director of the Center for Food Safety 850), Food and Drug Administration, and Applied Nutrition. Additional or 5001 Campus Dr., College Park, MD modified requirements, or the with- 20740. drawal of an exemption, apply only to (2) The manufacturer shall promptly those formulas that are manufactured notify the Food and Drug Administra- after the compliance date. A postpone- tion when the manufacturer has knowl- ment of the compliance date may be edge (as defined in section 412(c)(2) of granted for good cause. the Federal Food, Drug, and Cosmetic (3) FDA may decide that withdrawal Act) that reasonably supports the con- of an exemption is necessary when, on clusion that an exempt infant formula the basis of its review under paragraph that has been processed by the manu- (d)(1) of this section, it concludes that facturer and that has left an establish- quality control procedures are not ade- ment subject to the control of the man- quate to ensure that the formula con- ufacturer may not provide the nutri- tains all required nutrients, that devi- ents required by paragraph (b) or (c) of ations in nutrient levels are not sup- this section, or when there is an exported by generally accepted scientific, empt infant formula that may be oth- nutritional, or medical rationale, or erwise adulterated or misbranded and that deviations from subpart B of this if so adulterated or misbranded pre- part are not necessary to provide ap- sents a risk of human health. This no- propriate directions for preparation tification shall be made, by telephone, and use of the infant formula, or that to the Director of the appropriate Food additional labeling information is nec- and Drug Administration district office essary. specified in part 5, subpart M of this (4) FDA will use the following cri- chapter. After normal business hours (8 teria in determining whether devi- a.m. to 4:30 p.m.), contact the Food and ations from the requirements of this Drug Administration Emergency Call subpart are necessary and will ade- Center at 866–300–4374. The manufac- quately protect the public health: turer shall send a followup written con- (i) A deviation from the nutrient re- firmation to the Center for Food Safe- quirements of section 412(g) of the act ty and Applied Nutrition (HFS–605), or of regulations promulgated under Food and Drug Administration, 5001 section 412(a)(2) of the act is necessary Campus Dr., College Park, MD 20740, to provide an infant formula that is ap- and to the appropriate FDA district of- propriate for the dietary management fice specified in part 5, subpart M of of a specific disease, disorder, or med- this chapter. ical condition; (ii) For exempt infant formulas sub- [50 FR 48187, Nov. 22, 1985, as amended at 61 ject to paragraph (b) of this section, a FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, deviation from the quality control pro- 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, cedures requirements of part 106 is nec- Mar. 4, 2002; 75 FR 32659, June 9, 2010; 79 FR 8074, Feb. 10, 2014] essary because of unusal or difficult technological problems in manufacturing the infant formula; and Subpart D—Nutrient Requirements (iii) A deviation from the labeling requirements of subpart B of this part is § 107.100 Nutrient specifications. necessary because label information, (a) An infant formula shall contain including pictograms and symbols re- the following nutrients at a level not quired by those regulations, could lead less than the minimum level specified to inappropriate use of the product. and not more than the maximum level (e) Notification requirements. (1) Infor- specified for each 100 kilocalories of mation required by paragraphs (b) and the infant formula in the form pre- (c) of this section shall be submitted to pared for consumption as directed on the Food and Drug Administration, the container:

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Nutrients Unit of measurement Minimum level Maximum level

Protein ...... Grams ...... 1.8 4.5 Fat ...... Do...... 3.3 6.0 Percent calories ...... 30 54 Linoleic acid ...... Milligrams ...... 300 Percent calories ...... 2.7

Vitamins

Vitamin A ...... International Units ...... 250 750 Vitamin D ...... Do...... 40 100 Vitamin E ...... Do...... 0.7 Vitamin K ...... Micrograms ...... 4 Thiamine (Vitamin B1) ...... Do...... 40 Riboflavin (Vitamin B2) ...... Do...... 60 Vitamin B6 ...... Do...... 35 Vitamin B12 ...... Do...... 0.15 Niacin 1 ...... Do...... 250 Folic acid (Folacin) ...... Do...... 4 Pantothenic acid ...... Do...... 300 Biotin 2 ...... Do...... 1.5 Vitamin C (Ascorbic acid) ...... Milligrams ...... 8 Choline 2 ...... Do...... 7 Inositol 2 ...... Do...... 4

Minerals

Calcium ...... Do...... 60 Phosphorus ...... Do...... 30 Magnesium ...... Do...... 6 Iron ...... Do...... 0.15 3.0 Zinc ...... Do...... 0.5 Manganese ...... Micrograms ...... 5 Copper ...... Do...... 60 Iodine ...... Do...... 5 75 Selenium ...... Do...... 2 7 Sodium ...... Milligrams ...... 20 60 Potassium ...... Do...... 80 200 Chloride ...... Do...... 55 150 1 The generic term ‘‘niacin’’ includes niacin (nicotinic acid) and niacinamide (nicotinamide). 2 Required only for non-milk-based infant formulas.

(b) Vitamin E shall be present at a logical quality is equivalent to or bet- level of at least 0.7 International Unit ter than that of casein. If the biologi- of vitamin E per gram of linoleic acid. cal quality of the protein is less than (c) Any vitamin K added shall be in that of casein, the minimum amount of the form of phylloquinone. protein shall be increased proportion- (d) Vitamin B6 shall be present at a ately to compensate for its lower bio- level of at least 15 micrograms of vita- logical quality. For example, an infant min B6 for each gram of protein in ex- formula containing protein with a bio- cess of 1.8 grams of protein per 100 logical quality of 75 percent of casein kilocalories of infant formula in the shall contain at least 2.4 grams of pro- form prepared for consumption as di- tein (1.8/0.75). No protein with a bio- rected on the container. logical quality less than 70 percent of (e) The ratio of calcium to phos- casein shall be used. phorus in infant formula in the form prepared for consumption as directed [50 FR 45108, Oct. 30, 1985, as amended at 80 on the container shall be no less than FR 35841, June 23, 2015] 1.1 and not more than 2.0. (f) Protein shall be present in an Subpart E—Infant Formula Recalls amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 SOURCE: 54 FR 4008, Jan. 27, 1989, unless otherwise noted. kilocalories of infant formula in the form prepared for consumption as directed on the container when its bio-

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§ 107.200 Food and Drug Administra- (i) Is no longer subject to the manu- tion-required recall. facturer’s control; When the Food and Drug Administra- (ii) Is in violation of the laws and tion determines that an adulterated or regulations administered by the Food misbranded infant formula presents a and Drug Administration and against risk to human health, a manufacturer which the agency could initiate legal shall immediately take all actions nec- or regulatory action; and essary to recall that formula, extend- (iii) Does not present a human risk. ing to and including the retail level, (b) The Food and Drug Administra- consistent with the requirements of tion will monitor continually the re- this subpart. call action and will take appropriate actions to ensure that the violative in- § 107.210 Firm-initiated product re- fant formula is removed from the mar- movals. ket. (a) If a manufacturer has determined § 107.230 Elements of an infant for- to recall voluntarily from the market mula recall. an infant formula that is not subject to A recalling firm shall conduct an in- § 107.200 but that otherwise violates the fant formula recall with the following laws and regulations administered by elements: the Food and Drug Administration (a) The recalling firm shall evaluate (FDA) and that would be subject to in writing the hazard to human health legal action, the manufacturer, upon associated with the use of the infant prompt notification to FDA, shall ad- formula. This health hazard evaluation minister such voluntary recall con- shall include consideration of any dis- sistent with the requirements of this ease, injury, or other adverse physio- subpart. logical effect that has been or that (b) If a manufacturer has determined could be caused by the infant formula to withdraw voluntarily from the mar- and of the seriousness, likelihood, and ket an infant formula that is adulter- consequences of the diseases, injury, or ated or misbranded in only a minor other adverse physiological effect. The way and that would not be subject to Food and Drug Administration will legal action, such removal from the conduct its own health hazard evalua- market is deemed to be a market with- tion and promptly notify the recalling drawal, as defined in § 7.3(j) of this firm of the results of that evaluation if chapter. As required by § 107.240(a), the the criteria for recall under § 107.200 manufacturer shall promptly notify have been met. FDA of such violative formula and (b) The recalling firm shall devise a may, but is not required to, conduct written recall strategy suited to the in- such market withdrawal consistent dividual circumstances of the par- with the requirements of this subpart ticular recall. The recall strategy shall pertaining to product recalls. take into account the health hazard evaluation and specify the following: § 107.220 Scope and effect of infant The extent of the recall; if necessary, formula recalls. the public warning to be given about (a) The requirements of this subpart any hazard presented by the infant for- apply: mula; the disposition of the recalled in- (1) When the Food and Drug Adminis- fant formula; and the effectiveness tration has determined that it is nec- checks that will be made to determine essary to remove from the market a that the recall is carried out. distributed infant formula that is in (c) The recalling firm shall promptly violation of the laws and regulations notify each of its affected direct ac- administered by the Food and Drug Ad- counts about the recall. The format of ministration and that poses a risk to a recall communication shall be dis- human health; or tinctive, and the content and extent of (2) When a manufacturer has deter- a recall communication shall be com- mined that it is necessary to remove mensurate with the hazard of the in- from the market a distributed infant fant formula being recalled and the formula that: strategy developed for the recall. The

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recall communication shall instruct port to the appropriate FDA district consignees to report back quickly to office. The report shall contain rel- the recalling firm about whether they evant information, including the fol- are in possession of the recalled infant lowing cumulative information con- formula and shall include a means of cerning the infant formula that is doing so. The recalled communication being recalled: shall also advise consignees how to re- (1) Number of consignees notified of turn the recall infant formula to the the recall and date and method of noti- manufacturer or otherwise dispose of fication, including recalls required by it. The recalling firm shall send a fol- § 107.200, information about the notice lowup recall communication to any consignee that does not respond to the provided for retail display, and the re- initial recall communication. quest for its display. (d) If the infant formula presents a (2) Number of consignees responding risk to human health, the recalling to the recall communication and quan- firm shall request that each establish- tity of recalled infant formula on hand ment, at which such infant formula is at each consignee at the time the com- sold or available for sale, post at the munication was received. point of purchase of such formula a no- (3) Quantity of recalled infant for- tice of such recall at such establish- mula returned or corrected by each ment. The notice shall be provided by consignee contacted and the quantity the recalling firm after approval of the of recalled infant formula accounted notice by the Food and Drug Adminis- for. tration. The recalling firm shall also (4) Number and results of effective- request that each retail establishment ness checks that were made. maintain such notice on display until (5) Estimated timeframes for comple- such time as the Food and Drug Ad- tion of the recall. ministration notifies the recalling firm that the agency considers the recall (c) Status reports. The recalling firm completed. shall submit to the appropriate FDA (e) The recalling firm shall furnish district office a written status report promptly to the appropriate Food and on the recall at least every 14 days Drug Administration district office until the recall is terminated. The sta- listed in part 5, subpart M of this chap- tus report shall describe the steps ter, as they are available, copies of the taken by the recalling firm to carry health hazard evaluation, the recall out the recall since the last report and strategy, and all recall communica- the results of these steps. tions (including, for a recall under [79 FR 8074, Feb. 10, 2014] § 107.200, the notice to be displayed at retail establishments) directed to con- § 107.250 Termination of an infant for- signees, distributors, retailers, and mula recall. members of the public. The recalling firm may submit a rec- [54 FR 4008, Jan. 27, 1989, as amended at 66 ommendation for termination of the FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2, recall to the appropriate FDA district 2004] office for transmittal to the Recall Co- § 107.240 Notification requirements. ordinator, Division of Enforcement (a) Telephone report. When a deter- (HFS–605), Office of Compliance, Center mination is made that an infant for- for Food Safety and Applied Nutrition, mula is to be recalled, the recalling 5001 Campus Dr., College Park, MD firm shall telephone within 24 hours 20740, or by email to the appropriate Food and Drug Admin- [email protected], for ac- istration district office listed in § 5.115 tion. Any such recommendation shall of this chapter and shall provide rel- contain information supporting a con- evant information about the infant for- clusion that the recall strategy has mula that is to be recalled. been effective. The Agency will respond (b) Initial written report. Within 14 within 15 days of receipt by the Divi- days after the recall has begun, the re- sion of Enforcement of the request for calling firm shall provide a written re- termination. The recalling firm shall

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continue to implement the recall strat- ing firm in determining how to comply egy until it receives final written noti- with these regulations. fication from the Agency that the re- [54 FR 4008, Jan. 27, 1989, as amended at 65 call has been terminated. The Agency FR 56479, Sept. 19, 2000] will send such notification, unless the Agency has information from FDA’s § 107.280 Records retention. own audits or from other sources dem- Each manufacturer of an infant for- onstrating that the recall has not been mula shall make and retain such effective. The Agency may conclude records respecting the distribution of that a recall has not been effective if: the infant formula through any estab- (a) The recalling firm’s distributors lishment owned or operated by such have failed to retrieve the recalled in- manufacturer as may be necessary to fant formula; or effect and monitor recalls of the for- (b) Stocks of the recalled infant formula. Such records shall be retained mula remain in distribution channels for at least 1 year after the expiration that are not in direct control of the re- of the shelf life of the infant formula. calling firm. [54 FR 4008, Jan. 27, 1989, as amended at 67 [54 FR 4008, Jan. 27, 1989, as amended at 61 FR 9585, Mar. 4, 2002] FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004; 79 FR 8075, Feb. 10, 2014] PART 108—EMERGENCY PERMIT CONTROL § 107.260 Revision of an infant formula recall. Subpart A—General Provisions If after a review of the recalling Sec. firm’s recall strategy or periodic re- 108.3 Definitions. ports or other monitoring of the recall, 108.5 Determination of the need for a per- the Food and Drug Administration con- mit. cludes that the actions of the recalling 108.6 Revocation of determination of need firm are deficient, the agency shall no- for permit. tify the recalling firm of any serious 108.7 Issuance or denial of permit. deficiency. The agency may require the 108.10 Suspension and reinstatement of permit. firm to: 108.12 Manufacturing, processing, or pack- (a) Change the extent of the recall, if ing without a permit, or in violation of a the agency concludes on the basis of permit. available data that the depth of the re- 108.19 Establishment of requirements for ex- call is not adequate in light of the risk emption from section 404 of the act. to human health presented by the infant formula. Subpart B—Specific Requirements and (b) Carry out additional effectiveness Conditions for Exemption From or checks, if the agency’s audits, or other Compliance With an Emergency Per- information, demonstrate that the re- mit call has not been effective. 108.25 Acidified foods. (c) Issue additional notifications to 108.35 Thermal processing of low-acid foods the firm’s direct accounts, if the agen- packaged in hermetically sealed con- cy’s audits, or other information dem- tainers. onstrate that the original notifications AUTHORITY: 21 U.S.C. 342, 344, 371. were not received, or were disregarded in a significant number of cases. SOURCE: 42 FR 14334, Mar. 15, 1977, unless otherwise noted. § 107.270 Compliance with this sub- EDITORIAL NOTE: Nomenclature changes to part. part 108 appear at 81 FR 49896, July 29, 2016. A recalling firm may satisfy the requirements of this subpart by any Subpart A—General Provisions means reasonable calculated to meet the obligations set forth in this Sub- § 108.3 Definitions. part E. The recall guidance in subpart (a) The definitions contained in sec- C of part 7 of this chapter specify pro- tion 201 of the Federal Food, Drug, and cedures that may be useful to a recall- Cosmetic Act are applicable to such terms when used in this part. 247

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(b) Commissioner means the Commis- a permit is effective immediately pend- sioner of Food and Drugs. ing an expedited hearing. (c) Act means the Federal Food, (b) A hearing under this section shall Drug, and Cosmetic Act, as amended. be conducted by the Commissioner or (d) Permit means an emergency per- his designee at a location agreed upon mit issued by the Commissioner pursu- by the objector and the Commissioner ant to section 404 of the act for such or, if such agreement cannot be temporary period of time as may be reached, at a location designated by necessary to protect the public health. the Commissioner. The manufacturer, (e) Manufacture, processing, or packing processor, or packer shall have the of food in any locality means activities right to cross-examine the Food and conducted in a single plant or estab- Drug Administration’s witnesses and to present witnesses on his own behalf. lishment, a series of plants under a sin- (c) Within 5 working days after the gle management, or all plants in an in- hearing, and based on the evidence pre- dustry or region, by a manufacturer, sented at the hearing, the Commis- processor, or packer. sioner shall determine whether a per- § 108.5 Determination of the need for a mit is required and shall so inform the permit. manufacturer, processor, or packer in writing, with the reasons for his deci- (a) Whenever the Commissioner de- sion. termines after investigation that a (d) The Commissioner’s determina- manufacturer, processor, or packer of a tion of the need for a permit con- food for which a regulation has been stitutes final agency action from which promulgated in subpart B of this part appeal lies to the courts. The Commis- does not meet the mandatory condi- sioner will not stay a determination of tions and requirements established in the need for a permit pending court ap- such regulation, he shall issue to such peal except in unusual circumstances, manufacturer, processor, or packer an but will participate in expediting any order determining that a permit shall such appeal. be required before the food may be introduced or delivered for introduction [42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, into interstate commerce by that per- 1996; 66 FR 56035, Nov. 6, 2001] son. The order shall specify the mandatory conditions and requirements with § 108.6 Revocation of determination of which there is a lack of compliance. need for permit. (1) The manufacturer, processor, or (a) A permit shall be required only packer shall have 3 working days after during such temporary period as is nec- receipt of such order within which to essary to protect the public health. file objections. Such objections may be (b) Whenever the Commissioner has filed by telegram, telex, or any other reason to believe that a permit holder mode of written communication ad- is in compliance with the mandatory dressed to the Center for Food Safety requirements and conditions estab- and Applied Nutrition, Food and Drug lished in subpart B of this part and is Administration (HFS–605), 5001 Campus likely to remain in compliance, he Dr., College Park, MD 20740. If such ob- shall, on his own initiative or on the jections are filed, the determination is application of the permit holder, re- stayed pending a hearing to be held voke both the determination of need within 5 working days after the filing for a permit and the permit that had of objections on the issues involved un- been issued. If denied, the applicant less the Commissioner determines that shall, upon request, be afforded a hear- the objections raise no genuine and ing conducted in accordance with § 108.5 substantial issue of fact to justify a (b) and (c) as soon as practicable. Such hearing. revocation is without prejudice to the (2) If the Commissioner finds that initiation of further permit pro- there is an imminent hazard to health, ceedings with respect to the same man- the order shall contain this finding and ufacturer, processor, or packer should the reasons therefor, and shall state later information again show the need that the determination of the need for for a permit.

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§ 108.7 Issuance or denial of permit. § 108.10 Suspension and reinstatement of permit. (a) After a determination and notification by the Commissioner in accord- (a) Whenever the Commissioner finds ance with the provisions of § 108.5 that that a permit holder is not in compli- a manufacturer, processor, or packer ance with the mandatory requirements requires a permit, such manufacturer, and conditions established by the per- processor, or packer may not there- mit, he shall immediately suspend the after introduce or deliver for introduc- permit and so inform the permit hold- tion into interstate commerce any er, with the reasons for the suspension. such food manufactured, processed, or (b) Upon application for reinstate- packed by him unless he holds a permit ment of a permit, the Commissioner issued by the Commissioner or obtains shall, within 10 working days, reinstate advance written approval of the Food the permit if he finds that the person is and Drug Administration pursuant to in compliance with the mandatory requirements and conditions established § 108.12(a). by the permit or deny the application. (b) Any manufacturer, processor, or (c) Any person whose permit has been packer for whom the Commissioner has suspended or whose application for re- made a determination that a permit is instatement has been denied may re- necessary may apply to the Commis- quest a hearing. The hearing shall be sioner for the issuance of such a per- conducted by the Commissioner or his mit. The application shall contain such designee within 5 working days of re- data and information as is necessary to ceipt of the request at a location show that all mandatory requirements agreed upon by the objector and the and conditions for the manufacturer, Commissioner or, if an agreement can- processing or packing of a food for not be reached, at a location des- which regulations are established in ignated by the Commissioner. The per- subpart B of this part are met and, in mit holder shall have the right to particular, shall show that the devi- present witnesses on his own behalf ations specified in the Commissioner’s and to cross-examine the Food and determination of the need for a permit Drug Administration’s witnesses. have been corrected or suitable interim (d) Within 5 working days after the measures established. Within 10 work- hearing, and based on the evidence pre- ing days after receipt of such applica- sented at the hearing, the Commis- tion, (except that the Commissioner sioner shall determine whether the per- may extend such time an additional 10 mit shall be reinstated and shall so in- working days where necessary), the form the permit holder, with the rea- Commissioner shall issue a permit, sons for his decision. deny the permit, or offer the applicant (e) Denial of an application for rein- a hearing conducted in accordance with statement of a permit constitutes final § 108.5 (b) and (c) as to whether the per- agency action from which appeal lies mit should be issued. The Commis- to the courts. The Commissioner will sioner shall issue such a permit to not stay such denial pending court ap- which shall be attached, in addition to peal except in unusual circumstances, the mandatory requirements and con- but will participate in expediting any ditions of subpart B of this part, any such appeal. additional requirements or conditions which may be necessary to protect the § 108.12 Manufacturing, processing, or public health if he finds that all man- packing without a permit, or in vio- datory requirements and conditions of lation of a permit. subpart B of this part are met or suit- (a) A manufacturer, processor, or able interim measures are established. packer may continue at his own risk to (c) Denial of a permit constitutes manufacture, process, or pack without final agency action from which appeal a permit a food for which the Commis- lies to the courts. The Commissioner sioner has determined that a permit is will not stay such denial pending court required. All food so manufactured, appeal except in unusual cir- processed, or packed during such period cumstances, but will participate in ex- without a permit shall be retained by pediting any such appeal. the manufacturer, processor, or packer

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and may not be introduced or delivered termined after such articles have en- for introduction into interstate com- tered interstate commerce, he shall merce without the advance written ap- promulgate regulations in Subpart B of proval of the Food and Drug Adminis- this part establishing requirements and tration. Such approval may be granted conditions governing the manufacture, only upon an adequate showing that processing, or packing of the food nec- such food is free from microorganisms essary to protect the public health. of public health significance. The man- Such regulations may be proposed by ufacturer, processor, or packer may the Commissioner on his own initiative provide to the Commissioner, for his or in response to a petition from any consideration in making any such de- interested person pursuant to part 10 of termination, an evaluation of the po- this chapter. tential public health significance of (b) A manufacturer, processor, or such food by a competent authority in packer of a food for which a regulation accordance with procedures recognized has been promulgated in subpart B of as being adequate to detect any potential hazard to public health. Within 20 this part shall be exempt from the re- working days after receipt of a written quirement for a permit only if he meets request for such written approval the all of the mandatory requirements and Food and Drug Administration shall ei- conditions established in that regula- ther issue such written approval or tion. deny the request. If the request is de- [42 FR 14334, Mar. 15, 1977, as amended at 42 nied, the applicant shall, upon request, FR 15673, Mar. 22, 1977] be afforded a prompt hearing conducted in accordance with § 108.5 (b) Subpart B—Specific Requirements and (c). (b) Except as provided in paragraph and Conditions for Exemption (a) of this section, no manufacturer, From or Compliance With an processor, or packer may introduce or Emergency Permit deliver for introduction into interstate commerce without a permit or in viola- § 108.25 Acidified foods. tion of a permit a food for which the (a) Inadequate or improper manufac- Commissioner has determined that a ture, processing, or packing of acidified permit is required. Where a manufac- foods may result in the distribution in turer, processor, or packer utilizes a interstate commerce of processed foods consolidation warehouse or other stor- that may be injurious to health. The age facility under his control, inter- harmful nature of such foods cannot be state shipment of any such food from adequately determined after these the point of production to that ware- foods have entered into interstate com- house or storage facility shall not vio- merce. The Commissioner of Food and late this paragraph, provided that no Drugs therefore finds that, to protect further introduction or delivery for in- the public health, it may be necessary troduction into interstate commerce is to require any commericial processor, made from that consolidated ware- in any establishment engaged in the house or storage facility except as provided in paragraph (a) of this section. manufacture, processing, or packing of acidified foods, to obtain and hold a § 108.19 Establishment of require- temporary emergency permit provided ments for exemption from section for under section 404 of the Federal 404 of the act. Food, Drug, and Cosmetic Act. Such a (a) Whenever the Commissioner finds permit may be required whenever the after investigation that the distribu- Commissioner finds, after investigation in interstate commerce of any tion, that the commercial processor class of food may, by reason of con- has failed to fulfill all the require- tamination with microorganisms dur- ments of this section, including reg- ing the manufacture, processing, or istration and filing of process informa- packing thereof in any locality, be in- tion, and the mandatory portions of jurious to health, and that such inju- §§ 114.10, 114.80(a) (1) and (2), and (b), rious nature cannot be adequately de- 114.83, 114.89, and 114.100 (b), (c), and (d)

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of this chapter as they relate to acidi- tion not later than 90 days after the fied foods. These requirements are in- commercial processor ceases or discon- tended to ensure safe manufacturing, tinues the manufacture, processing, or processing, and packing processes and packing of the foods in any establish- to permit the Food and Drug Adminis- ment, except that this notification tration to verify that these processes shall not be required for temporary are being followed. Failure to meet cessations due to the seasonal char- these requirements shall constitute a acter of an establishment’s production prima facie basis for the immediate ap- or by temporary conditions including, plication of the emergency permit con- but not limited to, labor disputes, fire, trol provisions of section 404 of the act or acts of God. to that establishment, under the proce- (2) Process filing. A commercial proc- dures established in subpart A of this essor engaged in the processing of part. acidified foods shall, not later than 60 (b) The definitions in § 114.3 of this days after registration, and before chapter are applicable when those packing any new product, provide the terms are used in this section. Food and Drug Administration infor- (c)(1) Registration. A commercial mation on the scheduled processes in- processor, when first engaging in the cluding, as necessary, conditions for manufacture, processing, or packing of heat processing and control of pH, salt, acidified foods in any State, as defined sugar, and preservative levels and in section 201(a)(1) of the act, shall, not source and date of the establishment of later than 10 days after first so engag- the process, for each acidified food in ing, register and file with the Food and each container size. Filing of this in- Drug Administration on Form FDA formation does not constitute approval 2541 (food canning establishment reg- of the information by the Food and istration) information including, but Drug Administration, and information not limited to, the name of the estab- concerning processes and other data so lishment, principal place of business, filed shall be regarded as trade secrets the location of each establishment in within the meaning of 21 U.S.C. 331(j) which that processing is carried on, the and 18 U.S.C. 1905. This information processing method in terms of acidity shall be submitted on Form FDA 2541e and pH control, and a list of foods so (Food Process Filing for Acidified processed in each establishment. These Method). Forms are available from the forms are available from the LACF LACF Registration Coordinator (HFS– Registration Coordinator (HFS–303), 303), Center for Food Safety and Ap- Center for Food Safety and Applied Nu- plied Nutrition, Food and Drug Admin- trition, Food and Drug Administration, istration, 5001 Campus Dr., College 5001 Campus Dr., College Park, MD Park, MD 20740, or at any Food and 20740, or at any Food and Drug Admin- Drug Administration district office. istration district office. The completed The completed form shall be submitted form shall be submitted to the Center to the LACF Registration Coordinator for Food Safety and Applied Nutrition (HFS–618), Center for Food Safety and (HFS–565), Food and Drug Administra- Applied Nutrition, Food and Drug Ad- tion, 5001 Campus Dr., College Park, ministration, 5001 Campus Dr., College MD 20740. These forms also are avail- Park, MD 20740. These forms also are able on the Food and Drug Administra- available on the Food and Drug Admin- tion’s Web site at http://www.fda.gov/ istration’s Web site at http:// Food/GuidanceRegulation/ www.fda.gov/Food/GuidanceRegulation/ FoodFacilityRegistration/ FoodFacilityRegistration/ AcidifiedLACFRegistration/ AcidifiedLACFRegistration/ ucm2007436.htm. For electronic submis- ucm2007436.htm. For electronic submission go to FDA’s Industry Systems Web sion go to FDA’s Industry Systems Web site at www.access.fda.gov. Foreign site at www.access.fda.gov. processors shall register before any of- (3) Process adherence and information— fering of foods for import into the (i) Scheduling. A commercial processor United States. Commercial processors engaged in processing acidified foods in duly registered under this section shall any registered establishment shall notify the Food and Drug Administra- process each food in conformity with at

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least the scheduled processes filed Commissioner will consider students under paragraph (c)(2) of this section. who have satisfactorily completed the (ii) Process and pH information avail- required portions of the courses pre- ability. When requested by the Food sented under § 108.35 and part 113 of this and Drug Administration in writing, a chapter before March 16, 1979, as having commercial processor engaged in the satisfactorily completed the prescribed processing of acidified foods shall pro- course of instruction under this section vide the Food and Drug Administration and part 114 of this chapter. The Com- with any process and procedure infor- missioner will not withhold approval of mation that the Food and Drug Admin- any school qualified to give such in- istration deems necessary to determine struction. the adequacy of the process. Fur- (g) A commercial processor engaged nishing of this information does not in the processing of acidified foods constitute approval by the Food and shall prepare, review, and retain at the Drug Administration of the content of processing plant or other reasonably the information filed, and the informa- accessible location for a period of 3 tion concerning processes and other years from the date of manufacture, all data so furnished shall be considered records of processing, deviations in trade secrets within the meaning of 21 processing, pH, and other records speci- U.S.C. 331(j) and 18 U.S.C. 1905 (to the fied in part 114 of this chapter. Upon extent that they qualify under those written demand during the course of a provisions). factory inspection under section 704 of (d) A commercial processor engaged the act by a duly authorized employee in the processing of acidified foods of the Food and Drug Administration, shall promptly report to the Food and a commercial processor shall permit Drug Administration any instance of the inspection and copying by that em- spoilage, process deviation, or con- ployee of these records to verify the pH tamination with microorganisms, the and the adequacy of processing. nature of which has potential health- (h) This section shall not apply to endangering significance, where any the commercial processing of any food lot of such food has in whole or in part processed under the continuous inspec- entered distribution in commerce. tion of the meat and poultry inspection (e) A commercial processor engaged program of the Food Safety and Inspec- in the processing of acidified foods tion Service of the Department of Agri- shall prepare and maintain files on a culture under the Federal Meat Inspec- current procedure for use for products tion Act (34 Stat. 1256, as amended by under the processor’s control, which 81 Stat. 584 (21 U.S.C. 601 et seq.)) and that processor will ask the distributor the Poultry Products Inspection Act to follow, including plans for recalling (71 Stat. 441, as amended by 82 Stat. 791 products that may be injurious to (21 U.S.C. 451 et seq.)). health; for identifying, collecting, (i) Wherever the Commissioner finds warehousing, and controlling products; that any State regulates the commer- for determining the effectiveness of re- cial processing of acidified foods under calls; for notifying the Food and Drug effective regulations specifying at least Administration of any recalls; and for the requirements of part 114 of this implementing recall programs. chapter, the Commissioner shall issue (f) All plant personnel involved in a notice stating that compliance with acidification, pH control, heat treat- such State regulations shall constitute ment, or other critical factors of the compliance with this section, if the operation shall be under the operating State through its regulatory agency or supervision of a person who has at- each processor of acidified foods in the tended a school approved by the Com- State files with the Food and Drug Ad- missioner for giving instruction in ministration the registration informa- food-handling techniques, food protection and the processing information tion principles, personal hygiene, plant prescribed in paragraph (c) of this sec- sanitation practices, pH controls, and tion. critical factors in acidification, and (j) Imports. (1) This section applies to who has satisfactorily completed the any foreign commercial processor en- prescribed course of instruction. The gaged in the processing of acidified

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foods and offering those foods for im- § 108.35 Thermal processing of low- port into the United States except acid foods packaged in hermetically that, in lieu of providing for the sealed containers. issuance of an emergency permit under (a) Inadequate or improper manufac- paragraph (a) of this section, the Com- ture, processing, or packing of ther- missioner will request the Secretary of mally processed low-acid foods in her- the Treasury to refuse admission into metically sealed containers may result the United States, under section 801 of in the distribution in interstate com- the act, to any acidified foods which merce of processed foods that may be the Commissioner determines, after in- injurious to health. The harmful na- vestigation, may result in the distribu- ture of such foods cannot be adequately tion in interstate commerce of proc- determined after these foods have en- essed foods that may be injurious to tered into interstate commerce. The health as set forth in paragraph (a) of Commissioner of Food and Drugs there- this section. fore finds that, in order to protect the (2) Any acidified food so refused ad- public health, it may be necessary to mission shall not be admitted until the require any commercial processor, in Commissioner determines that the any establishment engaged in the man- commercial processor offering the food ufacture, processing, or packing of for import has complied with the re- thermally processed low-acid foods in quirements of this section and that the hermetically sealed containers, to ob- food is not injurious to health. To as- tain and hold a temporary emergency sist the Commissioner in making this permit provided for under section 404 of determination, a duly authorized em- the Federal Food, Drug, and Cosmetic ployee of the Food and Drug Adminis- Act. Such a permit may be required tration shall be permitted to inspect whenever the Commissioner finds, after the commercial processor’s manufac- investigation, that the commercial turing, processing, and packing facili- processor has failed to fulfill all the re- ties. quirements of this section, including (k) The following information sub- registration and the filing of process mitted to the Food and Drug Adminis- information, and the mandatory por- tration under this section is not avail- tions of part 113 of this chapter. These able for public disclosure unless it has requirements are intended to ensure been previously disclosed to the public safe manufacture, processing, and as defined in § 20.81 of this chapter or it packing procedures and to permit the relates to a product or ingredient that Food and Drug Administration to has been abandoned and no longer rep- verify that these procedures are being resents a trade secret or confidential followed. Such failure shall constitute commercial or financial information as a prima facie basis for the immediate defined in § 20.61 of this chapter: application of the emergency permit (1) Manufacturing methods or proc- control provisions of section 404 of the esses, including quality control infor- act to that establishment, pursuant to mation. the procedures established in subpart A (2) Production, sales, distribution, of this part. and similar information, except that (b) The definitions in § 113.3 of this any compilation of the information ag- chapter are applicable when such terms gregated and prepared in a way that are used in this section. does not reveal information which is (c) Registration and process filing—(1) not available for public disclosure Registration. A commercial processor under this provision is available for when first engaging in the manufac- public disclosure. ture, processing, or packing of ther- (3) Quantitative or semiquantitative mally processed low-acid foods in her- formulas. metically sealed containers in any [44 FR 16207, Mar. 16, 1979, as amended at 54 State, as defined in section 201(a)(1) of FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, the act, shall, not later than 10 days 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 46831, after first so engaging, register with July 19, 2016] the Food and Drug Administration on

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Form FDA 2541 (food canning establish- of processing, sterilizing value (Fo), or ment registration) information includ- other equivalent scientific evidence of ing (but not limited to) his name, prin- process adequacy, critical control fac- cipal place of business, the location of tors affecting heat penetration, and each establishment in which such proc- source and date of the establishment of essing is carried on, the processing the process, for each such low-acid food method in terms of the type of proc- in each container size: Provided, that essing equipment employed, and a list the filing of such information does not of the low-acid foods so processed in constitute approval of the information each such establishment. These forms by the Food and Drug Administration, are available from the LACF Registra- and that information concerning proc- tion Coordinator (HFS–303), Center for esses and other data so filed shall be Food Safety and Applied Nutrition, regarded as trade secrets within the Food and Drug Administration, 5001 meaning of 21 U.S.C. 331(j) and 18 Campus Dr., College Park, MD 20740, or U.S.C. 1905. This information shall be at any Food and Drug Administration submitted on the following forms as district office. The completed form appropriate: Form FDA 2541d (Food shall be submitted to the LACF Reg- Process Filing for Low-Acid Retorted istration Coordinator (HFS–618), Cen- Method), Form FDA 2541f (Food Proc- ter for Food Safety and Applied Nutri- ess Filing for Water Activity/Formula- tion, Food and Drug Administration, tion Control Method), or Form FDA 5001 Campus Dr., College Park, MD 2541g (Food Process Filing for Low- 20740. These forms also are available on Acid Aseptic Systems). These forms are the Food and Drug Administration’s available from the LACF Registration Web site at http://www.fda.gov/Food/ Coordinator (HFS–303), Center for Food GuidanceRegulation/ Safety and Applied Nutrition, Food and FoodFacilityRegistration/ Drug Administration, 5001 Campus Dr., AcidifiedLACFRegistration/default.htm. College Park, MD 20740, or at any Food For electronic submission go to FDA’s and Drug Administration district of- Industry Systems Web site at fice. The completed form(s) shall be www.access.fda.gov. Commercial proc- submitted to the LACF Registration essors duly registered in accordance Coordinator (HFS–303), Center for Food with this section shall notify the Food Safety and Applied Nutrition, Food and and Drug Administration not later Drug Administration, 5001 Campus Dr., than 90 days after such commercial College Park, MD 20740. These forms processor ceases or discontinues the also are available on the Food and manufacture, processing, or packing of Drug Administration’s Web site at thermally processed foods in any estab- http://www.fda.gov/Food/ lishment: Provided, that such notifica- GuidanceRegulation/ tion shall not be required as to the FoodFacilityRegistration/ temporary cessation necessitated by AcidifiedLACFRegistration/default.htm. the seasonal character of the par- For electronic submission, go to FDA’s ticular establishment’s production or Industry Systems Web site at caused by temporary conditions includ- www.access.fda.gov. ing but not limited to strikes, (i) If all the necessary information is lockouts, fire, or acts of God. not available for existing products, the (2) Process filing. A commercial proc- processor shall, at the time the exist- essor engaged in the thermal proc- ing information is provided to the Food essing of low-acid foods packaged in and Drug Administration request in hermetically sealed containers shall, writing an extension of time for sub- not later than 60 days after registra- mission of such information, specifying tion and prior to the packing of a new what additional information is to be product, provide the Food and Drug supplied and the date by which it is to Administration information as to the be submitted. Within 30 working days scheduled processes including but not after receipt of such request the Food limited to the processing method, type and Drug Administration shall either of retort or other thermal processing grant or deny such request in writing. equipment employed, minimum initial (ii) If a packer intentionally makes a temperatures, times and temperatures change in a previously filed scheduled

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process by reducing the initial tem- in each container size in conformity perature or retort temperature, reduc- with at least the scheduled processes ing the time of processing, or changing and modifications filed pursuant to the product formulation, the container, paragraph (c)(2) of this section. or any other condition basic to the ade- (ii) Process information availability: quacy of scheduled process, he shall When requested by the Food and Drug prior to using such changed process ob- Administration in writing, a commer- tain substantiation by qualified sci- cial processor engaged in thermal proc- entific authority as to its adequacy. essing of low-acid foods packaged in Such substantiation may be obtained hermetically sealed containers shall by telephone, telegram, or other media, provide the Food and Drug Administra- but must be promptly recorded, tion with any information concerning verified in writing by the authority, processes and procedures which is and contained in the packer’s files for deemed necessary by the Food and review by the Food and Drug Adminis- Drug Administration to determine the tration. Within 30 days after first use, adequacy of the process: Provided, That the packer shall submit to the LACF the furnishing of such information does Registration Coordinator (HFS–303), not constitute approval of the informa- Center for Food Safety and Applied Nu- tion by the Food and Drug Administra- trition, Food and Drug Administration, tion, and that the information con- 5001 Campus Dr., College Park, MD cerning processes and other data so 20740 a complete description of the furnished shall be regarded as trade se- modifications made and utilized, to- crets within the meaning of 21 U.S.C. gether with a copy of his file record 331(j) and 18 U.S.C. 1905. showing prior substantiation by a (d) A commercial processor engaged qualified scientific authority as to the in the thermal processing of low-acid safety of the changed process. Any in- foods packaged in hermetically sealed tentional change of a previously filed containers shall promptly report to the scheduled process or modification Food and Drug Administration any in- thereof in which the change consists stance of spoilage or process deviation solely of a higher initial temperature, the nature of which indicates potential a higher retort temperature, or a longer processing time, shall not be health significance where any lot of considered a change subject to this such food has in whole or in part en- paragraph, but if that modification is tered distribution. thereafter to be regularly scheduled, (e) A commercial processor engaged the modified process shall be promptly in thermal processing of low-acid foods filed as a scheduled process, accom- packaged in hermetically sealed con- panied by full information on the speci- tainers shall promptly report to the fied forms as provided in this para- Food and Drug Administration any in- graph. stance wherein any lot of such food, (iii) Many packers employ an ‘‘oper- which may be injurious to health by ating’’ process in which retort opera- reason of contamination with micro- tors are instructed to use retort tem- organisms, has in whole or in part en- peratures and/or processing times tered distribution. slightly in excess of those specified in (f) A commercial processor engaged the scheduled process as a safety factor in the thermal processing of low-acid to compensate for minor fluctuations foods packaged in hermetically sealed in temperature or time to assure that containers shall have prepared and in the minimum times and temperatures his files a current procedure which he in the scheduled process are always will use for products under his control met. This would not constitute a modi- and which he will ask his distributor to fication of the scheduled process. follow, including plans for effecting re- (3) Process adherence and information. calls of any product that may be inju- (i) A commercial processor engaged in rious to health; for identifying, col- the thermal processing of low-acid lecting, warehousing, and controlling foods packaged in hermetically sealed the product; for determining the effec- containers in any registered establish- tiveness of such recall; for notifying ment shall process each low-acid food the Food and Drug Administration of

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any such recall; and for implementing 81 Stat. 584 (21 U.S.C. 601 et seq.)) and such recall program. the Poultry Products Inspection Act (g) All operators of retorts, thermal (71 Stat. 441, as amended by 82 Stat. 791 processing systems, aseptic processing (21 U.S.C. 451 et seq.)). and packaging systems, or other ther- (j) Compliance with State regulations. mal processing systems, and container (1) Wherever the Commissioner finds closure inspectors shall be under the that any State regulates the commer- operating supervision of a person who cial thermal processing of low-acid has attended a school approved by the foods in accordance with effective reg- Commissioner for giving instruction in ulations specifying at least the require- retort operations, aseptic processing ments of part 113 of this chapter, he and packaging systems operations or shall issue a notice stating that com- other thermal processing systems oper- pliance with such State regulations ations, and container closure inspec- shall constitute compliance with part tions, and has satisfactorily completed 113 of this chapter. However, the provi- the prescribed course of instruction: sions of this section shall remain appli- Provided, That this requirement shall cable to the commercial processing of not apply in the State of California as low-acid foods in any such State, ex- listed in paragraph (j) of this section. cept that, either the State through its The Commissioner will not withhold regulatory agency or each processor of approval of any school qualified to give low-acid foods in such State shall file such instruction. with the Center for Food Safety and (h) A commercial processor engaged Applied Nutrition the registration in- in the thermal processing of low-acid formation and the processing informa- foods packaged in hermetically sealed tion prescribed in paragraph (c) of this containers shall prepare, review, and section. retain at the processing plant for a pe- (2) The Commissioner finds that the riod of not less than one year, and at regulations adopted by the State of the processing plant or other reason- California under the laws relating to ably accessible location for an addi- cannery inspections governing thermal tional two years, all records of proc- processing of low-acid foods packaged essing, deviations in processing, con- in hermetically sealed containers sat- tainer closure inspections, and other isfy the requirements of part 113 of this records specified in part 113 of this chapter. chapter. If during the first year of the Accordingly, processors, who under the three-year record retention period the laws relating to cannery inspections processing plant is closed for a pro- are licensed by the State of California longed period between seasonal packs, and who comply with such state regu- the records may be transferred to some lations, shall be deemed to comply other reasonably accessible location at with the requirements of part 113 of the end of the seasonal pack. Upon this chapter. written demand during the course of a (k) Imports. (1) This section shall factory inspection pursuant to section apply to any foreign commercial proc- 704 of the act by a duly authorized em- essor engaged in the thermal proc- ployee of the Food and Drug Adminis- essing of low-acid foods packaged in tration, a commercial processor shall hermetically sealed containers and of- permit the inspection and copying by fering such foods for import into the such employee of these records to United States except that, in lieu of verify the adequacy of processing, the providing for the issuance of an emer- integrity of container closures, and the gency permit under paragraph (a) of coding of the products. this section, the Commissioner will re- (i) This section shall not apply to the quest the Secretary of the Treasury to commercial processing of any food refuse admission into the United processed under the continuous inspec- States, pursuant to section 801 of the tion of the meat and poultry inspection act, of any such low-acid foods which program of the Food Safety and Inspec- the Commissioner determines, after in- tion Service of the Department of Agri- vestigation, may result in the distribu- culture under the Federal Meat Inspec- tion in interstate commerce of proc- tion Act (34 Stat. 1256, as amended by essed foods that may be injurious to

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health as set forth in paragraph (a) of 109.7 Unavoidability. this section. 109.15 Use of polychlorinated biphenyls (2) Any such food refused admission (PCB’s) in establishments manufacturing shall not be admitted until such time food-packaging materials. as the Commissioner may determine 109.16 Ornamental and decorative that the commercial processor offering ceramicware. the food for import is in compliance with the requirements and conditions Subpart B—Tolerances for Unavoidable of this section and that such food is not Poisonous or Deleterious Substances injurious to health. For the purpose of 109.30 Tolerances for polychlorinated making such determination, the Com- biphenyls (PCB’s). missioner reserves the right for a duly authorized employee of the Food and Subpart C—Regulatory Limits for Added Drug Administration to inspect the Poisonous or Deleterious Substances commercial processor’s manufacturing, [Reserved] processing, and packing facilities. (l) The following data and informa- Subpart D—Naturally Occurring Poisonous tion submitted to the Food and Drug or Deleterious Substances [Reserved] Administration pursuant to this section are not available for public disclo- AUTHORITY: 21 U.S.C. 321, 336, 342, 346, 346a, sure unless they have been previously 348, 371. disclosed to the public as defined in § 20.81 of this chapter or they relate to SOURCE: 42 FR 52819, Sept. 30, 1977, unless otherwise noted. a product or ingredient that has been abandoned and they no longer rep- EDITORIAL NOTE: Nomenclature changes to resent a trade secret or confidential part 109 appear at 81 FR 49896, July 29, 2016. commercial or financial information as defined in § 20.81 of this chapter: Subpart A—General Provisions (1) Manufacturing methods or processes, including quality control infor- § 109.3 Definitions and interpretations. mation. (a) Act means the Federal Food, (2) Production, sales, distribution, Drug, and Cosmetic Act. and similar data and information, except that any compilation of such data (b) The definitions of terms con- and information aggregated and pre- tained in section 201 of the act are ap- pared in a way that does not reveal plicable to such terms when used in data or information which is not avail- this part unless modified in this sec- able for public disclosure under this tion. provision is available for public disclo- (c) A naturally occurring poisonous or sure. deleterious substance is a poisonous or (3) Quantitative or semiquantitative deleterious substance that is an inher- formulas. ent natural constituent of a food and is [42 FR 14334, Mar. 15, 1977, as amended at 42 not the result of environmental, agri- FR 15673, Mar. 22, 1977; 54 FR 24891, June 12, cultural, industrial, or other contami- 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, nation. Nov. 6, 2001; 81 FR 46831, July 19, 2016] (d) An added poisonous or deleterious substance is a poisonous or deleterious PART 109—UNAVOIDABLE CON- substance that is not a naturally oc- TAMINANTS IN FOOD FOR curring poisonous or deleterious sub- HUMAN CONSUMPTION AND stance. When a naturally occurring FOOD-PACKAGING MATERIAL poisonous or deleterious substance is increased to abnormal levels through Subpart A—General Provisions mishandling or other intervening acts, it is an added poisonous or deleterious Sec. substance to the extent of such in- 109.3 Definitions and interpretations. crease. 109.4 Establishment of tolerances, regulatory limits, and action levels. (e) Food includes human food and 109.6 Added poisonous or deleterious sub- substances migrating to food from stances. food-contact articles.

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§ 109.4 Establishment of tolerances, tion issued under section 409 of the act regulatory limits, and action levels. when possible. When such a use cannot (a) When appropriate under the cri- be approved under the criteria of sec- teria of § 109.6, a tolerance for an added tion 409 of the act, or when the added poisonous or deleterious substance, poisonous or deleterious substance is which may be a food additive, may be not a food additive, a tolerance, regu- established by regulation in subpart B latory limit, or action level may be es- of this part under the provisions of sec- tablished pursuant to the criteria in tion 406 of the act. A tolerance may paragraphs (b), (c), or (d) of this sec- prohibit any detectable amount of the tion. Residues resulting from the use of substance in food. an added poisonous or deleterious sub- (b) When appropriate under the cri- stance that is also a pesticide chemical teria of § 109.6, and under section will ordinarily be controlled by a toler- 402(a)(1) of the act, a regulatory limit ance established in a regulation issued for an added poisonous or deleterious under sections 406, 408, or 409 of the act substance, which may be a food addi- by the U.S. Environmental Protection tive, may be established by regulation Agency (EPA). When such a regulation in subpart C of this part under the pro- has not been issued, an action level for visions of sections 402(a)(1) and 701(a) of an added poisonous or deleterious sub- the act. A regulatory limit may pro- stance that is also a pesticide chemical hibit any detectable amount of the sub- may be established by the Food and stance in food. The regulatory limit es- Drug Administration. The Food and tablished represents the level at which Drug Administration will request EPA food is adulterated within the meaning to recommend such an action level pur- of section 402(a)(1) of the act. suant to the criteria established in (c)(1) When appropriate under the cri- paragraph (d) of this section. teria of § 109.6, an action level for an (b) A tolerance for an added poi- added poisonous or deleterious sub- sonous or deleterious substance in any stance, which may be a food additive, food may be established when the fol- may be established to define a level of lowing criteria are met: contamination at which a food may be (1) The substance cannot be avoided regarded as adulterated. by good manufacturing practice. (2) Whenever an action level is estab- (2) The tolerance established is suffi- lished or changed, a notice shall be cient for the protection of the public published in the FEDERAL REGISTER as health, taking into account the extent soon as practicable thereafter. The no- to which the presence of the substance tice shall call attention to the mate- cannot be avoided and the other ways rial supporting the action level which in which the consumer may be affected shall be on file with the Division of by the same or related poisonous or Dockets Management before the notice deleterious substances. is published. The notice shall invite (3) No technological or other changes public comment on the action level. are foreseeable in the near future that (d) A regulation may be established might affect the appropriateness of the in subpart D of this part to identify a tolerance established. Examples of food containing a naturally occurring changes that might affect the appro- poisonous or deleterious substance priateness of the tolerance include an- which will be deemed to be adulterated ticipated improvements in good manu- under section 402(a)(1) of the act. These facturing practice that would change regulations do not constitute a com- the extent to which use of the sub- plete list of such foods. stance is unavoidable and anticipated [42 FR 52819, Sept. 30, 1977, as amended at 55 studies expected to provide significant FR 20785, May 21, 1990] new toxicological or use data. (c) A regulatory limit for an added § 109.6 Added poisonous or deleterious poisonous or deleterious substance in substances. any food may be established when each (a) Use of an added poisonous or dele- of the following criteria is met: terious substance, other than a pes- (1) The substance cannot be avoided ticide chemical, that is also a food ad- by current good manufacturing prac- ditive, will be controlled by a regula- tices.

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(2) There is no tolerance established (b) Compliance with tolerances, regu- for the substance in the particular food latory limits, and action levels does under sections 406, 408, or 409 of the act. not excuse failure to observe either the (3) There is insufficient information requirement in section 402(a)(4) of the by which a tolerance may be estab- act that food may not be prepared, lished for the substance under section packed, or held under insanitary condi- 406 of the act or technological changes tions or the other requirements in this appear reasonably possible that may chapter that food manufacturers must affect the appropriateness of a toler- observe current good manufacturing ance. The regulatory limit established practices. Evidence obtained through represents the level at which food is factory inspection or otherwise indi- adulterated within the meaning of sec- cating such a violation renders the tion 402(a)(1) of the act. food unlawful, even though the (d) An action level for an added poi- amounts of poisonous or deleterious sonous or deleterious substance in any substances are lower than the cur- food may be established when the cri- rently established tolerances, regu- teria in paragraph (b) of this section latory limits, or action levels. The are met, except that technological or manufacturer of food must at all times other changes that might affect the ap- utilize quality control procedures propriateness of the tolerance are fore- which will reduce contamination to the seeable in the near future. An action lowest level currently feasible. level for an added poisonous or deleterious substance in any food may be es- [42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990] tablished at a level at which the Food and Drug Administration may regard § 109.15 Use of polychlorinated the food as adulterated within the biphenyls (PCB’s) in establishments meaning of section 402(a)(1) of the act, manufacturing food-packaging ma- without regard to the criteria in para- terials. graph (b) of this section or in section (a) Polychlorinated biphenyls (PCB’s) 406 of the act. An action level will be represent a class of toxic industrial withdrawn when a tolerance or regu- chemicals manufactured and sold under latory limit for the same substance and a variety of trade names, including: use has been established. Aroclor (United States); Phenoclor (e) Tolerances will be established (France); Colphen (Germany); and under authority appropriate for action Kanaclor (Japan). PCB’s are highly sta- levels (sections 306, 402(a), and 701(a) of ble, heat resistant, and nonflammable the act, together with section 408 or 409 chemicals. Industrial uses of PCB’s in- of the act, if appropriate) as well as clude, or did include in the past, their under authority appropriate for toler- use as electrical transformer and ca- ances (sections 406 and 701 of the act). pacitor fluids, heat transfer fluids, hy- In the event the effectiveness of a tol- draulic fluids, and plasticizers, and in erance is stayed pursuant to section formulations of lubricants, coatings, 701(e)(2) of the act by the filing of an and inks. Their unique physical and objection, the order establishing the chemical properties and widespread, tolerance shall be deemed to be an order establishing an action level until uncontrolled industrial applications final action is taken upon such objec- have caused PCB’s to be a persistent tion. and ubiquitous contaminant in the environment, causing the contamination [42 FR 52819, Sept. 30, 1977, as amended at 55 of certain foods. In addition, incidents FR 20785, May 21, 1990] have occurred in which PCB’s have directly contaminated animal feeds as a § 109.7 Unavoidability. result of industrial accidents (leakage (a) Tolerances and action levels in or spillage of PCB fluids from plant this part are established at levels based equipment). These accidents in turn on the unavoidability of the poisonous caused the contamination of food prod- or deleterious substance concerned and ucts intended for human consumption do not establish a permissible level of (meat, milk and eggs). Investigations contamination where it is avoidable. by the Food and Drug Administration

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have revealed that a significant per- as a result of normal use or as a result centage of paper food-packaging mate- of accident, breakage, or other mishap. rial contains PCB’s which can migrate (iii) The toxicity and other charac- to the packaged food. The origin of teristics of fluids selected as PCB re- PCB’s in such material is not fully un- placements must be adequately deter- derstood. Reclaimed fibers containing mined so that the least potentially carbonless copy paper (contains 3 to 5 hazardous replacement is used. In mak- percent PCB’s) have been identified as ing this determination with respect to a primary source of PCB’s in paper a given fluid, consideration should be products. Some virgin paper products given to (a) its toxicity; (b) the max- have also been found to contain PCB’s, imum quantity that could be spilled the source of which is generally attrib- onto a given quantity of food before it uted to direct contamination from in- would be noticed, taking into account dustrial accidents from the use of PCB- its color and odor; (c) possible signaling containing equipment and machinery devices in the equipment to indicate a in food packaging manufacturing es- loss of fluid, etc.; and (d) its environ- tablishments. Since PCB’s are toxic mental stability and tendency to sur- chemicals, the PCB contamination of vive and be concentrated through the food-packaging materials as a result of food chain. The judgment as to wheth- industrial accidents, which can cause er a replacement fluid is sufficiently the PCB contamination of food, rep- non-hazardous is to be made on an indi- resents a hazard to public health. It is vidual installation and operation basis. therefore necessary to place certain re- (c) The provisions of this section do strictions on the industrial uses of not apply to electrical transformers PCB’s in establishments manufac- and condensers containing PCB’s in turing food-packaging materials. sealed containers. (b) The following special provisions are necessary to preclude the acci- § 109.16 Ornamental and decorative dental PCB contamination of food- ceramicware. packaging materials: (1) New equipment or machinery for (a) Lead is a toxic metal that is used manufacturing food-packaging mate- as a component of glazes and decora- rials shall not contain or use PCB’s. tive decals on ceramics, including some (2) On or before September 4, 1973, the ornamental and decorative management of establishments manu- ceramicware. The use of ornamental or facturing food-packaging materials decorative ceramicware to prepare, shall: serve, or hold food may result in the (i) Have the heat exchange fluid used leaching of lead from the glaze or deco- in existing equipment for manufac- ration into the food. The provisions of turing food-packaging materials sam- paragraph (b) of this section are nec- pled and tested to determine whether it essary to ensure that ornamental or contains PCB’s or verify the absence of decorative ceramicware bear adequate PCB’s in such formulations by other indications that they are not to be appropriate means. On or before Sept. used for food-handling purposes. 4, 1973, any such fluid formulated with (b) Ornamental or decorative PCB’s must to the fullest extent pos- ceramicware initially introduced or sible commensurate with current good initially delivered for introduction into manufacturing practices be replaced interstate commerce on or after July with a heat exchange fluid that does 13, 1994 appears to be suitable for food not contain PCB’s. use will be considered to be for food use (ii) Eliminate to the fullest extent unless: possible commensurate with current (1) It bears: good manufacturing practices from the (i) A conspicuous stick-on label on a establishment any other PCB-con- surface clearly visible to consumers taining equipment, machinery and ma- that states in legible script in letters terials wherever there is a reasonable at least 3.2 millimeters (0.125 inch) in expectation that such articles could height one of the following messages: cause food-packaging materials to be- ‘‘Not for Food Use. May Poison Food,’’ come contaminated with PCB’s either ‘‘Not for Food Use. Glaze contains lead.

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Food Use May Result in Lead Poi- Subpart B—Tolerances for Un- soning,’’ and ‘‘Not for Food Use—Food avoidable Poisonous or Dele- Consumed from this Vessel May be terious Substances Harmful,’’ and (ii) A conspicuous and legible perma- § 109.30 Tolerances for polychlorinated nent statement of the message selected biphenyls (PCB’s). from paragraph (b)(1)(i) of this section (a) Polychlorinated biphenyls (PCB’s) molded or fired onto the exterior sur- are toxic, industrial chemicals. Be- face of the base or, when the cause of their widespread, uncontrolled ceramicware is not fired after decora- industrial applications, PCB’s have be- tion, permanently painted onto the ex- come a persistent and ubiquitous con- terior surface of the base. This perma- taminant in the environment. As a re- nent statement shall be in letters at sult, certain foods and animal feeds, least 3.2 millimeters (0.125 inch) in principally those of animal and marine height, except that if insufficient space origin, contain PCB’s as unavoidable, exists for the permanent statement in environmental contaminants. PCB’s letters of such height, the statement are transmitted to the food portion shall be in the largest letters that will (meat, milk, and eggs) of food-pro- allow it to fit on the base of the piece, ducing animals ingesting PCB-con- provided that the letters are at least taminated animal feed. In addition, a 1.6 millimeters (0.062 inch) in height; or significant percentage of paper food- (2) A hole is bored through the poten- packaging materials contain PCB’s which may migrate to the packaged tial food-contact surface. food. The source of PCB’s in paper (c) In addition to steps required food-packaging materials is primarily under paragraphs (b)(1) and (b)(2) of of certain types of carbonless copy this section, the following optional in- paper (containing 3 to 5 percent PCB’s) formation may be provided on the in waste paper stocks used for manu- ware: facturing recycled paper. Therefore, (1) A further explanatory statement temporary tolerances for residues of concerning the decorative nature of the PCB’s as unavoidable environmental or piece, such as ‘‘Decorative’’ or ‘‘For industrial contaminants are estab- Decorative Purposes Only,’’ may be lished for a sufficient period of time used; however, such additional state- following the effective date of this ment shall be placed after the required paragraph to permit the elimination of statement. such contaminants at the earliest prac- (2) A symbol may be used to advise ticable time. For the purposes of this that a piece of ornamental or decora- paragraph, the term ‘‘polychlorinated tive ceramicware is not to be used with biphenyls (PCB’s)’’ is applicable to food, as illustrated below. mixtures of chlorinated biphenyl compounds, irrespective of which mixture of PCB’s is present as the residue. The temporary tolerances for residues of PCB’s are as follows: (1) 1.5 parts per million in milk (fat basis). (2) 1.5 parts per million in manufactured dairy products (fat basis). (3) 3 parts per million in poultry (fat The circle of the above symbol should basis). be at least 2.54 centimeters (1 inch) in (4) 0.3 parts per million in eggs. diameter. The symbol may be used on (5) 0.2 parts per million in finished the temporary label or applied to the animal feed for food-producing animals (except the following finished animal base of the piece in the same manner as feeds: feed concentrates, feed supple- the permanent statement. ments, and feed premixes). [59 FR 1641, Jan. 12, 1994] (6) 2 parts per million in animal feed components of animal origin, including

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fishmeal and other by-products of ma- for inspection at the National Archives rine origin and in finished animal feed and Records Administration (NARA). concentrates, supplements, and pre- For information on the availability of mixes intended for food producing ani- this material at NARA, call 202–741– mals. 6030, or go to: http://www.archives.gov/ (7) 2 parts per million in fish and federallregister/ shellfish (edible portion). The edible codeloflfederallregulations/ portion of fish excludes head, scales, ibrllocations.html. A class of barrier viscera, and inedible bones. material shall be deemed functional (8) 0.2 parts per million in infant and only if the definition of the class and junior foods. the designation of one or more rep- (9) 10 parts per million in paper food- resentative barriers has been approved packaging material intended for or by the Director, Center for Food Safety used with human food, finished animal and Applied Nutrition, Food and Drug feed and any components intended for Administration. In the event that the animal feeds. The tolerance shall not Director, Center for Food Safety and apply to paper food-packaging material Applied Nutrition, does not approve a separated from the food therein by a proposal made to the Center regarding functional barrier which is imper- the definition of a class of barrier ma- meable to migration of PCB’s. terial or the designation of representa- (b) A compilation entitled ‘‘Analyt- tive barriers, the Director shall advise ical Methodology for Polychlorinated the person making the proposal of the Biphenyls, June 1979’’ for determining reasons for the Center’s disapproval compliance with the tolerances estab- within 90 days of receipt of the pro- lished in this section is available from posal. All proposals for definition of the Division of Dockets Management classes and determinations of the Food (HFA–305), Food and Drug Administra- and Drug Administration regarding tion, 5630 Fishers Lane, rm. 1061, Rock- such proposals shall be on file with the ville, MD 20852. Division of Dockets Management (c) A barrier is functional for pur- (HFA–305), Food and Drug Administra- poses of paragraph (a)(9) of this section tion, 5630 Fishers Lane, rm. 1061, Rock- if the barrier limits migration of PCB’s ville, MD 20852. from the packaging material to food to (d) Any person who asserts that a a level not exceeding the migration barrier or class of barriers is functional which occurs under the same test con- shall submit the results of tests conditions from packaging material conducted to determine the functionality taining 10 parts per million PCB with- of the barrier or class of barriers to out the use of a barrier. A class of bar- Center for Food Safety and Applied Nu- rier material is functional for purposes trition (HFS–308), Food and Drug Ad- of paragraph (a)(9) of this section if a ministration, 5001 Campus Dr., College representative barrier of the class lim- Park, MD 20740. All barriers or classes its migration of PCB’s from the pack- of barriers shall be tested with the four aging material to food to a level not solid food receptors specified in ‘‘Test exceeding the migration which occurs Procedures for Determination of PCB under the same test conditions from Permeability of Food Packaging, packaging material containing 10 parts Inner-Wraps, September 1976, revised per million PCB without the use of a May 1983’’, which is incorporated by barrier. Migration levels shall be deter- reference. The availability of this ref- mined for purpose of this paragraph erence is given in paragraph (c) of this solely by use of testing conditions de- section. The test results as to each bar- scribed in ‘‘Test Procedures for Deter- rier shall be accompanied by (1) a de- mination of PCB Permeability of Food scription of the barrier’s composition Packaging, Inner-Wraps, September adequate to enable identification; and 1976, revised May 1983’’, which is incor- (2) a specific definition of the barrier porated by reference. Copies are avail- by relevant technical characteristics. able from the Division of Dockets Man- The Center for Food Safety and Ap- agement (HFA–305), Food and Drug Ad- plied Nutrition shall review submitted ministration, 5630 Fishers Lane, rm. test results promptly. Within 60 days of 1061, Rockville, MD 20852, or available the receipt of test results, the Director,

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Center for Food Safety and Applied Nu- 110.10 Personnel. trition, shall notify the person submit- 110.19 Exclusions. ting the test results whether the tests were conducted in accordance with the Subpart B—Buildings and Facilities ‘‘Analytical Methodology for Poly- 110.20 Plant and grounds. chlorinated Biphenyls; June 1979’’, 110.35 Sanitary operations. which is incorporated by reference, or 110.37 Sanitary facilities and controls. the ‘‘Test Procedures for Determina- tion of PCB Permeability of Food Subpart C—Equipment Packaging, Inner-Wraps, September 110.40 Equipment and utensils. 1976, revised May 1983’’ and whether, therefore, the barrier or class of bar- Subpart D [Reserved] riers is deemed functional within the meaning of paragraph (c) of this sec- Subpart E—Production and Process tion. The test results and any response Controls of the Food and Drug Administration 110.80 Processes and controls. shall be placed on file with the Division 110.93 Warehousing and distribution. of Dockets Management, Food and Drug Administration, 5630 Fishers Subpart F [Reserved] Lane, rm. 1061, Rockville, MD 20852. Subpart G—Defect Action Levels [42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29, 1979; 46 FR 8459, Jan. 27, 110.110 Natural or unavoidable defects in 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021, food for human use that present no Aug. 16, 1983; 54 FR 24892, June 12, 1989; 59 FR health hazard. 14364, Mar. 28, 1994; 61 FR 14480, Apr. 2, 1996; AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 66 FR 56035, Nov. 6, 2001] 264. EFFECTIVE DATE NOTE: At 38 FR 22794, Aug. 24, 1973, the following appeared concerning SOURCE: 51 FR 22475, June 19, 1986, unless § 109.30(a)(9) (formerly 122.10(a)(9)): otherwise noted. * * * § 109.30(a)(9) is hereby stayed pending EDITORIAL NOTE: Nomenclature changes to full review of the objections and requests for part 110 appear at 81 FR 49896, July 29, 2016. hearing. * * * In the interim, as stated in the final order EFFECTIVE DATE NOTE: At 80 FR 56144, (38 FR 18098) the Food and Drug Administra- Sept. 17, 2015, part 110 was removed, effective tion will enforce the temporary tolerance Sept. 17, 2018. level established by § 109.30(a)(9) by seizing any paper food-packaging material shipped Subpart A—General Provisions in interstate commerce after September 4, 1973 containing higher than the specified § 110.3 Definitions. level of PCB’s as adulterated in violation of sec. 402 of the act. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) Subpart C—Regulatory Limits for are applicable to such terms when used Added Poisonous or Delete- in this part. The following definitions rious Substances [Reserved] shall also apply: (a) Acid foods or acidified foods means Subpart D—Naturally Occurring foods that have an equilibrium pH of Posionous or Deleterious Sub- 4.6 or below. stances [Reserved] (b) Adequate means that which is needed to accomplish the intended pur- PART 110—CURRENT GOOD MAN- pose in keeping with good public health practice. UFACTURING PRACTICE IN MAN- (c) Batter means a semifluid sub- UFACTURING, PACKING, OR stance, usually composed of flour and HOLDING HUMAN FOOD other ingredients, into which principal components of food are dipped or with Subpart A—General Provisions which they are coated, or which may Sec. be used directly to form bakery foods. 110.3 Definitions. (d) Blanching, except for tree nuts 110.5 Current good manufacturing practice. and peanuts, means a prepackaging

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heat treatment of foodstuffs for a suffi- processing for reasons other than in- cient time and at a sufficient tempera- sanitary conditions or that has been ture to partially or completely inac- successfully reconditioned by reproc- tivate the naturally occurring enzymes essing and that is suitable for use as and to effect other physical or bio- food. chemical changes in the food. (n) Safe-moisture level is a level of (e) Critical control point means a point moisture low enough to prevent the in a food process where there is a high growth of undesirable microorganisms probability that improper control may in the finished product under the in- cause, allow, or contribute to a hazard tended conditions of manufacturing, or to filth in the final food or decompo- storage, and distribution. The max- sition of the final food. imum safe moisture level for a food is (f) Food means food as defined in sec- based on its water activity (aw). An aw tion 201(f) of the act and includes raw will be considered safe for a food if ade- materials and ingredients. quate data are available that dem- (g) Food-contact surfaces are those onstrate that the food at or below the surfaces that contact human food and given aw will not support the growth of those surfaces from which drainage undesirable microorganisms. onto the food or onto surfaces that (o) Sanitize means to adequately treat contact the food ordinarily occurs dur- food-contact surfaces by a process that ing the normal course of operations. is effective in destroying vegetative ‘‘Food-contact surfaces’’ includes uten- cells of microorganisms of public sils and food-contact surfaces of equip- health significance, and in substan- ment. tially reducing numbers of other unde- (h) Lot means the food produced dur- sirable microorganisms, but without ing a period of time indicated by a spe- adversely affecting the product or its cific code. safety for the consumer. (i) Microorganisms means yeasts, (p) Shall is used to state mandatory molds, bacteria, and viruses and in- requirements. cludes, but is not limited to, species (q) Should is used to state rec- having public health significance. The ommended or advisory procedures or term ‘‘undesirable microorganisms’’ in- identify recommended equipment. cludes those microorganisms that are (r) Water activity (aw) is a measure of of public health significance, that sub- the free moisture in a food and is the ject food to decomposition, that indi- quotient of the water vapor pressure of cate that food is contaminated with the substance divided by the vapor filth, or that otherwise may cause food pressure of pure water at the same to be adulterated within the meaning temperature. of the act. Occasionally in these regulations, FDA used the adjective ‘‘mi- § 110.5 Current good manufacturing crobial’’ instead of using an adjectival practice. phrase containing the word microorga- (a) The criteria and definitions in nism. this part shall apply in determining (j) Pest refers to any objectionable whether a food is adulterated (1) within animals or insects including, but not the meaning of section 402(a)(3) of the limited to, birds, rodents, flies, and lar- act in that the food has been manufac- vae. tured under such conditions that it is (k) Plant means the building or facil- unfit for food; or (2) within the mean- ity or parts thereof, used for or in con- ing of section 402(a)(4) of the act in nection with the manufacturing, pack- that the food has been prepared, aging, labeling, or holding of human packed, or held under insanitary condi- food. tions whereby it may have become con- (l) Quality control operation means a taminated with filth, or whereby it planned and systematic procedure for may have been rendered injurious to taking all actions necessary to prevent health. The criteria and definitions in food from being adulterated within the this part also apply in determining meaning of the act. whether a food is in violation of sec- (m) Rework means clean, unadulter- tion 361 of the Public Health Service ated food that has been removed from Act (42 U.S.C. 264).

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(b) Food covered by specific current and sanitary condition and which effec- good manufacturing practice regula- tively protects against the contamina- tions also is subject to the require- tion by these objects of the food, food- ments of those regulations. contact surfaces, or food-packaging materials. § 110.10 Personnel. (5) Maintaining gloves, if they are The plant management shall take all used in food handling, in an intact, reasonable measures and precautions clean, and sanitary condition. The to ensure the following: gloves should be of an impermeable (a) Disease control. Any person who, material. by medical examination or supervisory (6) Wearing, where appropriate, in an observation, is shown to have, or ap- effective manner, hair nets, headbands, pears to have, an illness, open lesion, caps, beard covers, or other effective including boils, sores, or infected hair restraints. wounds, or any other abnormal source (7) Storing clothing or other personal of microbial contamination by which belongings in areas other than where there is a reasonable possibility of food is exposed or where equipment or food, food-contact surfaces, or food- utensils are washed. packaging materials becoming con- (8) Confining the following to areas taminated, shall be excluded from any other than where food may be exposed operations which may be expected to or where equipment or utensils are result in such contamination until the washed: eating food, chewing gum, condition is corrected. Personnel shall drinking beverages, or using tobacco. be instructed to report such health (9) Taking any other necessary pre- conditions to their supervisors. cautions to protect against contamina- (b) Cleanliness. All persons working in tion of food, food-contact surfaces, or direct contact with food, food-contact food-packaging materials with micro- surfaces, and food-packaging materials organisms or foreign substances includ- shall conform to hygienic practices ing, but not limited to, perspiration, while on duty to the extent necessary hair, cosmetics, tobacco, chemicals, to protect against contamination of and medicines applied to the skin. food. The methods for maintaining (c) Education and training. Personnel cleanliness include, but are not limited responsible for identifying sanitation to: failures or food contamination should (1) Wearing outer garments suitable have a background of education or ex- to the operation in a manner that pro- perience, or a combination thereof, to tects against the contamination of provide a level of competency nec- food, food-contact surfaces, or food- essary for production of clean and safe packaging materials. food. Food handlers and supervisors (2) Maintaining adequate personal should receive appropriate training in cleanliness. proper food handling techniques and (3) Washing hands thoroughly (and food-protection principles and should sanitizing if necessary to protect be informed of the danger of poor per- against contamination with undesir- sonal hygiene and insanitary practices. able microorganisms) in an adequate (d) Supervision. Responsibility for as- hand-washing facility before starting suring compliance by all personnel work, after each absence from the work with all requirements of this part shall station, and at any other time when be clearly assigned to competent super- the hands may have become soiled or visory personnel. contaminated. [51 FR 22475, June 19, 1986, as amended at 54 (4) Removing all unsecured jewelry FR 24892, June 12, 1989] and other objects that might fall into food, equipment, or containers, and re- § 110.19 Exclusions. moving hand jewelry that cannot be (a) The following operations are not adequately sanitized during periods in subject to this part: Establishments which food is manipulated by hand. If engaged solely in the harvesting, stor- such hand jewelry cannot be removed, age, or distribution of one or more it may be covered by material which ‘‘raw agricultural commodities,’’ as de- can be maintained in an intact, clean, fined in section 201(r) of the act, which

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are ordinarily cleaned, prepared, treat- (2) Permit the taking of proper pre- ed, or otherwise processed before being cautions to reduce the potential for marketed to the consuming public. contamination of food, food-contact (b) FDA, however, will issue special surfaces, or food-packaging materials regulations if it is necessary to cover with microorganisms, chemicals, filth, these excluded operations. or other extraneous material. The potential for contamination may be re- Subpart B—Buildings and Facilities duced by adequate food safety controls and operating practices or effective de- § 110.20 Plant and grounds. sign, including the separation of oper- (a) Grounds. The grounds about a food ations in which contamination is likely plant under the control of the operator to occur, by one or more of the fol- shall be kept in a condition that will lowing means: location, time, parti- protect against the contamination of tion, air flow, enclosed systems, or food. The methods for adequate main- other effective means. tenance of grounds include, but are not (3) Permit the taking of proper pre- limited to: cautions to protect food in outdoor (1) Properly storing equipment, re- bulk fermentation vessels by any effec- moving litter and waste, and cutting tive means, including: weeds or grass within the immediate (i) Using protective coverings. vicinity of the plant buildings or struc- (ii) Controlling areas over and around tures that may constitute an attract- the vessels to eliminate harborages for ant, breeding place, or harborage for pests. pests. (iii) Checking on a regular basis for (2) Maintaining roads, yards, and parking lots so that they do not con- pests and pest infestation. stitute a source of contamination in (iv) Skimming the fermentation ves- areas where food is exposed. sels, as necessary. (3) Adequately draining areas that (4) Be constructed in such a manner may contribute contamination to food that floors, walls, and ceilings may be by seepage, foot-borne filth, or pro- adequately cleaned and kept clean and viding a breeding place for pests. kept in good repair; that drip or con- (4) Operating systems for waste densate from fixtures, ducts and pipes treatment and disposal in an adequate does not contaminate food, food-con- manner so that they do not constitute tact surfaces, or food-packaging mate- a source of contamination in areas rials; and that aisles or working spaces where food is exposed. are provided between equipment and walls and are adequately unobstructed If the plant grounds are bordered by and of adequate width to permit em- grounds not under the operator’s con- ployees to perform their duties and to trol and not maintained in the manner protect against contaminating food or described in paragraph (a) (1) through food-contact surfaces with clothing or (3) of this section, care shall be exercised in the plant by inspection, exter- personal contact. mination, or other means to exclude (5) Provide adequate lighting in pests, dirt, and filth that may be a hand-washing areas, dressing and lock- source of food contamination. er rooms, and toilet rooms and in all (b) Plant construction and design. areas where food is examined, proc- Plant buildings and structures shall be essed, or stored and where equipment suitable in size, construction, and de- or utensils are cleaned; and provide sign to facilitate maintenance and san- safety-type light bulbs, fixtures, sky- itary operations for food-manufac- lights, or other glass suspended over turing purposes. The plant and facili- exposed food in any step of preparation ties shall: or otherwise protect against food con- (1) Provide sufficient space for such tamination in case of glass breakage. placement of equipment and storage of (6) Provide adequate ventilation or materials as is necessary for the main- control equipment to minimize odors tenance of sanitary operations and the and vapors (including steam and nox- production of safe food. ious fumes) in areas where they may

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contaminate food; and locate and oper- (c) Pest control. No pests shall be al- ate fans and other air-blowing equip- lowed in any area of a food plant. ment in a manner that minimizes the Guard or guide dogs may be allowed in potential for contaminating food, food- some areas of a plant if the presence of packaging materials, and food-contact the dogs is unlikely to result in con- surfaces. tamination of food, food-contact sur- (7) Provide, where necessary, ade- faces, or food-packaging materials. Ef- quate screening or other protection fective measures shall be taken to ex- against pests. clude pests from the processing areas and to protect against the contamina- § 110.35 Sanitary operations. tion of food on the premises by pests. (a) General maintenance. Buildings, The use of insecticides or rodenticides fixtures, and other physical facilities is permitted only under precautions of the plant shall be maintained in a and restrictions that will protect sanitary condition and shall be kept in against the contamination of food, repair sufficient to prevent food from food-contact surfaces, and food-pack- becoming adulterated within the mean- aging materials. ing of the act. Cleaning and sanitizing (d) Sanitation of food-contact surfaces. of utensils and equipment shall be con- All food-contact surfaces, including ducted in a manner that protects utensils and food-contact surfaces of against contamination of food, food- equipment, shall be cleaned as fre- contact surfaces, or food-packaging quently as necessary to protect against materials. contamination of food. (b) Substances used in cleaning and (1) Food-contact surfaces used for sanitizing; storage of toxic materials. (1) manufacturing or holding low-moisture Cleaning compounds and sanitizing food shall be in a dry, sanitary condi- agents used in cleaning and sanitizing tion at the time of use. When the sur- procedures shall be free from undesir- faces are wet-cleaned, they shall, when able microorganisms and shall be safe necessary, be sanitized and thoroughly and adequate under the conditions of dried before subsequent use. use. Compliance with this requirement (2) In wet processing, when cleaning may be verified by any effective means is necessary to protect against the in- including purchase of these substances troduction of microorganisms into under a supplier’s guarantee or certifi- food, all food-contact surfaces shall be cation, or examination of these sub- cleaned and sanitized before use and stances for contamination. Only the after any interruption during which following toxic materials may be used the food-contact surfaces may have be- or stored in a plant where food is proc- come contaminated. Where equipment essed or exposed: and utensils are used in a continuous (i) Those required to maintain clean production operation, the utensils and and sanitary conditions; food-contact surfaces of the equipment (ii) Those necessary for use in labora- shall be cleaned and sanitized as nec- tory testing procedures; essary. (iii) Those necessary for plant and (3) Non-food-contact surfaces of equipment maintenance and operation; equipment used in the operation of and food plants should be cleaned as fre- (iv) Those necessary for use in the quently as necessary to protect against plant’s operations. contamination of food. (2) Toxic cleaning compounds, sani- (4) Single-service articles (such as tizing agents, and pesticide chemicals utensils intended for one-time use, shall be identified, held, and stored in a paper cups, and paper towels) should be manner that protects against contami- stored in appropriate containers and nation of food, food-contact surfaces, shall be handled, dispensed, used, and or food-packaging materials. All rel- disposed of in a manner that protects evant regulations promulgated by against contamination of food or food- other Federal, State, and local govern- contact surfaces. ment agencies for the application, use, (5) Sanitizing agents shall be ade- or holding of these products should be quate and safe under conditions of use. followed. Any facility, procedure, or machine is

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acceptable for cleaning and sanitizing (c) Sewage disposal. Sewage disposal equipment and utensils if it is estab- shall be made into an adequate sewer- lished that the facility, procedure, or age system or disposed of through machine will routinely render equip- other adequate means. ment and utensils clean and provide (d) Toilet facilities. Each plant shall adequate cleaning and sanitizing treat- provide its employees with adequate, ment. readily accessible toilet facilities. (e) Storage and handling of cleaned Compliance with this requirement may portable equipment and utensils. Cleaned be accomplished by: and sanitized portable equipment with (1) Maintaining the facilities in a food-contact surfaces and utensils sanitary condition. should be stored in a location and man- (2) Keeping the facilities in good re- ner that protects food-contact surfaces pair at all times. from contamination. (3) Providing self-closing doors. [51 FR 22475, June 19, 1986, as amended at 54 (4) Providing doors that do not open FR 24892, June 12, 1989] into areas where food is exposed to airborne contamination, except where al- § 110.37 Sanitary facilities and con- ternate means have been taken to pro- trols. tect against such contamination (such Each plant shall be equipped with as double doors or positive air-flow sys- adequate sanitary facilities and accom- tems). modations including, but not limited (e) Hand-washing facilities. Hand- to: washing facilities shall be adequate (a) Water supply. The water supply and convenient and be furnished with shall be sufficient for the operations running water at a suitable tempera- intended and shall be derived from an ture. Compliance with this require- adequate source. Any water that con- ment may be accomplished by pro- tacts food or food-contact surfaces viding: shall be safe and of adequate sanitary (1) Hand-washing and, where appro- quality. Running water at a suitable priate, hand-sanitizing facilities at temperature, and under pressure as each location in the plant where good needed, shall be provided in all areas sanitary practices require employees where required for the processing of to wash and/or sanitize their hands. food, for the cleaning of equipment, utensils, and food-packaging materials, (2) Effective hand-cleaning and sani- or for employee sanitary facilities. tizing preparations. (b) Plumbing. Plumbing shall be of (3) Sanitary towel service or suitable adequate size and design and ade- drying devices. quately installed and maintained to: (4) Devices or fixtures, such as water (1) Carry sufficient quantities of control valves, so designed and con- water to required locations throughout structed to protect against recontami- the plant. nation of clean, sanitized hands. (2) Properly convey sewage and liquid (5) Readily understandable signs di- disposable waste from the plant. recting employees handling unpro- (3) Avoid constituting a source of tected food, unprotected food-pack- contamination to food, water supplies, aging materials, of food-contact sur- equipment, or utensils or creating an faces to wash and, where appropriate, unsanitary condition. sanitize their hands before they start (4) Provide adequate floor drainage in work, after each absence from post of all areas where floors are subject to duty, and when their hands may have flooding-type cleaning or where normal become soiled or contaminated. These operations release or discharge water signs may be posted in the processing or other liquid waste on the floor. room(s) and in all other areas where (5) Provide that there is not backflow employees may handle such food, ma- from, or cross-connection between, pip- terials, or surfaces. ing systems that discharge waste water (6) Refuse receptacles that are con- or sewage and piping systems that structed and maintained in a manner carry water for food or food manufac- that protects against contamination of turing. food.

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(f) Rubbish and offal disposal. Rubbish microorganisms shall be fitted with an and any offal shall be so conveyed, indicating thermometer, temperature- stored, and disposed of as to minimize measuring device, or temperature-re- the development of odor, minimize the cording device so installed as to show potential for the waste becoming an at- the temperature accurately within the tractant and harborage or breeding compartment, and should be fitted place for pests, and protect against with an automatic control for regu- contamination of food, food-contact lating temperature or with an auto- surfaces, water supplies, and ground matic alarm system to indicate a sig- surfaces. nificant temperature change in a manual operation. Subpart C—Equipment (f) Instruments and controls used for measuring, regulating, or recording § 110.40 Equipment and utensils. temperatures, pH, acidity, water activ- (a) All plant equipment and utensils ity, or other conditions that control or shall be so designed and of such mate- prevent the growth of undesirable rial and workmanship as to be ade- microorganisms in food shall be accu- quately cleanable, and shall be prop- rate and adequately maintained, and erly maintained. The design, construc- adequate in number for their des- tion, and use of equipment and utensils ignated uses. shall preclude the adulteration of food (g) Compressed air or other gases me- with lubricants, fuel, metal fragments, chanically introduced into food or used contaminated water, or any other con- to clean food-contact surfaces or equip- taminants. All equipment should be so ment shall be treated in such a way installed and maintained as to facilitate the cleaning of the equipment and that food is not contaminated with un- of all adjacent spaces. Food-contact lawful indirect food additives. surfaces shall be corrosion-resistant when in contact with food. They shall Subpart D [Reserved] be made of nontoxic materials and designed to withstand the environment of Subpart E—Production and their intended use and the action of Process Controls food, and, if applicable, cleaning compounds and sanitizing agents. Food- § 110.80 Processes and controls. contact surfaces shall be maintained to protect food from being contaminated All operations in the receiving, in- by any source, including unlawful indi- specting, transporting, segregating, rect food additives. preparing, manufacturing, packaging, (b) Seams on food-contact surfaces and storing of food shall be conducted shall be smoothly bonded or main- in accordance with adequate sanitation tained so as to minimize accumulation principles. Appropriate quality control of food particles, dirt, and organic mat- operations shall be employed to ensure ter and thus minimize the opportunity that food is suitable for human con- for growth of microorganisms. sumption and that food-packaging ma- (c) Equipment that is in the manu- terials are safe and suitable. Overall facturing or food-handling area and sanitation of the plant shall be under that does not come into contact with the supervision of one or more com- food shall be so constructed that it can petent individuals assigned responsi- be kept in a clean condition. bility for this function. All reasonable (d) Holding, conveying, and manufac- precautions shall be taken to ensure turing systems, including gravimetric, that production procedures do not con- pneumatic, closed, and automated sys- tribute contamination from any tems, shall be of a design and construc- source. Chemical, microbial, or extra- tion that enables them to be main- neous-material testing procedures tained in an appropriate sanitary con- shall be used where necessary to iden- dition. tify sanitation failures or possible food (e) Each freezer and cold storage contamination. All food that has be- compartment used to store and hold come contaminated to the extent that food capable of supporting growth of it is adulterated within the meaning of

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the act shall be rejected, or if permis- comply with applicable Food and Drug sible, treated or processed to eliminate Administration regulations and defect the contamination. action levels for natural or unavoidable (a) Raw materials and other ingredi- defects if a manufacturer wishes to use ents. (1) Raw materials and other ingre- the materials in manufacturing food. dients shall be inspected and seg- Compliance with this requirement may regated or otherwise handled as nec- be verified by any effective means, in- essary to ascertain that they are clean cluding purchasing the materials under and suitable for processing into food a supplier’s guarantee or certification, and shall be stored under conditions or examination of these materials for that will protect against contamina- contamination. tion and minimize deterioration. Raw (5) Raw materials, other ingredients, materials shall be washed or cleaned as and rework shall be held in bulk, or in necessary to remove soil or other con- containers designed and constructed so tamination. Water used for washing, as to protect against contamination rinsing, or conveying food shall be safe and shall be held at such temperature and of adequate sanitary quality. and relative humidity and in such a Water may be reused for washing, rins- manner as to prevent the food from being, or conveying food if it does not in- coming adulterated within the mean- crease the level of contamination of ing of the act. Material scheduled for the food. Containers and carriers of rework shall be identified as such. raw materials should be inspected on (6) Frozen raw materials and other receipt to ensure that their condition ingredients shall be kept frozen. If has not contributed to the contamina- thawing is required prior to use, it tion or deterioration of food. shall be done in a manner that pre- (2) Raw materials and other ingredi- vents the raw materials and other in- ents shall either not contain levels of gredients from becoming adulterated microorganisms that may produce food within the meaning of the act. poisoning or other disease in humans, (7) Liquid or dry raw materials and or they shall be pasteurized or otherwise treated during manufacturing op- other ingredients received and stored erations so that they no longer contain in bulk form shall be held in a manner levels that would cause the product to that protects against contamination. be adulterated within the meaning of (b) Manufacturing operations. (1) the act. Compliance with this require- Equipment and utensils and finished ment may be verified by any effective food containers shall be maintained in means, including purchasing raw mate- an acceptable condition through appro- rials and other ingredients under a sup- priate cleaning and sanitizing, as nec- plier’s guarantee or certification. essary. Insofar as necessary, equipment (3) Raw materials and other ingredi- shall be taken apart for thorough ents susceptible to contamination with cleaning. aflatoxin or other natural toxins shall (2) All food manufacturing, including comply with current Food and Drug packaging and storage, shall be con- Administration regulations and action ducted under such conditions and con- levels for poisonous or deleterious sub- trols as are necessary to minimize the stances before these materials or ingre- potential for the growth of microorga- dients are incorporated into finished nisms, or for the contamination of food. Compliance with this require- food. One way to comply with this re- ment may be accomplished by pur- quirement is careful monitoring of chasing raw materials and other ingre- physical factors such as time, tempera- dients under a supplier’s guarantee or ture, humidity, aw, pH, pressure, flow certification, or may be verified by rate, and manufacturing operations analyzing these materials and ingredi- such as freezing, dehydration, heat ents for aflatoxins and other natural processing, acidification, and refrigera- toxins. tion to ensure that mechanical break- (4) Raw materials, other ingredients, downs, time delays, temperature fluc- and rework susceptible to contamina- tuations, and other factors do not con- tion with pests, undesirable microorga- tribute to the decomposition or con- nisms, or extraneous material shall tamination of food.

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(3) Food that can support the rapid sieves, traps, magnets, electronic growth of undesirable microorganisms, metal detectors, or other suitable ef- particularly those of public health sig- fective means. nificance, shall be held in a manner (9) Food, raw materials, and other in- that prevents the food from becoming gredients that are adulterated within adulterated within the meaning of the the meaning of the act shall be dis- act. Compliance with this requirement posed of in a manner that protects may be accomplished by any effective against the contamination of other means, including: food. If the adulterated food is capable (i) Maintaining refrigerated foods at of being reconditioned, it shall be re- 45 °F (7.2 °C) or below as appropriate for conditioned using a method that has the particular food involved. been proven to be effective or it shall (ii) Maintaining frozen foods in a fro- be reexamined and found not to be zen state. adulterated within the meaning of the (iii) Maintaining hot foods at 140 °F act before being incorporated into (60 °C) or above. other food. (iv) Heat treating acid or acidified (10) Mechanical manufacturing steps foods to destroy mesophilic microorga- such as washing, peeling, trimming, nisms when those foods are to be held cutting, sorting and inspecting, mash- in hermetically sealed containers at ing, dewatering, cooling, shredding, ex- ambient temperatures. truding, drying, whipping, defatting, (4) Measures such as sterilizing, irra- and forming shall be performed so as to diating, pasteurizing, freezing, refrig- protect food against contamination. erating, controlling pH or controlling Compliance with this requirement may aw that are taken to destroy or prevent be accomplished by providing adequate the growth of undesirable microorga- physical protection of food from con- nisms, particularly those of public taminants that may drip, drain, or be health significance, shall be adequate drawn into the food. Protection may be under the conditions of manufacture, provided by adequate cleaning and handling, and distribution to prevent sanitizing of all food-contact surfaces, food from being adulterated within the and by using time and temperature meaning of the act. controls at and between each manufac- (5) Work-in-process shall be handled turing step. in a manner that protects against contamination. (11) Heat blanching, when required in (6) Effective measures shall be taken the preparation of food, should be ef- to protect finished food from contami- fected by heating the food to the re- nation by raw materials, other ingredi- quired temperature, holding it at this ents, or refuse. When raw materials, temperature for the required time, and other ingredients, or refuse are unpro- then either rapidly cooling the food or tected, they shall not be handled si- passing it to subsequent manufacturing multaneously in a receiving, loading, without delay. Thermophilic growth or shipping area if that handling could and contamination in blanchers should result in contaminated food. Food be minimized by the use of adequate transported by conveyor shall be pro- operating temperatures and by periodic tected against contamination as nec- cleaning. Where the blanched food is essary. washed prior to filling, water used (7) Equipment, containers, and uten- shall be safe and of adequate sanitary sils used to convey, hold, or store raw quality. materials, work-in-process, rework, or (12) Batters, breading, sauces, gra- food shall be constructed, handled, and vies, dressings, and other similar prep- maintained during manufacturing or arations shall be treated or maintained storage in a manner that protects in such a manner that they are pro- against contamination. tected against contamination. Compli- (8) Effective measures shall be taken ance with this requirement may be ac- to protect against the inclusion of complished by any effective means, in- metal or other extraneous material in cluding one or more of the following: food. Compliance with this require- (i) Using ingredients free of contami- ment may be accomplished by using nation.

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(ii) Employing adequate heat proc- microorganisms shall be monitored and esses where applicable. maintained at a pH of 4.6 or below. (iii) Using adequate time and tem- Compliance with this requirement may perature controls. be accomplished by any effective (iv) Providing adequate physical pro- means, including employment of one or tection of components from contami- more of the following practices: nants that may drip, drain, or be drawn (i) Monitoring the pH of raw mate- into them. rials, food in process, and finished food. (v) Cooling to an adequate tempera- (ii) Controlling the amount of acid or ture during manufacturing. acidified food added to low-acid food. (vi) Disposing of batters at appropriate intervals to protect against the (16) When ice is used in contact with growth of microorganisms. food, it shall be made from water that (13) Filling, assembling, packaging, is safe and of adequate sanitary qual- and other operations shall be per- ity, and shall be used only if it has formed in such a way that the food is been manufactured in accordance with protected against contamination. Com- current good manufacturing practice pliance with this requirement may be as outlined in this part. accomplished by any effective means, (17) Food-manufacturing areas and including: equipment used for manufacturing (i) Use of a quality control operation human food should not be used to man- in which the critical control points are ufacture nonhuman food-grade animal identified and controlled during manu- feed or inedible products, unless there facturing. is no reasonable possibility for the con- (ii) Adequate cleaning and sanitizing tamination of the human food. of all food-contact surfaces and food containers. [51 FR 22475, June 19, 1986, as amended at 65 (iii) Using materials for food con- FR 56479, Sept. 19, 2000] tainers and food- packaging materials that are safe and suitable, as defined in § 110.93 Warehousing and distribution. § 130.3(d) of this chapter. Storage and transportation of fin- (iv) Providing physical protection ished food shall be under conditions from contamination, particularly air- that will protect food against physical, borne contamination. chemical, and microbial contamination (v) Using sanitary handling proce- as well as against deterioration of the dures. food and the container. (14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies Subpart F [Reserved] on the control of aw for preventing the growth of undesirable microorganisms Subpart G—Defect Action Levels shall be processed to and maintained at a safe moisture level. Compliance with § 110.110 Natural or unavoidable de- this requirement may be accomplished fects in food for human use that by any effective means, including em- present no health hazard. ployment of one or more of the fol- (a) Some foods, even when produced lowing practices: under current good manufacturing (i) Monitoring the aw of food. practice, contain natural or unavoid- (ii) Controlling the soluble solids- able defects that at low levels are not water ratio in finished food. hazardous to health. The Food and (iii) Protecting finished food from Drug Administration establishes max- moisture pickup, by use of a moisture imum levels for these defects in foods barrier or by other means, so that the produced under current good manufac- aw of the food does not increase to an turing practice and uses these levels in unsafe level. deciding whether to recommend regu- (15) Food such as, but not limited to, latory action. acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable

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(b) Defect action levels are estab- 111.5 Do other statutory provisions and reg- lished for foods whenever it is nec- ulations apply? essary and feasible to do so. These levels are subject to change upon the de- Subpart B—Personnel velopment of new technology or the 111.8 What are the requirements under this availability of new information. subpart B for written procedures? (c) Compliance with defect action 111.10 What requirements apply for pre- levels does not excuse violation of the venting microbial contamination from requirement in section 402(a)(4) of the sick or infected personnel and for hygien- act that food not be prepared, packed, ic practices? or held under unsanitary conditions or 111.12 What personnel qualification requirements apply? the requirements in this part that food 111.13 What supervisor requirements apply? manufacturers, distributors, and hold- 111.14 Under this subpart B, what records ers shall observe current good manu- must you make and keep? facturing practice. Evidence indicating that such a violation exists causes the Subpart C—Physical Plant and Grounds food to be adulterated within the meaning of the act, even though the 111.15 What sanitation requirements apply to your physical plant and grounds? amounts of natural or unavoidable de- 111.16 What are the requirements under this fects are lower than the currently es- subpart C for written procedures? tablished defect action levels. The 111.20 What design and construction re- manufacturer, distributor, and holder quirements apply to your physical plant? of food shall at all times utilize quality 111.23 Under this subpart C, what records control operations that reduce natural must you make and keep? or unavoidable defects to the lowest level currently feasible. Subpart D—Equipment and Utensils (d) The mixing of a food containing 111.25 What are the requirements under this defects above the current defect action subpart D for written procedures? level with another lot of food is not 111.27 What requirements apply to the permitted and renders the final food equipment and utensils that you use? adulterated within the meaning of the 111.30 What requirements apply to auto- act, regardless of the defect level of the mated, mechanical, or electronic equip- final food. ment? (e) A compilation of the current de- 111.35 Under this subpart D, what records must you make and keep? fect action levels for natural or unavoidable defects in food for human use Subpart E—Requirement to Establish a that present no health hazard may be Production and Process Control System obtained upon request from the Center for Food Safety and Applied Nutrition 111.55 What are the requirements to imple- (HFS–565), Food and Drug Administra- ment a production and process control tion, 5001 Campus Dr., College Park, system? MD 20740. 111.60 What are the design requirements for the production and process control sys- [51 FR 22475, June 19, 1986, as amended at 61 tem? FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 111.65 What are the requirements for qual- 2001] ity control operations? 111.70 What specifications must you establish? PART 111—CURRENT GOOD MAN- 111.73 What is your responsibility for deter- UFACTURING PRACTICE IN MAN- mining whether established specifica- UFACTURING, PACKAGING, LA- tions are met? BELING, OR HOLDING OPER- 111.75 What must you do to determine whether specifications are met? ATIONS FOR DIETARY SUPPLE- 111.77 What must you do if established spec- MENTS ifications are not met? 111.80 What representative samples must Subpart A—General Provisions you collect? 111.83 What are the requirements for re- Sec. serve samples? 111.1 Who is subject to this part? 111.87 Who conducts a material review and 111.3 What definitions apply to this part? makes a disposition decision?

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111.90 What requirements apply to treat- 111.180 Under this subpart G, what records ments, in-process adjustments, and re- must you make and keep? processing when there is a deviation or unanticipated occurrence or when a spec- Subpart H—Production and Process Con- ification established in accordance with trol System: Requirements for the Mas- § 111.70 is not met? ter Manufacturing Record 111.95 Under this subpart E, what records must you make and keep? 111.205 What is the requirement to establish a master manufacturing record? Subpart F—Production and Process Control 111.210 What must the master manufac- System: Requirements for Quality Control turing record include?

111.103 What are the requirements under Subpart I—Production and Process Control this subpart F for written procedures? 111.105 What must quality control personnel System: Requirements for the Batch do? Production Record 111.110 What quality control operations are 111.255 What is the requirement to establish required for laboratory operations asso- a batch production record? ciated with the production and process 111.260 What must the batch record include? control system? 111.113 What quality control operations are required for a material review and dis- Subpart J—Production and Process Control position decision? System: Requirements for Laboratory 111.117 What quality control operations are Operations required for equipment, instruments, and controls? 111.303 What are the requirements under 111.120 What quality control operations are this subpart J for written procedures? required for components, packaging, and 111.310 What are the requirements for the labels before use in the manufacture of a laboratory facilities that you use? dietary supplement? 111.315 What are the requirements for lab- 111.123 What quality control operations are oratory control processes? required for the master manufacturing 111.320 What requirements apply to labora- record, the batch production record, and tory methods for testing and examina- manufacturing operations? tion? 111.127 What quality control operations are 111.325 Under this subpart J, what records required for packaging and labeling oper- must you make and keep? ations? 111.130 What quality control operations are Subpart K—Production and Process Control required for returned dietary supple- System: Requirements for Manufac- ments? turing Operations 111.135 What quality control operations are required for product complaints? 111.353 What are the requirements under 111.140 Under this subpart F, what records this subpart K for written procedures? must you make and keep? 111.355 What are the design requirements for manufacturing operations? Subpart G—Production and Process Con- 111.360 What are the requirements for sani- trol System: Requirements for Compo- tation? nents, Packaging, and Labels and for 111.365 What precautions must you take to Product That You Receive for Pack- prevent contamination? aging or Labeling as a Dietary Supple- 111.370 What requirements apply to rejected dietary supplements? ment 111.375 Under this subpart K, what records 111.153 What are the requirements under must you make and keep? this subpart G for written procedures? 111.155 What requirements apply to compo- Subpart L—Production and Process Control nents of dietary supplements? System: Requirements for Packaging 111.160 What requirements apply to pack- and Labeling Operations aging and labels received? 111.165 What requirements apply to a prod- 111.403 What are the requirements under uct received for packaging or labeling as this subpart L for written procedures? a dietary supplement (and for distribu- 111.410 What requirements apply to pack- tion rather than for return to the sup- aging and labels? plier)? 111.415 What requirements apply to filling, 111.170 What requirements apply to rejected assembling, packaging, labeling, and re- components, packaging, and labels, and lated operations? to rejected products that are received for 111.420 What requirements apply to repack- packaging or labeling as a dietary sup- aging and relabeling? plement? 274

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111.425 What requirements apply to a pack- Subpart A—General Provisions aged and labeled dietary supplement that is rejected for distribution? § 111.1 Who is subject to this part? 111.430 Under this subpart L, what records must you make and keep? (a) Except as provided by paragraph (b) of this section, you are subject to Subpart M—Holding and Distributing this part if you manufacture, package, label, or hold a dietary supplement, in- 111.453 What are the requirements under cluding: this subpart M for written procedures? (1) A dietary supplement you manu- 111.455 What requirements apply to holding facture but that is packaged or labeled components, dietary supplements, pack- by another person; and aging, and labels? (2) A dietary supplement imported or 111.460 What requirements apply to holding offered for import in any State or terri- in-process material? tory of the United States, the District 111.465 What requirements apply to holding of Columbia, or the Commonwealth of reserve samples of dietary supplements? Puerto Rico. 111.470 What requirements apply to distrib- (b) The requirements pertaining to uting dietary supplements? holding dietary supplements do not 111.475 Under this subpart M, what records must you make and keep? apply to you if you are holding those dietary supplements at a retail estab- Subpart N—Returned Dietary Supplements lishment for the sole purpose of direct retail sale to individual consumers. A 111.503 What are the requirements under retail establishment does not include a this subpart N for written procedures? warehouse or other storage facility for 111.510 What requirements apply when a re- a retailer or a warehouse or other stor- turned dietary supplement is received? age facility that sells directly to indi- 111.515 When must a returned dietary sup- vidual consumers. plement be destroyed, or otherwise suitably disposed of? § 111.3 What definitions apply to this 111.520 When may a returned dietary supple- part? ment be salvaged? 111.525 What requirements apply to a re- The definitions and interpretations turned dietary supplement that quality of terms in section 201 of the Federal control personnel approve for reprocess- Food, Drug, and Cosmetic Act (the act) ing? apply to such terms when used in this 111.530 When must an investigation be con- part. For the purpose of this part, the ducted of your manufacturing processes following definitions also apply: and other batches? Actual yield means the quantity that 111.535 Under this subpart N, what records is actually produced at any appropriate must you make and keep? step of manufacture or packaging of a particular dietary supplement. Subpart O—Product Complaints Batch means a specific quantity of a 111.553 What are the requirements under dietary supplement that is uniform, this subpart O for written procedures? that is intended to meet specifications 111.560 What requirements apply to the re- for identity, purity, strength, and com- view and investigation of a product composition, and that is produced during a plaint? specified time period according to a 111.570 Under this subpart O, what records single manufacturing record during the must you make and keep? same cycle of manufacture. Batch number, lot number, or control Subpart P—Records and Recordkeeping number means any distinctive group of letters, numbers, or symbols, or any 111.605 What requirements apply to the combination of them, from which the records that you make and keep? 111.610 What records must be made avail- complete history of the manufacturing, able to FDA? packaging, labeling, and/or holding of a batch or lot of dietary supplements can AUTHORITY: 21 U.S.C. 321, 342, 343, 371, 374, be determined. 381, 393; 42 U.S.C. 264. Component means any substance in- SOURCE: 72 FR 34942, June 25, 2007, unless tended for use in the manufacture of a otherwise noted. dietary supplement, including those

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that may not appear in the finished Pest means any objectionable insect batch of the dietary supplement. Com- or other animal including birds, ro- ponent includes dietary ingredients (as dents, flies, mites, and larvae. described in section 201(ff) of the act) Physical plant means all or any part and other ingredients. of a building or facility used for or in Contact surface means any surface connection with manufacturing, pack- that contacts a component or dietary aging, labeling, or holding a dietary supplement, and those surfaces from supplement. which drainage onto the component or Product complaint means any commu- dietary supplement, or onto surfaces nication that contains any allegation, that contact the component or dietary written, electronic, or oral, expressing supplement, occurs during the normal course of operations. Examples of con- concern, for any reason, with the qual- tact surfaces include containers, uten- ity of a dietary supplement, that could sils, tables, contact surfaces of equip- be related to current good manufac- ment, and packaging. turing practice. Examples of product Ingredient means any substance that complaints are: Foul odor, off taste, ill- is used in the manufacture of a dietary ness or injury, disintegration time, supplement and that is intended to be color variation, tablet size or size vari- present in the finished batch of the die- ation, under-filled container, foreign tary supplement. An ingredient in- material in a dietary supplement concludes, but is not necessarily limited tainer, improper packaging, to, a dietary ingredient as defined in mislabeling, or dietary supplements section 201(ff) of the act. that are superpotent, subpotent, or In-process material means any mate- contain the wrong ingredient, or con- rial that is fabricated, compounded, tain a drug or other contaminant (e.g., blended, ground, extracted, sifted, bacteria, pesticide, mycotoxin, glass, sterilized, derived by chemical reac- lead). tion, or processed in any other way for Quality means that the dietary sup- use in the manufacture of a dietary plement consistently meets the estab- supplement. lished specifications for identity, pu- Lot means a batch, or a specific iden- rity, strength, and composition, and tified portion of a batch, that is uni- limits on contaminants, and has been form and that is intended to meet spec- manufactured, packaged, labeled, and ifications for identity, purity, strength, and composition; or, in the held under conditions to prevent adul- case of a dietary supplement produced teration under section 402(a)(1), (a)(2), by continuous process, a specific iden- (a)(3), and (a)(4) of the act. tified amount produced in a specified Quality control means a planned and unit of time or quantity in a manner systematic operation or procedure for that is uniform and that is intended to ensuring the quality of a dietary sup- meet specifications for identity, pu- plement. rity, strength, and composition. Quality control personnel means any Microorganisms means yeasts, molds, person, persons, or group, within or bacteria, viruses, and other similar mi- outside of your organization, who you croscopic organisms having public designate to be responsible for your health or sanitary concern. This defini- quality control operations. tion includes species that: Representative sample means a sample (1) May have public health signifi- that consists of an adequate number of cance; units that are drawn based on rational (2) May cause a component or dietary criteria, such as random sampling, and supplement to decompose; that are intended to ensure that the (3) Indicate that the component or di- sample accurately portrays the mate- etary supplement is contaminated with rial being sampled. filth; or (4) Otherwise may cause the compo- Reprocessing means using, in the nent or dietary supplement to be adul- manufacture of a dietary supplement, terated. clean, uncontaminated components or Must is used to state a requirement. dietary supplements that have been

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previously removed from manufac- § 111.10 What requirements apply for turing and that have been made suit- preventing microbial contamination able for use in the manufacture of a di- from sick or infected personnel and etary supplement. for hygienic practices? Reserve sample means a representa- (a) Preventing microbial contamination. tive sample of product that is held for You must take measures to exclude a designated period of time. from any operations any person who Sanitize means to adequately treat might be a source of microbial con- cleaned equipment, containers, uten- tamination, due to a health condition, sils, or any other cleaned contact sur- where such contamination may occur, face by a process that is effective in de- of any material, including components, stroying vegetative cells of microorga- dietary supplements, and contact sur- nisms of public health significance, and faces used in the manufacture, pack- in substantially reducing numbers of aging, labeling, or holding of a dietary other microorganisms, but without ad- supplement. Such measures include the versely affecting the product or its following: safety for the consumer. (1) Excluding from working in any Theoretical yield means the quantity operations that may result in contami- that would be produced at any appro- nation any person who, by medical ex- priate step of manufacture or pack- amination, the person’s acknowledge- aging of a particular dietary supplement, or supervisory observation, is ment, based upon the quantity of com- shown to have, or appears to have, an ponents or packaging to be used, in the illness, infection, open lesion, or any absence of any loss or error in actual other abnormal source of microbial production. contamination, that could result in mi- Water activity (aw) is a measure of the crobial contamination of components, free moisture in a component or die- dietary supplements, or contact sur- tary supplement and is the quotient of faces, until the health condition no the water vapor pressure of the sub- longer exists; and stance divided by the vapor pressure of (2) Instructing your employees to no- pure water at the same temperature. tify their supervisor(s) if they have or We means the U.S. Food and Drug if there is a reasonable possibility that Administration (FDA). they have a health condition described You means a person who manufac- in paragraph (a)(1) of this section that tures, packages, labels, or holds die- could result in microbial contamina- tary supplements. tion of any components, dietary sup- § 111.5 Do other statutory provisions plements, or any contact surface. and regulations apply? (b) Hygienic practices. If you work in an operation during which adulteration In addition to this part, you must of the component, dietary supplement, comply with other applicable statutory or contact surface could occur, you provisions and regulations under the must use hygienic practices to the exact related to dietary supplements. For tent necessary to protect against such importers of dietary supplements and contamination of components, dietary dietary supplement components, the supplements, or contact surfaces. regulation on foreign supplier These hygienic practices include the verification programs can be found in following: subpart L of part 1 of this chapter. (1) Wearing outer garments in a man- [72 FR 34942, June 25, 2007, as amended at 80 ner that protects against the contami- FR 74352, Nov. 27, 2015] nation of components, dietary supplements, or any contact surface; Subpart B—Personnel (2) Maintaining adequate personal cleanliness; § 111.8 What are the requirements (3) Washing hands thoroughly (and under this subpart B for written sanitizing if necessary to protect procedures? against contamination with microorga- You must establish and follow writ- nisms) in an adequate hand-washing fa- ten procedures for fulfilling the re- cility: quirements of this subpart. (i) Before starting work; and

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(ii) At any time when the hands may person otherwise has when not per- have become soiled or contaminated; forming such operations. (4) Removing all unsecured jewelry (c) Each person engaged in manufac- and other objects that might fall into turing, packaging, labeling, or holding, components, dietary supplements, or in performing any quality control equipment, or packaging, and removing operations, must have the education, hand jewelry that cannot be ade- training, or experience to perform the quately sanitized during periods in person’s assigned functions. which components or dietary supplements are manipulated by hand. If § 111.13 What supervisor requirements hand jewelry cannot be removed, it apply? must be covered by material that is (a) You must assign qualified per- maintained in an intact, clean, and sonnel to supervise the manufacturing, sanitary condition and that effectively packaging, labeling, or holding of die- protects against contamination of tary supplements. components, dietary supplements, or (b) Each supervisor whom you use contact surfaces; must be qualified by education, train- (5) Maintaining gloves used in han- ing, or experience to supervise. dling components or dietary supplements in an intact, clean, and sanitary § 111.14 Under this subpart B, what condition. The gloves must be of an im- records must you make and keep? permeable material; (a) You must make and keep records (6) Wearing, where appropriate, in an required under this subpart B in ac- effective manner, hair nets, caps, beard cordance with subpart P of this part. covers, or other effective hair re- (b) You must make and keep the fol- straints; lowing records: (7) Not storing clothing or other per- (1) Written procedures for fulfilling sonal belongings in areas where compo- the requirements of this subpart B; and nents, dietary supplements, or any con- (2) Documentation of training, intact surfaces are exposed or where concluding the date of the training, the tact surfaces are washed; type of training, and the person(s) (8) Not eating food, chewing gum, trained. drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact Subpart C—Physical Plant and surfaces are exposed, or where contact Grounds surfaces are washed; and (9) Taking any other precautions nec- § 111.15 What sanitation requirements essary to protect against the contami- apply to your physical plant and grounds? nation of components, dietary supplements, or contact surfaces with micro- (a) Grounds. You must keep the organisms, filth, or any other extra- grounds of your physical plant in a neous materials, including perspira- condition that protects against the tion, hair, cosmetics, tobacco, chemi- contamination of components, dietary cals, and medicines applied to the skin. supplements, or contact surfaces. The methods for adequate ground mainte- § 111.12 What personnel qualification nance include: requirements apply? (1) Properly storing equipment, re- (a) You must have qualified employ- moving litter and waste, and cutting ees who manufacture, package, label, weeds or grass within the immediate or hold dietary supplements. vicinity of the physical plant so that it (b) You must identify who is respon- does not attract pests, harbor pests, or sible for your quality control oper- provide pests a place for breeding; ations. Each person who is identified to (2) Maintaining roads, yards, and perform quality control operations parking lots so that they do not con- must be qualified to do so and have dis- stitute a source of contamination in tinct and separate responsibilities re- areas where components, dietary sup- lated to performing such operations plements, or contact surfaces are ex- from those responsibilities that the posed;

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(3) Adequately draining areas that your physical plant. Guard or guide may contribute to the contamination dogs are allowed in some areas of your of components, dietary supplements, or physical plant if the presence of the contact surfaces by seepage, filth or dogs will not result in contamination any other extraneous materials, or by of components, dietary supplements, or providing a breeding place for pests; contact surfaces; (4) Adequately operating systems for (2) You must take effective measures waste treatment and disposal so that to exclude pests from the physical they do not constitute a source of con- plant and to protect against contami- tamination in areas where components, nation of components, dietary supple- dietary supplements, or contact sur- ments, and contact surfaces on the faces are exposed; and premises by pests; and (5) If your plant grounds are bordered (3) You must not use insecticides, fu- by grounds not under your control, and migants, fungicides, or rodenticides, if those other grounds are not main- unless you take precautions to protect tained in the manner described in this against the contamination of compo- section, you must exercise care in the nents, dietary supplements, or contact plant by inspection, extermination, or surfaces. other means to exclude pests, dirt, and (e) Water supply. (1) You must provide filth or any other extraneous materials water that is safe and sanitary, at suit- that may be a source of contamination. able temperatures, and under pressure (b) Physical plant facilities. (1) You as needed, for all uses where water does must maintain your physical plant in a not become a component of the dietary clean and sanitary condition; and supplement. (2) You must maintain your physical (2) Water that is used in a manner plant in repair sufficient to prevent such that the water may become a components, dietary supplements, or component of the dietary supplement, contact surfaces from becoming con- e.g., when such water contacts compo- taminated. nents, dietary supplements, or any con- (c) Cleaning compounds, sanitizing tact surface, must, at a minimum, agents, pesticides, and other toxic mate- comply with applicable Federal, State, rials. (1) You must use cleaning com- and local requirements and not con- pounds and sanitizing agents that are taminate the dietary supplement. free from microorganisms of public (f) Plumbing. The plumbing in your health significance and that are safe physical plant must be of an adequate and adequate under the conditions of size and design and be adequately in- use. stalled and maintained to: (2) You must not use or hold toxic (1) Carry sufficient amounts of water materials in a physical plant in which to required locations throughout the components, dietary supplements, or physical plant; contact surfaces are manufactured or (2) Properly convey sewage and liquid exposed, unless those materials are disposable waste from your physical necessary as follows: plant; (i) To maintain clean and sanitary (3) Avoid being a source of contami- conditions; nation to components, dietary supple- (ii) For use in laboratory testing pro- ments, water supplies, or any contact cedures; surface, or creating an unsanitary con- (iii) For maintaining or operating the dition; physical plant or equipment; or (4) Provide adequate floor drainage in (iv) For use in the plant’s operations. all areas where floors are subject to (3) You must identify and hold clean- flooding-type cleaning or where normal ing compounds, sanitizing agents, pes- operations release or discharge water ticides, pesticide chemicals, and other or other liquid waste on the floor; and toxic materials in a manner that pro- (5) Not allow backflow from, or cross tects against contamination of compo- connection between, piping systems nents, dietary supplements, or contact that discharge waste water or sewage surfaces. and piping systems that carry water (d) Pest control. (1) You must not used for manufacturing dietary supple- allow animals or pests in any area of ments, for cleaning contact surfaces, or

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for use in bathrooms or hand-washing (a) Be suitable in size, construction, facilities. and design to facilitate maintenance, (g) Sewage disposal. You must dispose cleaning, and sanitizing operations; of sewage into an adequate sewage sys- (b) Have adequate space for the or- tem or through other adequate means. derly placement of equipment and (h) Bathrooms. You must provide your holding of materials as is necessary for employees with adequate, readily ac- maintenance, cleaning, and sanitizing cessible bathrooms. The bathrooms operations and to prevent contamina- must be kept clean and must not be a tion and mixups of components and di- potential source of contamination to etary supplements during manufac- components, dietary supplements, or turing, packaging, labeling, or holding; contact surfaces. (c) Permit the use of proper pre- (i) Hand-washing facilities. You must cautions to reduce the potential for provide hand-washing facilities that mixups or contamination of compo- are designed to ensure that an employ- nents, dietary supplements, or contact ee’s hands are not a source of contami- surfaces, with microorganisms, chemi- nation of components, dietary supple- cals, filth, or other extraneous mate- ments, or any contact surface, by pro- rial. Your physical plant must have, viding facilities that are adequate, con- and you must use, separate or defined venient, and furnish running water at a areas of adequate size or other control suitable temperature. systems, such as computerized inven- (j) Trash disposal. You must convey, tory controls or automated systems of store, and dispose of trash to: separation, to prevent contamination and mixups of components and dietary (1) Minimize the development of supplements during the following oper- odors; ations: (2) Minimize the potential for the (1) Receiving, identifying, holding, trash to attract, harbor, or become a and withholding from use, components, breeding place for pests; dietary supplements, packaging, and (3) Protect against contamination of labels that will be used in or during the components, dietary supplements, any manufacturing, packaging, labeling, or contact surface, water supplies, and holding of dietary supplements; grounds surrounding your physical (2) Separating, as necessary, compo- plant; and nents, dietary supplements, packaging, (4) Control hazardous waste to pre- and labels that are to be used in manu- vent contamination of components, di- facturing from components, dietary etary supplements, and contact sur- supplements, packaging, or labels that faces. are awaiting material review and dis- (k) Sanitation supervisors. You must position decision, reprocessing, or are assign one or more employees to super- awaiting disposal after rejection; vise overall sanitation. Each of these (3) Separating the manufacturing, supervisors must be qualified by edu- packaging, labeling, and holding of dif- cation, training, or experience to de- ferent product types including dif- velop and supervise sanitation proce- ferent types of dietary supplements dures. and other foods, cosmetics, and phar- maceutical products; § 111.16 What are the requirements (4) Performing laboratory analyses under this subpart C for written and holding laboratory supplies and procedures? samples; You must establish and follow writ- (5) Cleaning and sanitizing contact ten procedures for cleaning the phys- surfaces; ical plant and for pest control. (6) Packaging and label operations; and § 111.20 What design and construction (7) Holding components or dietary requirements apply to your phys- supplements. ical plant? (d) Be designed and constructed in a Any physical plant you use in the manner that prevents contamination of manufacture, packaging, labeling, or components, dietary supplements, or holding of dietary supplements must: contact surfaces.

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(1) The design and construction must breakage of glass or glass-like mate- include: rials. (i) Floors, walls, and ceilings that (g) Provide effective protection can be adequately cleaned and kept against contamination of components clean and in good repair; and dietary supplements in bulk fer- (ii) Fixtures, ducts, and pipes that do mentation vessels, by, for example: not contaminate components, dietary (1) Use of protective coverings; supplements, or contact surfaces by (2) Placement in areas where you can dripping or other leakage, or conden- eliminate harborages for pests over and sate; around the vessels; (iii) Adequate ventilation or environ- (3) Placement in areas where you can mental control equipment such as air- check regularly for pests, pest infesta- flow systems, including filters, fans, tion, filth or any other extraneous ma- and other air-blowing equipment, that terials; and minimize odors and vapors (including (4) Use of skimming equipment. steam and noxious fumes) in areas (h) Use adequate screening or other where they may contaminate compo- protection against pests, where nec- nents, dietary supplements, or contact essary. surfaces; (iv) Equipment that controls tem- § 111.23 Under this subpart C, what perature and humidity, when such records must you make and keep? equipment is necessary to ensure the (a) You must make and keep records quality of the dietary supplement; and required under this subpart C in ac- (v) Aisles or working spaces between cordance with subpart P of this part. equipment and walls that are ade- (b) You must make and keep records quately unobstructed and of adequate of the written procedures for cleaning width to permit all persons to perform the physical plant and for pest control. their duties and to protect against contamination of components, dietary sup- (c) You must make and keep records plements, or contact surfaces with that show that water, when used in a clothing or personal contact. manner such that the water may become a component of the dietary sup- (2) When fans and other air-blowing equipment are used, such fans and plement, meets the requirements of equipment must be located and oper- § 111.15(e)(2). ated in a manner that minimizes the potential for microorganisms and par- Subpart D—Equipment and ticulate matter to contaminate compo- Utensils nents, dietary supplements, or contact surfaces; § 111.25 What are the requirements (e) Provide adequate light in: under this subpart D for written procedures? (1) All areas where components or dietary supplements are examined, proc- You must establish and follow writ- essed, or held; ten procedures for fulfilling the re- (2) All areas where contact surfaces quirements of this subpart D, including are cleaned; and written procedures for: (3) Hand-washing areas, dressing and (a) Calibrating instruments and con- locker rooms, and bathrooms. trols that you use in manufacturing or (f) Use safety-type light bulbs, fix- testing a component or dietary supple- tures, skylights, or other glass or ment; glass-like materials when the light (b) Calibrating, inspecting, and bulbs, fixtures, skylights or other glass checking automated, mechanical, and or glass-like materials are suspended electronic equipment; and over exposed components or dietary (c) Maintaining, cleaning, and sani- supplements in any step of preparation, tizing, as necessary, all equipment, unless your physical plant is otherwise utensils, and any other contact sur- constructed in a manner that will pro- faces that are used to manufacture, tect against contamination of compo- package, label, or hold components or nents or dietary supplements in case of dietary supplements.

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§ 111.27 What requirements apply to (5) Each freezer, refrigerator, and the equipment and utensils that other cold storage compartment you you use? use to hold components or dietary sup- (a) You must use equipment and plements: utensils that are of appropriate design, (i) Must be fitted with an indicating construction, and workmanship to en- thermometer, temperature-measuring able them to be suitable for their in- device, or temperature-recording de- tended use and to be adequately vice that indicates and records, or al- cleaned and properly maintained. lows for recording by hand, the tem- (1) Equipment and utensils include perature accurately within the com- the following: partment; and (i) Equipment used to hold or convey; (ii) Must have an automated device (ii) Equipment used to measure; for regulating temperature or an auto- (iii) Equipment using compressed air mated alarm system to indicate a sig- or gas; nificant temperature change in a man- (iv) Equipment used to carry out ual operation. processes in closed pipes and vessels; (6) Instruments or controls used in and the manufacturing, packaging, label- (v) Equipment used in automated, ing, or holding of a dietary supplement, mechanical, or electronic systems. and instruments or controls that you (2) You must use equipment and use to measure, regulate, or record utensils of appropriate design and con- temperatures, hydrogen-ion concentra- struction so that use will not result in tion (pH), water activity, or other con- the contamination of components or ditions, to control or prevent the dietary supplements with: growth of microorganisms or other (i) Lubricants; contamination must be: (ii) Fuel; (i) Accurate and precise; (iii) Coolants; (ii) Adequately maintained; and (iv) Metal or glass fragments; (iii) Adequate in number for their (v) Filth or any other extraneous ma- designated uses. terial; (7) Compressed air or other gases you (vi) Contaminated water; or introduce mechanically into or onto a (vii) Any other contaminants. component, dietary supplement, or (3) All equipment and utensils you contact surface or that you use to use must be: clean any contact surface must be (i) Installed and maintained to facili- treated in such a way that the compo- tate cleaning the equipment, utensils, nent, dietary supplement, or contact and all adjacent spaces; surface is not contaminated. (ii) Corrosion-resistant if the equip- (b) You must calibrate instruments ment or utensils contact components and controls you use in manufacturing or dietary supplements; or testing a component or dietary sup- (iii) Made of nontoxic materials; plement. You must calibrate: (iv) Designed and constructed to (1) Before first use; and withstand the environment in which (2) At the frequency specified in writ- they are used, the action of compo- ing by the manufacturer of the instru- nents or dietary supplements, and, if ment and control; or applicable, cleaning compounds and (3) At routine intervals or as other- sanitizing agents; and wise necessary to ensure the accuracy (v) Maintained to protect compo- and precision of the instrument and nents and dietary supplements from control. being contaminated by any source. (c) You must repair or replace instru- (4) Equipment and utensils you use ments or controls that cannot be ad- must have seams that are smoothly justed to agree with the reference bonded or maintained to minimize ac- standard. cumulation of dirt, filth, organic mate- (d) You must maintain, clean, and rial, particles of components or dietary sanitize, as necessary, all equipment, supplements, or any other extraneous utensils, and any other contact sur- materials or contaminants. faces used to manufacture, package,

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label, or hold components or dietary § 111.30 What requirements apply to supplements. automated, mechanical, or elec- (1) Equipment and utensils must be tronic equipment? taken apart as necessary for thorough For any automated, mechanical, or maintenance, cleaning, and sanitizing. electronic equipment that you use to (2) You must ensure that all contact manufacture, package, label, or hold a surfaces, used for manufacturing or dietary supplement, you must: holding low-moisture components or (a) Design or select equipment to en- dietary supplements, are in a dry and sure that dietary supplement specifica- sanitary condition when in use. When tions are consistently met; the surfaces are wet-cleaned, they (b) Determine the suitability of the must be sanitized, when necessary, and equipment by ensuring that your thoroughly dried before subsequent equipment is capable of operating sat- use. isfactorily within the operating limits (3) If you use wet processing during required by the process; manufacturing, you must clean and (c) Routinely calibrate, inspect, or sanitize all contact surfaces, as nec- check the equipment to ensure proper essary, to protect against the introduc- performance. Your quality control per- tion of microorganisms into compo- sonnel must periodically review these nents or dietary supplements. When calibrations, inspections, or checks; cleaning and sanitizing is necessary, (d) Establish and use appropriate you must clean and sanitize all contact controls for automated, mechanical, surfaces before use and after any inter- and electronic equipment (including ruption during which the contact sur- software for a computer controlled face may have become contaminated. If process) to ensure that any changes to you use contact surfaces in a contin- the manufacturing, packaging, label- uous production operation or in con- ing, holding, or other operations are secutive operations involving different approved by quality control personnel batches of the same dietary supple- and instituted only by authorized per- ment, you must adequately clean and sonnel; and sanitize the contact surfaces, as nec- (e) Establish and use appropriate con- essary. trols to ensure that the equipment (4) You must clean surfaces that do functions in accordance with its in- not come into direct contact with com- tended use. These controls must be ap- ponents or dietary supplements as fre- proved by quality control personnel. quently as necessary to protect against contaminating components or dietary § 111.35 Under this subpart D, what supplements. records must you make and keep? (5) Single-service articles (such as (a) You must make and keep records utensils intended for one-time use, required under this subpart D in ac- paper cups, and paper towels) must be: cordance with subpart P of this part. (i) Stored in appropriate containers; (b) You must make and keep the fol- and lowing records: (ii) Handled, dispensed, used, and dis- (1) Written procedures for fulfilling posed of in a manner that protects the requirements of this subpart, in- against contamination of components, cluding written procedures for: dietary supplements, or any contact (i) Calibrating instruments and con- surface. trols that you use in manufacturing or (6) Cleaning compounds and sani- testing a component or dietary supple- tizing agents must be adequate for ment; their intended use and safe under their (ii) Calibrating, inspecting, and conditions of use; checking automated, mechanical, and (7) You must store cleaned and sani- electronic equipment; and tized portable equipment and utensils (iii) Maintaining, cleaning, and sani- that have contact surfaces in a loca- tizing, as necessary, all equipment, tion and manner that protects them utensils, and any other contact sur- from contamination. faces that are used to manufacture, [72 FR 34942, June 25, 2007, as amended at 73 package, label, or hold components or FR 13124, Mar. 12, 2008] dietary supplements;

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(2) Documentation, in individual Subpart E—Requirement to Estab- equipment logs, of the date of the use, lish a Production and Process maintenance, cleaning, and sanitizing of equipment, unless such documenta- Control System tion is kept with the batch record; § 111.55 What are the requirements to (3) Documentation of any calibration, implement a production and proc- each time the calibration is performed, ess control system? for instruments and controls that you use in manufacturing or testing a com- You must implement a system of proponent or dietary supplement. In your duction and process controls that cov- documentation, you must: ers all stages of manufacturing, pack- (i) Identify the instrument or control aging, labeling, and holding of the die- calibrated; tary supplement to ensure the quality (ii) Provide the date of calibration; of the dietary supplement and that the (iii) Identify the reference standard dietary supplement is packaged and la- used including the certification of ac- beled as specified in the master manu- curacy of the known reference standard facturing record. and a history of recertification of accuracy; § 111.60 What are the design require- (iv) Identify the calibration method ments for the production and process control system? used, including appropriate limits for accuracy and precision of instruments (a) Your production and in-process and controls when calibrating; control system must be designed to en- (v) Provide the calibration reading or sure that the dietary supplement is readings found; manufactured, packaged, labeled, and (vi) Identify the recalibration meth- held in a manner that will ensure the od used, and reading or readings found, quality of the dietary supplement and if accuracy or precision or both accu- that the dietary supplement is pack- racy and precision limits for instru- aged and labeled as specified in the ments and controls were not met; and master manufacturing record; and (vii) Include the initials of the person (b) The production and in-process who performed the calibration and any control system must include all re- recalibration. quirements of subparts E through L of (4) Written records of calibrations, this part and must be reviewed and ap- inspections, and checks of automated, proved by quality control personnel. mechanical, and electronic equipment; (5) Backup file(s) of current software § 111.65 What are the requirements for programs (and of outdated software quality control operations? that is necessary to retrieve records You must implement quality control that you are required to keep in ac- operations in your manufacturing, cordance with subpart P of this part, packaging, labeling, and holding oper- when current software is not able to re- ations for producing the dietary sup- trieve such records) and of data entered plement to ensure the quality of the di- into computer systems that you use to manufacture, package, label, or hold etary supplement and that the dietary dietary supplements. supplement is packaged and labeled as (i) Your backup file (e.g., a hard copy specified in the master manufacturing of data you have entered, diskettes, record. tapes, microfilm, or compact disks) must be an exact and complete record § 111.70 What specifications must you establish? of the data you entered. (ii) You must keep your backup soft- (a) You must establish a specification ware programs and data secure from al- for any point, step, or stage in the terations, inadvertent erasures, or loss; manufacturing process where control is and necessary to ensure the quality of the (6) Documentation of the controls dietary supplement and that the die- that you use to ensure that equipment tary supplement is packaged and la- functions in accordance with its in- beled as specified in the master manu- tended use. facturing record.

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(b) For each component that you use (e) For each dietary supplement that in the manufacture of a dietary supple- you manufacture you must establish ment, you must establish component product specifications for the identity, specifications as follows: purity, strength, and composition of (1) You must establish an identity the finished batch of the dietary sup- specification; plement, and for limits on those types (2) You must establish component of contamination that may adulterate, specifications that are necessary to en- or that may lead to adulteration of, sure that specifications for the purity, the finished batch of the dietary sup- strength and composition of dietary plement to ensure the quality of the di- supplements manufactured using the etary supplement. components are met; and (f) If you receive a product from a (3) You must establish limits on supplier for packaging or labeling as a those types of contamination that may dietary supplement (and for distribu- adulterate or may lead to adulteration tion rather than for return to the sup- of the finished batch of the dietary supplier), you must establish specifica- plement to ensure the quality of the ditions to provide sufficient assurance etary supplement. that the product you receive is adequately identified and is consistent (c) For the in-process production: with your purchase order. (1) You must establish in-process (g) You must establish specifications specifications for any point, step, or for the packaging and labeling of the stage in the master manufacturing finished packaged and labeled dietary record where control is necessary to supplements, including specifications help ensure that specifications are met that ensure that you used the specified for the identity, purity, strength, and packaging and that you applied the composition of the dietary supplements specified label. and, as necessary, for limits on those types of contamination that may adul- § 111.73 What is your responsibility for terate or may lead to adulteration of determining whether established the finished batch of the dietary sup- specifications are met? plement; You must determine whether the (2) You must provide adequate docu- specifications you establish under mentation of your basis for why meet- § 111.70 are met. ing the in-process specifications, in combination with meeting component § 111.75 What must you do to deter- specifications, will help ensure that the mine whether specifications are specifications are met for the identity, met? purity, strength, and composition of (a) Before you use a component, you the dietary supplements and for limits must: on those types of contamination that (1)(i) Conduct at least one appro- may adulterate or may lead to adulter- priate test or examination to verify the ation of the finished batch of the die- identity of any component that is a di- tary supplement; and etary ingredient, unless you petition (3) Quality control personnel must the agency under paragraph (a)(1)(ii) of review and approve the documentation this section and the agency exempts that you provide under paragraph (c)(2) you from such testing; of this section. (ii) You may submit a petition, under (d) You must establish specifications 21 CFR 10.30, to request an exemption for dietary supplement labels (label from the testing requirements in para- specifications) and for packaging that graph (a)(1)(i) of this section. The peti- may come in contact with dietary sup- tion must set forth the scientific ra- plements (packaging specifications). tionale, and must be accompanied by Packaging that may come into contact the supporting data and information, with dietary supplements must be safe for proposed alternative testing that and suitable for its intended use and will demonstrate that there is no mate- must not be reactive or absorptive or rial diminution of assurance, compared otherwise affect the safety or quality to the assurance provided by 100 per- of the dietary supplement. cent identity testing, of the identity of

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the dietary ingredient before use when adulteration of the finished batch of the dietary ingredient is obtained from the dietary supplement. To do so: one or more suppliers identified in the (1) You must select one or more es- petition. If FDA grants the petition, tablished specifications for identity, you must conduct the tests and exami- purity, strength, composition, and the nations for the dietary ingredient, oth- limits on those types of contamination erwise required under § 111.75(a)(1)(i), that may adulterate or that may lead under the terms specified by FDA when to adulteration of the dietary supple- the petition is granted; and ment that, if tested or examined on the (2) Confirm the identity of other finished batches of the dietary supple- components and determine whether ment, would verify that the production other applicable component specifica- and process control system is pro- tions established in accordance with ducing a dietary supplement that § 111.70(b) are met. To do so, you must meets all product specifications (or either: only those product specifications not (i) Conduct appropriate tests or ex- otherwise exempted from this provision aminations; or by quality control personnel under (ii) Rely on a certificate of analysis paragraph (d) of this section); from the supplier of the component (2) You must conduct appropriate that you receive, provided that: tests or examinations to determine (A) You first qualify the supplier by compliance with the specifications se- establishing the reliability of the sup- lected in paragraph (c)(1) of this sec- plier’s certificate of analysis through tion; confirmation of the results of the sup- (3) You must provide adequate docu- plier’s tests or examinations; mentation of your basis for deter- (B) The certificate of analysis in- mining that compliance with the speci- cludes a description of the test or ex- fication(s) selected under paragraph amination method(s) used, limits of (c)(1) of this section, through the use of the test or examinations, and actual appropriate tests or examinations con- results of the tests or examinations; ducted under paragraph (c)(2) of this (C) You maintain documentation of section, will ensure that your finished how you qualified the supplier; batch of the dietary supplement meets (D) You periodically re-confirm the all product specifications for identity, supplier’s certificate of analysis; and purity, strength, and composition, and (E) Your quality control personnel the limits on those types of contamina- review and approve the documentation tion that may adulterate, or that may setting forth the basis for qualification lead to the adulteration of, the dietary (and re-qualification) of any supplier. supplement; and (b) You must monitor the in-process (4) Your quality control personnel points, steps, or stages where control is must review and approve the docu- necessary to ensure the quality of the mentation that you provide under finished batch of dietary supplement paragraph (c)(3) of this section. to: (d)(1) You may exempt one or more (1) Determine whether the in-process product specifications from specifications are met; and verification requirements in paragraph (2) Detect any deviation or unantici- (c)(1) of this section if you determine pated occurrence that may result in a and document that the specifications failure to meet specifications. you select under paragraph (c)(1) of (c) For a subset of finished dietary this section for determination of com- supplement batches that you identify pliance with specifications are not able through a sound statistical sampling to verify that the production and proc- plan (or for every finished batch), you ess control system is producing a die- must verify that your finished batch of tary supplement that meets the ex- the dietary supplement meets product empted product specification and there specifications for identity, purity, is no scientifically valid method for strength, composition, and for limits testing or examining such exempted on those types of contamination that product specification at the finished may adulterate or that may lead to batch stage. In such a case, you must

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document why, for example, any com- (i) You must establish corrective ac- ponent and in-process testing, exam- tion plans for use when an established ination, or monitoring, and any other specification is not met. information, will ensure that such ex- [72 FR 34942, June 25, 2007, as amended at 72 empted product specification is met FR 34968, June 25, 2007; 73 FR 27727, May 14, without verification through periodic 2008] testing of the finished batch; and (2) Your quality control personnel § 111.77 What must you do if estab- must review and approve the docu- lished specifications are not met? mentation that you provide under (a) For specifications established paragraph (d)(1) of this section. under § 111.70(a), (b)(2), (b)(3), (c), (d), (e) Before you package or label a (e), and (g) that you do not meet, qual- product that you receive for packaging ity control personnel, in accordance or labeling as a dietary supplement with the requirements in subpart F of (and for distribution rather than for re- this part, must reject the component, turn to the supplier), you must vis- dietary supplement, package or label ually examine the product and have unless such personnel approve a treat- documentation to determine whether ment, an in-process adjustment, or re- the specifications that you established processing that will ensure the quality under § 111.70 (f) are met. of the finished dietary supplement and that the dietary supplement is pack- (f)(1) Before you use packaging, you aged and labeled as specified in the must, at a minimum, conduct a visual master manufacturing record. No fin- identification of the containers and ished batch of dietary supplements closures and review the supplier’s in- may be released for distribution unless voice, guarantee, or certification to de- it complies with § 111.123(b). termine whether the packaging speci- (b) For specifications established fications are met; and under § 111.70(b)(1) that you do not (2) Before you use labels, you must, meet, quality control personnel must at a minimum, conduct a visual exam- reject the component and the compo- ination of the label and review the sup- nent must not be used in manufac- plier’s invoice, guarantee, or certifi- turing the dietary supplement. cation to determine whether label (c) For specifications established specifications are met. under § 111.70(f) that you do not meet, (g) You must, at a minimum, conduct quality control personnel must reject a visual examination of the packaging the product and the product may not and labeling of the finished packaged be packaged or labeled for distribution and labeled dietary supplements to de- as a dietary supplement. termine whether you used the specified packaging and applied the specified § 111.80 What representative samples must you collect? label. (h)(1) You must ensure that the tests The representative samples that you and examinations that you use to de- must collect include: termine whether the specifications are (a) Representative samples of each met are appropriate, scientifically unique lot of components, packaging, valid methods. and labels that you use to determine (2) The tests and examinations that whether the components, packaging, you use must include at least one of and labels meet specifications established in accordance with § 111.70(b) and the following: (d), and as applicable, § 111.70(a) (and, (i) Gross organoleptic analysis; when you receive components, pack- (ii) Macroscopic analysis; aging, or labels from a supplier, rep- (iii) Microscopic analysis; resentative samples of each unique (iv) Chemical analysis; or shipment, and of each unique lot with- (v) Other scientifically valid meth- in each unique shipment); ods. (b) Representative samples of in- process materials for each manufactured batch at points, steps, or stages,

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in the manufacturing process as speci- (2) Be identified with the batch, lot, fied in the master manufacturing or control number; record where control is necessary to (3) Be retained for 1 year past the ensure the identity, purity, strength, shelf life date (if shelf life dating is and composition of dietary supple- used), or for 2 years from the date of ments to determine whether the in- distribution of the last batch of dietary process materials meet specifications supplements associated with the re- established in accordance with serve sample, for use in appropriate in- § 111.70(c), and as applicable, § 111.70(a); vestigations; and (c) Representative samples of a sub- (4) Consist of at least twice the quan- set of finished batches of each dietary tity necessary for all tests or examina- supplement that you manufacture, tions to determine whether or not the which you identify through a sound dietary supplement meets product statistical sampling plan (or otherwise specifications. every finished batch), before releasing for distribution to verify that the fin- § 111.87 Who conducts a material re- ished batch of dietary supplement view and makes a disposition decision? meets product specifications established in accordance with § 111.70(e), Quality control personnel must con- and as applicable, § 111.70(a); duct all required material reviews and (d) Representative samples of each make all required disposition deci- unique shipment, and of each unique sions. lot within each unique shipment, of product that you receive for packaging § 111.90 What requirements apply to treatments, in-process adjustments, or labeling as a dietary supplement and reprocessing when there is a (and for distribution rather than for re- deviation or unanticipated occur- turn to the supplier) to determine rence or when a specification estab- whether the received product meets lished in accordance with § 111.70 is specifications established in accord- not met? ance with § 111.70(f), and as applicable, (a) You must not reprocess a rejected § 111.70(a); and dietary supplement or treat or provide (e) Representative samples of each an in-process adjustment to a compo- lot of packaged and labeled dietary nent, packaging, or label to make it supplements to determine whether the suitable for use in the manufacture of packaging and labeling of the finished a dietary supplement unless: packaged and labeled dietary supple- (1) Quality control personnel conduct ments meet specifications established a material review and make a disposi- in accordance with § 111.70(g), and as tion decision to approve the reprocess- applicable, § 111.70(a). ing, treatment, or in-process adjustment; and § 111.83 What are the requirements for (2) The reprocessing, treatment, or reserve samples? in-process adjustment is permitted by (a) You must collect and hold reserve § 111.77; samples of each lot of packaged and la- (b) You must not reprocess any die- beled dietary supplements that you dis- tary supplement or treat or provide an tribute. in-process adjustment to a component (b) The reserve samples must: to make it suitable for use in the man- (1) Be held using the same container- ufacture of a dietary supplement, un- closure system in which the packaged less: and labeled dietary supplement is dis- (1) Quality control personnel conduct tributed, or if distributing dietary sup- a material review and make a disposi- plements to be packaged and labeled, tion decision that is based on a sci- using a container-closure system that entifically valid reason and approves provides essentially the same charac- the reprocessing, treatment, or in-proc- teristics to protect against contamina- ess adjustment; and tion or deterioration as the one in (2) The reprocessing, treatment or in- which it is distributed for packaging process adjustment is permitted by and labeling elsewhere; § 111.77;

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(c) Any batch of dietary supplement (6) Documentation of FDA’s response that is reprocessed, that contains com- to a petition submitted under ponents that you have treated, or to § 111.75(a)(1)(ii) providing for an exemp- which you have made in-process adjust- tion from the provisions of ments to make them suitable for use in § 111.75(a)(1)(i). the manufacture of the dietary supple- [72 FR 34942, June 25, 2007, as amended at 72 ment must be approved by quality con- FR 34968, June 25, 2007] trol personnel and comply with § 111.123(b) before releasing for distribu- Subpart F—Production and Proc- tion. ess Control System: Require- § 111.95 Under this subpart E, what ments for Quality Control records must you make and keep? § 111.103 What are the requirements (a) You must make and keep records under this subpart F for written required under this subpart E in ac- procedures? cordance with subpart P of this part. You must establish and follow writ- (b) Under this subpart E, you must ten procedures for the responsibilities make and keep the following records: of the quality control operations, in- (1) The specifications established; cluding written procedures for con- (2) Documentation of your qualifica- ducting a material review and making tion of a supplier for the purpose of re- a disposition decision, and for approv- lying on the supplier’s certificate of ing or rejecting any reprocessing. analysis; § 111.105 What must quality control (3) Documentation for why meeting personnel do? in-process specifications, in combination with meeting component speci- Quality control personnel must en- fications, helps ensure that the dietary sure that your manufacturing, pack- supplement meets the specifications aging, labeling, and holding operations ensure the quality of the dietary sup- for identity, purity, strength, and com- plement and that the dietary supple- position; and for limits on those types ment is packaged and labeled as speci- of contamination that may adulterate fied in the master manufacturing or may lead to adulteration of the fin- record. To do so, quality control per- ished batch of the dietary supplement; sonnel must perform operations that and include: (4) Documentation for why the re- (a) Approving or rejecting all proc- sults of appropriate tests or examina- esses, specifications, written proce- tions for the product specifications se- dures, controls, tests, and examina- lected under § 111.75(c)(1) ensure that tions, and deviations from or modifica- the dietary supplement meets all prod- tions to them, that may affect the uct specifications; identity, purity, strength, or composi- (5) Documentation for why any com- tion of a dietary supplement; ponent and in-process testing, exam- (b) Reviewing and approving the doc- ination, or monitoring, and any other umentation setting forth the basis for information, will ensure that a product qualification of any supplier; specification that is exempted under (c) Reviewing and approving the doc- § 111.75(d) is met without verification umentation setting forth the basis for through periodic testing of the finished why meeting in-process specifications, batch, including documentation that in combination with meeting compo- the selected specifications tested or ex- nent specifications, will help ensure amined under § 111.75 (c)(1) are not able that the identity, purity, strength, and to verify that the production and proc- composition of the dietary supplement ess control system is producing a die- are met; tary supplement that meets the ex- (d) Reviewing and approving the doc- empted product specification and there umentation setting forth the basis for is no scientifically valid method for why the results of appropriate tests or testing or examining such exempted examinations for each product speci- product specification at the finished fication selected under § 111.75(c)(1) will batch stage. ensure that the finished batch of the

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dietary supplement meets product adulteration of the component, dietary specifications; supplement, or packaging, or could (e) Reviewing and approving the basis lead to the use of a label not specified and the documentation for why any in the master manufacturing record; product specification is exempted from (4) Calibration of an instrument or the verification requirements in control suggests a problem that may § 111.75(c)(1), and for why any compo- have resulted in a failure to ensure the nent and in-process testing, examina- quality of a batch or batches of a die- tion, or monitoring, or other methods tary supplement; or will ensure that such exempted product (5) A dietary supplement is returned. specification is met without (b)(1) When there is a deviation or verification through periodic testing of unanticipated occurrence during the the finished batch; production and in-process control sys- (f) Ensuring that required representative samples are collected; tem that results in or could lead to (g) Ensuring that required reserve adulteration of a component, dietary samples are collected and held; supplement, or packaging, or could (h) Determining whether all speci- lead to the use of a label not specified fications established under § 111.70(a) in the master manufacturing record, are met; and quality control personnel must reject (i) Performing other operations re- the component, dietary supplement, quired under this subpart. packaging, or label unless it approves a treatment, an in-process adjustment, § 111.110 What quality control oper- or reprocessing to correct the applica- ations are required for laboratory ble deviation or occurrence. operations associated with the pro- (2) When a specification established duction and process control sys- in accordance with § 111.70 is not met, tem? quality control personnel must reject Quality control operations for lab- the component, dietary supplement, oratory operations associated with the package or label, unless quality control production and process control system personnel approve a treatment, an in- must include: process adjustment, or reprocessing, as (a) Reviewing and approving all lab- permitted in § 111.77. oratory control processes associated (c) The person who conducts a mate- with the production and process con- rial review and makes the disposition trol system; decision must, at the time of perform- (b) Ensuring that all tests and exami- ance, document that material review nations required under § 111.75 are con- and disposition decision. ducted; and (c) Reviewing and approving the re- § 111.117 What quality control oper- sults of all tests and examinations re- ations are required for equipment, quired under § 111.75. instruments, and controls? § 111.113 What quality control oper- Quality control operations for equip- ations are required for a material ment, instruments, and controls must review and disposition decision? include: (a) Quality control personnel must (a) Reviewing and approving all proc- conduct a material review and make a esses for calibrating instruments and disposition decision if: controls; (1) A specification established in ac- (b) Periodically reviewing all records cordance with § 111.70 is not met; for calibration of instruments and con- (2) A batch deviates from the master trols; manufacturing record, including when (c) Periodically reviewing all records any step established in the master for calibrations, inspections, and manufacturing record is not completed checks of automated, mechanical, or and including any deviation from spec- electronic equipment; and ifications; (d) Reviewing and approving controls (3) There is any unanticipated occur- to ensure that automated, mechanical, rence during the manufacturing oper- or electronic equipment functions in ations that adulterates or may lead to accordance with its intended use.

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§ 111.120 What quality control oper- (b) Quality control personnel must ations are required for components, not approve and release for distribu- packaging, and labels before use in tion: the manufacture of a dietary sup- (1) Any batch of dietary supplement plement? for which any component in the batch Quality control operations for com- does not meet its identity specifica- ponents, packaging, and labels before tion; use in the manufacture of a dietary (2) Any batch of dietary supplement, supplement must include: including any reprocessed batch, that (a) Reviewing all receiving records does not meet all product specifica- for components, packaging, and labels; (b) Determining whether all compo- tions established in accordance with nents, packaging, and labels conform § 111.70(e); to specifications established under (3) Any batch of dietary supplement, § 111.70 (b) and (d); including any reprocessed batch, that (c) Conducting any required material has not been manufactured, packaged, review and making any required dis- labeled, and held under conditions to position decision; prevent adulteration under section (d) Approving or rejecting any treat- 402(a)(1), (a)(2), (a)(3), and (a)(4) of the ment and in-process adjustments of act; and components, packaging, or labels to (4) Any product received from a sup- make them suitable for use in the man- plier for packaging or labeling as a die- ufacture of a dietary supplement; and tary supplement (and for distribution (e) Approving, and releasing from rather than for return to the supplier) quarantine, all components, packaging, for which sufficient assurance is not and labels before they are used. provided to adequately identify the § 111.123 What quality control oper- product and to determine that the ations are required for the master product is consistent with your pur- manufacturing record, the batch chase order. production record, and manufacturing operations? § 111.127 What quality control oper- (a) Quality control operations for the ations are required for packaging master manufacturing record, the and labeling operations? batch production record, and manufac- Quality control operations for pack- turing operations must include: aging and labeling operations must in- (1) Reviewing and approving all mas- clude: ter manufacturing records and all (a) Reviewing the results of any vis- modifications to the master manufac- ual examination and documentation to turing records; ensure that specifications established (2) Reviewing and approving all batch under § 111.70(f) are met for all products production-related records; that you receive for packaging and la- (3) Reviewing all monitoring required beling as a dietary supplement (and for under subpart E; distribution rather than for return to (4) Conducting any required material the supplier); review and making any required dis- (b) Approving, and releasing from position decision; quarantine, all products that you re- (5) Approving or rejecting any reprocessing; ceive for packaging or labeling as a di- (6) Determining whether all in-proc- etary supplement (and for distribution ess specifications established in ac- rather than for return to the supplier) cordance with § 111.70(c) are met; before they are used for packaging or (7) Determining whether each fin- labeling; ished batch conforms to product speci- (c) Reviewing and approving all fications established in accordance records for packaging and label oper- with § 111.70(e); and ations; (8) Approving and releasing, or re- (d) Determining whether the finished jecting, each finished batch for dis- packaged and labeled dietary supple- tribution, including any reprocessed ment conforms to specifications estab- finished batch. lished in accordance with § 111.70(g);

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(e) Conducting any required material § 111.140 Under this subpart F, what review and making any required dis- records must you make and keep? position decision; (a) You must make and keep the (f) Approving or rejecting any re- records required under this subpart F packaging of a packaged dietary sup- in accordance with subpart P of this plement; part. (g) Approving or rejecting any re- (b) You must make and keep the fol- labeling of a packaged and labeled die- lowing records: tary supplement; and (1) Written procedures for the respon- (h) Approving for release, or reject- sibilities of the quality control oper- ing, any packaged and labeled dietary ations, including written procedures supplement (including a repackaged or for conducting a material review and relabeled dietary supplement) for dis- making a disposition decision and writ- tribution. ten procedures for approving or rejecting any reprocessing; § 111.130 What quality control oper- (2) Written documentation, at the ations are required for returned di- time of performance, that quality con- etary supplements? trol personnel performed the review, Quality control operations for re- approval, or rejection requirements by turned dietary supplements must in- recording the following: clude: (i) Date that the review, approval, or rejection was performed; and (a) Conducting any required material (ii) Signature of the person per- review and making any required dis- forming the review, approval, or rejec- position decision; including: tion; and (1) Determining whether tests or ex- (3) Documentation of any material amination are necessary to determine review and disposition decision and fol- compliance with product specifications lowup. Such documentation must be established in accordance with included in the appropriate batch pro- § 111.70(e); and duction record and must include: (2) Reviewing the results of any tests (i) Identification of the specific devi- or examinations that are conducted to ation or the unanticipated occurrence; determine compliance with product (ii) Description of your investigation specifications established in accord- into the cause of the deviation from ance with § 111.70(e); the specification or the unanticipated (b) Approving or rejecting any sal- occurrence; vage and redistribution of any returned (iii) Evaluation of whether or not the dietary supplement; deviation or unanticipated occurrence (c) Approving or rejecting any re- has resulted in or could lead to a fail- processing of any returned dietary sup- ure to ensure the quality of the dietary plement; and supplement or a failure to package and (d) Determining whether the reproc- label the dietary supplement as speci- essed dietary supplement meets prod- fied in the master manufacturing uct specifications and either approving record; for release, or rejecting, any returned (iv) Identification of the action(s) dietary supplement that is reprocessed. taken to correct, and prevent a recurrence of, the deviation or the unantici- § 111.135 What quality control oper- pated occurrence; ations are required for product (v) Explanation of what you did with complaints? the component, dietary supplement, packaging, or label; Quality control operations for prod- (vi) A scientifically valid reason for uct complaints must include reviewing any reprocessing of a dietary supple- and approving decisions about whether ment that is rejected or any treatment to investigate a product complaint and or in-process adjustment of a compo- reviewing and approving the findings nent that is rejected; and and followup action of any investiga- (vii) The signature of the indi- tion performed. vidual(s) designated to perform the

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quality control operation, who con- manufacture of a dietary supplement, ducted the material review and made and releases them from quarantine. the disposition decision, and of each (d)(1) You must identify each unique qualified individual who provides infor- lot within each unique shipment of mation relevant to that material re- components that you receive and any view and disposition decision. lot of components that you produce in a manner that allows you to trace the Subpart G—Production and Proc- lot to the supplier, the date received, ess Control System: Require- the name of the component, the status ments for Components, Pack- of the component (e.g., quarantined, approved, or rejected); and to the die- aging, and Labels and for tary supplement that you manufac- Product That You Receive for tured and distributed. Packaging or Labeling as a (2) You must use this unique identi- Dietary Supplement fier whenever you record the disposition of each unique lot within each § 111.153 What are the requirements unique shipment of components that under this subpart G for written you receive and any lot of components procedures? that you produce. You must establish and follow writ- (e) You must hold components under ten procedures for fulfilling the re- conditions that will protect against quirements of this subpart G. contamination and deterioration, and avoid mixups. § 111.155 What requirements apply to components of dietary supple- § 111.160 What requirements apply to ments? packaging and labels received? (a) You must visually examine each (a) You must visually examine each immediate container or grouping of immediate container or grouping of immediate containers in a shipment immediate containers in a shipment that you receive for appropriate con- for appropriate content label, content label, container damage, or bro- tainer damage, or broken seals to de- ken seals to determine whether the termine whether the container condi- container condition may have resulted tion may have resulted in contamina- in contamination or deterioration of tion or deterioration of the packaging the components; and labels. (b) You must visually examine the (b) You must visually examine the supplier’s invoice, guarantee, or cer- supplier’s invoice, guarantee, or certification in a shipment you receive to tification in a shipment to ensure that ensure the components are consistent the packaging or labels are consistent with your purchase order; with your purchase order. (c) You must quarantine components (c) You must quarantine packaging before you use them in the manufac- and labels before you use them in the ture of a dietary supplement until: manufacture of a dietary supplement (1) You collect representative sam- until: ples of each unique lot of components (1) You collect representative sam- (and, for components that you receive, ples of each unique shipment, and of of each unique shipment, and of each each unique lot within each unique unique lot within each unique ship- shipment, of packaging and labels and, ment); at a minimum, conduct a visual identi- (2) Quality control personnel review fication of the immediate containers and approve the results of any tests or and closures; examinations conducted on compo- (2) Quality control personnel review nents; and and approve the results of any tests or (3) Quality control personnel approve examinations conducted on the pack- the components for use in the manufac- aging and labels; and ture of a dietary supplement, including (3) Quality control personnel approve approval of any treatment (including the packaging and labels for use in the in-process adjustments) of components manufacture of a dietary supplement to make them suitable for use in the and release them from quarantine.

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(d)(1) You must identify each unique (d)(1) You must identify each unique lot within each unique shipment of lot within each unique shipment of repackaging and labels in a manner that ceived product in a manner that allows allows you to trace the lot to the sup- you to trace the lot to the supplier, the plier, the date received, the name of date received, the name of the received the packaging and label, the status of product, the status of the received the packaging and label (e.g., quar- product (e.g., quarantined, approved, or antined, approved, or rejected); and to rejected), and to the product that you the dietary supplement that you dis- packaged or labeled and distributed as tributed; and a dietary supplement. (2) You must use this unique identi- (2) You must use this unique identifier whenever you record the disposi- fier whenever you record the disposition of each unique lot within each tion of each unique lot within each unique shipment of packaging and la- unique shipment of the received prod- bels. uct. (e) You must hold packaging and la- (e) You must hold the received prod- bels under conditions that will protect uct under conditions that will protect against contamination and deteriora- against contamination and deterioration, and avoid mixups. tion, and avoid mixups.

§ 111.165 What requirements apply to a § 111.170 What requirements apply to product received for packaging or rejected components, packaging, labeling as a dietary supplement and labels, and to rejected products (and for distribution rather than that are received for packaging or for return to the supplier)? labeling as a dietary supplement? (a) You must visually examine each You must clearly identify, hold, and immediate container or grouping of control under a quarantine system for immediate containers in a shipment of appropriate disposition any compo- product that you receive for packaging nent, packaging, and label, and any or labeling as a dietary supplement product that you receive for packaging (and for distribution rather than for re- or labeling as a dietary supplement turn to the supplier) for appropriate (and for distribution rather than for re- content label, container damage, or turn to the supplier), that is rejected broken seals to determine whether the and unsuitable for use in manufac- container condition may have resulted turing, packaging, or labeling oper- in contamination or deterioration of ations. the received product. (b) You must visually examine the § 111.180 Under this subpart G, what supplier’s invoice, guarantee, or cer- records must you make and keep? tification in a shipment of the received (a) You must make and keep records product to ensure that the received required under this subpart G in ac- product is consistent with your pur- cordance with subpart P of this part. chase order. (b) You must make and keep the fol- (c) You must quarantine the received lowing records: product until: (1) Written procedures for fulfilling (1) You collect representative sam- the requirements of this subpart. ples of each unique shipment, and of (2) Receiving records (including each unique lot within each unique records such as certificates of analysis, shipment, of received product; suppliers’ invoices, and suppliers’ guar- (2) Quality control personnel review antees) for components, packaging, and and approve the documentation to de- labels and for products that you re- termine whether the received product ceive for packaging or labeling as a di- meets the specifications that you es- etary supplement (and for distribution tablished under § 111.70(f); and rather than for return to the supplier); (3) Quality control personnel approve and the received product for packaging or (3) Documentation that the require- labeling as a dietary supplement and ments of this subpart were met. release the received product from quar- (i) The person who performs the re- antine. quired operation must document, at

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the time of performance, that the re- § 111.210 What must the master manu- quired operation was performed. facturing record include? (ii) The documentation must include: The master manufacturing record (A) The date that the components, must include: packaging, labels, or products that you (a) The name of the dietary supple- receive for packaging or labeling as a ment to be manufactured and the dietary supplement were received; strength, concentration, weight, or (B) The initials of the person per- measure of each dietary ingredient for forming the required operation; each batch size; (C) The results of any tests or exami- (b) A complete list of components to nations conducted on components, be used; packaging, or labels, and of any visual (c) An accurate statement of the examination of product that you re- weight or measure of each component ceive for packaging or labeling as a di- to be used; etary supplement; and (d) The identity and weight or meas- (D) Any material review and disposi- ure of each dietary ingredient that will tion decision conducted on compo- be declared on the Supplement Facts nents, packaging, labels, or products label and the identity of each ingre- that you receive for packaging or la- dient that will be declared on the ingredients list of the dietary supple- beling as a dietary supplement. ment; (e) A statement of any intentional Subpart H—Production and Proc- overage amount of a dietary ingre- ess Control System: Require- dient; ments for the Master Manu- (f) A statement of theoretical yield of facturing Record a manufactured dietary supplement expected at each point, step, or stage of § 111.205 What is the requirement to the manufacturing process where con- establish a master manufacturing trol is needed to ensure the quality of record? the dietary supplement, and the ex- (a) You must prepare and follow a pected yield when you finish manufac- written master manufacturing record turing the dietary supplement, includ- for each unique formulation of dietary ing the maximum and minimum per- supplement that you manufacture, and centages of theoretical yield beyond which a deviation investigation of a for each batch size, to ensure uni- batch is necessary and material review formity in the finished batch from is conducted and disposition decision is batch to batch. made; (b) The master manufacturing record (g) A description of packaging and a must: representative label, or a cross-ref- (1) Identify specifications for the erence to the physical location of the points, steps, or stages in the manufac- actual or representative label; turing process where control is nec- (h) Written instructions, including essary to ensure the quality of the die- the following: tary supplement and that the dietary (1) Specifications for each point, supplement is packaged and labeled as step, or stage in the manufacturing specified in the master manufacturing process where control is necessary to record; and ensure the quality of the dietary sup- (2) Establish controls and procedures plement and that the dietary supple- to ensure that each batch of dietary ment is packaged and labeled as speci- supplement that you manufacture fied in the master manufacturing meets the specifications identified in record; accordance with paragraph (b)(1) of (2) Procedures for sampling and a this section. cross-reference to procedures for tests (c) You must make and keep master or examinations; manufacturing records in accordance (3) Specific actions necessary to per- with subpart P of this part. form and verify points, steps, or stages in the manufacturing process where

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control is necessary to ensure the qual- (ii) Each lot of dietary supplement, ity of the dietary supplement and that from the finished batch of dietary sup- the dietary supplement is packaged plement, that you distribute to an- and labeled as specified in the master other person for packaging or labeling; manufacturing record. (b) The identity of equipment and (i) Such specific actions must include processing lines used in producing the verifying the weight or measure of any batch; component and verifying the addition (c) The date and time of the mainte- of any component; and nance, cleaning, and sanitizing of the (ii) For manual operations, such spe- equipment and processing lines used in cific actions must include: producing the batch, or a cross-ref- (A) One person weighing or meas- erence to records, such as individual uring a component and another person equipment logs, where this information verifying the weight or measure; and is retained; (B) One person adding the component (d) The unique identifier that you as- and another person verifying the addi- signed to each component (or, when ap- tion. plicable, to a product that you receive (4) Special notations and precautions from a supplier for packaging or label- to be followed; and ing as a dietary supplement), pack- (5) Corrective action plans for use aging, and label used; when a specification is not met. (e) The identity and weight or measure of each component used; Subpart I—Production and Process (f) A statement of the actual yield Control System: Requirements and a statement of the percentage of for the Batch Production theoretical yield at appropriate phases Record of processing; (g) The actual results obtained dur- § 111.255 What is the requirement to ing any monitoring operation; establish a batch production record? (h) The results of any testing or examination performed during the batch (a) You must prepare a batch produc- production, or a cross-reference to such tion record every time you manufac- results; ture a batch of a dietary supplement; (i) Documentation that the finished (b) Your batch production record dietary supplement meets specifica- must include complete information re- tions established in accordance with lating to the production and control of § 111.70(e) and (g); each batch; (j) Documentation, at the time of (c) Your batch production record performance, of the manufacture of the must accurately follow the appropriate batch, including: master manufacturing record and you must perform each step in the produc- (1) The date on which each step of the tion of the batch; and master manufacturing record was per- (d) You must make and keep batch formed; and production records in accordance with (2) The initials of the persons per- subpart P of this part. forming each step, including: (i) The initials of the person respon- § 111.260 What must the batch record sible for weighing or measuring each include? component used in the batch; The batch production record must in- (ii) The initials of the person respon- clude the following: sible for verifying the weight or meas- (a) The batch, lot, or control number: ure of each component used in the (1) Of the finished batch of dietary batch; supplement; and (iii) The initials of the person respon- (2) That you assign in accordance sible for adding the component to the with § 111.415(f) for the following: batch; and (i) Each lot of packaged and labeled (iv) The initials of the person respon- dietary supplement from the finished sible for verifying the addition of com- batch of dietary supplement; ponents to the batch;

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(k) Documentation, at the time of Subpart J—Production and Proc- performance, of packaging and labeling ess Control System: Require- operations, including: ments for Laboratory Oper- (1) The unique identifier that you as- ations signed to packaging and labels used, the quantity of the packaging and la- § 111.303 What are the requirements bels used, and, when label reconcili- under this subpart J for written ation is required, reconciliation of any procedures? discrepancies between issuance and use You must establish and follow writ- of labels; ten procedures for laboratory oper- (2) An actual or representative label, ations, including written procedures or a cross-reference to the physical lo- for the tests and examinations that cation of the actual or representative you conduct to determine whether label specified in the master manufac- specifications are met. turing record; and (3) The results of any tests or exami- § 111.310 What are the requirements for the laboratory facilities that you nations conducted on packaged and la- use? beled dietary supplements (including repackaged or relabeled dietary supple- You must use adequate laboratory facilities to perform whatever testing ments), or a cross-reference to the and examinations are necessary to de- physical location of such results; termine whether: (l) Documentation at the time of per- (a) Components that you use meet formance that quality control per- specifications; sonnel: (b) In-process specifications are met (1) Reviewed the batch production as specified in the master manufac- record, including: turing record; and (i) Review of any monitoring oper- (c) Dietary supplements that you ation required under subpart E of this manufacture meet specifications. part; and (ii) Review of the results of any tests § 111.315 What are the requirements and examinations, including tests and for laboratory control processes? examinations conducted on compo- You must establish and follow lab- nents, in-process materials, finished oratory control processes that are re- batches of dietary supplements, and viewed and approved by quality control packaged and labeled dietary supple- personnel, including the following: ments; (a) Use of criteria for establishing ap- (2) Approved or rejected any reproc- propriate specifications; essing or repackaging; and (b) Use of sampling plans for obtain- (3) Approved and released, or re- ing representative samples, in accord- jected, the batch for distribution, in- ance with subpart E of this part, of: cluding any reprocessed batch; and (1) Components, packaging, and labels; (4) Approved and released, or re- (2) In-process materials; jected, the packaged and labeled die- (3) Finished batches of dietary sup- tary supplement, including any repack- plements; aged or relabeled dietary supplement. (4) Product that you receive for pack- (m) Documentation at the time of aging or labeling as a dietary supple- performance of any required material ment (and for distribution rather than review and disposition decision. for return to the supplier); and (n) Documentation at the time of (5) Packaged and labeled dietary sup- performance of any reprocessing. plements. (c) Use of criteria for selecting appropriate examination and testing methods; (d) Use of criteria for selecting standard reference materials used in performing tests and examinations; and

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(e) Use of test methods and examina- § 111.355 What are the design require- tions in accordance with established ments for manufacturing oper- criteria. ations? You must design or select manufac- § 111.320 What requirements apply to turing processes to ensure that product laboratory methods for testing and specifications are consistently met. examination? (a) You must verify that the labora- § 111.360 What are the requirements tory examination and testing meth- for sanitation? odologies are appropriate for their in- You must conduct all manufacturing tended use. operations in accordance with adequate (b) You must identify and use an ap- sanitation principles. propriate scientifically valid method § 111.365 What precautions must you for each established specification for take to prevent contamination? which testing or examination is re- You must take all the necessary pre- quired to determine whether the speci- cautions during the manufacture of a fication is met. dietary supplement to prevent contamination of components or dietary § 111.325 Under this subpart J, what records must you make and keep? supplements. These precautions include: (a) You must make and keep records (a) Performing manufacturing oper- required under this subpart J in ac- ations under conditions and controls cordance with subpart P of this part. that protect against the potential for (b) You must make and keep the fol- growth of microorganisms and the po- lowing records: tential for contamination; (1) Written procedures for laboratory (b) Washing or cleaning components operations, including written proce- that contain soil or other contami- dures for the tests and examinations nants; that you conduct to determine whether (c) Using water that, at a minimum, specifications are met; complies with the applicable Federal, State, and local requirements and does (2) Documentation that laboratory not contaminate the dietary supple- methodology established in accordance ment when the water may become a with this subpart J is followed. component of the finished batch of die- (i) The person who conducts the test- tary supplement; ing and examination must document, (d) Performing chemical, micro- at the time of performance, that lab- biological, or other testing, as nec- oratory methodology established in ac- essary to prevent the use of contami- cordance with this subpart J is fol- nated components; lowed. (e) Sterilizing, pasteurizing, freezing, (ii) The documentation for labora- refrigerating, controlling hydrogen-ion tory tests and examinations must in- concentration (pH), controlling humid- clude the results of the testing and ex- ity, controlling water activity (aw), or amination. using any other effective means to remove, destroy, or prevent the growth Subpart K—Production and Proc- of microorganisms and prevent decomposition; ess Control System: Require- (f) Holding components and dietary ments for Manufacturing Op- supplements that can support the rapid erations growth of microorganisms of public health significance in a manner that § 111.353 What are the requirements prevents the components and dietary under this subpart K for written supplements from becoming adulter- procedures? ated; You must establish and follow writ- (g) Identifying and holding any com- ten procedures for manufacturing oper- ponents or dietary supplements, for ations. which a material review and disposition decision is required, in a manner

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that protects components or dietary Subpart L—Production and Proc- supplements that are not under a ma- ess Control System: Require- terial review against contamination ments for Packaging and La- and mixups with those that are under a beling Operations material review; (h) Performing mechanical manufac- § 111.403 What are the requirements turing steps (such as cutting, sorting, under this subpart L for written inspecting, shredding, drying, grinding, procedures? blending, and sifting) by any effective You must establish and follow writ- means to protect the dietary supple- ten procedures for packaging and label- ments against contamination, by, for ing operations. example: (1) Cleaning and sanitizing contact § 111.410 What requirements apply to surfaces; packaging and labels? (2) Using temperature controls; and (a) You must take necessary actions (3) Using time controls. to determine whether packaging for di- (i) Using effective measures to pro- etary supplements meets specifications tect against the inclusion of metal or so that the condition of the packaging other foreign material in components will ensure the quality of your dietary or dietary supplements, by, for exam- supplements; ple: (b) You must control the issuance (1) Filters or strainers, and use of packaging and labels and reconciliation of any issuance and use (2) Traps, discrepancies. Label reconciliation is (3) Magnets, or not required for cut or rolled labels if a (4) Electronic metal detectors. 100-percent examination for correct la- (j) Segregating and identifying all bels is performed by appropriate elec- containers for a specific batch of die- tronic or electromechanical equipment tary supplements to identify their con- during or after completion of finishing tents and, when necessary, the phase of operations; and manufacturing; and (c) You must examine, before pack- (k) Identifying all processing lines aging and labeling operations, pack- and major equipment used during man- aging and labels for each batch of die- ufacturing to indicate their contents, tary supplement to determine whether including the name of the dietary sup- the packaging and labels conform to plement and the specific batch or lot the master manufacturing record; and number and, when necessary, the phase (d) You must be able to determine of manufacturing. the complete manufacturing history and control of the packaged and la- § 111.370 What requirements apply to beled dietary supplement through dis- rejected dietary supplements? tribution. You must clearly identify, hold, and § 111.415 What requirements apply to control under a quarantine system for filling, assembling, packaging, la- appropriate disposition any dietary beling, and related operations? supplement that is rejected and unsuit- You must fill, assemble, package, able for use in manufacturing, pack- label, and perform other related oper- aging, or labeling operations. ations in a way that ensures the quality of the dietary supplement and that § 111.375 Under this subpart K, what the dietary supplement is packaged records must you make and keep? and labeled as specified in the master (a) You must make and keep records manufacturing record. You must do required under this subpart K in ac- this using any effective means, includ- cordance with subpart P of this part. ing the following: (b) You must make and keep records (a) Cleaning and sanitizing all filling of the written procedures for manufac- and packaging equipment, utensils, and turing operations. dietary supplement packaging, as appropriate;

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(b) Protecting manufactured dietary appropriate disposition any packaged supplements from contamination, par- and labeled dietary supplement that is ticularly airborne contamination; rejected for distribution. (c) Using sanitary handling procedures; § 111.430 Under this subpart L, what (d) Establishing physical or spatial records must you make and keep? separation of packaging and label oper- (a) You must make and keep records ations from operations on other compo- required under this subpart L in ac- nents and dietary supplements to pre- cordance with subpart P of this part. vent mixups; (b) You must make and keep records (e) Identifying, by any effective of the written procedures for packaging means, filled dietary supplement con- and labeling operations. tainers that are set aside and held in unlabeled condition for future label op- Subpart M—Holding and erations, to prevent mixups; (f) Assigning a batch, lot, or control Distributing number to: § 111.453 What are the requirements (1) Each lot of packaged and labeled under this subpart for M written dietary supplement from a finished procedures? batch of dietary supplement; and, You must establish and follow writ- (2) Each lot of dietary supplement, ten procedures for holding and distrib- from a finished batch of dietary supple- uting operations. ment, that you distribute to another person for packaging or labeling. § 111.455 What requirements apply to (g) Examining a representative sam- holding components, dietary supple of each batch of the packaged and plements, packaging, and labels? labeled dietary supplement to deter- (a) You must hold components and mine whether the dietary supplement dietary supplements under appropriate meets specifications established in ac- conditions of temperature, humidity, cordance with § 111.70(g); and and light so that the identity, purity, (h) Suitably disposing of labels and strength, and composition of the com- packaging for dietary supplements that are obsolete or incorrect to ensure that ponents and dietary supplements are they are not used in any future pack- not affected. aging and label operations. (b) You must hold packaging and labels under appropriate conditions so § 111.420 What requirements apply to that the packaging and labels are not repackaging and relabeling? adversely affected. (a) You may repackage or relabel die- (c) You must hold components, dietary supplements only after quality tary supplements, packaging, and la- control personnel have approved such bels under conditions that do not lead repackaging or relabeling. to the mixup, contamination, or dete- (b) You must examine a representa- rioration of components, dietary sup- tive sample of each batch of repack- plements, packaging, and labels. aged or relabeled dietary supplements § 111.460 What requirements apply to to determine whether the repackaged holding in-process material? or relabeled dietary supplements meet all specifications established in accord- (a) You must identify and hold in- ance with § 111.70(g). process material under conditions that (c) Quality control personnel must protect against mixup, contamination, approve or reject each batch of repack- and deterioration. aged or relabeled dietary supplement (b) You must hold in-process mate- prior to its release for distribution. rial under appropriate conditions of temperature, humidity, and light. § 111.425 What requirements apply to a packaged and labeled dietary sup- § 111.465 What requirements apply to plement that is rejected for dis- holding reserve samples of dietary tribution? supplements? You must clearly identify, hold, and (a) You must hold reserve samples of control under a quarantine system for dietary supplements in a manner that

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protects against contamination and de- § 111.510 What requirements apply terioration. This includes: when a returned dietary supple- (1) Holding the reserve samples under ment is received? conditions consistent with product la- You must identify and quarantine re- bels or, if no storage conditions are turned dietary supplements until qual- recommended on the label, under ordi- ity control personnel conduct a mate- nary storage conditions; and rial review and make a disposition de- (2) Using the same container-closure cision. system in which the packaged and labeled dietary supplement is distrib- § 111.515 When must a returned die- uted, or if distributing dietary supple- tary supplement be destroyed, or ments to be packaged and labeled, otherwise suitably disposed of? using a container-closure system that You must destroy, or otherwise suit- provides essentially the same charac- ably dispose of, any returned dietary teristics to protect against contamina- supplement unless the outcome of a tion or deterioration as the one in material review and disposition deci- which you distribute the dietary sup- sion is that quality control personnel plement for packaging and labeling do the following: elsewhere. (a) Approve the salvage of the re- (b) You must retain reserve samples turned dietary supplement for redis- for 1 year past the shelf life date (if tribution or shelf life dating is used), or for 2 years (b) Approve the returned dietary sup- from the date of distribution of the last plement for reprocessing. batch of dietary supplements associated with the reserve samples, for use § 111.520 When may a returned dietary in appropriate investigations. supplement be salvaged? You may salvage a returned dietary § 111.470 What requirements apply to supplement only if quality control per- distributing dietary supplements? sonnel conduct a material review and You must distribute dietary supple- make a disposition decision to allow ments under conditions that will pro- the salvage. tect the dietary supplements against contamination and deterioration. § 111.525 What requirements apply to a returned dietary supplement that § 111.475 Under this subpart M, what quality control personnel approve records must you make and keep? for reprocessing? (a) You must make and keep records (a) You must ensure that any re- required under this subpart M in ac- turned dietary supplements that are cordance with subpart P of this part. reprocessed meet all product specifica- (b) You must make and keep the fol- tions established in accordance with lowing records: § 111.70(e); and (1) Written procedures for holding (b) Quality control personnel must and distributing operations; and approve or reject the release for dis- (2) Records of product distribution. tribution of any returned dietary supplement that is reprocessed.

Subpart N—Returned Dietary § 111.530 When must an investigation Supplements be conducted of your manufacturing processes and other batches? § 111.503 What are the requirements under this subpart N for written If the reason for a dietary supple- procedures? ment being returned implicates other batches, you must conduct an inves- You must establish and follow writ- tigation of your manufacturing proc- ten procedures to fulfill the require- esses and each of those other batches ments of this subpart. to determine compliance with specifications.

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§ 111.535 Under this subpart N, what ings and followup action of any inves- records must you make and keep? tigation performed. (a) You must make and keep records (c) The review and investigation of required under this subpart N in ac- the product complaint by a qualified cordance with subpart P of this part. person, and the review by quality con- (b) You must make and keep the fol- trol personnel about whether to inves- lowing records: tigate a product complaint, and the (1) Written procedures for fulfilling findings and followup action of any in- the requirements of this subpart N. vestigation performed, must extend to (2) Any material review and disposi- all relevant batches and records. tion decision on a returned dietary supplement; § 111.570 Under this subpart O, what (3) The results of any testing or ex- records must you make and keep? amination conducted to determine (a) You must make and keep the compliance with product specifications records required under this subpart O established under § 111.70(e); and, in accordance with subpart P of this (4) Documentation of the reevalua- part. tion by quality control personnel of (b) You must make and keep the fol- any dietary supplement that is reproc- lowing records: essed and the determination by quality (1) Written procedures for fulfilling control personnel of whether the re- the requirements of this subpart, processed dietary supplement meets (2) A written record of every product product specifications established in complaint that is related to good man- accordance with § 111.70(e). ufacturing practice, (i) The person who performs the re- Subpart O—Product Complaints quirements of this subpart must document, at the time of performance, that § 111.553 What are the requirements the requirement was performed. under this subpart O for written (ii) The written record of the product procedures? complaint must include the following: You must establish and follow writ- (A) The name and description of the ten procedures to fulfill the require- dietary supplement; ments of this subpart O. (B) The batch, lot, or control number of the dietary supplement, if available; § 111.560 What requirements apply to the review and investigation of a (C) The date the complaint was re- product complaint? ceived and the name, address, or telephone number of the complainant, if (a) A qualified person must: available; (1) Review all product complaints to (D) The nature of the complaint in- determine whether the product com- cluding, if known, how the product was plaint involves a possible failure of a used; dietary supplement to meet any of its (E) The reply to the complainant, if specifications, or any other require- any; and ments of this part 111, including those specifications and other requirements (F) Findings of the investigation and that, if not met, may result in a risk of followup action taken when an inves- illness or injury; and tigation is performed. (2) Investigate any product complaint that involves a possible failure of a die- Subpart P—Records and tary supplement to meet any of its Recordkeeping specifications, or any other requirements of this part, including those § 111.605 What requirements apply to specifications and other requirements the records that you make and that, if not met, may result in a risk of keep? illness or injury. (a) You must keep written records re- (b) Quality control personnel must quired by this part for 1 year past the review and approve decisions about shelf life date, if shelf life dating is whether to investigate a product com- used, or 2 years beyond the date of dis- plaint and review and approve the find- tribution of the last batch of dietary

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supplements associated with those 112.22 What minimum requirements apply records. for training personnel who conduct a (b) Records must be kept as original covered activity? records, as true copies (such as photo- 112.23 What requirements apply regarding supervisors? copies, microfilm, microfiche, or other 112.30 Under this subpart, what require- accurate reproductions of the original ments apply regarding records? records), or as electronic records. (c) All electronic records must com- Subpart D—Health and Hygiene ply with part 11 of this chapter. 112.31 What measures must I take to pre- § 111.610 What records must be made vent ill or infected persons from con- available to FDA? taminating covered produce with microorganisms of public health significance? (a) You must have all records re- 112.32 What hygienic practices must per- quired under this part, or copies of sonnel use? such records, readily available during 112.33 What measures must I take to pre- the retention period for inspection and vent visitors from contaminating cov- copying by FDA when requested. ered produce and food contact surfaces (b) If you use reduction techniques, with microorganisms of public health such as microfilming, you must make significance? suitable reader and photocopying Subpart E—Agricultural Water equipment readily available to FDA. 112.41 What requirements apply to the quality of agricultural water? PART 112—STANDARDS FOR THE 112.42 What requirements apply to my agri- GROWING, HARVESTING, PACK- cultural water sources, water distribu- ING, AND HOLDING OF tion system, and pooling of water? PRODUCE FOR HUMAN CON- 112.43 What requirements apply to treating agricultural water? SUMPTION 112.44 What specific microbial quality criteria apply to agricultural water used for Subpart A—General Provisions certain intended uses? Sec. 112.45 What measures must I take if my ag- 112.1 What food is covered by this part? ricultural water does not meet the re- 112.2 What produce is not covered by this quirements of § 112.41 or § 112.44? part? 112.46 How often must I test agricultural 112.3 What definitions apply to this part? water that is subject to the requirements 112.4 Which farms are subject to the re- of § 112.44? quirements of this part? 112.47 Who must perform the tests required 112.5 Which farms are eligible for a quali- under § 112.46 and what methods must be fied exemption and associated modified used? requirements based on average monetary 112.48 What measures must I take for water value of all food sold and direct farm that I use during harvest, packing, and marketing? holding activities for covered produce? 112.6 What modified requirements apply to 112.49 What alternatives may I establish me if my farm is eligible for a qualified and use in lieu of the requirements of exemption in accordance with § 112.5? this subpart? 112.7 What records must I establish and 112.50 Under this subpart, what require- keep if my farm is eligible for a qualified ments apply regarding records? exemption in accordance with § 112.5? Subpart F—Biological Soil Amendments of Subpart B—General Requirements Animal Origin and Human Waste 112.11 What general requirements apply to 112.51 What requirements apply for deter- persons who are subject to this part? mining the status of a biological soil 112.12 Are there any alternatives to the re- amendment of animal origin? quirements established in this part? 112.52 How must I handle, convey, and store biological soil amendments of animal or- Subpart C—Personnel Qualifications and igin? Training 112.53 What prohibitions apply regarding use of human waste? 112.21 What requirements apply regarding 112.54 What treatment processes are accept- qualifications and training for personnel able for a biological soil amendment of who handle (contact) covered produce or animal origin that I apply in the growing food contact surfaces? of covered produce?

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112.55 What microbial standards apply to 112.127 What requirements apply regarding the treatment processes in § 112.54? domesticated animals in and around a 112.56 What application requirements and fully-enclosed building? minimum application intervals apply to 112.128 What requirements apply regarding biological soil amendments of animal or- pest control in buildings? igin? 112.129 What requirements apply to toilet 112.60 Under this subpart, what require- facilities? ments apply regarding records? 112.130 What requirements apply for hand- washing facilities? Subpart G–H [Reserved] 112.131 What must I do to control and dispose of sewage? Subpart I—Domesticated and Wild Animals 112.132 What must I do to control and dis- 112.81 How do the requirements of this sub- pose of trash, litter, and waste in areas part apply to areas where covered activi- used for covered activities? ties take place? 112.133 What requirements apply to plumb- 112.83 What requirements apply regarding ing? grazing animals, working animals, and 112.134 What must I do to control animal animal intrusion? excreta and litter from domesticated ani- 112.84 Does this regulation require covered mals that are under my control? farms to take actions that would con- 112.140 Under this subpart, what require- stitute a ‘‘taking’’ of threatened or en- ments apply regarding records? dangered species; to take measures to exclude animals from outdoor growing Subpart M—Sprouts areas; or to destroy animal habitat or otherwise clear farm borders around out- 112.141 What commodities are subject to door growing areas or drainages? this subpart? 112.142 What requirements apply to seeds or Subpart J [Reserved] beans used to grow sprouts? 112.143 What measures must I take for Subpart K—Growing, Harvesting, Packing, growing, harvesting, packing, and hold- and Holding Activities ing sprouts? 112.144 What testing must I do during grow- 112.111 What measures must I take if I grow, ing, harvesting, packing, and holding harvest, pack or hold both covered and sprouts? excluded produce? 112.145 What requirements apply to testing 112.112 What measures must I take imme- the environment for Listeria species or L. diately prior to and during harvest ac- monocytogenes? tivities? 112.113 How must I handle harvested cov- 112.146 What actions must I take if the ered produce during covered activities? growing, harvesting, packing, or holding 112.114 What requirements apply to dropped environment tests positive for Listeria covered produce? species or L. monocytogenes? 112.115 What measures must I take when 112.147 What must I do to collect and test packaging covered produce? samples of spent sprout irrigation water 112.116 What measures must I take when or sprouts for pathogens? using food-packing (including food pack- 112.148 What actions must I take if the sam- aging) material? ples of spent sprout irrigation water or sprouts test positive for a pathogen? Subpart L—Equipment, Tools, Buildings, 112.150 Under this subpart, what require- and Sanitation ments apply regarding records? 112.121 What equipment and tools are sub- Subpart N—Analytical Methods ject to the requirements of this subpart? 112.122 What buildings are subject to the re- 112.151 What methods must I use to test the quirements of this subpart? quality of water to satisfy the require- 112.123 What requirements apply regarding ments of § 112.46? equipment and tools subject to this sub- 112.152 What methods must I use to test the part? growing, harvesting, packing, and hold- 112.124 What requirements apply to instru- ing environment for Listeria species or L. ments and controls used to measure, reg- monocytogenes to satisfy the require- ulate, or record? ments of § 112.144(a)? 112.125 What requirements apply to equip- 112.153 What methods must I use to test ment that is subject to this subpart used spent sprout irrigation water (or sprouts) in the transport of covered produce? from each production batch of sprouts 112.126 What requirements apply to my for pathogens to satisfy the requirements buildings? of § 112.144(b) and (c)?

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Subpart O—Records 112.204 What must I do if I receive an order to withdraw a qualified exemption appli- 112.161 What general requirements apply to cable to my farm? records required under this part? 112.205 Can I appeal or request a hearing on 112.162 Where must I store records? an order to withdraw a qualified exemp- 112.163 May I use existing records to satisfy tion applicable to my farm? the requirements of this part? 112.206 What is the procedure for submitting 112.164 How long must I keep records? an appeal? 112.165 What formats are acceptable for the 112.207 What is the procedure for requesting records I keep? an informal hearing? 112.166 What requirements apply for making 112.208 What requirements are applicable to records available and accessible to FDA? an informal hearing? 112.167 Can records that I provide to FDA be 112.209 Who is the presiding officer for an appeal and for an informal hearing? disclosed to persons outside of FDA? 112.210 What is the timeframe for issuing a decision on an appeal? Subpart P—Variances 112.211 When is an order to withdraw a 112.171 Who may request a variance from qualified exemption applicable to a farm the requirements of this part? revoked? 112.172 How may a State, tribe, or foreign 112.213 If my qualified exemption is with- country request a variance from one or drawn, under what circumstances would more requirements of this part? FDA reinstate my qualified exemption? 112.173 What must be included in the State- AUTHORITY: 21 U.S.C. 321, 331, 342, 350h, 371; ment of Grounds in a petition requesting 42 U.S.C. 243, 264, 271. a variance? SOURCE: 80 FR 74547, Nov. 27, 2015, unless 112.174 What information submitted in a pe- otherwise noted. tition requesting a variance or submitted in comments on such a petition are pub- EDITORIAL NOTE: Nomenclature changes to licly available? part 112 appear at 81 FR 49896, July 29, 2016. 112.175 Who responds to a petition requesting a variance? Subpart A—General Provisions 112.176 What process applies to a petition requesting a variance? § 112.1 What food is covered by this 112.177 Can an approved variance apply to part? any person other than those identified in the petition requesting that variance? (a) Unless it is excluded from this 112.178 Under what circumstances may FDA part under § 112.2, food that is produce deny a petition requesting a variance? within the meaning of this part and 112.179 When does a variance approved by that is a raw agricultural commodity FDA become effective? (RAC) is covered by this part. This in- 112.180 Under what circumstances may FDA cludes a produce RAC that is grown do- modify or revoke an approved variance? mestically and a produce RAC that will 112.181 What procedures apply if FDA deter- be imported or offered for import in mines that an approved variance should be modified or revoked? any State or territory of the United 112.182 What are the permissible types of States, the District of Columbia, or the variances that may be granted? Commonwealth of Puerto Rico. (b) For the purpose of this part and Subpart Q—Compliance and Enforcement subject to the exemptions and qualified exemptions therein, covered produce 112.192 What is the applicability and status includes all of the following: of this part? (1) Fruits and vegetables such as al- 112.193 What are the provisions for coordination of education and enforcement? monds, apples, apricots, apriums, Arti- chokes-globe-type, Asian pears, avoca- Subpart R—Withdrawal of Qualified dos, babacos, bananas, Belgian endive, Exemption blackberries, blueberries, boysenberries, brazil nuts, broad beans, broc- 112.201 Under what circumstances can FDA coli, Brussels sprouts, burdock, cab- withdraw a qualified exemption in ac- bages, Chinese cabbages (Bok Choy, cordance with the requirements of § 112.5? mustard, and Napa), cantaloupes, 112.202 What procedure will FDA use to withdraw an exemption? carambolas, carrots, cauliflower, 112.203 What information must FDA include celeriac, celery, chayote fruit, cherries in an order to withdraw a qualified ex- (sweet), chestnuts, chicory (roots and emption? tops), citrus (such as clementine,

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grapefruit, lemons, limes, mandarin, cept as noted in paragraphs (b)(1), (2), oranges, tangerines, tangors, and uniq and (3) of this section) under the fol- fruit), cowpea beans, cress-garden, cu- lowing conditions: cumbers, curly endive, currants, dan- (1) The produce receives commercial delion leaves, fennel-Florence, garlic, processing that adequately reduces the genip, gooseberries, grapes, green presence of microorganisms of public beans, guavas, herbs (such as basil, health significance. Examples of com- chives, cilantro, oregano, and parsley), mercial processing that adequately re- honeydew, huckleberries, Jerusalem duces the presence of microorganisms artichokes, kale, kiwifruit, kohlrabi, of public health significance are proc- kumquats, leek, lettuce, lychees, mac- essing in accordance with the require- adamia nuts, mangos, other melons ments of part 113, 114, or 120 of this (such as Canary, Crenshaw and Per- sian), mulberries, mushrooms, mustard chapter, treating with a validated proc- greens, nectarines, onions, papayas, ess to eliminate spore-forming micro- parsnips, passion fruit, peaches, pears, organisms (such as processing to peas, peas-pigeon, peppers (such as bell produce tomato paste or shelf-stable and hot), pine nuts, pineapples, plan- tomatoes), and processing such as retains, plums, plumcots, quince, rad- fining, distilling, or otherwise manu- ishes, raspberries, rhubarb, rutabagas, facturing/processing produce into prod- scallions, shallots, snow peas, soursop, ucts such as sugar, oil, spirits, wine, spinach, sprouts (such as alfalfa and beer or similar products; and mung bean), strawberries, summer (2) You must disclose in documents squash (such as patty pan, yellow and accompanying the produce, in accord- zucchini), sweetsop, Swiss chard, taro, ance with the practice of the trade, tomatoes, turmeric, turnips (roots and that the food is ‘‘not processed to ade- tops), walnuts, watercress, water- quately reduce the presence of micro- melons, and yams; and organisms of public health signifi- (2) Mixes of intact fruits and vegeta- cance;’’ and bles (such as fruit baskets). (3) You must either: § 112.2 What produce is not covered by (i) Annually obtain written assur- this part? ance, subject to the requirements of paragraph (b)(6) of this section, from (a) The following produce is not covered by this part: the customer that performs the com- (1) Produce that is rarely consumed mercial processing described in para- raw, specifically the produce on the graph (b)(1) of this section that the following exhaustive list: Asparagus; customer has established and is fol- beans, black; beans, great Northern; lowing procedures (identified in the beans, kidney; beans, lima; beans, written assurance) that adequately re- navy; beans, pinto; beets, garden (roots duce the presence of microorganisms of and tops); beets, sugar; cashews; cher- public health significance; or ries, sour; chickpeas; cocoa beans; cof- (ii) Annually obtain written assur- fee beans; collards; corn, sweet; cran- ance, subject to the requirements of berries; dates; dill (seeds and weed); paragraph (b)(6) of this section, from eggplants; figs; ginger; hazelnuts; your customer that an entity in the horseradish; lentils; okra; peanuts; pe- distribution chain subsequent to the cans; peppermint; potatoes; pumpkins; customer will perform commercial squash, winter; sweet potatoes; and processing described in paragraph (b)(1) water chestnuts. of this section and that the customer: (2) Produce that is produced by an in- (A) Will disclose in documents ac- dividual for personal consumption or companying the food, in accordance produced for consumption on the farm with the practice of the trade, that the or another farm under the same man- food is ‘‘not processed to adequately re- agement; and (3) Produce that is not a raw agricul- duce the presence of microorganisms of tural commodity. public health significance’’; and (b) Produce is eligible for exemption (B) Will only sell to another entity from the requirements of this part (ex- that agrees, in writing, it will either:

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(1) Follow procedures (identified in a ganic matter, and soluble chemical written assurance) that adequately re- components into an aqueous phase. Ag- duce the presence of microorganisms of ricultural teas are held for longer than public health significance; or one hour before application. Agricul- (2) Obtain a similar written assur- tural teas are soil amendments for the ance from its customer that the purposes of this rule. produce will receive commercial proc- Agricultural tea additive means a nu- essing described in paragraph (b)(1) of trient source (such as molasses, yeast this section, and that there will be dis- extract, or algal powder) added to agri- closure in documents accompanying cultural tea to increase microbial bio- the food, in accordance with the prac- mass. tice of the trade, that the food is ‘‘not Agricultural water means water used processed to adequately reduce the in covered activities on covered presence of microorganisms of public produce where water is intended to, or health significance’’; and is likely to, contact covered produce or (4) You must establish and maintain food contact surfaces, including water documentation of your compliance used in growing activities (including with applicable requirements in para- irrigation water applied using direct graphs (b)(2) and (3) in accordance with water application methods, water used the requirements of subpart O of this for preparing crop sprays, and water part, including: used for growing sprouts) and in har- (i) Documents containing disclosures vesting, packing, and holding activities required under paragraph (b)(2) of this (including water used for washing or section; and cooling harvested produce and water (ii) Annual written assurances ob- used for preventing dehydration of cov- tained from customers required under ered produce). paragraph (b)(3) of this section; and Animal excreta means solid or liquid (5) The requirements of this subpart animal waste. and subpart Q of this part apply to Application interval means the time such produce; and interval between application of an ag- (6) An entity that provides a written ricultural input (such as a biological assurance under § 112.2(b)(3)(i) or (ii) soil amendment of animal origin) to a must act consistently with the assur- growing area and harvest of covered ance and document its actions taken to produce from the growing area where satisfy the written assurance. the agricultural input was applied. Biological soil amendment means any § 112.3 What definitions apply to this soil amendment containing biological part? materials such as stabilized compost, The definitions and interpretations manure, non-fecal animal byproducts, of terms in section 201 of the Federal peat moss, pre-consumer vegetative Food, Drug, and Cosmetic Act apply to waste, sewage sludge biosolids, table such terms when used in this part. The waste, agricultural tea, or yard trim- following definitions also apply: mings, alone or in combination. Adequate means that which is needed Biological soil amendment of animal ori- to accomplish the intended purpose in gin means a biological soil amendment keeping with good public health prac- which consists, in whole or in part, of tice. materials of animal origin, such as ma- Adequately reduce microorganisms of nure or non-fecal animal byproducts public health significance means reduce including animal mortalities, or table the presence of such microorganisms to waste, alone or in combination. The an extent sufficient to prevent illness. term ‘‘biological soil amendment of Agricultural tea means a water ex- animal origin’’ does not include any tract of biological materials (such as form of human waste. stabilized compost, manure, non-fecal Composting means a process to animal byproducts, peat moss, pre-con- produce stabilized compost in which or- sumer vegetative waste, table waste, or ganic material is decomposed by the yard trimmings), excluding any form of actions of microorganisms under human waste, produced to transfer mi- thermophilic conditions for a des- crobial biomass, fine particulate or- ignated period of time (for example, 3

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days) at a designated temperature (for such activities is either consumed on example, 131 °F (55 °C)), followed by a that farm or another farm under the curing stage under cooler conditions. same management, or is processed food Covered activity means growing, har- identified in paragraph (1)(iii)(B)(1) of vesting, packing, or holding covered this definition; and produce on a farm. Covered activity in- (iii) Manufacture/process food, pro- cludes manufacturing/processing of vided that: covered produce on a farm, but only to (A) All food used in such activities is the extent that such activities are per- consumed on that farm or another formed on raw agricultural commod- farm under the same management; or ities and only to the extent that such (B) Any manufacturing/processing of activities are within the meaning of food that is not consumed on that farm ‘‘farm’’ as defined in this chapter. Pro- or another farm under the same man- viding, acting consistently with, and agement consists only of: documenting actions taken in compli- (1) Drying/dehydrating raw agricul- ance with written assurances as de- tural commodities to create a distinct scribed in § 112.2(b) are also covered ac- commodity (such as drying/dehy- tivities. This part does not apply to ac- drating grapes to produce raisins), and tivities of a facility that are subject to packaging and labeling such commod- part 117 of this chapter. ities, without additional manufac- Covered produce means produce that turing/processing (an example of addi- is subject to the requirements of this tional manufacturing/processing is part in accordance with §§ 112.1 and 112.2. The term ‘‘covered produce’’ re- slicing); fers to the harvestable or harvested (2) Treatment to manipulate the rip- part of the crop. ening of raw agricultural commodities Curing means the final stage of (such as by treating produce with composting, which is conducted after ethylene gas), and packaging and label- much of the readily metabolized bio- ing treated raw agricultural commod- logical material has been decomposed, ities, without additional manufac- at cooler temperatures than those in turing/processing; and the thermophilic phase of composting, (3) Packaging and labeling raw agri- to further reduce pathogens, promote cultural commodities, when these ac- further decomposition of cellulose and tivities do not involve additional man- lignin, and stabilize composition. Cur- ufacturing/processing (an example of ing may or may not involve insulation, additional manufacturing/processing is depending on environmental condi- irradiation); or tions. (2) Secondary activities farm. A sec- Direct water application method means ondary activities farm is an operation, using agricultural water in a manner not located on a primary production whereby the water is intended to, or is farm, devoted to harvesting (such as likely to, contact covered produce or hulling or shelling), packing, and/or food contact surfaces during use of the holding of raw agricultural commod- water. ities, provided that the primary pro- Farm means: duction farm(s) that grows, harvests, (1) Primary production farm. A pri- and/or raises the majority of the raw mary production farm is an operation agricultural commodities harvested, under one management in one general packed, and/or held by the secondary (but not necessarily contiguous) phys- activities farm owns, or jointly owns, a ical location devoted to the growing of majority interest in the secondary ac- crops, the harvesting of crops, the rais- tivities farm. A secondary activities ing of animals (including seafood), or farm may also conduct those addi- any combination of these activities. tional activities allowed on a primary The term ‘‘farm’’ includes operations production farm as described in para- that, in addition to these activities: graphs (1)(ii) and (iii) of this definition. (i) Pack or hold raw agricultural Food means food as defined in section commodities; 201(f) of the Federal Food, Drug, and (ii) Pack or hold processed food, pro- Cosmetic Act and includes seeds and vided that all processed food used in beans used to grow sprouts.

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Food contact surfaces means those dental to storage of a food (e.g., activi- surfaces that contact human food and ties performed for the safe or effective those surfaces from which drainage, or storage of that food, such as fumigat- other transfer, onto the food or onto ing food during storage, and drying/de- surfaces that contact the food ordi- hydrating raw agricultural commod- narily occurs during the normal course ities when the drying/dehydrating does of operations. ‘‘Food contact surfaces’’ not create a distinct commodity (such includes food contact surfaces of equip- as drying/dehydrating hay or alfalfa)). ment and tools used during harvest, Holding also includes activities per- packing and holding. formed as a practical necessity for the Ground water means the supply of distribution of that food (such as fresh water found beneath the Earth’s blending of the same raw agricultural surface, usually in aquifers, which sup- commodity and breaking down pallets), ply wells and springs. Ground water but does not include activities that does not include any water that meets transform a raw agricultural com- the definition of surface water. modity into a processed food as defined Growth media means material that in section 201(gg) of the Federal Food, acts as a substrate during the growth Drug, and Cosmetic Act. Holding facili- of covered produce (such as mushrooms ties could include warehouses, cold and some sprouts) that contains, may storage facilities, storage silos, grain contain, or consists of components that elevators, and liquid storage tanks. may include any animal waste (such as Known or reasonably foreseeable haz- stabilized compost, manure, non-fecal ard means a biological hazard that is animal byproducts or table waste). known to be, or has the potential to be, Harvesting applies to farms and farm associated with the farm or the food. mixed-type facilities and means activi- Manufacturing/processing means mak- ties that are traditionally performed ing food from one or more ingredients, on farms for the purpose of removing or synthesizing, preparing, treating, raw agricultural commodities from the modifying or manipulating food, in- place they were grown or raised and cluding food crops or ingredients. Ex- preparing them for use as food. Har- amples of manufacturing/processing ac- vesting is limited to activities performed on raw agricultural commod- tivities include: Baking, boiling, bot- ities, or on processed foods created by tling, canning, cooking, cooling, cut- drying/dehydrating a raw agricultural ting, distilling, drying/dehydrating raw commodity without additional manu- agricultural commodities to create a facturing/processing, on a farm. Har- distinct commodity (such as drying/de- vesting does not include activities that hydrating grapes to produce raisins), transform a raw agricultural com- evaporating, eviscerating, extracting modity into a processed food as defined juice, formulating, freezing, grinding, in section 201(gg) of the Federal Food, homogenizing, labeling, milling, mix- Drug, and Cosmetic Act. Examples of ing, packaging (including modified at- harvesting include cutting (or other- mosphere packaging), pasteurizing, wise separating) the edible portion of peeling, rendering, treating to manipu- the raw agricultural commodity from late ripening, trimming, washing, or the crop plant and removing or trim- waxing. For farms and farm mixed-type ming part of the raw agricultural com- facilities, manufacturing/processing modity (e.g., foliage, husks, roots or does not include activities that are stems). Examples of harvesting also in- part of harvesting, packing, or holding. clude cooling, field coring, filtering, Manure means animal excreta, alone gathering, hulling, shelling, sifting, or in combination with litter (such as threshing, trimming of outer leaves of, straw and feathers used for animal bed- and washing raw agricultural commod- ding) for use as a soil amendment. ities grown on a farm. Microorganisms means yeasts, molds, Hazard means any biological agent bacteria, viruses, protozoa, and micro- that has the potential to cause illness scopic parasites and includes species or injury in the absence of its control. having public health significance. The Holding means storage of food and term ‘‘undesirable microorganisms’’ in- also includes activities performed inci- cludes those microorganisms that are

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of public health significance, that sub- with an end user (consumer). Pre-con- ject food to decomposition, that indi- sumer vegetative waste includes mate- cate that food is contaminated with rial generated by farms, packing filth, or that otherwise may cause food houses, canning operations, wholesale to be adulterated. distribution centers and grocery stores; Mixed-type facility means an estab- products that have been removed from lishment that engages in both activi- their packaging (such as out-of-date ties that are exempt from registration juice, vegetables, condiments, and under section 415 of the Federal Food, bread); and associated packaging that Drug, and Cosmetic Act and activities is vegetative in origin (such as paper or that require the establishment to be corn-starch based products). Pre-con- registered. An example of such a facil- sumer vegetative waste does not in- ity is a ‘‘farm mixed-type facility,’’ clude table waste, packaging that has which is an establishment that is a come in contact with materials (such farm, but that also conducts activities as meat) that are not vegetative in ori- outside the farm definition that re- gin, or any waste generated by res- quire the establishment to be reg- taurants. istered. Produce means any fruit or vegetable Monitor means to conduct a planned (including mixes of intact fruits and sequence of observations or measure- vegetables) and includes mushrooms, ments to assess whether a process, sprouts (irrespective of seed source), point or procedure is under control peanuts, tree nuts, and herbs. A fruit is and, when required, to produce an ac- the edible reproductive body of a seed curate record of the observation or plant or tree nut (such as apple, or- measurement. ange, and almond) such that fruit Non-fecal animal byproduct means means the harvestable or harvested solid waste (other than manure) that is part of a plant developed from a flower. animal in origin (such as meat, fat, A vegetable is the edible part of an her- dairy products, eggs, carcasses, blood baceous plant (such as cabbage or po- meal, bone meal, fish meal, shellfish tato) or fleshy fruiting body of a fun- waste (such as crab, shrimp, and lob- gus (such as white button or shiitake) ster waste), fish emulsions, and offal) grown for an edible part such that veg- and is generated by commercial, insti- etable means the harvestable or har- tutional, or agricultural operations. vested part of any plant or fungus Packing means placing food into a whose fruit, fleshy fruiting bodies, container other than packaging the seeds, roots, tubers, bulbs, stems, food and also includes re-packing and leaves, or flower parts are used as food activities performed incidental to and includes mushrooms, sprouts, and packing or re-packing a food (e.g., ac- herbs (such as basil or cilantro). tivities performed for the safe or effec- Produce does not include food grains tive packing or re-packing of that food meaning the small, hard fruits or seeds (such as sorting, culling, grading, and of arable crops, or the crops bearing weighing or conveying incidental to these fruits or seeds, that are primarily packing or re-packing)), but does not grown and processed for use as meal, include activities that transform a raw flour, baked goods, cereals and oils agricultural commodity into a proc- rather than for direct consumption as essed food as defined in section 201(gg) small, hard fruits or seeds (including of the Federal Food, Drug, and Cos- cereal grains, pseudo cereals, oilseeds metic Act. and other plants used in the same fash- Pest means any objectionable ani- ion). Examples of food grains include mals or insects, including birds, ro- barley, dent- or flint-corn, sorghum, dents, flies, and larvae. oats, rice, rye, wheat, amaranth, Pre-consumer vegetative waste means quinoa, buckwheat, and oilseeds (e.g., solid waste that is purely vegetative in cotton seed, flax seed, rapeseed, soy- origin, not considered yard trash, and bean, and sunflower seed). derived from commercial, institu- Production batch of sprouts means all tional, or agricultural operations with- sprouts that are started at the same out coming in contact with animal time in a single growing unit (e.g., a products, byproducts or manure or single drum or bin, or a single rack of

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trays that are connected to each substrate during the growth of covered other), whether or not the sprouts are produce (such as mushrooms and some grown from a single lot of seed (includ- sprouts). ing, for example, when multiple types Spent sprout irrigation water means of seeds are grown in a single growing water that has been used in the grow- unit). ing of sprouts. Qualified end-user, with respect to a Stabilized compost means a stabilized food, means the consumer of the food (i.e., finished) biological soil amend- (where the term consumer does not in- ment produced through a controlled clude a business); or a restaurant or re- composting process. tail food establishment (as those terms Static composting means a process to are defined in § 1.227) that is located: produce stabilized compost in which air (1) In the same State or the same In- is introduced into biological material dian reservation as the farm that pro- (in a pile (or row) that may or may not duced the food; or be covered with insulating material, or (2) Not more than 275 miles from such in an enclosed vessel) by a mechanism farm. that does not include turning. Exam- Raw agricultural commodity (RAC) ples of structural features for intro- means ‘‘raw agricultural commodity’’ ducing air include embedded perforated as defined in section 201(r) of the Fed- pipes and a constructed permanent eral Food, Drug, and Cosmetic Act. base that includes aeration slots. Ex- Sanitize means to adequately treat amples of mechanisms for introducing cleaned surfaces by a process that is ef- air include passive diffusion and me- fective in destroying vegetative cells of chanical means (such as blowers that microorganisms of public health sig- suction air from the composting mate- nificance, and in substantially reduc- rial or blow air into the composting ing numbers of other undesirable material using positive pressure). microorganisms, but without adversely Surface water means all water open to affecting the product or its safety for the atmosphere (rivers, lakes, res- the consumer. ervoirs, streams, impoundments, seas, Sewage sludge biosolids means the estuaries, etc.) and all springs, wells, solid or semi-solid residue generated or other collectors that are directly in- during the treatment of domestic sew- fluenced by surface water. age in a treatment works within the Table waste means any post-consumer meaning of the definition of ‘‘sewage food waste, irrespective of whether the sludge’’ in 40 CFR 503.9(w). source material is animal or vegetative Small business means a farm that is in origin, derived from individuals, in- subject to any of the requirements of stitutions, restaurants, retail oper- this part and, on a rolling basis, the av- ations, or other sources where the food erage annual monetary value of has been served to a consumer. produce (as defined in this section) the Turned composting means a process to farm sold during the previous 3-year produce stabilized compost in which air period is no more than $500,000; and the is introduced into biological material farm is not a very small business as de- (in a pile, row, or enclosed vessel) by fined in this section. turning on a regular basis. Turning is Soil amendment means any chemical, the process of mechanically mixing bi- biological, or physical material (such ological material that is undergoing a as elemental fertilizers, stabilized com- composting process with the specific post, manure, non-fecal animal byprod- intention of moving the outer, cooler ucts, peat moss, perlite, pre-consumer sections of the material being vegetative waste, sewage sludge bio- composted to the inner, hotter sec- solids, table waste, agricultural tea tions. and yard trimmings) intentionally Very small business means a farm that added to the soil to improve the chem- is subject to any of the requirements of ical or physical condition of soil in re- this part and, on a rolling basis, the av- lation to plant growth or to improve erage annual monetary value of the capacity of the soil to hold water. produce (as defined in this section) the The term soil amendment also includes farm sold during the previous 3-year growth media that serve as the entire period is no more than $250,000.

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Visitor means any person (other than (1) During the previous 3-year period personnel) who enters your covered preceding the applicable calendar year, farm with your permission. the average annual monetary value of Water distribution system means a sys- the food (as defined in § 112.3(c)) the tem to carry water from its primary farm sold directly to qualified end- source to its point of use, including users (as defined in § 112.3(c)) during pipes, sprinklers, irrigation canals, such period exceeded the average an- pumps, valves, storage tanks, res- nual monetary value of the food the ervoirs, meters, and fittings. farm sold to all other buyers during We means the U.S. Food and Drug that period; and Administration (FDA). (2) The average annual monetary Yard trimmings means purely vegeta- value of all food (as defined in § 112.3(c)) tive matter resulting from landscaping the farm sold during the 3-year period maintenance or land clearing oper- preceding the applicable calendar year ations, including materials such as tree was less than $500,000, adjusted for in- and shrub trimmings, grass clippings, flation. palm fronds, trees, tree stumps, un- (b) For the purpose of determining treated lumber, untreated wooden pal- whether the average annual monetary lets, and associated rocks and soils. value of all food sold during the 3-year You, for purposes of this part, means period preceding the applicable cal- the owner, operator, or agent in charge endar year was less than $500,000, ad- of a covered farm that is subject to justed for inflation, the baseline year some or all of the requirements of this for calculating the adjustment for in- part. flation is 2011.

[80 FR 74547, Nov. 27, 2015, as amended at 81 § 112.6 What modified requirements FR 26467, May 3, 2016] apply to me if my farm is eligible for a qualified exemption in accord- § 112.4 Which farms are subject to the ance with § 112.5? requirements of this part? (a) If your farm is eligible for a quali- (a) Except as provided in paragraph fied exemption in accordance with (b) of this section, a farm or farm § 112.5, you are subject to the require- mixed-type facility with an average an- ments of: nual monetary value of produce (as (1) This subpart (General Provisions); ‘‘produce’’ is defined in § 112.3(c)) sold (2) Subpart O of this part (Records); during the previous 3-year period of more than $25,000 (on a rolling basis), (3) Subpart Q of this part (Compli- adjusted for inflation using 2011 as the ance and Enforcement); and baseline year for calculating the ad- (4) Subpart R of this part (With- justment, is a ‘‘covered farm’’ subject drawal of Qualified Exemption). to this part. Covered farms subject to (b) In addition, you are subject to the this part must comply with all applica- following modified requirements: ble requirements of this part when con- (1) When a food packaging label is re- ducting a covered activity on covered quired on food that would otherwise be produce. covered produce under the Federal (b) A farm is not a covered farm if it Food, Drug, and Cosmetic Act or its satisfies the requirements in § 112.5 and implementing regulations, you must we have not withdrawn the farm’s ex- include prominently and conspicuously emption in accordance with the re- on the food packaging label the name quirements of subpart R of this part. and the complete business address of the farm where the produce was grown. § 112.5 Which farms are eligible for a (2) When a food packaging label is qualified exemption and associated not required on food that would other- modified requirements based on av- wise be covered produce under the Fed- erage monetary value of all food eral Food, Drug, and Cosmetic Act, you sold and direct farm marketing? must prominently and conspicuously (a) A farm is eligible for a qualified display, at the point of purchase, the exemption and associated modified re- name and complete business address of quirements in a calendar year if: the farm where the produce was grown,

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on a label, poster, sign, placard, or doc- § 112.12 Are there any alternatives to uments delivered contemporaneously the requirements established in this with the produce in the normal course part? of business, or, in the case of Internet (a) You may establish alternatives to sales, in an electronic notice. certain specific requirements of sub- (3) The complete business address part E of this part, as specified in that you must include in accordance § 112.49, provided that you satisfy the with the requirements of paragraph requirements of paragraphs (b) and (c) (b)(1) or (2) of this section must include of this section. the street address or post office box, city, state, and zip code for domestic (b) You may establish and use an al- farms, and comparable full address in- ternative to any of the requirements formation for foreign farms. specified in paragraph (a) of this section, provided you have adequate sci- § 112.7 What records must I establish entific data or information to support and keep if my farm is eligible for a a conclusion that the alternative would qualified exemption in accordance provide the same level of public health with § 112.5? protection as the applicable require- If your farm is eligible for a qualified ment established in this part, and exemption in accordance with § 112.5: would not increase the likelihood that (a) You must establish and keep your covered produce will be adulter- records required under this provision in ated under section 402 of the Federal accordance with the requirements of Food, Drug, and Cosmetic Act, in light subpart O of this part, except that the of your covered produce, practices, and requirement in § 112.161(a)(4) for a sig- conditions. nature or initial of the person per- (c) Scientific data and information forming the activity is not required for used to support an alternative to a re- sales receipts kept in the normal quirement specified in paragraph (a) of course of business. Such receipts must this section may be developed by you, be dated as required under available in the scientific literature, or § 112.161(a)(4). available to you through a third party. (b) You must establish and keep ade- You must establish and maintain docu- quate records necessary to dem- mentation of the scientific data and in- onstrate that your farm satisfies the formation on which you rely in accord- criteria for a qualified exemption that ance with the requirements of subpart are described in § 112.5, including a O of this part. You are not required to written record reflecting that you have notify or seek prior approval from FDA performed an annual review and regarding your decision to establish or verification of your farm’s continued use an alternative under this section. eligibility for the qualified exemption.

Subpart B—General Requirements Subpart C—Personnel Qualifications and Training § 112.11 What general requirements apply to persons who are subject to § 112.21 What requirements apply re- this part? garding qualifications and training for personnel who handle (contact) You must take appropriate measures covered produce or food contact to minimize the risk of serious adverse surfaces? health consequences or death from the use of, or exposure to, covered produce, All of the following requirements including those measures reasonably apply regarding qualifications and necessary to prevent the introduction training for personnel who handle (con- of known or reasonably foreseeable tact) covered produce or food contact hazards into covered produce, and to surfaces: provide reasonable assurances that the (a) All personnel (including tem- produce is not adulterated under sec- porary, part time, seasonal, and con- tion 402 of the Federal Food, Drug, and tracted personnel) who handle covered Cosmetic Act on account of such haz- produce or food contact surfaces, or ards. who are engaged in the supervision

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thereof, must receive adequate train- tained so as not to become a source of ing, as appropriate to the person’s du- contamination of covered produce with ties, upon hiring, and periodically known or reasonably foreseeable haz- thereafter, at least once annually. ards; and (b) All personnel (including tem- (3) Correcting problems with harvest porary, part time, seasonal, and con- containers or equipment, or reporting tracted personnel) who handle covered such problems to the supervisor (or produce or food contact surfaces, or other responsible party), as appropriate who are engaged in the supervision to the person’s job responsibilities. thereof, must have a combination of (c) At least one supervisor or respon- education, training, and experience sible party for your farm must have necessary to perform the person’s as- successfully completed food safety signed duties in a manner that ensures training at least equivalent to that re- compliance with this part. ceived under standardized curriculum (c) Training must be conducted in a recognized as adequate by the Food and manner that is easily understood by Drug Administration. personnel being trained. (d) Training must be repeated as nec- § 112.23 What requirements apply re- essary and appropriate in light of ob- garding supervisors? servations or information indicating You must assign or identify per- that personnel are not meeting stand- sonnel to supervise (or otherwise be re- ards established by FDA in subparts C sponsible for) your operations to en- through O of this part. sure compliance with the requirements of this part. § 112.22 What minimum requirements apply for training personnel who § 112.30 Under this subpart, what re- conduct a covered activity? quirements apply regarding (a) At a minimum, all personnel who records? handle (contact) covered produce dur- (a) You must establish and keep ing covered activities or supervise the records required under this subpart in conduct of such activities must receive accordance with the requirements of training that includes all of the fol- subpart O of this part. lowing: (b) You must establish and keep (1) Principles of food hygiene and records of training that document re- food safety; quired training of personnel, including (2) The importance of health and per- the date of training, topics covered, sonal hygiene for all personnel and and the persons(s) trained. visitors, including recognizing symptoms of a health condition that is rea- Subpart D—Health and Hygiene sonably likely to result in contamination of covered produce or food contact § 112.31 What measures must I take to surfaces with microorganisms of public prevent ill or infected persons from health significance; and contaminating covered produce (3) The standards established by FDA with microorganisms of public in subparts C through O of this part health significance? that are applicable to the employee’s (a) You must take measures to pre- job responsibilities. vent contamination of covered produce (b) Persons who conduct harvest ac- and food contact surfaces with micro- tivities for covered produce must also organisms of public health significance receive training that includes all of the from any person with an applicable following: health condition (such as commu- (1) Recognizing covered produce that nicable illnesses that present a public must not be harvested, including cov- health risk in the context of normal ered produce that may be contami- work duties, infection, open lesion, nated with known or reasonably fore- vomiting, or diarrhea). seeable hazards; (b) The measures you must take to (2) Inspecting harvest containers and satisfy the requirements of paragraph equipment to ensure that they are (a) of this section must include all of functioning properly, clean, and main- the following measures:

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(1) Excluding any person from work- (iv) Upon return to the work station ing in any operations that may result after any break or other absence from in contamination of covered produce or the work station; food contact surfaces with microorga- (v) As soon as practical after touch- nisms of public health significance ing animals (including livestock and when the person (by medical examina- working animals), or any waste of ani- tion, the person’s acknowledgement, or mal origin; and observation) is shown to have, or ap- (vi) At any other time when the pears to have, an applicable health con- hands may have become contaminated dition, until the person’s health condi- in a manner that is reasonably likely tion no longer presents a risk to public to lead to contamination of covered health; and produce with known or reasonably (2) Instructing personnel to notify foreseeable hazards; their supervisor(s) (or a responsible (4) If you choose to use gloves in han- party) if they have, or if there is a rea- dling covered produce or food contact sonable possibility that they have an surfaces, maintaining gloves in an in- applicable health condition. tact and sanitary condition and replac- ing such gloves when no longer able to § 112.32 What hygienic practices must do so; personnel use? (5) Removing or covering hand jewelry that cannot be adequately cleaned (a) Personnel who work in an oper- and sanitized during periods in which ation in which covered produce or food covered produce is manipulated by contact surfaces are at risk of contami- hand; and nation with known or reasonably fore- (6) Not eating, chewing gum, or using seeable hazards must use hygienic tobacco products in an area used for a practices while on duty to the extent covered activity (however, drinking necessary to protect against such con- beverages is permitted in designated tamination. areas). (b) The hygienic practices that personnel use to satisfy the requirements § 112.33 What measures must I take to of paragraph (a) of this section when prevent visitors from contami- handling (contacting) covered produce nating covered produce and food or food contact surfaces during a cov- contact surfaces with microorganisms of public health significance? ered activity must include all of the following practices: (a) You must make visitors aware of (1) Maintaining adequate personal policies and procedures to protect cov- cleanliness to protect against contami- ered produce and food contact surfaces nation of covered produce and food con- from contamination by people and take tact surfaces; all steps reasonably necessary to ensure that visitors comply with such (2) Avoiding contact with animals policies and procedures. other than working animals, and tak- (b) You must make toilet and hand- ing appropriate steps to minimize the washing facilities accessible to visi- likelihood of contamination of covered tors. produce when in direct contact with working animals; (3) Washing hands thoroughly, in- Subpart E—Agricultural Water cluding scrubbing with soap (or other § 112.41 What requirements apply to effective surfactant) and running water the quality of agricultural water? that satisfies the requirements of All agricultural water must be safe § 112.44(a) (as applicable) for water used and of adequate sanitary quality for its to wash hands, and drying hands thor- intended use. oughly using single-service towels, sanitary towel service, electric hand dry- § 112.42 What requirements apply to ers, or other adequate hand drying de- my agricultural water sources, vices: water distribution system, and pool- (i) Before starting work; ing of water? (ii) Before putting on gloves; (a) At the beginning of a growing sea- (iii) After using the toilet; son, as appropriate, but at least once

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annually, you must inspect all of your contamination of covered produce with agricultural water systems, to the ex- known or reasonably foreseeable haz- tent they are under your control (in- ards as a result of contact of covered cluding water sources, water distribu- produce with pooled water. For exam- tion systems, facilities, and equip- ple, such measures may include using ment), to identify conditions that are protective barriers or staking to keep reasonably likely to introduce known covered produce from touching the or reasonably foreseeable hazards into ground or using an alternative irriga- or onto covered produce or food con- tion method. tact surfaces in light of your covered produce, practices, and conditions, in- § 112.43 What requirements apply to cluding consideration of the following: treating agricultural water? (1) The nature of each agricultural (a) When agricultural water is treat- water source (for example, ground ed in accordance with § 112.45: water or surface water); (1) Any method you use to treat agri- (2) The extent of your control over cultural water (such as with physical each agricultural water source; treatment, including using a pesticide (3) The degree of protection of each device as defined by the U.S. Environ- agricultural water source; mental Protection Agency (EPA); EPA- (4) Use of adjacent and nearby land; registered antimicrobial pesticide and product; or other suitable method) (5) The likelihood of introduction of must be effective to make the water known or reasonably foreseeable haz- safe and of adequate sanitary quality ards to agricultural water by another for its intended use and/or meet the user of agricultural water before the relevant microbial quality criteria in water reaches your covered farm. § 112.44, as applicable. (b) You must adequately maintain all (2) You must deliver any treatment agricultural water distribution sys- of agricultural water in a manner to tems to the extent they are under your ensure that the treated water is con- control as necessary and appropriate to sistently safe and of adequate sanitary prevent the water distribution system quality for its intended use and/or con- from being a source of contamination sistently meets the relevant microbial to covered produce, food contact sur- quality criteria in § 112.44, as applica- faces, areas used for a covered activity, ble. or water sources, including by regu- (b) You must monitor any treatment larly inspecting and adequately storing of agricultural water at a frequency all equipment used in the system. adequate to ensure that the treated (c) You must adequately maintain all water is consistently safe and of ade- agricultural water sources to the ex- quate sanitary quality for its intended tent they are under your control (such use and/or consistently meets the rel- as wells). Such maintenance includes evant microbial quality criteria in regularly inspecting each source to § 112.44, as applicable. identify any conditions that are reasonably likely to introduce known or § 112.44 What specific microbial qual- reasonably foreseeable hazards into or ity criteria apply to agricultural onto covered produce or food contact water used for certain intended surfaces; correcting any significant de- uses? ficiencies (e.g., repairs to well cap, well (a) When you use agricultural water casing, sanitary seals, piping tanks and for any one or more of these following treatment equipment, and control of purposes, you must ensure there is no cross-connections); and keeping the detectable generic Escherichia coli (E. source free of debris, trash, domes- coli) in 100 milliliters (mL) of agricul- ticated animals, and other possible tural water, and you must not use un- sources of contamination of covered treated surface water for any of these produce to the extent practicable and purposes: appropriate under the circumstances. (1) Used as sprout irrigation water; (d) As necessary and appropriate, you (2) Applied in any manner that di- must implement measures reasonably rectly contacts covered produce during necessary to reduce the potential for or after harvest activities (for example,

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water that is applied to covered produce or food contact surfaces, make produce for washing or cooling activi- necessary changes, and take adequate ties, and water that is applied to har- measures to determine if your changes vested crops to prevent dehydration be- were effective and, as applicable, ade- fore cooling), including when used to quately ensure that your agricultural make ice that directly contacts cov- water meets the microbial quality cri- ered produce during or after harvest terion in § 112.44(a); or activities; (2) Treat the water in accordance (3) Used to contact food contact sur- with the requirements of § 112.43. faces, or to make ice that will contact (b) If you have determined that your food contact surfaces; and agricultural water does not meet the (4) Used for washing hands during and microbial quality criteria (or any al- after harvest activities. ternative microbial quality criteria, if (b) When you use agricultural water applicable) required under § 112.44(b), as during growing activities for covered soon as practicable and no later than produce (other than sprouts) using a di- the following year, you must dis- rect water application method, the fol- continue that use, unless you either: lowing criteria apply (unless you estab- (1) Apply a time interval(s) (in days) lish and use alternative criteria in ac- and/or a (calculated) log reduction by: cordance with § 112.49): (i) Applying a time interval between (1) A geometric mean (GM) of your last irrigation and harvest using ei- agricultural water samples of 126 or ther: less colony forming units (CFU) of ge- (A) A microbial die-off rate of 0.5 log neric E. coli per 100 mL of water (GM is per day to achieve a (calculated) log re- a measure of the central tendency of duction of your geometric mean (GM) your water quality distribution); and and statistical threshold value (STV) (2) A statistical threshold value to meet the microbial quality criteria (STV) of your agricultural water sam- in § 112.44(b) (or any alternative micro- ples of 410 or less CFU of generic E. coli bial criteria, if applicable), but no per 100 mL of water (STV is a measure greater than a maximum time interval of variability of your water quality dis- of 4 consecutive days; or tribution, derived as a model-based cal- (B) An alternative microbial die-off culation approximating the 90th per- rate and any accompanying maximum centile using the lognormal distribu- time interval, in accordance with tion). § 112.49; and/or (ii) Applying a time interval between § 112.45 What measures must I take if harvest and end of storage using an ap- my agricultural water does not propriate microbial die-off rate be- meet the requirements of § 112.41 or tween harvest and end of storage, and/ § 112.44? or applying a (calculated) log reduction (a) If you have determined or have using appropriate microbial removal reason to believe that your agricul- rates during activities such as commer- tural water is not safe or of adequate cial washing, to meet the microbial sanitary quality for its intended use as quality criteria in § 112.44(b) (or any al- required under § 112.41 and/or if your ternative microbial criteria, if applica- agricultural water does not meet the ble), and any accompanying maximum microbial quality criterion for the time interval or log reduction, pro- specified purposes as required under vided you have adequate supporting § 112.44(a), you must immediately dis- scientific data and information; continue that use(s), and before you (2) Re-inspect the entire affected ag- may use the water source and/or dis- ricultural water system to the extent tribution system again for the intended it is under your control, identify any use(s), you must either: conditions that are reasonably likely (1) Re-inspect the entire affected ag- to introduce known or reasonably fore- ricultural water system to the extent seeable hazards into or onto covered it is under your control, identify any produce or food contact surfaces, make conditions that are reasonably likely necessary changes, and take adequate to introduce known or reasonably fore- measures to determine if your changes seeable hazards into or onto covered were effective and adequately ensure

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that your agricultural water meets the (ii) The samples of agricultural water microbial quality criteria in § 112.44(b) must be representative of your use of (or any alternative microbial criteria, the water and must be collected as if applicable); or close in time as practicable to, but (3) Treat the water in accordance prior to, harvest. The microbial water with the requirements of § 112.43. quality profile initially consists of the geometric mean (GM) and the statis- § 112.46 How often must I test agricul- tical threshold value (STV) of generic tural water that is subject to the re- Escherichia coli (E. coli) (colony forming quirements of § 112.44? units (CFU) per 100 milliliter (mL)) cal- (a) There is no requirement to test culated using this data set. You must any agricultural water that is subject determine the appropriate way(s) in to the requirements of § 112.44 when: which the water may be used based on (1) You receive water from a Public your microbial water quality profile in Water System, as defined under the accordance with § 112.45(b). Safe Drinking Water Act (SDWA) regu- (iii) You must update the microbial lations, 40 CFR part 141, that furnishes water quality profile annually as re- water that meets the microbial required under paragraph (b)(2) of this quirements under those regulations or section, and otherwise required under under the regulations of a State (as de- paragraph (b)(3) of this section. fined in 40 CFR 141.2) approved to ad- (2) Conduct an annual survey to up- minister the SDWA public water sup- date the microbial water quality pro- ply program, and you have Public file of your agricultural water. Water System results or certificates of (i) After the initial survey described compliance that demonstrate that the in paragraph (b)(1)(i) of this section, water meets that requirement; you must test the water annually to (2) You receive water from a public update your existing microbial water water supply that furnishes water that quality profile to confirm that the meets the microbial quality require- way(s) in which the water is used con- ment described in § 112.44(a), and you tinues to be appropriate. You must have public water system results or analyze: certificates of compliance that dem- (A) For an untreated surface water onstrate that the water meets that resource, a minimum number of five quirement; or samples per year (or an alternative (3) You treat water in accordance testing frequency that you establish with the requirements of § 112.43. and use, in accordance with § 112.49). (b) Except as provided in paragraph (B) For an untreated ground water (a) of this section, you must take the source, a minimum of one sample per following steps for each source of water year. used for purposes that are subject to (ii) The samples of agricultural water the requirements of § 112.44(b): must be representative of your use of (1) Conduct an initial survey to de- the water and must be collected as velop a microbial water quality profile close in time as practicable to, but of the agricultural water source. prior to, harvest. (i) The initial survey must be con- (iii) To update the microbial water ducted: quality profile, you must calculate re- (A) For an untreated surface water vised GM and STV values using your source, by taking a minimum total of current annual survey data, combined 20 samples of agricultural water (or an with your most recent initial or annual alternative testing frequency that you survey data from within the previous 4 establish and use, in accordance with years, to make up a rolling data set of: § 112.49) over a minimum period of 2 (A) At least 20 samples for untreated years, but not greater than 4 years. surface water sources; and (B) For an untreated ground water (B) At least 4 samples for untreated source, by taking a minimum total of ground water sources. four samples of agricultural water dur- (iv) You must modify your water use, ing the growing season or over a period as appropriate, based on the revised of 1 year. GM and STV values in your updated

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microbial water quality profile in ac- (1) Test results from your agricul- cordance with § 112.45(b). tural water source(s) performed by you, (3) If you have determined or have or by a person or entity acting on your reason to believe that your microbial behalf; or water quality profile no longer rep- (2) Data collected by a third party or resents the quality of your water (for parties, provided the water source(s) example, if there are significant sampled by the third party or parties changes in adjacent land use that are adequately represent your agricultural reasonably likely to adversely affect water source(s) and all other applicable the quality of your water source), you requirements of this part are met. must develop a new microbial water (b) Agricultural water samples must quality profile reflective of the time be aseptically collected and tested period at which you believe your mi- using a method as set forth in § 112.151. crobial water quality profile changed. (i) To develop a new microbial water § 112.48 What measures must I take for quality profile, you must calculate new water that I use during harvest, GM and STV values using your current packing, and holding activities for annual survey data (if taken after the covered produce? time of the change), combined with (a) You must manage the water as new data, to make up a data set of: necessary, including by establishing (A) At least 20 samples for untreated and following water-change schedules surface water sources; and for re-circulated water, to maintain its (B) At least 4 samples for untreated safety and adequate sanitary quality ground water sources. and minimize the potential for con- (ii) You must modify your water use tamination of covered produce and food based on the new GM and STV values contact surfaces with known or reason- in your new microbial water quality ably foreseeable hazards (for example, profile in accordance with § 112.45(b). hazards that may be introduced into (c) If you use untreated ground water the water from soil adhering to the for the purposes that are subject to the covered produce). requirements of § 112.44(a), you must (b) You must visually monitor the initially test the microbial quality of quality of water that you use during each source of the untreated ground harvest, packing, and holding activi- water at least four times during the ties for covered produce (for example, growing season or over a period of 1 water used for washing covered produce year, using a minimum total of four in dump tanks, flumes, or wash tanks, samples collected to be representative and water used for cooling covered of the intended use(s). Based on these produce in hydrocoolers) for buildup of results, you must determine whether organic material (such as soil and the water can be used for that purpose, plant debris). in accordance with § 112.45(a). If your four initial sample results meet the (c) You must maintain and monitor microbial quality criteria of § 112.44(a), the temperature of water at a tempera- you may test once annually thereafter, ture that is appropriate for the com- using a minimum of one sample col- modity and operation (considering the lected to be representative of the in- time and depth of submersion) and is tended use(s). You must resume testing adequate to minimize the potential for at least four times per growing season infiltration of microorganisms of pub- or year if any annual test fails to meet lic health significance into covered the microbial quality criteria in produce. § 112.44(a). § 112.49 What alternatives may I estab- § 112.47 Who must perform the tests lish and use in lieu of the require- required under § 112.46 and what ments of this subpart? methods must be used? Provided you satisfy the require- (a) You may meet the requirements ments of § 112.12, you may establish and related to agricultural water testing use one or more of the following alter- required under § 112.46 using: natives:

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(a) An alternative microbial quality culated) log reduction applied in ac- criterion (or criteria) using an appro- cordance with § 112.45(b)(1)(i) and/or (ii), priate indicator of fecal contamina- such documentation must include the tion, in lieu of the microbial quality specific time interval or log reduction criteria in § 112.44(b); applied, how the time interval or log (b) An alternative microbial die-off reduction was determined, and the rate and an accompanying maximum dates of corresponding activities such time interval, in lieu of the microbial as the dates of last irrigation and har- die-off rate and maximum time inter- vest, the dates of harvest and end of val in § 112.45(b)(1)(i); storage, and/or the dates of activities (c) An alternative minimum number such as commercial washing); of samples used in the initial survey (7) Annual documentation of the re- for an untreated surface water source, sults or certificates of compliance from in lieu of the minimum number of sam- a public water system required under ples required under § 112.46(b)(1)(i)(A); § 112.46(a)(1) or (2), if applicable; and (8) Scientific data or information you (d) An alternative minimum number rely on to support any alternative that of samples used in the annual survey you establish and use in accordance for an untreated surface water source, with § 112.49; and in lieu of the minimum number of sam- (9) Any analytical methods you use ples required under § 112.46(b)(2)(i)(A). in lieu of the method that is incorporated by reference in § 112.151(a). § 112.50 Under this subpart, what requirements apply regarding Subpart F—Biological Soil Amend- records? ments of Animal Origin and (a) You must establish and keep Human Waste records required under this subpart in accordance with the requirements of § 112.51 What requirements apply for subpart O of this part. determining the status of a biologi- (b) You must establish and keep the cal soil amendment of animal ori- following records: gin? (1) The findings of the inspection of (a) A biological soil amendment of your agricultural water system in ac- animal origin is treated if it has been cordance with the requirements of processed to completion to adequately § 112.42(a); reduce microorganisms of public health (2) Documentation of the results of significance in accordance with the re- all analytical tests conducted on agri- quirements of § 112.54, or, in the case of cultural water for purposes of compli- an agricultural tea, the biological ma- ance with this subpart; terials of animal origin used to make (3) Scientific data or information you the tea have been so processed, the rely on to support the adequacy of a water used to make the tea is not un- method used to satisfy the require- treated surface water, and the water ments of § 112.43(a)(1) and (2); used to make the tea has no detectable (4) Documentation of the results of generic Escherichia coli (E. coli) in 100 water treatment monitoring under milliliters (mL) of water. § 112.43(b); (b) A biological soil amendment of (5) Scientific data or information you animal origin is untreated if it: rely on to support the microbial die-off (1) Has not been processed to comple- or removal rate(s) that you used to de- tion in accordance with the require- termine the time interval (in days) be- ments of § 112.54, or in the case of an tween harvest and end of storage, in- agricultural tea, the biological mate- cluding other activities such as com- rials of animal origin used to make the mercial washing, as applicable, used to tea have not been so processed, or the achieve the calculated log reduction of water used to make the tea is un- generic Escherichia coli (E. coli), in ac- treated surface water, or the water cordance with § 112.45(b)(1)(ii); used to make the tea has detectable ge- (6) Documentation of actions you neric E. coli in 100 mL of water; take in accordance with § 112.45. With (2) Has become contaminated after respect to any time interval or (cal- treatment;

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(3) Has been recombined with an un- cal soil amendment of animal origin treated biological soil amendment of that you apply in the growing of cov- animal origin; ered produce, provided that the result- (4) Is or contains a component that is ing biological soil amendments are ap- untreated waste that you know or have plied in accordance with the applicable reason to believe is contaminated with requirements of § 112.56: a hazard or has been associated with (a) A scientifically valid controlled foodborne illness; or physical process (e.g., thermal), chem- (5) Is an agricultural tea made with ical process (e.g., high alkaline pH), bi- biological materials of animal origin that contains an agricultural tea addi- ological process (e.g., composting), or a tive. combination of scientifically valid controlled physical, chemical and/or bio- § 112.52 How must I handle, convey, logical processes that has been vali- and store biological soil amend- dated to satisfy the microbial standard ments of animal origin? in § 112.55(a) for Listeria monocytogenes (a) You must handle, convey and (L. monocytogenes), Salmonella species, store any biological soil amendment of and E. coli O157:H7; or animal origin in a manner and location (b) A scientifically valid controlled such that it does not become a poten- physical, chemical, or biological proc- tial source of contamination to covered ess, or a combination of scientifically produce, food contact surfaces, areas valid controlled physical, chemical, used for a covered activity, water and/or biological processes, that has sources, water distribution systems, been validated to satisfy the microbial and other soil amendments. Agricul- standard in § 112.55(b) for Salmonella tural teas that are biological soil amendments of animal origin may be species and fecal coliforms. Examples used in water distribution systems proof scientifically valid controlled bio- vided that all other requirements of logical (e.g., composting) processes this rule are met. that meet the microbial standard in (b) You must handle, convey and § 112.55(b) include: store any treated biological soil (1) Static composting that maintains amendment of animal origin in a man- aerobic (i.e., oxygenated) conditions at ner and location that minimizes the a minimum of 131 °F (55 °C) for 3 con- risk of it becoming contaminated by an secutive days and is followed by ade- untreated or in-process biological soil quate curing; and amendment of animal origin. (2) Turned composting that main- (c) You must handle, convey, and tains aerobic conditions at a minimum store any biological soil amendment of of 131 °F (55 °C) for 15 days (which do animal origin that you know or have not have to be consecutive), with a reason to believe may have become minimum of five turnings, and is fol- contaminated as if it was untreated. lowed by adequate curing. § 112.53 What prohibitions apply regarding use of human waste? § 112.55 What microbial standards apply to the treatment processes in You may not use human waste for § 112.54? growing covered produce, except sewage sludge biosolids used in accordance The following microbial standards with the requirements of 40 CFR part apply to the treatment processes in 503, subpart D, or equivalent regu- § 112.54 as set forth in that section. latory requirements. (a) For L. monocytogenes, Salmonella species, and E. coli O157:H7, the rel- § 112.54 What treatment processes are evant standards in the table in this acceptable for a biological soil paragraph (a); or amendment of animal origin that I apply in the growing of covered produce? Each of the following treatment processes are acceptable for a biologi-

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For the microorganism— The microbial standard is—

(1) L. monocytogenes ...... Not detected using a method that can detect one colony forming unit (CFU) per 5 gram (or milliliter, if liquid is being sampled) analytical portion. (2) Salmonella species ...... Not detected using a method that can detect three most probable numbers (MPN) per 4 grams (or milliliter, if liquid is being sampled) of total solids. (3) E. coli O157:H7 ...... Not detected using a method that can detect 0.3 MPN per 1 gram (or milliliter, if liquid is being sampled) analytical portion.

(b) Salmonella species are not de- § 112.56 What application require- tected using a method that can detect ments and minimum application in- three MPN Salmonella species per 4 tervals apply to biological soil grams (or milliliter, if liquid is being amendments of animal origin? sampled) of total solids; and less than (a) You must apply the biological soil 1,000 MPN fecal coliforms per gram (or amendments of animal origin specified milliliter, if liquid is being sampled) of in the first column of the table in this total solids. paragraph (a) in accordance with the application requirements specified in [80 FR 74547, Nov. 27, 2015, as amended at 81 the second column of the table in this FR 26468, May 3, 2016] paragraph (a) and the minimum application intervals specified in the third column of the table in this paragraph (a).

And then the If the biological soil amendment of animal origin Then the biological soil amendment of animal or- minimum application in- is— igin must be applied— terval is—

(1)(i) Untreated ...... In a manner that does not contact covered [Reserved]. produce during application and minimizes the potential for contact with covered produce after application. (ii) Untreated...... In a manner that does not contact covered 0 days. produce during or after application. (2) Treated by a scientifically valid controlled In a manner that minimizes the potential for con- 0 days. physical, chemical, or biological process, or tact with covered produce during and after ap- combination of scientifically valid controlled plication. physical, chemical, and/or biological processes, in accordance with the requirements of § 112.54(b) to meet the microbial standard in § 112.55(b). (3) Treated by a scientifically valid controlled In any manner (i.e., no restrictions) ...... 0 days. physical, chemical, or biological process, or combination of scientifically valid controlled physical, chemical, or biological processes, in accordance with the requirements of § 112.54(a) to meet the microbial standard in § 112.55(a).

(b) [Reserved] (1) For a treated biological soil amendment of animal origin you re- § 112.60 Under this subpart, what receive from a third party, documenta- quirements apply regarding tion (such as a Certificate of Conform- records? ance) at least annually that: (a) You must establish and keep (i) The process used to treat the bio- records required under this subpart in logical soil amendment of animal ori- accordance with the requirements of gin is a scientifically valid process that subpart O of this part. has been carried out with appropriate (b) For any biological soil amend- process monitoring; and ment of animal origin you use, you must establish and keep the following records:

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(ii) The biological soil amendment of quirements of § 112.112 and take meas- animal origin has been handled, con- ures reasonably necessary during grow- veyed and stored in a manner and loca- ing to assist you later during harvest tion to minimize the risk of contami- when you must identify, and not har- nation by an untreated or in process bi- vest, covered produce that is reason- ological soil amendment of animal ori- ably likely to be contaminated with a gin; and known or reasonably foreseeable haz- (2) For a treated biological soil ard. amendment of animal origin you produce for your own covered farm(s), § 112.84 Does this regulation require documentation that process controls covered farms to take actions that would constitute a ‘‘taking’’ of (for example, time, temperature, and threatened or endangered species; turnings) were achieved. to take measures to exclude animals from outdoor growing areas; Subpart G–H [Reserved] or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drain- Subpart I—Domesticated and Wild ages? Animals No. Nothing in this regulation au- § 112.81 How do the requirements of thorizes the ‘‘taking’’ of threatened or this subpart apply to areas where endangered species as that term is de- covered activities take place? fined by the Endangered Species Act (16 U.S.C. 1531–1544) ( to harass, (a) The requirements of this subpart i.e., harm, pursue, hunt, shoot, wound, kill, apply when a covered activity takes trap, capture, or collect, or to attempt place in an outdoor area or a partially- to engage in any such conduct), in vio- enclosed building and when, under the lation of the Endangered Species Act. circumstances, there is a reasonable This regulation does not require cov- probability that animals will contami- ered farms to take measures to exclude nate covered produce. animals from outdoor growing areas, or (b) The requirements of this subpart to destroy animal habitat or otherwise do not apply: clear farm borders around outdoor (1) When a covered activity takes growing areas or drainages. place in a fully-enclosed building; or (2) To fish used in aquaculture operations. Subpart J [Reserved] § 112.83 What requirements apply re- Subpart K—Growing, Harvesting, garding grazing animals, working Packing, and Holding Activities animals, and animal intrusion? (a) You must take the steps set forth § 112.111 What measures must I take if in paragraph (b) of this section if under I grow, harvest, pack or hold both the circumstances there is a reasonable covered and excluded produce? probability that grazing animals, If you grow, harvest, pack or hold working animals, or animal intrusion produce that is not covered in this part will contaminate covered produce. (i.e., excluded produce in accordance (b) You must: with § 112.2) and also conduct such ac- (1) Assess the relevant areas used for tivities on covered produce, and the ex- a covered activity for evidence of po- cluded produce is not grown, harvested, tential contamination of covered packed or held in accordance with this produce as needed during the growing part, you must take measures during season (based on your covered produce; these covered activities, as applicable, your practices and conditions; and to: your observations and experience); and (a) Keep covered produce separate (2) If significant evidence of potential from excluded produce (except when contamination is found (such as obser- covered produce and excluded produce vation of animals, animal excreta or are placed in the same container for crop destruction), you must evaluate distribution); and whether the covered produce can be (b) Adequately clean and sanitize, as harvested in accordance with the re- necessary, any food contact surfaces

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that contact excluded produce before § 112.116 What measures must I take using such food contact surfaces for when using food-packing (including covered activities on covered produce. food packaging) material? (a) You must use food-packing mate- § 112.112 What measures must I take rial that is adequate for its intended immediately prior to and during harvest activities? use, which includes being: (1) Cleanable or designed for single You must take all measures reason- use; and ably necessary to identify, and not har- (2) Unlikely to support growth or vest, covered produce that is reason- transfer of bacteria. ably likely to be contaminated with a (b) If you reuse food-packing mate- known or reasonably foreseeable haz- rial, you must take adequate steps to ard, including steps to identify and not ensure that food contact surfaces are harvest covered produce that is visibly clean, such as by cleaning food-packing contaminated with animal excreta. At containers or using a clean liner. a minimum, identifying and not harvesting covered produce that is reasonably likely to be contaminated with Subpart L—Equipment, Tools, animal excreta or that is visibly con- Buildings, and Sanitation taminated with animal excreta requires a visual assessment of the grow- § 112.121 What equipment and tools ing area and all covered produce to be are subject to the requirements of this subpart? harvested, regardless of the harvest method used. Equipment and tools subject to the requirements of this subpart are those § 112.113 How must I handle harvested that are intended to, or likely to, con- covered produce during covered ac- tact covered produce; and those instru- tivities? ments or controls used to measure, reg- You must handle harvested covered ulate, or record conditions to control produce during covered activities in a or prevent the growth of microorga- manner that protects against contami- nisms of public health significance. Ex- nation with known or reasonably fore- amples include knives, implements, seeable hazards—for example, by avoid- mechanical harvesters, waxing machin- ing, to the degree practicable, contact ery, cooling equipment (including of cut surfaces of harvested produce hydrocoolers), grading belts, sizing with soil. equipment, palletizing equipment, and equipment used to store or convey har- § 112.114 What requirements apply to vested covered produce (such as con- dropped covered produce? tainers, bins, food-packing material, You must not distribute dropped cov- dump tanks, flumes, and vehicles or ered produce. Dropped covered produce other equipment used for transport is covered produce that drops to the that are intended to, or likely to, con- ground before harvest. Dropped covered tact covered produce). produce does not include root crops that grow underground (such as car- § 112.122 What buildings are subject to rots), crops that grow on the ground the requirements of this subpart? (such as cantaloupe), or produce that is Buildings subject to the require- intentionally dropped to the ground as ments of this subpart include: part of harvesting (such as almonds). (a) Any fully- or partially-enclosed building used for covered activities, in- § 112.115 What measures must I take cluding minimal structures that have a when packaging covered produce? roof but do not have any walls; and You must package covered produce in (b) Storage sheds, buildings, or other a manner that prevents the formation structures used to store food contact of Clostridium botulinum toxin if such surfaces (such as harvest containers toxin is a known or reasonably foresee- and food-packing materials). able hazard (such as for mushrooms).

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§ 112.123 What general requirements (pH), sanitizer efficacy or other condi- apply regarding equipment and tions, in order to control or prevent tools subject to this subpart? the growth of microorganisms of public All of the following requirements health significance, must be: apply regarding equipment and tools (a) Accurate and precise as necessary subject to this subpart: and appropriate in keeping with their (a) You must use equipment and purpose; tools that are of adequate design, con- (b) Adequately maintained; and struction, and workmanship to enable (c) Adequate in number for their des- them to be adequately cleaned and ignated uses. properly maintained; and (b) Equipment and tools must be: § 112.125 What requirements apply to (1) Installed and maintained as to fa- equipment that is subject to this subpart used in the transport of cilitate cleaning of the equipment and covered produce? of all adjacent spaces; and (2) Stored and maintained to protect Equipment that is subject to this covered produce from being contami- subpart that you use to transport cov- nated with known or reasonably fore- ered produce must be: seeable hazards and to prevent the (a) Adequately clean before use in equipment and tools from attracting transporting covered produce; and and harboring pests. (b) Adequate for use in transporting (c) Seams on food contact surfaces of covered produce. equipment and tools that you use must be either smoothly bonded, or main- § 112.126 What requirements apply to my buildings? tained to minimize accumulation of dirt, filth, food particles, and organic (a) All of the following requirements material and thus minimize the oppor- apply regarding buildings: tunity for harborage or growth of (1) Buildings must be suitable in size, microorganisms. construction, and design to facilitate (d)(1) You must inspect, maintain, maintenance and sanitary operations and clean and, when necessary and ap- for covered activities to reduce the po- propriate, sanitize all food contact sur- tential for contamination of covered faces of equipment and tools used in produce or food contact surfaces with covered activities as frequently as rea- known or reasonably foreseeable haz- sonably necessary to protect against ards. Buildings must: contamination of covered produce. (i) Provide sufficient space for place- (2) You must maintain and clean all ment of equipment and storage of ma- non-food-contact surfaces of equipment terials; and tools subject to this subpart used (ii) Permit proper precautions to be during harvesting, packing, and hold- taken to reduce the potential for con- ing as frequently as reasonably nec- tamination of covered produce, food essary to protect against contamina- contact surfaces, or packing materials tion of covered produce. with known or reasonably foreseeable (e) If you use equipment such as pal- hazards. The potential for contamina- lets, forklifts, tractors, and vehicles tion must be reduced by effective de- such that they are intended to, or like- sign including the separation of oper- ly to, contact covered produce, you ations in which contamination is likely must do so in a manner that minimizes to occur, by one or more of the fol- the potential for contamination of cov- lowing means: Location, time, parti- ered produce or food contact surfaces tion, enclosed systems, or other effec- with known or reasonably foreseeable tive means; and hazards. (2) You must provide adequate drainage in all areas where normal oper- § 112.124 What requirements apply to ations release or discharge water or instruments and controls used to other liquid waste on the ground or measure, regulate, or record? floor of the building. Instruments or controls you use to (b) You must implement measures to measure, regulate, or record tempera- prevent contamination of your covered tures, hydrogen-ion concentration produce and food contact surfaces in

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your buildings, as appropriate, consid- cilities, including toilet facilities read- ering the potential for such contamina- ily accessible to growing areas during tion through: harvesting activities. (1) Floors, walls, ceilings, fixtures, (b) Your toilet facilities must be de- ducts, or pipes; and signed, located, and maintained to: (2) Drip or condensate. (1) Prevent contamination of covered produce, food contact surfaces, areas § 112.127 What requirements apply reused for a covered activity, water garding domesticated animals in sources, and water distribution sys- and around a fully-enclosed building? tems with human waste; (2) Be directly accessible for serv- (a) You must take reasonable pre- icing, be serviced and cleaned at a fre- cautions to prevent contamination of quency sufficient to ensure suitability covered produce, food contact surfaces, of use, and be kept supplied with toilet and food-packing materials in fully-en- paper; and closed buildings with known or reason- (3) Provide for the sanitary disposal ably foreseeable hazards from domes- of waste and toilet paper. ticated animals by: (c) During growing activities that (1) Excluding domesticated animals take place in a fully-enclosed building, from fully-enclosed buildings where and during covered harvesting, pack- covered produce, food contact surfaces, ing, or holding activities, you must or food-packing material is exposed; or provide a hand-washing station in suf- (2) Separating domesticated animals ficiently close proximity to toilet fa- in a fully enclosed building from an cilities to make it practical for persons area where a covered activity is con- who use the toilet facility to wash ducted on covered produce by location, time, or partition. their hands. (b) Guard or guide dogs may be al- § 112.130 What requirements apply for lowed in some areas of a fully enclosed hand-washing facilities? building if the presence of the dogs is unlikely to result in contamination of All of the following requirements produce, food contact surfaces, or food- apply to hand-washing facilities: packing materials. (a) You must provide personnel with adequate, readily accessible hand- § 112.128 What requirements apply re- washing facilities during growing ac- garding pest control in buildings? tivities that take place in a fully-en- (a) You must take those measures closed building, and during covered reasonably necessary to protect cov- harvest, packing, or holding activities. ered produce, food contact surfaces, (b) Your hand-washing facilities must and food-packing materials from con- be furnished with: tamination by pests in buildings, in- (1) Soap (or other effective surfac- cluding routine monitoring for pests as tant); necessary and appropriate. (2) Running water that satisfies the (b) For fully-enclosed buildings, you requirements of § 112.44(a) for water must take measures to exclude pests used to wash hands; and from your buildings. (3) Adequate drying devices (such as (c) For partially-enclosed buildings, single service towels, sanitary towel you must take measures to prevent service, or electric hand dryers). pests from becoming established in (c) You must provide for appropriate your buildings (such as by use of disposal of waste (for example, waste screens or by monitoring for the pres- water and used single-service towels) ence of pests and removing them when associated with a hand-washing facility present). and take appropriate measures to prevent waste water from a hand-washing § 112.129 What requirements apply to facility from contaminating covered toilet facilities? produce, food contact surfaces, areas All of the following requirements used for a covered activity, agricul- apply to toilet facilities: tural water sources, and agricultural (a) You must provide personnel with water distribution systems with known adequate, readily accessible toilet fa- or reasonably foreseeable hazards.

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(d) You may not use antiseptic hand known or reasonably foreseeable haz- rubs as a substitute for soap (or other ards. effective surfactant) and water. (b) You must adequately operate systems for waste treatment and disposal § 112.131 What must I do to control so that they do not constitute a poten- and dispose of sewage? tial source of contamination in areas All of the following requirements used for a covered activity. apply for the control and disposal of § 112.133 What requirements apply to sewage: plumbing? (a) You must dispose of sewage into The plumbing must be of an adequate an adequate sewage or septic system or size and design and be adequately in- through other adequate means. stalled and maintained to: (b) You must maintain sewage and (a) Distribute water under pressure septic systems in a manner that pre- as needed, in sufficient quantities, in vents contamination of covered all areas where used for covered activi- produce, food contact surfaces, areas ties, for sanitary operations, or for used for a covered activity, agricul- hand-washing and toilet facilities; tural water sources, and agricultural (b) Properly convey sewage and liq- water distribution systems with known uid disposable waste; or reasonably foreseeable hazards. (c) Avoid being a source of contami- (c) You must manage and dispose of nation to covered produce, food contact leakages or spills of human waste in a surfaces, areas used for a covered activ- manner that prevents contamination of ity, or agricultural water sources; and covered produce, and prevents or mini- (d) Not allow backflow from, or cross mizes contamination of food contact connection between, piping systems surfaces, areas used for a covered activ- that discharge waste water or sewage ity, agricultural water sources, or agri- and piping systems that carry water cultural water distribution systems. used for a covered activity, for sani- (d) After a significant event (such as tary operations, or for use in hand- flooding or an earthquake) that could washing facilities. negatively impact a sewage or septic system, you must take appropriate § 112.134 What must I do to control animal excreta and litter from do- steps to ensure that sewage and septic mesticated animals that are under systems continue to operate in a man- my control? ner that does not contaminate covered (a) If you have domesticated animals, produce, food contact surfaces, areas to prevent contamination of covered used for a covered activity, agricul- produce, food contact surfaces, areas tural water sources, or agricultural used for a covered activity, agricul- water distribution systems. tural water sources, or agricultural water distribution systems with ani- § 112.132 What must I do to control and dispose of trash, litter, and mal waste, you must: waste in areas used for covered ac- (1) Adequately control their excreta tivities? and litter; and (2) Maintain a system for control of All of the following requirements animal excreta and litter. apply to the control and disposal of (b) [Reserved] trash, litter, and waste in areas used for covered activities: § 112.140 Under this subpart, what re- (a) You must convey, store, and dis- quirements apply regarding pose of trash, litter and waste to: records? (1) Minimize the potential for trash, (a) You must establish and keep litter, or waste to attract or harbor records required under this subpart in pests; and accordance with the requirements of (2) Protect against contamination of subpart O of this part. covered produce, food contact surfaces, (b) You must establish and keep doc- areas used for a covered activity, agri- umentation of the date and method of cultural water sources, and agricul- cleaning and sanitizing of equipment tural water distribution systems with subject to this subpart used in:

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(1) Growing operations for sprouts; that are likely to occur in the seeds or and beans; or (2) Covered harvesting, packing, or (2) You are not required to take the holding activities. steps set forth in paragraphs (b)(1) and (2) of this section if you later reason- Subpart M—Sprouts ably determine, through appropriate followup actions, that the lot of seeds § 112.141 What commodities are sub- or beans is not the source of contami- ject to this subpart? nation (e.g., the lot of seeds or beans is The requirements of this subpart not the source of a pathogen found in apply to growing, harvesting, packing, spent sprout irrigation water or and holding of all sprouts, except soil- sprouts). or substrate-grown sprouts harvested (d) You must visually examine seeds without their roots. and beans, and packaging used to ship seeds or beans, for signs of potential § 112.142 What requirements apply to contamination with known or reason- seeds or beans used to grow ably foreseeable hazards. sprouts? (e) You must either: In addition to the requirements of (1) Treat seeds or beans that will be this part, all of the following require- used to grow sprouts using a scientif- ments apply to seeds or beans used to ically valid method to reduce micro- grow sprouts. organisms of public health signifi- (a) You must take measures reason- cance; or ably necessary to prevent the introduc- (2) Rely on prior treatment of seeds tion of known or reasonably foresee- or beans conducted by a grower, dis- able hazards into or onto seeds or tributor, or supplier of the seeds or beans that you will use for sprouting. beans (whether to fulfill this require- (b) Except as provided in paragraph ment completely or for the purpose of (c) of this section, if you know or have considering such prior treatment when reason to believe that a lot of seeds or applying appropriate additional treat- beans may be contaminated with a ment of the seeds or beans at the cov- pathogen (either because it has been ered farm immediately before sprout- associated with foodborne illness; or ing), provided that you obtain docu- based on microbial test results, includ- mentation (such as a Certificate of ing a positive finding of a pathogen in Conformance) from the grower, dis- tests required under § 112.144(b)), you tributor, or supplier that: must: (i) The prior treatment was con- (1) Discontinue use of all seeds or ducted using a scientifically valid beans from that lot for sprout produc- method to reduce microorganisms of tion and ensure that sprouts grown public health significance; and from that lot of seeds or beans do not (ii) The treated seeds or beans were enter commerce; and handled and packaged following the (2) Report the information (associa- treatment in a manner that minimizes tion with illness and/or findings of mi- the potential for contamination. crobial testing) to the seed grower, distributor, supplier, or other entity from § 112.143 What measures must I take whom you received the seeds or beans. for growing, harvesting, packing, (c) If your reason to believe that a lot and holding sprouts? of seeds or beans may be contaminated You must take all of the following was based only on microbial test re- measures for growing, harvesting, sults: packing, and holding sprouts: (1) You are not required to take the (a) You must grow, harvest, pack, steps set forth in paragraph (b)(1) of and hold sprouts in a fully-enclosed this section if you treat your lot of building. seeds or beans with a process that is (b) Any food contact surfaces you use reasonably certain to achieve destruc- to grow, harvest, pack, or hold sprouts tion or elimination in the seeds or must be cleaned and sanitized before beans of the most resistant microorga- contact with sprouts or seeds or beans nisms of public health significance used to grow sprouts.

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(c) You must conduct testing during or death from use of, or exposure to, growing, harvesting, packing, and hold- sprouts; and ing sprouts, as specified in § 112.144. (2) A scientifically valid test method (d) You must establish and imple- for the pathogen is available to detect ment a written environmental moni- the pathogen in spent sprout irrigation toring plan as specified in § 112.145. water (or sprouts). (e) You must take certain actions if you detect Listeria species or L. § 112.145 What requirements apply to monocytogenes in the growing, har- testing the environment for Listeria vesting, packing, or holding environ- species or L. monocytogenes? ment, as specified in § 112.146. All of the following testing require- (f) You must establish and implement ments apply for the growing, har- a written sampling plan to test spent vesting, packing, and holding environ- sprout irrigation water or sprouts for ment for Listeria species or L. pathogens as specified in § 112.147. monocytogenes. (g) You must take certain actions if (a) You must establish and imple- the samples of spent sprout irrigation ment a written environmental moni- water or sprouts test positive for a toring plan that is designed to identify pathogen as specified in § 112.148. L. monocytogenes if it is present in the growing, harvesting, packing, or hold- § 112.144 What testing must I do during growing, harvesting, packing, ing environment. and holding sprouts? (b) Your written environmental monitoring plan must be directed to sam- All of the following testing must be pling and testing for either Listeria spe- done during growing, harvesting, pack- cies or L. monocytogenes. ing, and holding sprouts: (a) You must test the growing, har- (c) Your written environmental mon- vesting, packing, and holding environ- itoring plan must include a sampling ment for Listeria species or L. plan that specifies: monocytogenes in accordance with the (1) What you will test collected sam- requirements of § 112.145. ples for (i.e., Listeria species or L. (b) You must either: monocytogenes); (1) Test spent sprout irrigation water (2) How often you will collect envi- from each production batch of sprouts ronmental samples, which must be no for E. coli O157:H7, Salmonella species, less than monthly, and at what point and any pathogens meeting the criteria during production you will collect the in paragraph (c) of this section, in ac- samples; and cordance with the requirements of (3) Sample collection sites; the num- § 112.147; or ber and location of sampling sites must (2) If testing spent sprout irrigation be sufficient to determine whether water is not practicable (for example, measures are effective and must in- soil-grown sprouts harvested with clude appropriate food contact surfaces roots or for hydroponically grown and non-food-contact surfaces of equip- sprouts that use very little water), test ment, and other surfaces within the each production batch of sprouts at the growing, harvesting, packing, and hold- in-process stage (i.e., while sprouts are ing environment. still growing) for E. coli O157:H7, Sal- (d) You must aseptically collect envi- monella species, and any pathogens ronmental samples and test them for meeting the criteria in paragraph (c) of Listeria species or L. monocytogenes this section, in accordance with the re- using a method as set forth in § 112.152. quirements of § 112.147. (e) Your written environmental mon- (c) In addition to E. coli O157:H7 and itoring plan must include a corrective Salmonella species, you must conduct action plan that, at a minimum, re- tests as provided in paragraph (b) of quires you to take the actions in this section for additional pathogens § 112.146, and details when and how you when the following conditions are met: will accomplish those actions, if the (1) Testing for the pathogen is rea- growing, harvesting, packing, or hold- sonably necessary to minimize the risk ing environment tests positive for Lis- of serious adverse health consequences teria species or L. monocytogenes.

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§ 112.146 What actions must I take if gens using a method as set forth in the growing, harvesting, packing, § 112.153. You must not allow the pro- or holding environment tests posi- duction batch of sprouts to enter into tive for Listeria species or L. commerce unless the results of the monocytogenes? testing of spent sprout irrigation water You must, at a minimum, take the or sprouts are negative for E. coli following actions if you detect Listeria O157:H7, Salmonella species, and, if ap- species or L. monocytogenes in the grow- plicable, a pathogen meeting the cri- ing, harvesting, packing, or holding en- teria in § 112.144(c). vironment: (c) Your written sampling plan must (a) Conduct additional testing of sur- include a corrective action plan that at faces and areas surrounding the area a minimum, requires you to take the where Listeria species or L. actions in § 112.148, and details when monocytogenes was detected to evaluate and how you will accomplish those ac- the extent of the problem, including tions, if the samples of spent sprout ir- the potential for Listeria species or L. rigation water or sprouts test positive monocytogenes to have become estab- for E. coli O157:H7, Salmonella species, lished in a niche; or a pathogen meeting the criteria in (b) Clean and sanitize the affected § 112.144(c). surfaces and surrounding areas; § 112.148 What actions must I take if (c) Conduct additional sampling and the samples of spent sprout irriga- testing to determine whether the Lis- tion water or sprouts test positive teria species or L. monocytogenes has for a pathogen? been eliminated; You must, at a minimum, take the (d) Conduct finished product testing following actions if the samples of when appropriate; spent sprout irrigation water or (e) Perform any other actions nec- sprouts test positive for E. coli O157:H7, essary to prevent recurrence of the Salmonella species, or a pathogen meet- contamination; and ing the criteria in § 112.144(c): (f) Take appropriate action to pre- (a) Take appropriate action to prevent any food that is adulterated under vent any food that is adulterated under section 402 of the Federal Food, Drug, section 402 of the Federal Food, Drug, and Cosmetic Act from entering into and Cosmetic Act from entering into commerce. commerce; (b) Take the steps required in § 112.147 What must I do to collect and § 112.142(b) with respect to the lot of test samples of spent sprout irriga- seeds or beans used to grow the af- tion water or sprouts for pathogens? fected production batch of sprouts (except as allowed under § 112.142(c)); All of the following requirements (c) Clean and sanitize the affected apply for collecting and testing sam- surfaces and surrounding areas; and ples of spent sprout irrigation water or (d) Perform any other actions nec- sprouts for pathogens as required in essary to prevent reoccurrence of the § 112.144(b): contamination. (a) You must establish and implement a written sampling plan that § 112.150 Under this subpart, what re- identifies the number and location of quirements apply regarding samples (of spent sprout irrigation records? water or sprouts) to be collected for (a) You must establish and keep each production batch of sprouts to en- records required under this subpart in sure that the collected samples are rep- accordance with the requirements of resentative of the production batch subpart O of this part. when testing for contamination. (b) You must establish and keep the (b) In accordance with the written following records: sampling plan required under para- (1) Documentation of your treatment graph (a) of this section, you must of seeds or beans to reduce microorga- aseptically collect samples of spent nisms of public health significance in sprout irrigation water or sprouts, and the seeds or beans, at your farm; or al- test the collected samples for patho- ternatively, documentation (such as a

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Certificate of Conformance) from your od of analysis in § 112.151(a) in accu- seed supplier that seeds or beans are racy, precision, and sensitivity; or treated to reduce microorganisms of (2) For any other indicator of fecal public health significance and are ap- contamination you may test for pursu- propriately handled and packaged fol- ant to § 112.49(a), a scientifically valid lowing the treatment, in accordance method. with the requirements of § 112.142(e); (2) Your written environmental mon- § 112.152 What methods must I use to itoring plan in accordance with the retest the growing, harvesting, pack- quirements of § 112.145; ing, and holding environment for (3) Your written sampling plan for Listeria species or L. each production batch of sprouts in ac- monocytogenes to satisfy the re- cordance with the requirements of quirements of § 112.144(a)? § 112.147(a) and (c); You must test the growing, har- (4) Documentation of the results of vesting, packing, and holding environ- all analytical tests conducted for pur- ment for Listeria species or L. poses of compliance with this subpart; monocytogenes using: (5) Any analytical methods you use (a) The method of analysis described in lieu of the methods that are incor- in ‘‘Testing Methodology for Listeria porated by reference in §§ 112.152 and species or L. monocytogenes in Environ- 112.153; and mental Samples,’’ Version 1, October (6) Documentation of actions you 2015, U.S. Food and Drug Administra- take in accordance with §§ 112.142(b) tion. The Director of the Federal Reg- and (c), 112.146, and 112.148. ister approves this incorporation by reference in accordance with 5 U.S.C. Subpart N—Analytical Methods 552(a) and 1 CFR part 5. You may obtain a copy from, and/or inspect a copy § 112.151 What methods must I use to at, the Division of Produce Safety, test the quality of water to satisfy Center for Food Safety and Applied Nu- the requirements of § 112.46? trition (CFSAN), U.S. Food and Drug You must test the quality of water Administration, 5001 Campus Dr., Col- using: lege Park, MD 20740, 240–402–1600; (a) The method of analysis published FDA’s Main Library, 10903 New Hamp- by the U.S. Environmental Protection shire Ave., Bldg. 2, Third Floor, Silver Agency (EPA), ‘‘Method 1603: Esch- Spring, MD 20993, 301–796–2039; http:// erichia coli (E. coli) in Water by Mem- www.fda.gov/fsma; or at the National brane Filtration Using Modified mem- Archives and Records Administration brane-Thermotolerant Escherichia coli (NARA). For information on the avail- Agar (Modified mTEC), EPA–821–R–09– ability of this material at NARA, call 007),’’ December, 2009. The Director of 202–741–6030, or go to: http:// the Federal Register approves this in- www.archives.gov/federallregister/ corporation by reference in accordance codeloflfederallregulation/ with 5 U.S.C. 552(a) and 1 CFR part 51. ibrllocations.html; or You may obtain a copy from EPA, Of- (b) A scientifically valid method that fice of Water (4303T), 1200 Pennsylvania is at least equivalent to the method of Avenue NW., Washington, DC 20460. analysis in § 112.152(a) in accuracy, pre- You may inspect a copy at FDA’s Main cision, and sensitivity. Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD § 112.153 What methods must I use to 20993, 301–796–2039, or at the National test spent sprout irrigation water Archives and Records Administration (or sprouts) from each production (NARA). For information on the avail- batch of sprouts for pathogens to ability of this material at NARA, call satisfy the requirements of § 112.144(b) and (c)? 202–741–6030, or go to: http:// www.archives.gov/federallregister/ You must test spent sprout irrigation codeloflfederallregulations/ water (or sprouts) from each produc- ibrllocations.html; or tion batch for pathogens using: (b)(1) A scientifically valid method (a) For E. coli O157:H7, Salmonella spe- that is at least equivalent to the meth- cies:

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(1) The method of analysis described (2) Be created at the time an activity in ‘‘Testing Methodologies for E. coli is performed or observed; O157:H7 and Salmonella species in Spent (3) Be accurate, legible, and indelible; Sprout Irrigation Water (or Sprouts),’’ and Version 1, October 2015, U.S. Food and (4) Be dated, and signed or initialed Drug Administration. The Director of by the person who performed the activ- the Federal Register approves this in- ity documented. corporation by reference in accordance (b) Records required under §§ 112.7(b), with 5 U.S.C. 552(a) and 1 CFR part 5. 112.30(b)(2), 112.50(b)(2), (4), and (6), You may obtain a copy from, and/or in- 112.60(b)(2), 112.140(b)(1) and (2), and spect a copy at, the Division of 112.150(b)(1), (4), and (6), must be re- Produce Safety, Center for Food Safety viewed, dated, and signed, within a rea- and Applied Nutrition (CFSAN), Food sonable time after the records are and Drug Administration, 5001 Campus made, by a supervisor or responsible Dr., College Park, MD 20740, 240–402– party. 1600; FDA’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, § 112.162 Where must I store records? Silver Spring, MD 20993, 301–796–2039; (a) Offsite storage of records is per- http://www.fda.gov/fsma; or at the Na- mitted if such records can be retrieved tional Archives and Records Adminis- and provided onsite within 24 hours of tration (NARA). For information on request for official review. the availability of this material at NARA, call 202–741–6030, or go to: http:// (b) Electronic records are considered www.archives.gov/federallregister/ to be onsite at your farm if they are codeloflfederallregulation/ accessible from an onsite location at ibrllocations.html; or your farm. (2) A scientifically valid method that § 112.163 May I use existing records to is at least equivalent to the method of satisfy the requirements of this analysis in § 112.153(a)(1) in accuracy, part? precision, and sensitivity; and (a) Existing records (e.g., records that (b) For any other pathogen(s) meet- are kept to comply with other Federal, ing the criteria in § 112.144(c), a sci- State, or local regulations, or for any entifically valid method. other reason) do not need to be duplicated if they contain all of the required Subpart O—Records information and satisfy the requirements of this part. Existing records § 112.161 What general requirements may be supplemented as necessary to apply to records required under include all of the required information this part? and satisfy the requirements of this (a) Except as otherwise specified, all part. records required under this part must: (b) The information required by this (1) Include, as applicable: part does not need to be kept in one set (i) The name and location of your of records. If existing records contain farm; some of the required information, any (ii) Actual values and observations new information required by this part obtained during monitoring; may be kept either separately or com- (iii) An adequate description (such as bined with the existing records. the commodity name, or the specific variety or brand name of a commodity, § 112.164 How long must I keep and, when available, any lot number or records? other identifier) of covered produce ap- (a)(1) You must keep records required plicable to the record; by this part for at least 2 years past (iv) The location of a growing area the date the record was created. (for example, a specific field) or other (2) Records that a farm relies on dur- area (for example, a specific packing ing the 3-year period preceding the ap- shed) applicable to the record; and plicable calendar year to satisfy the (v) The date and time of the activity criteria for a qualified exemption, in documented; accordance with §§ 112.5 and 112.7, must

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be retained as long as necessary to sup- turned to your farm within 24 hours for port the farm’s status during the appli- official review upon request. cable calendar year. (b) Records that relate to the general § 112.167 Can records that I provide to adequacy of the equipment or processes FDA be disclosed to persons outside or records that relate to analyses, sam- of FDA? pling, or action plans being used by a Records obtained by FDA in accord- farm, including the results of scientific ance with this part are subject to the studies, tests, and evaluations, must be disclosure requirements under part 20 retained at the farm for at least 2 years of this chapter. after the use of such equipment or processes, or records related to anal- Subpart P—Variances yses, sampling, or action plans, is discontinued. § 112.171 Who may request a variance from the requirements of this part? § 112.165 What formats are acceptable for the records I keep? A State, Federally-recognized tribe You must keep records as: (or ‘‘tribe’’), or a foreign country from (a) Original records; which food is imported into the United (b) True copies (such as photocopies, States may request a variance from pictures, scanned copies, microfilm, one or more requirements of this part, microfiche, or other accurate reproduc- where the State, tribe, or foreign coun- tions of the original records); or try determines that: (c) Electronic records. Records that (a) The variance is necessary in light are established or maintained to sat- of local growing conditions; and isfy the requirements of this part and (b) The procedures, processes, and that meet the definition of electronic practices to be followed under the vari- records in § 11.3(b)(6) of this chapter are ance are reasonably likely to ensure exempt from the requirements of part that the produce is not adulterated 11 of this chapter. Records that satisfy under section 402 of the Federal Food, the requirements of this part, but that Drug, and Cosmetic Act and to provide also are required under other applica- the same level of public health protec- ble statutory provisions or regulations, tion as the requirements of this part. remain subject to part 11 of this chapter. § 112.172 How may a State, tribe, or foreign country request a variance § 112.166 What requirements apply for from one or more requirements of making records available and ac- this part? cessible to FDA? To request a variance from one or (a) You must have all records re- more requirements of this part, the quired under this part readily available competent authority (i.e., the regu- and accessible during the retention pe- latory authority for food safety) for a riod for inspection and copying by FDA State, tribe, or a foreign country must upon oral or written request, except submit a petition under § 10.30 of this that you have 24 hours to obtain chapter. records you keep offsite and make them available and accessible to FDA § 112.173 What must be included in the for inspection and copying. Statement of Grounds in a petition requesting a variance? (b) If you use electronic techniques to keep records, or to keep true copies In addition to the requirements set of records, or if you use reduction tech- forth in § 10.30 of this chapter, the niques such as microfilm to keep true Statement of Grounds in a petition re- copies of records, you must provide the questing a variance must: records to FDA in a format in which (a) Provide a statement that the ap- they are accessible and legible. plicable State, tribe, or foreign country (c) If your farm is closed for a pro- has determined that the variance is longed period, the records may be necessary in light of local growing con- transferred to some other reasonably ditions and that the procedures, proc- accessible location but must be re- esses, and practices to be followed

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under the variance are reasonably like- cause their farm is covered by the peti- ly to ensure that the produce is not tion or as a person similarly situated adulterated under section 402 of the to persons covered by the petition). Federal Food, Drug and Cosmetic Act (c) Under § 10.30(e)(3) of this chapter, and to provide the same level of public we will respond to the petitioner in health protection as the requirements writing and will also make public a no- of this part; tice on FDA’s Web site announcing our (b) Describe with particularity the decision to either grant or deny the pe- variance requested, including the per- tition. sons to whom the variance would apply (1) If we grant the petition, either in and the provision(s) of this part to whole or in part, we will specify the which the variance would apply; persons to whom the variance applies (c) Present information dem- and the provision(s) of this part to onstrating that the procedures, proc- which the variance applies. esses, and practices to be followed (2) If we deny the petition (including under the variance are reasonably like- partial denials), our written response ly to ensure that the produce is not to the petitioner and our public notice adulterated under section 402 of the announcing our decision to deny the Federal Food, Drug, and Cosmetic Act petition will explain the reason(s) for (21 U.S.C. 342) and to provide the same the denial. level of public health protection as the (d) We will make readily accessible requirements of this part. to the public, and periodically update, a list of filed petitions requesting § 112.174 What information submitted variances, including the status of each in a petition requesting a variance petition (for example, pending, grant- or submitted in comments on such ed, or denied). a petition are publicly available? We will presume that information § 112.177 Can an approved variance submitted in a petition requesting a apply to any person other than variance and comments submitted on those identified in the petition re- such a petition, including a request questing that variance? that a variance be applied to its simi- (a) A State, tribe, or a foreign coun- larly situated persons, does not contain try that believes that a variance re- information exempt from public disclo- quested by a petition submitted by an- sure under part 20 of this chapter and other State, tribe, or foreign country will be made public as part of the dock- should also apply to similarly situated et associated with this request. persons in its jurisdiction may request that the variance be applied to its § 112.175 Who responds to a petition similarly situated persons by submit- requesting a variance? ting comments in accordance with The Director or Deputy Directors of § 10.30 of this chapter. These comments the Center for Food Safety and Applied must include the information required Nutrition (CFSAN), or the Director, Of- in § 112.173. If FDA determines that fice of Compliance, CFSAN, responds these comments should instead be to a request for a variance. treated as a separate request for a variance, FDA will notify the State, tribe, § 112.176 What process applies to a pe- or foreign country that submitted tition requesting a variance? these comments that a separate re- (a) In general, the procedures set quest must be submitted in accordance forth in § 10.30 of this chapter govern with §§ 112.172 and 112.173. our response to a petition requesting a (b) If we grant a petition requesting a variance. variance, in whole or in part, we may (b) Under § 10.30(h)(3) of this chapter, specify that the variance also applies we will publish a notice in the FEDERAL to persons in a specific location who REGISTER, requesting information and are similarly situated to those identi- views on a filed petition, including in- fied in the petition. formation and views from persons who (c) If we specify that the variance could be affected by the variance if the also applies to persons in a specific lo- petition were to be granted (e.g., be- cation who are similarly situated to

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those identified in the petition, we will (2) We will publish a notice of our de- inform the applicable State, tribe, or termination that a variance should be foreign country where the similarly modified or revoked in the FEDERAL situated persons are located of our de- REGISTER. This notice will establish a cision in writing and will publish a no- public docket so that interested parties tice on our Web site announcing our may submit written comments on our decision to apply the variance to simi- determination. larly situated persons in that par- (3) When applicable, we will: ticular location. (i) Notify in writing any States, tribes, or foreign countries where a § 112.178 Under what circumstances variance applies to similarly situated may FDA deny a petition request- persons of our determination that the ing a variance? variance should be modified or re- We may deny a variance request if it voked; does not provide the information re- (ii) Provide those States, tribes, or quired under § 112.173 (including the re- foreign countries with an opportunity quirements of § 10.30 of this chapter), or to request an informal hearing under if we determine that the variance is part 16 of this chapter; and not reasonably likely to ensure that (iii) Include in the FEDERAL REGISTER the produce is not adulterated under notice described in paragraph (a)(2) of section 402 of the Federal Food, Drug this section public notification of our and Cosmetic Act and to provide the decision to modify or revoke the vari- same level of public health protection ance granted to States, tribes, or for- as the requirements of this part. eign countries in which similarly situated persons are located. § 112.179 When does a variance ap- (b) We will consider submissions from proved by FDA become effective? affected States, tribes, or foreign coun- A variance approved by FDA becomes tries and from other interested parties effective on the date of our written de- as follows: cision on the petition. (1) We will consider requests for hearings by affected States, tribes, or for- § 112.180 Under what circumstances eign countries under part 16 of this may FDA modify or revoke an ap- chapter. proved variance? (i) If FDA grants a hearing, we will We may modify or revoke a variance provide the State, tribe, or foreign if we determine that such variance is country with an opportunity to make not reasonably likely to ensure that an oral submission. We will provide no- the produce is not adulterated under tice on our Web site of the hearing, in- section 402 of the Federal Food, Drug, cluding the time, date, and place of the and Cosmetic Act and to provide the hearing. same level of public health protection (ii) If more than one State, tribe, or as the requirements of this part. foreign country requests an informal hearing under part 16 of this chapter § 112.181 What procedures apply if about our determination that a par- FDA determines that an approved ticular variance should be modified or variance should be modified or re- revoked, we may consolidate such revoked? quests (for example, into a single hear- (a) We will provide the following no- ing). tifications: (2) We will consider written submis- (1) We will notify a State, tribe, or a sions submitted to the public docket foreign country directly, in writing at from interested parties. the address identified in its petition, if (c) We will provide notice of our final we determine that a variance granted decision as follows: in response to its petition should be (1) On the basis of the administrative modified or revoked. Our direct, writ- record, FDA will issue a written deci- ten notification will provide the State, sion, as provided for under part 16 of tribe, or foreign country with an oppor- this chapter. tunity to request an informal hearing (2) We will publish a notice of our de- under part 16 of this chapter. cision in the FEDERAL REGISTER. The

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effective date of the decision will be (2) In violation of section 361 of the the date of publication of the notice. Public Health Service Act (42 U.S.C. 264). § 112.182 What are the permissible types of variances that may be § 112.193 What are the provisions for granted? coordination of education and en- A variance(s) may be requested for forcement? one or more requirements in subparts Under section 419(b)(2)(A) of the Fed- A through O of this part. Examples of eral Food, Drug, and Cosmetic Act, permissible types of variances include: FDA coordinates education and en- (a) Variance from the microbial qual- forcement activities by State, terri- ity criteria when agricultural water is torial, tribal, and local officials by used during growing activities for cov- helping develop education, training, ered produce (other than sprouts) using and enforcement approaches. a direct water application method, established in § 112.44(b); Subpart R—Withdrawal of (b) Variance from the microbial die- Qualified Exemption off rate that is used to determine the time interval between last irrigation § 112.201 Under what circumstances and harvest, and/or the accompanying can FDA withdraw a qualified ex- maximum time interval, established in emption in accordance with the re- § 112.45(b)(1)(i); and quirements of § 112.5? (c) Variance from the approach or (a) We may withdraw your qualified frequency for testing water used for exemption under § 112.5: purposes that are subject to the re- (1) In the event of an active inves- quirements of § 112.44(b), established in tigation of a foodborne illness outbreak § 112.46(b). that is directly linked to your farm; or (2) If we determine that it is nec- Subpart Q—Compliance and essary to protect the public health and Enforcement prevent or mitigate a foodborne illness outbreak based on conduct or condi- § 112.192 What is the applicability and status of this part? tions associated with your farm that are material to the safety of the food (a) The failure to comply with the re- that would otherwise be covered quirements of this part, issued under produce grown, harvested, packed or section 419 of the Federal Food, Drug, held at your farm. and Cosmetic Act, is a prohibited act (b) Before FDA issues an order to under section 301(vv) of the Federal withdraw your qualified exemption, Food, Drug, and Cosmetic Act. FDA: (b) The criteria and definitions in (1) May consider one or more other this part apply in determining whether actions to protect the public health a food is: and prevent or mitigate a foodborne (1) Adulterated within the meaning illness outbreak, including a warning of: letter, recall, administrative deten- (i) Section 402(a)(3) of the Federal tion, refusal of food offered for import, Food, Drug, and Cosmetic Act in that seizure, and injunction; the food has been grown, harvested, packed, or held under such conditions (2) Must notify the owner, operator, that it is unfit for food; or or agent in charge of the farm, in writ- (ii) Section 402(a)(4) of the Federal ing, of circumstances that may lead Food, Drug, and Cosmetic Act in that FDA to withdraw the exemption, and the food has been prepared, packed, or provide an opportunity for the owner, held under insanitary conditions operator, or agent in charge of the whereby it may have become contami- farm to respond in writing, within 15 nated with filth, or whereby it may calendar days of the date of receipt of have been rendered injurious to health; the notification, to FDA’s notification; or and

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(3) Must consider the actions taken frame, agreed to by FDA, based on a by the farm to address the cir- written justification, submitted to cumstances that may lead FDA to FDA, for a timeframe that exceeds 120 withdraw the exemption. calendar days from the date of receipt of the order; or § 112.202 What procedure will FDA use (2) Appeal the order within 15 cal- to withdraw an exemption? endar days of the date of receipt of the (a) An FDA District Director in order in accordance with the require- whose district the farm is located (or, ments of § 112.206. in the case of a foreign farm, the Direc- (e) A statement that a farm may re- tor of the Office of Compliance in the quest that FDA reinstate an exemption Center for Food Safety and Applied Nu- that was withdrawn by following the trition), or an FDA official senior to ei- procedures in § 112.213; ther such Director, must approve an (f) The text of section 419(f) of the order to withdraw the exemption be- Federal Food, Drug, and Cosmetic Act fore the order is issued. and of this subpart; (b) Any officer or qualified employee (g) A statement that any informal of FDA may issue an order to withdraw hearing on an appeal of the order must the exemption after it has been ap- be conducted as a regulatory hearing proved in accordance with paragraph under part 16 of this chapter, with cer- (a) of this section. tain exceptions described in § 112.208; (c) FDA must issue an order to withdraw the exemption to the owner, oper- (h) The mailing address, telephone ator, or agent in charge of the farm. number, email address, and facsimile (d) FDA must issue an order to with- number of the FDA district office and draw the exemption in writing, signed the name of the FDA District Director and dated by the officer or qualified in whose district the farm is located employee of FDA who is issuing the (or for foreign farms, the same infor- order. mation for the Director of the Office of Compliance in the Center for Food § 112.203 What information must FDA Safety and Applied Nutrition); and include in an order to withdraw a (i) The name and the title of the FDA qualified exemption? representative who approved the order. An order to withdraw a qualified exemption applicable to a farm under § 112.204 What must I do if I receive an § 112.5 must include the following infor- order to withdraw a qualified exemption applicable to my farm? mation: (a) The date of the order; The owner, operator, or agent in (b) The name, address and location of charge of a farm that receives an order the farm; to withdraw a qualified exemption ap- (c) A brief, general statement of the plicable to that farm under § 112.5 must reasons for the order, including infor- either: mation relevant to one or both of the (a) Comply with applicable require- following circumstances that leads ments of this part within 120 calendar FDA to issue the order: days of the date from receipt of the (1) An active investigation of a order or, if operations have ceased and foodborne illness outbreak that is di- will not resume within 120 calendar rectly linked to the farm; or days, before the beginning of oper- (2) Conduct or conditions associated ations in the next growing season, or with a farm that are material to the within a reasonable timeframe, agreed safety of the food that would otherwise to by FDA, based on a written jus- be covered produce grown, harvested, tification, submitted to FDA, for a packed and held at such farm. timeframe that exceeds 120 calendar (d) A statement that the farm must days from the date of receipt of the either: order; or (1) Comply with subparts B through O (b) Appeal the order within 15 cal- of this part on the date that is 120 calendar days of the date of receipt of the endar days from the date of receipt of order in accordance with the require- the order, or within a reasonable time- ments of § 112.206.

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§ 112.205 Can I appeal or request a agent in charge of the farm may in- hearing on an order to withdraw a clude a written request for an informal qualified exemption applicable to hearing as provided in § 112.207. my farm? (a) Submission of an appeal, includ- § 112.207 What is the procedure for re- ing submission of a request for an in- questing an informal hearing? formal hearing, will not operate to (a) If the owner, operator, or agent in delay or stay any administrative ac- charge of the farm appeals the order, tion, including enforcement action by the owner, operator, or agent in charge FDA, unless the Commissioner of Food of the farm: and Drugs, as a matter of discretion, (1) May request an informal hearing; determines that delay or a stay is in and the public interest. (2) Must submit any request for an (b) If the owner, operator, or agent in informal hearing together with its charge of the farm appeals the order, written appeal submitted in accordance and FDA confirms the order: with § 112.206 within 15 calendar days of (1) The owner, operator, or agent in the date of receipt of the order. charge of the farm must comply with (b) A request for an informal hearing applicable requirements of this part may be denied, in whole or in part, if within 120 calendar days from the date the presiding officer determines that of receipt of the order, or, if operations no genuine and substantial issue of ma- have ceased and will not resume within terial fact has been raised by the mate- 120 calendar days, before the beginning rial submitted. If the presiding officer of operations in the next growing sea- determines that a hearing is not justi- son, or within a reasonable timeframe, fied, a written notice of the determina- agreed to by FDA, based on a written tion will be given to the owner, oper- justification, submitted to FDA, for a ator, or agent in charge of the farm ex- timeframe that exceeds 120 calendar plaining the reason for the denial. days from the date of receipt of the order; and § 112.208 What requirements are appli- (2) The owner, operator, or agent in cable to an informal hearing? charge of the farm is no longer subject If the owner, operator, or agent in to the modified requirements in §§ 112.6 charge of the farm requests an infor- and 112.7. mal hearing, and FDA grants the request: § 112.206 What is the procedure for (a) The hearing will be held within 15 submitting an appeal? calendar days after the date the appeal (a) To appeal an order to withdraw a is filed or, if applicable, within a time- qualified exemption applicable to a frame agreed upon in writing by the farm under § 112.5, the owner, operator, owner, operator, or agent in charge of or agent in charge of the farm must: the farm and FDA. (1) Submit the appeal in writing to (b) The presiding officer may require the FDA District Director in whose dis- that a hearing conducted under this trict the farm is located (or in the case subpart be completed within 1 calendar of a foreign farm, the Director of the day, as appropriate. Office of Compliance in the Center for (c) FDA must conduct the hearing in Food Safety and Applied Nutrition), at accordance with part 16 of this chapter, the mailing address, email address, or except that: facsimile number identified in the (1) The order withdrawing an exemp- order within 15 calendar days of the tion under § 112.5, rather than the no- date of receipt of the order; and tice under § 16.22(a) of this chapter, pro- (2) Respond with particularity to the vides notice of the opportunity for a facts and issues contained in the order, hearing under this section and is part including any supporting documenta- of the administrative record of the reg- tion upon which the owner, operator or ulatory hearing under § 16.80(a) of this agent in charge of the farm relies. chapter. (b) In a written appeal of the order (2) A request for a hearing under this withdrawing an exemption provided subpart must be addressed to the FDA under § 112.5, the owner, operator, or District Director (or, in the case of a

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foreign farm, the Director of the Office hearing and the presiding officer’s final of Compliance in the Center for Food decision. Safety and Applied Nutrition) as provided in the order withdrawing an ex- § 112.209 Who is the presiding officer emption. for an appeal and for an informal hearing? (3) Section 112.209, rather than § 16.42(a) of this chapter, describes the The presiding officer for an appeal, FDA employees who preside at hear- and for an informal hearing, must be ings under this subpart. an Office of Regulatory Affairs Pro- (4) Section 16.60(e) and (f) of this gram Director or another FDA official chapter does not apply to a hearing senior to an FDA District Director. under this subpart. The presiding offi- [82 FR 14145, Mar. 17, 2017] cer must prepare a written report of the hearing. All written material pre- § 112.210 What is the timeframe for sented at the hearing will be attached issuing a decision on an appeal? to the report. The presiding officer (a) If the owner, operator, or agent in must include as part of the report of charge of a farm appeals the order the hearing a finding on the credibility without requesting a hearing, the pre- of witnesses (other than expert wit- siding officer must issue a written re- nesses) whenever credibility is a mate- port that includes a final decision con- rial issue, and must include a proposed firming or revoking the withdrawal by decision, with a statement of reasons. the 10th calendar day after the appeal The hearing participant may review is filed. and comment on the presiding officer’s (b) If the owner, operator, or agent in report within 2 calendar days of charge of a farm appeals the order and issuance of the report. The presiding requests an informal hearing: officer will then issue the final deci- (1) If FDA grants the request for a sion. hearing and the hearing is held, the (5) Section 16.80(a)(4) of this chapter presiding officer must provide a 2 cal- does not apply to a regulatory hearing endar day opportunity for the hearing under this subpart. The presiding offi- participants to review and submit com- cer’s report of the hearing and any ments on the report of the hearing comments on the report by the hearing under § 112.208(c)(4), and must issue a participant under § 112.208(c)(4) are part final decision within 10 calendar days of the administrative record. after the hearing is held; or (2) If FDA denies the request for a (6) No party shall have the right, hearing, the presiding officer must under § 16.119 of this chapter to petition issue a final decision on the appeal the Commissioner of Food and Drugs confirming or revoking the withdrawal for reconsideration or a stay of the pre- within 10 calendar days after the date siding officer’s final decision. the appeal is filed. (7) If FDA grants a request for an informal hearing on an appeal of an order § 112.211 When is an order to with- withdrawing an exemption, the hearing draw a qualified exemption applica- must be conducted as a regulatory ble to a farm revoked? hearing under a regulation in accord- An order to withdraw a qualified ex- ance with part 16 of this chapter, exemption applicable to a farm under cept that § 16.95(b) does not apply to a § 112.5 is revoked if: hearing under this subpart. With re- (a) The owner, operator, or agent in spect to a regulatory hearing under charge of the farm appeals the order this subpart, the administrative record and requests an informal hearing, FDA of the hearing specified in §§ 16.80(a)(1), grants the request for an informal (2), (3), and (5) of this chapter and hearing, and the presiding officer does 112.208(c)(5) constitutes the exclusive not confirm the order within the 10 cal- record for the presiding officer’s final endar days after the hearing, or issues decision. For purposes of judicial re- a decision revoking the order within view under § 10.45 of this chapter, the that time; or record of the administrative pro- (b) The owner, operator, or agent in ceeding consists of the record of the charge of the farm appeals the order

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and requests an informal hearing, FDA are material to the safety of the food denies the request for an informal produced and harvested at your farm, hearing, and FDA does not confirm the such that continued withdrawal of the order within the 10 calendar days after exemption is not necessary to protect the appeal is filed, or issues a decision the public health and prevent or miti- revoking the order within that time; or gate a foodborne illness outbreak. (c) The owner, operator, or agent in (c) If your qualified exemption was charge of the farm appeals the order withdrawn under § 112.201(a)(1) and FDA without requesting an informal hear- later determines, after finishing the ing, and FDA does not confirm the active investigation of a foodborne ill- order within the 10 calendar days after ness outbreak, that the outbreak is not the appeal is filed, or issues a decision directly linked to your farm, FDA will revoking the order within that time. reinstate your qualified exemption (d) Confirmation of a withdrawal under § 112.5, and FDA will notify you order by the presiding officer is consid- in writing that your exempt status has ered a final Agency action for purposes been reinstated. of 5 U.S.C. 702. (d) If your qualified exemption was withdrawn under § 112.201(a)(1) and (2) § 112.213 If my qualified exemption is and FDA later determines, after fin- withdrawn, under what cir- ishing the active investigation of a cumstances would FDA reinstate foodborne illness outbreak, that the my qualified exemption? outbreak is not directly linked to your (a) If the FDA District Director in farm, FDA will inform you of this find- whose district your farm is located (or, ing, and you may ask FDA to reinstate in the case of a foreign farm, the Direc- your qualified exemption under § 112.5, tor of the Office of Compliance in the in accordance with the requirements of Center for Food Safety and Applied Nu- paragraph (b) of this section. trition) determines that the farm has adequately resolved any problems with PART 113—THERMALLY PROCESSED the conduct and conditions that are material to the safety of the food pro- LOW-ACID FOODS PACKAGED duced or harvested at such farm, and IN HERMETICALLY SEALED CON- that continued withdrawal of the ex- TAINERS emption is not necessary to protect the public health or prevent or mitigate a Subpart A—General Provisions foodborne illness outbreak, the FDA Sec. District Director in whose district your 113.3 Definitions. farm is located (or, in the case of a for- 113.5 Current good manufacturing practice. eign farm, the Director of the Office of 113.10 Personnel. Compliance in the Center for Food Safety and Applied Nutrition) will, on Subpart B [Reserved] his own initiative or at the request of a farm, reinstate the qualified exemp- Subpart C—Equipment tion. (b) You may ask FDA to reinstate a 113.40 Equipment and procedures. qualified exemption that has been Subpart D—Control of Components, Food withdrawn under the procedures of this Product Containers, Closures, and In- subpart as follows: Process Material (1) Submit a request, in writing, to the FDA District Director in whose dis- 113.60 Containers. trict your farm is located (or, in the case of a foreign farm, the Director of Subpart E—Production and Process the Office of Compliance in the Center Controls for Food Safety and Applied Nutrition); 113.81 Product preparation. and 113.83 Establishing scheduled processes. (2) Present, in writing, data and in- 113.87 Operations in the thermal processing formation to demonstrate that you room. have adequately resolved any problems 113.89 Deviations in processing, venting, or with the conduct and conditions that control of critical factors.

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Subpart F—Records and Reports processing and packaging of food means the condition achieved by appli- 113.100 Processing and production records. cation of heat, chemical sterilant(s), or AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. other appropriate treatment that ren- 264. ders the equipment and containers free SOURCE: 44 FR 16215, Mar. 16, 1979, unless of viable microorganisms having public otherwise noted. health significance, as well as microorganisms of nonhealth significance, Subpart A—General Provisions capable of reproducing in the food under normal nonrefrigerated condi- § 113.3 Definitions. tions of storage and distribution. For the purposes of this part, the fol- (f) Critical factor means any property, lowing definitions apply: characteristic, condition, aspect, or (a) Aseptic processing and packaging other parameter, variation of which means the filling of a commercially may affect the scheduled process and sterilized cooled product into pre- the attainment of commercial ste- sterilized containers, followed by asep- rility. tic hermetical sealing, with a (g) Flame sterilizer means an appa- presterilized closure, in an atmosphere ratus in which hermetically sealed con- free of microorganisms. tainers are agitated at atmospheric (b) Bleeders means openings used to pressure, by either continuous, dis- remove air that enters with steam continuous, or reciprocating move- from retorts and steam chambers and ment, with impinging gas flames to to promote circulation of steam in achieve sterilization temperatures. A such retorts and steam chambers. holding period in a heated section may Bleeders may serve as a means of re- follow the initial heating period. moving condensate. (h) Headspace, gross is the vertical (c) Come-up-time means the time distance between the level of the prod- which elapses between the introduction uct (generally the liquid surface) in an of steam into the closed retort and the upright rigid container and the top time when the retort reaches the re- edge of the container (the top of the quired processing temperature. double seam of a can or the top edge of (d) Commercial processor includes any a glass jar). person engaged in commercial, custom, (i) Headspace, net of a container is the or institutional (church, school, penal, vertical distance between the level of or other organization) processing of the product (generally the liquid sur- food, including pet food. Persons en- face) in the upright rigid container and gaged in the production of foods that the inside surface of the lid. are to be used in market or consumer (j) Hermetically sealed container means tests are also included. a container that is designed and in- (e) Commercial sterility: (1) ‘‘Commer- tended to be secure against the entry cial sterility’’ of thermally processed of microorganisms and thereby to food means the condition achieved— maintain the commercial sterility of (i) By the application of heat which its contents after processing. renders the food free of— (k) Incubation means the holding of a (a) Microorganisms capable of repro- sample(s) at a specified temperature ducing in the food under normal non- for a specified period of time for the refrigerated conditions of storage and purpose of permitting or stimulating distribution; and the growth of microorganisms. (b) Viable microorganisms (including (l) Initial temperature means the aver- spores) of public health significance; or age temperature of the contents of the (ii) By the control of water activity coldest container to be processed at the and the application of heat, which ren- time the thermal processing cycle be- ders the food free of microorganisms gins, as determined after thorough stir- capable of reproducing in the food ring or shaking of the filled and sealed under normal nonrefrigerated condi- container. tions of storage and distribution. (m) Lot means that amount of a prod- (2) ‘‘Commercial sterility’’ of equip- uct produced during a period of time ment and containers used for aseptic indicated by a specific code.

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(n) Low-acid foods means any foods, § 113.5 Current good manufacturing other than alcoholic beverages, with a practice. finished equilibrium pH greater than The criteria in §§ 113.10, 113.40, 113.60, 4.6 and a water activity (aw) greater 113.81, 113.83, 113.87, 113.89, and 113.100 than 0.85. Tomatoes and tomato prod- shall apply in determining whether the ucts having a finished equilibrium pH facilities, methods, practices, and con- less than 4.7 are not classed as low-acid trols used by the commercial processor foods. in the manufacture, processing, or (o) Minimum thermal process means packing of low-acid foods in hermeti- the application of heat to food, either cally sealed containers are operated or before or after sealing in a hermeti- administered in a manner adequate to cally sealed container, for a period of protect the public health. time and at a temperature scientifically determined to be adequate to en- § 113.10 Personnel. sure destruction of microorganisms of The operators of processing systems, public health significance. retorts, aseptic processing and pack- (p) Operating process means the proc- aging systems and product formulating ess selected by the processor that systems (including systems wherein equals or exceeds the minimum re- water activity is used in conjunction quirements set forth in the scheduled with thermal processing) and container process. closure inspectors shall be under the (q) Retort means any closed vessel or operating supervision of a person who other equipment used for the thermal has attended a school approved by the processing of foods. Commissioner for giving instruction (r) Scheduled process means the proc- appropriate to the preservation tech- ess selected by the processor as ade- nology involved and who has been iden- quate under the conditions of manufac- tified by that school as having satisfac- ture for a given product to achieve torily completed the prescribed course commercial sterility. This process may of instruction. This person shall super- be in excess of that necessary to ensure vise only in those areas for which a destruction of microorganisms of pub- school approved by the Commissioner lic health significance, and shall be at identifies the person as having satisfac- least equivalent to the process estab- torily completed training. lished by a competent processing authority to achieve commercial ste- Subpart B [Reserved] rility. (s) Shall is used to state mandatory Subpart C—Equipment requirements. (t) Should is used to state rec- § 113.40 Equipment and procedures. ommended or advisory procedures or to (a) Equipment and procedures for pres- identify recommended equipment. sure processing in steam in still retorts— (u) Vacuum-packed products means (1) Temperature-indicating device. Each those products that are sealed in a con- retort shall be equipped with at least tainer under the vacuum specified in one temperature-indicating device that the scheduled process, the maintenance accurately indicates the temperature of which vacuum is critical to the ade- during processing. Each temperature- quacy of the scheduled process. indicating device shall have a sensor (v) Vents means openings through the and a display. Each temperature-indi- retort shell, controlled by gate, plug cating device and each reference device cock, or other adequate valves used for that is maintained by the processor the elimination of air during the vent- shall be tested for accuracy against a ing period. reference device for which the accuracy (w) Water activity (aw) is a measure of is traceable to a National Institute of the free moisture in a product and is Standards and Technology (NIST), or the quotient of the water vapor pres- other national metrology institute, sure of the substance divided by the standard reference device by appro- vapor pressure of pure water at the priate standard procedures, upon in- same temperature. stallation and at least once a year

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thereafter, or more frequently if nec- The temperature-recording device sen- essary, to ensure accuracy during proc- sor shall be installed either within the essing. Each temperature-indicating retort shell or in a well attached to the device and each reference device that is shell. Each temperature-recording de- maintained by the processor shall have vice sensor well shall have a 1⁄16-inch a tag, seal, or other means of identity. (1.5 millimeters) or larger bleeder that (i) The design of the temperature-in- emits steam continuously during the dicating device shall ensure that the processing period. accuracy of the device is not affected (i) Analog or graphical recordings. by electromagnetic interference and Temperature-recording devices that environmental conditions. create analog or graphical recordings (ii) Records of the accuracy of the may be used. Temperature-recording temperature-indicating device and of a devices that record to charts shall be reference device that is maintained by used only with the appropriate chart. the processor shall be established and Each chart shall have a working scale maintained in accordance with of not more than 55 °F per inch (12 °C § 113.100(c) and (d). per centimeter) within a range of 20 °F (iii) A temperature-indicating device (10 °C) of the process temperature. that is defective or cannot be adjusted Chart graduations shall not exceed 2 °F to the accurate calibrated reference de- (1 °C) within a range of 10 °F (5 °C) of vice shall be repaired before further the process temperature. Temperature- use or replaced. recording devices that create (iv) A temperature-indicating device multipoint plottings of temperature ° ° shall be accurate to 1 F (0.5 C). The readings shall record the temperature temperature range of a mercury-in- at intervals that will assure that the glass thermometer shall not exceed 17 parameters of the process time and ° ° F per inch (4 C per centimeter) of process temperature have been met. graduated scale. A mercury-in-glass (ii) Digital recordings. Temperature- thermometer that has a divided mer- recording devices, such as data loggers, cury column shall be considered defec- that record numbers or create other tive. digital records may be used. Such a de- (v) Each temperature-indicating device shall record the temperature at in- vice shall be installed where it can be tervals that will assure that the pa- accurately and easily read. The tem- rameters of the process time and proc- perature-indicating device sensor shall ess temperature have been met. be installed either within the retort shell or in external wells attached to (iii) Adjustments. The temperature-re- the retort. External wells or pipes shall cording device shall be adjusted with be connected to the retort through at sufficient frequency to ensure agreement as nearly as possible with, but to least a 3⁄4-inch (2 centimeters) diameter be in no event higher than, the tem- opening and equipped with a 1⁄16-inch (1.5 millimeters) or larger bleeder open- perature-indicating device during proc- ing so located as to provide a full flow essing. A means of preventing unau- of steam past the length of the tem- thorized changes in adjustment shall perature-indicating device sensor. The be provided. A lock or a notice from bleeders for external wells shall emit management posted at or near the tem- steam continuously during the entire perature-recording device that provides processing period. The temperature-in- a warning that only authorized persons dicating device—not the temperature are permitted to make adjustments is a recording device—shall be the ref- satisfactory means of preventing unau- erence instrument for indicating the thorized changes. processing temperature. (iv) Temperature controller. The tem- (2) Temperature-recording device. Each perature-recording device may be com- retort shall have an accurate tempera- bined with the steam controller and ture-recording device. Each tempera- may be a recorder-controller. ture-recording device shall have a sen- (3) Pressure gages. Each retort should sor and a mechanism for recording be equipped with a pressure gage that temperatures to a permanent record, is accurate to 2 pounds per square inch such as a temperature-recording chart. (13.8 kilopascals) or less.

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(4) Steam controller. Each retort shall bleeders shall be located within ap- be equipped with an automatic steam proximately 1 foot (30.5 centimeters) of controller to maintain the retort tem- the outermost locations of containers perature. This may be a recorder-con- at each end along the top of the retort. troller when combined with a tempera- Additional bleeders shall be located ture-recording device. The steam con- not more than 8 feet (2.4 meters) apart troller may be air-operated and actu- along the top. Bleeders may be in- ated by a temperature sensor posi- stalled at positions other than those tioned near the temperature-indicating specified in this paragraph, as long as device in the retort. Air-operated tem- there is evidence in the form of heat perature controllers should have ade- distribution data that they accomplish quate filter systems to ensure a supply adequate removal of air and circula- of clean, dry air. A steam controller action of steam within the retort. tivated by the steam pressure of the re- Vertical retorts shall have at least one tort is acceptable if it is carefully bleeder opening located in that portion maintained mechanically so that it op- of the retort opposite the steam inlet. erates satisfactorily. In retorts having top steam inlet and (5) Steam inlet. The steam inlet to bottom venting, a bleeder shall be in- each still retort shall be large enough stalled in the bottom of the retort to to provide sufficient steam for proper remove condensate. All bleeders shall operation of the retort. Steam may be arranged so that the operator can enter either the top portion or the bot- observe that they are functioning prop- tom portion of the retort but, in any erly. case, shall enter the portion of the re- (9) Stacking equipment and position of tort opposite the vent; for example, containers. Crates, trays, gondolas, etc., steam inlet in bottom portion and vent for holding containers shall be made of in top portion. strap iron, adequately perforated sheet (6) Crate supports. A bottom crate metal, or other suitable material. support shall be used in vertical still When perforated sheet metal is used for retorts. Baffle plates shall not be used the bottoms, the perforations should be in the bottom of still retorts. approximately the equivalent of 1-inch (7) Steam spreaders. Steam spreaders (2.5 centimeters) holes on 2-inch (5.1 are continuations of the steam inlet centimeters) centers. If dividers are line inside the retort. Horizontal still used between the layers of containers, retorts shall be equipped with steam they should be perforated as stated in spreaders that extend the length of the this paragraph. The positioning of con- retort. For steam spreaders along the tainers in the retort, when specified in bottom of the retort, the perforations the scheduled process, shall be in ac- should be along the top 90° of the pipe, that is, within 45° on either side of the cordance with that process. top center. Horizontal still retorts over (10) Air valves. Retorts using air for 30 feet (9.1 meters) long should have pressure cooling shall be equipped with two steam inlets connected to the a suitable valve to prevent air leakage spreader. In vertical still retorts, the into the retort during processing. steam spreaders, if used, should be per- (11) Water valves. Retorts using water forated along the center line of the for cooling shall be equipped with a pipe facing the interior of the retort or suitable valve to prevent leakage of along the sides of the pipe. The number water into the retort during proc- of perforations should be such that the essing. total cross-sectional area of the per- (12) Vents. Vents shall be installed in forations is equal to 1.5 to 2 times the such a way that air is removed from cross-sectional area of the smallest re- the retort before timing of the process striction in the steam inlet line. is started. Vents shall be controlled by (8) Bleeders. Bleeders, except those for gate, plug cock, or other adequate type temperature-indicating device wells, valves which shall be fully open to per- shall be 1/8-inch (3 millimeters) or larg- mit rapid discharge of air from the re- er and shall be wide open during the tort during the venting period. Vents entire process, including the come-up shall not be connected directly to a time. For horizontal still retorts, closed drain system. If the overflow is

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used as a vent, there shall be an atmos- trolled by a valve and shall be of a size pheric break in the line before it con- that the cross-sectional area is at least nects to a closed drain. The vent shall equal to the total cross-sectional area be located in that portion of the retort of all connecting retort manifold pipes opposite the steam inlet; for example, from all retorts venting simulta- steam inlet in bottom portion and vent neously. Timing of the process shall in top portion. Where a retort manifold not begin until the retort has been connects several vent pipes from a sin- properly vented and the processing gle still retort, it shall be controlled by temperature has been reached. Some a gate, plug cock, or other adequate typical installations and operating pro- type of valve. The retort manifold shall cedures reflecting the requirements of be of a size that the cross-sectional area of the pipe is larger than the total this section for venting still retorts cross-sectional area of all connecting without divider plates are given in vents. The discharge shall not be di- paragraphs (a)(12)(i)(A) through rectly connected to a closed drain (a)(12)(i)(D) and (a)(12)(ii)(A) and without an atmospheric break in the (a)(12)(ii)(B) of this section. line. A manifold header connecting (i) Venting horizontal retorts. (A) Vent- vents or manifolds from several still ing through multiple 1-inch (2.5 centi- retorts shall lead to the atmosphere. meters) vents discharging directly to The manifold header shall not be con- atmosphere.

(1) Specifications. One 1-inch (2.5 cen- (2) Venting method. Vent valves timeters) vent for every 5 feet (1.5 me- should be wide open for at least 5 min- ters) of retort length equipped with a utes and to at least 225 °F (107 °C), or at gate or plug cock valve and discharging least 7 minutes and to at least 220 °F to atmosphere; end vents not more (104.5 °C). than 2.5 feet (76 centimeters) from ends (B) Venting through multiple 1-inch of retort. (2.5 centimeters) vents discharging through a manifold to atmosphere.

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(1) Specifications. One 1-inch (2.5 cen- 15 feet (4.6 meters) and over in length, timeters) vent for every 5 feet (1.5 me- 3 inches (7.6 centimeters). ters) of retort length; and vents not (2) Venting method. Manifold vent over 2.5 feet (76 centimeters) from ends gate or plug cock valve should be wide of retort. Size of manifold—for retorts open for at least 6 minutes and to at less than 15 feet (4.6 meters) in length, least 225 °F (107 °C), or for at least 8 2.5 inches (6.4 centimeters); for retorts minutes and to at least 220 °F (104.5 °C). (C) Venting through water spreaders.

(1) Size of vent and vent valve. For re- length, 2 inches (5.1 centimeters); for torts less than 15 feet (4.6 meters) in

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retorts 15 feet (4.6 meters) and over in (3) Venting method. Water spreader length, 2.5 inches (6.4 centimeters). vent gate or plug cock valve should be (2) Size of water spreader. For retorts wide open for at least 5 minutes and to less than 15 feet (4.6 meters) in length, at least 225 °F (107 °C), or for at least 7 1.5 inches (3.8 centimeters); for retorts minutes and to at least 220 °F (104.5 °C). 15 feet (4.6 meters) and over in length, (D) Venting through a single 2.5-inch 2 inches (5.1 centimeters). The number (6.4 centimeters) top vent (for retorts of holes should be such that their total not exceeding 15 feet (4.6 meters) in cross-sectional area is approximately length). equal to the cross-sectional area of the vent pipe inlet.

(1) Specifications. A 2.5-inch (6.4 centi- least 4 minutes and to at least 220 °F meters) vent equipped with a 2.5-inch (104.5 °C). (6.4 centimeters) gate or plug cock (ii) Venting vertical retorts. (A) Vent- valve and located within 2 feet (61 cen- ing through a 1.5-inch (3.8 centimeters) timeters) of the center of the retort. overflow. (2) Venting method. Vent gate or plug cock valve should be wide open for at

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(1) Specifications. A 1.5-inch (3.8 centi- (2) Venting method. Vent gate or plug meters) overflow pipe equipped with a cock valve should be wide open for at 1.5-inch (3.8 centimeters) gate or plug least 4 minutes and to at least 218 °F cock valve and with not more than 6 (103.5 °C), or for at least 5 minutes and feet (1.8 meters) of 1.5-inch (3.8 centi- to at least 215 °F (102 °C). meters) pipe beyond the valve before (B) Venting through a single 1-inch break to the atmosphere or to a mani- (2.5 centimeters) side or top vent. fold header.

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(1) Specifications. A 1-inch (2.5 centi- essing record at intervals of sufficient meters) vent in lid or top side, frequency to ensure that the factors equipped with a 1-inch (2.5 centimeters) are within the limits specified in the gate or plug cock valve and discharging scheduled process. directly into the atmosphere or to a (i) When maximum fill-in or drained manifold header. weight is specified in the scheduled (2) Venting method. Vent gate or plug process, it shall be measured and re- cock valve should be wide open for at corded at intervals of sufficient fre- least 5 minutes and to at least 230 °F quency to ensure that the weight of the (110 °C), or for at least 7 minutes and to at least 220 °F (104.5 °C). product does not exceed the maximum (iii) Other procedures. Other installa- for the given container size specified in tions and operating procedures that de- the scheduled process. viate from the requirements in para- (ii) Closing machine vacuum in vacu- graph (a)(12) of this section may be um-packed products shall be observed used if there is evidence in the form of and recorded at intervals of sufficient heat distribution data, which shall be frequency to ensure that the vacuum is kept on file, that they accomplish ade- as specified in the scheduled process. quate venting of air. (iii) Such measurements and record- (13) Critical factors. Critical factors ings should be made at intervals not to specified in the scheduled process shall exceed 15 minutes. be measured and recorded on the proc-

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(iv) When the product style results in izontal and vertical retorts, the tem- stratification or layering of the pri- perature-indicating device sensor shall mary product in the containers, the po- be inserted directly into the retort sitioning of containers in the retort shell or in a separate well or sleeve at- shall be according to the scheduled tached to the retort. The temperature- process. indicating device sensor shall be lo- (b) Equipment and procedures for pres- cated so that it is beneath the surface sure processing in water in still retorts— of the water throughout the process (1) Temperature-indicating device. Each and where there is adequate circulation retort shall be equipped with at least to ensure accurate temperature meas- one temperature-indicating device that urement. On horizontal retorts, the accurately indicates the temperature temperature-indicating device sensor during processing. Each temperature- should be located in the side at the indicating device shall have a sensor and a display. Each temperature-indi- center of the retort. The temperature- cating device and each reference device indicating device—not the tempera- that is maintained by the processor ture-recording device—shall be the ref- shall be tested for accuracy against a erence instrument for indicating the reference device for which the accuracy processing temperature. is traceable to a National Institute of (2) Temperature-recording device. Each Standards and Technology (NIST), or retort shall have an accurate tempera- other national metrology institute, ture-recording device. Each tempera- standard reference device by appro- ture-recording device shall have a sen- priate standard procedures, upon in- sor and a mechanism for recording stallation and at least once a year temperatures to a permanent record, thereafter, or more frequently if nec- such as a temperature-recording chart. essary, to ensure accuracy during proc- (i) Analog or graphical recordings. essing. Each temperature-indicating Temperature-recording devices that device and each reference device that is create analog or graphical recordings maintained by the processor shall have may be used. Temperature-recording a tag, seal, or other means of identity. devices that record to charts shall be (i) The design of the temperature-in- used only with the appropriate chart. dicating device shall ensure that the Each chart shall have a working scale accuracy of the device is not affected of not more than 55 °F per inch (12 °C by electromagnetic interference and per centimeter) within a range of 20 °F environmental conditions. ° (ii) Records of the accuracy of the (10 C) of the process temperature. ° temperature-indicating device and of a Chart graduations shall not exceed 2 F ° ° ° reference device that is maintained by (1 C) within a range of 10 F (5 C) of the processor shall be established and the process temperature. Temperature- maintained in accordance with recording devices that create § 113.100(c) and (d). multipoint plottings of temperature (iii) A temperature-indicating device readings shall record the temperature that is defective or cannot be adjusted at intervals that will assure that the to the accurate calibrated reference de- parameters of the process time and vice shall be repaired before further process temperature have been met. use or replaced. (ii) Digital recordings. Temperature- (iv) A temperature-indicating device recording devices, such as data loggers, shall be accurate to 1 °F (0.5 °C). The that record numbers or create other temperature range of a mercury-in- digital records may be used. Such a de- glass thermometer shall not exceed 17 vice shall record the temperature at in- ° ° F per inch (4 C per centimeter) of tervals that will assure that the pa- graduated scale. A mercury-in-glass rameters of the process time and proc- thermometer that has a divided mer- ess temperature have been met. cury column shall be considered defec- (iii) Adjustments. The temperature-re- tive. cording device shall be adjusted with (v) Each temperature-indicating device shall be installed where it can be sufficient frequency to ensure agree- accurately and easily read. In both hor- ment as nearly as possible with, but to

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be in no event higher than, the tem- (5) Steam introduction. Steam shall be perature-indicating device during proc- distributed in the bottom of the retort essing. A means of preventing unau- in a manner adequate to provide uni- thorized changes in adjustment shall form heat distribution throughout the be provided. A lock or a notice from retort. In vertical retorts, uniform management posted at or near the tem- steam distribution can be achieved by perature-recording device that provides any of several methods. In horizontal a warning that only authorized persons retorts, the steam distributor shall run are permitted to make adjustments is a the length of the bottom of the retort satisfactory means of preventing unau- with perforations distributed uni- thorized changes. formly along the upper part of the pipe. (iv) Temperature controller. The tem- (6) Crate supports. A bottom crate perature-recording device may be com- support shall be used in vertical still bined with the steam controller and retorts. Baffle plates shall not be used may be a combination recorder-con- in the bottom of the retort. Centering troller. For a vertical retort equipped guides should be installed so as to en- with a combination recorder-con- sure that there is about a 1.5-inch (3.8 troller, the temperature recorder-con- centimeters) clearance between the troller sensor shall be located at the side wall of the crate and the retort bottom of the retort below the lowest wall. crate rest in such a position that the (7) Stacking equipment and position of steam does not strike it directly. For a containers. Crates, trays, gondolas, etc., horizontal retort equipped with a com- for holding containers shall be made of bination recorder-controller, the tem- strap iron, adequately perforated sheet perature recorder-controller sensor metal, or other suitable material. shall be located between the water sur- When perforated sheet metal is used for face and the horizontal plane passing the bottoms, the perforations should be through the center of the retort so that approximately the equivalent of 1-inch there is no opportunity for direct (2.5 centimeters) holes on 2-inch (5.1 steam impingement on the sensor. For centimeters) centers. If divider plates all still retort systems that pressure are used between the layers of con- process in water and are equipped with tainers, they should be perforated as combination recorder-controllers, the stated in this paragraph. The posi- temperature recorder-controller sen- tioning of containers in the retort, sors shall be located where the re- when specified in the scheduled proc- corded temperature is an accurate ess, shall be in accordance with that measurement of the scheduled process process. Dividers, racks, trays, or other temperature and is not affected by the means of positioning of flexible con- heating media. tainers shall be designed and employed (3) Pressure gages. (i) Each retort to ensure even circulation of heating should be equipped with a pressure medium around all containers in the gage that is accurate to 2 pounds per retort. square inch (13.8 kilopascals) or less. (8) Drain valve. A nonclogging, water- (ii) Each retort should have an ad- tight valve shall be used. A screen shall justable pressure relief or control valve be installed or other suitable means of a capacity sufficient to prevent an shall be used on all drain openings to undesired increase in retort pressure prevent clogging. when the water valve is wide open and (9) Air supply and controls. In both should be installed in the overflow line. horizontal and vertical still retorts for (4) Steam controller. Each retort shall pressure processing in water, a means be equipped with an automatic steam shall be provided for introducing com- controller to maintain the retort tem- pressed air at the proper pressure and perature. The steam controller may be rate. The proper pressure shall be con- combined with a temperature-record- trolled by an automatic pressure con- ing device and, thus, may be a com- trol unit. A check valve shall be pro- bination recorder-controller. Air-oper- vided in the air supply line to prevent ated temperature controllers should water from entering the system. Air or have adequate filter systems to ensure water circulation shall be maintained a supply of clean, dry air. continuously during the come-up time

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and during processing and cooling peri- lating system. The pump shall be de- ods. The adequacy of the air or water signed to provide proper flow on start- circulation for uniform heat distribu- up and during operation, such as with a tion within the retort shall be estab- bleeder or other suitable means to re- lished in accordance with procedures move air during startup and with an recognized by a competent processing appropriate device or design to prevent authority and records shall be kept on pump cavitation during operation. The file. If air is used to promote circula- pump shall be equipped with a sig- tion, it shall be introduced into the naling device to warn the operator steam line at a point between the re- when it is not running. Alternative tort and the steam control valve at the methods for circulation of water in the bottom of the retort. retort may be used when established by (10) Water level indicator. There shall a competent authority as adequate for be a means of determining the water even heat distribution. level in the retort during operation, (12) Cooling water supply. In vertical e.g., by using a sensor, gage, water retorts, the cooling water should be in- glass, or petcock(s). Water shall cover troduced at the top of the retort be- the top layer of containers during the tween the water and container levels. entire come-up time and processing pe- In horizontal retorts the cooling water riods and should cover the top layer of should be introduced into the suction containers during the cooling periods. side of the pump. A check valve should The operator shall check and record the water level at intervals sufficient be included in the cooling water line. to ensure its adequacy. (13) Retort headspace. The headspace (11) Water circulation. When a water necessary to control the air pressure circulating system is used for heat dis- should be maintained between the tribution, it shall be installed in such a water level and the top of the retort manner that water will be drawn from shell. the bottom of the retort through a suc- (14) Vertical and horizontal still retorts. tion manifold and discharged through a Vertical and horizontal still retorts spreader which extends the length of should follow the arrangements in the the top of the retort. The holes in the diagrams in this paragraph. Other in- water spreader shall be uniformly dis- stallation and operating procedures tributed and should have an aggregate that deviate from these arrangements area not greater than the cross-sec- may be used, as long as there is evi- tional area of the outlet line from the dence in the form of heat distribution pump. The suction outlets shall be pro- data or other suitable information, tected with nonclogging screens or which shall be kept on file, which dem- other suitable means shall be used to onstrates that the heat distribution is keep debris from entering the circu- adequate.

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LEGEND FOR VERTICAL AND HORIZONTAL C—Temperature control. STILL RETORTS D—Overflow line. E1—Drain line. A—Water line. E2—Screens. B—Steam line. F—Check valves.

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G—Line from hot water storage. device shall have a sensor and a dis- H—Suction line and manifold. play. Each temperature-indicating de- I—Circulating pump. vice and each reference device that is J—Petcocks. K—Recirculating line. maintained by the processor shall be L—Steam distributor. tested for accuracy against a reference M—Temperature-controller sensor. device for which the accuracy is trace- N—Temperature-indicating device sensor. able to a National Institute of Stand- O—Water spreader. ards and Technology (NIST), or other P—Safety valve. national metrology institute, standard Q—Vent valve for steam processing. reference device by appropriate stand- R—Pressure gage. S—Inlet air control. ard procedures, upon installation and T—Pressure control. at least once a year thereafter, or more U—Air line. frequently if necessary, to ensure accu- V—To pressure control instrument. racy during processing. Each tempera- W—To temperature control instrument. ture-indicating device and each ref- X—Wing nuts. erence device that is maintained by the Y —Crate support. 1 processor shall have a tag, seal, or Y2—Crate guides. Z—Constant flow orifice valve. other means of identity. Z1—Constant flow orifice valve used during (i) The design of the temperature-in- come-up. dicating device shall ensure that the Z2—Constant flow orifice valve used during accuracy of the device is not affected cook. by electromagnetic interference and (15) Critical factors. Critical factors environmental conditions. specified in the scheduled process shall (ii) Records of the accuracy of the be measured and recorded on the proc- temperature-indicating device and of a essing record at intervals of sufficient reference device that is maintained by frequency to ensure that the factors the processor shall be established and are within the limits specified in the maintained in accordance with scheduled process. § 113.100(c) and (d). (i) When maximum fill-in or drained (iii) A temperature-indicating device weight is specified in the scheduled that is defective or cannot be adjusted process, it shall be measured and re- to the accurate calibrated reference de- corded at intervals of sufficient fre- vice shall be repaired before further quency to ensure that the weight of the use or replaced. product does not exceed the maximum (iv) A temperature-indicating device for the given container size specified in shall be accurate to 1 °F (0.5 °C). The the scheduled process. temperature range of a mercury-in- (ii) Closing machine vacuum in vacu- glass thermometer shall not exceed 17 um-packed products shall be observed °F per inch (4 °C per centimeter) of and recorded at intervals of sufficient graduated scale. A mercury-in-glass frequency to ensure that the vacuum is thermometer that has a divided mer- as specified in the scheduled process. cury column shall be considered defec- (iii) Such measurements and record- tive. ings should be made at intervals not to (v) Each temperature-indicating de- exceed 15 minutes. vice shall be installed where it can be (iv) When the product style results in accurately and easily read. The tem- stratification or layering of the pri- perature-indicating device sensor shall mary product in the containers, the po- be installed either within the retort sitioning of containers in the retort shell or in external wells attached to shall be according to the scheduled the retort. External wells or pipes shall process. be connected to the retort through at (c) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter sure processing in steam in continuous opening and equipped with a 1⁄16-inch agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open- cating device. Each retort shall be ing so located as to provide a full flow equipped with at least one tempera- of steam past the length of the tem- ture-indicating device that accurately perature-indicating device sensor. The indicates the temperature during proc- bleeders for external wells shall emit essing. Each temperature-indicating steam continuously during the entire

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processing period. The temperature-in- are permitted to make adjustments is a dicating device—not the temperature- satisfactory means of preventing unau- recording device—shall be the ref- thorized changes. erence instrument for indicating the (iv) Temperature controller. The tem- processing temperature. perature-recording device may be com- (2) Temperature-recording device. Each bined with the steam controller and retort shall have an accurate tempera- may be a recorder-controller. ture-recording device. Each tempera- (3) Pressure gages. Each retort should ture-recording device shall have a sen- be equipped with a pressure gage that sor and a mechanism for recording is accurate to 2 pounds per square inch temperatures to a permanent record, (13.8 kilopascals) or less. such as a temperature-recording chart. (4) Steam controller. Each retort shall The temperature-recording device sen- be equipped with an automatic steam sor shall be installed either within the controller to maintain the retort tem- retort shell or in a well attached to the perature. This may be a recorder-con- shell. Each temperature-recording de- troller when combined with a tempera- vice sensor well shall have a 1⁄16-inch ture-recording device. A steam con- (1.5 millimeters) or larger bleeder that troller activated by the steam pressure emits steam continuously during the of the retort is acceptable if it is care- processing period. fully maintained mechanically so that (i) Analog or graphical recordings. it operates satisfactorily. Air-operated Temperature-recording devices that temperature controllers should have create analog or graphical recordings adequate filter systems to ensure a may be used. Temperature-recording supply of clean, dry air. devices that record to charts shall be (5) Bleeders. Bleeders, except those for used only with the appropriate chart. temperature-indicating device wells, Each chart shall have a working scale shall be 1⁄8-inch (3 millimeters) or larg- of not more than 55 °F per inch (12 °C er and shall be wide open during the per centimeter) within a range of 20 °F entire process, including the come-up (10 °C) of the process temperature. time. Bleeders shall be located within Chart graduations shall not exceed 2 °F approximately 1 foot (30.5 centimeters) (1 °C) within a range of 10 °F (5 °C) of of the outermost location of containers the process temperature. Temperature- at each end along the top of the retort. recording devices that create Additional bleeders shall be located multipoint plottings of temperature not more than 8 feet (2.4 meters) apart readings shall record the temperature along the top of the retort. All bleeders at intervals that will assure that the shall be arranged so that the operator parameters of the process time and can observe that they are functioning process temperature have been met. properly. The condensate bleeder shall (ii) Digital recordings. Temperature- be checked with sufficient frequency to recording devices, such as data loggers, ensure adequate removal of condensate that record numbers or create other or shall be equipped with an automatic digital records may be used. Such a de- alarm system(s) that would serve as a vice shall record the temperature at in- continuous monitor of condensate- tervals that will assure that the pa- bleeder functioning. Visual checks rameters of the process time and proc- should be done at intervals of not more ess temperature have been met. than 15 minutes. A record of such (iii) Adjustments. The temperature-re- checks should be kept to show that the cording device shall be adjusted with bleeder is functioning properly. sufficient frequency to ensure agree- (6) Venting and condensate removal. ment as nearly as possible with, but to Vents shall be located in that portion be in no event higher than, the tem- of the retort opposite the steam inlet. perature-indicating device during proc- Air shall be removed before processing essing. A means of preventing unau- is started. Heat distribution data or thorized changes in adjustment shall documentary proof from the manufac- be provided. A lock or a notice from turer or from a competent processing management posted at or near the tem- authority, demonstrating that ade- perature-recording device that provides quate venting is achieved, shall be kept a warning that only authorized persons on file. At the time steam is turned on,

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the drain should be opened for a time records required in this chapter. If the sufficient to remove steam condensate alternative procedure of prompt cool- from the retort, and provision shall be ing is followed, the subsequent han- made for continuing drainage of con- dling methods used for the containers densate during the retort operation. in the retort at the time of stopping The condensate bleeder in the bottom and cooling shall be entered on the proof the shell serves as an indicator of duction records. continuous condensate removal. (9) Temperature drop. If the tempera- (7) Retort speed timing. The rotational ture of the continuous retort drops speed of the retort shall be specified in below the temperature specified in the the scheduled process. The speed shall scheduled process while containers are be adjusted and recorded when the rein the retort, the retort reel shall be tort is started, at any time a speed stopped promptly. An automatic device change is made, and at intervals of suf- should be used to stop the reel when ficient frequency to ensure that the re- the temperature drops below the speci- tort speed is maintained as specified in fied process temperature. Before the the scheduled process. These adjust- reel is restarted, all containers in the ments and recordings should be made retort shall be given a complete sched- every 4 hours or less. Alternatively, a uled still retort process if the tempera- recording tachometer may be used to ture drop was 10 °F (5 °C) or more below provide a continuous record of the the specified temperature, or alter- speed. A means of preventing unau- natively, container entry to the retort thorized speed changes on retorts shall shall be stopped and the reel restarted be provided. A lock or a notice from to empty the retort. The discharged management posted at or near the containers shall be either reprocessed, speed adjustment device that provides repacked and reprocessed, or discarded. a warning that only authorized persons Both the time at which the reel are permitted to make adjustments is a stopped and the time the retort was satisfactory means of preventing unau- used for a still retort process, if so thorized changes. used, shall be indicated on the tem- (8) Emergency stops. If a retort jams perature-recording device record and or breaks down during processing oper- entered on the other production ations, necessitating cooling the retort records required in this chapter. If the for repairs, the retort shall be operated alternative procedure of emptying the in such a way that ensures that the retort is followed, the subsequent han- product is commercially sterile, or the dling methods used for the containers retort is to be cooled promptly and all in the retort at the time of the tem- containers either reprocessed, repacked perature drop shall be entered on the and reprocessed, or discarded. When op- production records. If the temperature erated as a still retort, all containers drop was less than 10 °F (5 °C), a sched- shall be given a full still retort process uled authorized emergency still process before the retort is cooled. If, in such approved by a qualified person(s) hav- an emergency, a scheduled still process ing expert knowledge of thermal proc- or another process established to en- essing requirements may be used before sure commercial sterility is to be used, restarting the retort reel. Alter- it shall be made readily available to natively, container entry to the retort the retort operator. shall be stopped and an authorized (i) Any containers in the retort in- emergency agitating process may be take valve or in transfer valves be- used before container entry to the re- tween cooker shells of a continuous retort is restarted. When emergency pro- tort at the time of breakdown shall ei- cedures are used, no containers may ther be reprocessed, repacked and re- enter the retort and the process and processed, or discarded. procedures used shall be noted on the (ii) Both the time at which the reel production records. stopped and the time the retort was (10) Critical factors. Critical factors used for a still retort process, if so specified in the scheduled process shall used, shall be indicated on the tem- be measured and recorded on the proc- perature-recording device record and essing record at intervals of sufficient entered on the other production frequency to ensure that the factors

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are within the limits specified in the frequently if necessary, to ensure accu- scheduled process. The minimum racy during processing. Each tempera- headspace of containers, if specified in ture-indicating device and each ref- the scheduled process, shall be meas- erence device that is maintained by the ured and recorded at intervals of suffi- processor shall have a tag, seal, or cient frequency to ensure that the other means of identity. headspace is as specified in the sched- (i) The design of the temperature-in- uled process. The headspace of solder- dicating device shall ensure that the tipped, lapseam (vent hole) cans may accuracy of the device is not affected be measured by net weight determina- by electromagnetic interference and tions. The headspace of double seamed environmental conditions. cans may also be measured by net (ii) Records of the accuracy of the weight determinations for homogenous temperature-indicating device and of a liquids, taking into account the spe- reference device that is maintained by cific can end profile and other factors the processor shall be established and which affect the headspace, if proof of maintained in accordance with the accuracy of such measurements is § 113.100(c) and (d). maintained and the procedure and re- (iii) A temperature-indicating device sultant headspace is in accordance that is defective or cannot be adjusted with the scheduled process. When the to the accurate calibrated reference de- product consistency is specified in the vice shall be repaired before further scheduled process, the consistency of use or replaced. the product shall be determined by ob- (iv) A temperature-indicating device jective measurements on the product shall be accurate to 1 °F (0.5 °C). The taken from the filler before processing temperature range of a mercury-in- and recorded at intervals of sufficient glass thermometer shall not exceed 17 frequency to ensure that the consist- °F per inch (4 °C per centimeter) of ency is as specified in the scheduled graduated scale. A mercury-in-glass process. Minimum closing machine thermometer that has a divided mer- vacuum in vacuum-packed products, cury column shall be considered defec- maximum fill-in or drained weight, tive. minimum net weight, and percent sol- (v) Each temperature-indicating de- ids shall be as specified in the sched- vice shall be installed where it can be uled process for all products when devi- accurately and easily read. The tem- ations from such specifications may af- perature-indicating device sensor shall fect the scheduled process. All meas- be installed either within the retort urements and recordings of critical fac- shell or in external wells attached to tors should be made at intervals not to the retort. External wells or pipes shall exceed 15 minutes. be connected to the retort through at (d) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter sure processing in steam in discontinuous opening and equipped with a 1⁄16-inch agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open- cating device. Each retort shall be ing so located as to provide a full flow equipped with at least one tempera- of steam past the length of the tem- ture-indicating device that accurately perature-indicating device sensor. The indicates the temperature during proc- bleeders for external wells shall emit essing. Each temperature-indicating steam continuously during the entire device shall have a sensor and a dis- processing period. The temperature-in- play. Each temperature-indicating de- dicating device—not the temperature- vice and each reference device that is recording device—shall be the ref- maintained by the processor shall be erence instrument for indicating the tested for accuracy against a reference processing temperature. device for which the accuracy is trace- (2) Temperature-recording device. Each able to a National Institute of Stand- retort shall have an accurate tempera- ards and Technology (NIST), or other ture-recording device. Each tempera- national metrology institute, standard ture-recording device shall have a sen- reference device by appropriate stand- sor and a mechanism for recording ard procedures, upon installation and temperatures to a permanent record, at least once a year thereafter, or more such as a temperature-recording chart.

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The temperature-recording device sen- (4) Steam controller. Each retort shall sor shall be installed either within the be equipped with an automatic steam retort shell or in a well attached to the controller to maintain the retort tem- shell. Each temperature-recording de- perature. This may be a recorder-con- vice sensor well shall have a 1⁄16-inch troller when combined with a tempera- (1.5 millimeters) or larger bleeder that ture-recording device. A steam con- emits steam continuously during the troller activated by the steam pressure processing period. of the retort is acceptable if it is me- (i) Analog or graphical recordings. chanically maintained so that it oper- Temperature-recording devices that ates satisfactorily. Air-operated tem- create analog or graphical recordings perature controllers should have ade- may be used. Temperature-recording quate filter systems to ensure a supply devices that record to charts shall be of clean, dry air. used only with the appropriate chart. (5) Bleeders. Bleeders, except those for Each chart shall have a working scale temperature-indicating device wells, of not more than 55 °F per inch (12 °C shall be 1⁄8-inch (3 millimeters) or larg- per centimeter) within a range of 20 °F er and shall be wide open during the (10 °C) of the process temperature. entire process, including the come-up Chart graduations shall not exceed 2 °F time. Bleeders shall be located within (1 °C) within a range of 10 °F (5 °C) of approximately 1 foot (30.5 centimeters) the process temperature. Temperature- of the outermost location of con- recording devices that create tainers, at each end along the top of multipoint plottings of temperature the retort; additional bleeders shall be readings shall record the temperature located not more than 8 feet (2.4 meat intervals that will assure that the ters) apart along the top. Bleeders may parameters of the process time and be installed at positions other than process temperature have been met. those specified in this paragraph, as (ii) Digital recordings. Temperature- long as there is evidence in the form of recording devices, such as data loggers, heat distribution data that they ac- that record numbers or create other complish adequate removal of air and digital records may be used. Such a de- circulation of heat within the retort. vice shall record the temperature at in- In retorts having top steam inlet and tervals that will assure that the pa- bottom venting, a bleeder shall be in- rameters of the process time and proc- stalled in the bottom of the retort to ess temperature have been met. remove condensate. All bleeders shall (iii) Adjustments. The temperature-re- be arranged in a way that enables the cording device shall be adjusted with operator to observe that they are func- sufficient frequency to ensure agree- tioning properly. ment as nearly as possible with, but to (6) Venting and condensate removal. be in no event higher than, the tem- The air in each retort shall be removed perature-indicating device during proc- before processing is started. Heat dis- essing. A means of preventing unau- tribution data or documentary proof thorized changes in adjustment shall from the manufacturer or from a com- be provided. A lock or a notice from petent processing authority, dem- management posted at or near the tem- onstrating that adequate venting is perature-recording device that provides achieved, shall be kept on file. At the a warning that only authorized persons time steam is turned on, the drain are permitted to make adjustments is a should be opened for a time sufficient satisfactory means of preventing unau- to remove steam condensate from the thorized changes. retort and provision should be made for (iv) Temperature controller. The tem- continuing drainage of condensate dur- perature-recording device may be coming the retort operation. bined with the steam controller and (7) Retort speed timing. The rotational may be a recorder-controller. speed of the retort shall be specified in (3) Pressure gages. Each retort should the scheduled process. The speed shall be equipped with a pressure gage that be adjusted, as necessary, to ensure is accurate to 2 pounds per square inch that the speed is as specified in the (13.8 kilopascals) or less. scheduled process. The rotational speed

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as well as the process time shall be re- maintained by the processor shall be corded for each retort load processed. tested for accuracy against a reference Alternatively, a recording tachometer device for which the accuracy is trace- may be used to provide a continuous able to a National Institute of Stand- record of the speed. A means of pre- ards and Technology (NIST), or other venting unauthorized speed changes on national metrology institute, standard retorts shall be provided. A lock or a reference device by appropriate stand- notice from management posted at or ard procedures, upon installation and near the speed-adjustment device that at least once a year thereafter, or more provides a warning that only author- frequently if necessary, to ensure accu- ized persons are permitted to make ad- racy during processing. Each tempera- justments is a satisfactory means of ture-indicating device and each ref- preventing unauthorized changes. erence device that is maintained by the (8) Critical factors. Critical factors processor shall have a tag, seal, or specified in the scheduled process shall other means of identity. be measured and recorded on the processing record at intervals of sufficient (i) The design of the temperature-in- frequency to ensure that the factors dicating device shall ensure that the are within the limits specified in the accuracy of the device is not affected scheduled process. The minimum by electromagnetic interference and headspace of containers in each retort environmental conditions. load to be processed, if specified in the (ii) Records of the accuracy of the scheduled process, shall be measured temperature-indicating device and of a and recorded at intervals of sufficient reference device that is maintained by frequency to ensure that the headspace the processor shall be established and is as specified in the scheduled process. maintained in accordance with The headspace of solder-tipped, lap § 113.100(c) and (d). seam (vent hole) cans may be measured (iii) A temperature-indicating device by net weight determinations. When that is defective or cannot be adjusted the product consistency is specified in to the accurate calibrated reference de- the scheduled process, the consistency vice shall be repaired before further of the product shall be determined by use or replaced. objective measurements on the product (iv) A temperature-indicating device taken from the filler before processing shall be accurate to 1 °F (0.5 °C). The and recorded at intervals of sufficient temperature range of a mercury-in- frequency to ensure that the consist- glass thermometer shall not exceed 17 ency is as specified in the scheduled °F per inch (4 °C per centimeter) of process. Minimum closing machine graduated scale. A mercury-in-glass vacuum in vacuum-packed products, thermometer that has a divided mer- maximum fill-in or drained weight, cury column shall be considered defec- minimum net weight, and percent sol- tive. ids shall be as specified in the scheduled process for all products for which (v) Each temperature-indicating de- deviations from such specifications vice shall be installed where it can be may affect the scheduled process. All accurately and easily read. In both hor- measurements and recordings of crit- izontal and vertical retorts, the tem- ical factors should be made at intervals perature-indicating device sensor shall not to exceed 15 minutes. be inserted directly into the retort (e) Equipment and procedures for pres- shell or in a separate well or sleeve at- sure processing in water in discontinuous tached to the retort. The temperature- agitating retorts—(1) Temperature-indi- indicating device sensor shall be locating device. Each retort shall be cated so that it is beneath the surface equipped with at least one tempera- of the water throughout the process ture-indicating device that accurately and where there is adequate circulation indicates the temperature during proc- to ensure accurate temperature meas- essing. Each temperature-indicating urement. On horizontal retorts, the device shall have a sensor and a dis- temperature-indicating device sensor play. Each temperature-indicating de- should be located in the side at the vice and each reference device that is center of the retort. The temperature-

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indicating device—not the tempera- bined with the steam controller and ture-recording device—shall be the ref- may be a recorder-controller. Air-oper- erence instrument for indicating the ated temperature controllers should processing temperature. have adequate filter systems to ensure (2) Temperature-recording device. Each a supply of clean, dry air. retort shall have an accurate tempera- (3) Pressure gages. Each retort should ture-recording device. Each tempera- be equipped with a pressure gage that ture-recording device shall have a sen- is accurate to 2 pounds per square inch sor and a mechanism for recording (13.8 kilopascals) or less. temperatures to a permanent record, (4) Steam controller. Each retort shall such as a temperature-recording chart. be equipped with an automatic steam The temperature-recording device sen- controller to maintain the retort tem- sor shall be installed either within the perature. This may be a recorder-con- retort shell or in a well attached to the troller when combined with a tempera- shell. ture-recording device. Air-operated (i) Analog or graphical recordings. temperature controllers should have Temperature-recording devices that adequate filter systems to ensure a create analog or graphical recordings supply of clean, dry air. may be used. Temperature-recording (5) Retort speed timing. The rotational devices that record to charts shall be speed of the retort shall be specified in used only with the appropriate chart. the scheduled process. The speed shall Each chart shall have a working scale be adjusted, as necessary, to ensure of not more than 55 °F per inch (12 °C that the speed is as specified in the per centimeter) within a range of 20 °F scheduled process. The rotational speed (10 °C) of the process temperature. as well as the process time shall be re- Chart graduations shall not exceed 2 °F corded for each retort load processed. (1 °C) within a range of 10 °F (5 °C) of Alternatively, a recording tachometer the process temperature. Temperature- may be used to provide a continuous recording devices that create record of the speed. A means of pre- multipoint plottings of temperature venting unauthorized speed changes readings shall record the temperature shall be provided. A lock or a notice at intervals that will assure that the from management posted at or near parameters of the process time and the speed adjustment device that pro- process temperature have been met. vides a warning that only authorized (ii) Digital recordings. Temperature- persons are permitted to make adjust- recording devices, such as data loggers, ment is a satisfactory means of pre- that record numbers or create other venting unauthorized changes. digital records may be used. Such a de- (6) Air supply and controls. When air is vice shall record the temperature at in- used to provide overpressure: tervals that will assure that the pa- (i) A means shall be provided for in- rameters of the process time and proc- troducing compressed air at the proper ess temperature have been met. pressure and rate. The proper pressure (iii) Adjustments. The temperature-re- shall be controlled by an automatic cording device shall be adjusted with pressure control unit. A check valve sufficient frequency to ensure agree- shall be provided in the air supply line ment as nearly as possible with, but to to prevent water from entering the sys- be in no event higher than, the tem- tem. perature-indicating device during proc- (ii) A water level indicator, e.g., sen- essing. A means of preventing unau- sor, gage, water glass, or petcock(s), thorized changes in adjustment shall shall be used for determining the water be provided. A lock or a notice from level in the retort during operation. management posted at or near the tem- Water shall cover the top layer of con- perature-recording device that provides tainers during the entire come-up time a warning that only authorized persons and processing periods and should also are permitted to make adjustments is a cover the top layer of containers dur- satisfactory means of preventing unau- ing the cooling periods. The operator thorized changes. shall check and record the water level (iv) Temperature controller. The tem- at intervals sufficient to ensure its perature-recording device may be com- adequacy.

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(7) Water circulation. When a water ing machine vacuum in vacuum-packed circulating system is used for heat dis- products, maximum fill-in or drained tribution, it shall be installed in such a weight, minimum net weight, and per- manner that water will be drawn from cent solids shall be as specified in the the bottom of the retort through a suc- scheduled process for all products when tion manifold and discharged through a deviations from such specifications spreader which extends the length of may affect the scheduled process. All the top of the retort. The holes in the measurements and recordings of crit- water spreader shall be uniformly dis- ical factors should be made at intervals tributed and should have an aggregate not to exceed 15 minutes. area not greater than the cross-sec- (f) Equipment and procedures for pres- tional area of the outlet line from the sure processing in steam in hydrostatic re- pump. The suction outlets shall be pro- torts—(1) Temperature-indicating device. tected with nonclogging screens or Each retort shall be equipped with at other suitable means shall be used to least one temperature-indicating de- keep debris from entering the circulating system. The pump shall be device that accurately indicates the tem- signed to provide proper flow on start- perature during processing. Each tem- up and during operation, such as with a perature-indicating device shall have a bleeder or other suitable means to re- sensor and a display. Each tempera- move air during startup and with an ture-indicating device and each ref- appropriate device or design to prevent erence device that is maintained by the pump cavitation during operation. The processor shall be tested for accuracy pump shall be equipped with a sig- against a reference device for which naling device to warn the operator the accuracy is traceable to a National when it is not running. Alternative Institute of Standards and Technology methods for circulation of water in the (NIST), or other national metrology in- retort may be used when established by stitute, standard reference device by a competent authority as adequate for appropriate standard procedures, upon even heat distribution. installation and at least once a year (8) Drain valve. A nonclogging, water- thereafter, or more frequently if nec- tight valve shall be used. A screen shall essary, to ensure accuracy during proc- be installed or other suitable means essing. Each temperature-indicating shall be used on all drain openings to device and each reference device that is prevent clogging. maintained by the processor shall have (9) Critical factors. Critical factors a tag, seal, or other means of identity. specified in the scheduled process shall (i) The design of the temperature-in- be measured and recorded on the proc- dicating device shall ensure that the essing record at intervals of sufficient accuracy of the device is not affected frequency to ensure that the factors by electromagnetic interference and are within the limits specified in the environmental conditions. scheduled process. The minimum (ii) Records of the accuracy of the headspace of containers, if specified in temperature-indicating device and of a the scheduled process, shall be measured and recorded at intervals of suffi- reference device that is maintained by cient frequency to ensure that the the processor shall be established and headspace is as specified in the sched- maintained in accordance with uled process. The headspace of solder- § 113.100(c) and (d). tipped, lap seam (vent hole) cans may (iii) A temperature-indicating device be measured by net weight determina- that is defective or cannot be adjusted tions. When the product consistency is to the accurate calibrated reference de- specified in the scheduled process, the vice shall be repaired before further consistency of the product shall be de- use or replaced. termined by objective measurements (iv) A temperature-indicating device on the product taken from the filler be- shall be accurate to 1 °F (0.5 °C). The fore processing and recorded at inter- temperature range of a mercury-in- vals of sufficient frequency to ensure glass thermometer shall not exceed 17 that the consistency is as specified in °F per inch (4 °C per centimeter) of the scheduled process. Minimum clos- graduated scale. A mercury-in-glass

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thermometer that has a divided mer- parameters of the process time and cury column shall be considered defec- process temperature have been met. tive. (ii) Digital recordings. Temperature- (v) Each temperature-indicating de- recording devices, such as data loggers, vice shall be installed where it can be that record numbers or create other accurately and easily read. The tem- digital recordings may be used. Such a perature-indicating device sensor shall device shall record the temperature at be located in the steam dome near the intervals that will assure that the pa- steam-water interface. When the sched- rameters of the process time and proc- uled process specifies maintenance of ess temperature have been met. particular temperatures in the hydro- (iii) Adjustments. The temperature-re- static water legs, a temperature-indi- cording device shall be adjusted with cating device sensor shall be located in sufficient frequency to ensure agree- each hydrostatic water leg in a posi- ment as nearly as possible with, but to tion near the bottom temperature-re- be in no event higher than, the tem- cording device sensor. The tempera- perature-indicating device during proc- ture-indicating device—not the tem- essing. A means of preventing unau- perature-recording device—shall be the thorized changes in adjustment shall reference instrument for indicating the be provided. A lock or a notice from processing temperature. management posted at or near the temperature-recording device that provides (2) Temperature-recording device. Each a warning that only authorized persons retort shall have an accurate tempera- are permitted to make adjustments is a ture-recording device. Each tempera- satisfactory means of preventing unau- ture-recording device shall have a sen- thorized changes. sor and a mechanism for recording (iv) Temperature controller. The tem- temperatures to a permanent record, perature-recording device may be com- such as a temperature-recording chart. bined with the steam controller and The temperature-recording device sen- may be a recorder-controller. sor shall be installed either within the (3) Pressure gages. Each retort should steam dome or in a well attached to be equipped with a pressure gage that the dome. Each temperature-recording is accurate to 2 pounds per square inch 1 device sensor well shall have a ⁄16-inch (13.8 kilopascals) or less. (1.5 millimeters) or larger bleeder that (4) Recording of temperatures. Tem- emits steam continuously during the peratures indicated by the tempera- processing period. Additional temperature-indicating device or devices shall ture-recording device sensors shall be be entered on a suitable form during installed in the hydrostatic water legs processing operations. Temperatures in situations where the scheduled proc- shall be recorded by an accurate tem- ess specifies maintenance of particular perature-recording device or devices at temperatures in the hydrostatic water the following points: legs. (i) In the steam chamber between the (i) Analog or graphical recordings. steam-water interface and the lowest Temperature-recording devices that container position. create analog or graphical recordings (ii) Near the top and the bottom of may be used. Temperature-recording each hydrostatic water leg if the sched- devices that record to charts shall be uled process specifies maintenance of used only with the appropriate chart. particular temperatures in the legs. Each chart shall have a working scale (5) Steam controller. Each retort shall of not more than 55 °F per inch (12 °C be equipped with an automatic steam per centimeter) within a range of 20 °F controller to maintain the retort tem- (10 °C) of the process temperature. perature. This may be a recorder-con- Chart graduations shall not exceed 2 °F troller when combined with a tempera- (1 °C) within a range of 10 °F (5 °C) of ture-recording device. A steam con- the process temperature. Temperature- troller activated by the steam pressure recording devices that create of the retort is acceptable if it is care- multipoint plottings of temperature fully mechanically maintained so that readings shall record the temperature it operates satisfactorily. Air-operated at intervals that will assure that the temperature controllers should have

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adequate filter systems to ensure a (iii) Such measurements and record- supply of clean, dry air. ings should be made at intervals not to (6) Venting. Before the start of proc- exceed 15 minutes. essing operations, the retort steam (g) Aseptic processing and packaging chamber or chambers shall be vented systems—(1) Product sterilizer—(i) Equip- to ensure removal of air. ment—(A) Temperature-indicating device. Each product sterilizer shall be (7) Bleeders. Bleeder openings 1⁄4-inch (6 millimeters) or larger shall be lo- equipped with at least one tempera- cated at the top of the steam chamber ture-indicating device that accurately or chambers opposite the point of indicates the temperature during proc- steam entry. Bleeders shall be wide essing. Each temperature-indicating device shall have a sensor and a dis- open and shall emit steam continu- play. Each temperature-indicating de- ously during the entire process, includ- vice and each reference device that is ing the come-up time. All bleeders maintained by the processor shall be shall be arranged in such a way that tested for accuracy against a reference the operator can observe that they are device for which the accuracy is trace- functioning properly. able to a National Institute of Stand- (8) Retort speed. The speed of the con- ards and Technology (NIST), or other tainer-conveyor chain shall be speci- national metrology institute, standard fied in the scheduled process and shall reference device by appropriate stand- be determined and recorded at the ard procedures, upon installation and start of processing and at intervals of at least once a year thereafter, or more sufficient frequency to ensure that the frequently if necessary, to ensure accu- retort speed is maintained as specified. racy during processing. Each tempera- The speed should be determined and re- ture-indicating device and each ref- corded every 4 hours. An automatic de- erence device that is maintained by the vice should be used to stop the chain processor shall have a tag, seal, or when the temperature drops below that other means of identity. specified in the scheduled process. A (1) The design of the temperature-in- means of preventing unauthorized dicating device shall ensure that the speed changes shall be provided. A lock accuracy of the device is not affected or a notice from management posted at by electromagnetic interference and or near the speed-adjusting device that environmental conditions. provides a warning that only author- (2) Records of the accuracy of the ized persons are permitted to make ad- temperature-indicating device and of a justments is a satisfactory means of reference device that is maintained by preventing unauthorized changes. the processor shall be established and maintained in accordance with (9) Critical factors. Critical factors § 113.100(c) and (d). specified in the scheduled process shall (3) A temperature-indicating device be measured and recorded on the proc- that is defective or cannot be adjusted essing record at intervals of sufficient to the accurate calibrated reference de- frequency to ensure that the factors vice shall be repaired before further are within the limits specified in the use or replaced. scheduled process. (4) A temperature-indicating device (i) When maximum fill-in or drained shall be accurate to 1 °F (0.5 °C). The weight is specified in the scheduled temperature range of a mercury-in- process, it shall be measured and re- glass thermometer shall not exceed 17 corded at intervals of sufficient fre- °F per inch (4 °C per centimeter) of quency to ensure that the weight of the graduated scale. A mercury-in-glass product does not exceed the maximum thermometer that has a divided mer- for the given container size specified in cury column shall be considered defec- the scheduled process. tive. (ii) Closing machine vacuum in vacu- (5) Each temperature-indicating de- um-packed products shall be observed vice shall be installed where it can be and recorded at intervals of sufficient accurately and easily read. The tem- frequency to ensure that the vacuum is perature-indicating device—not the as specified in the scheduled process. temperature-recording device—shall be

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the reference instrument for indicating satisfactory means of preventing unau- the processing temperature. thorized changes. (B) Temperature-recording device. Each (C) Temperature controller. An accu- product sterilizer shall have an accurate temperature controller shall be in- rate temperature-recording device. stalled and capable of ensuring that Each temperature-recording device the desired product sterilization tem- shall have a sensor and a mechanism perature is maintained. Air-operated for recording temperatures to a perma- temperature controllers should have nent record, such as a temperature-re- adequate filter systems to ensure a cording chart. A temperature-recording supply of clean, dry air. device sensor shall be installed in the (D) Product-to-product regenerators. product at the holding-tube outlet be- When a product-to-product regenerator tween the holding tube and the inlet to is used to heat the cold unsterilized the cooler. Additional temperature-re- product entering the sterilizer by cording device sensors shall be located means of a heat exchange system, it at each point where temperature is shall be designed, operated, and con- specified as a critical factor in the trolled so that the pressure of the scheduled process. sterilized product in the regenerator is (1) Analog or graphical recordings. greater than the pressure of any Temperature-recording devices that unsterilized product in the regenerator create analog or graphical recordings to ensure that any leakage in the re- may be used. Temperature-recording generator is from the sterilized product devices that record to charts shall be into the unsterilized product. used only with the appropriate chart. (E) Differential pressure recorder-con- Each chart shall have a working scale troller. When a product-to-product re- of not more than 55 °F per inch (12 °C generator is used, it shall be equipped per centimeter) within a range of 20 °F with an accurate differential pressure (10 °C) of the desired product steriliza- recorder-controller. The differential tion temperature. Chart graduations pressure recorder-controller shall be shall not exceed 2 °F (1 °C) within a accurate to within 2 pounds per square range of 10 °F (5 °C) of the process tem- inch (13.8 kilopascals). One pressure perature. Temperature-recording de- sensor shall be installed at the steri- vices that create multipoint plottings lized product regenerator outlet and of temperature readings shall record the other pressure sensor shall be in- the temperature at intervals that will stalled at the unsterilized product re- assure that the parameters of the proc- generator inlet. The sensor and re- ess time and process temperature have corder of the differential pressure re- been met. corder-controller shall be tested for ac- (2) Digital recordings. Temperature-re- curacy against an accurate reference cording devices, such as data loggers, device upon installation and at least that record numbers or create other once every 3 months of operation digital recordings may be used. Such a thereafter, or more frequently if nec- device shall record the temperature at essary, to ensure its accuracy. intervals that will assure that the pa- (1) Analog or graphical recordings. Dif- rameters of the process time and proc- ferential pressure recorder-controllers ess temperature have been met. that create analog or graphical record- (3) Adjustments. The temperature-re- ings may be used. Differential pressure cording device shall be adjusted with recorder-controllers that record to sufficient frequency to ensure agree- charts shall be used only with the ap- ment as nearly as possible with, but to propriate chart. The scale divisions of be in no event higher than, the tem- the chart shall not exceed 2 pounds per perature-indicating device during proc- square inch (13.8 kilopascals) on a essing. A means of preventing unau- working scale of not more than 20 thorized changes in adjustment shall pounds per square inch per inch of be provided. A lock or a notice from scale (55 kilopascals per centimeter). management posted at or near the tem- (2) Digital recordings. Differential perature-recording device that provides pressure recorder-controllers, such as a warning that only authorized persons data loggers, that record numbers or are permitted to make adjustments is a create other digital recordings may be

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used. Such differential pressure re- seals or other effective barriers at the corder-controllers shall record the dif- potential access points. Appropriate ferential pressure at intervals that will means should be provided to permit the assure that the minimum differential operator to monitor the performance of pressure is maintained. the seals or barriers during operations. (F) Flow control. A flow control de- (ii) Operation—(A) Startup. Before the vice shall be located upstream from the start of aseptic processing operations holding tube and shall be operated to the product sterilizer and all product- maintain the required rate of product contact surfaces downstream shall be flow. A means of preventing unauthor- brought to a condition of commercial ized flow adjustments shall be pro- sterility. vided. A lock or a notice from manage- (B) Temperature drop in product-steri- ment posted at or near the flow con- lizing holding tube. When product tem- trolling device that provides a warning perature in the holding tube drops that only authorized persons are per- below the temperature specified in the mitted to make adjustments is a satis- scheduled process, product flow should factory means of preventing unauthor- be diverted away from the filler or ized changes. aseptic surge tank by means of a flow- (G) Product holding tube. The product- diversion system. If for any reason sterilizing holding tube shall be de- product subjected to a temperature signed to give continuous holding of drop below the scheduled process is every particle of food for at least the filled into containers, the product shall minimum holding time specified in the be segregated from product that re- scheduled process. The holding tube ceived the scheduled process. The proc- shall be designed so that no portion of essing deviation shall be handled in ac- the tube between the product inlet and cordance with § 113.89. The product the product outlet can be heated, and holding tube and any further system it must be sloped upward at least 1⁄4- portions affected shall be returned to a inch per foot (2.1 centimeters per condition of commercial sterility be- meter). fore product flow is resumed to the (H) Flow-diversion systems. If a proc- filler or to the aseptic surge tank. essor elects to install a flow-diversion system, it should be installed in the (C) Loss of proper pressures in the re- product piping located between the generator. When a regenerator is used, product cooler and the product filler or the product may lose sterility when- aseptic surge tank and should be de- ever the pressure of sterilized product signed to divert flow away from the in the regenerator is less than 1 pound filler or aseptic surge tank automati- per square inch (6.9 kilopascals) greater cally. Controls and/or warning systems than the pressure of unsterilized prod- should be designed and installed with uct in the regenerator. In this case, necessary sensors and actuators to op- product flow should be diverted away erate whenever the sterilizing tempera- from the filler or aseptic surge tank by ture in the holding tube or pressure dif- means of the flow-diversion system. If ferential in the product regenerator for any reason the product is filled into drops below specified limits. Flow-di- containers, the product shall be seg- version systems should be designed and regated from product that received the operated in accordance with rec- scheduled process. The processing devi- ommendations of an aseptic processing ation shall be handled in accordance and packaging authority. with § 113.89. Product flow to the filler (I) Equipment downstream from the or to the aseptic surge tank shall not holding tube. Product coolers, aseptic be resumed until the cause of the im- surge tanks, or any other equipment proper pressure relationships in the re- downstream from the holding tube, generator has been corrected and the with rotating or reciprocating shafts, affected system(s) has been returned to valve stems, instrument connections, a condition of commercial sterility. or other such points, are subject to po- (D) Loss of sterile air pressure or other tential entry of microorganisms into protection level in the aseptic surge tank. the product. Such locations in the sys- When an aseptic surge tank is used, tem should be equipped with steam conditions of commercial sterility may

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be lost when the sterile air over- factory means of preventing unauthor- pressure or other means of protection ized changes. drops below the scheduled process (ii) Operation—(A) Startup. Before the value. Product flow to and/or from the start of packaging operations, both the aseptic surge tank shall not be re- container and closure sterilizing sys- sumed until the potentially contami- tem and the product filling and closing nated product in the tank is removed, system shall be brought to a condition and the aseptic surge tank has been re- of commercial sterility. turned to a condition of commercial (B) Loss of sterility. A system shall be sterility. provided to stop packaging operations, (E) Records. Readings at the following or alternatively to ensure segregation points shall be observed and recorded of any product packaged when the at the start of aseptic packaging oper- packaging conditions fall below sched- ations and at intervals of sufficient fre- uled processes. Compliance with this quency to ensure that these values are requirement may be accomplished by as specified in the scheduled process: diverting product away from the filler, Temperature-indicating device in hold- by preventing containers from entering ing tube outlet; temperature-recording the filler, or by other suitable means. device in holding tube outlet; differen- In the event product is packaged under tial pressure recorder-controller, if a conditions below those specified in the product-to-product regenerator is used; scheduled process, all such product product flow rate as established by the shall be segregated from product that flow control device or as determined by received the scheduled process. The filling and closing rates and, if an asep- processing deviation shall be handled tic surge tank is used, sterile air pres- in accordance with § 113.89. In the event sure or other protection means; and of loss of sterility, the system(s) shall proper performance of steam seals or be returned to a condition of commer- other similar devices. The measure- cial sterility before resuming pack- ments and recordings should be made aging operations. at intervals not to exceed 1 hour. (C) Observations and meas- (2) Container sterilizing, filling, and Records. closing operation—(i) Equipment—(A) Re- urements of operating conditions shall cording device. The container and clo- be made and recorded at intervals of sure sterilization system and product sufficient frequency to ensure that filling and closing system shall be in- commercial sterility of the food prod- strumented to demonstrate that the re- uct is being achieved; such measure- quired sterilization is being accom- ments shall include the sterilization plished continuously. Recording de- media flow rates, temperatures, the vices shall be used to record, when ap- container and closure rates (if applica- plicable, the sterilization media flow ble) through the sterilizing system, and rates, temperature, concentration, or the sterilization conditions if a batch other factors. When a batch system is system is used for container steriliza- used for container sterilization, the tion. The measurements and recordings sterilization conditions shall be re- should be made at intervals not to ex- corded. ceed 1 hour. (B) Timing method(s). A method(s) (3) Incubation. Incubation tests shall be used either to give the reten- should be conducted on a representation time of containers, and closures if tive sample of containers of product applicable, in the sterilizing environ- from each code; records of the test re- ment specified in the scheduled proc- sults should be maintained. ess, or to control the sterilization cycle (4) Critical factors. Critical factors at the rate specified in the scheduled specified in the scheduled process shall process. A means of preventing unau- be measured and recorded on the proc- thorized speed changes must be pro- essing record at intervals of sufficient vided. A lock or a notice from manage- frequency to ensure that the factors ment posted at or near the speed ad- are within the limits specified in the justing device that provides a warning scheduled process. Such measurements that only authorized persons are per- and recordings should be done at inter- mitted to make adjustments is a satis- vals not to exceed 15 minutes.

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(h) Equipment and procedures for flame specified in the scheduled process shall sterilizers. The container conveyor be measured with instruments having speed shall be specified in the sched- the accuracy and dependability ade- uled process. The container conveyor quate to ensure that the requirements speed shall be measured and recorded of the scheduled process are met. All at the start of operations and at inter- measurements shall be made and re- vals of sufficient frequency to ensure corded at intervals of sufficient fre- that the conveyor speed is as specified quency to ensure that the critical fac- in the scheduled process. Such meas- tors are within the limits specified in urements and recordings should be the scheduled process. done at 1-hour intervals. Alternatively, (j) Other systems. All systems, wheth- a recording tachometer may be used to er or not specifically mentioned in this provide a continuous record of the part, for the thermal processing of low- speed. A means of preventing changes acid foods in hermetically sealed con- in flame intensity and unauthorized tainers shall conform to the applicable speed changes on the conveyor shall be requirements of this part and the provided. A lock or a notice from man- methods and controls used for the management posted at or near the speed ufacture, processing, and packing of adjusting device that provides a warn- these foods shall be as established in ing that only authorized persons are the scheduled process. These systems permitted to make adjustments is a shall be operated or administered in a satisfactory means of preventing unau- manner adequate to ensure that com- thorized changes. The surface tempera- mercial sterility is achieved. Critical ture of at least one container from factors specified in the scheduled proc- each conveyor channel shall be meas- ess shall be measured and recorded at ured and recorded at the entry and at intervals of sufficient frequency to en- the end of the holding period at inter- sure that the critical factors are within vals of sufficient frequency to ensure the limits specified in the scheduled that the temperatures specified in the process. scheduled process are maintained. Such [76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28, measurements and recordings should 2011] be done at intervals not to exceed 15 minutes. (1) Process interruption. In the event Subpart D—Control of Compo- of process interruption wherein the nents, Food Product Con- temperature of the product may have tainers, Closures, and In-Proc- dropped, an authorized, scheduled ess Materials emergency plan approved by a qualified person having expert knowledge of the § 113.60 Containers. process requirements may be used. (a) Closures. Regular observations (2) Critical factors. Critical factors shall be maintained during production specified in the scheduled process shall runs for gross closure defects. Any such be measured and recorded on the proc- defects shall be recorded and corrective essing record at intervals of sufficient action taken and recorded. At intervals frequency to ensure that the factors of sufficient frequency to ensure proper are within the limits specified in the closure, the operator, closure super- scheduled process. visor, or other qualified container clo- (i) Equipment and procedures for ther- sure inspection person shall visually mal processing of foods wherein critical examine either the top seam of a can factors such as water activity are used in randomly selected from each seaming conjunction with thermal processing. The head or the closure of any other type of methods and controls used for the man- container being used and shall record ufacture, processing, and packing of the observations made. For double- such foods shall be as established in seam cans, each can should be exam- the scheduled process and shall be op- ined for cutover or sharpness, skidding erated or administered in a manner or deadheading, false seam, droop at adequate to ensure that the product is the crossover or lap, and condition of safe. The time and temperature of inside of countersink wall for evidence processing and other critical factors of broken chuck. Such measurements

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and recordings should be made at inter- down examinations shall be recorded vals not to exceed 30 minutes. Addi- and the corrective action taken, if any, tional visual closure inspections shall shall be noted. be made immediately following a jam (i) Required and optional can seam in a closing machine, after closing ma- measurements: chine adjustment, or after startup of a (a) Micrometer measurement system: machine following a prolonged shut- Required Optional down. All pertinent observations shall be recorded. When irregularities are Cover hook Overlap (by calculation). found, the corrective action shall be re- Body hook Countersink. Width (length, height) corded. Tightness (observation for wrinkle) (1) Teardown examinations for dou- Thickness ble-seam cans shall be performed by a qualified individual and the results (b) Seam scope or projector: therefrom shall be recorded at inter- Required Optional vals of sufficient frequency on enough containers from each seaming station Body hook Width (length, height). Overlap Cover hook. to ensure maintenance of seam integ- Tightness (observation for wrinkle) Countersink. rity. Such examinations and recordings Thickness by micrometer should be made at intervals not to exceed 4 hours. The results of the tear- (c) Can double seam terminology:

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(1) ‘‘Crossover’’: The portion of a dou- (2) ‘‘Cutover’’: A fracture, sharp bend, ble seam at the lap. or break in the metal at the top of the inside portion of the double seam.

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(3) ‘‘Deadhead’’: A seam which is in- ibly perforated or otherwise marked, if complete due to chuck spinning in the the label is securely affixed to the countersink. product container. The required identi- (4) ‘‘Droop’’: Smooth projection of fication shall identify in code the es- double seam below bottom of normal tablishment where packed, the product seam. contained therein, the year packed, the (5) ‘‘False seam’’: A small seam day packed, and the period during breakdown where the cover hook and which packed. The packing period code the body hook are not overlapped. shall be changed with sufficient fre- (6) ‘‘Lap’’: Two thicknesses of mate- quency to enable ready identification rial bonded together. of lots during their sale and distribu- (ii) Two measurements at different tion. Codes may be changed on the locations, excluding the side seam, basis of one of the following: intervals shall be made for each double seam of 4 to 5 hours; personnel shift changes; characteristic if a seam scope or seam or batches, as long as the containers projector is used. When a micrometer that constitute the batch do not extend is used, three measurements shall be over a period of more than one per- made at points approximately 120° sonnel shift. apart, excluding the side seam. (d) Postprocess handling. Container (iii) Overlap length can be calculated handling equipment used in handling by the following formula: filled containers shall be designed, constructed, and operated to preserve the The theoretical overlap length = CH + can seam or other container closure in- BH + T ¥ W, where tegrity. Container handling equipment, CH = cover hook including automated and non-auto- BH = body hook mated equipment, shall be checked T = cover thickness, and with sufficient frequency and repaired W = seam width (height, length) or replaced as necessary to prevent (2) For glass containers with vacuum damage to containers and container closures, capper efficiency must be closures. When cans are handled on checked by a measurement of the cold belt conveyors, the conveyors should water vacuum. This shall be done be- be constructed to minimize contact by fore actual filling operations, and the the belt with the double seam, i.e., cans results shall be recorded. should not be rolled on the double (3) For closures other than double seam. All worn and frayed belting, can seams and glass containers, appro- retarders, cushions, etc. should be re- priate detailed inspections and tests placed with new nonporous material. shall be conducted by qualified per- All tracks and belts that come into sonnel at intervals of sufficient fre- contact with the can seams should be quency to ensure proper closing ma- thoroughly scrubbed and sanitized at chine performance and consistently re- intervals of sufficient frequency to liable hermetic seal production. avoid product contamination. Records of such tests shall be maintained. [44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11922, Mar. 3, 2011] (b) Cooling water. Container cooling water shall be chlorinated or otherwise sanitized as necessary for cooling ca- Subpart E—Production and nals and for recirculated water sup- Process Controls plies. There should be a measurable residual of the sanitizer employed at the § 113.81 Product preparation. water discharge point of the container (a) Before using raw materials and cooler. ingredients susceptible to micro- (c) Coding. Each hermetically sealed biological contamination, the proc- container of low-acid processed food essor shall ensure that those materials shall be marked with an identifying and ingredients are suitable for use in code that shall be permanently visible processing low-acid food. Compliance to the naked eye. When the container with this requirement may be accom- does not permit the code to be em- plished by receiving the raw materials bossed or inked, the label may be leg- and ingredients under a supplier’s

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guarantee that they are suitable for the food free of microorganisms capa- use, by examining them for their ble of reproducing in the food under microbiological condition, or by other normal nonrefrigerated conditions of acceptable means. storage and distribution. (b) Blanching by heat, when required in the preparation of food for canning, § 113.83 Establishing scheduled proc- should be effected by heating the food esses. to the required temperature, holding it Scheduled processes for low-acid at this temperature for the required foods shall be established by qualified time, and then either rapidly cooling persons having expert knowledge of the food or passing it to subsequent thermal processing requirements for processing without delay. low-acid foods in hermetically sealed Thermophilic growth and contamina- containers and having adequate facili- tion in blanchers should be minimized ties for making such determinations. by the use of adequate operating tem- The type, range, and combination of peratures and by cleaning. If the variations encountered in commercial blanched food product is washed before production shall be adequately pro- filling, potable water should be used. vided for in establishing the scheduled (c) The filling of containers, either process. Variations include those that mechanically or by hand, shall be con- occur due to seasonal or growing fluc- trolled so as to ensure that the filling tuations, variety differences, supplier requirements specified in the scheduled process are met. processes, reprocessing, and mixing a (d) The exhausting of containers for batch of processed product with the the removal of air shall be controlled same unprocessed product before it is so as to meet the conditions for which processed. Critical factors, e.g., min- the process was designed. Compliance imum headspace, consistency, max- with the requirement may be accom- imum fill-in or drained weight, aw, etc., plished by heat exhausting, mechanical that may affect the scheduled process, exhausting, hot brining, or steam in- shall be specified in the scheduled proc- jection. ess. Acceptable scientific methods of (e) When the maintenance of pH establishing heat sterilization proc- (above 4.6) of a normally low-acid food esses shall include, when necessary, is a basis for a scheduled process, there but shall not be limited to, the use of shall be careful supervision to ensure microbial thermal death time data, that the equilibrium pH of the finished process calculations based on product product meets that of the scheduled heat penetration data, and inoculated process. The methodology described in packs. Calculation shall be performed § 114.90 of this chapter should be used. according to procedures recognized by (f) When the scheduled process sets competent processing authorities. If in- forth critical factors to prevent the cubation tests are necessary for proc- growth of microorganisms not de- ess confirmation, they shall include stroyed by the thermal process, the containers from test trials and from factors shall be carefully controlled to actual commercial production runs ensure that the limits established in during the period of instituting the the scheduled process are not exceeded. process. The incubation tests for con- When normally low-acid foods require firmation of the scheduled processes sufficient solute to permit safe proc- should include the containers from the essing at low temperatures, such as in test trials and a number of containers boiling water, there shall be careful su- from each of four or more actual com- pervision to ensure that the equi- mercial production runs. The number librium water activity (aw) of the fin- of containers from actual commercial ished product meets that of the sched- production runs should be determined uled process. The scheduled thermal on the basis of recognized scientific processes for foods having an aw great- methods to be of a size sufficient to ener than 0.85 and less than the aw that sure the adequacy of the process. Com- would allow the growth of spores of plete records covering all aspects of microorganisms of public health sig- the establishment of the process and nificance shall be sufficient to render associated incubation tests shall be

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prepared and shall be permanently re- mine the initial temperature shall be tained by the person or organization tested for accuracy against a reference making the determination. device for which the accuracy is traceable to a National Institute of Stand- [76 FR 11922, Mar. 3, 2011] ards and Technology (NIST), or other § 113.87 Operations in the thermal national metrology institute, standard processing room. reference device, by appropriate stand- (a) Operating processes and retort ard procedures, with sufficient fre- venting procedures to be used for each quency to ensure that initial tempera- product and container size being ture measurements are accurate. packed shall either be posted in a con- Records of the accuracy of the tem- spicuous place near the processing perature-indicating device and of a ref- equipment or be made readily available erence device that is maintained by the to the retort or processing system op- processor shall be established and erator and any duly authorized em- maintained in accordance with ployee of the Food and Drug Adminis- § 113.100(c) and (d). tration. Scheduled processes must be (d) Timing devices used in recording made readily available to the super- thermal process time information shall visor and any duly authorized em- be accurate to the extent needed to en- ployee of the Food and Drug Adminis- sure that the processing time and vent- tration. ing time specified in the scheduled (b) A system for product traffic con- process are achieved. Pocket or wrist trol in the retort room shall be estab- watches are not considered satisfactory lished to prevent unretorted product for timing purposes. Digital clocks from bypassing the retort process. may be used if the operating process Each retort basket, truck, car, or crate and the venting schedule have a 1- used to hold containers in a retort, or minute or greater safety factor over one or more containers therein, shall, the scheduled process. if it contains any retorted food prod- (e) Clock times on temperature-re- uct, be plainly and conspicuously cording device records shall reasonably marked with a heat-sensitive indicator, correspond to the time of day on the or by other effective means that will processing records to provide correla- indicate visually, to thermal proc- tion of these records. essing personnel, those units that have (f) The steam supply to the thermal been retorted. A visual check shall be processing system shall be adequate to performed to determine whether or not the extent needed to ensure that suffi- the appropriate change has occurred in cient steam pressure is maintained the heat-sensitive indicator as a result during thermal processing, regardless of retorting for all retort baskets, of other demands of steam by the trucks, cars, or crates, to ensure that plant. each unit of product has been retorted. (g) If mufflers are used on bleeders or A record of these checks should be vent systems, evidence that the bleed- made. ers or vents are operated in a manner (c) The initial temperature of the that does not significantly impede the contents of the containers to be proc- removal of air shall be kept on file. essed shall be accurately determined This evidence may be in the form of and recorded with sufficient frequency heat distribution data or other satis- to ensure that the temperature of the factory evidence such as a letter from product is no lower than the minimum the manufacturer, the designer, or a initial temperature specified in the competent processing authority. scheduled process. For those operations [44 FR 16215, Mar. 16, 1979, as amended at 76 that use water during the filling of the FR 11923, Mar. 3, 2011] retort or during processing, provision shall be made to ensure that the water § 113.89 Deviations in processing, vent- will not, before the start of each ther- ing, or control of critical factors. mal process, lower the initial tempera- Whenever any process is less than the ture of the product below that specified scheduled process or when critical fac- in the scheduled process. The tempera- tors are out of control for any low-acid ture-indicating device used to deter- food or container system as disclosed

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from records by processor check or oth- cating device and temperature-record- erwise, the commerical processor of ing device readings, and other appro- that low-acid food shall either fully re- priate processing data. Closing ma- process that portion of the production chine vacuum in vacuum-packed prod- involved, keeping full records of the re- ucts, maximum fill-in or drained processing conditions or, alternatively, weight, or other critical factors speci- must set aside that portion of the prod- fied in the scheduled process shall also uct involved for further evaluation as be recorded. In addition, the following to any potential public health signifi- records shall be maintained: cance. Such evaluation shall be made (1) Still retorts. Time steam on; time by a competent processing authority temperature up to processing tempera- and shall be in accordance with proce- ture; time steam off; venting time and dures recognized by competent proc- temperature to which vented. essing authorities as being adequate to (2) Agitating retorts. Functioning of detect any potential hazard to public condensate bleeder; retort speed; and, health. Unless this evaluation dem- when specified in the scheduled proc- onstrates that the product had been ess, headspace, consistency, maximum given a thermal process that rendered drained weight, minimum net weight, it free of microorganisms of potential and percent solids. public health significance, the product (3) Hydrostatic retorts. The tempera- set aside shall be either fully reproc- ture in the steam chamber between the essed to render it commercially sterile steam-water interface and the lowest or destroyed. A record shall be made of container position; speed of the con- the evaluation procedures used and the tainer conveyor chain; and, when the results. Either upon completion of full scheduled process specifies mainte- reprocessing and the attainment of nance of particular temperatures in the commerical sterility or after the deter- hydrostatic water legs, the tempera- mination that no significant potential tures near the top and the bottom of for public health hazard exists, that each hydrostatic water leg. portion of the product involved may be (4) Aseptic processing and packaging shipped in normal distribution. Other- systems. Product temperature in the wise, the portion of the product in- holding tube outlet as indicated by the volved shall be destroyed. All process temperature-indicating device and the deviations involving a failure to satisfy temperature-recording device; differen- the minimum requirements of the tial pressure as indicated by the dif- scheduled process, including emer- ferential pressure recorder-controller, gencies arising from a jam or break- if a product-to-product regenerator is down of a continuous agitating retort used; product flow rate, as determined necessitating cooling the retort for re- by the flow controlling device or by pairs, shall be recorded and made the filling and closing rates; sterilization subject of a separate file (or a log iden- media flow rate or temperature or tifying the appropriate data) detailing both; retention time of containers, and those deviations and the actions taken. closures when applicable, in the sterilizing environment; and, when a batch Subpart F—Records and Reports system is used for container and/or closure sterilization, sterilization cycle § 113.100 Processing and production times and temperatures. records. (5) Flame sterilizers. Container con- (a) Processing and production infor- veyor speed; surface temperature at mation shall be entered at the time it the beginning and at the end of the is observed by the retort or processing holding period; nature of container. system operator, or other designated (6) Food preservation methods wherein person, on forms that include the prod- critical factors such as water activity are uct, the code number, the date, the reused in conjunction with thermal proc- tort or processing system number, the essing. Product formulation and sched- size of container, the approximate uled processes used, including the ther- number of containers per coding inter- mal process, its associated critical fac- val, the initial temperature, the actual tors, as well as other critical factors, processing time, the temperature-indi- and results of aw determinations. 373

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(7) Other systems. Critical factors (5) The date and results of each accu- specified in the formulation of the racy test, including the amount of cali- product or in the scheduled process. bration adjustment; and (b) Temperature-recording device (6) The date on or before which the records shall be identified by date, re- next accuracy test must be performed. tort number, and other data as nec- (d) Records of the accuracy of a ref- essary, so they can be correlated with erence device maintained by the proc- the record of lots processed. Each entry essor shall include: on the processing and production (1) A reference to the tag, seal, or records shall be made by the retort or other means of identity used by the processing system operator, or other processor to identify the reference de- designated person, at the time the spe- vice; cific retort or processing system condi- (2) The name of the manufacturer of tion or operation occurs, and this re- the reference device; tort or processing system operator or (3) The identity of the equipment and other designated person shall sign or reference to procedures used for the ac- initial each record form. Not later than curacy test and to adjust or calibrate 1 working day after the actual process, the reference device or, if an outside and before shipment or release for dis- facility is used to conduct the accuracy tribution, a representative of plant test for the reference device, a guar- management who is qualified by suit- antee, certificate of accuracy, certifi- able training or experience shall review cate of calibration, or other document all processing and production records from the facility that includes a state- for completeness and to ensure that ment or other documentation regard- the product received the scheduled ing the traceability of the accuracy to process. The records, including tem- a NIST or other national metrology institute standard; perature-recording device records, shall be signed or initialed and dated (4) The identity of the person or facil- by the reviewer. ity that performed the accuracy test and adjusted or calibrated the ref- (c) Records of the accuracy of a tem- erence device; perature-indicating device shall in- (5) The date and results of each accu- clude: racy test, including the amount of cali- (1) A reference to the tag, seal, or bration adjustment; and other means of identity used by the (6) The date on or before which the processor to identify the temperature- next accuracy test must be performed. indicating device; (e) Records of all container closure (2) The name of the manufacturer of examinations shall specify the product the temperature-indicating device; code, the date and time of container (3) The identity of the reference de- closure inspections, the measurements vice, equipment, and procedures used obtained, and all corrective actions for the accuracy test and to adjust the taken. Records shall be signed or ini- temperature-indicating device or, if an tialed by the container closure inspec- outside facility is used to conduct the tor and reviewed by management with accuracy test for the temperature-indi- sufficient frequency to ensure that the cating device, a guarantee, certificate containers are hermetically sealed. of accuracy, certificate of calibration, The records shall be signed or initialed or other document from the facility and dated by the reviewer. that includes a statement or other doc- (f) Records shall be maintained to umentation regarding the traceability identify the initial distribution of the of the accuracy to a National Institute finished product to facilitate, when of Standards and Technology (NIST) or necessary, the segregation of specific other national metrology institute food lots that may have become con- standard; taminated or otherwise rendered unfit (4) The identity of the person or facil- for their intended use. ity that performed the accuracy test (g) Copies of all records provided for and adjusted or calibrated the tempera- in this part, except those required ture-indicating device; under § 113.83 establishing scheduled

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processes, shall be retained at the proc- singly or in any combination. They essing plant for a period of not less have a water activity (aw) greater than than 1 year from the date of manufac- 0.85 and have a finished equilibrium pH ture, and at the processing plant or of 4.6 or below. These foods may be other reasonably accessible location called, or may purport to be, ‘‘pickles’’ for an additional 2 years. If, during the or ‘‘pickled lll.’’ Carbonated bev- first year of the 3-year record-retention erages, jams, jellies, preserves, acid period, the processing plant is closed foods (including such foods as stand- for a prolonged period between sea- ardized and nonstandardized food sonal packs, the records may be trans- dressings and condiment sauces) that ferred to some other reasonably acces- contain small amounts of low-acid sible location at the end of the seafood(s) and have a resultant finished sonal pack. (h) Records of this part may be main- equilibrium pH that does not signifi- tained electronically, provided they cantly differ from that of the predomi- are in compliance with part 11 of this nant acid or acid food, and foods that chapter. are stored, distributed, and retailed under refrigeration are excluded from [44 FR 16215, Mar. 16, 1979, as amended at 76 the coverage of this part. FR 11923, Mar. 3, 2011] (c) Lot means the product produced during a period indicated by a specific PART 114—ACIDIFIED FOODS code. Subpart A—General Provisions (d) Low-acid foods means any foods, other than alcoholic beverages, with a Sec. finished equilibrium pH greater than 114.3 Definitions. 4.6 and a water activity (a ) greater 114.5 Current good manufacturing practices. w 114.10 Personnel. than 0.85. Tomatoes and tomato products having a finished equilibrium pH Subparts B–D [Reserved] less than 4.7 are not classed as low-acid foods. Subpart E—Production and Process (e) Scheduled process means the proc- Controls ess selected by a processor as adequate 114.80 Processes and controls. for use under the conditions of manu- 114.83 Establishing scheduled processes. facture for a food in achieving and 114.89 Deviations from scheduled proce- maintaining a food that will not per- dures. mit the growth of microorganisms hav- 114.90 Methodology. ing public health significance. It in- Subpart F—Records and Reports cludes control of pH and other critical factors equivalent to the process estab- 114.100 Records. lished by a competent processing au- AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. thority. 264. (f) Shall is used to state mandatory SOURCE: 44 FR 16235, Mar. 16, 1979, unless requirements. otherwise noted. (g) Should is used to state recommended or advisory procedures or to Subpart A—General Provisions identify recommended equipment. (h) Water activity (a ) is a measure of § 114.3 Definitions. w the free moisture in a product and is For the purposes of this part, the fol- the quotient of the water vapor pres- lowing definitions apply. sure of the substance divided by the (a) Acid foods means foods that have vapor pressure of pure water at the a natural pH of 4.6 or below. same temperature. (b) Acidified foods means low-acid foods to which acid(s) or acid food(s) [44 FR 16235, Mar. 16, 1979, as amended at 61 are added; these foods include, but are FR 14245, Apr. 1, 1996] not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, pud- dings, peppers, tropical fruits, and fish,

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§ 114.5 Current good manufacturing designated in the scheduled process and practice. maintained in all finished foods. Manu- The criteria in §§ 114.10, 114.80, 114.83, facturing shall be in accordance with 114.89, and 114.100, as well as the cri- the scheduled process. Acidified foods teria in parts 110 and 117 of this chap- shall be thermally processed to an exter, apply in determining whether an tent that is sufficient to destroy the article of acidified food is adulterated: vegetative cells of microorganisms of (a) Within the meaning of section public health significance and those of 402(a)(3) of the Federal Food, Drug, and nonhealth significance capable of re- Cosmetic Act in that it has been manu- producing in the food under the condi- factured under such conditions that it tions in which the food is stored, dis- is unfit for food; or tributed, retailed and held by the user. (b) Within the meaning of section Permitted preservatives may be used 402(a)(4) of the Federal Food, Drug, and to inhibit reproduction of microorga- Cosmetic Act in that it has been pre- nisms of nonhealth significance (in lieu pared, packed, or held under insanitary of thermal processing). conditions whereby it may have be- (2) Sufficient control, including fre- come contaminated with filth, or quent testing and recording of results, whereby it may have been rendered in- shall be exercised so that the finished jurious to health. equilibrium pH values for acidified foods are not higher than 4.6. Measure- [80 FR 56144, Sept. 17, 2015] ment of acidity of foods in-process may § 114.10 Personnel. be made by potentiometric methods, titratable acidity, or colorimetric All operators of processing and pack- methods. If the finished equilibrium pH aging systems shall be under the oper- of the food is above 4.0, the measure- ating supervisions of a person who has ment of the finished equilibrium pH attended a school approved by the shall be by a potentiometric method, Commissioner for giving instruction in and the in-process measurements by ti- food-handling techniques, food-protec- tration or colorimetry shall be related tion principles, personal hygiene and to the finished equilibrium pH. If the plant sanitation practices, pH controls finished equilibrium pH is 4.0 or below, and critical factors in acidification, then the measurement of acidity of the and who has been identified by that final product may be made by any suit- school as having satisfactorily com- able method. Special care should be pleted the prescribed course of instruction. The Commissioner will consider taken when food ingredients have been students who have satisfactorily com- subjected to lye, lime, or similar high pleted the required portions of the pH materials. courses presented under § 108.35 and (3) Procedures for acidification to at- part 113 of this chapter before March tain acceptable equilibrium pH levels 16, 1979, to be in compliance with the in the final food include, but are not requirement of this section. limited to, the following: (i) Blanching of the food ingredients in acidified aqueous solutions. Subparts B–D [Reserved] (ii) Immersion of the blanched food in acid solutions. Although immersion Subpart E—Production and of food in an acid solution is a satisfac- Process Controls tory method for acidification, care must be taken to ensure that the acid § 114.80 Processes and controls. concentration is properly maintained. (a) Processing operations. The manu- (iii) Direct batch acidification, which facturer shall employ appropriate qual- can be achieved by adding a known ity control procedures to ensure that amount of an acid solution to a speci- finished foods do not present a health fied amount of food during acidifica- hazard. tion. (1) Acidified foods shall be so manu- (iv) Direct addition of a predeter- factured, processed, and packaged that mined amount of acid to individual a finished equilibrium pH value of 4.6 containers during production. Liquid or lower is achieved within the time acids are generally more effective than

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solid or pelleted acids. Care must be of this chapter; or (c) set aside that taken to ensure that the proper portion of the food involved for further amount of acid is added to each con- evaluation as to any potential public tainer. health significance. The evaluation (v) Addition of acid foods to low-acid shall be made by a competent proc- foods in controlled proportions to con- essing authority and shall be in accord- form to specific formulations. ance with procedures recognized by (4) Testing and examinations of con- competent processing authorities as tainers shall occur often enough to en- being adequate to detect any potential sure that the container suitably pro- hazard to public health. Unless the tects the food from leakage or con- evaluation demonstrates that the food tamination. has undergone a process that has ren- (b) Coding. Each container or product dered it safe, the food set aside shall ei- shall be marked with an identifying ther be fully reprocessed to render it code permanently visible to the naked safe, or be destroyed. A record shall be eye. If the container does not permit made of the procedures used in the the code to be embossed or inked, the evaluation and the results. Either upon label may be legibly perforated or oth- completion of full reprocessing and the erwise marked, as long as the label is attainment of a safe food, or after the securely affixed to the product con- determination that no significant po- tainer. The required identification tential for public health hazard exists, shall specify in code the establishment that portion of the food involved may where the product was packed, the be shipped in normal distribution. Oth- product contained therein, and the erwise, the portion of the food involved year, day, and period during which it shall be destroyed. was packed. The packing period code shall be changed often enough to en- § 114.90 Methodology. able ready identification of lots during Methods that may be used to deter- their sale and distribution. Codes may mine pH or acidity for acidified foods be changed periodically on one of the include, but are not limited to, the fol- following bases: intervals of 4 to 5 lowing: hours; personnel shift changes; or (a) Potentiometric method for the deter- batches, as long as the containers con- mination of pH—(1) Principles. The term stituting the batch do not represent ‘‘pH’’ is used to designate the intensity those processed during more than one or degree of acidity. The value of pH, personnel shift. the logarithm of the reciprocal of the hydrogen ion concentration in solu- § 114.83 Establishing scheduled proc- tion, is determined by measuring the esses. difference in potential between two The scheduled process shall be estab- electrodes immersed in a sample solu- lished by a qualified person who has ex- tion. A suitable system consists of a pert knowledge acquired through ap- potentiometer, a glass electrode, and a propriate training and experience in reference electrode. A precise pH deter- the acidification and processing of mination can be made by making an acidified foods. electromotive force (emf) measurement of a standard buffer solution whose pH § 114.89 Deviations from scheduled is known, and then comparing that processes. measurement to an emf measurement Whenever any process operation devi- of a sample of the solution to be tested. ates from the scheduled process for any (2) Instruments. The primary instru- acidified food and/or the equilibrium ment for use in pH determination is pH of the finished product is higher the pH meter or potentiometer. For than 4.6, the commercial processor of most work, an instrument with a di- the acidified food shall either: (a) Fully rect-reading pH scale is necessary. Bat- reprocess that portion of the food by a tery and line-operated instruments are process established by a competent available commercially. If the line processing authority as adequate to en- voltage is unstable, line-operated insure a safe product; (b) thermally proc- struments should be fitted with voltage ess it as a low-acid food under part 113 regulators to eliminate drifting of

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meter-scale readings. Batteries should automatic temperature compensator be checked frequently to ensure proper may be used. operation of battery operated instru- (iii) Accuracy. The accuracy of most ments. An instrument using an ex- pH meters is stated to be approxi- panded unit scale or a digital readout mately 0.1 pH unit, and reproducibility system is preferred since it allows is usually ±0.05 pH unit or less. Some more precise measurements. meters permit the expansion of any pH (3) Electrodes. The typical pH meter is unit range to cover the entire scale and equipped with a glass membrane elec- have an accuracy of approximately trode and a reference electrode or a ±0.01 pH unit and a reproducibility of single probe combination electrode. ±0.005 pH units. Various types of electrodes designed (4) General procedure for determining for specific uses are available. The pH. When operating an instrument, the most commonly used reference elec- operator should use the manufacturer’s trode is the calomel electrode, which instructions and should observe the fol- incorporates a salt bridge filled with lowing techniques for pH determina- saturated potassium chloride solution. tions: (i) Care and use of electrodes. Calomel (i) Switch the instrument on and electrodes should be kept filled with allow the electronic components to saturated potassium chloride solution warm up and stabilize before pro- or other solution specified by the man- ceeding. ufacturer because they may become (ii) Standardize the instrument and damaged if they are allowed to dry out. electrodes with commercially prepared For best results, electrodes should be standard 4.0 pH buffer or with freshly soaked in buffer solution, distilled or prepared 0.05 molar potassium acid deionized water, or other liquid speci- phthalate buffer solution prepared as fied by the manufacturer for several outlined in ‘‘Official Methods of Anal- hours before using and kept ready by ysis of the Association of Official Ana- storing with tips immersed in distilled lytical Chemists’’ (AOAC), 13th Ed. water or in buffer solution used for (1980), section 50.007(c), under ‘‘Buffer standardization. Electrodes should be Solutions for Calibration of pH Equip- rinsed with water before immersing in ment—Official Final Action,’’ which is the standard buffers and rinsed with incorporated by reference. Copies may water or the solution to be measured be obtained from the AOAC INTER- next between sample determinations. A NATIONAL, 481 North Frederick Ave., lag in meter response may indicate suite 500, Gaithersburg, MD 20877, or aging effects or fouling of the elec- may be examined at the National Ar- trodes, and cleaning and rejuvenation chives and Records Administration of the electrodes may be necessary and (NARA). For information on the avail- may be accomplished by placing the ability of this material at NARA, call electrodes in 0.1 molar sodium hydrox- 202–741–6030, or go to: http:// ide solution for 1 minute and then www.archives.gov/ federallregister/ transferring them to 0.1 molar hydro- codeloflfederallregulations/ chloric acid solution for 1 minute. The ibrllocations.html. Note the tempera- cycle should be repeated two times, ture of the buffer solution and set the ending with the electrodes in the acid temperature compensator control at solution. The electrodes should then be the observed temperature (room tem- thoroughly rinsed with water and blot- perature is near 25 °C). ted with soft tissue before proceeding (iii) Rinse the electrodes with water with the standardization. and blot, but do not wipe, with soft tis- (ii) Temperature. To obtain accurate sue. results, a uniform temperature should (iv) Immerse the tips in the buffer so- be maintained for the electrodes, the lution and take the pH reading, allow- standard buffer solutions, and the sam- ing about 1 minute for the meter to ples. Tests should be made at a tem- stabilize. Adjust the standardization perature between 20° and 30 °C, the op- control so that the meter reading cor- timum being 25 °C. Any temperature responds to the pH of the known buffer determinations made without meter (for example, 4.0) for the temperature compensation may affect pH values. An observed. Rinse the electrodes with

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water and blot with soft tissue. Repeat the temperature of the buffer solution procedure with fresh portions of buffer used for the standardization. solution until the instrument remains (ii) Rinse and blot the electrodes. Im- in balance on two successive trials. To merse the electrodes in the sample and check the operation of the pH meter, take the pH reading, allowing 1 minute check the pH reading using another for the meter to stabilize. Rinse and standard buffer such as one having a blot the electrodes and repeat on a pH of 7.0, or check it with freshly pre- fresh portion of sample. Oil and grease pared 0.025 molar phosphate solution from the samples may coat the elec- prepared as outlined in the AOAC, 13th trodes; therefore, it is advisable to Ed. (1980), section 50.007(e), which is in- clean and standardize the instrument corporated by reference. The avail- frequently. When oily samples cause ability of this incorporation by ref- fouling problems, it may become nec- erence is given in paragraph (a)(4)(ii) of essary to rinse the electrodes with this section. Expanded scale pH meters ethyl ether. may be checked with pH 3.0 or pH 5.0 (iii) Determine two pH values on the standard buffers. Buffers and instru- well-mixed sample. These readings ments can be further checked by com- should agree with one another to indi- parison with values obtained with a cate that the sample is homogeneous. second properly standardized instru- Report values to the nearest 0.05 pH ment. unit. (v) Indicating electrodes may be (6) Preparation of samples. Some food checked for proper operation by first products may consist of a mixture of using an acid buffer and then a base liquid and solid components that differ buffer. First standardize the electrodes in acidity. Other food products may be using a pH 4.0 buffer at or near 25 °C. semisolid in character. The following Standardization control should be ad- are examples of preparation procedures justed so that the meter reads exactly for pH testing for each of these cat- 4.0. Electrodes should be rinsed with egories: water, then blotted and immersed in a (i) Liquid and solid component mix- pH 9.18 borax buffer prepared as out- tures. Drain the contents of the con- lined in the AOAC, 13th Ed. (1980), sec- tainer for 2 minutes on a U.S. standard tion 50.007(f), which is incorporated by No. 8 sieve (preferably stainless steel) reference. The availability of this in- inclined at a 17- to 20-degree angle. corporation by reference is given in Record weight of the liquid and solid paragraph (a)(4)(ii) of this section. The portions and retain each portion sepa- pH reading should be within ±0.3 units rately. of the 9.18 value. (a) If the liquid contains sufficient (vi) The pH meter can be tested for oil to cause electrode fouling, separate proper operation by shorting the glass the layers with a separatory funnel and and reference electrode inputs, thereby retain the aqueous layer. The oil layer reducing the voltage to zero. In some may be discarded. Adjust the tempera- meters this shorting is done by switch- ture of the aqueous layer to 25 °C and ing the instrument to standby, and in determine its pH. other instruments by use of a shorting (b) Remove the drained solids from strap. With the instrument shorted the sieve, blend to a uniform paste, ad- out, standardization control should be just the temperature of the paste to 25 turned from one extreme to another. °C and determine its pH. This operation should produce a deflec- (c) Mix aliquots of solid and liquid tion greater than ±1.5 pH unit from fractions in the same ratio as found in center scale. the original container and blend to a (5) Determining pH on samples. (i) Ad- uniform consistency. Adjust the tem- just the temperature of the sample to perature of the blend to 25 °C and de- room temperature (25 °C), and set the termine the equilibriated pH. Alter- temperature compensator control to natively, blend the entire contents of the observed temperature. With some the container to a uniform paste, ad- expanded scale instruments, the sam- just the temperature of the paste to 25 ple temperature must be the same as °C, and determine the equilibriated pH.

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(ii) Marinated oil products. Separate (b) Colorimetric methods for the deter- the oil from the solid product. Blend mination of pH. This method may be the solid in a blender to a paste con- used in lieu of the potentiometric sistency; it may become necessary to method if the pH is 4.0 or lower. add a small amount of distilled water (1) Principle. The colorimetric method to some samples to facilitate the for pH involves the use of indicator blending. A small amount of added dyes in solutions that gradually change water will not alter the pH of most color over limited pH ranges. An indi- food products, but caution must be ex- cator that has the greatest color ercised concerning poorly buffered change at approximately the pH of the foods. No more than 20 milliliters of sample being tested is selected. The pH distilled water should be added to each is determined by the color of the indi- 100 grams of product. Determine the pH cator when exposed to the sample by immersing electrodes in the pre- under test. pared paste after adjusting the tem- (2) Indicator solutions. Most indicator perature to 25 °C. solutions are prepared as a 0.04 percent (iii) Semisolid products. Food products solution of the indicator dye in alco- of a semisolid consistency, such as pud- dings, potato salad, etc., may be blend- hol. In testing, a few drops of indicator ed to a paste consistency, and the pH solution are added to 10-milliliter por- may be determined on the prepared tions of the sample solution. Colors paste. If more fluidity is required, 10 to should be compared using a bright 20 milliliters of distilled water may be background. Approximate determina- added to 100 grams of product. Adjust tions can be made on white porcelain the temperature of the prepared paste spot plates, the test colors being com- to 25 °C and determine its pH. pared thereon with a set of color stand- (iv) Special product mixtures. For spe- ards. More accurate colorimetric tests cial product mixtures such as anti- can be made using a comparator block pasto, pour off the oil, blend the re- fitted with sets of tubes of standard in- maining product to a paste, and deter- dicator solutions of known pH. mine the pH of the blended paste. If (3) Indicator paper. A paper tape more fluidity is required, add 10 to 20 treated with indicator dye is dipped milliliters of distilled water to each 100 into the sample solution. Depending grams of product and blend. Adjust the upon the pH of the solution, the tape temperature of the prepared paste to 25 will change color and an approximate °C and determine its pH. pH can be determined by comparison (7) Process pH determination. Obtain with a standard color chart. sample portions of material for pH de- (c) Titratable acidity. Acceptable termination. methods for determining titratable (i) For process liquids, adjust the acidity are described in the AOAC, 13th temperature of the liquid to 25 °C and Ed. (1980), section 22.060, under ‘‘Ti- determine the pH by immersing the tratable Acidity—Official Final Ac- electrodes in the liquid. tion,’’ for ‘‘Indicator Method,’’ and sec- (ii) Drain solid materials on a sieve tion 22.061 for ‘‘Glass Electrode Meth- and blend to a workable paste. Adjust od—Official Final Action,’’ which is in- the temperature of the prepared paste corporated by reference. The avail- to 25 °C and determine its pH. ability of this incorporation by ref- (iii) If enough solid materials are erence is given in paragraph (a)(4)(ii) of available to make a paste, blend rep- this section. The procedure for pre- resentative aliquots of liquid and solid paring and standardizing the sodium materials to a workable paste. Adjust hydroxide solution is described in the the temperature of the prepared paste AOAC, 13th Ed. (1980), sections 50.032– ° to 25 C and determine the equilibrated 50.035, under ‘‘Sodium Hydroxide—Offi- pH. Alternatively, blend the entire con- cial Final Action’’ by the ‘‘Standard tents of the container to a uniform paste, adjust the temperature of the paste to 25 °C, and determine the equilibrated pH.

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Potassium Hydroxide Phthalate Meth- PART 115—SHELL EGGS od,’’ which is also incorporated by reference and available as set forth in paragraph (a)(4)(ii) of this section. AUTHORITY: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271. [44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, § 115.50 Refrigeration of shell eggs 1984; 54 FR 24892, June 12, 1989; 63 FR 14035, held for retail distribution. Mar. 24, 1998] (a) For purposes of this section a ‘‘retail establishment’’ is an operation Subpart F—Records and Reports that stores, prepares, packages, serves, vends, or otherwise provides food for § 114.100 Records. human consumption directly to con- (a) Records shall be maintained of ex- sumers. aminations of raw materials, pack- (b) Except as provided in paragraph aging materials, and finished products, (c) of this section, all shell eggs, and of suppliers’ guarantees or certifi- whether in intrastate or interstate cations that verify compliance with commerce, held for retail distribution: Food and Drug Administration regula- (1) Shall promptly be placed under re- tions and guidance documents or ac- frigeration as specified in paragraph tion levels. (b)(2) of this section upon receipt at a (b) Processing and production records retail establishment, except that, when showing adherence to scheduled proc- short delays are unavoidable, the eggs esses, including records of pH measure- shall be placed under refrigeration, as ments and other critical factors in- soon as reasonably possible; and tended to ensure a safe product, shall (2) Shall be stored and displayed be maintained and shall contain suffi- under refrigeration at an ambient tem- cient additional information such as perature not greater than 7.2 °C (45 °F) product code, date, container size, and while held at a retail establishment. product, to permit a public health haz- (c) Shell eggs that have been specifi- ard evaluation of the processes applied cally processed to destroy all viable to each lot, batch, or other portion of Salmonella shall be exempt from the reproduction. quirements of paragraph (b) of this sec- (c) All departures from scheduled tion. processes having a possible bearing on (d) Under sections 311 and 361 of the public health or the safety of the food Public Health Service Act (PHS Act), shall be noted and the affected portion any State or locality that is willing of the product identified; these depar- and able to assist the agency in the en- tures shall be recorded and made the forcement of paragraph (b) of this sec- subject of a separate file (or log identi- tion, and is authorized to inspect or fying the appropriate data) delineating regulate retail establishments, may, in them, the action taken to rectify them, its own jurisdiction, enforce paragraph and the disposition of the portion of (b) of this section through inspections the product involved. under paragraph (f) of this section and (d) Records shall be maintained iden- through administrative enforcement tifying initial distribution of the fin- remedies identified in paragraph (e) of ished product to facilitate, when nec- this section until FDA notifies the essary, the segregation of specific food State or locality in writing that such lots that may have become contami- assistance is no longer needed. When nated or otherwise unfit for their in- providing assistance under paragraph tended use. (e) of this section, a State or locality (e) Copies of all records provided for may follow the hearing procedures set in paragraphs (b), (c), and (d) of this out in paragraphs (e)(2)(iii) through section shall be retained at the proc- (e)(2)(iv) of this section, substituting, essing plant or other reasonably acces- where necessary, appropriate State or sible location for a period of 3 years local officials for designated FDA offi- from the date of manufacture. cials or may utilize State or local hear- [44 FR 16235, Mar. 16, 1979, as amended at 65 ing procedures if such procedures sat- FR 56479, Sept. 19, 2000] isfy due process.

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(e) This section is established under (E) Identification or description of authority of both the Federal Food, the eggs; Drug, and Cosmetic Act (the act) and (F) The order number; the PHS Act. Under the act, the agency (G) The date of the order; can enforce the food adulteration pro- (H) The text of this entire section; visions under 21 U.S.C. 331, 332, 333, and (I) A statement that the order may 334. However, 42 U.S.C. 264 provides for be appealed by written appeal or by re- the issuance of implementing enforce- questing an informal hearing; ment regulations; therefore, FDA has (J) The name and phone number of established the following administra- the person issuing the order; and tive enforcement procedures for the di- (K) The location and telephone num- version or destruction of shell eggs and ber of the office or agency and the for informal hearings under the PHS name of its director. Act: (iii) Approval of District Director. An (1) Upon finding that any shell eggs order, before issuance, shall be ap- have been held in violation of this sec- proved by the Food and Drug Adminis- tion, an authorized FDA representative tration (FDA) District Director in or a State or local representative in ac- whose district the shell eggs are lo- cordance with paragraph (d) of this sec- cated. If prior written approval is not tion may order such eggs to be di- feasible, prior oral approval shall be verted, under the supervision of said obtained and confirmed by written representative, for processing in ac- memorandum as soon as possible. cordance with the Egg Products Inspec- (iv) Labeling or marking of shell eggs tion Act (EPIA) (21 U.S.C. 1031 et seq.) under order. An FDA, State, or local or destroyed by or under the super- agency representative issuing an order vision of an officer or employee of the under paragraph (e)(1) of this section FDA, or, if applicable, of the State or shall label or mark the shell eggs with locality in accordance with the fol- official tags that include the following lowing procedures: information: (i) Order for diversion or destruction. (A) A statement that the shell eggs Any district office of FDA or any State are detained in accordance with regula- or local agency acting under paragraph tions issued under section 361(a) of the (d) of this section, upon finding shell PHS Act (42 U.S.C. 264(a)). eggs held in violation of this section, (B) A statement that the shell eggs may serve upon the person in whose shall not be sold, distributed or other- possession such eggs are found a writ- wise disposed of or moved except, after ten order that such eggs be diverted, notifying the issuing entity in writing, under the supervision of an officer or to: employee of the issuing entity, for (1) Divert them for processing in ac- processing in accordance with the cordance with the EPIA or destroy EPIA (21 U.S.C. 1031 et seq.) or de- them; or stroyed by or under the supervision of (2) Move them to an another location said district office, within 10-working for holding pending appeal. days from the date of receipt of the (C) A statement that the violation of order. the order or the removal or alteration (ii) Issuance of order. The order shall of the tag is punishable by fine or im- include the following information: prisonment or both (section 368 of the (A) A statement that the shell eggs PHS Act, 42 U.S.C. 271). identified in the order are subject to di- (D) The order number and the date of version for processing in accordance the order, and the name of the govern- with the EPIA or destruction; ment representative who issued the (B) A detailed description of the facts order. that justify the issuance of the order; (v) Sale or other disposition of shell eggs (C) The location of the eggs; under order. After service of the order, (D) A statement that these eggs shall the person in possession of the shell not be sold, distributed, or otherwise eggs that are the subject of the order disposed of or moved except as pro- shall not sell, distribute, or otherwise vided in paragraph (e)(1)(v) of this sec- dispose of or move any eggs subject to tion; the order unless and until the notice is

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withdrawn after an appeal except, after proceedings shall be prepared by the notifying FDA’s district office or, if ap- presiding FDA official. plicable, the State or local agency in (A) The presiding FDA official may writing, to: direct that the hearing be conducted in (A) Divert or destroy them as speci- any suitable manner permitted by law fied in paragraph (e)(1)(i) of this sec- and this section. The presiding FDA of- tion; or ficial has the power to take such ac- (B) Move them to another location tions and make such rulings as are nec- for holding pending appeal. essary or appropriate to maintain (2) The person on whom the order for order and to conduct an informal, fair, diversion or destruction is served may expeditious, and impartial hearing, and either comply with the order or appeal to enforce the requirements concerning the order to an Office of Regulatory Af- the conduct of hearings. fairs Program Director in accordance (B) Employees of FDA will first give with the following procedures: a full and complete statement of the (i) Appeal of a detention order. Any ap- action which is the subject of the hear- peal shall be submitted in writing to ing, together with the information and FDA’s District Director in whose dis- reasons supporting it, and may present trict the shell eggs are located within oral or written information relevant to 5-working days of the issuance of the the hearing. The party requesting the order. If the appeal includes a request hearing may then present oral or writ- for an informal hearing, the hearing ten information relevant to the hear- shall be held within 5-working days ing. All parties may conduct reason- after the appeal is filed or, if requested able examination of any person (except by the appellant, at a later date, which for the presiding officer and counsel for shall not be later than 20-calendar days the parties) who makes any statement after the issuance of the order. The on the matter at the hearing. order may also be appealed within the (C) The hearing shall be informal in same period of 5-working days by any nature, and the rules of evidence do not other person having an ownership or apply. No motions or objections relat- proprietary interest in such shell eggs. ing to the admissibility of information The appellant of an order shall state and views will be made or considered, the ownership or proprietary interest but any party may comment upon or the appellant has in the shell eggs. rebut any information and views pre- (ii) Summary decision. A request for a sented by another party. hearing may be denied, in whole or in (D) The party requesting the hearing part and at any time after a request for may have the hearing transcribed, at a hearing has been submitted, if the Of- the party’s expense, in which case a fice of Regulatory Affairs Program Di- copy of the transcript is to be fur- rector or another FDA official senior nished to FDA. Any transcript of the to an FDA District Director deter- hearing will be included with the pre- mines that no genuine and substantial siding FDA official’s report of the hear- issue of fact has been raised by the ma- ing. terial submitted in connection with the (E) The presiding FDA official shall hearing or from matters officially no- prepare a written report of the hearing. ticed. If the presiding FDA official de- All written material presented at the termines that a hearing is not justi- hearing will be attached to the report. fied, written notice of the determina- Whenever time permits, the presiding tion will be given to the parties ex- FDA official may give the parties the plaining the reason for denial. opportunity to review and comment on (iii) Informal hearing. Appearance by the report of the hearing. any appellant at the hearing may be by (F) The presiding FDA official shall mail or in person, with or without include as part of the report of the counsel. The informal hearing shall be hearing a finding on the credibility of conducted by the Office of Regulatory witnesses (other than expert witnesses) Affairs Program Director or another whenever credibility is a material FDA official senior to an FDA District issue, and shall include a recommended Director, and a written summary of the decision, with a statement of reasons.

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(iv) Written appeal. If the appellant may be necessary in the judgement of appeals the detention order but does such representatives to determine com- not request a hearing, the presiding pliance with the provisions of this sec- FDA official shall render a decision on tion. Inspections may be made with or the appeal affirming or revoking the without notice and will ordinarily be detention within 5-working days after made during regular business hours. the receipt of the appeal. (g) Preemption. No State or local gov- (v) Presiding FDA official’s decision. If, erning entity shall establish or con- based on the evidence presented at the tinue in effect any law, rule, regula- hearing or by the appellant in a writ- tion, or other requirement allowing reten appeal, the presiding FDA official frigeration of unpasteurized shell eggs finds that the shell eggs were held in at retail establishments at any tem- violation of this section, he shall af- ° ° firm the order that they be diverted, perature greater than 7.2 C (45 F). under the supervision of an officer or [65 FR 76112, Dec. 5, 2000, as amended at 82 employee of FDA for processing under FR 14145, Mar. 17, 2017] the EPIA or destroyed by or under the supervision of an officer or employee of PART 117—CURRENT GOOD MAN- FDA; otherwise, the presiding FDA official shall issue a written notice that UFACTURING PRACTICE, HAZARD the prior order is withdrawn. If the pre- ANALYSIS, AND RISK–BASED PRE- siding FDA official affirms the order, VENTIVE CONTROLS FOR HUMAN he shall order that the diversion or de- FOOD struction be accomplished within 10- working days from the date of the Subpart A—General Provisions issuance of his decision. The presiding FDA official’s decision shall be accom- Sec. panied by a statement of the reasons 117.1 Applicability and status. for the decision. The decision of the 117.3 Definitions. presiding FDA official shall constitute 117.4 Qualifications of individuals who man- final agency action, reviewable in the ufacture, process, pack, or hold food. courts. 117.5 Exemptions. (vi) No appeal. If there is no appeal of 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged the order and the person in possession in the storage of unexposed packaged of the shell eggs that are subject to the food. order fails to divert or destroy them 117.8 Applicability of subpart B of this part within 10-working days, or if the de- to the off-farm packing and holding of mand is affirmed by the presiding FDA raw agricultural commodities official after an appeal and the person 117.9 Records required for this subpart. in possession of such eggs fails to divert or destroy them within 10-working Subpart B—Current Good Manufacturing days, FDA’s district office or appro- Practice priate State or local agency may designate an officer or employee to divert 117.10 Personnel. or destroy such eggs. It shall be unlaw- 117.20 Plant and grounds. ful to prevent or to attempt to prevent 117.35 Sanitary operations. such diversion or destruction of the 117.37 Sanitary facilities and controls. shell eggs by the designated officer or 117.40 Equipment and utensils. employee. 117.80 Processes and controls. (f) Inspection. Persons engaged in re- 117.93 Warehousing and distribution. 117.95 Holding and distribution of human tail distribution of shell eggs shall per- food by-products for use as animal food. mit authorized representatives of FDA 117.110 Defect action levels. to make at any reasonable time such inspection of the retail establishment Subpart C—Hazard Analysis and Risk- in which shell eggs are being held, in- Based Preventive Controls cluding inspection and sampling of such eggs and the equipment in which 117.126 Food safety plan. shell eggs are held and any records re- 117.130 Hazard analysis. lating to such equipment or eggs, as 117.135 Preventive controls.

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117.136 Circumstances in which the owner, 117.310 Additional requirements applying to operator, or agent in charge of a manu- the food safety plan. facturing/processing facility is not re- 117.315 Requirements for record retention. quired to implement a preventive con- 117.320 Requirements for official review. trol. 117.325 Public disclosure. 117.137 Provision of assurances required 117.330 Use of existing records. under § 117.136(a)(2), (3), and (4). 117.335 Special requirements applicable to a 117.139 Recall plan. written assurance. 117.140 Preventive control management components. Subpart G—Supply-Chain Program 117.145 Monitoring. 117.150 Corrective actions and corrections. 117.405 Requirement to establish and imple- 117.155 Verification. ment a supply-chain program. 117.160 Validation. 117.410 General requirements applicable to a 117.165 Verification of implementation and supply-chain program. effectiveness. 117.415 Responsibilities of the receiving fa- 117.170 Reanalysis. cility. 117.420 Using approved suppliers. 117.180 Requirements applicable to a pre- 117.425 Determining appropriate supplier ventive controls qualified individual and verification activities (including deter- a qualified auditor. mining the frequency of conducting the 117.190 Implementation records required for activity). this subpart. 117.430 Conducting supplier verification activities for raw materials and other in- Subpart D—Modified Requirements gredients. 117.201 Modified requirements that apply to 117.435 Onsite audit. a qualified facility. 117.475 Records documenting the supply- 117.206 Modified requirements that apply to chain program. a facility solely engaged in the storage of AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note, unexposed packaged food. 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. Subpart E—Withdrawal of a Qualified SOURCE: 80 FR 56145, Sept. 17, 2015, unless Facility Exemption otherwise noted. EDITORIAL NOTE: Nomenclature changes to 117.251 Circumstances that may lead FDA part 117 appear at 81 FR 49896, July 29, 2016. to withdraw a qualified facility exemption. 117.254 Issuance of an order to withdraw a Subpart A—General Provisions qualified facility exemption. 117.257 Contents of an order to withdraw a § 117.1 Applicability and status. qualified facility exemption. (a) The criteria and definitions in 117.260 Compliance with, or appeal of, an this part apply in determining whether order to withdraw a qualified facility ex- a food is: emption. 117.264 Procedure for submitting an appeal. (1) Adulterated within the meaning 117.267 Procedure for requesting an informal of: hearing. (i) Section 402(a)(3) of the Federal 117.270 Requirements applicable to an infor- Food, Drug, and Cosmetic Act in that mal hearing. the food has been manufactured under 117.274 Presiding officer for an appeal and such conditions that it is unfit for for an informal hearing. food; or 117.277 Timeframe for issuing a decision on (ii) Section 402(a)(4) of the Federal an appeal. 117.280 Revocation of an order to withdraw Food, Drug, and Cosmetic Act in that a qualified facility exemption. the food has been prepared, packed, or 117.284 Final agency action. held under insanitary conditions 117.287 Reinstatement of a qualified facility whereby it may have become contami- exemption that was withdrawn. nated with filth, or whereby it may have been rendered injurious to health; Subpart F—Requirements Applying to and Records That Must Be Established and (2) In violation of section 361 of the Maintained Public Health Service Act (42 U.S.C. 117.301 Records subject to the requirements 264). of this subpart. (b) The operation of a facility that 117.305 General requirements applying to manufactures, processes, packs, or records. holds food for sale in the United States

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if the owner, operator, or agent in Correction means an action to iden- charge of such facility is required to tify and correct a problem that oc- comply with, and is not in compliance curred during the production of food, with, section 418 of the Federal Food, without other actions associated with Drug, and Cosmetic Act or subpart C, a corrective action procedure (such as D, E, F, or G of this part is a prohibited actions to reduce the likelihood that act under section 301(uu) of the Federal the problem will recur, evaluate all af- Food, Drug, and Cosmetic Act. fected food for safety, and prevent af- (c) Food covered by specific current fected food from entering commerce). good manufacturing practice regula- Critical control point means a point, tions also is subject to the require- step, or procedure in a food process at ments of those regulations. which control can be applied and is es- [80 FR 56145, Sept. 17, 2015, as amended at 81 sential to prevent or eliminate a food FR 3715, Jan. 22, 2016] safety hazard or reduce such hazard to an acceptable level. § 117.3 Definitions. Defect action level means a level of a The definitions and interpretations non-hazardous, naturally occurring, of terms in section 201 of the Federal unavoidable defect at which FDA may Food, Drug, and Cosmetic Act apply to regard a food product ‘‘adulterated’’ such terms when used in this part. The and subject to enforcement action following definitions also apply: under section 402(a)(3) of the Federal Acid foods or acidified foods means Food, Drug, and Cosmetic Act. foods that have an equilibrium pH of Environmental pathogen means a 4.6 or below. pathogen capable of surviving and per- Adequate means that which is needed sisting within the manufacturing, proc- to accomplish the intended purpose in essing, packing, or holding environ- keeping with good public health prac- ment such that food may be contami- tice. nated and may result in foodborne ill- Affiliate means any facility that con- ness if that food is consumed without trols, is controlled by, or is under com- treatment to significantly minimize mon control with another facility. the environmental pathogen. Examples Allergen cross-contact means the unin- of environmental pathogens for the tentional incorporation of a food aller- purposes of this part include Listeria gen into a food. monocytogenes and Salmonella spp. but Audit means the systematic, inde- do not include the spores of pathogenic pendent, and documented examination sporeforming bacteria. (through observation, investigation, Facility means a domestic facility or records review, discussions with em- a foreign facility that is required to ployees of the audited entity, and, as register under section 415 of the Fed- appropriate, sampling and laboratory eral Food, Drug, and Cosmetic Act, in analysis) to assess an audited entity’s accordance with the requirements of food safety processes and procedures. part 1, subpart H of this chapter. Batter means a semifluid substance, Farm means farm as defined in § 1.227 usually composed of flour and other in- of this chapter. gredients, into which principal compo- FDA means the Food and Drug Ad- nents of food are dipped or with which ministration. they are coated, or which may be used Food means food as defined in section directly to form bakery foods. 201(f) of the Federal Food, Drug, and Blanching, except for tree nuts and Cosmetic Act and includes raw mate- peanuts, means a prepackaging heat rials and ingredients. treatment of foodstuffs for an adequate Food allergen means a major food al- time and at an adequate temperature lergen as defined in section 201(qq) of to partially or completely inactivate the Federal Food, Drug, and Cosmetic the naturally occurring enzymes and to Act. effect other physical or biochemical Food-contact surfaces are those sur- changes in the food. faces that contact human food and Calendar day means every day shown those surfaces from which drainage, or on the calendar. other transfer, onto the food or onto

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surfaces that contact the food ordi- would, based on the outcome of a haz- narily occurs during the normal course ard analysis (which includes an assess- of operations. ‘‘Food-contact surfaces’’ ment of the severity of the illness or includes utensils and food-contact sur- injury if the hazard were to occur and faces of equipment. the probability that the hazard will Full-time equivalent employee is a term occur in the absence of preventive con- used to represent the number of em- trols), establish one or more preventive ployees of a business entity for the pur- controls to significantly minimize or pose of determining whether the busi- prevent the hazard in a food and com- ness qualifies for the small business ex- ponents to manage those controls (such emption. The number of full-time as monitoring, corrections or correc- equivalent employees is determined by tive actions, verification, and records) dividing the total number of hours of as appropriate to the food, the facility, salary or wages paid directly to em- and the nature of the preventive con- ployees of the business entity and of all trol and its role in the facility’s food of its affiliates and subsidiaries by the safety system. number of hours of work in 1 year, 2,080 Holding means storage of food and × hours (i.e., 40 hours 52 weeks). If the also includes activities performed inci- result is not a whole number, round dental to storage of a food (e.g., activi- down to the next lowest whole number. ties performed for the safe or effective Harvesting applies to farms and farm storage of that food, such as fumigat- mixed-type facilities and means activi- ing food during storage, and drying/de- ties that are traditionally performed hydrating raw agricultural commod- on farms for the purpose of removing ities when the drying/dehydrating does raw agricultural commodities from the not create a distinct commodity (such place they were grown or raised and as drying/dehydrating hay or alfalfa)). preparing them for use as food. Har- Holding also includes activities per- vesting is limited to activities performed as a practical necessity for the formed on raw agricultural commod- distribution of that food (such as ities, or on processed foods created by blending of the same raw agricultural drying/dehydrating a raw agricultural commodity and breaking down pallets), commodity without additional manu- but does not include activities that facturing/processing, on a farm. Har- transform a raw agricultural com- vesting does not include activities that modity into a processed food as defined transform a raw agricultural com- in section 201(gg) of the Federal Food, modity into a processed food as defined Drug, and Cosmetic Act. Holding facili- in section 201(gg) of the Federal Food, ties could include warehouses, cold Drug, and Cosmetic Act. Examples of storage facilities, storage silos, grain harvesting include cutting (or otherwise separating) the edible portion of elevators, and liquid storage tanks. the raw agricultural commodity from Known or reasonably foreseeable haz- the crop plant and removing or trim- ard means a biological, chemical (in- ming part of the raw agricultural com- cluding radiological), or physical haz- modity (e.g., foliage, husks, roots or ard that is known to be, or has the po- stems). Examples of harvesting also in- tential to be, associated with the facil- clude cooling, field coring, filtering, ity or the food. gathering, hulling, shelling, sifting, Lot means the food produced during a threshing, trimming of outer leaves of, period of time and identified by an es- and washing raw agricultural commod- tablishment’s specific code. ities grown on a farm. Manufacturing/processing means mak- Hazard means any biological, chem- ing food from one or more ingredients, ical (including radiological), or phys- or synthesizing, preparing, treating, ical agent that has the potential to modifying or manipulating food, in- cause illness or injury. cluding food crops or ingredients. Ex- Hazard requiring a preventive control amples of manufacturing/processing ac- means a known or reasonably foresee- tivities include: Baking, boiling, bot- able hazard for which a person knowl- tling, canning, cooking, cooling, cut- edgeable about the safe manufacturing, ting, distilling, drying/dehydrating raw processing, packing, or holding of food agricultural commodities to create a

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distinct commodity (such as drying/de- Pest refers to any objectionable ani- hydrating grapes to produce raisins), mals or insects including birds, ro- evaporating, eviscerating, extracting dents, flies, and larvae. juice, formulating, freezing, grinding, Plant means the building or structure homogenizing, irradiating, labeling, or parts thereof, used for or in connec- milling, mixing, packaging (including tion with the manufacturing, proc- modified atmosphere packaging), pas- essing, packing, or holding of human teurizing, peeling, rendering, treating food. to manipulate ripening, trimming, Preventive controls means those risk- washing, or waxing. For farms and based, reasonably appropriate proce- farm mixed-type facilities, manufac- dures, practices, and processes that a turing/processing does not include ac- person knowledgeable about the safe tivities that are part of harvesting, manufacturing, processing, packing, or packing, or holding. holding of food would employ to significantly minimize or prevent the haz- Microorganisms means yeasts, molds, ards identified under the hazard anal- bacteria, viruses, protozoa, and micro- ysis that are consistent with the cur- scopic parasites and includes species rent scientific understanding of safe that are pathogens. The term ‘‘unde- food manufacturing, processing, pack- sirable microorganisms’’ includes those ing, or holding at the time of the anal- microorganisms that are pathogens, ysis. that subject food to decomposition, Preventive controls qualified individual that indicate that food is contaminated means a qualified individual who has with filth, or that otherwise may cause successfully completed training in the food to be adulterated. development and application of risk- Mixed-type facility means an estab- based preventive controls at least lishment that engages in both activi- equivalent to that received under a ties that are exempt from registration standardized curriculum recognized as under section 415 of the Federal Food, adequate by FDA or is otherwise quali- Drug, and Cosmetic Act and activities fied through job experience to develop that require the establishment to be and apply a food safety system. registered. An example of such a facil- Qualified auditor means a person who ity is a ‘‘farm mixed-type facility,’’ is a qualified individual as defined in which is an establishment that is a this part and has technical expertise farm, but also conducts activities out- obtained through education, training, side the farm definition that require or experience (or a combination there- the establishment to be registered. of) necessary to perform the auditing Monitor means to conduct a planned function as required by § 117.180(c)(2). sequence of observations or measure- Examples of potential qualified audi- ments to assess whether control meas- tors include: (1) A government employee, includ- ures are operating as intended. ing a foreign government employee; Packing means placing food into a and container other than packaging the (2) An audit agent of a certification food and also includes re-packing and body that is accredited in accordance activities performed incidental to with regulations in part 1, subpart M of packing or re-packing a food (e.g., ac- this chapter. tivities performed for the safe or effec- Qualified end-user, with respect to a tive packing or re-packing of that food food, means the consumer of the food (such as sorting, culling, grading, and (where the term consumer does not in- weighing or conveying incidental to clude a business); or a restaurant or re- packing or re-packing)), but does not tail food establishment (as those terms include activities that transform a raw are defined in § 1.227 of this chapter) agricultural commodity into a proc- that: essed food as defined in section 201(gg) (1) Is located: of the Federal Food, Drug, and Cos- (i) In the same State or the same In- metic Act. dian reservation as the qualified facil- Pathogen means a microorganism of ity that sold the food to such res- public health significance. taurant or establishment; or

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(ii) Not more than 275 miles from esses a raw material or other ingre- such facility; and dient that it receives from a supplier. (2) Is purchasing the food for sale di- Rework means clean, unadulterated rectly to consumers at such restaurant food that has been removed from proc- or retail food establishment. essing for reasons other than insani- Qualified facility means (when includ- tary conditions or that has been suc- ing the sales by any subsidiary; affil- cessfully reconditioned by reprocessing iate; or subsidiaries or affiliates, col- and that is suitable for use as food. lectively, of any entity of which the fa- Safe-moisture level is a level of mois- cility is a subsidiary or affiliate) a fa- ture low enough to prevent the growth cility that is a very small business as of undesirable microorganisms in the defined in this part, or a facility to finished product under the intended which both of the following apply: conditions of manufacturing, proc- (1) During the 3-year period preceding essing, packing, and holding. The safe the applicable calendar year, the aver- moisture level for a food is related to age annual monetary value of the food its water activity (aw). An aw will be manufactured, processed, packed or considered safe for a food if adequate held at such facility that is sold di- data are available that demonstrate rectly to qualified end-users (as defined that the food at or below the given aw in this part) during such period exceed- will not support the growth of undesired the average annual monetary value able microorganisms. of the food sold by such facility to all Sanitize means to adequately treat other purchasers; and cleaned surfaces by a process that is effective in destroying vegetative cells of (2) The average annual monetary pathogens, and in substantially reduc- value of all food sold during the 3-year ing numbers of other undesirable period preceding the applicable cal- microorganisms, but without adversely endar year was less than $500,000, ad- affecting the product or its safety for justed for inflation. the consumer. means an Qualified facility exemption Significantly minimize means to reduce exemption applicable to a qualified fa- to an acceptable level, including to cility under § 117.5(a). eliminate. Qualified individual means a person Small business means, for purposes of who has the education, training, or ex- this part, a business (including any perience (or a combination thereof) subsidiaries and affiliates) employing necessary to manufacture, process, fewer than 500 full-time equivalent em- pack, or hold clean and safe food as ap- ployees. propriate to the individual’s assigned Subsidiary means any company which duties. A qualified individual may be, is owned or controlled directly or indi- but is not required to be, an employee rectly by another company. of the establishment. Supplier means the establishment Quality control operation means a that manufactures/processes the food, planned and systematic procedure for raises the animal, or grows the food taking all actions necessary to prevent that is provided to a receiving facility food from being adulterated. without further manufacturing/proc- Raw agricultural commodity has the essing by another establishment, ex- meaning given in section 201(r) of the cept for further manufacturing/proc- Federal Food, Drug, and Cosmetic Act. essing that consists solely of the addi- Ready-to-eat food (RTE food) means tion of labeling or similar activity of a any food that is normally eaten in its de minimis nature. raw state or any other food, including Supply-chain-applied control means a a processed food, for which it is reason- preventive control for a hazard in a ably foreseeable that the food will be raw material or other ingredient when eaten without further processing that the hazard in the raw material or other would significantly minimize biologi- ingredient is controlled before its re- cal hazards. ceipt. Receiving facility means a facility Unexposed packaged food means pack- that is subject to subparts C and G of aged food that is not exposed to the en- this part and that manufactures/proc- vironment.

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Validation means obtaining and eval- all individuals who manufacture, proc- uating scientific and technical evi- ess, pack, or hold food subject to sub- dence that a control measure, combina- part C, D, E, F, or G of this part are tion of control measures, or the food qualified to perform their assigned du- safety plan as a whole, when properly ties. implemented, is capable of effectively (b) Qualifications of all individuals en- controlling the identified hazards. gaged in manufacturing, processing, Verification means the application of packing, or holding food. Each indi- methods, procedures, tests and other vidual engaged in manufacturing, proc- evaluations, in addition to monitoring, essing, packing, or holding food (in- to determine whether a control meas- cluding temporary and seasonal per- ure or combination of control measures sonnel) or in the supervision thereof is or has been operating as intended must: and to establish the validity of the food (1) Be a qualified individual as that safety plan. term is defined in § 117.3—i.e., have the Very small business means, for pur- education, training, or experience (or a poses of this part, a business (including combination thereof) necessary to any subsidiaries and affiliates) aver- manufacture, process, pack, or hold aging less than $1,000,000, adjusted for clean and safe food as appropriate to inflation, per year, during the 3-year the individual’s assigned duties; and period preceding the applicable cal- (2) Receive training in the principles endar year in sales of human food plus of food hygiene and food safety, includ- the market value of human food manu- ing the importance of employee health factured, processed, packed, or held and personal hygiene, as appropriate to without sale (e.g., held for a fee). the food, the facility and the individ- Water activity (aw) is a measure of the ual’s assigned duties. free moisture in a food and is the (c) Additional qualifications of super- quotient of the water vapor pressure of visory personnel. Responsibility for en- the substance divided by the vapor suring compliance by individuals with pressure of pure water at the same the requirements of this part must be temperature. clearly assigned to supervisory per- Written procedures for receiving raw sonnel who have the education, train- materials and other ingredients means ing, or experience (or a combination written procedures to ensure that raw thereof) necessary to supervise the pro- materials and other ingredients are reduction of clean and safe food. ceived only from suppliers approved by (d) Records. Records that document the receiving facility (or, when nec- training required by paragraph (b)(2) of essary and appropriate, on a temporary this section must be established and basis from unapproved suppliers whose maintained. raw materials or other ingredients are subjected to adequate verification ac- § 117.5 Exemptions. tivities before acceptance for use). (a) Except as provided by subpart E You means, for purposes of this part, of this part, subparts C and G of this the owner, operator, or agent in charge part do not apply to a qualified facil- of a facility. ity. Qualified facilities are subject to [80 FR 56145, Sept. 17, 2015, as amended at 81 the modified requirements in § 117.201. FR 3715, Jan. 22, 2016] (b) Subparts C and G of this part do not apply with respect to activities § 117.4 Qualifications of individuals that are subject to part 123 of this who manufacture, process, pack, or chapter (Fish and Fishery Products) at hold food. a facility if you are required to comply (a) Applicability. (1) The management with, and are in compliance with, part of an establishment must ensure that 123 of this chapter with respect to such all individuals who manufacture, proc- activities. ess, pack, or hold food subject to sub- (c) Subparts C and G of this part do parts B and F of this part are qualified not apply with respect to activities to perform their assigned duties. that are subject to part 120 of this (2) The owner, operator, or agent in chapter (Hazard Analysis and Critical charge of a facility must ensure that Control Point (HACCP) Systems) at a

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facility if you are required to comply (2) For the purposes of paragraphs with, and are in compliance with, part (g)(3) and (h)(3) of this section, the fol- 120 of this chapter with respect to such lowing terms describe the foods associ- activities. ated with the activity/food combina- (d)(1) Subparts C and G of this part tions. Several foods that are fruits or do not apply with respect to activities vegetables are separately considered that are subject to part 113 of this for the purposes of these activity/food chapter (Thermally Processed Low- combinations (i.e., coffee beans, cocoa Acid Foods Packaged in Hermetically beans, fresh herbs, peanuts, sugarcane, Sealed Containers) at a facility if you sugar beets, tree nuts, seeds for direct are required to comply with, and are in consumption) to appropriately address compliance with, part 113 of this chap- specific hazards associated with these ter with respect to such activities. foods and/or processing activities con- (2) The exemption in paragraph (d)(1) ducted on these foods. of this section is applicable only with (i) Dried/dehydrated fruit and vegetable respect to the microbiological hazards products includes only those processed that are regulated under part 113 of food products such as raisins and dried this chapter. legumes made without additional man- (e) Subparts C and G do not apply to ufacturing/processing beyond drying/ any facility with regard to the manu- dehydrating, packaging, and/or label- facturing, processing, packaging, or ing. holding of a dietary supplement that is (ii) Other fruit and vegetable products in compliance with the requirements of includes those processed food products part 111 of this chapter (Current Good that have undergone one or more of the Manufacturing Practice in Manufac- following processes: acidification, boil- turing, Packaging, Labeling, or Hold- ing, canning, coating with things other ing Operations for Dietary Supple- than wax/oil/resin, cooking, cutting, ments) and section 761 of the Federal chopping, grinding, peeling, shredding, Food, Drug, and Cosmetic Act (Serious slicing, or trimming. Examples include Adverse Event Reporting for Dietary flours made from legumes (such as Supplements). chickpea flour), pickles, and snack (f) Subparts C and G of this part do chips made from potatoes or plantains. not apply to activities of a facility that Examples also include dried fruit and are subject to section 419 of the Federal vegetable products made with addi- Food, Drug, and Cosmetic Act (Stand- tional manufacturing/processing (such ards for Produce Safety). as dried apple slices; pitted, dried (g)(1) The exemption in paragraph plums, cherries, and apricots; and (g)(3) of this section applies to packing sulfited raisins). This category does or holding of processed foods on a farm not include dried/dehydrated fruit and mixed-type facility, except for proc- vegetable products made without addi- essed foods produced by drying/dehy- tional manufacturing/processing as de- drating raw agricultural commodities scribed in paragraph (g)(2)(i) of this to create a distinct commodity (such section. This category also does not in- as drying/dehydrating grapes to clude products that require time/tem- produce raisins, and drying/dehy- perature control for safety (such as drating fresh herbs to produce dried fresh-cut fruits and vegetables). herbs), and packaging and labeling (iii) Peanut and tree nut products in- such commodities, without additional cludes processed food products such as manufacturing/processing (such as roasted peanuts and tree nuts, sea- chopping and slicing), the packing and soned peanuts and tree nuts, and pea- holding of which are within the ‘‘farm’’ nut and tree nut flours. definition in § 1.227 of this chapter. Ac- (iv) Processed seeds for direct consump- tivities that are within the ‘‘farm’’ def- tion include processed food products inition, when conducted on a farm such as roasted pumpkin seeds, roasted mixed-type facility, are not subject to sunflower seeds, and roasted flax seeds. the requirements of subparts C and G (v) Dried/dehydrated herb and spice of this part and therefore do not need products includes only processed food to be specified in the exemption. products such as dried intact herbs

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made without additional manufac- dental to packing or re-packing); sort- turing/processing beyond drying/dehy- ing, culling, or grading incidental to drating, packaging, and/or labeling. packing or storing; and storing (ambi- (vi) Other herb and spice products in- ent, cold and controlled atmosphere) cludes those processed food products of: such as chopped fresh herbs, chopped or (i) Baked goods (e.g., bread and cook- ground dried herbs (including tea), ies); herbal extracts (e.g., essential oils, ex- (ii) Candy (e.g., hard candy, fudge, tracts containing more than 20 percent maple candy, maple cream, nut ethanol, extracts containing more than brittles, taffy, and toffee); 35 percent glycerin), dried herb- or (iii) Cocoa beans (roasted); spice-infused honey, and dried herb- or (iv) Cocoa products; spice-infused oils and/or vinegars. This (v) Coffee beans (roasted); category does not include dried/dehy- (vi) Game meat jerky; drated herb and spice products made (vii) Gums, latexes, and resins that without additional manufacturing/ are processed foods; processing beyond drying/dehydrating, (viii) Honey (pasteurized); packaging, and/or labeling as described (ix) Jams, jellies, and preserves; in paragraph (g)(2)(v) of this section. (x) Milled grain products (e.g., flour, This category also does not include bran, and corn meal); products that require time/temperature (xi) Molasses and treacle; control for safety, such as fresh herb- (xii) Oils (e.g., olive oil and sunflower infused oils. seed oil); (vii) Grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, (xiii) Other fruit and vegetable prod- wheat, amaranth, quinoa, buckwheat ucts (e.g., flours made from legumes; and oilseeds for oil extraction (such as pitted, dried fruits; sliced, dried apples; cotton seed, flax seed, rapeseed, soy- snack chips); beans, and sunflower seed). (xiv) Other grain products (e.g., dried (viii) Milled grain products include pasta, oat flakes, and popcorn); processed food products such as flour, (xv) Other herb and spice products bran, and corn meal. (e.g., chopped or ground dried herbs, (ix) Baked goods include processed herbal extracts); food products such as breads, brownies, (xvi) Peanut and tree nut products cakes, cookies, and crackers. This cat- (e.g., roasted peanuts and tree nut egory does not include products that flours); require time/temperature control for (xvii) Processed seeds for direct con- safety, such as cream-filled pastries. sumption (e.g., roasted pumpkin seeds); (x) Other grain products include proc- (xviii) Soft drinks and carbonated essed food products such as dried ce- water; real, dried pasta, oat flakes, and pop- (xix) Sugar; corn. This category does not include (xx) Syrups (e.g., maple syrup and milled grain products as described in agave syrup); paragraph (g)(2)(viii) of this section or (xxi) Trail mix and granola; baked goods as described in paragraph (xxii) Vinegar; and (g)(2)(ix) of this section. (xxiii) Any other processed food that (3) Subparts C and G of this part do does not require time/temperature con- not apply to on-farm packing or hold- trol for safety (e..g., vitamins, mining of food by a small or very small erals, and dietary ingredients (e.g., business, and § 117.201 does not apply to bone meal) in powdered, granular, or on-farm packing or holding of food by a other solid form). very small business, if the only pack- (h)(1) The exemption in paragraph ing and holding activities subject to (h)(3) of this section applies to manu- section 418 of the Federal Food, Drug, facturing/processing of foods on a farm and Cosmetic Act that the business mixed-type facility, except for manu- conducts are the following low-risk facturing/processing that is within the packing or holding activity/food com- ‘‘farm’’ definition in § 1.227 of this chap- binations—i.e., packing (or re-packing) ter. Drying/dehydrating raw agricul- (including weighing or conveying inci- tural commodities to create a distinct

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commodity (such as drying/dehy- tree nut products (e.g., chopping roast- drating grapes to produce raisins, and ed peanuts); drying/dehydrating fresh herbs to (iii) Coating dried/dehydrated fruit produce dried herbs), and packaging and vegetable products (e.g., coating and labeling such commodities, with- raisins with chocolate), other fruit and out additional manufacturing/proc- vegetable products except for non- essing (such as chopping and slicing), dried, non-intact fruits and vegetables are within the ‘‘farm’’ definition in (e.g., coating dried plum pieces, dried § 1.227 of this chapter. In addition, pitted cherries, and dried pitted apri- treatment to manipulate ripening of cots with chocolate are low-risk activ- raw agricultural commodities (such as ity/food combinations but coating ap- by treating produce with ethylene gas), ples on a stick with caramel is not a and packaging and labeling the treated low-risk activity/food combination), raw agricultural commodities, without other grain products (e.g., adding car- additional manufacturing/processing, amel to popcorn or adding seasonings is within the ‘‘farm’’ definition. In ad- to popcorn provided that the dition, coating intact fruits and vege- seasonings have been treated to signifi- tables with wax, oil, or resin used for cantly minimize pathogens, peanuts the purpose of storage or transpor- and tree nuts (e.g., adding seasonings tation is within the ‘‘farm’’ definition. provided that the seasonings have been Activities that are within the ‘‘farm’’ treated to significantly minimize definition, when conducted on a farm pathogens), and peanut and tree nut mixed-type facility, are not subject to products (e.g., adding seasonings pro- the requirements of subparts C and G vided that the seasonings have been of this part and therefore do not need treated to significantly minimize to be specified in the exemption. pathogens)); (2) The terms in paragraph (g)(2) of (iv) Drying/dehydrating (that in- this section describe certain foods asso- cludes additional manufacturing or is ciated with the activity/food combina- performed on processed foods) other tions in paragraph (h)(3) of this sec- fruit and vegetable products with pH tion. less than 4.2 (e.g., drying cut fruit and (3) Subparts C and G of this part do vegetables with pH less than 4.2), and not apply to on-farm manufacturing/ other herb and spice products (e.g., dry- processing activities conducted by a ing chopped fresh herbs, including tea); small or very small business for dis- (v) Extracting (including by pressing, tribution into commerce, and § 117.201 by distilling, and by solvent extrac- does not apply to on-farm manufac- tion) dried/dehydrated herb and spice turing/processing activities conducted products (e.g., dried mint), fresh herbs by a very small business for distribu- (e.g., fresh mint), fruits and vegetables tion into commerce, if the only manu- (e.g., olives, avocados), grains (e.g., oil- facturing/processing activities subject seeds), and other herb and spice prod- to section 418 of the Federal Food, ucts (e.g., chopped fresh mint, chopped Drug, and Cosmetic Act that the busi- dried mint); ness conducts are the following low- (vi) Freezing acid fruits and vegeta- risk manufacturing/processing activ- bles with pH less than 4.2 and other ity/food combinations: fruit and vegetable products with pH (i) Boiling gums, latexes, and resins; less than 4.2 (e.g., cut fruits and vegeta- (ii) Chopping, coring, cutting, peel- bles); ing, pitting, shredding, and slicing acid (vii) Grinding/cracking/crushing/mill- fruits and vegetables that have a pH ing baked goods (e.g., crackers), cocoa less than 4.2 (e.g., cutting lemons and beans (roasted), coffee beans (roasted), limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable dried/dehydrated fruit and vegetable products (e.g., raisins and dried leg- products (e.g., pitting dried plums), umes), dried/dehydrated herb and spice dried herbs and other spices (e.g., chop- products (e.g., intact dried basil), ping intact, dried basil), game meat grains (e.g., oats, rice, rye, wheat), jerky, gums/latexes/resins, other grain other fruit and vegetable products (e.g., products (e.g., shredding dried cereal), dried, pitted dates), other grain prod- peanuts and tree nuts, and peanut and ucts (e.g., dried cereal), other herb and

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spice products (e.g., chopped dried (xiii) Making jams, jellies, and pre- herbs), peanuts and tree nuts, and pea- serves from acid fruits and vegetables nut and tree nut products (e.g., roasted with a pH of 4.6 or below; peanuts); (xiv) Making molasses and treacle (viii) Labeling baked goods that do from sugar beets and sugarcane; not contain food allergens, candy that (xv) Making oat flakes from grains; does not contain food allergens, cocoa (xvi) Making popcorn from grains; beans (roasted), cocoa products that do (xvii) Making snack chips from fruits not contain food allergens), coffee and vegetables (e.g., making plantain beans (roasted), game meat jerky, and potato chips); gums/latexes/resins that are processed (xviii) Making soft drinks and car- foods, honey (pasteurized), jams/jellies/ bonated water from sugar, syrups, and preserves, milled grain products that water; do not contain food allergens (e.g., corn (xix) Making sugars and syrups from meal) or that are single-ingredient fruits and vegetables (e.g., dates), foods (e.g., wheat flour, wheat bran), grains (e.g., rice, sorghum), other grain molasses and treacle, oils, other fruit products (e.g., malted grains such as and vegetable products that do not barley), saps (e.g., agave, birch, maple, contain food allergens (e.g., snack chips palm), sugar beets, and sugarcane; made from potatoes or plantains), (xx) Making trail mix and granola other grain products that do not con- from cocoa products (e.g., chocolate), tain food allergens (e.g., popcorn), dried/dehydrated fruit and vegetable other herb and spice products (e.g., products (e.g., raisins), other fruit and chopped or ground dried herbs), peanut vegetable products (e.g., chopped dried or tree nut products, (provided that fruits), other grain products (e.g., oat they are single-ingredient, or are in flakes), peanut and tree nut products, forms in which the consumer can rea- and processed seeds for direct consump- sonably be expected to recognize the tion, provided that peanuts, tree nuts, food allergen(s) without label declara- and processed seeds are treated to sig- tion, or both (e.g., roasted or seasoned nificantly minimize pathogens; whole nuts, single-ingredient peanut or (xxi) Making vinegar from fruits and tree nut flours)), processed seeds for di- vegetables, other fruit and vegetable rect consumption, soft drinks and car- products (e.g., fruit wines, apple cider), bonated water, sugar, syrups, trail mix and other grain products (e.g., malt); and granola (other than those con- (xxii) Mixing baked goods (e.g., types taining milk chocolate and provided of cookies), candy (e.g., varieties of that peanuts and/or tree nuts are in taffy), cocoa beans (roasted), coffee forms in which the consumer can rea- beans (roasted), dried/dehydrated fruit sonably be expected to recognize the and vegetable products (e.g., dried blue- food allergen(s) without label declara- berries, dried currants, and raisins), tion), vinegar, and any other processed dried/dehydrated herb and spice prod- food that does not require time/tem- ucts (e.g., dried, intact basil and dried, perature control for safety and that intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, does not contain food allergens (e.g., vi- and corn meal), other fruit and vege- tamins, minerals, and dietary ingredi- table products (e.g., dried, sliced apples ents (e.g., bone meal) in powdered, and dried, sliced peaches), other grain granular, or other solid form); products (e.g., different types of dried (ix) Making baked goods from milled pasta), other herb and spice products grain products (e.g., breads and cook- (e.g., chopped or ground dried herbs, ies); dried herb- or spice-infused honey, and (x) Making candy from peanuts and dried herb- or spice-infused oils and/or tree nuts (e.g., nut brittles), sugar/syr- vinegars), peanut and tree nut prod- ups (e.g., taffy, toffee), and saps (e.g., ucts, sugar, syrups, vinegar, and any maple candy, maple cream); other processed food that does not re- (xi) Making cocoa products from quire time/temperature control for roasted cocoa beans; safety (e.g., vitamins, minerals, and di- (xii) Making dried pasta from grains; etary ingredients (e.g., bone meal) in

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powdered, granular, or other solid ity because it is engaged in manufac- form); turing, processing, packing, or holding (xxiii) Packaging baked goods (e.g., one or more alcoholic beverages. bread and cookies), candy, cocoa beans (2) Subparts C and G of this part do (roasted), cocoa products, coffee beans not apply with respect to food that is (roasted), game meat jerky, gums/ not an alcoholic beverage at a facility latexes/resins that are processed foods, described in paragraph (i)(1) of this sec- honey (pasteurized), jams/jellies/pre- tion, provided such food: serves, milled grain products (e.g., (i) Is in prepackaged form that pre- flour, bran, corn meal), molasses and vents any direct human contact with treacle, oils, other fruit and vegetable such food; and products (e.g., pitted, dried fruits; (ii) Constitutes not more than 5 per- sliced, dried apples; snack chips), other cent of the overall sales of the facility, grain products (e.g., popcorn), other as determined by the Secretary of the herb and spice products (e.g., chopped Treasury. or ground dried herbs), peanut and tree (j) Subparts C and G of this part do nut products, processed seeds for direct not apply to facilities that are solely consumption, soft drinks and carbon- engaged in the storage of raw agricul- ated water, sugar, syrups, trail mix and tural commodities (other than fruits granola, vinegar, and any other proc- and vegetables) intended for further essed food that does not require time/ distribution or processing. temperature control for safety (e.g., vi- (k)(1) Except as provided by para- tamins, minerals, and dietary ingredi- graph (k)(2) of this section, subpart B ents (e.g., bone meal) in powdered, of this part does not apply to any of granular, or other solid form); the following: (xxiv) Pasteurizing honey; (i) ‘‘Farms’’ (as defined in § 1.227 of (xxv) Roasting and toasting baked this chapter); goods (e.g., toasting bread for crou- (ii) Fishing vessels that are not sub- tons); ject to the registration requirements of (xxvi) Salting other grain products part 1, subpart H of this chapter in ac- (e.g., soy nuts), peanut and tree nut cordance with § 1.226(f) of this chapter; products, and processed seeds for direct (iii) Establishments solely engaged in consumption; and the holding and/or transportation of (xxvii) Sifting milled grain products one or more raw agricultural commod- (e.g., flour, bran, corn meal), other ities; fruit and vegetable products (e.g., (iv) Activities of ‘‘farm mixed-type chickpea flour), and peanut and tree facilities’’ (as defined in § 1.227 of this nut products (e.g., peanut flour, almond chapter) that fall within the definition flour). of ‘‘farm’’; or (i)(1) Subparts C and G of this part do (v) Establishments solely engaged in not apply with respect to alcoholic bev- hulling, shelling, drying, packing, and/ erages at a facility that meets the fol- or holding nuts (without additional lowing two conditions: manufacturing/processing, such as (i) Under the Federal Alcohol Admin- roasting nuts). istration Act (27 U.S.C. 201 et seq.) or (2) If a ‘‘farm’’ or ‘‘farm mixed-type chapter 51 of subtitle E of the Internal facility’’ dries/dehydrates raw agricul- Revenue Code of 1986 (26 U.S.C. 5001 et tural commodities that are produce as seq.) the facility is required to obtain a defined in part 112 of this chapter to permit from, register with, or obtain create a distinct commodity, subpart B approval of a notice or application of this part applies to the packaging, from the Secretary of the Treasury as packing, and holding of the dried com- a condition of doing business in the modities. Compliance with this re- United States, or is a foreign facility of quirement may be achieved by com- a type that would require such a per- plying with subpart B of this part or mit, registration, or approval if it were with the applicable requirements for a domestic facility; and packing and holding in part 112 of this (ii) Under section 415 of the Federal chapter. Food, Drug, and Cosmetic Act the fa- [80 FR 56145, Sept. 17, 2015, as amended at 81 cility is required to register as a facil- FR 3716, Jan. 22, 2016]

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§ 117.7 Applicability of subparts C, D, (a) Disease control. Any person who, and G of this part to a facility solely by medical examination or supervisory engaged in the storage of unex- observation, is shown to have, or ap- posed packaged food. pears to have, an illness, open lesion, (a) Applicability of subparts C and G. including boils, sores, or infected Subparts C and G of this part do not wounds, or any other abnormal source apply to a facility solely engaged in of microbial contamination by which the storage of unexposed packaged there is a reasonable possibility of food. food, food-contact surfaces, or food- (b) Applicability of subpart D. A facil- packaging materials becoming con- ity solely engaged in the storage of un- taminated, must be excluded from any exposed packaged food, including unex- operations which may be expected to posed packaged food that requires result in such contamination until the time/temperature control to signifi- condition is corrected, unless condi- cantly minimize or prevent the growth tions such as open lesions, boils, and of, or toxin production by, pathogens is infected wounds are adequately cov- subject to the modified requirements ered (e.g., by an impermeable cover). in § 117.206 for any unexposed packaged Personnel must be instructed to report food that requires time/temperature such health conditions to their super- control to significantly minimize or visors. prevent the growth of, or toxin produc- (b) Cleanliness. All persons working in tion by, pathogens. direct contact with food, food-contact surfaces, and food-packaging materials § 117.8 Applicability of subpart B of must conform to hygienic practices this part to the off-farm packing and holding of raw agricultural while on duty to the extent necessary commodities. to protect against allergen cross-contact and against contamination of Except as provided by § 117.5(k)(1), food. The methods for maintaining subpart B of this part applies to the cleanliness include: off-farm packaging, packing, and hold- (1) Wearing outer garments suitable ing of raw agricultural commodities. to the operation in a manner that pro- Compliance with this requirement for tects against allergen cross-contact raw agricultural commodities that are and against the contamination of food, produce as defined in part 112 of this food-contact surfaces, or food-pack- chapter may be achieved by complying with subpart B of this part or with the aging materials. applicable requirements for packing (2) Maintaining adequate personal and holding in part 112 of this chapter. cleanliness. (3) Washing hands thoroughly (and [81 FR 3956, Jan. 25, 2016] sanitizing if necessary to protect against contamination with undesir- § 117.9 Records required for this subpart. able microorganisms) in an adequate hand-washing facility before starting (a) Records that document training work, after each absence from the work required by § 117.4(b)(2) must be estab- station, and at any other time when lished and maintained. the hands may have become soiled or (b) The records that must be estab- contaminated. lished and maintained are subject to (4) Removing all unsecured jewelry the requirements of subpart F of this and other objects that might fall into part. food, equipment, or containers, and removing hand jewelry that cannot be Subpart B—Current Good adequately sanitized during periods in Manufacturing Practice which food is manipulated by hand. If such hand jewelry cannot be removed, § 117.10 Personnel. it may be covered by material which The management of the establish- can be maintained in an intact, clean, ment must take reasonable measures and sanitary condition and which effec- and precautions to ensure the fol- tively protects against the contamina- lowing: tion by these objects of the food, food-

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contact surfaces, or food-packaging be exercised in the plant by inspection, materials. extermination, or other means to ex- (5) Maintaining gloves, if they are clude pests, dirt, and filth that may be used in food handling, in an intact, a source of food contamination. clean, and sanitary condition. (b) Plant construction and design. The (6) Wearing, where appropriate, in an plant must be suitable in size, con- effective manner, hair nets, headbands, struction, and design to facilitate caps, beard covers, or other effective maintenance and sanitary operations hair restraints. for food-production purposes (i.e., man- (7) Storing clothing or other personal ufacturing, processing, packing, and belongings in areas other than where holding). The plant must: food is exposed or where equipment or (1) Provide adequate space for such utensils are washed. placement of equipment and storage of (8) Confining the following to areas materials as is necessary for mainte- other than where food may be exposed nance, sanitary operations, and the or where equipment or utensils are production of safe food. washed: eating food, chewing gum, (2) Permit the taking of adequate drinking beverages, or using tobacco. precautions to reduce the potential for (9) Taking any other necessary pre- allergen cross-contact and for contami- cautions to protect against allergen nation of food, food-contact surfaces, cross-contact and against contamina- or food-packaging materials with tion of food, food-contact surfaces, or microorganisms, chemicals, filth, and food-packaging materials with micro- other extraneous material. The poten- organisms or foreign substances (in- tial for allergen cross-contact and for cluding perspiration, hair, cosmetics, contamination may be reduced by ade- tobacco, chemicals, and medicines ap- quate food safety controls and oper- plied to the skin). ating practices or effective design, including the separation of operations in § 117.20 Plant and grounds. which allergen cross-contact and con- (a) Grounds. The grounds about a food tamination are likely to occur, by one plant under the control of the operator or more of the following means: loca- must be kept in a condition that will tion, time, partition, air flow systems, protect against the contamination of dust control systems, enclosed sys- food. The methods for adequate main- tems, or other effective means. tenance of grounds must include: (3) Permit the taking of adequate (1) Properly storing equipment, re- precautions to protect food in installed moving litter and waste, and cutting outdoor bulk vessels by any effective weeds or grass within the immediate means, including: vicinity of the plant that may con- (i) Using protective coverings. stitute an attractant, breeding place, (ii) Controlling areas over and around or harborage for pests. the vessels to eliminate harborages for (2) Maintaining roads, yards, and pests. parking lots so that they do not con- (iii) Checking on a regular basis for stitute a source of contamination in pests and pest infestation. areas where food is exposed. (iv) Skimming fermentation vessels, (3) Adequately draining areas that as necessary. may contribute contamination to food (4) Be constructed in such a manner by seepage, foot-borne filth, or pro- that floors, walls, and ceilings may be viding a breeding place for pests. adequately cleaned and kept clean and (4) Operating systems for waste kept in good repair; that drip or con- treatment and disposal in an adequate densate from fixtures, ducts and pipes manner so that they do not constitute does not contaminate food, food-con- a source of contamination in areas tact surfaces, or food-packaging mate- where food is exposed. rials; and that aisles or working spaces (5) If the plant grounds are bordered are provided between equipment and by grounds not under the operator’s walls and are adequately unobstructed control and not maintained in the and of adequate width to permit em- manner described in paragraphs (a)(1) ployees to perform their duties and to through (4) of this section, care must protect against contaminating food,

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food-contact surfaces, or food-pack- (i) Those required to maintain clean aging materials with clothing or per- and sanitary conditions; sonal contact. (ii) Those necessary for use in labora- (5) Provide adequate lighting in tory testing procedures; hand-washing areas, dressing and lock- (iii) Those necessary for plant and er rooms, and toilet rooms and in all equipment maintenance and operation; areas where food is examined, manu- and factured, processed, packed, or held (iv) Those necessary for use in the and where equipment or utensils are plant’s operations. cleaned; and provide shatter-resistant (2) Toxic cleaning compounds, sani- light bulbs, fixtures, skylights, or tizing agents, and pesticide chemicals other glass suspended over exposed must be identified, held, and stored in food in any step of preparation or oth- a manner that protects against con- erwise protect against food contamina- tamination of food, food-contact sur- tion in case of glass breakage. faces, or food-packaging materials. (6) Provide adequate ventilation or (c) Pest control. Pests must not be al- control equipment to minimize dust, lowed in any area of a food plant. odors and vapors (including steam and Guard, guide, or pest-detecting dogs noxious fumes) in areas where they may be allowed in some areas of a may cause allergen cross-contact or plant if the presence of the dogs is un- contaminate food; and locate and oper- likely to result in contamination of ate fans and other air-blowing equip- food, food-contact surfaces, or food- ment in a manner that minimizes the packaging materials. Effective meas- potential for allergen cross-contact and ures must be taken to exclude pests for contaminating food, food-packaging from the manufacturing, processing, materials, and food-contact surfaces. packing, and holding areas and to pro- (7) Provide, where necessary, ade- tect against the contamination of food quate screening or other protection on the premises by pests. The use of against pests. pesticides to control pests in the plant is permitted only under precautions § 117.35 Sanitary operations. and restrictions that will protect (a) General maintenance. Buildings, against the contamination of food, fixtures, and other physical facilities food-contact surfaces, and food-pack- of the plant must be maintained in a aging materials. clean and sanitary condition and must (d) Sanitation of food-contact surfaces. be kept in repair adequate to prevent All food-contact surfaces, including food from becoming adulterated. Clean- utensils and food-contact surfaces of ing and sanitizing of utensils and equipment, must be cleaned as fre- equipment must be conducted in a quently as necessary to protect against manner that protects against allergen allergen cross-contact and against con- cross-contact and against contamina- tamination of food. tion of food, food-contact surfaces, or (1) Food-contact surfaces used for food-packaging materials. manufacturing/processing, packing, or (b) Substances used in cleaning and holding low-moisture food must be in a sanitizing; storage of toxic materials. (1) clean, dry, sanitary condition before Cleaning compounds and sanitizing use. When the surfaces are wet-cleaned, agents used in cleaning and sanitizing they must, when necessary, be sani- procedures must be free from undesir- tized and thoroughly dried before sub- able microorganisms and must be safe sequent use. and adequate under the conditions of (2) In wet processing, when cleaning use. Compliance with this requirement is necessary to protect against allergen must be verified by any effective cross-contact or the introduction of means, including purchase of these sub- microorganisms into food, all food-con- stances under a letter of guarantee or tact surfaces must be cleaned and sani- certification or examination of these tized before use and after any interrup- substances for contamination. Only the tion during which the food-contact sur- following toxic materials may be used faces may have become contaminated. or stored in a plant where food is proc- Where equipment and utensils are used essed or exposed: in a continuous production operation,

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the utensils and food-contact surfaces equipment, or utensils or creating an of the equipment must be cleaned and unsanitary condition. sanitized as necessary. (4) Provide adequate floor drainage in (3) Single-service articles (such as all areas where floors are subject to utensils intended for one-time use, flooding-type cleaning or where normal paper cups, and paper towels) must be operations release or discharge water stored, handled, and disposed of in a or other liquid waste on the floor. manner that protects against allergen (5) Provide that there is not backflow cross-contact and against contamina- from, or cross-connection between, pip- tion of food, food-contact surfaces, or ing systems that discharge waste water food-packaging materials. or sewage and piping systems that (e) Sanitation of non-food-contact sur- carry water for food or food manufac- faces. Non-food-contact surfaces of turing. equipment used in the operation of a (c) Sewage disposal. Sewage must be food plant must be cleaned in a manner disposed of into an adequate sewerage and as frequently as necessary to pro- system or disposed of through other tect against allergen cross-contact and adequate means. against contamination of food, food- (d) Toilet facilities. Each plant must contact surfaces, and food-packaging provide employees with adequate, read- materials. ily accessible toilet facilities. Toilet (f) Storage and handling of cleaned facilities must be kept clean and must portable equipment and utensils. Cleaned not be a potential source of contamina- and sanitized portable equipment with tion of food, food-contact surfaces, or food-contact surfaces and utensils food-packaging materials. (e) Each plant must be stored in a location and man- Hand-washing facilities. must provide hand-washing facilities ner that protects food-contact surfaces designed to ensure that an employee’s from allergen cross-contact and from hands are not a source of contamina- contamination. tion of food, food-contact surfaces, or § 117.37 Sanitary facilities and con- food-packaging materials, by providing trols. facilities that are adequate, convenient, and furnish running water at a Each plant must be equipped with suitable temperature. adequate sanitary facilities and accom- (f) Rubbish and offal disposal. Rubbish modations including: and any offal must be so conveyed, (a) Water supply. The water supply stored, and disposed of as to minimize must be adequate for the operations in- the development of odor, minimize the tended and must be derived from an potential for the waste becoming an at- adequate source. Any water that con- tractant and harborage or breeding tacts food, food-contact surfaces, or place for pests, and protect against food-packaging materials must be safe contamination of food, food-contact and of adequate sanitary quality. Run- surfaces, food-packaging materials, ning water at a suitable temperature, water supplies, and ground surfaces. and under pressure as needed, must be provided in all areas where required for § 117.40 Equipment and utensils. the processing of food, for the cleaning (a)(1) All plant equipment and uten- of equipment, utensils, and food-pack- sils used in manufacturing, processing, aging materials, or for employee sani- packing, or holding food must be so de- tary facilities. signed and of such material and work- (b) Plumbing. Plumbing must be of manship as to be adequately cleanable, adequate size and design and ade- and must be adequately maintained to quately installed and maintained to: protect against allergen cross-contact (1) Carry adequate quantities of and contamination. water to required locations throughout (2) Equipment and utensils must be the plant. designed, constructed, and used appro- (2) Properly convey sewage and liquid priately to avoid the adulteration of disposable waste from the plant. food with lubricants, fuel, metal frag- (3) Avoid constituting a source of ments, contaminated water, or any contamination to food, water supplies, other contaminants.

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(3) Equipment must be installed so as to clean food-contact surfaces or equip- to facilitate the cleaning and mainte- ment must be treated in such a way nance of the equipment and of adjacent that food is not contaminated with un- spaces. lawful indirect food additives. (4) Food-contact surfaces must be corrosion-resistant when in contact § 117.80 Processes and controls. with food. (a) General. (1) All operations in the (5) Food-contact surfaces must be manufacturing, processing, packing, made of nontoxic materials and de- and holding of food (including oper- signed to withstand the environment of ations directed to receiving, inspect- their intended use and the action of ing, transporting, and segregating) food, and, if applicable, cleaning com- must be conducted in accordance with pounds, sanitizing agents, and cleaning adequate sanitation principles. procedures. (2) Appropriate quality control oper- (6) Food-contact surfaces must be ations must be employed to ensure maintained to protect food from aller- that food is suitable for human con- gen cross-contact and from being consumption and that food-packaging ma- taminated by any source, including un- terials are safe and suitable. lawful indirect food additives. (b) Seams on food-contact surfaces (3) Overall sanitation of the plant must be smoothly bonded or main- must be under the supervision of one or tained so as to minimize accumulation more competent individuals assigned of food particles, dirt, and organic mat- responsibility for this function. ter and thus minimize the opportunity (4) Adequate precautions must be for growth of microorganisms and al- taken to ensure that production proce- lergen cross-contact. dures do not contribute to allergen (c) Equipment that is in areas where cross-contact and to contamination food is manufactured, processed, from any source. packed, or held and that does not come (5) Chemical, microbial, or extra- into contact with food must be so con- neous-material testing procedures structed that it can be kept in a clean must be used where necessary to iden- and sanitary condition. tify sanitation failures or possible al- (d) Holding, conveying, and manufac- lergen cross-contact and food contami- turing systems, including gravimetric, nation. pneumatic, closed, and automated sys- (6) All food that has become contami- tems, must be of a design and construc- nated to the extent that it is adulter- tion that enables them to be main- ated must be rejected, or if appro- tained in an appropriate clean and san- priate, treated or processed to elimi- itary condition. nate the contamination. (e) Each freezer and cold storage (b) Raw materials and other ingredi- compartment used to store and hold ents. (1) Raw materials and other ingre- food capable of supporting growth of dients must be inspected and seg- microorganisms must be fitted with an regated or otherwise handled as nec- indicating thermometer, temperature- essary to ascertain that they are clean measuring device, or temperature-re- and suitable for processing into food cording device so installed as to show and must be stored under conditions the temperature accurately within the that will protect against allergen compartment. cross-contact and against contamina- (f) Instruments and controls used for tion and minimize deterioration. Raw measuring, regulating, or recording materials must be washed or cleaned as temperatures, pH, acidity, water activ- necessary to remove soil or other con- ity, or other conditions that control or tamination. Water used for washing, prevent the growth of undesirable rinsing, or conveying food must be safe microorganisms in food must be accu- and of adequate sanitary quality. rate and precise and adequately main- Water may be reused for washing, rins- tained, and adequate in number for ing, or conveying food if it does not their designated uses. cause allergen cross-contact or in- (g) Compressed air or other gases me- crease the level of contamination of chanically introduced into food or used the food.

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(2) Raw materials and other ingredi- (2) All food manufacturing, proc- ents must either not contain levels of essing, packing, and holding must be microorganisms that may render the conducted under such conditions and food injurious to the health of humans, controls as are necessary to minimize or they must be pasteurized or other- the potential for the growth of micro- wise treated during manufacturing op- organisms, allergen cross-contact, con- erations so that they no longer contain tamination of food, and deterioration levels that would cause the product to of food. be adulterated. (3) Food that can support the rapid (3) Raw materials and other ingredi- growth of undesirable microorganisms ents susceptible to contamination with must be held at temperatures that will aflatoxin or other natural toxins must prevent the food from becoming adul- comply with FDA regulations for poi- terated during manufacturing, proc- sonous or deleterious substances before essing, packing, and holding. these raw materials or other ingredi- (4) Measures such as sterilizing, irra- ents are incorporated into finished diating, pasteurizing, cooking, freez- food. ing, refrigerating, controlling pH, or (4) Raw materials, other ingredients, controlling aw that are taken to de- and rework susceptible to contamina- stroy or prevent the growth of undesir- tion with pests, undesirable microorga- able microorganisms must be adequate nisms, or extraneous material must under the conditions of manufacture, comply with applicable FDA regula- handling, and distribution to prevent tions for natural or unavoidable defects food from being adulterated. if a manufacturer wishes to use the (5) Work-in-process and rework must materials in manufacturing food. be handled in a manner that protects (5) Raw materials, other ingredients, against allergen cross-contact, con- and rework must be held in bulk, or in tamination, and growth of undesirable containers designed and constructed so microorganisms. as to protect against allergen cross- contact and against contamination and (6) Effective measures must be taken must be held at such temperature and to protect finished food from allergen relative humidity and in such a man- cross-contact and from contamination ner as to prevent the food from becom- by raw materials, other ingredients, or ing adulterated. Material scheduled for refuse. When raw materials, other in- rework must be identified as such. gredients, or refuse are unprotected, (6) Frozen raw materials and other they must not be handled simulta- ingredients must be kept frozen. If neously in a receiving, loading, or ship- thawing is required prior to use, it ping area if that handling could result must be done in a manner that pre- in allergen cross-contact or contami- vents the raw materials and other in- nated food. Food transported by con- gredients from becoming adulterated. veyor must be protected against aller- (7) Liquid or dry raw materials and gen cross-contact and against contami- other ingredients received and stored nation as necessary. in bulk form must be held in a manner (7) Equipment, containers, and uten- that protects against allergen cross- sils used to convey, hold, or store raw contact and against contamination. materials and other ingredients, work- (8) Raw materials and other ingredi- in-process, rework, or other food must ents that are food allergens, and re- be constructed, handled, and main- work that contains food allergens, tained during manufacturing, proc- must be identified and held in a man- essing, packing, and holding in a manner that prevents allergen cross-con- ner that protects against allergen tact. cross-contact and against contamina- (c) Manufacturing operations. (1) tion. Equipment and utensils and food con- (8) Adequate measures must be taken tainers must be maintained in an ade- to protect against the inclusion of quate condition through appropriate metal or other extraneous material in cleaning and sanitizing, as necessary. food. Insofar as necessary, equipment must (9) Food, raw materials, and other in- be taken apart for thorough cleaning. gredients that are adulterated:

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(i) Must be disposed of in a manner must be processed to and maintained that protects against the contamina- at a safe moisture level. tion of other food; or (15) Food, such as acid and acidified (ii) If the adulterated food is capable food, that relies principally on the con- of being reconditioned, it must be: trol of pH for preventing the growth of (A) Reconditioned (if appropriate) undesirable microorganisms must be using a method that has been proven to monitored and maintained at a pH of be effective; or 4.6 or below. (B) Reconditioned (if appropriate) (16) When ice is used in contact with and reexamined and subsequently food, it must be made from water that found not to be adulterated within the is safe and of adequate sanitary quality meaning of the Federal Food, Drug, in accordance with § 117.37(a), and must and Cosmetic Act before being incor- be used only if it has been manufac- porated into other food. tured in accordance with current good (10) Steps such as washing, peeling, manufacturing practice as outlined in trimming, cutting, sorting and inspect- this part. ing, mashing, dewatering, cooling, shredding, extruding, drying, whipping, § 117.93 Warehousing and distribution. defatting, and forming must be per- Storage and transportation of food formed so as to protect food against al- must be under conditions that will pro- lergen cross-contact and against con- tect against allergen cross-contact and tamination. Food must be protected against biological, chemical (including from contaminants that may drip, radiological), and physical contamina- drain, or be drawn into the food. tion of food, as well as against deterio- (11) Heat blanching, when required in ration of the food and the container. the preparation of food capable of supporting microbial growth, must be ef- § 117.95 Holding and distribution of fected by heating the food to the re- human food by-products for use as quired temperature, holding it at this animal food. temperature for the required time, and (a) Human food by-products held for then either rapidly cooling the food or distribution as animal food without ad- passing it to subsequent manufacturing ditional manufacturing or processing without delay. Growth and contamina- by the human food processor, as identi- tion by thermophilic microorganisms fied in § 507.12 of this chapter, must be in blanchers must be minimized by the held under conditions that will protect use of adequate operating temperatures against contamination, including the and by periodic cleaning and sanitizing following: as necessary. (1) Containers and equipment used to (12) Batters, breading, sauces, gra- convey or hold human food by-products vies, dressings, dipping solutions, and for use as animal food before distribu- other similar preparations that are tion must be designed, constructed of held and used repeatedly over time appropriate material, cleaned as nec- must be treated or maintained in such essary, and maintained to protect a manner that they are protected against the contamination of human against allergen cross-contact and food by-products for use as animal against contamination, and mini- food; mizing the potential for the growth of (2) Human food by-products for use as undesirable microorganisms. animal food held for distribution must (13) Filling, assembling, packaging, be held in a way to protect against con- and other operations must be per- tamination from sources such as trash; formed in such a way that the food is and protected against allergen cross-con- (3) During holding, human food by- tact, contamination and growth of un- products for use as animal food must desirable microorganisms. be accurately identified. (14) Food, such as dry mixes, nuts, in- (b) Labeling that identifies the by- termediate moisture food, and dehy- product by the common or usual name drated food, that relies principally on must be affixed to or accompany the control of aw for preventing the human food by-products for use as ani- growth of undesirable microorganisms mal food when distributed.

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(c) Shipping containers (e.g., totes, ventive controls as required by drums, and tubs) and bulk vehicles § 117.145(a)(1); used to distribute human food by-prod- (6) The written corrective action pro- ucts for use as animal food must be ex- cedures as required by § 117.150(a)(1); amined prior to use to protect against and contamination of the human food by- (7) The written verification proce- products for use as animal food from dures as required by § 117.165(b). the container or vehicle when the facil- (c) Records. The food safety plan re- ity is responsible for transporting the quired by this section is a record that human food by-products for use as ani- is subject to the requirements of sub- mal food itself or arranges with a third part F of this part. party to transport the human food by- products for use as animal food. § 117.130 Hazard analysis. [80 FR 56337, Sept. 17, 2015] (a) Requirement for a hazard analysis. (1) You must conduct a hazard analysis § 117.110 Defect action levels. to identify and evaluate, based on expe- (a) The manufacturer, processor, rience, illness data, scientific reports, packer, and holder of food must at all and other information, known or rea- times utilize quality control operations sonably foreseeable hazards for each that reduce natural or unavoidable de- type of food manufactured, processed, fects to the lowest level currently fea- packed, or held at your facility to de- sible. termine whether there are any hazards (b) The mixing of a food containing requiring a preventive control. defects at levels that render that food (2) The hazard analysis must be writ- adulterated with another lot of food is ten regardless of its outcome. not permitted and renders the final (b) Hazard identification. The hazard food adulterated, regardless of the de- identification must consider: fect level of the final food. For exam- (1) Known or reasonably foreseeable ples of defect action levels that may hazards that include: render food adulterated, see the Defect (i) Biological hazards, including Levels Handbook, which is accessible microbiological hazards such as athttp://www.fda.gov/pchfrule and parasites, environmental pathogens, athttp://www.fda.gov. and other pathogens; (ii) Chemical hazards, including radi- Subpart C—Hazard Analysis and ological hazards, substances such as Risk-Based Preventive Controls pesticide and drug residues, natural toxins, decomposition, unapproved food § 117.126 Food safety plan. or color additives, and food allergens; (a) Requirement for a food safety plan. and (1) You must prepare, or have prepared, (iii) Physical hazards (such as stones, and implement a written food safety glass, and metal fragments); and plan. (2) Known or reasonably foreseeable (2) The food safety plan must be pre- hazards that may be present in the pared, or its preparation overseen, by food for any of the following reasons: one or more preventive controls quali- (i) The hazard occurs naturally; fied individuals. (ii) The hazard may be unintention- (b) Contents of a food safety plan. The ally introduced; or written food safety plan must include: (iii) The hazard may be intentionally (1) The written hazard analysis as re- introduced for purposes of economic quired by § 117.130(a)(2); gain. (2) The written preventive controls as (c) Hazard evaluation. (1)(i) The haz- required by § 117.135(b); ard analysis must include an evalua- (3) The written supply-chain program tion of the hazards identified in para- as required by subpart G of this part; graph (b) of this section to assess the (4) The written recall plan as re- severity of the illness or injury if the quired by § 117.139(a); and hazard were to occur and the prob- (5) The written procedures for moni- ability that the hazard will occur in toring the implementation of the pre- the absence of preventive controls.

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(ii) The hazard evaluation required (1) Process controls. Process controls by paragraph (c)(1)(i) of this section include procedures, practices, and proc- must include an evaluation of environ- esses to ensure the control of param- mental pathogens whenever a ready-to- eters during operations such as heat eat food is exposed to the environment processing, acidifying, irradiating, and prior to packaging and the packaged refrigerating foods. Process controls food does not receive a treatment or must include, as appropriate to the na- otherwise include a control measure ture of the applicable control and its (such as a formulation lethal to the role in the facility’s food safety sys- pathogen) that would significantly tem: minimize the pathogen. (i) Parameters associated with the (2) The hazard evaluation must con- control of the hazard; and sider the effect of the following on the (ii) The maximum or minimum safety of the finished food for the in- value, or combination of values, to tended consumer: which any biological, chemical, or (i) The formulation of the food; physical parameter must be controlled (ii) The condition, function, and de- to significantly minimize or prevent a sign of the facility and equipment; hazard requiring a process control. (iii) Raw materials and other ingredi- (2) Food allergen controls. Food aller- ents; gen controls include procedures, prac- (iv) Transportation practices; tices, and processes to control food al- (v) Manufacturing/processing proce- lergens. Food allergen controls must dures; include those procedures, practices, (vi) Packaging activities and labeling and processes employed for: activities; (i) Ensuring protection of food from (vii) Storage and distribution; allergen cross-contact, including dur- (viii) Intended or reasonably foresee- ing storage, handling, and use; and able use; (ii) Labeling the finished food, in- (ix) Sanitation, including employee cluding ensuring that the finished food hygiene; and is not misbranded under section 403(w) (x) Any other relevant factors, such of the Federal Food, Drug, and Cos- as the temporal (e.g., weather-related) metic Act. nature of some hazards (e.g., levels of (3) Sanitation controls. Sanitation con- some natural toxins). trols include procedures, practices, and processes to ensure that the facility is § 117.135 Preventive controls. maintained in a sanitary condition (a)(1) You must identify and imple- adequate to significantly minimize or ment preventive controls to provide as- prevent hazards such as environmental surances that any hazards requiring a pathogens, biological hazards due to preventive control will be significantly employee handling, and food allergen minimized or prevented and the food hazards. Sanitation controls must in- manufactured, processed, packed, or clude, as appropriate to the facility held by your facility will not be adul- and the food, procedures, practices, and terated under section 402 of the Federal processes for the: Food, Drug, and Cosmetic Act or mis- (i) Cleanliness of food-contact sur- branded under section 403(w) of the faces, including food-contact surfaces Federal Food, Drug, and Cosmetic Act. of utensils and equipment; (2) Preventive controls required by (ii) Prevention of allergen cross-con- paragraph (a)(1) of this section include: tact and cross-contamination from in- (i) Controls at critical control points sanitary objects and from personnel to (CCPs), if there are any CCPs; and food, food packaging material, and (ii) Controls, other than those at other food-contact surfaces and from CCPs, that are also appropriate for raw product to processed product. food safety. (4) Supply-chain controls. Supply- (b) Preventive controls must be writ- chain controls include the supply-chain ten. program as required by subpart G of (c) Preventive controls include, as this part. appropriate to the facility and the (5) Recall plan. Recall plan as re- food: quired by § 117.139.

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(6) Other controls. Preventive controls manufacturing, processing, or pre- include any other procedures, prac- paring the food in accordance with ap- tices, and processes necessary to sat- plicable food safety requirements. isfy the requirements of paragraph (a) (4) You rely on your customer to proof this section. Examples of other con- vide assurance that the food will be trols include hygiene training and processed to control the identified haz- other current good manufacturing ard by an entity in the distribution practices. chain subsequent to the customer and you: § 117.136 Circumstances in which the owner, operator, or agent in charge (i) Disclose in documents accom- of a manufacturing/processing facil- panying the food, in accordance with ity is not required to implement a the practice of the trade, that the food preventive control. is ‘‘not processed to control [identified (a) Circumstances. If you are a manu- hazard]’’; and facturer/processor, you are not re- (ii) Annually obtain from your cus- quired to implement a preventive con- tomer written assurance, subject to the trol when you identify a hazard requir- requirements of § 117.137, that your cus- ing a preventive control (identified tomer: hazard) and any of the following cir- (A) Will disclose in documents ac- cumstances apply: companying the food, in accordance (1) You determine and document that with the practice of the trade, that the the type of food (e.g., raw agricultural food is ‘‘not processed to control [iden- commodities such as cocoa beans, cof- tified hazard]’’; and fee beans, and grains) could not be con- (B) Will only sell to another entity sumed without application of an appro- that agrees, in writing, it will: priate control. (1) Follow procedures (identified in a (2) You rely on your customer who is written assurance) that will signifi- subject to the requirements for hazard cantly minimize or prevent the identi- analysis and risk-based preventive con- fied hazard (if the entity is subject to trols in this subpart to ensure that the the requirements for hazard analysis identified hazard will be significantly and risk-based preventive controls in minimized or prevented and you: this subpart) or manufacture, process, (i) Disclose in documents accom- or prepare the food in accordance with panying the food, in accordance with applicable food safety requirements (if the practice of the trade, that the food the entity is not subject to the require- is ‘‘not processed to control [identified ments for hazard analysis and risk- hazard]’’; and based preventive controls in this sub- (ii) Annually obtain from your cus- part); or tomer written assurance, subject to the requirements of § 117.137, that the cus- (2) Obtain a similar written assur- tomer has established and is following ance from the entity’s customer, sub- procedures (identified in the written ject to the requirements of § 117.137, as assurance) that will significantly mini- in paragraphs (a)(4)(ii)(A) and (B) of mize or prevent the identified hazard. this section, as appropriate; or (3) You rely on your customer who is (5) You have established, docu- not subject to the requirements for mented, and implemented a system hazard analysis and risk-based preven- that ensures control, at a subsequent tive controls in this subpart to provide distribution step, of the hazards in the assurance it is manufacturing, proc- food you distribute and you document essing, or preparing the food in accord- the implementation of that system. ance with applicable food safety re- (b) Records. You must document any quirements and you: circumstance, specified in paragraph (i) Disclose in documents accom- (a) of this section, that applies to you, panying the food, in accordance with including: the practice of the trade, that the food (1) A determination, in accordance is ‘‘not processed to control [identified with paragraph (a) of this section, that hazard]’’; and the type of food could not be consumed (ii) Annually obtain from your cus- without application of an appropriate tomer written assurance that it is control;

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(2) The annual written assurance control management components as from your customer in accordance with appropriate to ensure the effectiveness paragraph (a)(2) of this section; of the preventive controls, taking into (3) The annual written assurance account the nature of the preventive from your customer in accordance with control and its role in the facility’s paragraph (a)(3) of this section; food safety system: (4) The annual written assurance (1) Monitoring in accordance with from your customer in accordance with § 117.145; paragraph (a)(4) of this section; and (2) Corrective actions and corrections (5) Your system, in accordance with in accordance with § 117.150; and paragraph (a)(5) of this section, that (3) Verification in accordance with ensures control, at a subsequent dis- § 117.155. tribution step, of the hazards in the (b) The supply-chain program estab- food you distribute. lished in subpart G of this part is sub- [80 FR 56145, Sept. 17, 2015, as amended at 81 ject to the following preventive control FR 3716, Jan. 22, 2016] management components as appropriate to ensure the effectiveness of the § 117.137 Provision of assurances re- supply-chain program, taking into acquired under § 117.136(a)(2), (3), and count the nature of the hazard con- (4). trolled before receipt of the raw mate- A facility that provides a written as- rial or other ingredient: surance under § 117.136(a)(2), (3), or (4) (1) Corrective actions and corrections must act consistently with the assur- in accordance with § 117.150, taking into ance and document its actions taken to account the nature of any supplier non- satisfy the written assurance. conformance; (2) Review of records in accordance § 117.139 Recall plan. with § 117.165(a)(4); and For food with a hazard requiring a (3) Reanalysis in accordance with preventive control: § 117.170. (a) You must establish a written re- (c) The recall plan established in call plan for the food. § 117.139 is not subject to the require- (b) The written recall plan must in- ments of paragraph (a) of this section. clude procedures that describe the steps to be taken, and assign responsi- § 117.145 Monitoring. bility for taking those steps, to perform the following actions as appro- As appropriate to the nature of the priate to the facility: preventive control and its role in the (1) Directly notify the direct con- facility’s food safety system: signees of the food being recalled, in- (a) Written procedures. You must es- cluding how to return or dispose of the tablish and implement written proce- affected food; dures, including the frequency with (2) Notify the public about any haz- which they are to be performed, for ard presented by the food when appro- monitoring the preventive control; and priate to protect public health; (b) Monitoring. You must monitor the (3) Conduct effectiveness checks to preventive controls with adequate fre- verify that the recall is carried out; quency to provide assurance that they and are consistently performed. (4) Appropriately dispose of recalled (c) Records. (1) Requirement to docu- food—e.g., through reprocessing, re- ment monitoring. You must document working, diverting to a use that does the monitoring of preventive controls not present a safety concern, or de- in accordance with this section in stroying the food. records that are subject to verification in accordance with § 117.155(a)(2) and § 117.140 Preventive control manage- records review in accordance with ment components. § 117.165(a)(4)(i). (a) Except as provided by paragraphs (2) Exception records. (i) Records of re- (b) and (c) of this section, the preven- frigeration temperature during storage tive controls required under § 117.135 of food that requires time/temperature are subject to the following preventive control to significantly minimize or

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prevent the growth of, or toxin produc- quirements of paragraphs (b)(2) of this tion by, pathogens may be affirmative section if any of the following cir- records demonstrating temperature is cumstances apply: controlled or exception records dem- (i) A preventive control is not prop- onstrating loss of temperature control. erly implemented and a corrective ac- (ii) Exception records may be ade- tion procedure has not been estab- quate in circumstances other than lished; monitoring of refrigeration tempera- (ii) A preventive control, combina- ture. tion of preventive controls, or the food [80 FR 56145, Sept. 17, 2015, as amended at 81 safety plan as a whole is found to be in- FR 3716, Jan. 22, 2016] effective; or § 117.150 Corrective actions and cor- (iii) A review of records in accord- rections. ance with § 117.165(a)(4) finds that the records are not complete, the activities (a) Corrective action procedures. As ap- conducted did not occur in accordance propriate to the nature of the hazard and the nature of the preventive con- with the food safety plan, or appro- trol, except as provided by paragraph priate decisions were not made about (c) of this section: corrective actions. (1) You must establish and imple- (2) If any of the circumstances listed ment written corrective action proce- in paragraph (b)(1) of this section dures that must be taken if preventive apply, you must: controls are not properly implemented, (i) Take corrective action to identify including procedures to address, as ap- and correct the problem, reduce the propriate: likelihood that the problem will recur, (i) The presence of a pathogen or ap- evaluate all affected food for safety, propriate indicator organism in a and, as necessary, prevent affected food ready-to-eat product detected as a re- from entering commerce as would be sult of product testing conducted in ac- done following a corrective action pro- cordance with § 117.165(a)(2); and cedure under paragraphs (a)(2)(i) (ii) The presence of an environmental through (iv) of this section; and pathogen or appropriate indicator or- (ii) When appropriate, reanalyze the ganism detected through the environ- food safety plan in accordance with mental monitoring conducted in ac- § 117.170 to determine whether modi- cordance with § 117.165(a)(3). (2) The corrective action procedures fication of the food safety plan is re- must describe the steps to be taken to quired. ensure that: (c) Corrections. You do not need to (i) Appropriate action is taken to comply with the requirements of para- identify and correct a problem that has graphs (a) and (b) of this section if: occurred with implementation of a pre- (1) You take action, in a timely man- ventive control; ner, to identify and correct conditions (ii) Appropriate action is taken, when and practices that are not consistent necessary, to reduce the likelihood with the food allergen controls in that the problem will recur; § 117.135(c)(2)(i) or the sanitation con- (iii) All affected food is evaluated for trols in § 117.135(c)(3)(i) or (ii); or safety; and (2) You take action, in a timely man- (iv) All affected food is prevented ner, to identify and correct a minor from entering into commerce, if you and isolated problem that does not di- cannot ensure that the affected food is rectly impact product safety. not adulterated under section 402 of the (d) All corrective actions Federal Food, Drug, and Cosmetic Act Records. or misbranded under section 403(w) of (and, when appropriate, corrections) the Federal Food, Drug, and Cosmetic taken in accordance with this section Act. must be documented in records. These (b) Corrective action in the event of an records are subject to verification in unanticipated food safety problem. (1) Ex- accordance with § 117.155(a)(3) and cept as provided by paragraph (c) of records review in accordance with this section, you are subject to the re- § 117.165(a)(4)(i).

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§ 117.155 Verification. mented, will effectively control the hazards; and (a) Verification activities. Verification (iii) Whenever a reanalysis of the activities must include, as appropriate food safety plan reveals the need to do to the nature of the preventive control so; and its role in the facility’s food safety (2) Must include obtaining and evalu- system: ating scientific and technical evidence (1) Validation in accordance with (or, when such evidence is not available § 117.160. or is inadequate, conducting studies) to (2) Verification that monitoring is determine whether the preventive con- being conducted as required by § 117.140 trols, when properly implemented, will (and in accordance with § 117.145). effectively control the hazards; and (3) Verification that appropriate de- (c) You do not need to validate: cisions about corrective actions are (1) The food allergen controls in being made as required by § 117.140 (and § 117.135(c)(2); in accordance with § 117.150). (2) The sanitation controls in (4) Verification of implementation § 117.135(c)(3); and effectiveness in accordance with (3) The recall plan in § 117.139; § 117.165; and (4) The supply-chain program in sub- (5) Reanalysis in accordance with part G of this part; and § 117.170. (5) Other preventive controls, if the (b) Documentation. All verification preventive controls qualified individual activities conducted in accordance prepares (or oversees the preparation with this section must be documented of) a written justification that valida- in records. tion is not applicable based on factors such as the nature of the hazard, and § 117.160 Validation. the nature of the preventive control (a) You must validate that the pre- and its role in the facility’s food safety ventive controls identified and imple- system. mented in accordance with § 117.135 are adequate to control the hazard as ap- § 117.165 Verification of implementa- propriate to the nature of the prevention and effectiveness. tive control and its role in the facili- (a) Verification activities. You must ty’s food safety system. verify that the preventive controls are (b) The validation of the preventive consistently implemented and are ef- controls: fectively and significantly minimizing (1) Must be performed (or overseen) or preventing the hazards. To do so you by a preventive controls qualified indi- must conduct activities that include vidual: the following, as appropriate to the fa- (i)(A) Prior to implementation of the cility, the food, and the nature of the food safety plan; or preventive control and its role in the (B) When necessary to demonstrate facility’s food safety system: the control measures can be imple- (1) Calibration of process monitoring mented as designed: instruments and verification instru- (1) Within 90 calendar days after pro- ments (or checking them for accuracy); duction of the applicable food first be- (2) Product testing, for a pathogen gins; or (or appropriate indicator organism) or (2) Within a reasonable timeframe, other hazard; provided that the preventive controls (3) Environmental monitoring, for an qualified individual prepares (or over- environmental pathogen or for an ap- sees the preparation of) a written jus- propriate indicator organism, if con- tification for a timeframe that exceeds tamination of a ready-to-eat food with 90 calendar days after production of the an environmental pathogen is a hazard applicable food first begins; requiring a preventive control, by col- (ii) Whenever a change to a control lecting and testing environmental sam- measure or combination of control ples; and measures could impact whether the (4) Review of the following records control measure or combination of con- within the specified timeframes, by (or trol measures, when properly imple- under the oversight of) a preventive

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controls qualified individual, to ensure tion. Procedures for environmental that the records are complete, the ac- monitoring must: tivities reflected in the records oc- (i) Be scientifically valid; curred in accordance with the food (ii) Identify the test microorga- safety plan, the preventive controls are nism(s); effective, and appropriate decisions (iii) Identify the locations from were made about corrective actions: which samples will be collected and the (i) Records of monitoring and correc- number of sites to be tested during rou- tive action records within 7 working tine environmental monitoring. The days after the records are created or number and location of sampling sites within a reasonable timeframe, pro- must be adequate to determine wheth- vided that the preventive controls er preventive controls are effective; qualified individual prepares (or over- (iv) Identify the timing and fre- sees the preparation of) a written jus- quency for collecting and testing sam- tification for a timeframe that exceeds 7 working days; and ples. The timing and frequency for col- (ii) Records of calibration, testing lecting and testing samples must be (e.g., product testing, environmental adequate to determine whether preven- monitoring), supplier and supply-chain tive controls are effective; verification activities, and other (v) Identify the test(s) conducted, in- verification activities within a reason- cluding the analytical method(s) used; able time after the records are created; (vi) Identify the laboratory con- and ducting the testing; and (5) Other activities appropriate for (vii) Include the corrective action verification of implementation and ef- procedures required by § 117.150(a)(1). fectiveness. (b) Written procedures. As appropriate § 117.170 Reanalysis. to the facility, the food, the nature of (a) You must conduct a reanalysis of the preventive control, and the role of the food safety plan as a whole at least the preventive control in the facility’s once every 3 years; food safety system, you must establish (b) You must conduct a reanalysis of and implement written procedures for the food safety plan as a whole, or the the following activities: applicable portion of the food safety (1) The method and frequency of cali- plan: brating process monitoring instru- (1) Whenever a significant change in ments and verification instruments (or the activities conducted at your facil- checking them for accuracy) as re- ity creates a reasonable potential for a quired by paragraph (a)(1) of this sec- new hazard or creates a significant in- tion. crease in a previously identified haz- (2) Product testing as required by ard; paragraph (a)(2) of this section. Proce- dures for product testing must: (2) Whenever you become aware of (i) Be scientifically valid; new information about potential haz- (ii) Identify the test microorga- ards associated with the food; nism(s) or other analyte(s); (3) Whenever appropriate after an un- (iii) Specify the procedures for iden- anticipated food safety problem in ac- tifying samples, including their rela- cordance with § 117.150(b); and tionship to specific lots of product; (4) Whenever you find that a preven- (iv) Include the procedures for sam- tive control, combination of preventive pling, including the number of samples controls, or the food safety plan as a and the sampling frequency; whole is ineffective. (v) Identify the test(s) conducted, in- (c) You must complete the reanalysis cluding the analytical method(s) used; required by paragraphs (a) and (b) of (vi) Identify the laboratory con- this section and validate, as appro- ducting the testing; and priate to the nature of the preventive (vii) Include the corrective action control and its role in the facility’s procedures required by § 117.150(a)(1). food safety system, any additional pre- (3) Environmental monitoring as re- ventive controls needed to address the quired by paragraph (a)(3) of this sec- hazard identified:

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(1) Before any change in activities to the nature of the preventive control (including any change in preventive and its role in the facility’s food safety control) at the facility is operative; or system, in a timeframe that exceeds (2) When necessary to demonstrate the first 90 calendar days of production the control measures can be imple- of the applicable food. mented as designed: (b) A qualified auditor must conduct (i) Within 90 calendar days after pro- an onsite audit (§ 117.435(a)). duction of the applicable food first be- (c)(1) To be a preventive controls gins; or qualified individual, the individual (ii) Within a reasonable timeframe, must have successfully completed provided that the preventive controls training in the development and appli- qualified individual prepares (or over- cation of risk-based preventive con- sees the preparation of) a written jus- trols at least equivalent to that re- tification for a timeframe that exceeds ceived under a standardized curriculum 90-calendar days after production of recognized as adequate by FDA or be the applicable food first begins. otherwise qualified through job experi- (d) You must revise the written food ence to develop and apply a food safety safety plan if a significant change in system. Job experience may qualify an the activities conducted at your facil- individual to perform these functions if ity creates a reasonable potential for a such experience has provided an indi- new hazard or a significant increase in vidual with knowledge at least equiva- a previously identified hazard or docu- lent to that provided through the ment the basis for the conclusion that standardized curriculum. This indi- no revisions are needed. vidual may be, but is not required to (e) A preventive controls qualified in- be, an employee of the facility. dividual must perform (or oversee) the (2) To be a qualified auditor, a quali- reanalysis. fied individual must have technical ex- (f) You must conduct a reanalysis of pertise obtained through education, the food safety plan when FDA deter- training, or experience (or a combina- mines it is necessary to respond to new tion thereof) necessary to perform the hazards and developments in scientific auditing function. understanding. (d) All applicable training in the development and application of risk- § 117.180 Requirements applicable to a based preventive controls must be doc- preventive controls qualified individual and a qualified auditor. umented in records, including the date of the training, the type of training, (a) One or more preventive controls and the person(s) trained. qualified individuals must do or oversee the following: § 117.190 Implementation records re- (1) Preparation of the food safety quired for this subpart. plan (§ 117.126(a)(2)); (a) You must establish and maintain (2) Validation of the preventive con- the following records documenting im- trols (§ 117.160(b)(1)); plementation of the food safety plan: (3) Written justification for valida- (1) Documentation, as required by tion to be performed in a timeframe § 117.136(b), of the basis for not estab- that exceeds the first 90 calendar days lishing a preventive control in accord- of production of the applicable food; ance with § 117.136(a); (4) Determination that validation is not required (§ 117.160(c)(5)); (2) Records that document the moni- (5) Review of records (§ 117.165(a)(4)); toring of preventive controls; (6) Written justification for review of (3) Records that document corrective records of monitoring and corrective actions; actions within a timeframe that ex- (4) Records that document ceeds 7 working days; verification, including, as applicable, (7) Reanalysis of the food safety plan those related to: (§ 117.170(d)); and (i) Validation; (8) Determination that reanalysis can (ii) Verification of monitoring; be completed, and additional preven- (iii) Verification of corrective active controls validated, as appropriate tions;

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(iv) Calibration of process moni- ies, copy centers, schools, and Internet toring and verification instruments; cafes. FDA encourages electronic sub- (v) Product testing; mission. (vi) Environmental monitoring; (2) Submission by mail. (i) You must (vii) Records review; and use Form FDA 3942a. You may obtain a (viii) Reanalysis; copy of this form by any of the fol- (5) Records that document the sup- lowing mechanisms: ply-chain program; and (A) Download it from http:// (6) Records that document applicable www.fda.gov/pchfrule; training for the preventive controls (B) Write to the U.S. Food and Drug qualified individual and the qualified Administration (HFS–681), 5001 Campus auditor. Dr., College Park, MD 20740; or (b) The records that you must estab- (C) Request a copy of this form by lish and maintain are subject to the re- phone at 1–800–216–7331 or 301–575–0156. quirements of subpart F of this part. (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug Administration Subpart D—Modified (HFS–681), 5001 Campus Dr., College Requirements Park, MD 20740. We recommend that you submit a paper copy only if your § 117.201 Modified requirements that facility does not have reasonable ac- apply to a qualified facility. cess to the Internet. (a) Attestations to be submitted. A (c) Frequency of determination of status qualified facility must submit the fol- and submission. (1) A facility must de- lowing attestations to FDA: termine and document its status as a (1) An attestation that the facility is qualified facility on an annual basis no a qualified facility as defined in § 117.3. later than July 1 of each calendar year. For the purpose of determining wheth- (2) The attestations required by para- er a facility satisfies the definition of graph (a) of this section must be: qualified facility, the baseline year for (i) Submitted to FDA initially: calculating the adjustment for infla- (A) By December 17, 2018, for a facil- tion is 2011; and ity that begins manufacturing, proc- (2)(i) An attestation that you have essing, packing, or holding food before identified the potential hazards associ- September 17, 2018; ated with the food being produced, are (B) Before beginning operations, for a implementing preventive controls to facility that begins manufacturing, address the hazards, and are moni- processing, packing, or holding food toring the performance of the preven- after September 17, 2018; or tive controls to ensure that such con- (C) By July 31 of the applicable cal- trols are effective; or endar year, when the status of a facil- (ii) An attestation that the facility is ity changes from ‘‘not a qualified facil- in compliance with State, local, coun- ity’’ to ‘‘qualified facility’’ based on ty, tribal, or other applicable non-Fed- the annual determination required by eral food safety law, including relevant paragraph (c)(1) of this section; and laws and regulations of foreign coun- (ii) Beginning in 2020, submitted to tries, including an attestation based on FDA every 2 years during the period licenses, inspection reports, certifi- beginning on October 1 and ending on cates, permits, credentials, certifi- December 31. cation by an appropriate agency (such (3) When the status of a facility as a State department of agriculture), changes from ‘‘qualified facility’’ to or other evidence of oversight. ‘‘not a qualified facility’’ based on the (b) Procedure for submission. The at- annual determination required by para- testations required by paragraph (a) of graph (c)(1) of this section, the facility this section must be submitted to FDA must notify FDA of that change in sta- by one of the following means: tus using Form 3942a by July 31 of the (1) Electronic submission. To submit applicable calendar year. electronically, go to http://www.fda.gov/ (d) Timeframe for compliance with sub- furls and follow the instructions. This parts C and G of this part when the facil- Web site is available from wherever the ity status changes to ‘‘not a qualified fa- Internet is accessible, including librar- cility.’’ When the status of a facility

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changes from ‘‘qualified facility’’ to (1) Establish and implement tempera- ‘‘not a qualified facility,’’ the facility ture controls adequate to significantly must comply with subparts C and G of minimize or prevent the growth of, or this part no later than December 31 of toxin production by, pathogens; the applicable calendar year unless (2) Monitor the temperature controls otherwise agreed to by FDA and the fa- with adequate frequency to provide as- cility. surance that the temperature controls (e) Notification to consumers. A quali- are consistently performed; fied facility that does not submit attes- (3) If there is a loss of temperature tations under paragraph (a)(2)(i) of this control that may impact the safety of section must provide notification to such refrigerated packaged food, take consumers as to the name and com- appropriate corrective actions to: plete business address of the facility (i) Correct the problem and reduce where the food was manufactured or the likelihood that the problem will processed (including the street address recur; or P.O. box, city, state, and zip code for (ii) Evaluate all affected food for domestic facilities, and comparable full safety; and address information for foreign facili- (iii) Prevent the food from entering ties), as follows: commerce, if you cannot ensure the af- (1) If a food packaging label is re- fected food is not adulterated under quired, the notification required by section 402 of the Federal Food, Drug, paragraph (e) of this section must ap- and Cosmetic Act; pear prominently and conspicuously on (4) Verify that temperature controls the label of the food. are consistently implemented by: (2) If a food packaging label is not re- (i) Calibrating temperature moni- quired, the notification required by toring and recording devices (or check- paragraph (e) of this section must ap- ing them for accuracy); pear prominently and conspicuously, at (ii) Reviewing records of calibration the point of purchase, on a label, post- within a reasonable time after the er, sign, placard, or documents deliv- records are created; and ered contemporaneously with the food (iii) Reviewing records of monitoring in the normal course of business, or in and corrective actions taken to correct an electronic notice, in the case of a problem with the control of tempera- Internet sales. ture within 7 working days after the (f) Records. (1) A qualified facility records are created or within a reason- must maintain those records relied able timeframe, provided that the pre- upon to support the attestations that ventive controls qualified individual are required by paragraph (a) of this prepares (or oversees the preparation section. of) a written justification for a time- (2) The records that a qualified facil- frame that exceeds 7 working days; ity must maintain are subject to the (5) Establish and maintain the fol- requirements of subpart F of this part. lowing records: [80 FR 56145, Sept. 17, 2015, as amended at 81 (i) Records (whether affirmative FR 3716, Jan. 22, 2016] records demonstrating temperature is controlled or exception records dem- § 117.206 Modified requirements that onstrating loss of temperature control) apply to a facility solely engaged in documenting the monitoring of tem- the storage of unexposed packaged perature controls for any such refrig- food. erated packaged food; (a) If a facility that is solely engaged (ii) Records of corrective actions in the storage of unexposed packaged taken when there is a loss of tempera- food stores any such refrigerated pack- ture control that may impact the safe- aged food that requires time/tempera- ty of any such refrigerated packaged ture control to significantly minimize food; and or prevent the growth of, or toxin pro- (iii) Records documenting duction by pathogens, the facility must verification activities. conduct the following activities as ap- (b) The records that a facility must propriate to ensure the effectiveness of establish and maintain under para- the temperature controls: graph (a)(5) of this section are subject

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to the requirements of subpart F of draw the exemption before the order is this part. issued. (b) Any officer or qualified employee Subpart E—Withdrawal of a of FDA may issue an order to withdraw Qualified Facility Exemption the exemption after it has been approved in accordance with paragraph § 117.251 Circumstances that may lead (a) of this section. FDA to withdraw a qualified facil- (c) FDA must issue an order to with- ity exemption. draw the exemption to the owner, operator, or agent in charge of the facility. (a) FDA may withdraw a qualified fa- (d) FDA must issue an order to with- cility exemption under § 117.5(a): draw the exemption in writing, signed (1) In the event of an active inves- and dated by the officer or qualified tigation of a foodborne illness outbreak employee of FDA who is issuing the that is directly linked to the qualified order. facility; or (2) If FDA determines that it is nec- § 117.257 Contents of an order to with- essary to protect the public health and draw a qualified facility exemption. prevent or mitigate a foodborne illness An order to withdraw a qualified fa- outbreak based on conditions or con- cility exemption under § 117.5(a) must duct associated with the qualified fa- include the following information: cility that are material to the safety of (a) The date of the order; the food manufactured, processed, (b) The name, address, and location packed, or held at such facility. of the qualified facility; (b) Before FDA issues an order to (c) A brief, general statement of the withdraw a qualified facility exemp- reasons for the order, including infor- tion, FDA: mation relevant to one or both of the (1) May consider one or more other following circumstances that leads actions to protect the public health or FDA to issue the order: mitigate a foodborne illness outbreak, (1) An active investigation of a including a warning letter, recall, ad- foodborne illness outbreak that is di- ministrative detention, suspension of rectly linked to the facility; or registration, refusal of food offered for (2) Conditions or conduct associated import, seizure, and injunction; with a qualified facility that are mate- (2) Must notify the owner, operator, rial to the safety of the food manufac- or agent in charge of the facility, in tured, processed, packed, or held at writing, of circumstances that may such facility. lead FDA to withdraw the exemption, (d) A statement that the facility and provide an opportunity for the must either: owner, operator, or agent in charge of (1) Comply with subparts C and G of the facility to respond in writing, with- this part on the date that is 120 cal- in 15 calendar days of the date of re- endar days after the date of receipt of ceipt of the notification, to FDA’s noti- the order, or within a reasonable time- fication; and frame, agreed to by FDA, based on a (3) Must consider the actions taken written justification, submitted to by the facility to address the cir- FDA, for a timeframe that exceeds 120 cumstances that may lead FDA to calendar days from the date of receipt withdraw the exemption. of the order; or (2) Appeal the order within 15 cal- § 117.254 Issuance of an order to with- endar days of the date of receipt of the draw a qualified facility exemption. order in accordance with the require- (a) An FDA District Director in ments of § 117.264. whose district the qualified facility is (e) A statement that a facility may located (or, in the case of a foreign fa- request that FDA reinstate an exemp- cility, the Director of the Office of tion that was withdrawn by following Compliance in the Center for Food the procedures in § 117.287; Safety and Applied Nutrition), or an (f) The text of section 418(l) of the FDA official senior to either such Di- Federal Food, Drug, and Cosmetic Act rector, must approve an order to with- and of this subpart;

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(g) A statement that any informal (2) You are no longer subject to the hearing on an appeal of the order must modified requirements in § 117.201. be conducted as a regulatory hearing under part 16 of this chapter, with cer- § 117.264 Procedure for submitting an tain exceptions described in § 117.270; appeal. (h) The mailing address, telephone (a) To appeal an order to withdraw a number, email address, and facsimile qualified facility exemption, you must: number of the FDA district office and (1) Submit the appeal in writing to the name of the FDA District Director the FDA District Director in whose dis- in whose district the facility is located trict the facility is located (or, in the (or, in the case of a foreign facility, the case of a foreign facility, the Director same information for the Director of of the Office of Compliance in the Cen- the Office of Compliance in the Center ter for Food Safety and Applied Nutri- for Food Safety and Applied Nutrition); tion), at the mailing address, email ad- and dress, or facsimile number identified in (i) The name and the title of the FDA the order within 15 calendar days of the representative who approved the order. date of receipt of confirmation of the [80 FR 56145, Sept. 17, 2015, as amended at 81 order; and FR 3716, Jan. 22, 2016] (2) Respond with particularity to the facts and issues contained in the order, § 117.260 Compliance with, or appeal of, an order to withdraw a qualified including any supporting documenta- facility exemption. tion upon which you rely. (b) In a written appeal of the order (a) If you receive an order under withdrawing an exemption provided § 117.254 to withdraw a qualified facility under § 117.5(a), you may include a exemption, you must either: (1) Comply with applicable require- written request for an informal hearing ments of this part within 120 calendar as provided in § 117.267. days of the date of receipt of the order, [80 FR 56145, Sept. 17, 2015, as amended at 81 or within a reasonable timeframe, FR 3716, Jan. 22, 2016] agreed to by FDA, based on a written justification, submitted to FDA, for a § 117.267 Procedure for requesting an timeframe that exceeds 120 calendar informal hearing. days from the date of receipt of the (a) If you appeal the order, you: order; or (1) May request an informal hearing; (2) Appeal the order within 15 cal- and endar days of the date of receipt of the (2) Must submit any request for an order in accordance with the require- informal hearing together with your ments of § 117.264. written appeal submitted in accordance (b) Submission of an appeal, includ- with § 117.264 within 15 calendar days of ing submission of a request for an in- the date of receipt of the order. formal hearing, will not operate to delay or stay any administrative ac- (b) A request for an informal hearing tion, including enforcement action by may be denied, in whole or in part, if FDA, unless the Commissioner of Food the presiding officer determines that and Drugs, as a matter of discretion, no genuine and substantial issue of ma- determines that delay or a stay is in terial fact has been raised by the mate- the public interest. rial submitted. If the presiding officer (c) If you appeal the order, and FDA determines that a hearing is not justi- confirms the order: fied, written notice of the determina- (1) You must comply with applicable tion will be given to you explaining the requirements of this part within 120 reason for the denial. calendar days of the date of receipt of the order, or within a reasonable time- § 117.270 Requirements applicable to an informal hearing. frame, agreed to by FDA, based on a written justification, submitted to If you request an informal hearing, FDA, for a timeframe that exceeds 120 and FDA grants the request: calendar days from the date of receipt (a) The hearing will be held within 15 of the order; and calendar days after the date the appeal

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is filed or, if applicable, within a time- for reconsideration or a stay of the pre- frame agreed upon in writing by you siding officer’s final decision. and FDA. (7) If FDA grants a request for an in- (b) The presiding officer may require formal hearing on an appeal of an order that a hearing conducted under this withdrawing an exemption, the hearing subpart be completed within 1-calendar must be conducted as a regulatory day, as appropriate. hearing under a regulation in accord- (c) FDA must conduct the hearing in ance with part 16 of this chapter, ex- accordance with part 16 of this chapter, cept that § 16.95(b) of this chapter does except that: not apply to a hearing under this sub- (1) The order withdrawing an exemp- part. With respect to a regulatory tion under §§ 117.254 and 117.257, rather hearing under this subpart, the admin- than the notice under § 16.22(a) of this istrative record of the hearing specified chapter, provides notice of opportunity in §§ 16.80(a)(1) through (3) and (a)(5) of for a hearing under this section and is this chapter and 117.270(c)(5) con- part of the administrative record of the stitutes the exclusive record for the regulatory hearing under § 16.80(a) of presiding officer’s final decision. For this chapter. purposes of judicial review under § 10.45 (2) A request for a hearing under this of this chapter, the record of the ad- subpart must be addressed to the FDA ministrative proceeding consists of the District Director (or, in the case of a record of the hearing and the presiding foreign facility, the Director of the Of- officer’s final decision. fice of Compliance in the Center for Food Safety and Applied Nutrition) as § 117.274 Presiding officer for an ap- provided in the order withdrawing an peal and for an informal hearing. exemption. (3) Section 117.274, rather than The presiding officer for an appeal, § 16.42(a) of this chapter, describes the and for an informal hearing, must be FDA employees who preside at hear- an Office of Regulatory Affairs Pro- ings under this subpart. gram Director or another FDA official (4) Section 16.60(e) and (f) of this senior to an FDA District Director. chapter does not apply to a hearing [82 FR 14146, Mar. 17, 2017] under this subpart. The presiding officer must prepare a written report of § 117.277 Timeframe for issuing a deci- the hearing. All written material pre- sion on an appeal. sented at the hearing will be attached (a) If you appeal the order without to the report. The presiding officer requesting a hearing, the presiding offi- must include as part of the report of cer must issue a written report that in- the hearing a finding on the credibility cludes a final decision confirming or of witnesses (other than expert witnesses) whenever credibility is a mate- revoking the withdrawal by the 10th rial issue, and must include a proposed calendar day after the appeal is filed. decision, with a statement of reasons. (b) If you appeal the order and re- The hearing participant may review quest an informal hearing: and comment on the presiding officer’s (1) If FDA grants the request for a report within 2-calendar days of hearing and the hearing is held, the issuance of the report. The presiding presiding officer must provide a 2-cal- officer will then issue the final deci- endar day opportunity for the hearing sion. participants to review and submit com- (5) Section 16.80(a)(4) of this chapter ments on the report of the hearing does not apply to a regulatory hearing under § 117.270(c)(4), and must issue a under this subpart. The presiding offi- final decision within 10-calendar days cer’s report of the hearing and any after the hearing is held; or comments on the report by the hearing (2) If FDA denies the request for a participant under § 117.270(c)(4) are part hearing, the presiding officer must of the administrative record. issue a final decision on the appeal (6) No party shall have the right, confirming or revoking the withdrawal under § 16.119 of this chapter to petition within 10 calendar days after the date the Commissioner of Food and Drugs the appeal is filed.

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§ 117.280 Revocation of an order to under the procedures of this subpart as withdraw a qualified facility ex- follows: emption. (1) Submit a request, in writing, to An order to withdraw a qualified fa- the FDA District Director in whose dis- cility exemption is revoked if: trict your facility is located (or, in the (a) You appeal the order and request case of a foreign facility, the Director an informal hearing, FDA grants the of the Office of Compliance in the Cen- request for an informal hearing, and ter for Food Safety and Applied Nutri- the presiding officer does not confirm tion); and the order within the 10-calendar days (2) Present data and information to after the hearing, or issues a decision demonstrate that you have adequately revoking the order within that time; or resolved any problems with the condi- (b) You appeal the order and request tions and conduct that are material to an informal hearing, FDA denies the the safety of the food manufactured, request for an informal hearing, and FDA does not confirm the order within processed, packed, or held at your fa- the 10-calendar days after the appeal is cility, such that continued withdrawal filed, or issues a decision revoking the of the exemption is not necessary to order within that time; or protect public health and prevent or (c) You appeal the order without re- mitigate a foodborne illness outbreak. questing an informal hearing, and FDA (c) If your exemption was withdrawn does not confirm the order within the under § 117.251(a)(1) and FDA later de- 10-calendar days after the appeal is termines, after finishing the active in- filed, or issues a decision revoking the vestigation of a foodborne illness out- order within that time. break, that the outbreak is not directly linked to your facility, FDA will § 117.284 Final agency action. reinstate your exemption under Confirmation of a withdrawal order § 117.5(a), and FDA will notify you in by the presiding officer is considered a writing that your exempt status has final agency action for purposes of 5 been reinstated. U.S.C. 702. (d) If your exemption was withdrawn under both § 117.251(a)(1) and (2) and § 117.287 Reinstatement of a qualified facility exemption that was with- FDA later determines, after finishing drawn. the active investigation of a foodborne (a) If the FDA District Director in illness outbreak, that the outbreak is whose district your facility is located not directly linked to your facility, (or, in the case of a foreign facility, the FDA will inform you of this finding, Director of the Office of Compliance in and you may ask FDA to reinstate the Center for Food Safety and Applied your exemption under § 117.5(a) in ac- Nutrition) determines that a facility cordance with the requirements of has adequately resolved any problems paragraph (b) of this section. with the conditions and conduct that are material to the safety of the food Subpart F—Requirements Apply- manufactured, processed, packed, or ing to Records That Must Be held at the facility and that continued Established and Maintained withdrawal of the exemption is not necessary to protect public health and § 117.301 Records subject to the re- prevent or mitigate a foodborne illness quirements of this subpart. outbreak, the FDA District Director in whose district your facility is located (a) Except as provided by paragraphs (or, in the case of a foreign facility, the (b) and (c) of this section, all records Director of the Office of Compliance in required by this part are subject to all the Center for Food Safety and Applied requirements of this subpart. Nutrition) will, on his own initiative or (b) The requirements of § 117.310 apply on the request of a facility, reinstate only to the written food safety plan. the exemption. (c) The requirements of § 117.305(b), (b) You may ask FDA to reinstate an (d), (e), and (f) do not apply to the exemption that has been withdrawn records required by § 117.201.

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§ 117.305 General requirements apply- essary to support the status of a facil- ing to records. ity as a qualified facility during the Records must: applicable calendar year. (a) Be kept as original records, true (b) Records that relate to the general copies (such as photocopies, pictures, adequacy of the equipment or processes scanned copies, microfilm, microfiche, being used by a facility, including the or other accurate reproductions of the results of scientific studies and evalua- original records), or electronic records; tions, must be retained by the facility (b) Contain the actual values and ob- for at least 2 years after their use is servations obtained during monitoring discontinued (e.g., because the facility and, as appropriate, during verification has updated the written food safety activities; plan (§ 117.126) or records that docu- (c) Be accurate, indelible, and legible; ment validation of the written food (d) Be created concurrently with per- safety plan (§ 117.155(b))); formance of the activity documented; (c) Except for the food safety plan, (e) Be as detailed as necessary to pro- offsite storage of records is permitted vide history of work performed; and if such records can be retrieved and (f) Include: provided onsite within 24 hours of re- (1) Information adequate to identify quest for official review. The food safe- the plant or facility (e.g., the name, ty plan must remain onsite. Electronic and when necessary, the location of the records are considered to be onsite if plant or facility); they are accessible from an onsite loca- (2) The date and, when appropriate, tion. the time of the activity documented; (d) If the plant or facility is closed (3) The signature or initials of the for a prolonged period, the food safety person performing the activity; and plan may be transferred to some other (4) Where appropriate, the identity of reasonably accessible location but the product and the lot code, if any. must be returned to the plant or facil- (g) Records that are established or ity within 24 hours for official review maintained to satisfy the requirements upon request. of this part and that meet the definition of electronic records in § 11.3(b)(6) § 117.320 Requirements for official re- of this chapter are exempt from the review. quirements of part 11 of this chapter. All records required by this part Records that satisfy the requirements must be made promptly available to a of this part, but that also are required duly authorized representative of the under other applicable statutory provi- Secretary of Health and Human Serv- sions or regulations, remain subject to ices for official review and copying part 11 of this chapter. upon oral or written request. § 117.310 Additional requirements applying to the food safety plan. § 117.325 Public disclosure. The owner, operator, or agent in Records obtained by FDA in accord- charge of the facility must sign and ance with this part are subject to the date the food safety plan: disclosure requirements under part 20 (a) Upon initial completion; and of this chapter. (b) Upon any modification. § 117.330 Use of existing records. § 117.315 Requirements for record re- (a) Existing records (e.g., records that tention. are kept to comply with other Federal, (a)(1) All records required by this State, or local regulations, or for any part must be retained at the plant or other reason) do not need to be dupli- facility for at least 2 years after the cated if they contain all of the required date they were prepared. information and satisfy the require- (2) Records that a facility relies on ments of this subpart. Existing records during the 3-year period preceding the may be supplemented as necessary to applicable calendar year to support its include all of the required information status as a qualified facility must be and satisfy the requirements of this retained at the facility as long as nec- subpart.

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(b) The information required by this assurance that the hazards requiring a part does not need to be kept in one set supply-chain-applied control for the of records. If existing records contain raw material or other ingredient have some of the required information, any been significantly minimized or pre- new information required by this part vented) need not conduct supplier may be kept either separately or com- verification activities for that raw ma- bined with the existing records. terial or other ingredient. (3) The requirements in this subpart § 117.335 Special requirements appli- do not apply to food that is supplied for cable to a written assurance. research or evaluation use, provided (a) Any written assurance required that such food: by this part must contain the following (i) Is not intended for retail sale and elements: is not sold or distributed to the public; (1) Effective date; (ii) Is labeled with the statement (2) Printed names and signatures of ‘‘Food for research or evaluation use’’; authorized officials; (iii) Is supplied in a small quantity (3) The applicable assurance under: that is consistent with a research, (i) Section 117.136(a)(2); analysis, or quality assurance purpose, (ii) Section 117.136(a)(3); the food is used only for this purpose, (iii) Section 117.136(a)(4); and any unused quantity is properly (iv) Section 117.430(c)(2); disposed of; and (v) Section 117.430(d)(2); or (vi) Section 117.430(e)(2); (iv) Is accompanied with documents, (b) A written assurance required in accordance with the practice of the under § 117.136(a)(2), (3), or (4) must in- trade, stating that the food will be clude: used for research or evaluation pur- (1) Acknowledgement that the facil- poses and cannot be sold or distributed ity that provides the written assurance to the public. assumes legal responsibility to act con- (b) The supply-chain program must sistently with the assurance and docu- be written. ment its actions taken to satisfy the (c) When a supply-chain-applied con- written assurance; and trol is applied by an entity other than (2) Provision that if the assurance is the receiving facility’s supplier (e.g., terminated in writing by either entity, when a non-supplier applies controls to responsibility for compliance with the certain produce (i.e., produce covered applicable provisions of this part re- by part 112 of this chapter), because verts to the manufacturer/processor as growing, harvesting, and packing ac- of the date of termination. tivities are under different management), the receiving facility must: Subpart G—Supply-Chain (1) Verify the supply-chain-applied Program control; or (2) Obtain documentation of an ap- § 117.405 Requirement to establish and propriate verification activity from an- implement a supply-chain program. other entity, review and assess the en- (a)(1) Except as provided by para- tity’s applicable documentation, and graphs (a)(2) and (3) of this section, the document that review and assessment. receiving facility must establish and [80 FR 56145, Sept. 17, 2015; 81 FR 3956, Jan. implement a risk-based supply-chain 25, 2016] program for those raw materials and EFFECTIVE DATE NOTE: At 80 FR 56145, other ingredients for which the receiv- Sept. 17, 2015, § 117.405 was added, effective ing facility has identified a hazard re- Nov. 16, 2015, except for paragraph (a)(2). quiring a supply-chain-applied control. FDA will publish a document in the FEDERAL (2) A receiving facility that is an im- REGISTER announcing the effective date for porter, is in compliance with the for- this paragraph. eign supplier verification program requirements under part 1, subpart L of § 117.410 General requirements appli- this chapter, and has documentation of cable to a supply-chain program. verification activities conducted under (a) The supply-chain program must § 1.506(e) of this chapter (which provides include:

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(1) Using approved suppliers as re- ty of the raw material and other ingre- quired by § 117.420; dients; (2) Determining appropriate supplier (B) Applicable FDA food safety regu- verification activities (including deter- lations and information relevant to the mining the frequency of conducting the supplier’s compliance with those regu- activity) as required by § 117.425; lations, including an FDA warning let- (3) Conducting supplier verification ter or import alert relating to the safe- activities as required by §§ 117.430 and ty of food and other FDA compliance 117.435; actions related to food safety (or, when (4) Documenting supplier verification applicable, relevant laws and regula- activities as required by § 117.475; and tions of a country whose food safety (5) When applicable, verifying a sup- system FDA has officially recognized ply-chain-applied control applied by an as comparable or has determined to be entity other than the receiving facili- equivalent to that of the United ty’s supplier and documenting that States, and information relevant to the verification as required by § 117.475, or supplier’s compliance with those laws obtaining documentation of an appro- and regulations); and priate verification activity from an- (C) The supplier’s food safety history other entity, reviewing and assessing relevant to the raw materials or other that documentation, and documenting ingredients that the receiving facility the review and assessment as required receives from the supplier, including by § 117.475. available information about results (b) The following are appropriate sup- from testing raw materials or other in- plier verification activities for raw ma- gredients for hazards, audit results re- terials and other ingredients: lating to the safety of the food, and re- (1) Onsite audits; sponsiveness of the supplier in cor- (2) Sampling and testing of the raw recting problems; and material or other ingredient; (iv) Any other factors as appropriate (3) Review of the supplier’s relevant and necessary, such as storage and food safety records; and transportation practices. (4) Other appropriate supplier verification activities based on sup- (2) Considering supplier performance plier performance and the risk associ- can be limited to the supplier’s compli- ated with the raw material or other in- ance history as required by paragraph gredient. (d)(1)(iii)(B) of this section, if the sup- (c) The supply-chain program must plier is: provide assurance that a hazard requir- (i) A qualified facility as defined by ing a supply-chain-applied control has § 117.3; been significantly minimized or pre- (ii) A farm that grows produce and is vented. not a covered farm under part 112 of (d)(1) Except as provided by para- this chapter in accordance with graph (d)(2) of this section, in approv- § 112.4(a), or in accordance with ing suppliers and determining the ap- §§ 112.4(b) and 112.5; or propriate supplier verification activi- (iii) A shell egg producer that is not ties and the frequency with which they subject to the requirements of part 118 are conducted, the following must be of this chapter because it has less than considered: 3,000 laying hens. (i) The hazard analysis of the food, (e) If the owner, operator, or agent in including the nature of the hazard con- charge of a receiving facility deter- trolled before receipt of the raw mate- mines through auditing, verification rial or other ingredient, applicable to testing, document review, relevant the raw material and other ingredients; consumer, customer or other com- (ii) The entity or entities that will be plaints, or otherwise that the supplier applying controls for the hazards re- is not controlling hazards that the requiring a supply-chain-applied control; ceiving facility has identified as re- (iii) Supplier performance, including: quiring a supply-chain-applied control, (A) The supplier’s procedures, proc- the receiving facility must take and esses, and practices related to the safe- document prompt action in accordance

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with § 117.150 to ensure that raw mate- (3) A review by its supplier of that rials or other ingredients from the sup- supplier’s own relevant food safety plier do not cause food that is manu- records; or factured or processed by the receiving (4) The conduct by its supplier of facility to be adulterated under section other appropriate supplier verification 402 of the Federal Food, Drug, and Cos- activities for that supplier within the metic Act or misbranded under section meaning of § 117.410(b)(4). 403(w) of the Federal Food, Drug, and (c) The requirements of this section Cosmetic Act. do not prohibit a receiving facility from relying on an audit provided by § 117.415 Responsibilities of the receiv- its supplier when the audit of the sup- ing facility. plier was conducted by a third-party (a)(1) The receiving facility must ap- qualified auditor in accordance with prove suppliers. §§ 117.430(f) and 117.435. (2) Except as provided by paragraphs (a)(3) and (4) of this section, the receiv- § 117.420 Using approved suppliers. ing facility must determine and con- (a) Approval of suppliers. The receiv- duct appropriate supplier verification ing facility must approve suppliers in activities, and satisfy all documenta- accordance with the requirements of tion requirements of this subpart. § 117.410(d), and document that ap- (3) An entity other than the receiving proval, before receiving raw materials facility may do any of the following, and other ingredients received from provided that the receiving facility re- those suppliers; views and assesses the entity’s applica- (b) Written procedures for receiving raw ble documentation, and documents materials and other ingredients. (1) Writ- that review and assessment: ten procedures for receiving raw mate- (i) Establish written procedures for rials and other ingredients must be es- receiving raw materials and other in- tablished and followed; gredients by the entity; (2) The written procedures for receiv- (ii) Document that written proce- ing raw materials and other ingredi- dures for receiving raw materials and ents must ensure that raw materials other ingredients are being followed by and other ingredients are received only the entity; and from approved suppliers (or, when nec- (iii) Determine, conduct, or both de- essary and appropriate, on a temporary termine and conduct the appropriate basis from unapproved suppliers whose supplier verification activities, with raw materials or other ingredients are appropriate documentation. subjected to adequate verification ac- (4) The supplier may conduct and tivities before acceptance for use); and document sampling and testing of raw (3) Use of the written procedures for materials and other ingredients, for receiving raw materials and other in- the hazard controlled by the supplier, gredients must be documented. as a supplier verification activity for a particular lot of product and provide § 117.425 Determining appropriate such documentation to the receiving supplier verification activities (in- facility, provided that the receiving fa- cluding determining the frequency cility reviews and assesses that docu- of conducting the activity). mentation, and documents that review Appropriate supplier verification ac- and assessment. tivities (including the frequency of (b) For the purposes of this subpart, a conducting the activity) must be deter- receiving facility may not accept any mined in accordance with the require- of the following as a supplier ments of § 117.410(d). verification activity: (1) A determination by its supplier of § 117.430 Conducting supplier the appropriate supplier verification verification activities for raw mate- activities for that supplier; rials and other ingredients. (2) An audit conducted by its sup- (a) Except as provided by paragraph plier; (c), (d), or (e) of this section, one or

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more of the supplier verification ac- (ii) A statement that the facility is tivities specified in § 117.410(b), as de- in compliance with State, local, coun- termined under § 117.410(d), must be ty, tribal, or other applicable non-Fed- conducted for each supplier before eral food safety law, including relevant using the raw material or other ingre- laws and regulations of foreign coun- dient from that supplier and periodi- tries. cally thereafter. (d) If a supplier is a farm that grows (b)(1) Except as provided by para- produce and is not a covered farm graph (b)(2) of this section, when a haz- under part 112 of this chapter in ac- ard in a raw material or other ingre- cordance with § 112.4(a), or in accord- dient will be controlled by the supplier ance with §§ 112.4(b) and 112.5, the re- and is one for which there is a reason- ceiving facility does not need to com- able probability that exposure to the ply with paragraphs (a) and (b) of this hazard will result in serious adverse section for produce that the receiving health consequences or death to hu- facility receives from the farm as a raw mans: material or other ingredient if the re- (i) The appropriate supplier ceiving facility: verification activity is an onsite audit (1) Obtains written assurance that of the supplier; and the raw material or other ingredient (ii) The audit must be conducted be- provided by the supplier is not subject fore using the raw material or other in- to part 112 of this chapter in accord- gredient from the supplier and at least ance with § 112.4(a), or in accordance annually thereafter. with §§ 112.4(b) and 112.5: (2) The requirements of paragraph (i) Before first approving the supplier (b)(1) of this section do not apply if for an applicable calendar year; and there is a written determination that (ii) On an annual basis thereafter, by other verification activities and/or less December 31 of each calendar year, for frequent onsite auditing of the supplier the following calendar year; and provide adequate assurance that the (2) Obtains written assurance, at hazards are controlled. least every 2 years, that the farm ac- (c) If a supplier is a qualified facility knowledges that its food is subject to as defined by § 117.3, the receiving facil- section 402 of the Federal Food, Drug, ity does not need to comply with para- and Cosmetic Act (or, when applicable, graphs (a) and (b) of this section if the that its food is subject to relevant laws receiving facility: and regulations of a country whose (1) Obtains written assurance that food safety system FDA has officially the supplier is a qualified facility as recognized as comparable or has deter- defined by § 117.3: mined to be equivalent to that of the (i) Before first approving the supplier United States). for an applicable calendar year; and (e) If a supplier is a shell egg pro- (ii) On an annual basis thereafter, by ducer that is not subject to the re- December 31 of each calendar year, for quirements of part 118 of this chapter the following calendar year; and because it has less than 3,000 laying (2) Obtains written assurance, at hens, the receiving facility does not least every 2 years, that the supplier is need to comply with paragraphs (a) and producing the raw material or other in- (b) of this section if the receiving facil- gredient in compliance with applicable ity: FDA food safety regulations (or, when (1) Obtains written assurance that applicable, relevant laws and regula- the shell eggs produced by the supplier tions of a country whose food safety are not subject to part 118 because the system FDA has officially recognized shell egg producer has less than 3,000 as comparable or has determined to be laying hens: equivalent to that of the United (i) Before first approving the supplier States). The written assurance must for an applicable calendar year; and include either: (ii) On an annual basis thereafter, by (i) A brief description of the preven- December 31 of each calendar year, for tive controls that the supplier is imple- the following calendar year; and menting to control the applicable haz- (2) Obtains written assurance, at ard in the food; or least every 2 years, that the shell egg

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producer acknowledges that its food is whose food safety system FDA has offi- subject to section 402 of the Federal cially recognized as comparable or de- Food, Drug, and Cosmetic Act (or, termined to be equivalent, the food when applicable, that its food is sub- that is the subject of the onsite audit ject to relevant laws and regulations of must be within the scope of the official a country whose food safety system recognition or equivalence determina- FDA has officially recognized as com- tion, and the foreign supplier must be parable or has determined to be equiva- in, and under the regulatory oversight lent to that of the United States). of, such country. (f) There must not be any financial (d) If the onsite audit is solely con- conflicts of interests that influence the ducted to meet the requirements of results of the verification activities this subpart by an audit agent of a cer- listed in § 117.410(b) and payment must tification body that is accredited in ac- not be related to the results of the accordance with regulations in part 1, tivity. subpart M of this chapter, the audit is § 117.435 Onsite audit. not subject to the requirements in those regulations. (a) An onsite audit of a supplier must be performed by a qualified auditor. EFFECTIVE DATE NOTE: At 80 FR 56145, (b) If the raw material or other ingre- Sept. 17, 2015, § 117.435 was added, effective dient at the supplier is subject to one Nov. 16, 2015, except for paragraph (d). FDA or more FDA food safety regulations, will publish a document in the FEDERAL REG- an onsite audit must consider such reg- ISTER announcing the effective date for this ulations and include a review of the paragraph. supplier’s written plan (e.g., Hazard § 117.475 Records documenting the Analysis and Critical Control Point supply-chain program. (HACCP) plan or other food safety plan), if any, and its implementation, (a) The records documenting the sup- for the hazard being controlled (or, ply-chain program are subject to the when applicable, an onsite audit may requirements of subpart F of this part. consider relevant laws and regulations (b) The receiving facility must re- of a country whose food safety system view the records listed in paragraph (c) FDA has officially recognized as com- of this section in accordance with parable or has determined to be equiva- § 117.165(a)(4). lent to that of the United States). (c) The receiving facility must docu- (c)(1) The following may be sub- ment the following in records as appli- stituted for an onsite audit, provided cable to its supply-chain program: that the inspection was conducted (1) The written supply-chain pro- within 1 year of the date that the on- gram; site audit would have been required to (2) Documentation that a receiving be conducted: facility that is an importer is in com- (i) The written results of an appro- pliance with the foreign supplier priate inspection of the supplier for verification program requirements compliance with applicable FDA food under part 1, subpart L of this chapter, safety regulations by FDA, by rep- including documentation of resentatives of other Federal Agencies verification activities conducted under (such as the United States Department § 1.506(e) of this chapter; of Agriculture), or by representatives (3) Documentation of the approval of of State, local, tribal, or territorial agencies; or a supplier; (ii) For a foreign supplier, the writ- (4) Written procedures for receiving ten results of an inspection by FDA or raw materials and other ingredients; the food safety authority of a country (5) Documentation demonstrating use whose food safety system FDA has offi- of the written procedures for receiving cially recognized as comparable or has raw materials and other ingredients; determined to be equivalent to that of (6) Documentation of the determina- the United States. tion of the appropriate supplier (2) For inspections conducted by the verification activities for raw mate- food safety authority of a country rials and other ingredients;

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(7) Documentation of the conduct of in a raw material or other ingredient an onsite audit. This documentation will be controlled by the supplier and is must include: one for which there is a reasonable (i) The name of the supplier subject probability that exposure to the hazard to the onsite audit; will result in serious adverse health (ii) Documentation of audit proce- consequences or death to humans; dures; (12) The following documentation of (iii) The dates the audit was con- an alternative verification activity for ducted; a supplier that is a qualified facility: (iv) The conclusions of the audit; (i) The written assurance that the (v) Corrective actions taken in re- supplier is a qualified facility as de- sponse to significant deficiencies iden- fined by § 117.3, before approving the tified during the audit; and supplier and on an annual basis there- (vi) Documentation that the audit after; and was conducted by a qualified auditor; (ii) The written assurance that the (8) Documentation of sampling and supplier is producing the raw material testing conducted as a supplier or other ingredient in compliance with verification activity. This documenta- applicable FDA food safety regulations tion must include: (or, when applicable, relevant laws and (i) Identification of the raw material regulations of a country whose food or other ingredient tested (including safety system FDA has officially recog- lot number, as appropriate) and the nized as comparable or has determined number of samples tested; to be equivalent to that of the United (ii) Identification of the test(s) con- States); ducted, including the analytical method(s) used; (13) The following documentation of (iii) The date(s) on which the test(s) an alternative verification activity for were conducted and the date of the re- a supplier that is a farm that supplies port; a raw material or other ingredient and (iv) The results of the testing; is not a covered farm under part 112 of (v) Corrective actions taken in re- this chapter: sponse to detection of hazards; and (i) The written assurance that sup- (vi) Information identifying the lab- plier is not a covered farm under part oratory conducting the testing; 112 of this chapter in accordance with (9) Documentation of the review of § 112.4(a), or in accordance with the supplier’s relevant food safety §§ 112.4(b) and 112.5, before approving records. This documentation must in- the supplier and on an annual basis clude: thereafter; and (i) The name of the supplier whose (ii) The written assurance that the records were reviewed; farm acknowledges that its food is sub- (ii) The date(s) of review; ject to section 402 of the Federal Food, (iii) The general nature of the records Drug, and Cosmetic Act (or, when ap- reviewed; plicable, that its food is subject to rel- (iv) The conclusions of the review; evant laws and regulations of a coun- and try whose food safety system FDA has (v) Corrective actions taken in re- officially recognized as comparable or sponse to significant deficiencies iden- has determined to be equivalent to tified during the review; that of the United States); (10) Documentation of other appro- (14) The following documentation of priate supplier verification activities an alternative verification activity for based on the supplier performance and a supplier that is a shell egg producer the risk associated with the raw mate- that is not subject to the requirements rial or other ingredient; established in part 118 of this chapter (11) Documentation of any deter- because it has less than 3,000 laying mination that verification activities hens: other than an onsite audit, and/or less (i) The written assurance that the frequent onsite auditing of a supplier, shell eggs provided by the supplier are provide adequate assurance that the not subject to part 118 of this chapter hazards are controlled when a hazard because the supplier has less than 3,000

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laying hens, before approving the sup- (v) Applicable documentation, from plier and on an annual basis thereafter; an entity other than the receiving fa- and cility, of verification activities when a (ii) The written assurance that the supply-chain-applied control is applied shell egg producer acknowledges that by an entity other than the receiving its food is subject to section 402 of the facility’s supplier. Federal Food, Drug, and Cosmetic Act EFFECTIVE DATE NOTE: At 80 FR 56145, (or, when applicable, that its food is Sept. 17, 2015, § 117.475 was added, effective subject to relevant laws and regula- Nov. 16, 2015, except for paragraph (c)(2). tions of a country whose safety system FDA will publish a document in the FEDERAL FDA has officially recognized as com- REGISTER announcing the effective date for parable or has determined to be equiva- this paragraph. lent to that of the United States); (15) The written results of an appro- PART 118—PRODUCTION, STOR- priate inspection of the supplier for AGE, AND TRANSPORTATION OF compliance with applicable FDA food SHELL EGGS safety regulations by FDA, by representatives of other Federal Agencies Sec. (such as the United States Department 118.1 Persons covered by the requirements of Agriculture), or by representatives in this part. from State, local, tribal, or territorial 118.3 Definitions. agencies, or the food safety authority 118.4 Salmonella Enteritidis (SE) prevention of another country when the results of measures. such an inspection is substituted for an 118.5 Environmental testing for Salmonella onsite audit; Enteritidis (SE). (16) Documentation of actions taken 118.6 Egg testing for Salmonella Enteritidis (SE). with respect to supplier non-conform- 118.7 Sampling methodology for Salmonella ance; Enteritidis (SE). (17) Documentation of verification of 118.8 Testing methodology for Salmonella a supply-chain-applied control applied Enteritidis (SE). by an entity other than the receiving 118.9 Administration of the Salmonella facility’s supplier; and Enteritidis (SE) prevention plan. (18) When applicable, documentation 118.10 Recordkeeping requirements for the of the receiving facility’s review and Salmonella Enteritidis (SE) prevention assessment of: plan. 118.11 Registration requirements for shell (i) Applicable documentation from an egg producers covered by the require- entity other than the receiving facility ments of this part. that written procedures for receiving 118.12 Enforcement and compliance. raw materials and other ingredients are being followed; AUTHORITY: 21 U.S.C. 321, 331–334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271. (ii) Applicable documentation, from an entity other than the receiving fa- SOURCE: 74 FR 33095, July 9, 2009, unless cility, of the determination of the ap- otherwise noted. propriate supplier verification activi- EDITORIAL NOTE: Nomenclature changes to ties for raw materials and other ingre- part 118 appear at 81 FR 49896, July 29, 2016. dients; (iii) Applicable documentation, from § 118.1 Persons covered by the require- an entity other than the receiving fa- ments in this part. cility, of conducting the appropriate (a) If you are a shell egg producer supplier verification activities for raw with 3,000 or more laying hens at a par- materials and other ingredients; ticular farm that does not sell all of (iv) Applicable documentation, from your eggs directly to consumers and its supplier, of: that produces shell eggs for the table (A) The results of sampling and test- market, you are covered by some or all ing conducted by the supplier; or of the requirements in this part, as fol- (B) The results of an audit conducted lows: by a third-party qualified auditor in (1) If any of your eggs that are pro- accordance with §§ 117.430(f) and 117.435; duced at a particular farm do not re- and ceive a treatment as defined in § 118.3,

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you must comply with all of the re- eggs between successive induced molt- quirements of this part for egg producing periods or between induced molting tion on that farm. and the time that the hen is perma- (2) If all of your eggs that are pro- nently taken out of production. duced at the particular farm receive a Molting means a life stage during treatment as defined in § 118.3, you which hens stop laying eggs and shed must comply only with the refrigera- their feathers. tion requirements in § 118.4(e) for pro- Pest means any objectionable animal duction of eggs on that farm and with including, but not limited to, rodents, the registration requirements in flies, and larvae. § 118.11. Positive flock means a flock that has (b) If you transport or hold shell eggs had an egg test that was positive for for shell egg processing or egg products SE. A flock is considered positive until facilities, you must comply with the that flock meets the egg testing re- refrigeration requirements in § 118.4(e). quirements in § 118.6(c) to return to This section applies only to eggs from table egg production. farms with 3,000 or more laying hens. Positive poultry house means a poultry house from which there has been an en- § 118.3 Definitions. vironmental test that was positive for The definitions and interpretations SE at any time during the life of a of terms in section 201 of the Federal group in the poultry house until that Food, Drug, and Cosmetic Act (the house is cleaned and disinfected ac- FFDCA) (21 U.S.C. 321) are applicable cording to § 118.4(d). to such terms when used in this part, Poultry house means a building, other except where they are redefined in this structure, or separate section within a part. The following definitions also structure used to house poultry. For apply: structures comprising more than one Biosecurity means a program, includ- section containing poultry, each sec- ing the limiting of visitors on the farm tion that is separated from the other and in poultry houses, maintaining sections is considered a separate house. personnel and equipment practices that Producer means a person who owns will protect against cross contamina- and/or operates a poultry house con- tion from one poultry house to an- taining laying hens which produce other, preventing stray poultry, wild shell eggs for human consumption. birds, cats, and other animals from en- Shell egg (or egg) means the egg of tering poultry houses, and not allowing the domesticated chicken. employees to keep birds at home, to Shell egg processing facility means a ensure that there is no introduction or facility that processes (e.g., washes, transfer of Salmonella Enteritidis (SE) grades, packs) shell eggs for the table onto a farm or among poultry houses. egg market. Egg products facility means a USDA- Treatment (or treated) means a tech- inspected egg products plant where liq- nology or process that achieves at least uid, frozen, and/or dried egg products a 5-log destruction of SE for shell eggs, are produced. or the processing of egg products in ac- Farm means all poultry houses and cordance with the Egg Products Inspec- grounds immediately surrounding the tion Act. poultry houses covered under a single biosecurity program. § 118.4 Salmonella Enteritidis (SE) pre- Flock means all laying hens within vention measures. one poultry house. You must follow the SE prevention Group means all laying hens of the measures set forth in this section. In same age within one poultry house. addition, you must have and imple- Induced molting means molting that ment a written SE prevention plan is artificially initiated. that is specific to each farm where you Laying cycle means the period of time produce eggs and that includes, at a that a hen begins to produce eggs until minimum, the following SE prevention it undergoes induced molting or is per- measures: manently taken out of production and (a) Pullets. You must procure pullets the period of time that a hen produces that are SE monitored or raise pullets

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under SE monitored conditions. ‘‘SE (c) Rodents, flies, and other pest con- monitored’’ means the pullets are trol. As part of this program, you must: raised under SE control conditions (1) Monitor for rodents by visual in- that prevent SE, including: spection and mechanical traps or (1) Procurement of chicks. Chicks are glueboards or another appropriate procured from SE-monitored breeder monitoring method and, when moni- flocks that meet the National Poultry toring indicates unacceptable rodent Improvement Plan’s standards for activity within a poultry house, use ap- ‘‘U.S. S. Enteritidis Clean’’ status (9 propriate methods to achieve satisfac- CFR 145.23(d)) or equivalent standard; tory rodent control; (2) Environmental testing. (i) The pul- (2) Monitor for flies by spot cards, let environment is tested for SE when Scudder grills, or sticky traps or an- pullets are 14 to 16 weeks of age; other appropriate monitoring method (ii) If the environmental test re- and, when monitoring indicates unac- quired in paragraph (a)(2)(i) of this sec- ceptable fly activity within a poultry tion is negative, you do not need to house, use appropriate methods to perform any additional testing of those birds or their environment until the achieve satisfactory fly control. environmental test at 40 to 45 weeks of (3) Remove debris within a poultry age specified in § 118.5(a); and house and vegetation and debris out- (iii) If the environmental test re- side a poultry house that may provide quired in paragraph (a)(2)(i) of this sec- harborage for pests. tion is positive, you must begin egg (d) Cleaning and disinfection. You testing, as specified in § 118.6, within 2 must clean and disinfect the poultry weeks of the start of egg laying. house according to these procedures be- (3) Cleaning and disinfection. If the en- fore new laying hens are added to the vironmental test required in paragraph house, if you have had an environ- (a)(2) of this section is positive, the mental test or an egg test that was pullet environment is cleaned and dis- positive for SE at any point during the infected, to include: life of a flock that was housed in the (i) Removal of all visible manure; poultry house prior to depopulation. As (ii) Dry cleaning the positive pullet part of the cleaning and disinfection house to remove dust, feathers, and old procedures, you must: feed; and (1) Remove all visible manure; (iii) Following cleaning, disinfection (2) Dry clean the positive poultry of the positive pullet house with spray, house to remove dust, feathers, and old aerosol, fumigation, or another appro- feed; and priate disinfection method. (3) Following cleaning, disinfect the (b) Biosecurity. As part of this pro- positive poultry house with spray, aer- gram, you must take steps to ensure osol, fumigation, or another appro- that there is no introduction or trans- priate disinfection method. fer of SE into or among poultry houses. (e) Refrigeration. You must hold and Among such biosecurity measures you transport eggs at or below 45 °F ambi- must, at a minimum: ent temperature beginning 36 hours (1) Limit visitors on the farm and in after time of lay. If the eggs are to be the poultry houses; processed as table eggs and are not (2) Maintain practices that will pro- processed for the ultimate consumer tect against cross contamination when equipment is moved among poultry within 36 hours from the time of lay houses; and, therefore, are held and trans- ° (3) Maintain practices that will pro- ported as required at or below 45 F tect against cross contamination when ambient temperature, then you may persons move between poultry houses; then hold them at room temperature (4) Prevent stray poultry, wild birds, for no more than 36 hours just prior to cats, and other animals from entering processing to allow an equilibration poultry houses; and step to temper the eggs. (5) Not allow employees to keep birds at home.

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§ 118.5 Environmental testing for Sal- (2) If the environmental test at 4 to 6 monella Enteritidis (SE). weeks after the end of a molting proc- (a) Environmental testing when laying ess is positive, then you must: hens are 40 to 45 weeks of age. As one in- (i) Review and make any necessary dicator of the effectiveness of your SE adjustments to your SE prevention prevention plan, you must perform en- plan to ensure that all measures are vironmental testing for SE (as de- being properly implemented; and scribed in §§ 118.7 and 118.8) in a poultry (ii) Begin egg testing (described in house when any group of laying hens § 118.6), unless you divert eggs to treat- constituting the flock within the poul- ment as defined in § 118.3 for the life of try house is 40 to 45 weeks of age. the flock in that poultry house. Re- (1) If an environmental test at 40 to sults of egg testing, when conducted, 45 weeks is negative and your laying must be available within 10-calendar days of receiving notification of the hens do not undergo induced molting, positive environmental test. then you do not need to perform any additional environmental testing with- § 118.6 Egg testing for Salmonella in that poultry house, unless the poul- Enteritidis (SE). try house contains more than one group of laying hens. If the poultry (a)(1) If the environmental test for house contains more than one group of pullets at 14 to 16 weeks of age required laying hens, then you must perform en- by § 118.4(a) is positive, you must divert vironmental testing on the poultry eggs to treatment (defined in § 118.3) for house when each group of laying hens the life of any flock or conduct egg is 40 to 45 weeks of age. testing within 2 weeks of the start of egg laying, as specified in paragraphs (2) If the environmental test at 40 to (b) through (e) of this section. 45 weeks is positive, then you must: (2) If you have an SE-positive envi- (i) Review and make any necessary ronmental test at any time during the adjustments to your SE prevention life of a flock, you must divert eggs to plan to ensure that all measures are treatment (defined in § 118.3) for the being properly implemented and life of the flock in that positive poultry (ii) Begin egg testing (described in house or conduct egg testing as speci- § 118.6), unless you divert eggs to treat- fied in paragraphs (b) through (e) of ment as defined in § 118.3 for the life of this section. the flock in that poultry house. Re- (b) Eggs must be sampled as de- sults of egg testing must be obtained scribed in § 118.7 and tested using meth- within 10-calendar days of receiving no- odology as described in § 118.8. tification of the positive environ- (c) You must conduct four egg tests, mental test. using sampling and methodology in (b) Environmental testing after an in- §§ 118.7 and 118.8, on the flock in the duced molting period. If you induce a positive poultry house at 2-week inter- molt in a flock or a group in a flock, vals. If all four tests are negative for you must perform environmental test- SE, you are not required to do further ing for SE in the poultry house at 4 to egg testing. 6 weeks after the end of any molting (d) If any of the four egg tests is posi- process. tive for SE, you must divert, upon re- (1) If an environmental test at 4 to 6 ceiving notification of an SE-positive weeks after the end of the molting egg test, all eggs from that flock to process is negative and none of your treatment (defined in § 118.3) until the laying hens in that poultry house is conditions of paragraph (c) of this sec- molted again, then you do not need to tion are met. perform any additional environmental (e) If you have a positive egg test in testing in that poultry house. Each a flock and divert eggs from that flock time a flock or group within the flock and later meet the negative test result is molted, you must perform environ- requirements described in paragraph mental testing in the poultry house at (c) of this section and return to table 4 to 6 weeks after the end of the molt- egg production, you must conduct one ing process. egg test per month on that flock, using

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sampling and methodology in §§ 118.7 § 118.8 Testing methodology for Sal- and 118.8, for the life of the flock. monella Enteritidis (SE). (1) If all the monthly egg tests in (a) Testing of environmental samples for paragraph (e) of this section are nega- SE. Testing to detect SE in environ- tive for SE, you may continue to sup- mental samples must be conducted by ply eggs to the table market. the method entitled ‘‘Environmental (2) If any of the monthly egg tests in Sampling and Detection of Salmonella paragraph (e) of this section is positive in Poultry Houses,’’ April 2008, or an for SE, you must divert eggs from the equivalent method in accuracy, preci- positive flock to treatment for the life sion, and sensitivity in detecting SE. of the flock or until the conditions of The April 2008 Environmental Sam- paragraph (c) of this section are met. pling and Detection of Salmonella Web site is located at http://www.fda.gov/ (f) If you are diverting eggs, the pal- Food/ScienceResearch/ let, case, or other shipping container LaboratoryMethods/ucm114716.htm, cur- must be labeled and all documents ac- rent as of June 26, 2009. The Director of companying the shipment must con- the Federal Register approves the in- tain the following statement: ‘‘Federal corporation by reference of ‘‘Environ- law requires that these eggs must be mental Sampling and Detection of Sal- treated to achieve at least a 5-log de- monella in Poultry Houses,’’ April 2008, struction of Salmonella Enteritidis or in accordance with 5 U.S.C. 552(a) and 1 processed as egg products in accord- CFR part 51. FDA will request approval ance with the Egg Products Inspection to incorporate by reference any up- Act, 21 CFR 118.6(f).’’ The statement dates to this Web site. FDA will change must be legible and conspicuous. the date of the Web site in this paragraph with each update. You may ob- § 118.7 Sampling methodology for Sal- tain a copy from Division of Microbi- monella Enteritidis (SE). ology (HFS–710), Center for Food Safe- (a) Environmental sampling. An envi- ty and Applied Nutrition, Food and ronmental test must be done for each Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301–436–2364, or poultry house in accordance with § 118.5 you may examine a copy at the Food (a) and (b). Within each poultry house, and Drug Administration’s Main Li- you must sample the environment brary, 10903 New Hampshire Ave., Bldg. using a sampling plan appropriate to 2, Third Floor, Silver Spring, MD 20993, the poultry house layout. 301–796–2039, or at the National Ar- (b) Egg sampling. When you conduct chives and Records Administration an egg test required under § 118.6, you (NARA). For information on the avail- must collect and test the following ability of this material at NARA, call number of eggs from the positive poul- 202–741–6030, or go to: http:// try house: www.archives.gov/federallregister/ (1) To meet the egg testing require- codeloflfederallregulation/ ments of § 118.6(c), you must collect and ibrllocations.html. deliver for testing a minimum of 1,000 (b) Testing of egg samples for SE. Test- intact eggs representative of a day’s ing to detect SE in egg samples must production. The 1,000-egg sample must be conducted according to Chapter 5 of be tested according to § 118.8. You must FDA’s Bacteriological Analytical Man- collect and test four 1,000-egg samples ual (BAM), December 2007 Edition, or at 2-week intervals for a total of 4,000 an equivalent method in accuracy, pre- eggs. cision, and sensitivity in detecting SE. Chapter 5 of FDA’s Bacteriological An- (2) To meet the monthly egg testing alytical Manual, December 2007 Edi- requirement of § 118.6(e), you must col- tion, is located at http://www.fda.gov/ lect and deliver for testing a minimum Food/ScienceResearch/ of 1,000 intact eggs representative of a LaboratoryMethods/ day’s production per month for the life BacteriologicalAnalyticalManualBAM/ of the flock. Eggs must be tested ac- ucm070149.htm, current as of June 26, cording to § 118.8. 2009. The method is incorporated by reference in accordance with 5 U.S.C.

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552(a) and 1 CFR part 51. FDA will re- § 118.10 Recordkeeping requirements quest approval to incorporate by ref- for the Salmonella Enteritidis (SE) erence any updates to this Web site. prevention plan. FDA will change the date of the Web (a) Records: You must maintain the site in this paragraph with each up- following records documenting your SE date. You may obtain a copy from Divi- prevention measures: sion of Microbiology (HFS–710), Center (1) A written SE prevention plan re- for Food Safety and Applied Nutrition, quired by § 118.4; Food and Drug Administration, 5001 (2) Documentation that pullets were Campus Dr., College Park, MD 20740, ‘‘SE monitored’’ or were raised under 301–436–2364, or you may examine a ‘‘SE monitored’’ conditions, including copy at the Food and Drug Administra- environmental testing records for pul- tion’s Main Library, 10903 New Hamp- lets, as required by § 118.4(a)(2); shire Ave., Bldg. 2, Third Floor, Silver (3) Records documenting compliance Spring, MD 20993, 301–796–2039, or at the with the SE prevention measures, as National Archives and Records Admin- follows: istration (NARA). For information on (i) Biosecurity measures; the availability of this material at NARA, call 202–741–6030, or go to: http:// (ii) Rodent and other pest control www.archives.gov/federallregister/ measures; codeloflfederallregulation/ (iii) Cleaning and disinfection proce- ibrllocations.html. dures performed at depopulation, when applicable; [74 FR 33095, July 9, 2009, as amended at 81 (iv) Refrigeration requirements; FR 5590, Feb. 3, 2016] (v) Environmental and egg sampling § 118.9 Administration of the Sal- procedures, when applicable, performed monella Enteritidis (SE) prevention under § 118.7; plan. (vi) Results of SE testing, when ap- You must have one or more super- plicable, performed under § 118.8 as re- visory personnel, who do not have to be quired in §§ 118.4(a)(2), 118.5, and 118.6; on-site employees, to be responsible for (vii) Diversion of eggs, if applicable, ensuring compliance with each farm’s as required in § 118.6; and SE prevention plan. This person must (viii) Eggs at a particular farm being have successfully completed training given a treatment as defined in § 118.3, on SE prevention measures for egg pro- if you are a producer complying with duction that is equivalent to that re- the requirements of this section as de- ceived under a standardized curriculum scribed in § 118.1(a)(2). recognized by the Food and Drug Ad- (4) Records of review and of modifica- ministration or must be otherwise tions of the SE prevention plan and qualified through job experience to ad- corrective actions taken. minister the SE prevention measures. (b) General requirements for records Job experience will qualify this person maintained by shell egg producers. All to perform these functions if it has pro- records required by § 118.10(a) must in- vided knowledge at least equivalent to clude: that provided through the standardized (1) Your name and the location of curriculum. This person is responsible your farm, for: (2) The date and time of the activity (a) Development and implementation that the record reflects, of an SE prevention plan that is appro- (3) The signature or initials of the priate for your specific farm and meets person performing the operation or cre- the requirements of § 118.4; ating the record. The written SE pre- (b) Reassessing and modifying the SE vention plan must be dated and carry prevention plan as necessary to ensure the signature(s) (not initials) of the that the requirements in § 118.4 are person(s) who administers the plan as met; and described in § 118.9, and (c) Review of records created under (4) Data and information reflecting § 118.10. This person does not need to compliance activities must be entered have performed the monitoring or cre- on records at the time the activity is ated the records. performed or observed, and the records

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must contain the actual values ob- tronic confirmation of registration and served, if applicable. a permanent registration number. (c) Length of time records must be re- (iv) You will be considered registered tained. You must retain all records re- once FDA electronically transmits quired by this part at your place of your confirmation and registration business, unless stored offsite under number. § 118.10(d), for 1 year after the flock to (2) Registration by mail or by fax. If, which they pertain has been taken per- for example, you do not have reason- manently out of production. able access to the Internet through any (d) Offsite storage of records. You may of the methods described in paragraph store the records required by this part, (b)(1) of this section, an individual au- except for the written SE prevention thorized by the owner or operator of a plan, offsite. You must be able to re- farm, such as an agent in charge, may trieve and provide the records at your register by mail or fax. place of business within 24 hours of re- (i) You must register using FDA quest for official review. Electronic Form No. 3733. You may obtain a copy records are considered to be onsite if of this form by writing to the U.S. they are accessible from an onsite loca- Food and Drug Administration, 5600 tion. Fishers Lane (HFS–681), Rockville, MD (e) Official review of records. You must 20857, or by requesting the form by have all records required by this part phone at 1–800–216–7331 or 301–575–0156. available for official review and copy- (ii) When you receive the form, you ing at reasonable times. must fill it out completely and legibly (f) Public disclosure of records. Records and either mail it to the address in required by this part are subject to the paragraph (b)(2)(i) of this section or fax disclosure requirements under part 20 it to the number on the form. of this chapter. (iii) If any required information on § 118.11 Registration requirements for the form is incomplete or illegible shell egg producers covered by the when FDA receives it, FDA will return requirements of this part. the form to you for revision, provided (a) Shell egg producers covered under that your mailing address or fax num- § 118.1(a) are required to register their ber is legible and valid. When returning farms with FDA within 30 days of be- a registration form for revision, FDA coming an egg producer or, if already will use the means by which the form an egg producer, by each farm’s appli- was received by the agency (i.e., by cable compliance date. mail or fax). (b) Shell egg producers may register (iv) FDA will enter complete and leg- their farms by any of the following ible mailed and faxed registration sub- means: missions into its registration system, (1) Electronic registration. To register along with CD–ROM submissions, as electronically, you must register at soon as practicable, in the order FDA http://www.access.fda.gov, which will be receives them. available for registration 24 hours a (v) FDA will then mail to the address day, 7 days a week beginning May 10, or fax to the fax number on the reg- 2010. This Web site is available from istration form a copy of the registra- wherever the Internet is accessible, in- tion as entered, confirmation of reg- cluding libraries, copy centers, schools, istration, and your registration num- and Internet cafes. ber. When responding to a registration (i) An individual authorized by the submission, FDA will use the means by owner or operator of a farm, such as an which the registration was received by agent in charge, may also register a the agency (i.e., by mail or fax). farm electronically. (vi) If any information you pre- (ii) FDA strongly encourages elec- viously submitted was incorrect at the tronic registration for the benefit of time of submission, you must imme- both FDA and the registrant. diately update your facility’s registra- (iii) Once you complete your election. If any information you previously tronic registration, FDA will auto- submitted that was correct at the time matically provide you with an elec- of submission subsequently changes,

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you must update your facility’s reg- date your facility’s registration. If any istration within 60 calendar days. information you previously submitted (vii) Your facility is considered reg- that was correct at the time of submis- istered once FDA enters your facility’s sion subsequently changes, you must registration data into the registration update your facility’s registration system and the system generates a reg- within 60 calendar days. istration number. (xi) Your facility is considered reg- (3) Registration by CD–ROM for mul- istered once FDA enters your facility’s tiple submissions. If, for example, you do registration data into the registration not have reasonable access to the system and the system generates a reg- Internet through any of the methods istration number. provided under paragraph (b)(1) of this (c) No registration fee is required. section, you may register by CD–ROM. (i) Registrants submitting their reg- (d) You must submit all registration istrations in CD–ROM format must use information in the English language. ISO 9660 (CD–R or CD–RW) data format. All information must be submitted (ii) These files must be submitted on using the Latin (Roman) alphabet. a portable document format (PDF) ren- (e) Each registrant must submit the dition of the registration form (FDA following information through one of Form No. 3733) and be accompanied by the methods described in paragraph (b) one signed copy of the certification of this section: statement that appears on the registra- (1) The name, full address, and phone tion form. number of the farm; and (iii) Each submission on the CD–ROM (2) The average or usual number of must contain the same preferred mail- layers of each house and number of ing address in the appropriate block on poultry houses on the farm. FDA Form No. 3733. (3) A statement in which the shell (iv) A CD–ROM may contain registra- egg producer certifies that the infor- tions for as many facilities as needed mation submitted is true and accurate. up to the CD–ROM’s capacity. If the individual submitting the form is (v) The registration on the CD–ROM not the shell egg producer in charge of for each separate facility must have a the farm, the registration must also in- unique file name up to 32 characters clude a statement in which the indi- long, the first part of which may be vidual certifies that the information used to identify the parent company. submitted is true and accurate, cer- (vi) You must mail the CD–ROM to tifies that he/she is authorized to sub- the U.S. Food and Drug Administra- mit registration, and identifies by tion, 5600 Fishers Lane (HFS–681), name, address, and telephone number, Rockville, MD 20857. the individual who authorized submis- (vii) If FDA receives a CD–ROM that sion of the registration. Each registra- does not comply with these specification must include the name of the indi- tions, it will return the CD–ROM to the vidual registering the farm submitting submitter unprocessed. the registration, and the individual’s (viii) FDA will enter CD–ROM submissions that comply with these speci- signature (for paper and CD–ROM op- fications into its registration system, tions). along with the complete and legible (f) Registered egg producers must mailed and faxed submissions, as soon submit an update to a registration as practicable, in the order FDA re- within 60-calendar days of any change ceives them. to any of the information previously (ix) For each facility on the CD– submitted by any of the means as pro- ROM, FDA will mail to the preferred vided in § 118.11(b). mailing address a copy of the registra- (g) Registered egg producers must no- tion(s) as entered, confirmation of reg- tify FDA within 120 days of ceasing egg istration, and each facility’s assigned production by completing sections 1b, registration number. 1c, and 2 of Form 3733. This notifica- (x) If any information you previously tion is not required if you are a sea- submitted was incorrect at the time of sonal egg producer or you temporarily submission, you must immediately up- cease operation due to labor disputes,

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fire, natural disasters, or other tem- stroyed consistent with the decision of porary conditions. the Office of Regulatory Affairs Pro- gram Director or another FDA official [74 FR 33095, July 9, 2009, as amended at 75 FR 18751, Apr. 13, 2010] senior to an FDA District Director under paragraph (a)(2)(v) of this sec- § 118.12 Enforcement and compliance. tion. The order must include the fol- (a) Authority. This part is established lowing information: under authority of the Public Health (A) A statement that the shell eggs Service Act (the PHS Act). Under the identified in the order are subject to di- FFDCA, the Food and Drug Adminis- version for processing in accordance tration (FDA) can enforce the food with the EPIA or by a treatment that adulteration provisions under 21 U.S.C. achieves at least a 5-log destruction of 331 through 334 and 342. Under the PHS SE or destruction; Act (42 U.S.C. 264), FDA has the au- (B) A detailed description of the facts thority to make and enforce regula- that justify the issuance of the order; tions for the control of communicable (C) The location of the eggs; diseases. FDA has established the fol- (D) A statement that these eggs must lowing administrative enforcement not be sold, distributed, or otherwise procedures for the diversion or destruc- disposed of or moved except as pro- tion of shell eggs and for informal vided in paragraph (a)(1)(iv) of this sec- hearings under the PHS Act: tion; (1) Upon a finding that any shell eggs (E) Identification or description of have been produced or held in violation the eggs; of this part, an authorized FDA rep- (F) The order number; resentative or a State or local rep- (G) The date of the order; resentative in accordance with para- (H) The text of this entire section; graph (c) of this section may order (I) A statement that the order may such eggs to be diverted, under the su- be appealed by written appeal or by re- pervision of said representative, for questing an informal hearing; processing in accordance with the Egg Products Inspection Act (EPIA) (21 (J) The name and phone number of U.S.C. 1031 et seq.) or by a treatment the person issuing the order; and that achieves at least a 5-log destruc- (K) The location and telephone num- tion of SE or destroyed by or under the ber of the office or agency issuing the supervision of an officer or employee of order and the name of its Director. FDA, or, if applicable, of the State or (ii) Approval of District Director. An locality in accordance with the fol- order, before issuance, must be ap- lowing procedures: proved by FDA’s District Director or (i) Order for diversion or destruction the Acting District Director. If prior under the PHS Act. Any district office written approval is not feasible, prior of FDA or any State or locality acting oral approval must be obtained and under paragraph (c) of this section, confirmed by written memorandum as upon finding shell eggs that have been soon as possible. produced or held in violation of this (iii) Labeling or marking of shell eggs regulation, may serve a written order under order. An FDA, State, or local upon the person in whose possession representative issuing an order under the eggs are found requiring that the paragraph (a)(1)(i) of this section must eggs be diverted, under the supervision label or mark the shell eggs with offi- of an officer or employee of the issuing cial tags that include the following in- entity, for processing in accordance formation: with the EPIA (21 U.S.C. 1031 et seq.) or (A) A statement that the shell eggs by a treatment that achieves at least a are detained in accordance with regula- 5-long destruction of SE or destroyed tions issued under section 361(a) of the by or under the supervision of the PHS Act (42 U.S.C. 264(a)). issuing entity, within 10-working days (B) A statement that the shell eggs from the date of receipt of the order, must not be sold, distributed or other- unless under paragraph (a)(2)(iii) of wise disposed of or moved except, after this section, a hearing is held, in which notifying the issuing entity in writing, case the eggs must be diverted or de- to:

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(1) Divert them for processing in ac- part and at any time after a request for cordance with the EPIA or by a treat- a hearing has been submitted, if the Of- ment that achieves at least a 5-log de- fice of Regulatory Affairs Program Di- struction of SE or destroy them or rector or another FDA official senior (2) Move them to another location for to an FDA District Director deter- holding pending appeal. mines that no genuine and substantial (C) A statement that the violation of issue of fact has been raised by the ma- the order or the removal or alteration terial submitted in connection with the of the tag is punishable by fine or im- hearing or from matters officially no- prisonment or both (section 368 of the ticed. If the presiding FDA official de- PHS Act (42 U.S.C. 271)). termines that a hearing is not justi- (D) The order number and the date of fied, written notice of the determina- the order, and the name of the govern- tion will be given to the parties ex- ment representative who issued the plaining the reason for denial. order. (iii) Informal hearing. Appearance by (iv) Sale or other disposition of shell any appellant at the hearing may be by eggs under order. After service of the mail or in person, with or without order, the person in possession of the counsel. The informal hearing must be shell eggs that are the subject of the conducted by the Office of Regulatory order must not sell, distribute, or oth- Affairs Program Director or another erwise dispose of or move any eggs sub- FDA official senior to an FDA District ject to the order unless and until re- Director, and a written summary of the ceiving a notice that the order is with- proceedings must be prepared by the drawn after an appeal except, after no- presiding FDA official. tifying FDA’s district office or, if ap- (A) The presiding FDA official may plicable, the State or local representa- direct that the hearing be conducted in tive, in writing, to: any suitable manner permitted by law (A) Divert or destroy them as speci- and by this section. The presiding FDA fied in paragraph (a)(1)(i) of this sec- official has the power to take such action, or tions and make such rulings as are nec- (B) Move them to another location essary or appropriate to maintain for holding pending appeal. order and to conduct an informal, fair, (2) The person on whom the order for expeditious, and impartial hearing, and diversion or destruction is served may to enforce the requirements concerning either comply with the order or appeal the conduct of hearings. the order to an Office of Regulatory Af- (B) Employees of FDA will first give fairs Program Director in accordance a full and complete statement of the with the following procedures: action that is the subject of the hear- (i) Appeal of a detention order. Any ap- ing, together with the information and peal must be submitted in writing to reasons supporting it, and may present FDA’s District Director in whose dis- oral or written information relevant to trict the shell eggs are located within the hearing. The party requesting the 5-working days of the issuance of the hearing may then present oral or writ- order. If the appeal includes a request ten information relevant to the hear- for an informal hearing, the hearing ing. All parties may conduct reason- must be held within 5-working days able examination of any person (except after the appeal is filed or, if requested for the presiding officer and counsel for by the appellant, at a later date, which the parties) who makes any statement must not be later than 20-calendar days on the matter at the hearing. after the issuance of the order. The (C) The hearing shall be informal in order may also be appealed within the nature, and the rules of evidence do not same period of 5-working days by any apply. No motions or objections relat- other person having an ownership or ing to the admissibility of information proprietary interest in such shell eggs. and views will be made or considered, The appellant of an order must state but any party may comment upon or the ownership or proprietary interest rebut any information and views pre- the appellant has in the shell eggs. sented by another party. (ii) Summary decision. A request for a (D) The party requesting the hearing hearing may be denied, in whole or in may have the hearing transcribed, at

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the party’s expense, in which case a within 10-working days, or if the de- copy of the transcript is to be fur- mand is affirmed by the presiding FDA nished to FDA. Any transcript of the official after an appeal and the person hearing will be included with the pre- in possession of such eggs fails to di- siding FDA official’s report of the hear- vert or destroy them within 10-working ing. days, FDA’s district office or, if appli- (E) The presiding FDA official must cable, the State or local representative prepare a written report of the hearing. may designate an officer or employee All written material presented at the to divert or destroy such eggs. It shall hearing will be attached to the report. be unlawful to prevent or to attempt to Whenever time permits, the presiding prevent such diversion or destruction FDA official may give the parties the of the shell eggs by the designated offi- opportunity to review and comment on cer or employee. the report of the hearing. (b) Inspection. Persons engaged in (F) The presiding FDA official must production of shell eggs must permit include as part of the report of the hearing a finding on the credibility of authorized representatives of FDA to witnesses (other than expert witnesses) make, at any reasonable time, an in- whenever credibility is a material spection of the egg production estab- issue, and must include a recommended lishment in which shell eggs are being decision, with a statement of reasons. produced. Such inspection includes the (iv) Written appeal. If the appellant inspection and sampling of shell eggs appeals the detention order but does and the environment, the equipment not request a hearing, the presiding related to production of shell eggs, the FDA official must render a decision on equipment in which shell eggs are held, the appeal affirming or revoking the and examination and copying of any detention order within 5-working days records relating to such equipment or after the receipt of the appeal. eggs, as may be necessary in the judg- (v) Presiding FDA official’s decision. If, ment of such representatives to deter- based on the evidence presented at the mine compliance with the provisions of hearing or by the appellant in a writ- this section. Inspections may be made ten appeal, the presiding FDA official with or without notice and will ordi- finds that the shell eggs were produced narily be made during regular business or held in violation of this section, he hours. must affirm the order that they be di- (c) State and local cooperation. Under verted, under the supervision of an offi- sections 311 and 361 of the Public cer or employee of FDA for processing Health Service Act, any State or local- under the EPIA or by a treatment that ity that is willing and able to assist achieves at least a 5-log destruction of the agency in the enforcement of SE or destroyed by or under the super- §§ 118.4 through 118.10, and is authorized vision of an officer or employee of to inspect or regulate egg production FDA; otherwise, the presiding FDA of- establishments, may, in its own juris- ficial must issue a written notice that diction, enforce §§ 118.4 through 118.10 the prior order is withdrawn. If the pre- through inspections under paragraph siding FDA official affirms the order, he must order that the diversion or de- (b) of this section and through adminis- struction be accomplished within 10- trative enforcement remedies specified working days from the date of the in paragraph (a) of this section unless issuance of his decision. The presiding FDA notifies the State or locality in FDA official’s decision must be accom- writing that such assistance is no panied by a statement of the reasons longer needed. A state or locality may for the decision. The decision of the substitute, where necessary, appro- presiding FDA official constitutes final priate State or local officials for des- agency action, subject to judicial re- ignated FDA officials in this section. view. When providing assistance under para- (vi) No appeal. If there is no appeal of graph (a) of this section, a State or lo- the order and the person in possession cality may follow the hearing proce- of the shell eggs that are subject to the dures set out in paragraphs (a)(2)(iii) order fails to divert or destroy them through (a)(2)(v) of this section, or may

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utilize comparable State or local hear- Subpart B—Pathogen Reduction ing procedures if such procedures satisfy due process. 120.20 General. (d) Preemption. No State or local gov- 120.24 Process controls. erning entity shall establish, or con- 120.25 Process verification for certain processors. tinue in effect any law, rule, regulation, or other requirement regarding AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, prevention of SE in shell eggs during 371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. production, storage, or transportation SOURCE: 66 FR 6197, Jan. 19, 2001, unless that is less stringent than those re- otherwise noted. quired by this part. [74 FR 33095, July 9, 2009, as amended at 82 Subpart A—General Provisions FR 14146, Mar. 17, 2017] § 120.1 Applicability. PART 119—DIETARY SUPPLEMENTS (a) Any juice sold as such or used as THAT PRESENT A SIGNIFICANT OR an ingredient in beverages shall be UNREASONABLE RISK processed in accordance with the requirements of this part. Juice means the aqueous liquid expressed or ex- AUTHORITY: 21 U.S.C. 321, 342, 343, 371. tracted from one or more fruits or vegetables, purees of the edible por- § 119.1 Dietary supplements con- tions of one or more fruits or vegeta- taining ephedrine alkaloids. bles, or any concentrates of such liquid Dietary supplements containing or puree. The requirements of this part ephedrine alkaloids present an unrea- shall apply to any juice regardless of sonable risk of illness or injury under whether the juice, or any of its ingredi- conditions of use recommended or sug- ents, is or has been shipped in inter- gested in the labeling, or if no condi- state commerce (as defined in section tions of use are recommended or sug- 201(b) of the Federal Food, Drug, and gested in the labeling, under ordinary Cosmetic Act, 21 U.S.C. 321(b)). Raw ag- conditions of use. Therefore, dietary ricultural ingredients of juice are not supplements containing ephedrine subject to the requirements of this alkaloids are adulterated under section part. Processors should apply existing 402(f)(1)(A) of the Federal Food, Drug, agency guidance to minimize microbial and Cosmetic Act. food safety hazards for fresh fruits and [69 FR 6853, Feb. 11, 2004] vegetables in handling raw agricultural products. PART 120—HAZARD ANALYSIS AND (b) The regulations in this part shall be effective January 22, 2002. However, CRITICAL CONTROL POINT by its terms, this part is not binding on (HACCP) SYSTEMS small and very small businesses until the dates listed in paragraphs (b)(1) and Subpart A—General Provisions (b)(2) of this section. Sec. (1) For small businesses employing 120.1 Applicability. fewer than 500 persons the regulations 120.3 Definitions. in this part are binding on January 21, 120.5 Current good manufacturing practice. 2003. 120.6 Sanitation standard operating proce- (2) For very small businesses that dures. have either total annual sales of less 120.7 Hazard analysis. than $500,000, or if their total annual 120.8 Hazard Analysis and Critical Control sales are greater than $500,000 but their Point (HACCP) plan. total food sales are less than $50,000; or 120.9 Legal basis. 120.10 Corrective actions. the person claiming this exemption 120.11 Verification and validation. employed fewer than an average of 100 120.12 Records. full-time equivalent employees and 120.13 Training. fewer than 100,000 units of juice were 120.14 Application of requirements to im- sold in the United States, the regula- ported products. tions are binding on January 20, 2004.

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§ 120.3 Definitions. the carrier, or the steamship represent- The definitions of terms in section ative. (i) means to conduct a 201 of the Federal Food, Drug, and Cos- Monitor planned sequence of observations or metic Act, § 101.9(j)(18)(vi) of this chap- measurements to assess whether a ter, and parts 110 and 117 of this chap- process, point, or procedure is under ter are applicable to such terms when used in this part, except that the defi- control and to produce an accurate nitions and terms in parts 110 and 117 record for use in verification. do not govern such terms where such (j)(1) Processing means activities that terms are redefined in this part and ex- are directly related to the production cept that the terms facility, hazard, of juice products. and manufacturing/processing in parts (2) For purposes of this part, proc- 110 and 117 do not govern such terms essing does not include: where used in this part. The following (i) Harvesting, picking, or trans- definitions shall also apply: porting raw agricultural ingredients of (a) Cleaned means washed with water juice products, without otherwise en- of adequate sanitary quality. gaging in processing; and (b) Control means to prevent, elimi- (ii) The operation of a retail estab- nate, or reduce. lishment. (c) Control measure means any action (k) Processor means any person en- or activity to prevent, reduce to ac- gaged in commercial, custom, or insti- ceptable levels, or eliminate a hazard. tutional processing of juice products, (d) Critical control point means a either in the United States or in a for- point, step, or procedure in a food proc- eign country, including any person en- ess at which a control measure can be gaged in the processing of juice prod- applied and at which control is essen- ucts that are intended for use in mar- tial to reduce an identified food hazard ket or consumer tests. to an acceptable level. (l) Retail establishment is an operation (e) Critical limit means the maximum that provides juice directly to the con- or minimum value to which a physical, sumers and does not include an estab- biological, or chemical parameter must lishment that sells or distributes juice be controlled at a critical control point to other business entities as well as di- to prevent, eliminate, or reduce to an rectly to consumers. ‘‘Provides’’ in- acceptable level the occurrence of the cludes storing, preparing, packaging, identified food hazard. serving, and vending. (f) Culled means separation of dam- (m) Shall is used to state mandatory aged fruit from undamaged fruit. For requirements. processors of citrus juices using treat- (n) Shelf-stable product means a prod- ments to fruit surfaces to comply with uct that is hermetically sealed and, § 120.24, culled means undamaged, tree- when stored at room temperature, picked fruit that is U.S. Department of should not demonstrate any microbial Agriculture choice or higher quality. growth. (g) Food hazard means any biological, (o) Should is used to state rec- chemical, or physical agent that is rea- ommended or advisory procedures or to sonably likely to cause illness or in- identify recommended equipment. jury in the absence of its control. (p) Validation means that element of (h) Importer means either the U.S. verification focused on collecting and owner or consignee at the time of entry evaluating scientific and technical in- of a food product into the United formation to determine whether the States, or the U.S. agent or representa- HACCP plan, when properly imple- tive of the foreign owner or consignee mented, will effectively control the at the time of entry into the United identified food hazards. States. The importer is responsible for (q) Verification means those activi- ensuring that goods being offered for ties, other than monitoring, that es- entry into the United States are in tablish the validity of the HACCP plan compliance with all applicable laws. and that the system is operating ac- For the purposes of this definition, the cording to the plan. importer is ordinarily not the custom [66 FR 6197, Jan. 19, 2001, as amended at 80 house broker, the freight forwarder, FR 56167, Sept. 17, 2015]

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§ 120.5 Current good manufacturing essed. Each processor shall correct, in practice. a timely manner, those conditions and Except as provided by § 117.5(c), parts practices that are not met. 110 and 117 of this chapter apply in de- (c) Records. Each processor shall termining whether the facilities, meth- maintain SSOP records that, at a min- ods, practices, and controls used to imum, document the monitoring and process juice are safe, and whether the corrections prescribed by paragraph (b) food has been processed under sanitary of this section. These records are sub- conditions. ject to the recordkeeping requirements [80 FR 56167, Sept. 17, 2015] of § 120.12. (d) Relationship to Hazard Analysis § 120.6 Sanitation standard operating and Critical Control Point (HACCP) plan. procedures. Sanitation standard operating proce- (a) Sanitation controls. Each processor dure controls may be included in the shall have and implement a sanitation HACCP plan required under § 120.8(b). standard operating procedure (SSOP) However, to the extent that they are that addresses sanitation conditions implemented in accordance with this and practices before, during, and after section, they need not be included in processing. The SSOP shall address: the HACCP plan. (1) Safety of the water that comes into contact with food or food contact [66 FR 6197, Jan. 19, 2001, as amended at 80 FR 56167, Sept. 17, 2015] surfaces or that is used in the manufacture of ice; § 120.7 Hazard analysis. (2) Condition and cleanliness of food contact surfaces, including utensils, (a) Each processor shall develop, or gloves, and outer garments; have developed for it, a written hazard (3) Prevention of cross contamination analysis to determine whether there from insanitary objects to food, food are food hazards that are reasonably packaging material, and other food likely to occur for each type of juice contact surfaces, including utensils, processed by that processor and to gloves, and outer garments, and from identify control measures that the raw product to processed product; processor can apply to control those (4) Maintenance of hand washing, hazards. The written hazard analysis hand sanitizing, and toilet facilities; shall consist of at least the following: (5) Protection of food, food packaging (1) Identification of food hazards; material, and food contact surfaces (2) An evaluation of each food hazard from adulteration with lubricants, fuel, identified to determine if the hazard is pesticides, cleaning compounds, sani- reasonably likely to occur and thus, tizing agents, condensate, and other constitutes a food hazard that must be chemical, physical, and biological con- addressed in the HACCP plan. A food taminants; hazard that is reasonably likely to (6) Proper labeling, storage, and use occur is one for which a prudent proc- of toxic compounds; (7) Control of employee health condi- essor would establish controls because tions that could result in the micro- experience, illness data, scientific re- biological contamination of food, food ports, or other information provide a packaging materials, and food contact basis to conclude that there is a rea- surfaces; and sonable possibility that, in the absence (8) Exclusion of pests from the food of those controls, the food hazard will plant. occur in the particular type of product (b) Monitoring. The processor shall being processed. This evaluation shall monitor the conditions and practices include an assessment of the severity during processing with sufficient fre- of the illness or injury if the food haz- quency to ensure, at a minimum, con- ard occurs; formance with those conditions and (3) Identification of the control meas- practices specified in part 110 of this ures that the processor can apply to chapter and in subpart B of part 117 of control the food hazards identified as this chapter that are appropriate both reasonably likely to occur in paragraph to the plant and to the food being proc- (a)(2) of this section;

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(4) Review of the current process to essing, as described in § 120.7. The determine whether modifications are HACCP plan shall be developed by an necessary; and individual or individuals who have (5) Identification of critical control been trained in accordance with § 120.13 points. and shall be subject to the record- (b) The hazard analysis shall include keeping requirements of § 120.12. A food hazards that can be introduced HACCP plan shall be specific to: both within and outside the processing (1) Each location where juice is proc- plant environment, including food haz- essed by that processor; and ards that can occur before, during, and (2) Each type of juice processed by after harvest. The hazard analysis shall the processor. The plan may group be developed by an individual or indi- types of juice products together, or viduals who have been trained in ac- group types of production methods to- cordance with § 120.13 and shall be sub- gether, if the food hazards, critical con- ject to the recordkeeping requirements trol points, critical limits, and proce- of § 120.12. dures required to be identified and per- (c) In evaluating what food hazards formed by paragraph (b) of this section are reasonably likely to occur, consid- are essentially identical, provided that eration should be given, at a minimum, any required features of the plan that to the following: are unique to a specific product or (1) Microbiological contamination; method are clearly delineated in the (2) Parasites; plan and are observed in practice. (3) Chemical contamination; (b) The contents of the HACCP plan. (4) Unlawful pesticides residues; The HACCP plan shall, at a minimum: (5) Decomposition in food where a (1) List all food hazards that are rea- food hazard has been associated with sonably likely to occur as identified in decomposition; accordance with § 120.7, and that thus (6) Natural toxins; must be controlled for each type of (7) Unapproved use of food or color product; additives; (8) Presence of undeclared ingredi- (2) List the critical control points for ents that may be allergens; and each of the identified food hazards that (9) Physical hazards. is reasonably likely to occur, including (d) Processors should evaluate prod- as appropriate: uct ingredients, processing procedures, (i) Critical control points designed to packaging, storage, and intended use; control food hazards that are reason- facility and equipment function and ably likely to occur and could be intro- design; and plant sanitation, including duced inside the processing plant envi- employee hygiene, to determine the po- ronment; and tential effect of each on the safety of (ii) Critical control points designed the finished food for the intended con- to control food hazards introduced out- sumer. side the processing plant environment, (e) HACCP plans for juice need not including food hazards that occur be- address the food hazards associated fore, during, and after harvest; with microorganisms and microbial (3) List the critical limits that shall toxins that are controlled by the re- be met at each of the critical control quirements of part 113 or part 114 of points; this chapter. A HACCP plan for such (4) List the procedures, and the fre- juice shall address any other food haz- quency with which they are to be per- ards that are reasonably likely to formed, that will be used to monitor occur. each of the critical control points to ensure compliance with the critical § 120.8 Hazard Analysis and Critical limits; Control Point (HACCP) plan. (5) Include any corrective action (a) HACCP plan. Each processor shall plans that have been developed in ac- have and implement a written HACCP cordance with § 120.10(a), and that are plan whenever a hazard analysis re- to be followed in response to deviations veals one or more food hazards that are from critical limits at critical control reasonably likely to occur during proc- points;

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(6) List the validation and (b) When a deviation from a critical verification procedures, and the fre- limit occurs, and the processor does quency with which they are to be per- not have a corrective action plan that formed, that the processor will use in is appropriate for that deviation, the accordance with § 120.11; and processor shall: (7) Provide for a recordkeeping sys- (1) Segregate and hold the affected tem that documents the monitoring of product, at least until the require- the critical control points in accord- ments of paragraphs (b)(2) and (b)(3) of ance with § 120.12. The records shall this section are met; contain the actual values and observa- (2) Perform or obtain a review to de- tions obtained during monitoring. termine the acceptability of the af- (c) Sanitation. Sanitation controls fected product for distribution. The re- may be included in the HACCP plan. view shall be performed by an indi- However, to the extent that they are vidual or individuals who have ade- monitored in accordance with § 120.6, quate training or experience to perform they are not required to be included in such review; the HACCP plan. (3) Take corrective action, when nec- § 120.9 Legal basis. essary, with respect to the affected Failure of a processor to have and to product to ensure that no product en- implement a Hazard Analysis and Crit- ters commerce that is either injurious ical Control Point (HACCP) system to health or is otherwise adulterated as that complies with §§ 120.6, 120.7, and a result of the deviation; 120.8, or otherwise to operate in accord- (4) Take corrective action, when nec- ance with the requirements of this essary, to correct the cause of the devi- part, shall render the juice products of ation; and that processor adulterated under sec- (5) Perform or obtain timely tion 402(a)(4) of the Federal Food, verification in accordance with § 120.11, Drug, and Cosmetic Act. Whether a by an individual or individuals who processor’s actions are consistent with have been trained in accordance with ensuring the safety of juice will be de- § 120.13, to determine whether modifica- termined through an evaluation of the tion of the HACCP plan is required to processor’s overall implementation of reduce the risk of recurrence of the de- its HACCP system. viation, and to modify the HACCP plan as necessary. § 120.10 Corrective actions. (c) All corrective actions taken in ac- Whenever a deviation from a critical cordance with this section shall be limit occurs, a processor shall take fully documented in records that are corrective action by following the pro- subject to verification in accordance cedures set forth in paragraph (a) or with § 120.11(a)(1)(iv)(B) and the record- paragraph (b) of this section. keeping requirements of § 120.12. (a) Processors may develop written corrective action plans, which become § 120.11 Verification and validation. part of their HACCP plans in accord- (a) Verification. Each processor shall ance with § 120.8(b)(5), by which proc- verify that the Hazard Analysis and essors predetermine the corrective ac- Critical Control Point (HACCP) system tions that they will take whenever there is a deviation from a critical is being implemented according to de- limit. A corrective action plan that is sign. appropriate for a particular deviation (1) Verification activities shall in- is one that describes the steps to be clude: taken and assigns responsibility for (i) A review of any consumer com- taking those steps, to ensure that: plaints that have been received by the (1) No product enters commerce that processor to determine whether such is either injurious to health or is other- complaints relate to the performance wise adulterated as a result of the devi- of the HACCP plan or reveal previously ation; and unidentified critical control points; (2) The cause of the deviation is cor- (ii) The calibration of process moni- rected. toring instruments;

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(iii) At the option of the processor, food hazards that are reasonably likely the performance of periodic end-prod- to occur; this validation shall occur at uct or in-process testing; except that least once within 12 months after im- processors of citrus juice that rely in plementation and at least annually whole or in part on surface treatment thereafter or whenever any changes in of fruit shall perform end-product test- the process occur that could affect the ing in accordance with § 120.25. hazard analysis or alter the HACCP (iv) A review, including signing and plan in any way. Such changes may in- dating, by an individual who has been clude changes in the following: Raw trained in accordance with § 120.13, of materials or source of raw materials; the records that document: product formulation; processing meth- (A) The monitoring of critical con- ods or systems, including computers trol points. The purpose of this review and their software; packaging; finished shall be, at a minimum, to ensure that product distribution systems; or the in- the records are complete and to verify tended use or consumers of the finished that the records document values that product. The validation shall be per- are within the critical limits. This re- formed by an individual or individuals view shall occur within 1 week (7 days) who have been trained in accordance of the day that the records are made; with § 120.13 and shall be subject to the (B) The taking of corrective actions. recordkeeping requirements of § 120.12. The purpose of this review shall be, at The HACCP plan shall be modified im- a minimum, to ensure that the records mediately whenever a validation re- are complete and to verify that appro- veals that the plan is no longer ade- priate corrective actions were taken in quate to fully meet the requirements of accordance with § 120.10. This review this part. shall occur within 1 week (7 days) of (c) Validation of the hazard analysis. the day that the records are made; and Whenever a juice processor has no (C) The calibrating of any process HACCP plan because a hazard analysis monitoring instruments used at crit- has revealed no food hazards that are ical control points and the performance reasonably likely to occur, the proc- of any periodic end-product or in-processor shall reassess the adequacy of ess testing that is part of the proc- that hazard analysis whenever there essor’s verification activities. The pur- are any changes in the process that pose of these reviews shall be, at a min- could reasonably affect whether a food imum, to ensure that the records are hazard exists. Such changes may incomplete and that these activities oc- clude changes in the following: Raw curred in accordance with the proc- materials or source of raw materials; essor’s written procedures. These re- product formulation; processing meth- views shall occur within a reasonable ods or systems, including computers time after the records are made; and and their software; packaging; finished (v) The following of procedures in product distribution systems; or the in- § 120.10 whenever any verification pro- tended use or intended consumers of cedure, including the review of con- the finished product. The validation of sumer complaints, establishes the need to take a corrective action; and the hazard analysis shall be performed (vi) Additional process verification if by an individual or individuals who required by § 120.25. have been trained in accordance with (2) Records that document the cali- § 120.13, and, records documenting the bration of process monitoring instru- validation shall be subject to the rec- ments, in accordance with paragraph ordkeeping requirements of § 120.12. (a)(1)(iv)(B) of this section, and the per- § 120.12 Records. formance of any periodic end-product and in-process testing, in accordance (a) Required records. Each processor with paragraph (a)(1)(iv)(C) of this sec- shall maintain the following records tion, are subject to the recordkeeping documenting the processor’s Hazard requirements of § 120.12. Analysis and Critical Control Point (b) Validation of the HACCP plan. (HACCP) system: Each processor shall validate that the (1) Records documenting the imple- HACCP plan is adequate to control mentation of the sanitation standard

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operating procedures (SSOP’s) (see the processing facility or at the im- § 120.6); porter’s place of business in the United (2) The written hazard analysis re- States for, in the case of perishable or quired by § 120.7; refrigerated juices, at least 1 year after (3) The written HACCP plan required the date that such products were pre- by § 120.8; pared, and for, in the case of frozen, (4) Records documenting the ongoing preserved, or shelf stable products, 2 application of the HACCP plan that in- years or the shelf life of the product, clude: whichever is greater, after the date (i) Monitoring of critical control that the products were prepared. points and their critical limits, includ- (2) Offsite storage of processing ing the recording of actual times, tem- records required by paragraphs (a)(1) peratures, or other measurements, as and (a)(4) of this section is permitted prescribed in the HACCP plan; and after 6 months following the date that (ii) Corrective actions, including all the monitoring occurred, if such actions taken in response to a deviation; and records can be retrieved and provided (5) Records documenting verification onsite within 24 hours of request for of- of the HACCP system and validation of ficial review. Electronic records are the HACCP plan or hazard analysis, as considered to be onsite if they are ac- appropriate. cessible from an onsite location and (b) General requirements. All records comply with paragraph (g) of this sec- required by this part shall include: tion. (1) The name of the processor or im- (3) If the processing facility is closed porter and the location of the processor for a prolonged period between sea- or importer, if the processor or im- sonal packs, the records may be trans- porter has more than one location; ferred to some other reasonably acces- (2) The date and time of the activity sible location at the end of the sea- that the record reflects, except that sonal pack but shall be immediately records required by paragraphs (a)(2), returned to the processing facility for (a)(3), and (a)(5) of this section need not official review upon request. include the time; (e) Official review. All records re- (3) The signature or initials of the quired by this part shall be available person performing the operation or cre- for review and copying at reasonable ating the record; and times. (4) Where appropriate, the identity of (f) Public disclosure. (1) All records re- the product and the production code, if quired by this part are not available any. Processing and other information for public disclosure unless they have shall be entered on records at the time been previously disclosed to the public, that it is observed. The records shall as defined in § 20.81 of this chapter, or contain the actual values and observa- unless they relate to a product or in- tions obtained during monitoring. gredient that has been abandoned and (c) Documentation. (1) The records in no longer represent a trade secret or paragraphs (a)(2) and (a)(3) of this section shall be signed and dated by the confidential commercial or financial most responsible individual onsite at information as defined in § 20.61 of this the processing facility or by a higher chapter. level official of the processor. These (2) Records required to be maintained signatures shall signify that these by this part are subject to disclosure to records have been accepted by the firm. the extent that they are otherwise pub- (2) The records in paragraphs (a)(2) licly available, or that disclosure could and (a)(3) of this section shall be signed not reasonably be expected to cause a and dated: competitive hardship, such as generic (i) Upon initial acceptance; type HACCP plans that reflect stand- (ii) Upon any modification; and ard industry practices. (iii) Upon verification and validation (g) Records maintained on computers. in accordance with § 120.11. The maintenance of computerized (d) Record retention. (1) All records re- records, in accordance with part 11 of quired by this part shall be retained at this chapter, is acceptable.

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§ 120.13 Training. (2) Have and implement written procedures for ensuring that the juice that (a) Only an individual who has met such importer receives for import into the requirements of paragraph (b) of the United States was processed in ac- this section shall be responsible for the cordance with the requirements of this following functions: part. The procedures shall provide, at a (1) Developing the hazard analysis, minimum: including delineating control meas- (i) Product specifications that are de- ures, as required by § 120.7. signed to ensure that the juice is not (2) Developing a Hazard Analysis and adulterated under section 402 of the Critical Control Point (HACCP) plan Federal Food, Drug, and Cosmetic Act that is appropriate for a specific proc- because it may be injurious to health essor, in order to meet the require- or because it may have been processed ments of § 120.8; under insanitary conditions; and (3) Verifying and modifying the (ii) Affirmative steps to ensure that HACCP plan in accordance with the the products being offered for entry corrective action procedures specified were processed under controls that in § 120.10(b)(5) and the validation ac- meet the requirements of this part. tivities specified in §§ 120.11(b) and (c); These steps may include any of the fol- and 120.7; lowing: (4) Performing the record review re- (A) Obtaining from the foreign proc- quired by § 120.11(a)(1)(iv). essor the Hazard Analysis and Critical (b) The individual performing the Control Point (HACCP) plan and pre- functions listed in paragraph (a) of this requisite program of the standard oper- section shall have successfully com- ating procedure records required by pleted training in the application of this part that relate to the specific lot HACCP principles to juice processing of food being offered for import; at least equivalent to that received (B) Obtaining either a continuing or under standardized curriculum recog- lot specific certificate from an appro- nized as adequate by the Food and priate foreign government inspection Drug Administration, or shall be other- authority or competent third party wise qualified through job experience certifying that the imported food has to perform these functions. Job experi- been processed in accordance with the ence may qualify an individual to per- requirements of this part; form these functions if such experience (C) Regularly inspecting the foreign has provided knowledge at least equiv- processor’s facilities to ensure that the alent to that provided through the imported food is being processed in ac- standardized curriculum. The trained cordance with the requirements of this individual need not be an employee of part; the processor. (D) Maintaining on file a copy, in English, of the foreign processor’s haz- § 120.14 Application of requirements to ard analysis and HACCP plan, and a imported products. written guarantee from the foreign This section sets forth specific re- processor that the imported food is quirements for imported juice. processed in accordance with the re- (a) Importer requirements. Every im- quirements of this part; porter of juice shall either: (E) Periodically testing the imported (1) Obtain the juice from a country food, and maintaining on file a copy, in that has an active memorandum of un- English, of a written guarantee from derstanding (MOU) or similar agree- the foreign processor that the imported ment with the Food and Drug Adminis- food is processed in accordance with tration, that covers the food and docu- the requirements of this part; or ments the equivalency or compliance (F) Other such verification measures of the inspection system of the foreign as appropriate that provide an equiva- country with the U.S. system, accu- lent level of assurance of compliance rately reflects the relationship be- with the requirements of this part. tween the signing parties, and is func- (b) Competent third party. An importer tioning and enforceable in its entirety; may hire a competent third party to or assist with or perform any or all of the

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verification activities specified in para- used to achieve shelf-stability or con- graph (a)(2) of this section, including centration in its written hazard anal- writing the importer’s verification pro- ysis required by § 120.7. cedures on the importer’s behalf. (b) All juice processors shall meet (c) Records. The importer shall main- the requirements of paragraph (a) of tain records, in English, that document this section through treatments that the performance and results of the af- are applied directly to the juice, except firmative steps specified in paragraph that citrus juice processors may use (a)(2)(ii) of this section. These records treatments to fruit surfaces, provided shall be subject to the applicable provi- that the 5-log reduction process begins sions of § 120.12. after culling and cleaning as defined in (d) Determination of compliance. The importer shall provide evidence that § 120.3(a) and (f) and the reduction is ac- all juice offered for entry into the complished within a single production United States has been processed under facility. conditions that comply with this part. (c) All juice processors shall meet the If assurances do not exist that an im- requirements of paragraphs (a) and (b) ported juice has been processed under of this section and perform final prod- conditions that are equivalent to those uct packaging within a single produc- required of domestic processors under tion facility operating under current this part, the product will appear to be good manufacturing practices. Proc- adulterated and will be denied entry. essors claiming an exemption under paragraph (a)(1) or (a)(2) of this section Subpart B—Pathogen Reduction shall also process and perform final product packaging of all juice subject § 120.20 General. to the claimed exemption within a sin- This subpart augments subpart A of gle production facility operating under this part by setting forth specific re- current good manufacturing practices. quirements for process controls. § 120.25 Process verification for cer- § 120.24 Process controls. tain processors. (a) In order to meet the requirements Each juice processor that relies on of subpart A of this part, processors of treatments that do not come into di- juice products shall include in their rect contact with all parts of the juice Hazard Analysis and Critical Control to achieve the requirements of § 120.24 Point (HACCP) plans control measures shall analyze the finished product for that will consistently produce, at a biotype I Escherichia coli as follows: 5 minimum, a 5 log (i.e., 10 ) reduction, (a) One 20 milliliter (mL) sample for a period at least as long as the shelf (consisting of two 10 mL subsamples) life of the product when stored under for each 1,000 gallons of juice produced normal and moderate abuse conditions, shall be sampled each production day. in the pertinent microorganism. For If less than 1,000 gallons of juice is pro- the purposes of this regulation, the duced per day, the sample must be ‘‘pertinent microorganism’’ is the most taken for each 1,000 gallons produced resistant microorganism of public but not less than once every 5 working health significance that is likely to occur in the juice. The following juice days that the facility is producing that processors are exempt from this para- juice. Each subsample shall be taken graph: by randomly selecting a package of (1) A juice processor that is subject juice ready for distribution to con- to the requirements of part 113 or part sumers. 114 of this chapter; and (b) If the facility is producing more (2) A juice processor using a single than one type of juice covered by this thermal processing step sufficient to section, processors shall take subsam- achieve shelf-stability of the juice or a ples according to paragraph (a) of this thermal concentration process that in- section for each of the covered juice cludes thermal treatment of all ingre- products produced. dients, provided that the processor in- (c) Processors shall analyze each sub- cludes a copy of the thermal process sample for the presence of E. coli by the

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method entitled ‘‘Analysis for Esch- ess or its delivery is identified), the erichia coli in Citrus Juices—Modifica- processor shall take corrective action tion of AOAC Official Method 992.30’’ or as set forth in § 120.10. another method that is at least equiva- (e) If two samples in a series of seven lent to this method in terms of accu- tests are positive for E. coli, the control racy, precision, and sensitivity in de- measures to attain the 5-log reduction tecting E. coli. This method is designed standard shall be deemed to be inad- to detect the presence or absence of E. equate and the processor shall imme- coli in a 20 mL sample of juice (con- diately: sisting of two 10 mL subsamples). The (1) Until corrective actions are com- method is as follows: pleted, use an alternative process or (1) Sample size. Total-20 mL of juice; processes that achieve the 5-log reduc- perform analysis using two 10 mL tion after the juice has been expressed; aliquots. (2) Perform a review of the moni- (2) Media. Universal Preenrichment toring records for control measures to Broth (Difco, Detroit, MI), EC Broth attain the 5-log reduction standard. (various manufacturers). The review shall be sufficiently exten- (3) Method. ColiComplete (AOAC Offi- sive to determine that there are no cial Method 992.30—modified). trends towards loss of control; (4) Procedure. Perform the following (i) If the conditions and practices are procedure two times: not being met, correct those that do (i) Aseptically inoculate 10 mL of not conform to the HACCP plan; or juice into 90 mL of Universal (ii) If the conditions and practices Preenrichment Broth (Difco) and incu- are being met, the processor shall vali- bate at 35 °C for 18 to 24 hours. date the HACCP plan in relation to the (ii) Next day, transfer 1 mL of 5-log reduction standard; and preenriched sample into 10 mL of EC (3) Take corrective action as set Broth, without durham gas vials. After forth in § 120.10. Corrective actions inoculation, aseptically add a shall include ensuring no product en- ColiComplete SSD disc into each tube. ters commerce that is injurious to (iii) Incubate at 44.5 °C for 18 to 24 health as set forth in § 120.10(a)(1). hours. (iv) Examine the tubes under PART 121—MITIGATION STRATEGIES longwave ultra violet light (366 nm). Fluorescent tubes indicate presence of TO PROTECT FOOD AGAINST IN- E. coli. TENTIONAL ADULTERATION (v) MUG positive and negative controls should be used as reference in in- Subpart A—General Provisions terpreting fluorescence reactions. Use Sec. an E. coli for positive control and 2 neg- 121.1 Applicability. ative controls—a MUG negative strain 121.3 Definitions. and an uninoculated tube media. 121.4 Qualifications of individuals who per- (d) If either 10 mL subsample is posi- form activities under subpart C of this tive for E. coli, the 20 mL sample is re- part. corded as positive and the processor 121.5 Exemptions. shall: (1) Review monitoring records for the Subpart B [Reserved] control measures to attain the 5-log re- Subpart C—Food Defense Measures duction standard and correct those conditions and practices that are not 121.126 Food defense plan. met. In addition, the processor may 121.130 Vulnerability assessment to identify choose to test the sample for the pres- significant vulnerabilities and actionable ence of pathogens of concern. process steps. (2) If the review of monitoring 121.135 Mitigation strategies for actionable process steps. records or the additional testing indi- 121.138 Mitigation strategies management cates that the 5-log reduction standard components. was not achieved (e.g., a sample is 121.140 Food defense monitoring. found to be positive for the presence of 121.145 Food defense corrective actions. a pathogen or a deviation in the proc- 121.150 Food defense verification.

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121.157 Reanalysis. Contaminant means, for purposes of this part, any biological, chemical, Subpart D—Requirements Applying to physical, or radiological agent that Records That Must Be Established and may be added to food to intentionally Maintained cause illness, injury, or death. 121.301 Records subject to the requirements Facility means a domestic facility or of this subpart. a foreign facility that is required to 121.305 General requirements applying to register under section 415 of the Fed- records. 121.310 Additional requirements applying to eral Food, Drug, and Cosmetic Act, in the food defense plan. accordance with the requirements of 121.315 Requirements for record retention. part 1, subpart H of this chapter. 121.320 Requirements for official review. Farm means farm as defined in § 1.227 121.325 Public disclosure. of this chapter. 121.330 Use of existing records. FDA means the Food and Drug Ad- Subpart E—Compliance ministration. Food means food as defined in section 121.401 Compliance. 201(f) of the Federal Food, Drug, and AUTHORITY: 21 U.S.C. 331, 342, 350g, 350(i), Cosmetic Act and includes raw mate- 371, 374. rials and ingredients. SOURCE: 81 FR 34219, May 27, 2016, unless Food defense means, for purposes of otherwise noted. this part, the effort to protect food from intentional acts of adulteration Subpart A—General Provisions where there is an intent to cause wide scale public health harm. § 121.1 Applicability. Food defense monitoring means to con- This part applies to the owner, oper- duct a planned sequence of observa- ator or agent in charge of a domestic tions or measurements to assess or foreign food facility that manufac- whether mitigation strategies are oper- tures/processes, packs, or holds food for ating as intended. consumption in the United States and is required to register under section 415 Food defense verification means the of the Federal Food, Drug, and Cos- application of methods, procedures, metic Act, unless one of the exemp- and other evaluations, in addition to tions in § 121.5 applies. food defense monitoring, to determine whether a mitigation strategy or com- § 121.3 Definitions. bination of mitigation strategies is or The definitions and interpretations has been operating as intended accord- of terms in section 201 of the Federal ing to the food defense plan. Food, Drug, and Cosmetic Act are ap- Full-time equivalent employee is a term plicable to such terms when used in used to represent the number of em- this part. The following definitions ployees of a business entity for the pur- also apply: pose of determining whether the busi- Actionable process step means a point, ness qualifies as a small business. The step, or procedure in a food process number of full-time equivalent employ- where a significant vulnerability exists ees is determined by dividing the total and at which mitigation strategies can number of hours of salary or wages be applied and are essential to signifi- paid directly to employees of the busi- cantly minimize or prevent the signifi- ness entity and of all of its affiliates cant vulnerability. and subsidiaries by the number of Adequate means that which is needed hours of work in 1 year, 2,080 hours to accomplish the intended purpose in (i.e., 40 hours × 52 weeks). If the result keeping with good public health prac- is not a whole number, round down to tices. Affiliate means any facility that con- the next lowest whole number. trols, is controlled by, or is under com- Holding means storage of food and mon control with another facility. also includes activities performed inci- Calendar day means every day as dental to storage of food (e.g., activi- shown on the calendar. ties performed for the safe or effective

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storage of that food, such as fumigat- registered. An example of such a facil- ing food during storage, and drying/de- ity is a ‘‘farm mixed-type facility,’’ hydrating raw agricultural commod- which is an establishment that is a ities when the drying/dehydrating does farm, but also conducts activities out- not create a distinct commodity (such side the farm definition that require as drying/dehydrating hay or alfalfa)). the establishment to be registered. Holding also includes activities per- Packing means placing food into a formed as a practical necessity for the container other than packaging the distribution of that food (such as food and also includes re-packing and blending of the same raw agricultural activities performed incidental to commodity and breaking down pallets), packing or re-packing a food (e.g., ac- but does not include activities that tivities performed for the safe or effec- transform a raw agricultural com- tive packing or re-packing of that food modity into a processed food as defined (such as sorting, culling, grading, and in section 201(gg) of the Federal Food, weighing or conveying incidental to Drug, and Cosmetic Act. Holding facili- packing or re-packing)), but does not ties could include warehouses, cold include activities that transform a raw storage facilities, storage silos, grain agricultural commodity into a proc- elevators, and liquid storage tanks. essed food as defined in section 201(gg) Manufacturing/processing means mak- of the Federal Food, Drug, and Cos- ing food from one or more ingredients, metic Act. or synthesizing, preparing, treating, Qualified individual means a person modifying or manipulating food, in- who has the education, training, or excluding food crops or ingredients. Ex- perience (or a combination thereof) amples of manufacturing/processing ac- necessary to perform an activity re- tivities include: Baking, boiling, bot- quired under subpart C of this part, as tling, canning, cooking, cooling, cut- appropriate to the individual’s assigned ting, distilling, drying/dehydrating raw duties. A qualified individual may be, agricultural commodities to create a but is not required to be, an employee distinct commodity (such as drying/de- of the establishment. hydrating grapes to produce raisins), evaporating, eviscerating, extracting Significant vulnerability means a vul- juice, formulating, freezing, grinding, nerability that, if exploited, could rea- homogenizing, irradiating, labeling, sonably be expected to cause wide scale milling, mixing, packaging (including public health harm. A significant vul- modified atmosphere packaging), pas- nerability is identified by a vulner- teurizing, peeling, rendering, treating ability assessment conducted by a to manipulate ripening, trimming, qualified individual, that includes con- washing, or waxing. For farms and sideration of the following: (1) Poten- farm mixed-type facilities, manufac- tial public health impact (e.g., severity turing/processing does not include ac- and scale) if a contaminant were added, tivities that are part of harvesting, (2) degree of physical access to the packing, or holding. product, and (3) ability of an attacker Mitigation strategies mean those risk- to successfully contaminate the prod- based, reasonably appropriate meas- uct. The assessment must consider the ures that a person knowledgeable possibility of an inside attacker. about food defense would employ to Significantly minimize means to reduce significantly minimize or prevent sig- to an acceptable level, including to nificant vulnerabilities identified at eliminate. actionable process steps, and that are Small business means, for purposes of consistent with the current scientific this part, a business (including any understanding of food defense at the subsidiaries and affiliates) employing time of the analysis. fewer than 500 full-time equivalent em- Mixed-type facility means an estab- ployees. lishment that engages in both activi- Subsidiary means any company which ties that are exempt from registration is owned or controlled directly or indi- under section 415 of the Federal Food, rectly by another company. Drug, and Cosmetic Act and activities Very small business means, for pur- that require the establishment to be poses of this part, a business (including

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any subsidiaries and affiliates) aver- these functions if such experience has aging less than $10,000,000, adjusted for provided an individual with knowledge inflation, per year, during the 3-year at least equivalent to that provided period preceding the applicable cal- through the standardized curriculum. endar year in sales of human food plus This individual may be, but is not re- the market value of human food manu- quired to be, an employee of the facil- factured, processed, packed, or held ity. without sale (e.g., held for a fee). (3) One or more qualified individuals Vulnerability means the susceptibility must do or oversee: of a point, step, or procedure in a fa- (i) The preparation of the food de- cility’s food process to intentional fense plan as required in § 121.126; adulteration. (ii) The conduct of a vulnerability as- You means, for purposes of this part, sessment as required in § 121.130; the owner, operator, or agent in charge (iii) The identification and expla- of a facility. nation of the mitigation strategies as required in § 121.135; and § 121.4 Qualifications of individuals (iv) Reanalysis as required in who perform activities under sub- § 121.157. part C of this part. (d) Additional qualifications of super- (a) Applicability. You must ensure visory personnel. Responsibility for en- that each individual who performs ac- suring compliance by individuals with tivities required under subpart C of the requirements of this part must be this part is a qualified individual as clearly assigned to supervisory per- that term is defined in § 121.3. sonnel with a combination of edu- (b) Qualifications of individuals as- cation, training, and experience nec- signed to an actionable process step. Each essary to supervise the activities under individual assigned to an actionable this subpart. process step (including temporary and (e) Records. Training required by seasonal personnel) or in the super- paragraphs (b)(2) and (c)(2) of this sec- vision thereof must: tion must be documented in records, (1) Be a qualified individual as that and must: term is defined in § 121.3—i.e., have the (1) Include the date of training, the appropriate education, training, or ex- type of training, and the persons perience (or a combination thereof) trained; and necessary to properly implement the (2) Be established and maintained in mitigation strategy or combination of accordance with the requirements of mitigation strategies at the actionable subpart D of this part. process step; and (2) Receive training in food defense § 121.5 Exemptions. awareness. (a) This part does not apply to a very (c) Qualifications of individuals for cer- small business, except that a very tain activities described in paragraph small business must, upon request, pro- (c)(3) of this section. Each individual as- vide for official review documentation signed to certain activities described in sufficient to show that the facility paragraph (c)(3) of this section must: meets this exemption. Such docu- (1) Be a qualified individual as that mentation must be retained for 2 years. term is defined in § 121.3—i.e., have the (b) This part does not apply to the appropriate education, training, or ex- holding of food, except the holding of perience (or a combination thereof) food in liquid storage tanks. necessary to properly perform the ac- (c) This part does not apply to the tivities; and packing, re-packing, labeling, or re-la- (2) Have successfully completed beling of food where the container that training for the specific function at directly contacts the food remains in- least equivalent to that received under tact. a standardized curriculum recognized (d) This part does not apply to activi- as adequate by FDA or be otherwise ties of a farm that are subject to sec- qualified through job experience to tion 419 of the Federal Food, Drug, and conduct the activities. Job experience Cosmetic Act (Standards for Produce may qualify an individual to perform Safety).

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(e)(1) This part does not apply with Subpart C—Food Defense respect to alcoholic beverages at a fa- Measures cility that meets the following two conditions: § 121.126 Food defense plan. (i) Under the Federal Alcohol Admin- (a) Requirement for a food defense plan. istration Act (27 U.S.C. 201 et seq.) or You must prepare, or have prepared, chapter 51 of subtitle E of the Internal and implement a written food defense Revenue Code of 1986 (26 U.S.C. 5001 et plan. seq.) the facility is required to obtain a (b) Contents of a food defense plan. The permit from, register with, or obtain written food defense plan must include: approval of a notice or application (1) The written vulnerability assess- from the Secretary of the Treasury as ment, including required explanations, a condition of doing business in the to identify significant vulnerabilities United States, or is a foreign facility of and actionable process steps as re- a type that would require such a per- quired by § 121.130(c); mit, registration, or approval if it were (2) The written mitigation strategies, a domestic facility; and including required explanations, as re- (ii) Under section 415 of the Federal quired by § 121.135(b); Food, Drug, and Cosmetic Act the fa- (3) The written procedures for the cility is required to register as a facil- food defense monitoring of the imple- ity because it is engaged in manufac- mentation of the mitigation strategies turing, processing, packing, or holding as required by § 121.140(a); one or more alcoholic beverages. (4) The written procedures for food (2) This part does not apply with re- defense corrective actions as required spect to food that is not an alcoholic by § 121.145(a)(1); and beverage at a facility described in (5) The written procedures for food defense verification as required by paragraph (e)(1) of this section, pro- § 121.150(b). vided such food: (c) Records. The food defense plan re- (i) Is in prepackaged form that pre- quired by this section is a record that vents any direct human contact with is subject to the requirements of sub- such food; and part D of this part. (ii) Constitutes not more than 5 percent of the overall sales of the facility, § 121.130 Vulnerability assessment to as determined by the Secretary of the identify significant vulnerabilities Treasury. and actionable process steps. (f) This part does not apply to the (a) Requirement for a vulnerability as- manufacturing, processing, packing, or sessment. You must conduct or have holding of food for animals other than conducted a vulnerability assessment man. for each type of food manufactured, (g) This part does not apply to on- processed, packed, or held at your fa- farm manufacturing, processing, pack- cility using appropriate methods to ing, or holding of the following foods evaluate each point, step, or procedure on a farm mixed-type facility, when in your food operation to identify sig- conducted by a small or very small nificant vulnerabilities and actionable business if such activities are the only process steps. Appropriate methods must include, at a minimum, an eval- activities conducted by the business uation of: subject to section 418 of the Federal (1) The potential public health im- Food, Drug, and Cosmetic Act. pact (e.g., severity and scale) if a con- (1) Eggs (in-shell, other than raw ag- taminant were added; ricultural commodities, e.g., pasteur- (2) The degree of physical access to ized); and the product; and (2) Game meats (whole or cut, not (3) The ability of an attacker to suc- ground or shredded, without secondary cessfully contaminate the product. ingredients). (b) Inside attacker. The assessment must consider the possibility of an in- Subpart B—Reserved side attacker. 448

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(c) Written vulnerability assessment. (b) Food defense monitoring. You must Regardless of the outcome, the vulner- monitor the mitigation strategies with ability assessment must be written and adequate frequency to provide assur- must include an explanation as to why ances that they are consistently per- each point, step, or procedure either formed. was or was not identified as an action- (c) Records—(1) Requirement to docu- able process step. ment food defense monitoring. You must document the monitoring of mitigation § 121.135 Mitigation strategies for ac- strategies in accordance with this sec- tionable process steps. tion in records that are subject to (a) You must identify and implement verification in accordance with mitigation strategies at each action- § 121.150(a)(1) and records review in ac- able process step to provide assurances cordance with § 121.150(a)(3)(i). that the significant vulnerability at (2) Exception records. Records may be each step will be significantly mini- affirmative records demonstrating the mized or prevented and the food manu- mitigation strategy is functioning as factured, processed, packed, or held by intended. Exception records dem- your facility will not be adulterated onstrating the mitigation strategy is under section 402 of the Federal Food, not functioning as intended may be Drug, and Cosmetic Act. For each miti- adequate in some circumstances. gation strategy implemented at each actionable process step, you must in- § 121.145 Food defense corrective ac- clude a written explanation of how the tions. mitigation strategy sufficiently minimizes or prevents the significant vul- (a) Food defense corrective action proce- nerability associated with the action- dures. As appropriate to the nature of able process step. the actionable process step and the nature of the mitigation strategy: (b) Mitigation strategies and accompanying explanations must be written. (1) You must establish and implement written food defense corrective § 121.138 Mitigation strategies man- action procedures that must be taken agement components. if mitigation strategies are not prop- Mitigation strategies required erly implemented. under§ 121.135 are subject to the fol- (2) The food defense corrective action lowing mitigation strategies manage- procedures must describe the steps to ment components as appropriate to en- be taken to ensure that: sure the proper implementation of the (i) Appropriate action is taken to mitigation strategies, taking into ac- identify and correct a problem that has count the nature of each such mitiga- occurred with implementation of a tion strategy and its role in the facili- mitigation strategy; and ty’s food defense system: (ii) Appropriate action is taken, when (a) Food defense monitoring in ac- necessary, to reduce the likelihood cordance with § 121.140; that the problem will recur. (b) Food defense corrective actions in (b) Records. All food defense correc- accordance with § 121.145; and tive actions taken in accordance with (c) Food defense verification in ac- this section must be documented in cordance with § 121.150. records that are subject to food defense verification in accordance with § 121.140 Food defense monitoring. § 121.150(a)(2) and records review in ac- As appropriate to the nature of the cordance with § 121.150(a)(3)(i). mitigation strategy and its role in the facility’s food defense system: § 121.150 Food defense verification. (a) Written procedures. You must es- (a) Food defense verification activities. tablish and implement written proce- Food defense verification activities dures, including the frequency with must include, as appropriate to the na- which they are to be performed, for ture of the mitigation strategy and its food defense monitoring of the mitiga- role in the facility’s food defense sys- tion strategies. tem:

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(1) Verification that food defense nificant increase in a previously identi- monitoring is being conducted as re- fied vulnerability; quired by § 121.138 (and in accordance (2) Whenever you become aware of with § 121.140); new information about potential (2) Verification that appropriate de- vulnerabilities associated with the food cisions about food defense corrective operation or facility; actions are being made as required by (3) Whenever you find that a mitiga- § 121.138 (and in accordance with tion strategy, a combination of mitiga- § 121.145); tion strategies, or the food defense plan (3) Verification that mitigation as a whole is not properly imple- strategies are properly implemented mented; and and are significantly minimizing or (4) Whenever FDA requires reanalysis preventing the significant to respond to new vulnerabilities, cred- vulnerabilities. To do so, you must ible threats to the food supply, and de- conduct activities that include the fol- velopments in scientific understanding lowing, as appropriate to the facility, including, as appropriate, results from the food, and the nature of the mitiga- the Department of Homeland Security tion strategy and its role in the facili- biological, chemical, radiological, or ty’s food defense system: other terrorism risk assessment. (i) Review of the food defense moni- (c) You must complete such reanaly- toring and food defense corrective ac- sis required by paragraphs (a) and (b) of tions records within appropriate time- this section and implement any addi- frames to ensure that the records are tional mitigation strategies needed to complete, the activities reflected in address the significant vulnerabilities the records occurred in accordance identified, if any: with the food defense plan, the mitiga- (1) Before any change in activities tion strategies are properly imple- (including any change in mitigation mented, and appropriate decisions were strategy) at the facility is operative; made about food defense corrective ac- (2) When necessary within 90-cal- tions; and endar days after production; and (ii) Other activities appropriate for verification of proper implementation (3) Within a reasonable timeframe, of mitigation strategies; and providing a written justification is prepared for a timeframe that exceeds 90 (4) Verification of reanalysis in ac- days after production of the applicable cordance with § 121.157. food first begins. (b) Written procedures. You must es- (d) You must revise the written food tablish and implement written proce- defense plan if a significant change in dures, including the frequency for which they are to be performed, for the activities conducted at your facil- verification activities conducted ac- ity creates a reasonable potential for a cording to § 121.150(a)(3)(ii). new vulnerability or a significant increase in a previously identified vul- (c) Documentation. All verification ac- nerability or document the basis for tivities conducted in accordance with the conclusion that no revisions are this section must be documented in needed. records.

§ 121.157 Reanalysis. Subpart D—Requirements Apply- (a) You must conduct a reanalysis of ing to Records That Must Be the food defense plan, as a whole at Established and Maintained least once every 3 years; (b) You must conduct a reanalysis of § 121.301 Records subject to the re- the food defense plan as a whole, or the quirements of this subpart. applicable portion of the food defense (a) Except as provided by paragraph plan: (b) of this section, all records required (1) Whenever a significant change by subpart C of this part are subject to made in the activities conducted at all requirements of this subpart. your facility creates a reasonable po- (b) The requirements of § 121.310 apply tential for a new vulnerability or a sig- only to the written food defense plan.

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§ 121.305 General requirements apply- of a facility as a very small business ing to records. during the applicable calendar year. Records must: (b) The food defense plan must be re- (a) Be kept as original records, true tained for at least 2 years after its use copies (such as photocopies, pictures, is discontinued. scanned copies, microfilm, microfiche, (c) Except for the food defense plan, or other accurate reproductions of the offsite storage of records is permitted original records), or electronic records; if such records can be retrieved and (b) Contain the actual values and ob- provided onsite within 24 hours of re- servations obtained during food defense quest for official review. The food de- monitoring; fense plan must remain onsite. Elec- (c) Be accurate, indelible, and legible; tronic records are considered to be on- (d) Be created concurrently with per- site if they are accessible from an on- formance of the activity documented; site location. (e) Be as detailed as necessary to pro- (d) If the facility is closed for a provide history of work performed; and longed period, the food defense plan (f) Include: may be transferred to some other rea- (1) Information adequate to identify sonably accessible location but must be the facility (e.g., the name, and when returned to the facility within 24 hours necessary, the location of the facility); for official review upon request. (2) The date and, when appropriate, the time of the activity documented; § 121.320 Requirements for official re- (3) The signature or initials of the view. person performing the activity; and All records required by this part (4) Where appropriate, the identity of must be made promptly available to a the product and the lot code, if any. duly authorized representative of the (g) Records that are established or maintained to satisfy the requirements Secretary of Health and Human Serv- of this part and that meet the defini- ices for official review and copying tion of electronic records in § 11.3(b)(6) upon oral or written request. of this chapter are exempt from the requirements of part 11 of this chapter. § 121.325 Public disclosure. Records that satisfy the requirements Records required by this part will be of this part, but that also are required protected from public disclosure to the under other applicable statutory provi- extent allowable under part 20 of this sions or regulations, remain subject to chapter. part 11 of this chapter. § 121.330 Use of existing records. § 121.310 Additional requirements applying to the food defense plan. (a) Existing records (e.g., records that are kept to comply with other Federal, The owner, operator, or agent in State, or local regulations, or for any charge of the facility must sign and other reason) do not need to be dupli- date the food defense plan: cated if they contain all of the required (a) Upon initial completion; and information and satisfy the require- (b) Upon any modification. ments of this subpart. Existing records § 121.315 Requirements for record re- may be supplemented as necessary to tention. include all of the required information (a)(1) All records required by this and satisfy the requirements of this part must be retained at the facility subpart. for at least 2 years after the date they (b) The information required by this were prepared. part does not need to be kept in one set (2) Records that a facility relies on of records. If existing records contain during the 3-year period preceding the some of the required information, any applicable calendar year to support its new information required by this part status as exempt as a very small busi- may be kept either separately or com- ness must be retained at the facility as bined with the existing records. long as necessary to support the status

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Subpart E—Compliance are applicable to such terms when used in this part, except that the definitions § 121.401 Compliance. and terms in parts 110 and 117 do not (a) The operation of a facility that govern such terms where such terms manufactures, processes, packs, or are redefined in this part and except holds food for sale in the United States that the terms facility, hazard, and if the owner, operator, or agent in manufacturing/processing in parts 110 charge of such facility is required to and 117 do not govern such terms where comply with, and is not in compliance used in this part. The following defini- with, section 418 of the Federal Food, tions shall also apply: Drug, and Cosmetic Act or subparts C (a) Certification number means a or D of this part is a prohibited act unique combination of letters and under section 301(uu) of the Federal numbers assigned by a shellfish control Food, Drug, and Cosmetic Act. authority to a molluscan shellfish (b) The failure to comply with sec- processor. tion 420 of the Federal Food, Drug, and (b) Critical control point means a Cosmetic Act or subparts C or D of this point, step, or procedure in a food proc- part is a prohibited act under section ess at which control can be applied, 301(ww) of the Federal Food, Drug, and and a food safety hazard can as a result Cosmetic Act. be prevented, eliminated, or reduced to acceptable levels. PART 123—FISH AND FISHERY (c) Critical limit means the maximum PRODUCTS or minimum value to which a physical, biological, or chemical parameter must Subpart A—General Provisions be controlled at a critical control point to prevent, eliminate, or reduce to an Sec. acceptable level the occurrence of the 123.3 Definitions. 123.5 Current good manufacturing practice. identified food safety hazard. 123.6 Hazard analysis and Hazard Analysis (d) Fish means fresh or saltwater Critical Control Point (HACCP) plan. finfish, crustaceans, other forms of 123.7 Corrective actions. aquatic animal life (including, but not 123.8 Verification. limited to, alligator, frog, aquatic tur- 123.9 Records. tle, jellyfish, sea cucumber, and sea ur- 123.10 Training. 123.11 Sanitation control procedures. chin and the roe of such animals) other 123.12 Special requirements for imported than birds or mammals, and all mol- products. lusks, where such animal life is intended for human consumption. Subpart B—Smoked and Smoke-Flavored (e) Fishery product means any human Fishery Products food product in which fish is a charac- 123.15 General. terizing ingredient. 123.16 Process controls. (f) Food safety hazard means any biological, chemical, or physical property Subpart C—Raw Molluscan Shellfish that may cause a food to be unsafe for human consumption. 123.20 General. 123.28 Source controls. (g) Importer means either the U.S. owner or consignee at the time of entry AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, into the United States, or the U.S. 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264. agent or representative of the foreign SOURCE: 60 FR 65197, Dec. 18, 1995, unless owner or consignee at the time of entry otherwise noted. into the United States, who is responsible for ensuring that goods being of- Subpart A—General Provisions fered for entry into the United States are in compliance with all laws affect- § 123.3 Definitions. ing the importation. For the purposes The definitions and interpretations of this definition, ordinarily the im- of terms in section 201 of the Federal porter is not the custom house broker, Food, Drug, and Cosmetic Act (the act) the freight forwarder, the carrier, or and in parts 110 and 117 of this chapter the steamship representative.

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(h) Molluscan shellfish means any edi- molluscan shellfish harvesting con- ble species of fresh or frozen oysters, trols, and certification of molluscan clams, mussels, or scallops, or edible shellfish processors. portions of such species, except when (p) Shellstock means raw, in-shell the product consists entirely of the molluscan shellfish. shucked adductor muscle. (q) Should is used to state rec- (i) Preventive measure means physical, ommended or advisory procedures or to chemical, or other factors that can be identify recommended equipment. used to control an identified food safe- (r) Shucked shellfish means molluscan ty hazard. shellfish that have one or both shells (j) Process-monitoring instrument removed. means an instrument or device used to (s) Smoked or smoke-flavored fishery indicate conditions during processing products means the finished food pre- at a critical control point. pared by: (k)(1) Processing means, with respect (1) Treating fish with salt (sodium to fish or fishery products: Handling, chloride), and storing, preparing, heading, evis- (2) Subjecting it to the direct action cerating, shucking, freezing, changing of smoke from burning wood, sawdust, into different market forms, manufac- or similar material and/or imparting to turing, preserving, packing, labeling, it the flavor of smoke by a means such dockside unloading, or holding. as immersing it in a solution of wood (2) The regulations in this part do smoke. not apply to: (t) Tag means a record of harvesting (i) Harvesting or transporting fish or information attached to a container of fishery products, without otherwise en- shellstock by the harvester or proc- gaging in processing. essor. (ii) Practices such as heading, evis- [60 FR 65197, Dec. 18, 1995, as amended at 80 cerating, or freezing intended solely to FR 56167, Sept. 17, 2015] prepare a fish for holding on board a harvest vessel. § 123.5 Current good manufacturing (iii) The operation of a retail estab- practice. lishment. (a) Except as provided by § 117.5(b), (l) Processor means any person en- parts 110 and 117 of this chapter apply gaged in commercial, custom, or insti- in determining whether the facilities, tutional processing of fish or fishery methods, practices, and controls used products, either in the United States or to process fish and fishery products are in a foreign country. A processing in- safe, and whether these products have cludes any person engaged in the pro- been processed under sanitary condi- duction of foods that are to be used in tions. market or consumer tests. (b) The purpose of this part is to set (m) Scombroid toxin-forming species forth requirements specific to the proc- means tuna, bluefish, mahi mahi, and essing of fish and fishery products. other species, whether or not in the [60 FR 65197, Dec. 18, 1995, as amended at 80 family Scombridae, in which signifi- FR 56167, Sept. 17, 2015] cant levels of histamine may be produced in the fish flesh by § 123.6 Hazard analysis and Hazard decarboxylation of free histidine as a Analysis Critical Control Point result of exposure of the fish after cap- (HACCP) plan. ture to temperatures that permit the (a) Hazard analysis. Every processor growth of mesophilic bacteria. shall conduct, or have conducted for it, (n) Shall is used to state mandatory a hazard analysis to determine whether requirements. there are food safety hazards that are (o) Shellfish control authority means a reasonably likely to occur for each Federal, State, or foreign agency, or kind of fish and fishery product proc- sovereign tribal government, legally essed by that processor and to identify responsible for the administration of a the preventive measures that the proc- program that includes activities such essor can apply to control those haz- as classification of molluscan shellfish ards. Such food safety hazards can be growing areas, enforcement of introduced both within and outside the

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processing plant environment, includ- fishery product will be consumed with- ing food safety hazards that can occur out a process sufficient to kill the before, during, and after harvest. A parasites, or where the processor rep- food safety hazard that is reasonably resents, labels, or intends for the prod- likely to occur is one for which a pru- uct to be so consumed; dent processor would establish controls (viii) Unapproved use of direct or in- because experience, illness data, sci- direct food or color additives; and entific reports, or other information (ix) Physical hazards; provide a basis to conclude that there (2) List the critical control points for is a reasonable possibility that it will each of the identified food safety haz- occur in the particular type of fish or ards, including as appropriate: fishery product being processed in the (i) Critical control points designed to absence of those controls. control food safety hazards that could (b) The HACCP plan. Every processor be introduced in the processing plant shall have and implement a written environment; and HACCP plan whenever a hazard anal- (ii) Critical control points designed ysis reveals one or more food safety to control food safety hazards intro- hazards that are reasonably likely to duced outside the processing plant en- occur, as described in paragraph (a) of vironment, including food safety haz- this section. A HACCP plan shall be ards that occur before, during, and specific to: after harvest; (1) Each location where fish and fish- (3) List the critical limits that must ery products are processed by that be met at each of the critical control processor; and points; (2) Each kind of fish and fishery prod- (4) List the procedures, and frequency uct processed by the processor. The thereof, that will be used to monitor plan may group kinds of fish and fish- each of the critical control points to ery products together, or group kinds ensure compliance with the critical of production methods together, if the limits; food safety hazards, critical control (5) Include any corrective action points, critical limits, and procedures plans that have been developed in ac- required to be identified and performed cordance with § 123.7(b), to be followed in paragraph (c) of this section are in response to deviations from critical identical for all fish and fishery prod- limits at critical control points; ucts so grouped or for all production methods so grouped. (6) List the verification procedures, (c) The contents of the HACCP plan. and frequency thereof, that the proc- The HACCP plan shall, at a minimum: essor will use in accordance with (1) List the food safety hazards that § 123.8(a); are reasonably likely to occur, as iden- (7) Provide for a recordkeeping sys- tified in accordance with paragraph (a) tem that documents the monitoring of of this section, and that thus must be the critical control points. The records controlled for each fish and fishery shall contain the actual values and ob- product. Consideration should be given servations obtained during monitoring. to whether any food safety hazards are (d) Signing and dating the HACCP reasonably likely to occur as a result plan. (1) The HACCP plan shall be of the following: signed and dated, either by the most (i) Natural toxins; responsible individual onsite at the (ii) Microbiological contamination; processing facility or by a higher level (iii) Chemical contamination; official of the processor. This signature (iv) Pesticides; shall signify that the HACCP plan has (v) Drug residues; been accepted for implementation by (vi) Decomposition in scombroid the firm. toxin-forming species or in any other (2) The HACCP plan shall be dated species where a food safety hazard has and signed: been associated with decomposition; (i) Upon initial acceptance; (vii) Parasites, where the processor (ii) Upon any modification; and has knowledge or has reason to know (iii) Upon verification of the plan in that the parasite-containing fish or accordance with § 123.8(a)(1).

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(e) Products subject to other regula- (2) The cause of the deviation is cor- tions. For fish and fishery products rected. that are subject to the requirements of (c) When a deviation from a critical part 113 or 114 of this chapter, the limit occurs and the processor does not HACCP plan need not list the food safe- have a corrective action plan that is ty hazard associated with the forma- appropriate for that deviation, the tion of Clostridium botulinum toxin in processor shall: the finished, hermetically sealed con- (1) Segregate and hold the affected tainer, nor list the controls to prevent product, at least until the require- that food safety hazard. A HACCP plan ments of paragraphs (c)(2) and (c)(3) of for such fish and fishery products shall this section are met; address any other food safety hazards (2) Perform or obtain a review to de- that are reasonably likely to occur. termine the acceptability of the af- (f) Sanitation. Sanitation controls fected product for distribution. The re- may be included in the HACCP plan. view shall be performed by an indi- However, to the extent that they are vidual or individuals who have ade- monitored in accordance with § 123.11(b) quate training or experience to perform they need not be included in the such a review. Adequate training may HACCP plan, and vice versa. or may not include training in accord- (g) Legal basis. Failure of a processor ance with § 123.10; to have and implement a HACCP plan (3) Take corrective action, when nec- that complies with this section when- essary, with respect to the affected ever a HACCP plan is necessary, other- product to ensure that no product en- wise operate in accordance with the re- ters commerce that is either injurious quirements of this part, shall render to health or is otherwise adulterated as the fish or fishery products of that a result of the deviation; processor adulterated under section (4) Take corrective action, when nec- 402(a)(4) of the act. Whether a proc- essary, to correct the cause of the devi- essor’s actions are consistent with en- ation; suring the safety of food will be deter- (5) Perform or obtain timely reassess- mined through an evaluation of the ment by an individual or individuals processors overall implementation of who have been trained in accordance its HACCP plan, if one is required. with § 123.10, to determine whether the HACCP plan needs to be modified to re- § 123.7 Corrective actions. duce the risk of recurrence of the devi- (a) Whenever a deviation from a crit- ation, and modify the HACCP plan as ical limit occurs, a processor shall take necessary. corrective action either by: (d) All corrective actions taken in ac- (1) Following a corrective action plan cordance with this section shall be that is appropriate for the particular fully documented in records that are deviation, or subject to verification in accordance (2) Following the procedures in para- with § 123.8(a)(3)(ii) and the record- graph (c) of this section. keeping requirements of § 123.9. (b) Processors may develop written corrective action plans, which become § 123.8 Verification. part of their HACCP plans in accord- (a) Overall verification. Every proc- ance with § 123.6(c)(5), by which they essor shall verify that the HACCP plan predetermine the corrective actions is adequate to control food safety haz- that they will take whenever there is a ards that are reasonably likely to deviation from a critical limit. A cor- occur, and that the plan is being effec- rective action plan that is appropriate tively implemented. Verification shall for a particular deviation is one that include, at a minimum: describes the steps to be taken and as- (1) Reassessment of the HACCP plan. A signs responsibility for taking those reassessment of the adequacy of the steps, to ensure that: HACCP plan whenever any changes (1) No product enters commerce that occur that could affect the hazard anal- is either injurious to health or is other- ysis or alter the HACCP plan in any wise adulterated as a result of the devi- way or at least annually. Such changes ation; and may include changes in the following:

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Raw materials or source of raw mate- views shall occur within a reasonable rials, product formulation, processing time after the records are made. methods or systems, finished product (b) Corrective actions. Processors shall distribution systems, or the intended immediately follow the procedures in use or consumers of the finished prod- § 123.7 whenever any verification proce- uct. The reassessment shall be per- dure, including the review of a con- formed by an individual or individuals sumer complaint, reveals the need to who have been trained in accordance take a corrective action. with § 123.10. The HACCP plan shall be (c) Reassessment of the hazard analysis. modified immediately whenever a reas- Whenever a processor does not have a sessment reveals that the plan is no HACCP plan because a hazard analysis longer adequate to fully meet the re- has revealed no food safety hazards quirements of § 123.6(c). that are reasonably likely to occur, the (2) Ongoing verification activities. On- processor shall reassess the adequacy going verification activities including: of that hazard analysis whenever there (i) A review of any consumer com- are any changes that could reasonably plaints that have been received by the affect whether a food safety hazard processor to determine whether they now exists. Such changes may include, relate to the performance of critical but are not limited to changes in: Raw control points or reveal the existence materials or source of raw materials, of unidentified critical control points; product formulation, processing methods or systems, finished product dis- (ii) The calibration of process-moni- tribution systems, or the intended use toring instruments; and, or consumers of the finished product. (iii) At the option of the processor, The reassessment shall be performed the performing of periodic end-product by an individual or individuals who or in-process testing. have been trained in accordance with (3) Records review. A review, including § 123.10. signing and dating, by an individual (d) Recordkeeping. The calibration of who has been trained in accordance process-monitoring instruments, and with § 123.10, of the records that docu- the performing of any periodic end- ment: product and in-process testing, in ac- (i) The monitoring of critical control cordance with paragraphs (a)(2)(ii) points. The purpose of this review shall through (iii) of this section shall be be, at a minimum, to ensure that the documented in records that are subject records are complete and to verify that to the recordkeeping requirements of they document values that are within § 123.9. the critical limits. This review shall occur within 1 week of the day that the § 123.9 Records. records are made; (a) General requirements. All records (ii) The taking of corrective actions. required by this part shall include: The purpose of this review shall be, at (1) The name and location of the a minimum, to ensure that the records processor or importer; are complete and to verify that appro- (2) The date and time of the activity priate corrective actions were taken in that the record reflects; accordance with § 123.7. This review (3) The signature or initials of the shall occur within 1 week of the day person performing the operation; and that the records are made; and (4) Where appropriate, the identity of (iii) The calibrating of any process the product and the production code, if control instruments used at critical any. Processing and other information control points and the performing of shall be entered on records at the time any periodic end-product or in-process that it is observed. testing that is part of the processor’s (b) Record retention. (1) All records re- verification activities. The purpose of quired by this part shall be retained at these reviews shall be, at a minimum, the processing facility or importer’s to ensure that the records are com- place of business in the United States plete, and that these activities oc- for at least 1 year after the date they curred in accordance with the proc- were prepared in the case of refrig- essor’s written procedures. These re- erated products and for at least 2 years

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after the date they were prepared in § 123.10 Training. the case of frozen, preserved, or shelf- At a minimum, the following func- stable products. tions shall be performed by an indi- (2) Records that relate to the general vidual who has successfully completed adequacy of equipment or processes training in the application of HACCP being used by a processor, including principles to fish and fishery product the results of scientific studies and processing at least equivalent to that evaluations, shall be retained at the received under standardized cur- processing facility or the importer’s riculum recognized as adequate by the place of business in the United States U.S. Food and Drug Administration or for at least 2 years after their applica- who is otherwise qualified through job bility to the product being produced at experience to perform these functions. the facility. Job experience will qualify an indi- (3) If the processing facility is closed vidual to perform these functions if it for a prolonged period between sea- has provided knowledge at least equiv- sonal packs, or if record storage capac- alent to that provided through the ity is limited on a processing vessel or standardized curriculum. at a remote processing site, the records (a) Developing a HACCP plan, which may be transferred to some other rea- could include adapting a model or ge- sonably accessible location at the end neric-type HACCP plan, that is appro- of the seasonal pack but shall be imme- priate for a specific processor, in order diately returned for official review to meet the requirements of § 123.6(b); upon demand. (b) Reassessing and modifying the (c) Official review. All records re- HACCP plan in accordance with the quired by this part and all plans and corrective action procedures specified procedures required by this part shall in § 123.7(c)(5), the HACCP plan in ac- be available for official review and cordance with the verification activi- copying at reasonable times. ties specified in § 123.8(a)(1), and the hazard analysis in accordance with the (d) Public disclosure. (1) Subject to the verification activities specified in limitations in paragraph (d)(2) of this § 123.8(c); and section, all plans and records required (c) Performing the record review re- by this part are not available for public quired by § 123.8(a)(3); The trained indi- disclosure unless they have been pre- vidual need not be an employee of the viously disclosed to the public as de- processor. fined in § 20.81 of this chapter or they relate to a product or ingredient that § 123.11 Sanitation control procedures. has been abandoned and they no longer (a) Sanitation SOP. Each processor represent a trade secret or confidential should have and implement a written commercial or financial information as sanitation standard operating proce- defined in § 20.61 of this chapter. dure (herein referred to as SSOP) or (2) However, these records and plans similar document that is specific to may be subject to disclosure to the ex- each location where fish and fishery tent that they are otherwise publicly products are produced. The SSOP available, or that disclosure could not should specify how the processor will reasonably be expected to cause a com- meet those sanitation conditions and petitive hardship, such as generic-type practices that are to be monitored in HACCP plans that reflect standard in- accordance with paragraph (b) of this dustry practices. section. (e) Tags. Tags as defined in § 123.3(t) (b) Sanitation monitoring. Each proc- are not subject to the requirements of essor shall monitor the conditions and this section unless they are used to ful- practices during processing with suffi- fill the requirements of § 123.28(c). cient frequency to ensure, at a min- (f) Records maintained on computers. imum, conformance with those condi- The maintenance of records on com- tions and practices specified in part 110 puters is acceptable, provided that ap- of this chapter and in subpart B of part propriate controls are implemented to 117 of this chapter that are both appro- ensure the integrity of the electronic priate to the plant and the food being data and signatures. processed and relate to the following:

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(1) Safety of the water that comes (a) Importer verification. Every im- into contact with food or food contact porter of fish or fishery products shall surfaces, or is used in the manufacture either: of ice; (1) Obtain the fish or fishery product (2) Condition and cleanliness of food from a country that has an active contact surfaces, including utensils, memorandum of understanding (MOU) gloves, and outer garments; or similar agreement with the Food (3) Prevention of cross-contamina- and Drug Administration, that covers tion from insanitary objects to food, the fish or fishery product and docu- food packaging material, and other ments the equivalency or compliance food contact surfaces, including uten- of the inspection system of the foreign sils, gloves, and outer garments, and country with the U.S. system, accu- from raw product to cooked product; rately reflects the current situation be- (4) Maintenance of hand washing, tween the signing parties, and is func- hand sanitizing, and toilet facilities; tioning and enforceable in its entirety; (5) Protection of food, food packaging or material, and food contact surfaces (2) Have and implement written from adulteration with lubricants, fuel, verification procedures for ensuring pesticides, cleaning compounds, sani- that the fish and fishery products that tizing agents, condensate, and other they offer for import into the United chemical, physical, and biological con- States were processed in accordance taminants; with the requirements of this part. The (6) Proper labeling, storage, and use procedures shall list at a minimum: of toxic compounds; (i) Product specifications that are de- (7) Control of employee health condi- signed to ensure that the product is not tions that could result in the micro- adulterated under section 402 of the biological contamination of food, food Federal Food, Drug, and Cosmetic Act packaging materials, and food contact because it may be injurious to health surfaces; and or have been processed under insani- (8) Exclusion of pests from the food tary conditions, and, plant. (ii) Affirmative steps that may in- The processor shall correct in a time- clude any of the following: ly manner, those conditions and prac- (A) Obtaining from the foreign proc- tices that are not met. essor the HACCP and sanitation moni- (c) Sanitation control records. Each toring records required by this part processor shall maintain sanitation that relate to the specific lot of fish or control records that, at a minimum, fishery products being offered for im- document the monitoring and correc- port; tions prescribed by paragraph (b) of (B) Obtaining either a continuing or this section. These records are subject lot-by-lot certificate from an appro- to the requirements of § 123.9. priate foreign government inspection authority or competent third party (d) Relationship to HACCP plan. Sani- certifying that the imported fish or tation controls may be included in the fishery product is or was processed in HACCP plan, required by § 123.6(b). accordance with the requirements of However, to the extent that they are this part; monitored in accordance with paragraph (b) of this section they need not (C) Regularly inspecting the foreign be included in the HACCP plan, and processor’s facilities to ensure that the imported fish or fishery product is vice versa. being processed in accordance with the [60 FR 65197, Dec. 18, 1995, as amended at 80 requirements of this part; FR 56167, Sept. 17, 2015] (D) Maintaining on file a copy, in English, of the foreign processor’s § 123.12 Special requirements for im- HACCP plan, and a written guarantee ported products. from the foreign processor that the im- This section sets forth specific reported fish or fishery product is proc- quirements for imported fish and fish- essed in accordance with the require- ery products. ments of the part;

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(E) Periodically testing the imported life of the product under normal and fish or fishery product, and maintain- moderate abuse conditions. ing on file a copy, in English, of a written guarantee from the foreign proc- Subpart C—Raw Molluscan essor that the imported fish or fishery Shellfish product is processed in accordance with the requirements of this part or, § 123.20 General. (F) Other such verification measures as appropriate that provide an equiva- This subpart augments subpart A of lent level of assurance of compliance this part by setting forth specific re- with the requirements of this part. quirements for processing fresh or frozen molluscan shellfish, where such (b) Competent third party. An importer processing does not include a treat- may hire a competent third party to ment that ensures the destruction of assist with or perform any or all of the vegetative cells of microorganisms of verification activities specified in para- public health concern. graph (a)(2) of this section, including writing the importer’s verification pro- § 123.28 Source controls. cedures on the importer’s behalf. (c) Records. The importer shall main- (a) In order to meet the requirements tain records, in English, that document of subpart A of this part as they apply the performance and results of the af- to microbiological contamination, firmative steps specified in paragraph chemical contamination, natural tox- (a)(2)(ii) of this section. These records ins, and related food safety hazards, shall be subject to the applicable provi- processors shall include in their sions of § 123.9. HACCP plans how they are controlling (d) Determination of compliance. There the origin of the molluscan shellfish must be evidence that all fish and fish- they process to ensure that the condi- ery products offered for entry into the tions of paragraphs (b), (c), and (d) of United States have been processed this section are met. under conditions that comply with this (b) Processors shall only process part. If assurances do not exist that the molluscan shellfish harvested from imported fish or fishery product has growing waters approved for harvesting been processed under conditions that by a shellfish control authority. In the are equivalent to those required of do- case of molluscan shellfish harvested mestic processors under this part, the from U.S. Federal waters, the require- product will appear to be adulterated ments of this paragraph will be met so and will be denied entry. long as the shellfish have not been harvested from waters that have been closed to harvesting by an agency of Subpart B—Smoked and Smoke- the Federal government. Flavored Fishery Products (c) To meet the requirements of paragraph (b) of this section, processors § 123.15 General. who receive shellstock shall accept This subpart augments subpart A of only shellstock from a harvester that this part by setting forth specific re- is in compliance with such licensure quirements for processing smoked and requirements as may apply to the har- smoke-flavored fishery products. vesting of molluscan shellfish or from a processor that is certified by a shell- § 123.16 Process controls. fish control authority, and that has a In order to meet the requirements of tag affixed to each container of subpart A of this part, processors of shellstock. The tag shall bear, at a smoked and smoke-flavored fishery minimum, the information required in products, except those subject to the § 1240.60(b) of this chapter. In place of requirements of part 113 or 114 of this the tag, bulk shellstock shipments may chapter, shall include in their HACCP be accompanied by a bill of lading or plans how they are controlling the food similar shipping document that con- safety hazard associated with the for- tains the information required in mation of toxin by Clostridium botu- § 1240.60(b) of this chapter. Processors linum for at least as long as the shelf shall maintain records that document

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that all shellstock have met the re- Subpart A—General Provisions quirements of this section. These records shall document: § 129.1 Current good manufacturing (1) The date of harvest; practice. (2) The location of harvest by State The applicable criteria in parts 110 and site; and 117 of this chapter, as well as the (3) The quantity and type of shellfish; criteria in §§ 129.20, 129.35, 129.37, 129.40, (4) The date of receipt by the proc- and 129.80 shall apply in determining essor; and whether the facilities, methods, prac- (5) The name of the harvester, the tices, and controls used in the proc- name or registration number of the essing, bottling, holding, and shipping harvester’s vessel, or an identification of bottled drinking water are in con- number issued to the harvester by the formance with or are operated or ad- shellfish control authority. ministered in conformity with good (d) To meet the requirements of para- manufacturing practice to assure that graph (b) of this section, processors bottled drinking water is safe and that who receive shucked molluscan shell- it has been processed, bottled, held, fish shall accept only containers of and transported under sanitary condi- shucked molluscan shellfish that bear tions. a label that complies with § 1240.60(c) of this chapter. Processors shall maintain [80 FR 56167, Sept. 17, 2015] records that document that all shucked molluscan shellfish have met the re- § 129.3 Definitions. quirements of this section. These For the purposes of this part, the fol- records shall document: lowing definitions apply: (1) The date of receipt; (a) Approved source when used in ref- (2) The quantity and type of shellfish; erence to a plant’s product water or op- and erations water means a source of water (3) The name and certification num- and the water therefrom, whether it be ber of the packer or repacker of the from a spring, artesian well, drilled product. well, municipal water supply, or any other source, that has been inspected PART 129—PROCESSING AND BOT- and the water sampled, analyzed, and TLING OF BOTTLED DRINKING found to be of a safe and sanitary qual- WATER ity according to applicable laws and regulations of State and local govern- Subpart A—General Provisions ment agencies having jurisdiction. The presence in the plant of current certifi- Sec. cates or notifications of approval from 129.1 Current good manufacturing practice. 129.3 Definitions. the government agency or agencies having jurisdiction constitutes ap- Subpart B—Buildings and Facilities proval of the source and the water supply. 129.20 Plant construction and design. (b) Bottled drinking water means all 129.35 Sanitary facilities. 129.37 Sanitary operations. water which is sealed in bottles, packages, or other containers and offered Subpart C—Equipment for sale for human consumption, including bottled mineral water. 129.40 Equipment and procedures. (c) Lot means a collection of primary Subpart D [Reserved] containers or unit packages of the same size, type, and style produced Subpart E—Production and Process under conditions as nearly uniform as Controls possible and designated by a common container code or marking. 129.80 Processes and controls. (d) Multiservice containers means con- AUTHORITY: 21 U.S.C. 342, 348, 371, 374; 42 tainers intended for use more than one U.S.C. 264. time. SOURCE: 42 FR 14355, Mar. 15, 1977, unless (e) Nontoxic materials means mate- otherwise noted. rials for product water contact surfaces

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utilized in the transporting, proc- shall be positioned within the room so essing, storing, and packaging of bot- as to minimize any possible post-sani- tled drinking water, which are free of tizing contamination of the containers substances which may render the water before they enter the bottling room. injurious to health or which may ad- (e) Rooms in which product water is versely affect the flavor, color, odor, or handled, processed, or held or in which bacteriological quality of the water. containers, utensils, or equipment are (f) Operations water means water washed or held shall not open directly which is delivered under pressure to a into any room used for domestic house- plant for container washing, hand hold purposes. washing, plant and equipment cleanup and for other sanitary purposes. § 129.35 Sanitary facilities. (g) Primary container means the im- Each plant shall provide adequate mediate container in which the product sanitary facilities including, but not water is packaged. limited to, the following: (h) Product water means processed (a) Product water and operations water used by a plant for bottled drink- water—(1) Product water. The product ing water. water supply for each plant shall be (i) Shall and should. ‘‘Shall’’ refers to from an approved source properly lo- mandatory requirements and ‘‘should’’ cated, protected, and operated and refers to recommended or advisory pro- shall be easily accessible, adequate, cedures or equipment. and of a safe, sanitary quality which (j) Shipping case means a container in shall be in conformance at all times which one or more primary containers with the applicable laws and regula- of the product are held. tions of the government agency or (k) Single-service container means a agencies having jurisdiction. container intended for one time usage (2) Operations water. If different from only. the product water supply, the oper- (l) Unit package means a standard ations water supply shall be obtained commercial package of bottled drink- from an approved source properly lo- ing water, which may consist of one or cated, protected, and operated and more containers. shall be easily accessible, adequate, [42 FR 14355, Mar. 6, 1977, as amended at 44 and of a safe, sanitary quality which FR 12175, Mar. 6, 1979] shall be in conformance at all times with the applicable laws and regula- Subpart B—Buildings and Facilities tions of the government agency or agencies having jurisdiction. § 129.20 Plant construction and design. (3) Product water and operations water (a) The bottling room shall be sepa- from approved sources. (i) Samples of rated from other plant operations or source water from each source in use storage areas by tight walls, ceilings, by the plant are to be taken and ana- and self-closing doors to protect lyzed by the plant as often as nec- against contamination. Conveyor open- essary, but at a minimum frequency of ings shall not exceed the size required once each year for chemical contami- to permit passage of containers. nants and once every 4 years for radio- (b) If processing operations are con- logical contaminants. Additionally, ducted in other than a sealed system source water obtained from other than under pressure, adequate protection a public water system is to be sampled shall be provided to preclude contami- and analyzed for total coliform at least nation of the water and the system. once each week. If any coliform orga- (c) Adequate ventilation shall be pro- nisms are detected, follow-up testing vided to minimize condensation in must be conducted to determine wheth- processing rooms, bottling rooms, and er any of the coliform organisms are in container washing and sanitizing Escherichia coli. This sampling is in ad- areas. dition to any performed by government (d) The washing and sanitizing of agencies having jurisdiction. Source containers for bottled drinking water water found to contain E. coli is not shall be performed in an enclosed room. considered water of a safe, sanitary The washing and sanitizing operation quality as required for use in bottled

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water by paragraph (a)(1) of this sec- infectant or ozone do not have to test tion. Before a bottler can use source their source water for the residual dis- water from a source that has tested infectants and DBP’s listed in positive for E. coli, the bottler must § 165.110(b)(4)(iii)(H) of this chapter. take appropriate measures to rectify or Firms that do not use a public water otherwise eliminate the cause of E. coli system as the source of their water but contamination of that source in a man- whose source water has been treated ner sufficient to prevent its reoccur- with a chlorine-based disinfectant or rence. A source previously found to ozone must test their source water for contain E. coli will be considered nega- the residual disinfectants and the tive for E. coli after five samples col- DBP’s listed in § 165.110(b)(4)(iii)(H) lected over a 24-hour period from the that are likely to result from such same sampling site that originally treatment. tested positive for E. coli are tested and (iv) The finished bottled water must found to be E. coli negative. Records of comply with bottled water quality approval of the source water by govern- standards (§ 165.110(b) of this chapter) ment agencies having jurisdiction, and section 402(a)(1) and (a)(3) of the records of sampling and analyses for Federal Food, Drug, and Cosmetic Act which the plant is responsible, and dealing with adulterated foods. records describing corrective measures (b) Air under pressure. Whenever air taken in response to a finding of E. coli under pressure is directed at product are to be maintained on file at the water or a product water-contact sur- plant. face, it shall be free of oil, dust, rust, (ii) Test and sample methods shall be excessive moisture, and extraneous ma- those recognized and approved by the terials; shall not affect the bacterio- government agency or agencies having logical quality of the water; and should jurisdiction over the approval of the not adversely affect the flavor, color, water source, and shall be consistent or odor of the water. with the minimum requirements set (c) Locker and lunchrooms. When em- forth in § 165.110(b) of this chapter. ployee locker and lunchrooms are pro- (iii) Analysis of the sample may be vided, they shall be separate from performed for the plant by competent plant operations and storage areas and commercial laboratories (e.g., Environ- shall be equipped with self-closing mental Protection Agency (EPA) and doors. The rooms shall be maintained State-certified laboratories). in a clean and sanitary condition and (4) Source water testing exemptions. (i) refuse containers should be provided. Firms that use a public water system Packaging or wrapping material or for source water may substitute public other processing supplies shall not be water system testing results, or certifi- stored in locker or lunchrooms. cates showing full compliance with all [42 FR 14355, Mar. 15, 1977, as amended at 44 provisions of EPA National Primary FR 12175, Mar. 6, 1979; 60 FR 57123, Nov. 13, and Secondary Drinking Water Regula- 1995; 66 FR 16865, Mar. 28, 2001; 74 FR 25664, tions pertaining to chemical contami- May 29, 2009] nants (40 CFR parts 141 and 143), for the testing requirements of § 129.35(a)(3). § 129.37 Sanitary operations. (ii) Firms that do not use a public (a) The product water-contact sur- water system as the source of their faces of all multiservice containers, water may reduce the frequency of utensils, pipes, and equipment used in their testing of that source, as well as the transportation, processing, han- the number of chemical contaminants dling, and storage of product water for which they test the source water, if shall be clean and adequately sanitized. they can document that such reduction All product water-contact surfaces is consistent with a State-issued waiv- shall be inspected by plant personnel as er under EPA regulations (40 CFR parts often as necessary to maintain the san- 141 and 143). itary condition of such surfaces and to (iii) Firms that do not use a public assure they are kept free of scale, evi- water system as the source of their dence of oxidation, and other residue. water and whose source water has not The presence of any unsanitary condi- been treated with a chlorine-based dis- tion, scale, residue, or oxidation shall

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be immediately remedied by adequate its intended purpose and in accordance cleaning and sanitizing of that product with section 409 of the Federal Food, water-contact surface prior to use. Drug, and Cosmetic Act. All such proc- (b) After cleaning, all multiservice esses shall be performed in and by containers, utensils, and disassembled equipment and with substances which piping and equipment shall be trans- will not adulterate the bottled product. ported and stored in such a manner as A record of the type and date of phys- to assure drainage and shall be pro- ical inspections of such equipment, tected from contamination. conditions found, and the performance (c) Single-service containers and caps and effectiveness of such equipment or seals shall be purchased and stored shall be maintained by the plant. Prod- in sanitary closures and kept clean uct water samples shall be taken after therein in a clean, dry place until used. processing and prior to bottling by the Prior to use they shall be examined, plant and analyzed as often as is nec- and as necessary, washed, rinsed, and essary to assure uniformity and effec- sanitized and shall be handled in a san- tiveness of the processes performed by itary manner. the plant. The methods of analysis (d) Filling, capping, closing, sealing, shall be those approved by the govern- and packaging of containers shall be ment agency or agencies having juris- done in a sanitary manner so as to pre- diction. clude contamination of the bottled (b) Containers. (1) Multiservice pri- drinking water. mary containers shall be adequately cleaned, sanitized, and inspected just Subpart C—Equipment prior to being filled, capped, and sealed. Containers found to be unsani- § 129.40 Equipment and procedures. tary or defective by the inspection (a) Suitability. (1) All plant equipment shall be reprocessed or discarded. All and utensils shall be suitable for their multiservice primary containers shall intended use. This includes all collec- be washed, rinsed, and sanitized by me- tion and storage tanks, piping, fittings, chanical washers or by any other meth- connections, bottle washers, fillers, od giving adequate sanitary results. cappers, and other equipment which Mechanical washers shall be inspected may be used to store, handle, process, as often as is necessary to assure ade- package, or transport product water. quate performance. Records of physical (2) All product water contact surfaces maintenance, inspections and condi- shall be constructed of nontoxic and tions found, and performance of the nonabsorbant material which can be mechanical washer shall be maintained adequately cleaned and sanitized and is by the plant. in compliance with section 409 of the (2) Multiservice shipping cases shall act. be maintained in such condition as to (b) Design. Storage tanks shall be of assure they will not contaminate the the type that can be closed to exclude primary container or the product all foreign matter and shall be ade- water. Adequate dry or wet cleaning quately vented. procedures shall be performed as often as necessary to maintain the cases in Subpart D [Reserved] satisfactory condition. (c) Cleaning and sanitizing solutions. Subpart E—Production and Cleaning and sanitizing solutions uti- Process Controls lized by the plant shall be sampled and tested by the plant as often as is nec- § 129.80 Processes and controls. essary to assure adequate performance (a) Treatment of product water. All in the cleaning and sanitizing oper- treatment of product water by distilla- ations. Records of these tests shall be tion, ion-exchanging, filtration, ultra- maintained by the plant. violet treatment, reverse osmosis, (d) Sanitizing operations. Sanitizing carbonation, mineral addition, or any operations, including those performed other process shall be done in a manner by chemical means or by any other so as to be effective in accomplishing means such as circulation of live steam

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or hot water, shall be adequate to ef- the filler, capper or sealer shall be fect sanitization of the intended prod- monitored and the filled containers uct water-contact surfaces and any visually or electronically inspected to other critical area. The plant should assure they are sound, properly capped maintain a record of the intensity of or sealed, and coded and labeled. Con- the sanitizing agent and the time dura- tainers which are not satisfactory shall tion that the agent was in contact with be reprocessed or rejected. Only the surface being sanitized. The fol- nontoxic containers and closures shall lowing times and intensities shall be be used. All containers and closures considered a minimum: shall be sampled and inspected to as- (1) Steam in enclosed system: At certain that they are free from con- least 170 °F for at least 15 minutes or at tamination. At least once each 3 least 200 °F for at least 5 minutes. months, a bacteriological swab and/or (2) Hot water in enclosed system: At rinse count should be made from at least 170 °F for at least 15 minutes or at least four containers and closures se- least 200 °F for at least 5 minutes. lected just prior to filling and sealing. (3) Chemical sanitizers shall be No more than one of the four samples equivalent in bactericidal action to a 2- may exceed more than one bacteria per minute exposure of 50 parts per million milliliter of capacity or one colony per of available chlorine at 57 °F when used square centimeter of surface area. All as an immersion or circulating solu- samples shall be free of coliform orga- tion. Chemical sanitizers applied as a nisms. The procedure and apparatus for spray or fog shall have as a minimum these bacteriological tests shall be in 100 parts per million of available chlo- conformance with those recognized by rine at 57 °F or its equivalent in bac- the government agency or agencies tericidal action. having jurisdiction. Tests shall be per- (4) 0.1 part per million ozone water formed either by qualified plant per- solution in an enclosed system for at sonnel or a competent commercial lab- least 5 minutes. oratory. (5) When containers are sanitized (g) Compliance procedures. A quality using a substance other than one pro- standard for bottled drinking water is vided for in § 178.1010 of this chapter, established in § 165.110(b) of this chap- such substance shall be removed from ter. To assure that the plant’s produc- the surface of the container by a rins- tion of bottled drinking water complies ing procedure. The final rinse, prior to with the applicable standards, laws, filling the container with product and regulations of the government water, shall be performed with a dis- agency or agencies having jurisdiction, infected water rinse free of pathogenic the plant will analyze product samples bacteria or by an additional sanitizing as follows: procedure equivalent in bactericidal (1) For bacteriological purposes, take action to that required in paragraph and analyze at least once a week for (d)(3) of this section. total coliform a representative sample (e) Unit package production code. Each from a batch or segment of a contin- unit package from a batch or segment uous production run for each type of of a continuous production run of bot- bottled drinking water produced during tled drinking water shall be identified a day’s production. The representative by a production code. The production sample shall consist of primary con- code shall identify a particular batch tainers of product or unit packages of or segment of a continuous production product. If any coliform organisms are run and the day produced. The plant detected, follow-up testing must be shall record and maintain information conducted to determine whether any of as to the kind of product, volume pro- the coliform organisms are E. coli. duced, date produced, lot code used, (2) For chemical, physical, and radio- and the distribution of the finished logical purposes, take and analyze at product to wholesale and retail outlets. least annually a representative sample (f) Filling, capping, or sealing. During from a batch or segment of a contin- the process of filling, capping or seal- uous production run for each type of ing either single-service or multi- bottled drinking water produced during service containers, the performance of a day’s production. The representtive

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sample(s) consists of primary con- Subpart A—General Provisions tainers of product of unit packages of product. § 130.3 Definitions and interpretations. (3) Analyze such samples by methods (a) The definitions and interpreta- approved by the government agency or tions of terms contained in section 201 agencies having jurisdiction. The plant of the act shall be applicable also to shall maintain records of date of sam- such terms when used in regulations pling, type of product sampled, produc- promulgated under the act. tion code, and results of the analysis. (b) If a regulation prescribing a defi- (h) Record retention. All records re- nition and standard of identity for a quired by §§ 129.1, 129.20, 129.35, 129.37, food has been promulgated under sec- 129.40, and 129.80 shall be maintained at tion 401 of the act and the name there- the plant for not less than 2 years. in specified for the food is used in any Plants shall also retain, on file at the other regulation under section 401 or plant, current certificates or notifica- any other provision of the act, such tions of approval issued by the govern- name means the food which conforms ment agency or agencies approving the to such definition and standard, except plant’s source and supply of product as otherwise specifically provided in water and operations water. All re- such other regulation. quired documents shall be available for (c) No provision of any regulation official review at reasonable times. prescribing a definition and standard of [42 FR 14355, Mar. 15, 1977, as amended at 44 identity or standard of quality or fill of FR 12175, Mar. 6, 1979; 60 FR 57124, Nov. 13, container under section 401 of the act 1995; 74 FR 25665, May 29, 2009] shall be construed as in any way affecting the concurrent applicability of the PART 130—FOOD STANDARDS: general provisions of the act and the GENERAL regulations thereunder relating to adulteration and misbranding. For ex- Subpart A—General Provisions ample, all regulations under section 401 contemplate that the food and all arti- Sec. cles used as components or ingredients 130.3 Definitions and interpretations. thereof shall not be poisonous or dele- 130.5 Procedure for establishing a food terious and shall be clean, sound, and standard. 130.6 Review of Codex Alimentarius food fit for food. A provision in such regula- standards. tions for the use of coloring or fla- 130.8 Conformity to definitions and stand- voring does not authorize such use ards of identity. under circumstances or in a manner 130.9 Sulfites in standardized food. whereby damage or inferiority is con- 130.10 Requirements for foods named by use cealed or whereby the food is made to of a nutrient content claim and a stand- appear better or of greater value than ardized term. 130.11 Label designations of ingredients for it is. standardized foods. (d) Safe and suitable means that the 130.12 General methods for water capacity ingredient: and fill of containers. (1) Performs an appropriate function 130.14 General statements of substandard in the food in which it is used. quality and substandard fill of container. (2) Is used at a level no higher than 130.17 Temporary permits for interstate necessary to achieve its intended pur- shipment of experimental packs of food pose in that food. varying from the requirements of definitions and standards of identity. (3) Is not a food additive or color additive as defined in section 201 (s) or (t) Subpart B—Food Additives in Standardized of the Federal Food, Drug, and Cos- Foods metic Act as used in that food, or is a food additive or color additive as so de- 130.20 Food additives proposed for use in fined and is used in conformity with foods for which definitions and standards regulations established pursuant to of identity are established. section 409 or 721 of the act. AUTHORITY: 21 U.S.C. 321, 336, 341, 343, 371. (e) Section 403(i) of the act requires EDITORIAL NOTE: Nomenclature changes to the listing of all ingredients in stand- part 130 appear at 81 FR 49896, July 29, 2016. ardized foods. All ingredients must be

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listed in accordance with the require- ard, and the reasons for any such devi- ments of part 101 of this chapter, ex- ations. The Commissioner shall publish cept that where a definition and stand- such a petition in the FEDERAL REG- ard of identity has specific labeling ISTER as a proposal, with an oppor- provisions for optional ingredients, op- tunity for comment, if reasonable tional ingredients may be declared in grounds are provided in the petition. accordance with those provisions. Any published proposal shall state any [42 FR 14357, Mar. 15, 1977, as amended at 58 deviations from the Codex standard FR 2876, Jan. 6, 1993] and the stated reasons therefor. (2) The Commissioner may on his § 130.5 Procedure for establishing a own initiative propose by publication food standard. in the FEDERAL REGISTER the adoption (a) The procedure for establishing a of a Codex standard, with or without food standard under section 401 of the change, through a new standard or an act shall be governed by part 10 of this appropriate amendment to an existing chapter. standard, pursuant to section 401 of the (b) Any petition for a food standard act. Any such proposal shall specify shall show that the proposal, if adopt- any deviations from the Codex stand- ed, would promote honesty and fair ard, and the reasons for any such devi- dealing in the interest of consumers. ations. (c) Any petition for a food standard (3) Any Codex standard not handled shall assert that the petitioner com- under paragraph (b) (1) or (2) of this mits himself to substantiate the infor- section may be published in the FED- mation in the petition by evidence in a ERAL REGISTER for review and informal public hearing, if such a hearing be- comment. Interested persons shall be comes necessary. requested to comment on the desir- (d) If a petitioner fails to appear, or ability and need for the standard, on to substantiate the information in his the specific provisions of the standard, petition, at a public hearing on the on additional or different provisions matter, the Commissioner may either that should be included in the stand- (1) withdraw the regulation and termi- nate the proceeding or (2) if he con- ard, and on any other pertinent points. cludes that it is in accordance with the After reviewing all such comments, the requirements of section 401 of the act, Commissioner either shall publish a continue the proceeding and introduce proposal to establish a food standard evidence to substantiate such informa- pursuant to section 401 of the act cov- tion. ering the food involved, or shall publish a notice terminating consideration [42 FR 14357, Mar. 15, 1977, as amended at 42 of such a standard. FR 15673, Mar. 22, 1977] (c) All interested persons are encour- § 130.6 Review of Codex Alimentarius aged to confer with different interest food standards. groups (consumers, industry, the aca- (a) All food standards adopted by the demic community, professional organi- Codex Alimentarius Commission will zations, and others) in formulating pe- be reviewed by the Food and Drug Ad- titions or comments pursuant to para- ministration and will be accepted with- graph (b) of this section. All such peti- out change, accepted with change, or tions or comments are requested to in- not accepted. clude a statement of any meetings and (b) Review of Codex standards will be discussions that have been held with accomplished in one of the following other interest groups. Appropriate three ways: weight will be given by the Commis- (1) Any interested person may peti- sioner to petitions or comments that tion the Commissioner to adopt a reflect a consensus of different interest Codex standard, with or without groups. change, by proposing a new standard or an appropriate amendment of an exist- § 130.8 Conformity to definitions and ing standard, pursuant to section 401 of standards of identity. the act. Any such petition shall specify In the following conditions, among any deviations from the Codex stand- others, a food does not conform to the

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definition and standard of identity ability of this material at NARA, call therefor: 202–741–6030, or go to: http:// (a) If it contains an ingredient for www.archives.gov/federallregister/ which no provision is made in such def- codeloflfederallregulations/ inition and standard, unless such ingre- ibrllocations.html. dient is an incidental additive intro- (b) Any standardized food that, as a duced at a nonfunctional and insignifi- result of actions that are consistent cant level as a result of its deliberate with current good manufacturing prac- and purposeful addition to another in- tice, contains an indirectly added gredient permitted by the terms of the sulfiting agent that has no functional applicable standard and the presence of effect in the food and that would, in such incidental additive in the absence of § 101.100(a)(4) of this unstandardized foods has been exempt- chapter, be considered to be an inci- ed from label declaration as provided dental additive for purposes of § 130.8, in § 101.100 of this chapter. conforms to the applicable definition (b) If it fails to contain any one or and standard of identity if the presence more ingredients required by such defi- of the sulfiting agent is declared on the nition and standard; label of the food. (c) If the quantity of any ingredient [58 FR 2876, Jan. 6, 1993, as amended at 63 FR or component fails to conform to the 14035, Mar. 24, 1998] limitation, if any, prescribed therefor by such definition and standard. § 130.10 Requirements for foods named by use of a nutrient content claim § 130.9 Sulfites in standardized food. and a standardized term. (a) Any standardized food that con- (a) Description. The foods prescribed tains a sulfiting agent or combination by this general definition and standard of sulfiting agents that is functional of identity are those foods that sub- and provided for in the applicable stitute (see § 101.13(d) of this chapter) standard or that is present in the fin- for a standardized food defined in parts ished food at a detectable level is mis- 131 through 169 of this chapter and that branded unless the presence of the use the name of that standardized food sulfiting agent or agents is declared on in their statement of identity but that the label of the food. A detectable do not comply with the standard of amount of sulfiting agent is 10 parts identity because of a deviation that is per million or more of the sulfite in the described by an expressed nutrient con- finished food. The level of sulfite in the tent claim that has been defined by finished food will be determined using FDA regulation. The nutrient content sections 20.123 through 20.125, ‘‘Sulfu- claim shall comply with the require- rous Acid (Total) in Food Modified ments of § 101.13 of this chapter and Monier-Williams Method Final Action’’ with the requirements of the regula- in ‘‘Official Methods of Analysis of the tions in part 101 of this chapter that Association of Official Analytical define the particular nutrient content Chemists,’’ 14th ed. (1984), which is in- claim that is used. The food shall com- corporated by reference in accordance ply with the relevant standard in all with 5 U.S.C. 552(a) and 1 CFR part 51, other respects except as provided in and the refinements of the ‘‘Total Sul- paragraphs (b), (c), and (d) of this sec- furous Acid’’ procedure in the ‘‘Monier- tion. Williams Procedure (with Modifica- (b) Nutrient addition. Nutrients shall tions) for Sulfites in Foods,’’ which is be added to the food to restore nutrient appendix A to part 101 of this chapter. levels so that the product is not nutri- A copy of sections 20.123 through 20.125 tionally inferior, as defined in of the ‘‘Official Methods of Analysis of § 101.3(e)(4) of this chapter, to the the Association of Official Analytical standardized food as defined in parts Chemists’’ is available from AOAC 131 through 169 of this chapter. The ad- INTERNATIONAL, 481 North Frederick dition of nutrients shall be reflected in Ave., suite 500, Gaithersburg, MD 20877 the ingredient statement. , or available for at the National Ar- (c) Performance characteristics. Devi- chives and Records Administration ations from noningredient provisions of (NARA). For information on the avail- the standard of identity (e.g., moisture

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content, food solids content require- (e.g., vegetable oil shall not replace ments, or processing conditions) are milkfat in light sour cream). permitted in order that the substitute (3) An ingredient or component of an food possesses performance character- ingredient that is specifically prohib- istics similar to those of the standard- ited by the standard as defined in parts ized food. Deviations from ingredient 131 through 169 of this chapter, shall and noningredient provisions of the not be added to a substitute food under standard must be the minimum nec- this section. essary to qualify for the nutrient con- (4) An ingredient that is specifically tent claim while maintaining similar required by the standard as defined in performance characteristics as the parts 131 through 169 of this chapter, standardized food, or the food will be shall be present in the product in a sig- deemed to be adulterated under section nificant amount. A significant amount 402(b) of the act. The performance char- of an ingredient or component of an in- acteristics (e.g., physical properties, gredient is at least that amount that is flavor characteristics, functional prop- required to achieve the technical effect erties, shelf life) of the food shall be of that ingredient in the food. similar to those of the standardized (5) Water and fat analogs may be food as produced under parts 131 added to replace fat and calories in ac- through 169 of this chapter, except that cordance with § 130.10(c), (d)(1), and if there is a significant difference in performance characteristics that mate- (d)(2). rially limits the uses of the food com- (e) Nomenclature. The name of a sub- pared to the uses of the standardized stitute food that complies with all food, the label shall include a state- parts of this regulation is the appro- ment informing the consumer of such priate expressed nutrient content difference (e.g., if appropriate, ‘‘not claim and the applicable standardized recommended for cooking’’). Such term. statement shall comply with the re- (f) Label declaration. (1) Each of the quirements of § 101.13(d) of this chapter. ingredients used in the food shall be de- The modified product shall perform at clared on the label as required by the least one of the principal functions of applicable sections of part 101 of this the standardized product substantially chapter and part 130. as well as the standardized product. (2) Ingredients not provided for, and (d) Other ingredients. (1) Ingredients ingredients used in excess of those lev- used in the product shall be those in- els provided for, by the standard as de- gredients provided for by the standard fined in parts 131 through 169 of this as defined in parts 131 through 169 of chapter, shall be identified as such this chapter and in paragraph (b) of with an asterisk in the ingredient this section, except that safe and suit- statement, except that ingredients able ingredients may be used to im- added to restore nutrients to the prod- prove texture, add flavor, prevent syn- uct as required in paragraph (b) of this eresis, extend shelf life, improve ap- section shall not be identified with an pearance, or add sweetness so that the asterisk. The statement product is not inferior in performance ‘‘*Ingredient(s) not in regular lll’’ characteristics to the standardized (fill in name of the traditional stand- food defined in parts 131 through 169 of ardized food) or ‘‘*Ingredient(s) in ex- this chapter. cess of amount permitted in regular (2) An ingredient or component of an lll’’ (fill in name of the traditional ingredient that is specifically required standardized food) or both as appro- by the standard (i.e., a mandatory in- priate shall immediately follow the ingredient) as defined in parts 131 gredient statement in the same type through 169 of this chapter, shall not be replaced or exchanged with a similar size. ingredient from another source unless [58 FR 2446, Jan. 6, 1993] the standard, as defined in parts 131 through 169 of this chapter, provides for the addition of such ingredient

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§ 130.11 Label designations of ingredi- (b) The term general method for fill of ents for standardized foods. containers means the following method: (1) In the case of a container with lid Some definitions and standards of attached by double seam, cut out the identity for foods set forth below re- lid without removing or altering the quire that designated optional ingredi- height of the double seam. ents such as spices, flavorings, color- (2) Measure the vertical distance ings, emulsifiers, flavor enhancers, sta- from the top level of the container to bilizers, preservatives, and sweeteners the top level of the food. be declared in a specified manner on (3) Remove the food from the con- the label wherever the name of the tainer; wash, dry, and weigh the con- standardized food appears on the label tainer. so conspicuously as to be easily seen (4) Fill the container with water to under customary conditions of pur- 3⁄16 inch vertical distance below the top chase. Such requirements shall apply level of the container. Record the tem- to a manufacturer, packer, or dis- perature of the water, weigh the con- tributor of a standardized food only if tainer thus filled, and determine the the words or statements on the label of weight of the water by subtracting the the standardized food significantly dif- weight of the container found in para- ferentiate between two or more foods graph (b)(3) of this section. that comply with the same standard by (5) Maintaining the water at the tem- describing the optional forms or vari- perature recorded in paragraph (b)(4) of eties, the packing medium, or signifi- this section, draw off water from the cant characterizing ingredients present container as filled in paragraph (b)(4) in the food. of this section to the level of the food [58 FR 2876, Jan. 6, 1993] found in paragraph (b)(2) of this section, weigh the container with remain- § 130.12 General methods for water ca- ing water, and determine the weight of pacity and fill of containers. the remaining water by subtracting the For the purposes of regulations pro- weight of the container found in para- mulgated under section 401 of the act: graph (b)(3) of this section. (a) The term general method for water (6) Divide the weight of water found capacity of containers means the fol- in paragraph (b)(5) of this section by lowing method: the weight of water found in paragraph (b)(4) of this section, and multiply by (1) In the case of a container with lid 100. The result shall be considered to be attached by double seam, cut out the the percent of the total capacity of the lid without removing or altering the container occupied by the food. height of the double seam. (2) Wash, dry, and weigh the empty In the case of a container with lid at- container. tached otherwise than by double seam, (3) Fill the container with distilled remove the lid and proceed as directed water at 68 °F to 3⁄16 inch vertical dis- in paragraphs (b) (2) to (6) of this sec- tance below the top level of the con- tion, except that under paragraph (b)(4) tainer, and weigh the container thus of this section, fill the container to the filled. level of the top thereof. (4) Subtract the weight found in § 130.14 General statements of subparagraph (a)(2) of this section from standard quality and substandard the weight found in paragraph (a)(3) of fill of container. this section. The difference shall be For the purposes of regulations pro- considered to be the weight of water re- mulgated under section 401 of the act: quired to fill the container. (a) The term general statement of sub- In the case of a container with lid at- standard quality means the statement tached otherwise than by double seam, ‘‘Below Standard in Quality Good remove the lid and proceed as directed Food—Not High Grade’’ printed in two in paragraphs (a) (2) to (4) of this sec- lines of Cheltenham bold condensed tion, except that under paragraph (a)(3) caps. The words ‘‘Below Standard in of this section, fill the container to the Quality’’ constitute the first line, and level of the top thereof. the second immediately follows. If the

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quantity of the contents of the con- (b) It is the purpose of the Food and tainer is less than 1 pound, the type of Drug Administration to permit such the first line is 12-point, and of the sec- tests when it can be ascertained that ond, 8-point. If such quantity is 1 pound the sole purpose of the tests is to ob- or more, the type of the first line is 14- tain data necessary for reasonable point, and of the second, 10-point. Such grounds in support of a petition to statement is enclosed within lines, not amend food standards, that the tests less than 6 points in width, forming a are necessary to the completion or con- rectangle. Such statement, with en- clusiveness of an otherwise adequate closing lines, is on a strongly con- investigation, and that the interests of trasting, uniform background, and is so consumers are adequately safeguarded; placed as to be easily seen when the permits for such tests shall normally name of the food or any pictorial rep- be for a period not to exceed 15 months. resentation thereof is viewed, wherever The Food and Drug Administration, or such name or representation appears so good cause shown by the applicant, conspicuously as to be easily seen may provide for a longer test market under customary conditions of pur- period. The Food and Drug Administra- chase. tion will therefore refrain from recom- (b) The term general statement of sub- mending regulatory proceedings under standard fill means the statement ‘‘Below Standard in Fill’’ printed in the act on the charge that a food does Cheltenham bold condensed caps. If the not conform to an applicable standard, quantity of the contents of the con- if the person who introduces or causes tainer is less than 1 pound, the state- the introduction of the food into inter- ment is in 12-point type; if such quan- state commerce holds an effective per- tity is 1 pound or more, the statement mit from the Food and Drug Adminis- is in 14-point type. Such statement is tration providing specifically for those enclosed within lines, not less than 6 variations in respect to which the food points in width, forming a rectangle; fails to conform to the applicable defi- but if the statement specified in para- nition and standard of identity. The graph (a) of this section is also used, test period will begin on the date the both statements (one following the person holding an effective permit other) may be enclosed within the from the Food and Drug Administra- same rectangle. Such statement or tion introduces or causes the introduc- statements, with enclosing lines, are tion of the food covered by the permit on a strongly contrasting, uniform into interstate commerce but not later background, and are so placed as to be than 3 months after notice of the easily seen when the name of the food issuance of the permit is published in or any pictorial representation thereof the FEDERAL REGISTER. The Food and is viewed, wherever such name or rep- Drug Administration shall be notified resentation appears so conspicuously in writing of the date on which the test as to be easily seen under customary period begins as soon as it is deter- conditions of purchase. mined. (c) Any person desiring a permit may § 130.17 Temporary permits for inter- file with the Team Leader, Conven- state shipment of experimental packs of food varying from the re- tional Foods Team, Division of Stand- quirements of definitions and ards and Labeling Regulations, Office standards of identity. of Nutritional Products, Labeling and (a) The Food and Drug Administra- Dietary Supplements, Center for Food tion recognizes that before petitions to Safety and Applied Nutrition (HFS– amend food standards can be sub- 822), 5001 Campus Dr., College Park, mitted, appropriate investigations of MD 20740, a written application in trip- potential advances in food technology licate containing as part thereof the sometimes require tests in interstate following: markets of the advantages to and ac- (1) Name and address of the appli- ceptance by consumers of experimental cant. packs of food varying from applicable (2) A statement of whether or not the definitions and standards of identity applicant is regularly engaged in pro- prescribed under section 401 of the act. ducing the food involved.

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(3) A reference to the applicable defi- uted in the State in which it was man- nition and standard of identity (citing ufactured. applicable section of regulations). (15) If it has not been or is not to be (4) A full description of the proposed so distributed, a statement showing variation from the standard. why. (5) The basis upon which the food so (16) If it has been or is to be so dis- varying is believed to be wholesome tributed, a statement of why it is and nondeleterious. deemed necessary to distribute such (6) The amount of any new ingredient food in other States. to be added; the amount of any ingre- (d) The Food and Drug Administra- dient, required by the standard, to be tion may require the applicant to fur- eliminated; any change of concentra- nish samples of the food varying from tion not contemplated by the standard; the standard and to furnish such addi- or any change in name that would tional information as may be deemed more appropriately describe the new necessary for action on the application. product under test. If such new ingre- (e) If the Food and Drug Administra- dient is not a commonly known food tion concludes that the variation may ingredient, a description of its prop- be advantageous to consumers and will erties and basis for concluding that it not result in failure of the food to con- is not a deleterious substance. form to any provision of the act except (7) The purpose of effecting the vari- section 403(g), a permit shall be issued ation. to the applicant for interstate ship- (8) A statement of how the variation ment of such food. The terms and con- is of potential advantage to consumers. ditions of the permit shall be those set The statement shall include the rea- forth in the application with such sons why the applicant does not con- modifications, restrictions, or quali- sider the data obtained in any prior in- fications as the Food and Drug Admin- vestigations which may have been con- istration may deem necessary and ducted sufficient to support a petition state in the permit. to amend the standard. (f) The terms and conditions of the (9) The proposed label (or an accurate permit may be modified at the discre- draft) to be used on the food to be mar- tion of the Food and Drug Administra- ket tested. The label shall conform in tion or upon application of the per- all respects to the general require- mittee during the effective period of ments of the act and shall provide a the permit. means whereby the consumer can distinguish between the food being tested (g) The Food and Drug Administra- and such food complying with the tion may revoke a permit for cause, standard. which shall include but not be limited (10) The period during which the ap- to the following: plicant desires to introduce such food (1) That the permittee has introduced into interstate commerce, with a state- a food into interstate commerce con- ment of the reasons supporting the trary to the terms and conditions of need for such period. If a period longer the permit. than 15 months is requested, a detailed (2) That the application for a permit explanation of why a 15-month period contains an untrue statement of a ma- is inadequate shall be provided. terial fact. (11) The probable amount of such (3) That the need therefor no longer food that will be distributed. The exists. amount distributed should be limited (h) During the period within which to the smallest number of units reason- any permit is effective, it shall be ably required for a bona fide market deemed to be included within the terms test. Justification for the amount re- of any guaranty or undertaking other- quested shall be included. wise effective pursuant to the provi- (12) The areas of distribution. sions of section 303(c) of the act. (13) The address at which such food (i) If an application is made for an will be manufactured. extension of the permit, it shall be ac- (14) A statement of whether or not companied by a description of experi- such food has been or is to be distrib- ments conducted under the permit,

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tentative conclusions reached, and rea- the Food and Drug Administration pur- sons why further experimental ship- suant to part 16 of this chapter. ments are considered necessary. The [42 FR 14357, Mar. 15, 1977, as amended at 42 application for an extension shall be FR 15673, Mar. 22, 1977; 46 FR 37500, July 21, filed not later than 3 months prior to 1981; 54 FR 24892, June 12, 1989; 59 FR 15051, the expiration date of the permit and Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR shall be accompanied by a petition to 56035, Nov. 6, 2001] amend the affected food standard. If the Food and Drug Administration con- Subpart B—Food Additives in cludes that it will be in the interest of Standardized Foods consumers to issue an extension of the time period for the market test, a no- § 130.20 Food additives proposed for tice will be published in the FEDERAL use in foods for which definitions REGISTER stating that fact. The notice and standards of identity are estab- will include an invitation to all inter- lished. ested persons to participate in the mar- (a) Where a petition is received for ket test under the same conditions the issuance or amendment of a regula- that applied to the initial permit hold- tion establishing a definition and er, including labeling and the amount standard of identity for a food under to be distributed, except that the des- section 401 of the act, which proposes ignated area of distribution shall not the inclusion of a food additive in such apply. The extended market test period definition and standard of identity, the shall not begin prior to the publication provisions of the regulations in part 171 of a notice in the FEDERAL REGISTER of this chapter shall apply with respect granting the extension and shall termi- to the information that must be sub- nate either on the effective date of an mitted with respect to the food addi- affirmative order ruling on the pro- tive. Since section 409(b)(5) of the act posal or 30 days after a negative order requires that the Commissioner publish ruling on the proposal, whichever the notice of a petition for the establish- case may be. Any interested person ment of a food additive regulation who accepts the invitation to partici- within 30 days after filing, notice of a pate in the extended market test shall petition relating to a definition and notify the Food and Drug Administra- standard of identity shall also be pub- tion in writing of that fact, the amount lished within that time limitation if it to be distributed, and the area of dis- includes a request, so designated, for tribution; and along with such notifica- the establishment of a regulation per- tion, he shall submit the labeling under taining to a food additive. which the food is to be distributed. (b) If a petition for a definition and (j) Notice of the granting or revoca- standard of identity contains a pro- tion of any permit shall be published in posal for a food additive regulation, the FEDERAL REGISTER. and the petitioner fails to designate it (k) All applications for a temporary as such, the Commissioner, upon deter- permit, applications for an extension of mining that the petition includes a a temporary permit, and related proposal for a food additive regulation, records are available for public disclo- shall so notify the petitioner and shall sure when the notice of a permit or ex- thereafter proceed in accordance with tension thereof is published in the FED- the regulations in part 171 of this chap- ERAL REGISTER. Such disclosure shall ter. be in accordance with the rules established in part 20 of this chapter. PART 131—MILK AND CREAM (l) Any person who contests denial, modification, or revocation of a tem- Subpart A—General Provisions porary permit shall have an opportunity for a regulatory hearing before Sec. 131.3 Definitions. 131.25 Whipped cream products containing flavoring or sweetening.

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Subpart B—Requirements for Specific Temperature Time Standardized Milk and Cream 212 °F ...... 0.01 second

131.110 Milk. 1 If the dairy ingredient has a fat content of 10 percent or 131.111 Acidified milk. more, or if it contains added sweeteners, the specified tem- ° 131.112 Cultured milk. perature shall be increased by 5 F. 131.115 Concentrated milk. (c) Ultra-pasteurized when used to de- 131.120 Sweetened condensed milk. scribe a dairy product means that such 131.125 Nonfat dry milk. product shall have been thermally 131.127 Nonfat dry milk fortified with vita- processed at or above 280 °F for at least mins A and D. 2 seconds, either before or after pack- 131.130 Evaporated milk. aging, so as to produce a product which 131.147 Dry whole milk. 131.149 Dry cream. has an extended shelf life under refrig- 131.150 Heavy cream. erated conditions. 131.155 Light cream. 131.157 Light whipping cream. § 131.25 Whipped cream products con- 131.160 Sour cream. taining flavoring or sweetening. 131.162 Acidified sour cream. The unqualified name ‘‘whipped 131.170 Eggnog. cream’’ should not be applied to any 131.180 Half-and-half. product other than one made by whip- 131.200 Yogurt. ping the cream that complies with the 131.203 Lowfat yogurt. standards of identity for whipping 131.206 Nonfat yogurt. cream (§§ 131.150 and 131.157 of this AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, chapter). If flavoring and/or sweetening 379e. is added, the resulting product is a fla- SOURCE: 42 FR 14360, Mar. 15, 1977, unless vored and/or sweetened whipped cream, otherwise noted. and should be so identified.

EDITORIAL NOTE: Nomenclature changes to part 131 appear at 63 FR 14035, Mar. 24, 1998. Subpart B—Requirements for Spe- cific Standardized Milk and Subpart A—General Provisions Cream

§ 131.3 Definitions. § 131.110 Milk. (a) Cream means the liquid milk prod- (a) Description. Milk is the lacteal se- uct high in fat separated from milk, cretion, practically free from colos- which may have been adjusted by add- trum, obtained by the complete milking thereto: Milk, concentrated milk, ing of one or more healthy cows. Milk dry whole milk, skim milk, con- that is in final package form for bev- centrated skim milk, or nonfat dry erage use shall have been pasteurized milk. Cream contains not less than 18 or ultrapasteurized, and shall contain percent milkfat. not less than 81⁄4 percent milk solids (b) Pasteurized when used to describe not fat and not less than 31⁄4 percent a dairy product means that every par- milkfat. Milk may have been adjusted ticle of such product shall have been by separating part of the milkfat heated in properly operated equipment therefrom, or by adding thereto cream, to one of the temperatures specified in concentrated milk, dry whole milk, the table of this paragraph and held skim milk, concentrated skim milk, or continuously at or above that tempera- nonfat dry milk. Milk may be homog- ture for the specified time (or other enized. time/temperature relationship which (b) Vitamin addition (Optional). (1) If has been demonstrated to be equivalent added, vitamin A shall be present in thereto in microbial destruction): such quantity that each quart of the Temperature Time food contains not less than 2000 Inter- national Units thereof within limits of ° 1 145 F ...... 30 minutes good manufacturing practice. 161 °F 1 ...... 15 seconds 191 °F ...... 1 second (2) If added, vitamin D shall be 204 °F ...... 0.05 second present in such quantity that each

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quart of the food contains 400 Inter- D added’’, as is appropriate. The word national Units thereof within limits of ‘‘vitamin’’ may be abbreviated ‘‘vit.’’. good manufacturing practice. (ii) The word ‘‘ultra-pasteurized’’ if (c) Optional ingredients. The following the food has been ultra-pasteurized. safe and suitable ingredients may be (2) The following terms may appear used: on the label: (1) Carriers for vitamins A and D. (i) The word ‘‘pasteurized’’ if the food (2) Characterizing flavoring ingredi- has been pasteurized. ents (with or without coloring, nutri- (ii) The word ‘‘homogenized’’ if the tive sweetener, emulsifiers, and stabi- food has been homogenized. lizers) as follows: (f) Label declaration. Each of the in- (i) Fruit and fruit juice (including gredients used in the food shall be de- concentrated fruit and fruit juice). clared on the label as required by the (ii) Natural and artificial food applicable sections of parts 101 and 130 flavorings. of this chapter. (d) Methods of analysis. Referenced methods are from ‘‘Official Methods of [42 FR 14360, Mar. 15, 1977, as amended at 47 Analysis of the Association of Official FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, Analytical Chemists,’’ 13th Ed. (1980), 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, which is incorporated by reference. Jan. 6, 1993] Copies may be obtained from the AOAC § 131.111 Acidified milk. INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, (a) Description. Acidified milk is the or may be examined at the National food produced by souring one or more Archives and Records Administration of the optional dairy ingredients speci- (NARA). For information on the avail- fied in pargaph (c) of this section with ability of this material at NARA, call one or more of the acidifying ingredi- 202–741–6030, or go to: http:// ents specified in paragraph (d) of this www.archives.gov/federallregister/ section, with or without the addition of codeloflfederallregulations/ characterizing microbial organisms. ibrllocations.html. One or more of the other optional in- (1) Milkfat content—‘‘Fat, Roese- gredients specified in paragraphs (b) Gottlieb Method—Official Final Ac- and (e) of this section may also be tion,’’ section 16.059. added. When one or more of the ingre- (2) Milk solids not fat content—Cal- dients specified in paragraph (e)(1) of culated by subtracting the milk fat this section are used, they shall be in- content from the total solids content cluded in the souring process. All in- as determined by the method ‘‘Total gredients used are safe and suitable. Solids, Method I—Official Final Ac- Acidified milk contains not less than tion,’’ section 16.032. 3.25 percent milkfat and not less than (3) Vitamin D content—‘‘Vitamin D— 8.25 percent milk solids not fat and has Official Final Action,’’ sections 43.195– a titratable acidity of not less than 0.5 43.208. percent, expressed as lactic acid. The (e) Nomenclature. The name of the food may be homogenized and shall be food is ‘‘milk’’. The name of the food pasteurized or ultra-pasteurized prior shall be accompanied on the label by a to the addition of the microbial culture declaration indicating the presence of and, when applicable, the addition of any characterizing flavoring, as speci- flakes or granules of butterfat or fied in § 101.22 of this chapter. milkfat. (1) The following terms shall accom- (b) Vitamin addition (optional). (1) If pany the name of the food wherever it added, vitamin A shall be present in appears on the principal display panel such quantity that each 946 milliliters or panels of the label in letters not less (quart) of the food contains not less than one-half the height of the letters than 2,000 International Units thereof, used in such name: within limits of good manufacturing (i) If vitamins are added, the phrase practice. ‘‘vitamin A’’ or ‘‘vitamin A added’’, or (2) If added, vitamin D shall be ‘‘vitamin D’’ or ‘‘vitamin D added’’, or present in such quantity that each 946 ‘‘vitamin A and D’’ or ‘‘vitamins A and milliliters (quart) of the food contains

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400 International Units thereof, within available for inspection at the National limits of good manufacturing practice. Archives and Records Administration (c) Optional dairy ingredients. Cream, (NARA). For information on the avail- milk, partially skimmed milk, or skim ability of this material at NARA, call milk, used alone or in combination. 202–741–6030, or go to: http:// (d) Optional acidifying ingredients. www.archives.gov/federallregister/ Acetic acid, adipic acid, citric acid, fu- codeloflfederallregulations/ maric acid, glucono-delta- lactone, hy- ibrllocations.html. drochloric acid, lactic acid, malic acid, (1) Milkfat content—As determined phosphoric acid, succinic acid, and tar- by the method prescribed in section taric acid. 16.059, ‘‘Roese-Gottlieb Method (Ref- (e) Other optional ingredients. (1) Con- erence Method) (11)—Official Final Ac- centrated skim milk, nonfat dry milk, tion,’’ under the heading ‘‘Fat.’’ buttermilk, whey, lactose, (2) Milk solids not fat content—Cal- lactalbumins, lactoglobulins, or whey culated by subtracting the milkfat con- modified by partial or complete re- tent from the total solids content as moval of lactose and/or minerals, to in- determined by the method prescribed crease the nonfat solids content of the in section 16.032, ‘‘Method I—Official food: Provided, That the ratio of pro- Final Action,’’ under the heading tein to total nonfat solids of the food, ‘‘Total Solids.’’ and the protein efficiency ratio of all (3) Titratable acidity—As determined protein present, shall not be decreased by the method prescribed in section as a result of adding such ingredients. 16.023, ‘‘Acidity (2)—Official Final Ac- (2) Nutritive carbohydrate sweet- tion,’’ or by an equivalent potentio- eners. Sugar (sucrose), beet or cane; in- metric method. vert sugar (in paste or sirup form); (g) Nomenclature. The name of the brown sugar; refiner’s sirup; molasses food is ‘‘acidified milk’’. The full name (other than blackstrap); high fructose of the food shall appear on the prin- corn sirup; fructose; fructose sirup; cipal display panel of the label in type maltose; maltose sirup, dried maltose of uniform size, style, and color. The sirup; malt extract, dried malt extract; name of the food shall be accompanied malt sirup, dried malt sirup; honey; by a declaration indicating the pres- maple sugar; or any of the sweeteners ence of any characterizing flavoring as listed in part 168 of this chapter, except specified in § 101.22 of this chapter, and table sirup. may be accompanied by a declaration (3) Flavoring ingredients. such as a traditional name of the food (4) Color additives that do not impart or the generic name of the organisms a color simulalting that of milkfat or used, thereby indicating the presence butterfat. of the characterizing microbial orga- (5) Stabilizers. nisms or ingredients when used, e.g., (6) Butterfat or milkfat, which may ‘‘acidified kefir milk’’, ‘‘acidified aci- or may not contain color additives, in dophilus milk’’, or when characterizing the form of flakes or granules. ingredients such as those in paragraphs (7) Aroma- and flavor-producing mi- (e) (6), (7), (8), and (9) of this section are crobial culture. used, the food may be named ‘‘acidified (8) Salt. buttermilk’’. (9) Citric acid, in a maximum amount (1) The following terms shall accom- of 0.15 percent by weight of the milk pany the name of the food wherever it used, or an equivalent amount of so- appears on the principal display panel dium citrate, as a flavor precursor. or panels of the label in letters not less (f) Methods of analysis. The following than one-half of the height of the let- referenced methods of analysis are ters used in such name: from ‘‘Official Methods of Analysis of (i) The phrase ‘‘vitamin A’’ or ‘‘vita- the Association of Official Analytical min A added’’, or ‘‘vitamin D’’ or ‘‘vi- Chemists,’’ 13th Ed. (1980), which is in- tamin D added’’, or ‘‘vitamins A and D corporated by reference. Copies are added’’, as appropriate. The word ‘‘vi- available from the AOAC INTER- tamin’’ may be abbreviated ‘‘vit.’’. NATIONAL, 481 North Frederick Ave., (ii) The word ‘‘sweetened’’ if nutri- suite 500, Gaithersburg, MD 20877, or tive carbohydrate sweetener is added

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without the addition of characterizing by partial or complete removal of lac- flavoring. tose and/or minerals, to increase the (2) The term ‘‘homogenized’’ may ap- nonfat solids content of the food: Pro- pear on the label if the dairy ingredi- vided, That the ratio of protein to total ents used are homogenized. nonfat solids of the food, and the pro- (h) Label declaration. Each of the in- tein efficiency ratio of all protein gredients used in the food shall be de- present, shall not be decreased as a re- clared on the label as required by the sult of adding such ingredients. applicable sections of parts 101 and 130 (2) Nutritive carbohydrate sweet- of this chapter. eners. Sugar (sucrose), beet or cane; in- [46 FR 9934, Jan. 30, 1981, as amended at 47 vert sugar (in paste or sirup form); FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, brown sugar; refiner’s sirup; molasses 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, (other than blackstrap); high fructose June 12, 1989; 58 FR 2890, Jan. 6, 1993] corn sirup; fructose; fructose sirup; maltose; maltose sirup, dried maltose § 131.112 Cultured milk. sirup; malt extract, dried malt extract; (a) Description. Cultured milk is the malt sirup, dried malt sirup; honey; food produced by culturing one or more maple sugar; or any of the sweeteners of the optional dairy ingredients speci- listed in part 168 of this chapter, except fied in paragraph (c) of this section table sirup. with characterizing microbial orga- (3) Flavoring ingredients. nisms. One or more of the other op- (4) Color additives that do not impart tional ingredients specified in para- a color simulating that of milkfat or graphs (b) and (d) of this section may butterfat. also be added. When one or more of the (5) Stabilizers. ingredients specified in paragraph (6) Butterfat or milkfat, which may (d)(1) of this section are used, they or may not contain color additives, in shall be included in the culturing proc- the form of flakes or granules. ess. All ingredients used are safe and (7) Aroma- and flavor-producing mi- suitable. Cultured milk contains not crobial culture. less than 3.25 percent milkfat and not (8) Salt. less than 8.25 percent milk solids not (9) Citric acid, in a maximum amount fat and has a titratable acidity of not of 0.15 percent by weight of the milk less than 0.5 percent, expressed as lac- used, or an equivalent amount of so- tic acid. The food may be homogenized dium citrate, as a flavor precursor. and shall be pasteurized or ultra-pas- (e) Methods of analysis. The following teurized prior to the addition to the referenced methods of analysis are microbial culture, and when applicable, from ‘‘Official Methods of Analysis of the addition of flakes or granules of the Association of Official Analytical butterfat or milkfat. Chemists,’’ 13th Ed. (1980), which is in- (b) Vitamin addition (optional). (1) If corporated by reference. Copies may be added, vitamin A shall be present in obtained from the AOAC INTER- such quantity that each 946 milliliters NATIONAL, 481 North Frederick Ave., (quart) of the food contains not less suite 500, Gaithersburg, MD 20877, or than 2,000 International Units thereof, available for inspection at the National within limits of good manufacturing Archives and Records Administration practice. (NARA). For information on the avail- (2) If added, vitamin D shall be ability of this material at NARA, call present in such quantity that each 946 202–741–6030, or go to: http:// milliliters (quart) of the food contains www.archives.gov/federallregister/ 400 International Units thereof, within codeloflfederallregulations/ limits of good manufacturing practice. ibrllocations.html. (c) Optional dairy ingredients. Cream, (1) Milkfat content—section 16.059, milk, partially skimmed milk, or skim ‘‘Roese-Gottlieb Method (Reference milk, used alone or in combination. Method) (11)—Official Final Action,’’ (d) Other optional ingredients. (1) Con- under the heading ‘‘Fat.’’ centrated skim milk, nonfat dry milk, (2) Milk solids not fat content—Cal- buttermilk, whey, lactose, lactalbum- culated by subtracting the milkfat con- ins, lactoglobulins, or whey modified tent from the total solids content as

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determined by the method prescribed § 131.115 Concentrated milk. in section 16.032, ‘‘Method I—Official (a) Description. Concentrated milk is Final Action,’’ under the heading the liquid food obtained by partial re- ‘‘Total Solids.’’ moval of water from milk. The milkfat (3) Titratable acidity—As determined and total milk solids contents of the by the methods prescribed in section food are not less than 7.5 and 25.5 per- 16.023 ‘‘Acidity (2)—Official Final Ac- cent, respectively. It is pasteurized, tion,’’ or by an equivalent potentio- but is not processed by heat so as to metric method. prevent spoilage. It may be homog- (f) Nomenclature. The name of the enized. food is ‘‘cultured milk’’. The full name (b) Vitamin addition (Optional). If of the food shall appear on the prin- added, vitamin D shall be present in cipal display panel in type of uniform such quantity that each fluid ounce of size, style, and color. The name of the the food contains 25 International food shall be accompanied by a declara- Units thereof, within limits of good tion indicating the presence of any manufacturing practice. characterizing flavoring as specified in (c) Optional ingredients. The following § 101.22 of this chapter, and may be ac- safe and suitable optional ingredients companied by a declaration such as a may be used: (1) Carrier for vitamin D. traditional name of the food or the ge- (2) Characterizing flavoring ingredi- neric name of the organisms used, ents, with or without coloring, as fol- thereby indicating the presence of the lows: characterizing microbial organisms or (i) Fruit and fruit juice, including ingredients, e.g., ‘‘kefir cultured concentrated fruit and fruit juice. milk’’, ‘‘acidophilus cultured milk’’, or (ii) Natural and artificial food fla- when characterizing ingredients such voring. as those in paragraphs (d) (6), (7), (8), (d) Methods of analysis. Referenced and (9) of this section, and lactic acid- methods are from ‘‘Official Methods of producing organisms are used the food Analysis of the Association of Official may be named ‘‘cultured buttermilk’’. Analytical Chemists,’’ 13th Ed. (1980), (1) The following terms shall accom- which is incorporated by reference. pany the name of the food wherever it Copies may be obtained from the AOAC appears on the principal display panel INTERNATIONAL, 481 North Frederick or panels of the label in letters not less Ave., suite 500, Gaithersburg, MD 20877, than one-half of the height of the let- or may be examined at the National ters used in such name: Archives and Records Administration (i) The phrase ‘‘vitamin A’’ or ‘‘vita- (NARA). For information on the avail- min A added’’, or ‘‘vitamin D’’ or ‘‘vi- ability of this material at NARA, call tamin D added’’, or ‘‘vitamin A and D 202–741–6030, or go to: http:// added’’, as appropriate. The word ‘‘vi- www.archives.gov/federallregister/ tamin’’ may be abbreviated ‘‘vit.’’. codeloflfederallregulations/ (ii) The word ‘‘sweetened’’ if nutri- ibrllocations.html. tive carbohydrate sweetener is added (1) Milkfat content—‘‘Fat—Official without the addition of characterizing Final Action,’’ section 16.172. flavoring. (2) Total milk solids—‘‘Total Solids— Official Final Action,’’ section 16.169. (2) The term ‘‘homogenized’’ may ap- (3) Vitamin D content—‘‘Vitamin D pear on the label if the dairy ingredi- in Milk—Official Final Action,’’ sec- ents used are homogenized. tions 43.195–43.208. (g) Label declaration. Each of the in- (e) Nomenclature. The name of the gredients used in the food shall be de- food is ‘‘Concentrated milk’’ or alter- clared on the label as required by the natively ‘‘Condensed milk’’. If the food applicable sections of parts 101 and 130 contains added vitamin D, the phrase of this chapter. ‘‘vitamin D’’ or ‘‘vitamin D added’’ [46 FR 9934, Jan. 30, 1981, as amended at 47 shall accompany the name of the food FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, wherever it appears on the principal 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, display panel or panels of the label in June 12, 1989; 58 FR 2890, Jan. 6, 1993] letters not less than one-half the

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height of the letters used in such name. (d) Nomenclature. The name of the The word ‘‘homogenized’’ may appear food is ‘‘Sweetened condensed milk.’’ on the label if the food has been ho- The word ‘‘homogenized’’ may appear mogenized. The name of the food shall on the label if the food has been ho- include a declaration of the presence of mogenized. The name of the food shall any characterizing flavoring, as speci- include a declaration of the presence of fied in § 101.22 of this chapter. any characterizing flavoring, as speci- (f) Label declaration. Each of the in- fied in § 101.22 of this chapter. gredients used in the food shall be de- (e) Label declaration. Each of the in- clared on the label as required by the gredients used in the food shall be de- applicable sections of parts 101 and 130 clared on the label as required by the of this chapter. applicable sections of parts 101 and 130 of this chapter. [42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 48 FR 13024, Mar. 29, [43 FR 21670, May 19, 1978, as amended at 47 1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, June 12, 1989; 58 FR 2890, Jan. 6, 1993] 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993] § 131.120 Sweetened condensed milk. § 131.125 Nonfat dry milk. (a) Description. Sweetened condensed (a) Description. Nonfat dry milk is the milk is the food obtained by partial re- product obtained by removal of water moval of water only from a mixture of only from pasteurized skim milk. It milk and safe and suitable nutritive contains not more than 5 percent by carbohydrate sweeteners. The finished weight of moisture, and not more than food contains not less than 8 percent 11⁄2 percent by weight of milkfat unless by weight of milkfat, and not less than otherwise indicated. 28 percent by weight of total milk sol- (b) Optional ingredients. Safe and suit- ids. The quantity of nutritive carbo- able characterizing flavoring ingredi- hydrate sweetener used is sufficient to ents (with or without coloring and nu- prevent spoilage. The food is pasteur- tritive carbohydrate sweetener) as fol- ized and may be homogenized. lows: (b) Optional ingredients. The following (1) Fruit and fruit juice, including safe and suitable characterizing fla- concentrated fruit and fruit juice. voring ingredients, with or without (2) Natural and artificial food coloring and nutritive carbohydrate flavorings. sweeteners, may be used: (c) Methods of analysis. The following (1) Fruit and fruit juice, including referenced methods of analysis are concentrated fruit and fruit juice. from ‘‘Official Methods of Analysis of (2) Natural and artificial food fla- the Association of Official Analytical voring. Chemists,’’ 13th Ed. (1980), which is in- (c) Methods of analysis. The milkfat corporated by reference. Copies may be content is determined by the method obtained from the AOAC INTER- prescribed in ‘‘Official Methods of NATIONAL, 481 North Frederick Ave., Analysis of the Association of Official suite 500, Gaithersburg, MD 20877, or Analytical Chemists,’’ 13th Ed. (1980), may be examined at the National Ar- section 16.185, under ‘‘Fat—Official chives and Records Administration Final Action,’’ which is incorporated (NARA). For information on the avail- by reference. Copies may be obtained ability of this material at NARA, call from the AOAC INTERNATIONAL, 481 202–741–6030, or go to: http:// North Frederick Ave., suite 500, Gai- www.archives.gov/federallregister/ thersburg, MD 20877, or may be exam- codeloflfederallregulations/ ined at the National Archives and ibrllocations.html. Records Administration (NARA). For (1) Milkfat content—‘‘Fat in Dried information on the availability of this Milk—Official Final Action,’’ sections material at NARA, call 202–741–6030, or 16.199–16.200. go to: http://www.archives.gov/ (2) Moisture content—‘‘Moisture—Of- federallregister/ ficial Final Action,’’ section 16.192. codeloflfederallregulations/ (d) Nomenclature. The name of the ibrllocations.html. food is ‘‘Nonfat dry milk’’. If the fat

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content is over 11⁄2 percent by weight, (i) Fruit and fruit juice, including the name of the food on the principal concentrated fruit and fruit juice. display panel or panels shall be accom- (ii) Natural and artificial food panied by the statement ‘‘Contains l% flavorings. milkfat’’, the blank to be filled in with (d) Methods of analysis. The following the percentage to the nearest one- referenced methods of analysis are tenth of 1 percent of fat contained, from ‘‘Official Methods of Analysis of within limits of good manufacturing the Association of Official Analytical practice. The name of the food shall in- Chemists,’’ 13th Ed. (1980), which is include a declaration of the presence of corporated by reference. Copies may be any characterizing flavoring, as speci- obtained from the AOAC INTER- fied in § 101.22 of this chapter. NATIONAL, 481 North Frederick Ave., (e) Label declaration. Each of the in- suite 500, Gaithersburg, MD 20877, or gredients used in the food shall be declared on the label as required by the may be examined at the National Ar- applicable sections of parts 101 and 130 chives and Records Administration of this chapter. (NARA). For information on the availability of this material at NARA, call [42 FR 14360, Mar. 15, 1977, as amended at 43 202–741–6030, or go to: http:// FR 19836, May 9, 1978; 47 FR 11823, Mar. 19, www.archives.gov/federallregister/ 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993] codeloflfederallregulations/ ibrllocations.html. § 131.127 Nonfat dry milk fortified (1) Milkfat content—‘‘Fat in Dried with vitamins A and D. Milk—Official Final Action,’’ sections (a) Description. Nonfat dry milk for- 16.199–16.200. tified with vitamins A and D conforms (2) Moisture content—‘‘Moisture—Of- to the standard of identity for nonfat ficial Final Action,’’ section 16.192. dry milk, except that vitamins A and D (3) Vitamin D content—‘‘Vitamin D— are added as prescribed by paragraph Official Final Action,’’ sections 43.195– (b) of this section. 43.208. (b) Vitamin addition. (1) Vitamin A is (e) Nomenclature. The name of the added in such quantity that, when pre- food is ‘‘Nonfat dry milk fortified with pared according to label directions, vitamins A and D’’. If the fat content is each quart of the reconstituted product over 11⁄2 percent by weight, the name of contains 2000 International Units the food on the principal display panel thereof. or panels shall be accompanied by the (2) Vitamin D is added in such quan- statement ‘‘Contains l% milkfat’’, the tity that, when prepared according to blank to be filled in to the nearest one- label directions, each quart of the re- tenth of 1 percent with the percentage constituted product contains 400 Inter- of fat contained within limits of good national Units thereof. manufacturing practice. The name of (3) The requirements of this para- the food shall include a declaration of graph will be deemed to have been met the presence of any characterizing fla- if reasonable overages, within limits of voring, as specified in § 101.22 of this good manufacturing practice, are chapter. present to ensure that the required lev- (f) Label declaration. Each of the in- els of vitamins are maintained throughout the expected shelf life of gredients used in the food shall be de- the food under customary conditions of clared on the label as required by the distribution. applicable sections of parts 101 and 130 (c) Optional ingredients. The following of this chapter. safe and suitable optional ingredients [42 FR 14360, Mar. 15, 1977, as amended at 43 may be used: FR 19836, May 9, 1978; 43 FR 29769, July 11, (1) Carriers for vitamins A and D. 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, (2) Characterizing flavoring ingredi- Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR ents, with or without coloring and nu- 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993] tritive carbohydrate sweetener, as follows:

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§ 131.130 Evaporated milk. codeloflfederallregulations/ (a) Description. Evaporated milk is ibrllocations.html. (1) Milkfat content—‘‘Fat—Official the liquid food obtained by partial re- Final Action,’’ section 16.172. moval of water only from milk. It con- (2) Total milk solids—‘‘Total Solids— tains not less than 6.5 percent by Official Final Action,’’ section 16.169. weight of milkfat, not less than 16.5 (3) Vitamin D content—‘‘Vitamin D percent by weight of milk solids not in Milk—Official Final Action,’’ sec- fat, and not less than 23 percent by weight of total milk solids. Evaporated tions 43.195–43.208. (e) The name of the milk contains added vitamin D as pre- Nomenclature. scribed by paragraph (b) of this section. food is ‘‘Evaporated milk.’’ The phrase It is homogenized. It is sealed in a con- ‘‘vitamin D’’ or ‘‘vitamin D added’’, or tainer and so processed by heat, either ‘‘vitamins A and D’’ or ‘‘vitamins A before or after sealing, as to prevent and D added’’, as is appropriate, shall spoilage. immediately precede or follow the (b) Vitamin addition. (1) Vitamin D name of the food wherever it appears shall be present in such quantity that on the principal display panel or panels each fluid ounce of the food contains 25 of the label in letters not less than one- International Units thereof within lim- half the height of the letters used in its of good manufacturing practice. such name. The name of the food shall (2) Addition of vitamin A is optional, include a declaration of a the presence If added, vitamin A shall be present in of any characterizing flavoring, as such quantity that each fluid ounce of specified in § 101.22 of this chapter. the food contains not less than 125 (f) Label declaration. Each of the in- International Units thereof within lim- gredients used in the food shall be de- its of good maufacturing practice. clared on the label as required by the (c) Optional ingredients. The following applicable sections of parts 101 and 130 safe and suitable ingredients may be of this chapter. used: [43 FR 21670, May 19, 1978, as amended at 47 (1) Carriers for vitamins A and D. FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, (2) Emulsifiers. 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, (3) Stabilizers, with or without Jan. 6, 1993; 59 FR 17691, Apr. 14, 1994] dioctyl sodium sulfosuccinate (when permitted by and complying with the § 131.147 Dry whole milk. provisions of § 172.810 of this chapter) as (a) Description. Dry whole milk is the a solubilizing agent. product obtained by removal of water (4) Characterizing flavoring ingredi- only from pasteurized milk, as defined ents, with or without coloring and nu- in § 131.110(a), which may have been ho- tritive carbohydrate sweeteners, as fol- mogenized. Alternatively, dry whole lows: milk may be obtained by blending (i) Fruit and fruit juice, including fluid, condensed, or dried nonfat milk concentrated fruit and fruit juice. with liquid or dried cream or with (ii) Natural and artificial food fla- fluid, condensed, or dried milk, as ap- voring. propriate, provided the resulting dry (d) Methods of analysis. The following whole milk is equivalent in composi- referenced methods of analysis are tion to that obtained by the method from ‘‘Official Methods of Analysis of described in the first sentence of this the Association of Official Analytical paragraph. It contains the lactose, Chemists,’’ 13th Ed. (1980), which is in- milk proteins, milkfat, and milk min- corporated by reference. Copies may be erals in the same relative proportions obtained from the AOAC INTER- as the milk from which it was made. It NATIONAL, 481 North Frederick Ave., contains not less than 26 percent but suite 500, Gaithersburg, MD 20877, or less than 40 percent by weight of may be examined at the National Ar- milkfat on an as is basis. It contains chives and Records Administration not more than 5 percent by weight of (NARA). For information on the avail- moisture on a milk solids not fat basis. ability of this material at NARA, call (b) Vitamin addition. (1) Addition of 202–741–6030, or go to: http:// vitamin A is optional. If added, vita- www.archives.gov/federallregister/ min A shall be present in such quantity

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that, when prepared according to label (e) Nomenclature. The name of the directions, each quart of the reconsti- food is ‘‘Dry whole milk.’’ The name of tuted product shall contain not less the food shall appear on the principal than 2,000 International Units thereof. display panel of the label in type of (2) Addition of vitamin D is optional. uniform size, style, and color. The If added, vitamin D shall be present in name of the food shall be accompanied such quantity that, when prepared ac- by a declaration indicating the pres- cording to label directions, each quart ence of any characterizing flavoring as of the reconstituted product shall con- specified in § 101.22 of this chapter. The tain 400 International Units thereof. following phrases in type size not less (3) The requirements of this para- than one-half the height of the type graph will be met if reasonable over- size used in such name shall accom- ages, within limits of good manufac- pany the name of the food wherever it turing practice, are present to ensure appears on the principal display panel that the required levels of vitamins are or panels. maintained throughout the expected (1) The phrase ‘‘Contains l% shelf life of the food under customary milkfat’’, the blank to be filled in with conditions of distribution. the whole number closest to the actual (c) Optional ingredients. The following fat content of the food. safe and suitable optional ingredients (2) If vitamins are ‘‘added’’, the may be used: phrase ‘‘vitamin A’’, or ‘‘vitamin A (1) Carriers for vitamins A and D. added’’, or ‘‘vitamin D’’, or ‘‘vitamin D (2) Emulsifiers. added’’, or ‘‘vitamins A and D’’, or ‘‘vi- (3) Stabilizers. tamins A and D added’’, as appropriate. (4) Anticaking agents. The word ‘‘vitamin’’ may be abbre- (5) Antioxidants. viated ‘‘vit.’’ (6) Characterizing flavoring ingredi- (f) Label declaration. Each of the in- ents (with or without coloring and nu- gredients used in the food shall be de- tritive carbohydrate sweetener) as fol- clared on the label as required by the lows: applicable sections of parts 101 and 130 (i) Fruit and fruit juice, including of this chapter. concentrated fruit and fruit juice. [43 FR 19836, May 9, 1978, as amended at 47 (ii) Natural and artificial food fla- FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, voring. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, (d) Methods of analysis. The following Jan. 6, 1993] referenced methods of analysis are from ‘‘Official Methods of Analysis of § 131.149 Dry cream. the Association of Official Analytical (a) Description. Dry cream is the prod- Chemists,’’ 13th Ed. (1980), which is in- uct obtained by removal of water only corporated by reference. Copies may be from pasteurized milk or cream or a obtained from the AOAC INTER- mixture thereof, which may have been NATIONAL, 481 North Frederick Ave., homogenized. Alternatively, dry cream suite 500, Gaithersburg, MD 20877, or may be obtained by blending dry milks may be examined at the National Ar- as defined in §§ 131.125(a) and 131.147(a) chives and Records Administration with dry cream as appropriate: Pro- (NARA). For information on the avail- vided, That the resulting product is ability of this material at NARA, call equivalent in composition to that ob- 202–741–6030, or go to: http:// tained by the method described in the www.archives.gov/federallregister/ first sentence of this paragraph. It con- codeloflfederallregulations/ tains not less than 40 percent but less ibrllocations.html. than 75 percent by weight of milkfat on (1) Milkfat content—‘‘Fat in Dried an as is basis. It contains not more Milk—Official Final Action,’’ sections than 5 percent by weight of moisture 16.199–16.200. on a milk solids not fat basis. (2) Moisture content—‘‘Moisture—Of- (b) Optional ingredients. The following ficial Final Action,’’ section 16.192. safe and suitable optional ingredients (3) Vitamin D content—‘‘Vitamin D— may be used: Official Final Action,’’ sections 43.195– (1) Emulsifiers. 43.208. (2) Stabilizers.

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(3) Anticaking agents. applicable sections of parts 101 and 130 (4) Antioxidants. of this chapter. (5) Nutritive carbohydrate sweeteners. [43 FR 19836, May 9, 1978, as amended at 44 FR 3965, Jan. 19, 1979; 47 FR 11824, Mar. 19, (6) Characterizing flavoring ingredi- 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092, ents, with or without coloring, as fol- Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR lows: 2891, Jan. 6, 1993; 61 FR 59002, Nov. 20, 1996] (i) Fruit and fruit juice, including concentrated fruit and fruit juice. § 131.150 Heavy cream. (ii) Natural and artificial food fla- (a) Description. Heavy cream is cream voring. which contains not less than 36 percent (c) Methods of analysis. The following milkfat. It is pasteurized or ultra-pas- referenced methods of analysis are teurized, and may be homogenized. from ‘‘Official Methods of Analysis of (b) Optional ingredients. The following the Association of Official Analytical safe and suitable optional ingredients Chemists,’’ 13th Ed. (1980), which is in- may be used: corporated by reference. Copies may be (1) Emulsifiers. obtained from the AOAC INTER- NATIONAL, 481 North Frederick Ave., (2) Stabilizers. suite 500, Gaithersburg, MD 20877, or (3) Nutritive sweeteners. may be examined at the National Ar- (4) Characterizing flavoring ingredi- chives and Records Administration ents (with or without coloring) as fol- (NARA). For information on the avail- lows: ability of this material at NARA, call (i) Fruit and fruit juice (including 202–741–6030, or go to: http:// concentrated fruit and fruit juice). www.archives.gov/federallregister/ (ii) Natural and artificial food fla- codeloflfederallregulations/ voring. ibrllocations.html. (c) Methods of analysis. The milkfat (1) Milkfat content—‘‘Fat in Dried content is determined by the method Milk—Official Final Action,’’ sections prescribed in ‘‘Official Methods of 16.199–16.200. Analysis of the Association of Official (2) Moisture content—‘‘Moisture—Of- Analytical Chemists,’’ 13th Ed. (1980), ficial Final Action,’’ section 16.192. sections 16.156 and 16.059, under ‘‘Fat, (d) Nomenclature. The name of the Roese-Gottlieb Method—Official Final food is ‘‘Dry cream.’’ The name of the Action,’’ which is incorporated by ref- food shall appear on the principal dis- erence. Copies may be obtained from play panel of the label in type of uni- the AOAC INTERNATIONAL, 481 North form size, style, and color. The name of Frederick Ave., suite 500, Gaithersburg, the food shall be accompanied by a dec- MD 20877, or may be examined at the laration indicating the presence of any National Archives and Records Admin- characterizing flavoring as specified in istration (NARA). For information on § 101.22 of this chapter. The following the availability of this material at terms shall accompany the name of the NARA, call 202–741–6030, or go to: http:// food wherever it appears on the prin- www.archives.gov/federallregister/ cipal display panel or panels of the codeloflfederallregulations/ label, in letters not less than one-half ibrllocations.html. of the height of the letters used in such (d) Nomenclature. (1) The name of the name: food is ‘‘Heavy cream’’ or alternatively (1) The phrase ‘‘Contains l% ‘‘Heavy whipping cream’’. The name of milkfat’’, the blank to be filled in with the food shall be accompanied on the the whole number closest to the actual label by a declaration indicating the fat content of the food. presence of any characterizing fla- (2) The word ‘‘sweetened’’ if no char- voring, as specified in § 101.22 of this acterizing flavoring ingredients are chapter. The following terms shall ac- used but nutritive carbohydrate sweet- company the name of the food wher- ener is added. ever it appears on the principal display (e) Label declaration. Each of the in- panel or panels of the label in letters gredients used in the food shall be de- not less than one-half the height of the clared on the label as required by the letters used in such name:

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(i) The word ‘‘ultra-pasteurized’’ if (d) Nomenclature. The name of the the food has been ultra-pasteurized. food is ‘‘Light cream’’, or alternatively (ii) The word ‘‘sweetened’’ if no char- ‘‘Coffee cream’’ or ‘‘Table cream’’. The acterizing flavoring ingredients are name of the food shall be accompanied used, but nutritive sweetener is added. on the label by a declaration indicating (2) The following terms may appear the presence of any characterizing fla- on the label: voring, as specified in § 101.22 of this (i) The word ‘‘pasteurized’’ if the food chapter. has been pasteurized. (1) The following terms shall accom- (ii) The word ‘‘homogenized’’ if the pany the name of the food wherever it food has been homogenized. appears on the principal display panel (e) Label declaration. Each of the in- or panels of the label in letters not less gredients used in the food shall be de- than one-half the height of the letters clared on the label as required by the used in such name: applicable sections of parts 101 and 130 (i) The word ‘‘ultra-pasteurized’’ if of this chapter. the food has been ultra-pasteurized. [42 FR 14360, Mar. 15, 1977, as amended at 47 (ii) The word ‘‘sweetened’’ if no char- FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, acterizing flavoring ingredients are 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, used, but nutritive sweetener is added. Jan. 6, 1993] (2) The following terms may appear on the label: § 131.155 Light cream. (i) The word ‘‘pasteurized’’ if the food (a) Description. Light cream is cream has been pasteurized. which contains not less than 18 percent (ii) The word ‘‘homogenized’’ if the but less than 30 percent milkfat. It is food has been homogenized. pasteurized or ultra-pasteurized, and (e) Label declaration. Each of the in- may be homogenized. gredients used in the food shall be de- (b) Optional ingredients. The following clared on the label as required by the safe and suitable ingredients may be applicable sections of parts 101 and 130 used: of this chapter. (1) Stabilizers. [42 FR 14360, Mar. 15, 1977, as amended at 47 (2) Emulsifiers. FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 1, (3) Nutritive sweeteners. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, (4) Characterizing flavoring ingredi- Jan. 6, 1993] ents (with or without coloring) as follows: § 131.157 Light whipping cream. (i) Fruit and fruit juice (including (a) Description. Light whipping cream concentrated fruit and fruit juice). is cream which contains not less than (ii) Natural and artificial food fla- 30 percent but less than 36 percent voring. milkfat. It is pasteurized or ultra-pas- (c) Methods of analysis. The milkfat teurized, and may be homogenized. content is determined by the method (b) Optional ingredients. The following prescribed in ‘‘Official Methods of safe and suitable optional ingredients Analysis of the Association of Official may be used: Analytical Chemists,’’ 13th Ed. (1980), (1) Emulsifiers. sections 16.156 and 16.059, under ‘‘Fat, (2) Stabilizers. Roese-Gottlieb Method—Official Final (3) Nutritive sweeteners. Action,’’ which is incorporated by ref- (4) Characterizing flavoring ingredi- erence. Copies may be obtained from ents (with or without coloring) as fol- the AOAC INTERNATIONAL, 481 North lows: Frederick Ave., suite 500, Gaithersburg, (i) Fruit and fruit juice (including MD 20877, or may be examined at the concentrated fruit and fruit juice). National Archives and Records Admin- (ii) Natural and artificial food fla- istration (NARA). For information on voring. the availability of this material at (c) Methods of analysis. The milkfat NARA, call 202–741–6030, or go to: http:// content is determined by the method www.archives.gov/federallregister/ prescribed in ‘‘Official Methods of codeloflfederallregulations/ Analysis of the Association of Official ibrllocations.html. Analytical Chemists,’’ 13th Ed. (1980),

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sections 16.156 and 16.059, under ‘‘Fat, mainder obtained by subtracting the Roese-Gottlieb Method—Official Final weight of such optional ingredients Action,’’ which is incorporated by ref- from the weight of the food; but in no erence. Copies may be obtained from case does the food contain less than the AOAC INTERNATIONAL, 481 North 14.4 percent milkfat. Sour cream has a Frederick Ave., suite 500, Gaithersburg, titratable acidity of not less than 0.5 MD 20877, or may be examined at the percent, calculated as lactic acid. National Archives and Records Admin- (b) Optional ingredients. (1) Safe and istration (NARA). For information on suitable ingredients that improve tex- the availability of this material at ture, prevent syneresis, or extend the NARA, call 202–741–6030, or go to: http:// shelf life of the product. www.archives.gov/federallregister/ (2) Sodium citrate in an amount not codeloflfederallregulations/ more than 0.1 percent may be added ibrllocations.html. prior to culturing as a flavor precursor. (d) Nomenclature. The name of the (3) Rennet. food is ‘‘Light whipping cream’’ or al- (4) Safe and suitable nutritive sweet- ternatively ‘‘Whipping cream’’. The eners. name of the food shall be accompanied (5) Salt. on the label by a declaration indicating (6) Flavoring ingredients, with or the presence of any characterizing fla- without safe and suitable coloring, as voring, as specified in § 101.22 of this follows: chapter. (i) Fruit and fruit juice (including (1) The following terms shall accom- concentrated fruit and fruit juice). pany the name of the food wherever it (ii) Safe and suitable natural and ar- appears on the principal display panel tificial food flavoring. or panels of the label in letters not less (c) Methods of analysis. Referenced than one-half the height of the letters methods in paragraph (c) (1) and (2) of used in such name: this section are from ‘‘Official Methods (i) The word ‘‘ultra-pasteurized’’ if of Analysis of the Association of Offi- the food has been ultra-pasteurized. cial Analytical Chemists,’’ 13th Ed. (ii) The word ‘‘sweetened’’ if no char- (1980), which is incorporated by ref- acterizing flavoring ingredients are erence. Copies may be obtained from used, but nutritive sweetener is added. the AOAC INTERNATIONAL, 481 North (2) The following terms may appear Frederick Ave., suite 500, Gaithersburg, on the label: MD 20877, or may be examined at the (i) The word ‘‘pasteurized’’ if the food National Archives and Records Admin- has been pasteurized. istration (NARA). For information on (ii) The word ‘‘homogenized’’ if the the availability of this material at food has been homogenized. NARA, call 202–741–6030, or go to: http:// (e) Label declaration. Each of the in- www.archives.gov/federallregister/ gredients used in the food shall be de- codeloflfederallregulations/ clared on the label as required by the ibrllocations.html. applicable sections of parts 101 and 130 (1) Milkfat content—‘‘Fat—Official of this chapter. Final Action,’’ section 16.172. [42 FR 14360, Mar. 15, 1977, as amended at 47 (2) Titratable acidity—‘‘Acidity—Of- FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, ficial Final Action,’’ section 16.023. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, (d) Nomenclature. The name of the Jan. 6, 1993] food is ‘‘Sour cream’’ or alternatively ‘‘Cultured sour cream’’. The full name § 131.160 Sour cream. of the food shall appear on the prin- (a) Description. Sour cream results cipal display panel of the label in type from the souring, by lactic acid proof uniform size, style, and color. The ducing bacteria, of pasteurized cream. name of the food shall be accompanied Sour cream contains not less than 18 by a declaration indicating the pres- percent milkfat; except that when the ence of any flavoring that character- food is characterized by the addition of izes the product, as specified in § 101.22 nutritive sweeteners or bulky flavoring of this chapter. If nutritive sweetener ingredients, the weight of the milkfat in an amount sufficient to characterize is not less than 18 percent of the re- the food is added without addition of

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characterizing flavoring, the name of the availability of this material at the food shall be preceded by the word NARA, call 202–741–6030, or go to: http:// ‘‘sweetened’’. www.archives.gov/federallregister/ (e) Label declaration. Each of the in- codeloflfederallregulations/ gredients used in the food shall be de- ibrllocations.html. clared on the label as required by the (1) Milkfat content—‘‘Fat—Official applicable sections of parts 101 and 130 Final Action,’’ section 16.172. of this chapter. (2) Titratable acidity—‘‘Acidity—Of- [42 FR 14360, Mar. 15, 1977, as amended at 47 ficial Final Action,’’ section 16.023. FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, (d) Nomenclature. The name of the 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, food is ‘‘Acidified sour cream’’. The full Jan. 6, 1993] name of the food shall appear on the principal display panel of the label in § 131.162 Acidified sour cream. type of uniform size, style, and color. (a) Description. Acidified sour cream The name of the food shall be accom- results from the souring of pasteurized panied by a declaration indicating the cream with safe and suitable acidifiers, presence of any flavoring that charac- with or without addition of lactic acid terizes the product, as specified in producing bacteria. Acidified sour § 101.22 of this chapter. If nutritive cream contains not less than 18 percent sweetener in an amount sufficient to milkfat; except that when the food is characterize the food is added without characterized by the addition of nutri- addition of characterizing flavoring, tive sweeteners or bulky flavoring in- the name of the food shall be preceded gredients, the weight of milkfat is not by the word ‘‘sweetened’’. less than 18 percent of the remainder (e) Label declaration. Each of the in- obtained by subtracting the weight of gredients used in the food shall be de- such optional ingredients from the clared on the label as required by the weight of the food; but in no case does applicable sections of parts 101 and 130 the food contain less than 14.4 percent of this chapter. milkfat. Acidified sour cream has a titratable acidity of not less than 0.5 per- [42 FR 14360, Mar. 15, 1977, as amended at 47 cent, calculated as lactic acid. FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19, (b) Optional ingredients. (1) Safe and 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, suitable ingredients that improve tex- Jan. 6, 1993] ture, prevent syneresis, or extend the § 131.170 Eggnog. shelf life of the product. (2) Rennet. (a) Description. Eggnog is the food (3) Safe and suitable nutritive sweet- containing one or more of the optional eners. dairy ingredients specified in para- (4) Salt. graph (b), one or more of the optional (5) Flavoring ingredients, with or egg yolk-containing ingredients speci- without safe and suitable coloring, as fied in paragraph (c) of this section, follows: and one or more of the optional nutri- (i) Fruit and fruit juice, including tive carbohydrate sweeteners specified concentrated fruit and fruit juice. in paragraph (d) of this section. One or (ii) Safe and suitable natural and ar- more of the optional ingredients speci- tificial food flavoring. fied in paragraph (e) of this section (c) Methods of analysis. Referenced may also be added. All ingredients used methods in paragraphs (c) (1) and (2) of are safe and suitable. Eggnog contains this section are from ‘‘Official Methods not less than 6 percent milkfat and not of Analysis of the Association of Offi- less than 8.25 percent milk solids not cial Analytical Chemists,’’ 13th Ed. fat. The egg yolk solids content is not (1980), which is incorporated by ref- less than 1 percent by weight of the fin- erence. Copies may be obtained from ished food. The food shall be pasteur- the AOAC INTERNATIONAL, 481 North ized or ultra-pasteurized and may be Frederick Ave., suite 500, Gaithersburg, homogenized. Flavoring ingredients MD 20877, or may be examined at the and color additives may be added after National Archives and Records Admin- the food is pasteurized or ultra-pas- istration (NARA). For information on teurized.

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(b) Optional dairy ingredients. Cream, 16.059, ‘‘Roese-Gottlieb Method (Ref- milk, partially skimmed milk, or skim erence Method) (11)—Official Final Ac- milk, used alone or in combination. tion,’’ under the heading ‘‘Fat.’’ (c) Egg yolk-containing ingredients. (2) Milk solids not fat content—Cal- Liquid egg yolk, frozen egg yolk, dried culated by subtracting the milkfat con- egg yolk, liquid whole eggs, frozen tent from the total solids content as whole eggs, dried whole eggs, or any determined by the method prescribed one or more of the foregoing ingredi- in section 16.032, ‘‘Method I—Official ents with liquid egg white or frozen egg Final Action,’’ under the heading white. ‘‘Total Solids.’’ (d) Nutritive carbohydrate sweeteners. (g) Nomenclature. The name of the Sugar (sucrose), beet or cane; invert food is ‘‘eggnog’’. The name of the food sugar (in paste or sirup form); brown shall be accompanied by a declaration sugar; refiner’s sirup; molasses (other indicating the presence of any charac- than blackstrap); high fructose corn terizing flavoring as specified in § 101.22 sirup; fructose; fructose sirup; maltose; of this chapter. If the food is ultra-pas- maltose sirup, dried maltose sirup; teurized, the phrase ‘‘ultra-pasteur- malt extract, dried malt extract; malt ized’’ shall accompany the name of the sirup, dried malt sirup; honey; maple food wherever it appears on the label in sugar; or any of the sweeteners listed letters not less than one-half of the in part 168 of this chapter, except table height of the letters used in the name. sirup. The following terms may accompany (e) Other optional ingredients. (1) Con- the name of the food on the label: centrated skim milk, nonfat dry milk, (1) The word ‘‘pasteurized’’ if the food buttermilk, whey, lactose, has been pasteurized. lactalbumins, lactoglobulins, or whey (2) The word ‘‘homogenized’’ if the modified by partial or complete re- food has been homogenized. moval of lactose and/or minerals, to in- (h) Label declaration. Each of the increase the nonfat solids content of the gredients used in the food shall be de- food: Provided, That the ratio of pro- clared on the label as required by the tein to total nonfat solids of the food, applicable sections of parts 101 and 130 and the protein efficiency ratio of all of this chapter. protein present shall not be decreased as a result of adding such ingredients. [46 FR 9938, Jan. 30, 1981, as amended at 47 (2) Salt. FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, (3) Flavoring ingredients. 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 12, 1989; 58 FR (4) Color additives that do not impart 2891, Jan. 6, 1993] a color simulating that of egg yolk, milkfat, or butterfat. § 131.180 Half-and-half. (5) Stabilizers. (f) Methods of analysis. The following (a) Description. Half-and-half is the referenced methods of analysis are food consisting of a mixture of milk from ‘‘Official Methods of Analysis of and cream which contains not less than the Association of Official Analytical 10.5 percent but less than 18 percent Chemists,’’ 13th Ed. (1980), which is in- milkfat. It is pasteurized or ultra-pas- corporated by reference. Copies are teurized, and may be homogenized. available from the AOAC INTER- (b) Optional ingredients. The following NATIONAL, 481 North Frederick Ave., safe and suitable optional ingredients suite 500, Gaithersburg, MD 20877, or may be used: available for inspection at the National (1) Emulsifiers. Archives and Records Administration (2) Stabilizers. (NARA). For information on the avail- (3) Nutritive sweeteners. ability of this material at NARA, call (4) Characterizing flavoring ingredi- 202–741–6030, or go to: http:// ents (with or without coloring) as fol- www.archives.gov/federallregister/ lows: codeloflfederallregulations/ (i) Fruit and fruit juice (including ibrllocations.html. concentrated fruit and fruit juice). (1) Milkfat content—As determined (ii) Natural and artificial food fla- by the method prescribed in section voring.

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(c) Methods of analysis. The milkfat contains the lactic acid-producing bac- content is determined by the method teria, Lactobacillus bulgaricus and Strep- prescribed in ‘‘Official Methods of tococcus thermophilus. One or more of Analysis of the Association of Official the other optional ingredients specified Analytical Chemists,’’ 13th Ed. (1980), in paragraphs (b) and (d) of this section in sections 16.156 and 16.059, under may also be added. When one or more ‘‘Fat, Roese-Gottlieb Method—Official of the ingredients specified in para- Final Action,’’ which is incorporated graph (d)(1) of this section are used, by reference. Copies may be obtained they shall be included in the culturing from the AOAC INTERNATIONAL, 481 process. All ingredients used are safe North Frederick Ave., suite 500, Gai- and suitable. Yogurt, before the addi- thersburg, MD 20877, at the National tion of bulky flavors, contains not less Archives and Records Administration than 3.25 percent milkfat and not less (NARA). For information on the avail- than 8.25 percent milk solids not fat, ability of this material at NARA, call and has a titratable acidity of not less 202–741–6030, or go to: http:// than 0.9 percent, expressed as lactic www.archives.gov/federallregister/ acid. The food may be homogenized and codeloflfederallregulations/ shall be pasteurized or ultra-pasteur- ibrllocations.html. ized prior to the addition of the bac- (d) Nomenclature. The name of the terial culture. Flavoring ingredients food is ‘‘Half-and-half’’. The name of may be added after pasteurization or the food shall be accompanied on the ultra-pasteurization. To extend the label by a declaration indicating the shelf life of the food, yogurt may be presence of any characterizing fla- heat treated after culturing is com- voring, as specified in § 101.22 of this pleted, to destroy viable microorga- chapter. nisms. (1) The following terms shall accom- (b) Vitamin addition (optional). (1) If pany the name of the food wherever it added, vitamin A shall be present in appears on the principal display panel such quantity that each 946 milliliters or panels of the label in letters not less (quart) of the food contains not less than one-half the height of the letters than 2,000 International Units thereof, used in such name: within limits of current good manufac- (i) The word ‘‘ultra-pasteurized’’ if turing practice. the food has been ultra-pasteurized. (2) If added, vitamin D shall be (ii) The word ‘‘sweetened’’ if no char- present in such quantity that each 946 acterizing flavor ingredients are used, milliliters (quart) of the food contains but nutritive sweetener is added. 400 International Units thereof, within (2) The following terms may appear limits of current good manufacturing on the label: practice. (i) The word ‘‘pasteurized’’ if the food (c) Optional dairy ingredients. Cream, has been pasteurized. milk, partially skimmed milk, or skim (ii) The word ‘‘homogenized’’ if the milk, used alone or in combination. food has been homogenized. (d) Other optional ingredients. (1) Con- (e) Label declaration. Each of the in- centrated skim milk, nonfat dry milk, gredients used in the food shall be de- buttermilk, whey, lactose, lactalbum- clared on the label as required by the ins, lactoglobulins, or whey modified applicable sections of parts 101 and 130 by partial or complete removal of lac- of this chapter. tose and/or minerals, to increase the [42 FR 14360, Mar. 15, 1977, as amended at 47 nonfat solids content of the food: Pro- FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19, vided, That the ratio of protein to total 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, nonfat solids of the food, and the pro- Jan. 6, 1993] tein efficiency ratio of all protein present shall not be decreased as a re- § 131.200 Yogurt. sult of adding such ingredients. (a) Description. Yogurt is the food (2) Nutritive carbohydrate sweet- produced by culturing one or more of eners. Sugar (sucrose), beet or cane; in- the optional dairy ingredients specified vert sugar (in paste or sirup form); in paragraph (c) of this section with a brown sugar; refiner’s sirup; molasses characterizing bacterial culture that (other than blackstrap); high fructose

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corn sirup; fructose; fructose sirup; out the addition of characterizing fla- maltose; maltose sirup, dried maltose vor. sirup; malt extract, dried malt extract; (ii) The parenthetical phrase ‘‘(heat- malt sirup, dried malt sirup; honey; treated after culturing)’’ shall follow maple sugar; or any of the sweeteners the name of the food if the dairy ingre- listed in part 168 of this chapter, except dients have been heat-treated after cul- table sirup. turing. (3) Flavoring ingredients. (iii) The phrase ‘‘vitamin A’’ or ‘‘vi- (4) Color additives. tamin A added’’, or ‘‘vitamin D’’ or (5) Stabilizers. ‘‘vitamin D added’’, or ‘‘vitamins A and (e) Methods of analysis. The following D added’’, as appropriate. The word referenced methods of analysis are ‘‘vitamin’’ may be abbreviated ‘‘vit’’. from ‘‘Official Methods of Analysis of (2) The term ‘‘homogenized’’ may ap- the Association of Official Analytical pear on the label if the dairy ingredi- Chemists,’’ 13th Ed. (1980), which is in- ents used are homogenized. corporated by reference. Copies are (g) Label declaration. Each of the in- available from the AOAC INTER- gredients used in the food shall be de- NATIONAL, 481 North Frederick Ave., clared on the label as required by the suite 500, Gaithersburg, MD 20877, or applicable sections of parts 101 and 130 available for inspection at the National of this chapter. Archives and Records Administration (NARA). For information on the avail- [46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, ability of this material at NARA, call 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, 202–741–6030, or go to: http:// June 12, 1989; 58 FR 2891, Jan. 6, 1993] www.archives.gov/federallregister/ codeloflfederallregulations/ § 131.203 Lowfat yogurt. ibrllocations.html. (a) Description. Lowfat yogurt is the (1) Milkfat content—As determined food produced by culturing one or more by the method prescribed in section of the optional dairy ingredients speci- 16.059 ‘‘Roese-Gottlieb Method (Ref- fied in paragraph (c) of this section erence Method) (11)—Official Final Ac- with a characterizing bacterial culture tion,’’ under the heading ‘‘Fat.’’ that contains the lactic acid-producing (2) Milk solids not fat content—Cal- bacteria, Lactobacillus bulgaricus and culated by subtracting the milkfat con- Streptococcus thermophilus. One or more tent from the total solids content as of the other optional ingredients speci- determined by the method prescribed fied in paragraphs (b) and (d) of this in section 16.032, ‘‘Method I—Official section may also be added. When one or Final Action,’’ under the heading more of the ingredients specified in ‘‘Total Solids.’’ paragraph (d)(1) of this section are (3) Titratable acidity—As determined used, they shall be included in the cul- by the method prescribed in section turing process. All ingredients used are 16.023, ‘‘Acidity (2)—Official Final Ac- safe and suitable. Lowfat yogurt, be- tion,’’ or by an equivalent potentio- fore the addition of bulky flavors, con- metric method. tains not less than 0.5 percent nor more (f) Nomenclature. The name of the than 2 percent milkfat and not less food is ‘‘yogurt’’. The name of the food than 8.25 percent milk solids not fat, shall be accompanied by a declaration and has a titratable acidity of not less indicating the presence of any charac- than 0.9 percent, expressed as lactic terizing flavoring as specified in § 101.22 acid. The food may be homogenized and of this chapter. shall be pasteurized or ultra-pasteur- (1) The following terms shall accom- ized prior to the addition of the bac- pany the name of the food wherever it terial culture. Flavoring ingredients appears on the principal display panel may be added after pasteurization or or panels of the label in letters not less ultra-pasteurization. To extend the than one-half of the height of the let- shelf life of the food, lowfat yogurt ters used in such name: may be heat treated after culturing is (i) The word ‘‘sweetened’’ if nutritive completed, to destroy viable micro- carbohydrate sweetener is added with- organisms.

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(b) Vitamin addition (optional). (1) If codeloflfederallregulations/ added, vitamin A shall be present in ibrllocations.html. such quantity that each 946 milliliters (1) Milkfat content—As determined (quart) of the food contains not less by the method prescribed in section than 2,000 International Units thereof, 16.059 ‘‘Roese-Gottlieb Method (Ref- within limits of current good manufac- erence Method) (11)—Official Final Ac- turing practice. tion,’’ under the heading ‘‘Fat.’’ (2) If added, vitamin D shall be (2) Milk solids not fat content—Cal- present in such quantity that each 946 culated by subtracting the milkfat con- milliliters (quart) of the food contains tent from the total solids content as 400 International Units thereof, within determined by the method prescribed limits of current good manufacturing in section 16.032, ‘‘Method I—Official practice. Final Action,’’ under the heading (c) Optional dairy ingredients. Cream, ‘‘Total Solids.’’ milk, partially skimmed milk, or skim (3) Titratable acidity—As determined milk, used alone or in combination. by the method prescribed in section (d) Other optional ingredients. (1) Con- 16.023, ‘‘Acidity (2)—Official Final Ac- centrated skim milk, nonfat dry milk, tion,’’ or by an equivalent potentio- buttermilk, whey, lactose, lactalbum- metric method. ins, lactoglobulins, or whey modified (f) Nomenclature. The name of the by partial or complete removal of lac- food is ‘‘lowfat yogurt’’. The full name tose and/or minerals, to increase the of the food shall appear on the prin- nonfat solids content of the food: Pro- cipal display panel of the label in type vided, That the ratio of protein to total of uniform size, style, and color. The nonfat solids of the food, and the pro- name of the food shall be accompanied tein efficiency ratio of all protein by a declaration indicating the pres- present shall not be decreased as a re- ence of any characterizing flavoring as sult of adding such ingredients. specified in § 101.22 of this chapter. (2) Nutritive carbohydrate sweet- (1) The following terms shall accom- eners. Sugar (sucrose), beet or cane; in- pany the name of the food wherever it vert sugar (in paste or sirup form); appears on the principal display panel brown sugar; refiner’s sirup; molasses or panels of the label in letters not less (other than blackstrap); high fructose than one-half of the height of the let- corn sirup; fructose; fructose sirup; ters used in such name. maltose, maltose sirup, dried maltose (i) The phrase ‘‘l% milkfat’’, the sirup; malt extract, dried malt extract; blank to be filled in with the fraction malt sirup, dried malt sirup; honey; 1⁄2 or multiple thereof closest to the ac- maple sugar; or any of the sweeteners tual fat content of the food. listed in part 168 of this chapter, except (ii) The word ‘‘sweetened’’ if nutri- table sirup. tive carbohydrate sweetener is added (3) Flavoring ingredients. without the addition of characterizing (4) Color additives. flavoring. (5) Stabilizers. (iii) The parenthetical phrase ‘‘(heat- (e) Methods of analysis. The following treated after culturing)’’ shall follow referenced methods of analysis are the name of the food if the dairy ingre- from ‘‘Official Methods of Analysis of dients have been heat-treated after cul- the Association of Official Analytical turing. Chemists,’’ 13th Ed. (1980), which is in- (iv) The phrase ‘‘vitamin A’’ or ‘‘vi- corporated by reference. Copies are tamin A added’’, or ‘‘vitamin D’’ or available from the AOAC INTER- ‘‘vitamin D added’’, or ‘‘vitamins A and NATIONAL, 481 North Frederick Ave., D added’’, as appropriate. The word suite 500, Gaithersburg, MD 20877 or ‘‘vitamin’’ may be abbreviated ‘‘vit’’. available for inspection at the National (2) The term ‘‘homogenized’’ may ap- Archives and Records Administration pear on the label if the dairy ingredi- (NARA). For information on the avail- ents used are homogenized. ability of this material at NARA, call (g) Label declaration. Each of the in- 202–741–6030, or go to: http:// gredients used in the food shall be de- www.archives.gov/federallregister/ clared on the label as required by the

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applicable sections of parts 101 and 130 moval of lactose and/or minerals, to in- of this chapter. crease the nonfat solids content of the [46 FR 9939, Jan. 30, 1981, as amended at 47 food: Provided, That the ratio of pro- FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, tein to total nonfat solids of the food, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, and the protein efficiency ratio of all June 12, 1989; 58 FR 2891, Jan. 6, 1993] protein present shall not be decreased as a result of adding such ingredients. § 131.206 Nonfat yogurt. (2) Nutritive carbohydrate sweet- (a) Description. Nonfat yogurt is the eners. Sugar (sucrose), beet or cane; in- food produced by culturing one or more vert sugar (in paste or sirup form); of the optional dairy ingredients speci- brown sugar; refiner’s sirup; molasses fied in paragraph (c) of this section (other than blackstrap); high fructose with a characterizing bacterial culture corn sirup; fructose; fructose sirup; that contains the lactic acid-producing maltose; maltose sirup, dried maltose bacteria, Lactobacillus bulgaricus and sirup; malt extract, dired malt extract; Streptococcus thermophilus. One or more malt sirup, dried malt sirup; honey; of the other optional ingredients speci- maple sugar; or any of the sweeteners fied in paragraphs (b) and (d) of this listed in part 168 of this chapter, except section may also be added. When one or table sirup. more of the ingredients specified in (3) Flavoring ingredients. paragraph (d)(1) of this section are (4) Color additives. used, they shall be included in the cul- (5) Stabilizers. turing process. All ingredients used are (e) Methods of analysis. The following safe and suitable. Nonfat yogurt, before the addition of bulky flavors, contains referenced methods of analysis are less than 0.5 percent milkfat and not from ‘‘Official Methods of Analysis of less than 8.25 percent milk solids not the Association of Official Analytical fat, and has a titratable acidity of not Chemists,’’ 13th Ed. (1980), which is in- less than 0.9 percent, expressed as lac- corporated by reference. Copies are tic acid. The food may be homogenized available from the AOAC INTER- and shall be pasteurized or ultra-pas- NATIONAL, 481 North Frederick Ave., teurized prior to the addition of the suite 500, Gaithersburg, MD 20877, or bacterial culture. Flavoring ingredi- available for inspection at the National ents may be added after pasteurization Archives and Records Administration or ultra-pasteurization. To extend the (NARA). For information on the avail- shelf life of the food, nonfat yogurt ability of this material at NARA, call may be heat treated after culturing is 202–741–6030, or go to: http:// completed, to destroy viable micro- www.archives.gov/federallregister/ organisms. codeloflfederallregulations/ (b) Vitamin addition (optional). (1) If ibrllocations.html. added, vitamin A shall be present in (1) Milkfat content—As determined such quantity that each 946 milliliters by the method prescribed in section (quart) of the food contains not less 16.059, ‘‘Roese-Gottlieb Method (Ref- than 2,000 International Units thereof, erence Method) (11)—Official Final Ac- within limits of good manufacturing tion,’’ under the heading ‘‘Fat.’’ practice. (2) Milk solids not fat content—Cal- (2) If added, vitamin D shall be culated by subtracting the milkfat con- present in such quantity that each 946 tent from the total solids content as milliliters (quart) of the food contains determined by the method prescribed 400 International Units thereof, within in section 16.032, ‘‘Method I—Official limits of good manufacturing practice. Final Action,’’ under the heading (c) Optional dairy ingredients. Cream, ‘‘Total Solids.’’ milk, partially skimmed milk, or skim (3) Titratable acidity—As determined milk, used alone or in combination. by the method prescribed in section (d) Other optional ingredients. (1) Con- 16.023, ‘‘Acidity (2)—Official Final Ac- centrated skim milk, nonfat dry milk, tion,’’ or by an equivalent potentio- buttermilk, whey, lactose, metric method. lactalbumins, lactoglobulins, or whey (f) Nomenclature. The name of the modified by partial or complete re- food is ‘‘nonfat yogurt’’. The full name

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of the food shall appear on the prin- 133.106 Blue cheese. cipal display panel of the label in type 133.108 Brick cheese. of uniform size, style, and color. The 133.109 Brick cheese for manufacturing. 133.111 Caciocavallo siciliano cheese. name of the food shall be accompanied 133.113 Cheddar cheese. by a declaration indicating the pres- 133.114 Cheddar cheese for manufacturing. ence of any characterizing flavoring as 133.116 Low sodium cheddar cheese. specified in § 101.22 of this chapter. 133.118 Colby cheese. (1) The following terms shall accom- 133.119 Colby cheese for manufacturing. pany the name of the food wherever it 133.121 Low sodium colby cheese. appears on the principal display panel 133.123 Cold-pack and club cheese. or panels of the label in letters not less 133.124 Cold-pack cheese food. 133.125 Cold-pack cheese food with fruits, than one-half of the height of the let- vegetables, or meats. ters used in such name: 133.127 Cook cheese, koch kaese. (i) The word ‘‘sweetened’’ if nutritive 133.128 Cottage cheese. carbohydrate sweetener is added with- 133.129 Dry curd cottage cheese. out the addition of characterizing fla- 133.133 Cream cheese. voring. 133.134 Cream cheese with other foods. (ii) The parenthetical phrase ‘‘(heat- 133.136 Washed curd and soaked curd cheese. treated after culturing)’’ shall follow 133.137 Washed curd cheese for manufacturing. the name of the food if the dairy ingre- 133.138 Edam cheese. dients have been heat-treated after cul- 133.140 Gammelost cheese. turing. 133.141 Gorgonzola cheese. (iii) The phrase ‘‘vitamin A’’ or ‘‘vi- 133.142 Gouda cheese. tamin A added’’, or ‘‘vitamin D’’ or 133.144 Granular and stirred curd cheese. ‘‘vitamin D added’’, or ‘‘vitamins A and 133.145 Granular cheese for manufacturing. D added’’, as appropriate. The word 133.146 Grated cheeses. 133.147 Grated American cheese food. ‘‘vitamin’’ may be abbreviated ‘‘vit’’. 133.148 Hard grating cheeses. (2) The term ‘‘homogenized’’ may ap- 133.149 Gruyere cheese. pear on the label if the dairy ingredi- 133.150 Hard cheeses. ents used are homogenized. 133.152 Limburger cheese. (g) Label declaration. Each of the in- 133.153 Monterey cheese and monterey jack gredients used in the food shall be de- cheese. clared on the label as required by the 133.154 High-moisture jack cheese. applicable sections of parts 101 and 130 133.155 Mozzarella cheese and scamorza cheese. of this chapter. 133.156 Low-moisture mozzarella and [46 FR 9940, Jan. 30, 1981, as amended at 47 scamorza cheese. FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, 133.157 Part-skim mozzarella and scamorza 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, cheese. June 12, 1989; 58 FR 2891, Jan. 6, 1993] 133.158 Low-moisture part-skim mozzarella and scamorza cheese. 133.160 Muenster and munster cheese. PART 133—CHEESES AND RELATED 133.161 Muenster and munster cheese for CHEESE PRODUCTS manufacturing. 133.162 Neufchatel cheese. Subpart A—General Provisions 133.164 Nuworld cheese. 133.165 Parmesan and reggiano cheese. Sec. 133.167 Pasteurized blended cheese. 133.3 Definitions. 133.168 Pasteurized blended cheese with 133.5 Methods of analysis. fruits, vegetables, or meats. 133.10 Notice to manufacturers, packers, 133.169 Pasteurized process cheese. and distributors of pasteurized blended 133.170 Pasteurized process cheese with cheese, pasteurized process cheese, fruits, vegetables, or meats. cheese food, cheese spread, and related 133.171 Pasteurized process pimento cheese. foods. 133.173 Pasteurized process cheese food. 133.174 Pasteurized process cheese food with Subpart B—Requirements for Specific fruits, vegetables, or meats. Standardized Cheese and Related 133.175 Pasteurized cheese spread. Products 133.176 Pasteurized cheese spread with fruits, vegetables, or meats. 133.102 Asiago fresh and asiago soft cheese. 133.178 Pasteurized neufchatel cheese spread 133.103 Asiago medium cheese. with other foods. 133.104 Asiago old cheese. 133.179 Pasteurized process cheese spread.

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133.180 Pasteurized process cheese spread Temperature Time with fruits, vegetables, or meats. 133.181 Provolone cheese. 145 °F1 ...... 30 min. 133.182 Soft ripened cheeses. 161 °F1 ...... 15 s. ° 133.183 Romano cheese. 191 F ...... 1 s. 204 °F ...... 0.05 s. 133.184 Roquefort cheese, sheep’s milk blue- 212 °F ...... 0.01 s. mold, and blue-mold cheese from sheep’s milk. 1 If the dairy ingredient has a fat content of 10 percent or ° 133.185 Samsoe cheese. more, the specified temperature shall be increased by 5 F. 133.186 Sap sago cheese. (e) Ultrapasteurized when used to de- 133.187 Semisoft cheeses. scribe a dairy ingredient means that 133.188 Semisoft part-skim cheeses. such ingredient shall have been ther- 133.189 Skim milk cheese for manufac- mally processed at or above 280 °F for turing. at least 2 seconds. 133.190 Spiced cheeses. 133.191 Part-skim spiced cheeses. [48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 133.193 Spiced, flavored standardized 1983] cheeses. 133.195 Swiss and emmentaler cheese. § 133.5 Methods of analysis. 133.196 Swiss cheese for manufacturing. Moisture, milkfat, and phosphatase AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, levels in cheeses will be determined by 379e. the following methods of analysis from ‘‘Official Methods of Analysis of the Subpart A—General Provisions Association of Official Analytical Chemists,’’ 13th ed., 1980, which is in- § 133.3 Definitions. corporated by reference (copies are (a) Milk means the lacteal secretion, available from the AOAC INTER- practically free from colostrum, ob- NATIONAL, 481 North Frederick Ave., tained by the complete milking of one suite 500, Gaithersburg, MD 20877, or or more healthy cows, which may be available for inspection at the National clarified and may be adjusted by sepa- Archives and Records Administration rating part of the fat therefrom; con- (NARA). For information on the avail- centrated milk, reconstituted milk, ability of this material at NARA, call and dry whole milk. Water, in a suffi- 202–741–6030, or go to: http:// cient quantity to reconstitute con- www.archives.gov/federallregister/ centrated and dry forms, may be added. codeloflfederallregulations/ (b) Nonfat milk means skim milk, ibrllocations.html): concentrated skim milk, reconstituted (a) Moisture content—section 16.233 skim milk, and nonfat dry milk. Water, ‘‘Method I (52)—Official Final Action’’, in a sufficient quantity to reconstitute under the heading ‘‘Moisture’’. concentrated and dry forms, may be (b) Milkfat content—section 16.255 added. ‘‘Fat (60)—Official Final Action’’. (c) Cream means cream, reconstituted (c) Phenol equivalent value—section cream, dry cream, and plastic cream. 16.275 ‘‘Reagents’’, section 16.276 Water, in a sufficient quantity to re- ‘‘Sampling’’, and section 16.277 ‘‘Deter- constitute concentrated and dry forms, mination’’, under the heading ‘‘Resid- may be added. ual Phosphatase (27) Official Final Ac- (d) Pasteurized when used to describe tion’’. a dairy ingredient means that every (d) Milkfat in solids (fat on a dry particle of such ingredient shall have basis)—Subtract the percent of mois- been heated in properly operated equip- ture found from 100; divide the remain- ment to one of the temperatures speci- der into the percent milkfat found. The fied in the table of this paragraph and held continuously at or above that quotient, multiplied by 100, shall be temperature for the specified time (or considered to be the percent of milkfat other time/temperature relationship contained in the solids. which has been demonstrated to be [48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, equivalent thereto in microbial de- 1983, as amended at 54 FR 24893, June 12, 1989; struction): 63 FR 14035, Mar. 24, 1998]

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§ 133.10 Notice to manufacturers, leading, and should not be used in la- packers, and distributors of pas- beling. teurized blended cheese, pasteurized process cheese, cheese food, Subpart B—Requirements for Spe- cheese spread, and related foods. cific Standardized Cheese (a) Definitions and standards of iden- and Related Products tity have recently been promulgated under the authority of the Federal § 133.102 Asiago fresh and asiago soft Food, Drug, and Cosmetic Act for a cheese. number of foods made in part from (a) Asiago fresh cheese, asiago soft cheese, including pasteurized process cheese, is the food prepared from milk cheese; pasteurized process cheese with and other ingredients specified in this fruits, vegetables, or meats; pasteur- section, by the procedure set forth in ized blended cheese; pasteurized proc- paragraph (b) of this section, or by an- ess cheese food; pasteurized process other procedure which produces a fin- cheese spread, and related foods. These ished cheese having the same physical standards prescribe the name for each and chemical properties as the cheese such food. The act requires that this produced when the procedure set forth name appear on the label. Many of in paragraph (b) of this section is used. these names consist of several words. It contains not more than 45 percent of In the past it has been the practice of moisture, and its solids contain not some manufacturers to subordinate the less than 50 percent of milkfat, as de- words ‘‘pasteurized,’’ ‘‘blended,’’ termined by the methods prescribed in ‘‘process,’’ ‘‘food,’’ and ‘‘spread’’ to § 133.5 (a), (b), and (d). It is cured for give undue prominence to the word not less than 60 days. ‘‘cheese’’ and to words naming the va- (b) Milk which may be pasteurized or riety of cheese involved. clarified or both, and which may be (b) When placing the names of these warmed, is subjected to the action of foods on labels so as to comply with harmless lactic-acid producing bac- the requirements of section 403 (a), (f), teria, present in such milk or added and (g) of the act, all the words form- thereto. Harmless artificial blue or ing the name specified by a definition green coloring in a quantity which neu- and standard of identity should be tralizes any natural yellow coloring in given equal prominence. This can read- the curd may be added. Sufficient ily be accomplished by printing the rennet, or other safe and suitable milk- specified name of the food in letters of clotting enzyme that produces equiva- the same size, color, and style of type, lent curd formation, or both, with or and with the same background. without purified calcium chloride in a (c) Where the names of optional in- quantity not more than 0.02 percent gredients are required to appear on the (calculated as anhydrous calcium chlo- label, the designations of all such in- ride) of the weight of the milk, is added gredients should be given equal promi- to set the milk to a semisolid mass. nence. The names of the optional ingre- The mass is cut, stirred, and heated to dients should appear prominently and promote and regulate separation of the conspicuously but should not be dis- whey from the curd. The whey is played with greater prominence than drained off. When the curd is suffi- the name of the food. The word ‘‘con- ciently firm it is removed from the tains’’ may precede the names of the kettle or vat, further drained for a optional ingredients, and when so used short time, packed into hoops, and will not be considered as intervening pressed. The pressed curd is salted in printed matter between name of food brine and cured in a well-ventilated and name of optional ingredients re- room. During curing the surface of the quired to be placed on the label. cheese is occasionally rubbed with a (d) Where a manufacturer elects to vegetable oil. A harmless preparation include a label statement of fat and of enzymes of animal or plant origin moisture content, the declaration capable of aiding in the curing or de- should be on the basis of the food as velopment of flavor of asiago fresh marketed. A fat declaration on a mois- cheese may be added during the proce- ture-free basis is likely to be mis- dure in such quantity that the weight

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of the solids of such preparation is not § 133.104 Asiago old cheese. more than 0.1 percent of the weight of Asiago old cheese conforms to the the milk used. definition and standard of identity and (c)(1) For the purposes of this sec- is subject to the requirements for label tion, the word ‘‘milk’’ means cow’s statement of ingredients prescribed by milk, which may be adjusted by sepa- § 133.102 for asiago fresh cheese, except rating part of the fat therefrom or by that it contains not more than 32 per- adding thereto one or more of the fol- cent moisture, its solids contain not lowing: Cream, skim milk, con- less than 42 percent of milk fat, and it centrated skim milk, nonfat dry milk, is cured for not less than 1 year. water in a quantity sufficient to reconstitute any concentrated skim milk or [58 FR 2892, Jan. 6, 1993] nonfat dry milk used. (2) Such milk may be bleached by the § 133.106 Blue cheese. use of benzoyl peroxide or a mixture of (a) Description. (1) Blue cheese is the benzoyl peroxide with potassium alum, food prepared by the procedure set calcium sulfate, and magnesium car- forth in paragraph (a)(2), of this sec- bonate; but the weight of the benzoyl tion, or by any other procedure which peroxide is not more than 0.002 percent produces a finished cheese having the of the weight of the milk bleached, and same physical and chemical properties. the weight of the potassium alum, cal- It is characterized by the presence of cium sulfate, and magnesium car- bluish-green mold, Penicillium roque- bonate, singly or combined, is not more fortii, throughout the cheese. The min- than six times the weight of the ben- imum milkfat content is 50 percent by zoyl peroxide used. If milk is bleached weight of the solids and the maximum in this manner, sufficient vitamin A is moisture content is 46 percent by added to the curd to compensate for weight, as determined by the methods the vitamin A or its precursors de- described in § 133.5. The dairy ingredi- stroyed in the bleaching process, and ents used may be pasteurized. Blue artificial coloring is not used. cheese is at least 60 days old. (d) Safe and suitable antimycotic (2) One or more of the dairy ingredi- agent(s), the cumulative levels of ents specified in paragraph (b)(1) of which shall not exceed current good this section may be homogenized, manufacturing practice, may be added bleached, warmed, and is subjected to to the surface of the cheese. the action of a lactic acid-producing (e) Label declaration. Each of the in- bacterial culture. One or more of the gredients used in the food shall be de- clotting enzymes specified in para- clared on the label as required by the graph (b)(2) of this section is added to applicable sections of parts 101 and 130 set the dairy ingredients to a semisolid of this chapter, except that enzymes of mass. The mass is cut into smaller por- animal, plant, or microbial origin may tions and allowed to stand for a time. be declared as ‘‘enzymes’’. The mixed curd and whey is placed in forms permitting further drainage. [42 FR 14366, Mar. 15, 1977, as amended at 48 While the curd is being placed in forms, FR 49013, Oct. 24, 1983; 49 FR 10093, Mar. 19, 1984; 58 FR 2891, Jan. 6, 1993] spores of the mold Penicillium roquefortii are added. The forms are turned § 133.103 Asiago medium cheese. several times during drainage. When sufficiently drained, the shaped curd is Asiago medium cheese conforms to removed from the forms and salted the definition and standard of identity with dry salt or brine. Perforations are and is subject to the requirements for then made in the shaped curd, and it is label statement of ingredients pre- held at a temperature of approximately scribed by § 133.102 for asiago fresh 50 °F. at 90 to 95 percent relative hu- cheese, except that it contains not midity, until the characteristic mold more than 35 percent moisture, its sol- growth has developed. During storage ids contain not less than 45 percent of the surface of the cheese may be milkfat, and it is cured for not less scraped to remove surface growth of than 6 months. undesirable microorganisms. [58 FR 2892, Jan. 6, 1993] Antimycotics may be applied to the

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surface of the whole cheese. One or (1) Enzymes of animal, plant, or mi- more of the other optional ingredients crobial origin may be declared as ‘‘en- specified in paragraph (b)(3) of this sec- zymes’’; and tion may be added during the proce- (2) The dairy ingredients may be de- dure. clared, in descending order of predomi- (b) Optional ingredients. The following nance, by the use of the terms ‘‘milkfat safe and suitable ingredients may be and nonfat milk’’ or ‘‘nonfat milk and used: milkfat’’, as appropriate. (1) Dairy ingredients. Milk, nonfat [48 FR 2742, Jan. 21, 1983, as amended at 54 milk, or cream, as defined in § 133.3, FR 32052, Aug. 4, 1989; 58 FR 2892, Jan. 6, 1993] used alone or in combination. § 133.108 Brick cheese. (2) Clotting enzymes. Rennet and/or other clotting enzymes of animal, (a) Description. (1) Brick cheese is the plant, or microbial origin. food prepared from dairy ingredients (3) Other optional ingredients. (i) Blue and other ingredients specified in this or green color in an amount to neu- section by the procedure set forth in tralize the natural yellow color of the paragraph (a)(3) of this section, or by any other procedure which produces a curd. finished cheese having the same phys- (ii) Calcium chloride in an amount ical and chemical properties. The min- not more than 0.02 percent (calculated imum milkfat content is 50 percent by as anhydrous calcium chloride) of the weight of the solids and the maximum weight of the dairy ingredients, used as moisture content is 44 percent by a coagulation aid. weight, as determined by the methods (iii) Enzymes of animal, plant, or mi- described in § 133.5. If the dairy ingredi- crobial origin, used in curing or flavor ents used are not pasteurized, the development. cheese is cured at a temperature of not (iv) Antimycotic agents, applied to less than 35 °F for at least 60 days. the surface of slices or cuts in con- (2) If pasteurized dairy ingredients sumer-sized packages or to the surface are used, the phenol equivalent value of the bulk cheese during curing. of 0.25 gram of brick cheese is not more (v) Benzoyl peroxide or a mixture of than 5 micrograms as determined by benzoyl peroxide with potassium alum, the method described in § 133.5. calcium sulfate, and magnesium car- (3) One or more of the dairy ingredi- bonate used to bleach the dairy ingre- ents specified in paragraph (b)(1) of dients. The weight of the benzoyl per- this section is brought to a tempera- ° oxide is not more than 0.002 percent of ture of about 88 F and subjected to the the weight of the milk being bleached, action of a lactic acid-producing bac- and the weight of the potassium alum, terial culutre. One or more of the clot- calcium sulfate, and magnesium car- ting enzymes specified in paragraph bonate, singly or combined, is not more (b)(2) of this section is added to set the dairy ingredients to a semisolid mass. than six times the weight of the ben- The mass is cut into cubes with sides zoyl peroxide used. If milk is bleached approximately 3⁄8 inch long, and stirred in this manner, vitamin A is added to and heated so that the temperature the curd in such quantity as to com- rises slowly to about 96 °F. The stirring pensate for the vitamin A or its precur- is continued until the curd is suffi- sors destroyed in the bleaching process, ciently firm. Part of the whey is then and artificial coloring is not used. removed, and the mixture diluted with (vi) Vegetable fats or oils, which may water or salt brine to control the acid- be hydrogenated, used as a coating for ity. The curd is transferred to forms, the rind. and drained. During drainage it is (c) Nomenclature. The name of the pressed and turned. After drainage the food is ‘‘blue cheese.’’ curd is salted, and the biological curing (d) Label declaration. Each of the in- agents characteristic of brick cheese gredients used in the food shall be de- are applied to the surface. The cheese clared on the label as required by the is then cured to develop the character- applicable sections of parts 101 and 130 istics of brick cheese. One or more of of this chapter, except that: the other optional ingredients specified

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in paragraph (b)(3) of this section may of two or all of these and other ingredi- be added during the procedure. ents specified in this section, by the (b) Optional ingredients. The following procedure set forth in paragraph (b) of safe and suitable ingredients may be this section, or by another procedure used: which produces a finished cheese hav- (1) Dairy ingredients. Milk, nonfat ing the same physical and chemical milk, or cream, as defined in § 133.3, properties as the cheese produced when used alone or in combination. the procedure set forth in paragraph (b) (2) Clotting enzymes. Rennet and/or of this section is used. It has a stringy other clotting enzymes of animal, texture, and is made in oblong shapes. plant, or microbial origin. It contains not more than 40 percent of (3) Other optional ingredients. (i) moisture, and its solids contain not Coloring. less than 42 percent milkfat as deter- (ii) Calcium chloride in an amount mined by the methods prescribed in not more than 0.02 percent (calculated § 133.5 (a), (b), and (d). It is cured for as anhydrous calcium chloride) of the weight of the dairy ingredients, used as not less than 90 days at a temperature ° a coagulation aid. of not less than 35 F. (iii) Enzymes of animal, plant, or mi- (b) Milk, which may be pasteurized or crobial origin, used in curing or flavor clarified or both, and which may be development. warmed, is subjected to the action of (iv) Antimycotic agents, the cumu- harmless lactic-acid-producing bac- lative level of which shall not exceed teria, present in such milk or added current good manufacturing practice, thereto. Harmless artificial blue or may be added to the surface of the green coloring in a quantity which neu- cheese. tralizes any natural yellow coloring in (c) Nomenclature. The name of the the curd may be added. Sufficient food is ‘‘brick cheese’’. rennet, rennet paste, extract of rennet (d) Label declaration. Each of the in- paste, or other safe and suitable milk- gredients used in the food shall be de- clotting enzyme that produces equiva- clared on the label as required by the lent curd formation, singly or in any applicable sections of parts 101 and 130 combination (with or without purified of this chapter, except that: calcium chloride in a quantity not (1) Enzymes of animal, plant, or mi- more than 0.02 percent, calculated as crobial origin may be declared as ‘‘en- anhydrous calcium chloride, of the zymes’’; and weight of the milk) is added to set the (2) The dairy ingredients may be de- milk to a semisolid mass. The mass is clared, in descending order of predomi- cut, stirred, and heated so as to pro- nance, by the use of the terms ‘‘milkfat mote and regulate the separation of and nonfat milk’’ or ‘‘nonfat milk and whey from curd. The whey is drained milkfat’’, as appropriate. off, and the curd is removed to another [54 FR 32052, Aug. 4, 1989; 54 FR 35756, Aug. 29, vat containing hot whey, in which it is 1989, as amended at 58 FR 2892, Jan. 6, 1993; soaked for several hours. This whey is 58 FR 17105, Apr. 1, 1993] withdrawn, the curd is allowed to mat, and is cut into blocks. These are § 133.109 Brick cheese for manufacturing. washed in hot whey until the desired elasticity is obtained. The curd is re- Brick cheese for manufacturing con- moved from the vat, drained, pressed forms to the definition and standard of into oblong forms, dried, and salted in identity for brick cheese prescribed by brine, and cured. It may be paraffined. § 133.108, except that the dairy ingredi- A harmless preparation of enzymes of ents are not pasteurized and curing is animal or plant origin capable of aid- not required. ing in the curing or development of fla- [54 FR 32053, Aug. 4, 1989] vor of caciocavallo siciliano cheese may be added during the procedure, in § 133.111 Caciocavallo siciliano cheese. such quantity that the weight of the (a) Caciocavallo siciliano cheese is solids of such preparation is not more the food prepared from cow’s milk or than 0.1 percent of the weight of the sheep’s milk or goat’s milk or mixtures milk used.

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(c)(1) For the purposes of this sec- animal, plant, or microbial origin may tion, the word ‘‘milk’’ means cow’s be declared as ‘‘enzymes’’. milk or goat’s milk or sheep’s milk or [42 FR 14366, Mar. 15, 1977, as amended at 42 mixtures of two or all of these. Such FR 39102, Aug. 2, 1977; 48 FR 49013, Oct. 24, milk may be adjusted by separating 1983; 49 FR 10093, Mar. 19, 1984; 58 FR 2892, part of the fat therefrom or (in the case Jan. 6, 1993] of cow’s milk) by adding one or more of the following: Cream, skim milk, con- § 133.113 Cheddar cheese. centrated skim milk, nonfat dry milk; (a) Description. (1) Cheddar cheese is (in the case of goat’s milk) the cor- the food prepared by the procedure set responding products from goat’s milk; forth in paragraph (a)(3) of this section, (in the case of sheep’s milk) the cor- or by any other procedure which pro- responding products from sheep’s milk; duces a finished cheese having the water in a quantity sufficient to recon- same physical and chemical properties. stitute any such concentrated or dried The minimum milkfat content is 50 products used. percent by weight of the solids, and the (2) Such milk may be bleached by the maximum moisture content is 39 per- use of benzoyl peroxide or a mixture of cent by weight, as determined by the benzoyl peroxide with potassium alum, methods described in § 133.5. If the calcium sulfate, and magnesium car- dairy ingredients used are not pasteur- bonate; but the weight of the benzoyl ized, the cheese is cured at a tempera- peroxide is not more than 0.002 percent ture of not less than 35 °F for at least of the weight of the milk bleached, and 60 days. the weight of the potassium alum, cal- (2) If pasteurized dairy ingredients cium sulfate, and magnesium car- are used, the phenol equivalent value bonate, singly or combined, is not more of 0.25 gram of cheddar cheese is not than six times the weight of the ben- more than 3 micrograms as determined zoyl peroxide used. If milk is bleached by the method described in § 133.5. in this manner, sufficient vitamin A is (3) One or more of the dairy ingredi- added to the curd to compensate for ents specified in paragraph (b)(1) of the vitamin A or its precursors de- this section may be warmed, treated with hydrogen peroxide/catalase, and is stroyed in the bleaching process, and subjected to the action of a lactic acid- artificial coloring is not used. producing bacterial culture. One or (d) Safe and suitable antimycotic more of the clotting enzymes specified agent(s), the cumulative levels of in paragraph (b)(2) of this section is which shall not exceed current good added to set the dairy ingredients to a manufacturing practice, may be added semisolid mass. The mass is so cut, to the cheese during the kneading and stirred, and heated with continued stir- stretching process and/or applied to the ring, as to promote and regulate the surface of the cheese. separation of whey and curd. The whey (e) When caciocavallo siciliano is drained off, and the curd is matted cheese is made solely from cow’s milk, into a cohesive mass. The mass is cut the name of such cheese is into slabs, which are so piled and han- ‘‘Caciocavallo siciliano cheese’’. When dled as to promote the drainage of made from sheep’s milk or goat’s milk whey and the development of acidity. or mixtures of these, or one or both of The slabs are then cut into pieces, these with cow’s milk, the name is fol- which may be rinsed by sprinkling or lowed by the words ‘‘made from pouring water over them, with free and lll’’, the blank being filled in with continuous drainage; but the duration the name or names of the milks used, of such rinsing is so limited that only in order of predominance by weight. the whey on the surface of such pieces is removed. The curd is salted, stirred, (f) Label declaration. Each of the in- further drained, and pressed into gredients used in the food shall be de- forms. One or more of the other op- clared on the label as required by the tional ingredients specified in para- applicable sections of parts 101 and 130 graph (b)(3) of this section may be of this chapter, except that enzymes of added during the procedure.

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(b) Optional ingredients. The following § 133.116 Low sodium cheddar cheese. safe and suitable ingredients may be used: Low sodium cheddar cheese is the (1) Dairy ingredients. Milk, nonfat food prepared from the same ingredi- milk, or cream, as defined in § 133.3, ents and in the same manner pre- used alone or in combination. scribed in § 133.113 for cheddar cheese (2) Clotting enzymes. Rennet and/or and complies with all the provisions of other clotting enzymes of animal, § 133.113, including the requirements for plant, or microbial origin. label statement of ingredients, except (3) Other optional ingredients. (i) that: Coloring. (a) It contains not more than 96 mil- (ii) Calcium chloride in an amount ligrams of sodium per pound of finished not more than 0.02 percent (calculated food. as anhydrous calcium chloride) of the (b) The name of the food is ‘‘low so- weight of the dairy ingredients, used as dium cheddar cheese’’. The letters in a coagulation aid. the words ‘‘low sodium’’ shall be of the (iii) Enzymes of animal, plant, or mi- same size and style of type as the let- crobial orgin, used in curing or flavor ters in the words ‘‘cheddar cheese’’, development. wherever such words appear on the (iv) Antimycotic agents, applied to label. the surface of slices or cuts in con- (c) If a salt substitute is used, the sumer-sized packages. label shall bear the statement ‘‘lll (v) Hydrogen peroxide, followed by a added as a salt substitute’’, the blank sufficient quantity of catalase prepara- being filled in with the common name tion to eliminate the hydrogen per- or names of the ingredient or ingredi- oxide. The weight of the hydrogen per- ents used as a salt substitute. oxide shall not exceed 0.05 percent of (d) Low sodium cheddar cheese is the weight of the milk and the weight subject to § 105.69 of this chapter. of the catalase shall not exceed 20 parts per million of the weight of the milk [48 FR 2743, Jan. 21, 1983] treated. (c) Nomenclature. The name of the § 133.118 Colby cheese. food is ‘‘cheddar cheese’’. (a) Colby cheese is the food prepared (d) Label declaration. Each of the in- from milk and other ingredients speci- gredients used in the food shall be de- fied in this section, by the procedure clared on the label as required by the set forth in paragraph (b) of this sec- applicable sections of parts 101 and 130 tion, or by another procedure which of this chapter, except that: produces a finished cheese having the (1) Enzymes of animal, plant, or mi- same physical and chemical properties crobial origin may be declared as ‘‘en- as the cheese produced when the proce- zymes’’; and dure set forth in paragraph (b) of this (2) The dairy ingredients may be de- section is used. It contains not more clared, in descending order or predomi- than 40 percent of moisture, and its nance, by the use of the terms ‘‘milkfat solids contain not less than 50 percent and nonfat milk’’ or ‘‘nonfat milk and of milkfat, as determined by the meth- milkfat’’, as appropriate. ods prescribed in § 133.5 (a), (b), and (d). [48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, If the milk used is not pasteurized, the 1983, as amended at 58 FR 2892, Jan. 6, 1993] cheese so made is cured at a temperature of not less than 35 °F for not less § 133.114 Cheddar cheese for manufac- than 60 days. turing. (b) Milk, which may be pasteurized or Cheddar cheese for manufacturing clarified or both, and which may be conforms to the definition and stand- warmed, is subjected to the action of ard of identity prescribed for cheddar harmless lactic-acid-producing bac- cheese by § 133.113, except that the milk teria, present in such milk or added is not pasteurized, curing is not re- thereto. Harmless artificial coloring quired, and the provisions of paragraph may be added. Sufficient rennet, or (b)(3)(iv) of that section do not apply. other safe and suitable milk-clotting [48 FR 2743, Jan. 21, 1983] enzyme that produces equivalent curd

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formation, or both, with or without pu- bate, or any combination of two or rified calcium chloride in a quantity more of these, in an amount not to ex- not more than 0.02 percent (calculated ceed 0.3 percent by weight calculated as anhydrous calcium chloride) of the as sorbic acid. weight of the milk, is added to set the (e)(1) If colby cheese has added to it milk to a semisolid mass. The mass is a clear aqueous solution prepared by so cut, stirred, and heated with contin- condensing or precipitating wood ued stirring, as to promote and regu- smoke in water as provided in para- late the separation of whey and curd. A graph (d)(1) of this section, the name of part of the whey is drained off, and the the food is immediately followed by curd is cooled by adding water, the the words ‘‘with added smoke fla- stirring being continued so as to pre- voring’’ with all words in this phrase of vent the pieces of curd from matting. the same type size, style, and color The curd is drained, salted, stirred, fur- without intervening written, printed, ther drained, and pressed into forms. A or graphic matter. harmless preparation of enzymes of (2) If colby cheese in sliced or cut animal or plant origin capable of aid- form contains an optional mold-inhib- ing in the curing or development of fla- iting ingredient as specified in para- vor of colby cheese may be added dur- graph (d)(2) of this section, the label ing the procedure, in such quantity shall bear the statement ‘‘lll added that the weight of the solids of such to retard mold growth’’ or ‘‘lll preparation is not more than 0.1 per- added as a preservative’’, the blank cent of the weight of the milk used. being filled in with the common name (c) For the purposes of this section: or names of the mold-inhibiting ingre- (1) The word ‘‘milk’’ means cow’s dient or ingredients used. milk, which may be adjusted by sepa- (3) Wherever the name of the food ap- rating part of the fat therefrom or by pears on the label so conspicuously as adding thereto one or more of the fol- to be easily seen under customary con- lowing: Cream, skim milk, conditions of purchase, the statement centrated skim milk, nonfat dry milk, specified in paragraph (e)(2) of this sec- water, in a quantity sufficient to re- tion, showing the optional ingredient constitute any concentrated skim milk used, shall immediately and conspicu- or nonfat dry milk used. ously precede or follow such name, (2) Milk shall be deemed to have been without intervening written, printed, pasteurized if it has been held at a tem- ° or graphic matter except for the state- perature of not less than 143 F for a ment ‘‘with added smoke flavoring,’’ as period of not less than 30 minutes, or set forth in paragraph (e)(1) of this sec- for a time and at a temperature equiva- tion. lent thereto in phosphatase destruc- (f) Each of the ingredients used in the tion. Colby cheese shall be deemed not food shall be declared on the label as to have been made from pasteurized required by the applicable sections of milk if 0.25 gram shows a phenol equiv- parts 101 and 130 of this chapter, except alent of more than 3 micrograms when that enzymes of animal, plant, or mi- tested by the method prescribed in crobial origin may be declared as ‘‘en- § 133.5(c). zymes’’. (3) During the cheesemaking process the milk may be treated with hydrogen [42 FR 14366, Mar. 15, 1977, as amended at 49 peroxide/catalase as provided in FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, § 133.113(a)(3). 1993] (d)(1) Colby cheese in the form of slices or cuts may have added to it a § 133.119 Colby cheese for manufac- clear aqueous solution prepared by con- turing. densing or precipitating wood smoke in Colby cheese for manufacturing con- water. forms to the definition and standard of (2) Colby cheese in the form of slices identity prescribed for colby cheese by or cuts in consumer-sized packages § 133.118, except that the milk is not may contain an optional mold-inhib- pasteurized, curing is not required, and iting ingredient consisting of sorbic the provisions of paragraph (d) of that acid, potassium sorbate, sodium sor- section do not apply.

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§ 133.121 Low sodium colby cheese. imum moisture content prescribed by the definition and standard of identity, Low sodium colby cheese is the food if any there be, for the variety of prepared from the same ingredients cheese used. If there is no applicable and in the same manner prescribed in definition and standard of identity, or § 133.118 for colby cheese and complies if such standard contains no provision with all the provisions of § 133.118, in- as to maximum moisture content, no cluding the requirements for label water is used in the preparation of the statement of ingredients, except that: cold-pack cheese. (a) Salt is not used. Any safe and (ii) The fat content of the solids of a suitable ingredient or combination of cold-pack cheese made from a single ingredients that contains no sodium variety of cheese is not less than the and that is recognized as a salt sub- minimum prescribed by the definition stitute may be used. and standard of identity, if any there (b) Sodium sorbate is not used. be, for the variety of cheese used, but (c) It contains not more than 96 mil- in no case is less than 47 percent, ex- ligrams of sodium per pound of finished cept that the fat content of the solids food. of cold-pack swiss cheese is not less (d) The name of the food is ‘‘low so- than 43 percent, and the fat content of dium colby cheese’’. The letters in the the solids of cold-pack gruyere cheese words ‘‘low sodium’’ shall be of the is not less than 45 percent. same size and style of type as the let- (4)(i) The moisture content of a cold- ters in the words ‘‘colby cheese’’, wher- pack cheese made from two or more va- ever such words appear on the label. rieties of cheese is not more than the (e) If a salt substitute as provided for arithmetical average of the maximum in paragraph (a) of this section is used, moisture contents prescribed by the the label shall bear the statement definitions and standards of identity, if ‘‘lll added as a salt substitute’’, the any there be, for the varieties of cheese blank being filled in with the common used, but in no case is the moisture name or names of the ingredient or in- content more than 42 percent, except gredients used as a salt substitute. that the moisture content of a cold- (f) Low sodium colby cheese is sub- pack cheese made from two or more of ject to § 105.69 of this chapter. the varieties cheddar cheese, washed [42 FR 14366, Mar. 15, 1977, as amended at 58 curd cheese, colby cheese, and granular FR 2892, Jan. 6, 1993] cheese is not more than 39 percent. (ii) The fat content of the solids of a § 133.123 Cold-pack and club cheese. cold-pack cheese made from two or (a)(1) Cold-pack cheese, club cheese, more varieties of cheese is not less is the food prepared by comminuting, than the arithmetical average of the without the aid of heat, one or more minimum percent of fat prescribed by cheeses of the same or two or more va- the definitions and standards of iden- rieties, except cream cheese, neuf- tity, if any there be, for the varieties of chatel cheese, cottage cheese, lowfat cheese used, but in no case is less than cottage cheese, cottage cheese dry 47 percent, except that the fat content curd, hard grating cheese, semisoft of the solids of a cold-pack cheese part-skim cheese, part-skim spiced made from swiss cheese and gruyere cheese and skim milk cheese for manu- cheese is not less than 45 percent. facturing, into a homogeneous plastic (5) Moisture and fat are determined mass. One or more of the optional in- by the methods prescribed in § 133.5(a), gredients designated in paragraph (c) of (b), and (d). this section may be used. (6) The weight of each variety of (2) All cheeses used in a cold-pack cheese in a cold-pack cheese made from cheese are made from pasteurized milk two varieties of cheese is not less than or are held for not less than 60 days at 25 percent of the total weight of both, a temperature of not less than 35 °F be- except that the weight of blue cheese, fore being comminuted. nuworld cheese, roquefort cheese, or (3)(i) The moisture content of a cold- gorgonzola cheese is not less than 10 pack cheese made from a single variety percent of the total weight of both, and of cheese is not more than the max- the weight of limburger cheese is not

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less than 5 percent of the total weight identity is prescribed by this section is of both. The weight of each variety of ‘‘Cold-pack lll cheese’’, ‘‘lll cold- cheese in a cold-pack cheese made from pack cheese’’ or ‘‘lll club cheese’’, three or more varieties of cheese is not the blanks being filled in with the less than 15 percent of the total weight name or names of the varieties of of all, except that the weight of blue cheese used, in order of predominance cheese, nuworld cheese, roquefort by weight. cheese, or gorgonzola cheese is not less (2) If the cold-pack cheese is made of than 5 percent of the total weight of cheddar cheese, washed curd cheese, all, and the weight of limburger cheese colby cheese, or granular cheese or any is not less than 3 percent of the total mixture of two or more of these, it may weight of all. These limits do not apply be designated ‘‘Cold-pack American to the quantity of cheddar cheese, cheese’’; or when cheddar cheese, washed curd cheese, colby cheese, and washed curd cheese, colby cheese, granular cheese in mixtures which are granular cheese, or any mixture of two designated as ‘‘American cheese’’ as or more of these is combined with prescribed in paragraph (d)(2) of this other varieties of cheese in the cheese section. Such mixtures are considered ingredient any of such cheeses or such as one variety of cheese for the purpose mixture may be designated as ‘‘Amer- of this paragraph (a)(6). ican cheese’’. (b) Cold-pack cheese may be smoked, (3) The full name of the food shall ap- or the cheese or cheeses from which it pear on the principal display panel of is made may be smoked, before the label in type of uniform size, style, comminuting and mixing, or it may and color. Wherever any word or state- contain substances prepared by con- ment emphasizing the name of any in- densing or precipitating wood smoke. gredient appears on the label (other (c) The optional ingredients referred than in an ingredient statement as to in paragraph (a) of this section are: specified in paragraph (f) of this sec- (1) An acidifying agent consisting of tion) so conspicuously as to be easily one or any mixture of two or more of seen under customary conditions of the following: A vinegar, lactic acid, purchase, the full name of the food citric acid, acetic acid, and phosphoric shall immediately and conspicuously acid, in such quantity that the pH of precede or follow such word or state- the finished cold-pack cheese is not ment in type of at least the same size below 4.5. For the purposes of this sec- as the type used in such word or state- tion vinegar is considered to be acetic ment. acid. (e) The name of the food shall include (2) Water. a declaration of any flavoring, includ- (3) Salt. ing smoke and substances prepared by (4) Harmless artificial coloring. condensing or precipitating wood (5) Spices or flavorings, other than smoke, that characterizes the product any which singly or in combination as specified in § 101.22 of this chapter with other ingredients simulate the and a declaration of any spice that flavor of a cheese of any age or variety. characterizes the product. (6) Cold-pack cheese in consumer- (f) Each of the ingredients used in the sized packages may contain an op- food shall be declared on the label as tional mold-inhibiting ingredient con- required by the applicable sections of sisting of sorbic acid, potassium sor- parts 101 and 130 of this chapter, except bate, sodium sorbate, or any combina- that cheddar cheese, washed curd tion of two or more of these, in an cheese, colby cheese, granular cheese, amount not to exceed 0.3 percent by or any mixture of two or more of these, weight, calculated as sorbic acid or may be designated as ‘‘American consisting of not more than 0.3 percent cheese’’. by weight of sodium propionate, cal- (1) Artificial coloring need not be de- cium propionate, or a combination of clared. sodium propionate and calcium propio- (2) If the cheese ingredient contains nate. cheddar cheese, washed curd cheese, (d)(1) The name of a cold-pack cheese colby cheese, granular cheese, or any for which a definition and standard of mixture of two or more of these, such

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cheese or such mixture may be des- cheese, washed curd cheese, colby ignated as ‘‘American cheese’’. cheese, and granular cheese in mixtures which are designated as ‘‘Amer- [42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, ican cheese’’ as prescribed in paragraph 1993] (h)(5) of this section. Such mixtures are considered as one variety of cheese for § 133.124 Cold-pack cheese food. the purposes of this paragraph (a)(6). (a)(1) Cold-pack cheese food is the (b) Cold-pack cheese food may be food prepared by comminuting and smoked, or the cheese or cheeses from mixing, without the aid of heat, one or which it is made may be smoked, be- more of the optional cheese ingredients fore comminuting and mixing, or it prescribed in paragraph (c) of this sec- may contain substances prepared by tion with one or more of the optional condensing or precipitating wood dairy ingredients prescribed in para- smoke. graph (d) of this section, into a homo- (c) The optional cheese ingredients geneous plastic mass. One or more of referred to in paragraph (a) of this sec- the optional ingredients specified in tion are: One or more cheeses of the paragraph (e) of this section may be same or two or more varieties, except used. that cream cheese, neufchatel cheese, (2) All cheeses used in a cold-pack cottage cheese, creamed cottage cheese food are made from pasteurized cheese, cook cheese, and skim-milk milk, or are held for not less than 60 cheese for manufacturing are not used, days at a temperature of not less than and except that semisoft part-skim 35 °F before being comminuted. cheese, part-skim spiced cheese, and (3) The moisture content of a cold- hard grating cheese may not be used, pack cheese food is not more than 44 alone or in combination with each percent, and the fat content is not less other, as the cheese ingredient. than 23 percent. (d) The optional dairy ingredients re- (4) Moisture and fat are determined ferred to in paragraph (a) of this sec- by the methods prescribed in § 133.5 (a), tion are: Cream, milk, skim milk, but- (b), and (d), except that in determining termilk, cheese whey, any of the fore- moisture the loss in weight which oc- going from which part of the water has curs in drying for 5 hours, under the been removed, anhydrous milkfat, de- conditions prescribed in such method, hydrated cream, skim milk cheese for is taken as the weight of moisture. manufacturing, and albumin from (5) The weight of the cheese ingre- cheese whey. All optional dairy ingredient prescribed by paragraph (a)(1) of dients used in cold-pack cheese food this section constitutes not less than 51 are pasteurized or made from products percent of the weight of the finished that have been pasteurized. cold-pack cheese food. (e) The other optional ingredients re- (6) The weight of each variety of ferred to in paragraph (a) of this sec- cheese in the cold-pack cheese food tion are: made with two varieties of cheese is (1) An acidifying agent consisting of not less than 25 percent of the total one or any mixture of two or more of weight of both, except that the weight the following: A vinegar, lactic acid, of blue cheese, nuworld cheese, roque- citric acid, acetic acid, and phosphoric fort cheese, gorgonzola cheese, or lim- acid, in such quantity that the pH of burger cheese is not less than 10 per- the finished cold-pack cheese food is cent of the total weight of both. The not below 4.5. weight of each variety of cheese in the (2) Water. cold-pack cheese food made with three (3) Salt. or more varieties of cheese is not less (4) Harmless artificial coloring. than 15 percent of the total weight of (5) Spices or flavorings, other than all, except that the weight of blue any which singly or in combination cheese, nuworld cheese, roquefort with other ingredients simulate the cheese, gorgonzola cheese, or limburger flavor of cheese of any age or variety. cheese is not less than 5 percent of the (6) A sweetening agent consisting of total weight of all. These limits do not one or any mixture of two or more of apply to the quantity of cheddar the following: Sugar, dextrose, corn

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sugar, corn sirup, corn sirup solids, of parts 101 and 130 of this chapter, ex- glucose sirup, glucose sirup solids, cept that cheddar cheese, washed curd maltose, malt sirup, and hydrolyzed cheese, colby cheese, granular cheese, lactose, in a quantity necessary for or any mixture of two or more of these, seasoning. may be designated as ‘‘American (7) Cold-pack cheese food in con- cheese’’. sumer-sized packages may contain an [42 FR 14366, Mar. 15, 1977, as amended at 49 optional mold-inhibiting ingredient FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, consisting of sorbic acid, potassium 1993] sorbate, sodium sorbate, or any combination of two or more of these, in an § 133.125 Cold-pack cheese food with amount not to exceed 0.3 percent by fruits, vegetables, or meats. weight, calculated as sorbic acid or (a) Cold-pack cheese food with fruits, consisting of not more than 0.3 percent vegetables, or meats or mixtures of by weight of sodium propionate, cal- these is the food which conforms to the cium propionate, or a combination of definition and standard of identity, and sodium propionate and calcium propio- is subject to the requirements for label nate. declaration of ingredients, prescribed (8) In the preparation of cold-pack for cold pack cheese food by § 133.124, cheese food, guar gum or xanthan gum, except that: or both, may be used, but the total (1) Its milk fat content is not less quantity of such ingredient or com- than 22 percent. bination is not to exceed 0.3 percent of (2) It contains one or any mixture of the weight of the finished food. When two or more of the following: Any prop- one or both such optional ingredients erly prepared fresh, cooked, canned, or is used, dioctyl sodium sulfosuccinate dried vegetable; any properly prepared complying with the requirements of cooked or canned meat. § 172.810 of this chapter may be used in (3) When the added fruits, vegetables, a quantity not in excess of 0.5 percent or meats contain fat, the method pre- by weight of such ingredient or ingredi- scribed for the determination of fat by ents. § 133.5(b) and (d) is not applicable. (f) The name of the food is ‘‘cold- (b) The name of a cold-pack cheese pack cheese food’’. The full name of the food with fruits, vegetables or meats is food shall appear on the principal dis- ‘‘Cold-pack cheese food with lll’’, play panel of the label in type of uni- the blank being filled in with the com- form size, style, and color. Wherever mon or usual name or names of the any word or statement emphasizing the fruits, vegetables, or meats used, in name of (other than in an ingredient order of predominance by weight. statement any ingredient appears on the label as specified in paragraph (h) [42 FR 14366, Mar. 15, 1977, as amended at 49 of this section) so conspicuously as to FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, be easily seen under customary condi- 1993] tions of purchase, the full name of the food shall immediately and conspicu- § 133.127 Cook cheese, koch kaese. ously precede or follow such word or (a) Description. (1) Cook cheese, koch statement in type of at least the same kaese, is the food prepared by the pro- size as the type used in such word or cedure set forth in paragraph (a)(3) of statement. this section or by any other procedure (g) The name of the food shall include which produces a finished cheese hav- a declaration of any flavoring, including the same physical and chemical ing smoke and substances prepared by properties. The maximum moisture condensing or precipitating wood content is 80 percent by weight, as de- smoke, that characterizes the product termined by the method described in as specified in § 101.22 of this chapter § 133.5. The dairy ingredients used may and a declaration of any spice that be pasteurized. characterizes the product. (2) The phenol equivalent value of (h) Each of the ingredients used in 0.25 gram of cook cheese is not more the food shall be declared on the label than 3 micrograms as determined by as required by the applicable sections the method described in § 133.5.

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(3) One or more of the dairy ingredi- this section. The milkfat content is not ents specified in paragraph (b)(1) of less than 4 percent by weight of the fin- this section may be warmed and is sub- ished food, within limits of good manu- jected to the action of a lactic acid- facturing practice. The finished food producing bacterial culture. One or contains not more than 80 percent of more of the clotting enzymes specified moisture, as determined by the method in paragraph (b)(2) of this section is prescribed in § 133.129(a). added to set the dairy ingredients to a (b) The creaming mixture is prepared semisolid mass. The mass is cut, from safe and suitable ingredients in- stirred, and heated with continued stir- cluding, but not limited to, milk or ring, so as to separate the curd and substances derived from milk. Any in- whey. The whey is drained from the gredients used that are not derived curd and the curd is cured for 2 or 3 from milk shall serve a useful function days. It is then heated to a tempera- other than building the total solids ture of not less than 180 °F until the content of the finished food, and shall hot curd will drop from a ladle with a be used in a quantity not greater than consistency like that of honey. The hot is reasonably required to accomplish cheese is filled into packages and their intended effect. The creaming cooled. One or more of the other op- mixture shall be pasteurized; however, tional ingredients specified in para- heat labile ingredients, such as bac- graph (b)(3) of this section may be terial starters, may be added following added during the procedure. pasteurization. (b) Optional ingredients. The following (c) The name of the food consists of safe and suitable ingredients may be the following two phrases which shall used: appear together: (1) Dairy ingredients. Nonfat milk as defined in § 133.3. (1) The words ‘‘cottage cheese’’ which (2) Clotting enzymes. Rennet and/or shall appear in type of the same size other clotting enzymes of animal, and style. plant, or microbial origin. (2) The statement ‘‘not less than l (3) Other optional ingredients. (i) Cal- percent milkfat’’ or ‘‘l percent cium chloride in an amount not more milkfat minimum’’, the blank being than 0.02 percent (calculated as anhy- filled in with the whole number that is drous calcium chloride) of the weight closest to, but does not exceed, the ac- of the dairy ingredients, used as a co- tual fat content of the product. This agulation aid. statement of fat content shall appear (ii) Culture of white mold. in letters not less than one-half of the (iii) Pasteurized cream. height of the letters in the phrase spec- (iv) Caraway seed. ified in paragraph (c)(1) of this section, (v) Salt. but in no case less than one-eighth of (c) Nomenclature. The name of the an inch in height. food is ‘‘cook cheese’’ or, alternatively, (d) When the optional process de- ‘‘koch kaese’’. scribed in § 133.129(b)(1) (ii) or (iii) is (d) Label declaration. Each of the in- used to make the cottage cheese dry gredients used in the food shall be de- curd used in cottage cheese, the label clared on the label as required by the shall bear the statement ‘‘Directly set’’ applicable sections of parts 101 and 130, or ‘‘Curd set by direct acidification’’. except that enzymes of animal, plant, Wherever the name of the food appears or microbial origin may be declared as on the label so conspicuously as to be ‘‘enzymes’’. seen under customary conditions of [54 FR 32053, Aug. 4, 1989, as amended at 55 purchase, the statement specified in FR 51409, Dec. 14, 1990; 58 FR 2892, Jan. 6, this paragraph, showing the optional 1993] process used, shall immediately and conspicuously precede or follow such § 133.128 Cottage cheese. name without intervening written, (a) Cottage cheese is the soft uncured printed, or graphic matter. cheese prepared by mixing cottage (e) Each of the ingredients used in cheese dry curd with a creaming mix- the food shall be declared on the label ture as provided in paragraph (b) of as required by the applicable sections

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of parts 101 and 130 of this chapter, ex- held until it becomes coagulated. The cept that milk-clotting enzymes may coagulated mass may be cut; it may be be declared by the word ‘‘enzymes’’. warmed; it may be stirred; it is then [42 FR 14366, Mar. 15, 1977, as amended at 58 drained. The curd is then washed with FR 2892, Jan. 6, 1993] water, and further drained. It may be pressed, chilled, worked, and seasoned § 133.129 Dry curd cottage cheese. with salt. (a) Cottage cheese dry curd is the (2) The dairy ingredients referred to soft uncured cheese prepared by the in paragraph (b)(1) of this section are procedure set forth in paragraph (b) of sweet skim milk, concentrated skim this section. The finished food contains milk, and nonfat dry milk. If con- less than 0.5 percent milkfat. It concentrated skim milk or nonfat dry tains not more than 80 percent of mois- milk is used, water may be added in a ture, as determined by the method pre- quantity not in excess of that removed scribed in § 133.5(a). when the skim milk was concentrated (b)(1) One or more of the dairy ingre- or dried. dients specified in paragraph (b)(2) of this section is pasteurized; calcium (3) For the purposes of this section chloride may be added in a quantity of the term ‘‘skim milk’’ means the milk not more than 0.02 percent (calculated of cows from which the milk fat has as anhydrous calcium chloride) of the been separated, and ‘‘concentrated weight of the mix; thereafter one of the skim milk’’ means skim milk from following methods is employed: which a portion of the water has been (i) Harmless lactic-acid-producing removed by evaporation. bacteria, with or without rennet and/or (c) The name of the food consists of other safe and suitable milk-clotting the following two phrases which shall enzyme that produces equivalent curd appear together: formation, are added and it is held (1) The words ‘‘cottage cheese dry until it becomes coagulated. The co- curd’’ or alternatively ‘‘dry curd cot- agulated mass may be cut; it may be tage cheese’’ which shall all appear in warmed; it may be stirred; it is then type of the same size and style. drained. The curd may be washed with (2) The words ‘‘less than 1⁄2% water and further drained; it may be pressed, chilled, worked, seasoned with milkfat’’ which shall all appear in let- salt; or ters not less than one-half of the (ii) Food grade phosphoric acid, lac- height of the letters in the phrase spec- tic acid, citric acid, or hydrochloric ified in paragraph (c)(1) of this section, acid, with or without rennet and/or but in no case less than one-eighth of other safe and suitable milk-clotting an inch in height. enzyme that produces equivalent curd (d) When either of the optional proc- formation, is added in such amount as esses described in paragraph (b)(1) (ii) to reach a pH of between 4.5 and 4.7; co- or (iii) of this section is used to make agulation to a firm curd is achieved cottage cheese dry curd, the label shall while heating to a maximum of 120 °F bear the statement ‘‘Directly set’’ or without agitation during a continuous ‘‘Curd set by direct acidification’’. process. The coagulated mass may be Wherever the name of the food appears cut; it may be warmed; it may be on the label so conspicuously as to be stirred; it is then drained. The curd is seen under customary conditions of washed with water, stirred, and further purchase, the statement specified in drained. It may be pressed, chilled, this paragraph, showing the optional worked, seasoned with salt. process used, shall immediately and (iii) Food grade acids as provided in conspicuously precede or follow such paragraph (b)(1)(ii) of this section, D- name without intervening written, Glucono-delta-lactone with or without printed, or graphic matter. rennet, and/or other safe and suitable milk clotting enzyme that produces (e) Each of the ingredients used in equivalent curd formation, are added in the food shall be declared on the label such amounts as to reach a final pH as required by the applicable sections value in the range of 4.5–4.8, and it is

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of parts 101 and 130 of this chapter, ex- (iii) Stabilizers, in a total amount cept that milk-clotting enzymes may not to exceed 0.5 percent of the weight be declared by the word ‘‘enzymes’’. of the finished food, with or without the addition of dioctyl sodium sulfo- [42 FR 14366, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 49 FR 10093, Mar. 19, succinate in a maximum amount of 0.5 1984; 58 FR 2892, Jan. 6, 1993] percent of the weight of the sta- bilizer(s) used. § 133.133 Cream cheese. (c) Nomenclature. The name of the (a) Description. (1) Cream cheese is food is ‘‘cream cheese’’. the soft, uncured cheese prepared by (d) Label declaration. Each of the in- the procedure set forth in paragraph gredients used in the food shall be de- (a)(2) of this section, or by any other clared on the label as required by the procedure which produces a finished applicable sections of parts 101 and 130 cheese having the same physical and of this chapter, except that: chemical properties. The minimum (1) Enzymes of animal, plant, or mi- milkfat content is 33 percent by weight crobial original may be declared as of the finished food, and the maximum ‘‘enzymes’’; and moisture content is 55 percent by (2) The dairy ingredients may be de- weight, as determined by the methods clared, in descending order of predomi- described in § 133.5. The dairy ingredi- nance, by the use of the terms ‘‘milkfat ents used are pasteurized. and nonfat milk’’ or ‘‘nonfat milk and (2) One or more of the dairy ingredi- milkfat’’, as appropriate. ents specified in paragraph (b)(1) of [54 FR 32053, Aug. 4, 1989, as amended at 58 this section may be homogenized and is FR 2892, Jan. 6, 1993] subjected to the action of lactic acid- producing bacterial culture. One or § 133.134 Cream cheese with other more of the clotting enzymes specified foods. in paragraph (b)(2) of this section is (a) Description. Cream cheese with added to coagulate the dairy ingredi- other foods is the class of foods pre- ents. The coagulated mass may be pared by mixing, with or without the warmed and stirred and it is drained. aid of heat, cream cheese with one or a The moisture content may be adjusted mixture of two or more types of foods with one or more of the optional ingre- (except other cheeses) listed in para- dients specified in paragraph (b)(3)(ii) graph (b)(1) of this section, in an of this section. The curd may be amount sufficient to differentiate the pressed, chilled, and worked and it may mixture from cream cheese. One or be heated until it becomes fluid. It may more of the other optional ingredients then be homogenized or otherwise in paragraph (b)(2) of this section may mixed. One or more of the optional be used. The maximum moisture con- dairy ingredients specified in para- tent of the mixture is 60 percent by graph (b)(1) and the other optional in- weight. The minimum milkfat is 33 gredients specified in paragraph (b)(3) percent by weight of the cream cheese of this section may be added during the and in no case less than 27 percent of procedure. the finished food. The moisture and fat (b) Optional ingredients. The following contents will be determined by the safe and suitable ingredients may be methods described in § 133.5, except used: that the method for determination of (1) Dairy ingredients. Milk, nonfat fat content is not applicable when the milk, or cream, as defined in § 133.3, added food contains fat. used alone or in combination. (b) Optional ingredients. The following (2) Clotting enzymes. Rennet and/or safe and suitable optional ingredients other clotting enzymes of animal, may be used: plant, or microbial origin. (1) Foods. Properly prepared fresh, (3) Other optional ingredients. (i) Salt. cooked, canned, or dried fruits or vege- (ii) Cheese whey, concentrated cheese tables; cooked or canned meats, rel- whey, dried cheese whey, or reconsti- ishes, pickles, or other suitable foods. tuted cheese whey prepared by addition (2) Other optional ingredients. (i) Sta- of water to concentrated cheese whey bilizers, in a total amount not to ex- or dried cheese whey. ceed 0.8 percent, with or without the

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addition of dioctyl sodium sulfo- semisolid mass. The mass is so cut, succinate in a maximum amount of 0.5 stirred, and heated with continued stir- percent of the weight of the sta- ring, as to promote and regulate the bilizer(s) used. separation of whey and curd. The whey (ii) Coloring. is drained off, and the curd is matted (c) Nomenclature. The name of the into a cohesive mass. The mass is cut food is ‘‘cream cheese with lll’’ or, into slabs, which are so piled and han- alternatively, ‘‘cream cheese and dled as to promote the drainage of lll’’, the blank being filled in with whey and the development of acidity. the name of the foods used in order of The slabs are then cut into pieces, predominance by weight. cooled in water, and soaked therein (d) Label declaration. Each of the in- until the whey is partly extracted and gredients used in the food shall be de- water is absorbed. The curd is drained, clared on the label as required by the salted, stirred, and pressed into forms. applicable sections of parts 101 and 130 One or more of the other optional in- of this chapter, except that: gredients specified in paragraph (b)(3) (1) Enzymes of animal, plant, or mi- of this section may be added during the crobial origin may be declared as ‘‘en- procedure. zymes’’; and (b) Optional ingredients. The following (2) The dairy ingredients may be de- safe and suitable ingredients may be clared, in descending order of predomi- used: nance, by the use of the terms ‘‘milkfat (1) Dairy ingredients. Milk, nonfat and nonfat milk’’ or ‘‘nonfat milk and milk, or cream, as defined in § 133.3, milkfat’’, as appropriate. used alone or in combination. [54 FR 32053, Aug. 4, 1989, as amended at 58 (2) Clotting enzymes. Rennet and/or FR 2893, Jan. 6, 1993] other clotting enzymes of animal, plant, or microbial origin. § 133.136 Washed curd and soaked (3) Other optional ingredients. (i) curd cheese. Coloring. (a) Description. (1) Washed curd, (ii) Calcium chloride in an amount soaked curd cheese is the food prepared not more than 0.02 percent (calculated by the procedure set forth in paragraph as anhydrous calcium chloride) of the (a)(3) of this section or by any other weight of the dairy ingredients, used as procedure which produces a finished a coagulation aid. cheese having the same physical and (iii) Enzymes of animal, plant, or mi- chemical properties. The minimum crobial origin, used in curing or flavor milkfat content is 50 percent by weight development. of the solids and the maximum mois- (iv) Antimycotic agents, the cumu- ture content is 42 percent by weight, as lative levels of which shall not exceed determined by the methods described current good manufacturing practice, in § 133.5. If the dairy ingredients used may be added to the surface of the are not pasteurized, the cheese is cured cheese. at a temperature of not less than 35 °F (v) Hydrogen peroxide, followed by a for at least 60 days. sufficient quantity of catalase prepara- (2) If pasteurized dairy ingredients tion to eliminate the hydrogen per- are used, the phenol equivalent value oxide. The weight of the hydrogen per- of 0.25 gram of washed curd cheese is oxide shall not exceed 0.05 percent of not more than 3 micrograms as deter- the weight of the dairy ingredients and mined by the method described in the weight of the catalase shall not § 133.5. exeed 20 parts per million of the weight (3) One or more of the dairy ingredi- of dairy ingredients treated. ents specified in paragraph (b)(1) of (c) Nomenclature. The name of the this section may be warmed, treated food is ‘‘washed curd cheese’’ or, alter- with hydrogen peroxide/catalase, and is natively, ‘‘soaked curd cheese’’. subjected to the action of a lactic acid- (d) Label declaration. Each of the in- producing bacterial culture. One or gredients used in the food shall be de- more of the clotting enzymes specified clared on the label as required by the in paragraph (b)(2) of this section is applicable sections of parts 101 and 130 added to set the dairy ingredients to a of this chapter, except that:

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(1) Enzymes of animal, plant or mi- aration of curd and whey. When the de- crobial origin may be declared as ‘‘en- sired curd is obtained, it is transferred zymes’’; and to forms permitting drainage of whey. (2) The dairy ingredients may be de- During drainage the curd is pressed and clared, in descending order of predomi- turned. After drainage the curd is re- nance, by the use of the terms ‘‘milkfat moved from the forms and is salted and and nonfat milk’’ or ‘‘nonfat milk and cured. One or more of the other op- milkfat’’, as appropriate. tional ingredients specified in paragraph (b)(3) of this section may be [54 FR 32054, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993] added during the procedures. (b) Optional ingredients. The following § 133.137 Washed curd cheese for man- safe and suitable ingredients may be ufacturing. used: (1) Dairy ingredients. Milk, nonfat Washed curd cheese for manufac- milk, or cream, as defined in § 133.3, turing conforms to the definition and used alone or in combination. standard of identity prescribed for (2) Clotting enzymes. Rennet and/or washed curd cheese by § 133.136, except other clotting enzymes of animal, that the dairy ingredients are not pas- plant, or microbial origin. teurized and curing is not required. (3) Other optional ingredients. (i) [54 FR 32054, Aug. 4, 1989] Coloring. (ii) Calcium chloride in an amount § 133.138 Edam cheese. not more than 0.02 percent (calculated (a) Description. (1) Edam cheese is the as anhydrous calcium chloride) of the food prepared by the procedure set weight of the dairy ingredients, used as forth in paragraph (a)(3) of this section a coagulation aid. or by any other procedure which pro- (iii) Enzymes of animal, plant, or mi- duces a finished cheese having the crobial origin, used in curing or flavor same physical and chemical properties. development. The minimum milkfat content is 40 (iv) Antimycotic agents, the cumu- percent by weight of the solids and the lative levels of which shall not exceed maximum moisture content is 45 per- current good manufacturing practice, cent by weight, as determined by the may be added to the surface of the methods described in § 133.5. If the cheese. dairy ingredients used are not (c) Nomenclature. The name of the pasturized, the cheese is cured at a food is ‘‘edam cheese.’’ temperature of not less than than 35 °F (d) Label declaration. Each of the infor at least 60 days. gredients used in the food shall be de- (2) If pasteurized dairy ingredients clared on the label as required by the are used, the phenol equivalent value applicable sections of parts 101 and 130 of 0.25 gram of edam cheese is not more of this chapter, except that: than 3 micrograms, as determined by (1) Enzymes of animal, plant, or mi- the method described in § 133.5. crobial origin may be declared as ‘‘en- (3) One or more of the dairy ingredi- zymes’’; and ents specified in paragraph (b)(1) of (2) The dairy ingredients may be de- this section may be warmed and is sub- clared, in descending order of predomi- jected to the action of a lactic acid- nance, by the use of the terms ‘‘milkfat producing bacterial culture. One or and nonfat milk’’ or ‘‘nonfat milk and more of the clotting enzymes specified milkfat,’’ as appropriate. in paragraph (b)(2) of this section is [48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, added to set the dairy ingredients to a 1983, as amended at 55 FR 6795, Feb. 27, 1990; semisolid mass. After coagulation the 58 FR 2893, Jan. 6, 1993] mass is cut into small cube-shaped pieces with sides approximately three- § 133.140 Gammelost cheese. eighths-inch long. The mass is stirred (a) Description. (1) Gammelost cheese and heated to about 90 °F. and so han- is the food prepared from nonfat milk, dled by further stirring, heating, dilu- as defined in § 133.3, by the procedure tion with water or salt brine, and salt- set forth in paragraph (a)(2) of this sec- ing as to promote and regulate the sep- tion, or by any other procedure which

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produces a finished cheese having the drainage. While being placed in forms, same physical and chemical properties. spores of the mold Penicillium roque- The maximum moisture content is 52 fortii are added. The forms are turned percent by weight, as determined by several times during drainage. When the methods described in § 133.5. sufficiently drained, the shaped curd is (2) The dairy ingredients are sub- removed from the forms and salted jected to the action of a lactic acid- with dry salt or brine. Perforations are producing bacterial culture. The devel- then made in the shaped curd and it is opment of acidity is continued until held at a temperature of approximately the dairy ingredients coagulate to a 50 °F at 90 to 95 percent relative humid- semisolid mass. The mass is stirred and ity, until the characteristic mold heated until a temperature of about 145 growth has developed. During storage, °F is reached, and is held at that tem- the surface of the cheese may be perature for at least 30 minutes. The scraped to remove surface growth of whey is drained off and the curd re- undesirable microorganisms. One or moved and placed in forms and pressed. more of the other optional ingredients The shaped curd is placed in whey and specified in paragraph (b)(3) of this sec- heated for 3 or 4 hours, and may again tion may be added during the proce- be pressed. It is then stored under con- dure. ditions suitable for curing. (b) Optional ingredients. The following (b) Nomenclature. The name of the safe and suitable ingredients may be food is ‘‘gammelost cheese’’. used: (c) Label declaration. Each of the in- (1) Dairy ingredients. Milk, nonfat gredients used in the food shall be de- milk, or cream, as defined in § 133.3, or clared on the label as required by the corresponding products of goat origin, applicable sections of parts 101 and 130 used alone or in combination. of this chapter. (2) Clotting enzymes. Rennet and/or [54 FR 32054, Aug. 4, 1989, as amended at 58 other clotting enzymes of animal, FR 2893, Jan. 6, 1993] plant, or microbial origin. (3) Other optional ingredients. (i) Blue § 133.141 Gorgonzola cheese. or green color in an amount to neu- (a) Description. (1) Gorgonzola cheese tralize the natural yellow color of the is the food prepared by the procedure curd. set forth in paragraph (a)(2) of this sec- (ii) Calcium chloride in an amount tion or by any other procedure which not more than 0.02 percent (calculated produces a finished cheese having the as anhydrous calcium chloride) of the same physical and chemical properties. weight of the dairy ingredients, used as It is characterized by the presence of a coagulation aid. bluish-green mold, Penicillium roque- (iii) Enzymes of animal, plant, or mi- fortii, throughout the cheese. The min- crobial origin, used in curing or flavor imum milkfat content is 50 percent by development. weight of the solids and the maximum (iv) Antimycotic agents, the cumu- moisture content is 42 percent by lative levels of which shall not exceed weight, as determined by the methods current good manufacturing practice, described in § 133.5. The dairy ingredi- may be added to the surface of the ents used may be pasteurized. Gorgon- cheese. zola cheese is at least 90 days old. (v) Benzoyl peroxide, or a mixture of (2) One or more of the dairy ingredi- benzoyl peroxide with potassium alum, ents specified in paragraph (b)(1) of calcium sulfate, and magnesium car- this section may be warmed and is sub- bonate used to bleach the dairy ingre- jected to the action of a lactic acid- dients. The weight of the benzoyl per- producing bacterial culture. One or oxide is not more than 0.002 percent of more of the clotting enzymes specified the weight of the dairy ingredients in paragraph (b)(2) of this section is being bleached, and the weight of the added to set the dairy ingredients to a potassium alum, calcium sulfate, and semisolid mass. The mass is cut into magnesium carbonate, singly or com- smaller portions and allowed to stand bined, is not more than six times the for a time. The mixed curd and whey is weight of the benzoyl peroxide used. If placed into forms permitting further the dairy ingredients are bleached in

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this manner, vitamin A is added to the (2) If pasteurized dairy ingredients curd in such quantity as to compensate are used, the phenol equivalent value for the vitamin A or its precursors de- of 0.25 gram of granular cheese is not stroyed in the bleaching process, and more than 3 micrograms as determined artificial coloring is not used. by the method described in § 133.5. (vi) Vegetable fats or oil which may (3) One or more of the dairy ingredi- be hydrogenated, used as a coating for ents specified in paragraph (b)(1) of the rind. this section may be warmed, treated (c) Nomenclature. The name of the with hydrogen peroxide/catalase, and is food is ‘‘gorgonzola cheese’’. subjected to the action of a lactic acid- (d) Label declaration. Each of the in- producing bacterial culture. One or gredients used in the food shall be de- more of the clotting enzymes specified clared on the label as required by the in paragraph (b)(2) of this section is applicable sections of parts 101 and 130 added to set the dairy ingredients to a of this chapter, except that: semisolid mass. The mass is so cut, (1) Enzymes of animal, plant, or mi- stirred, and heated with continued stir- crobial origin may be declared as ‘‘en- ring, as to promote and regulate the zymes’’; and separation of whey and curd. A part of (2) The dairy ingredients may be declared, in descending order of predomi- the whey is drained off. The curd is nance, by the use of the terms ‘‘milkfat then alternately stirred and drained to and nonfat milk’’ or ‘‘nonfat milk and prevent matting and to remove whey milkfat’’, as appropriate; ‘‘milkfat from curd. The curd is then salted, from goat’s milk and nonfat goat’s stirred, drained, and pressed into milk’’, etc. forms. One or more of the other optional ingredients specified in para- [54 FR 32054, Aug. 4, 1989, as amended at 58 graph (b)(3) of this section may be FR 2893, Jan. 6, 1993] added during the procedure. § 133.142 Gouda cheese. (b) Optional ingredients. The following safe and suitable ingredients may be Gouda cheese conforms to the defini- used: tion and standard of identity and com- (1) Dairy ingredients. Milk, nonfat plies with the requirements for label milk, or cream, as defined in § 133.3, declaration of ingredients prescribed used alone or in combination. for edam cheese by § 133.138, except that the minimum milkfat content is 46 per- (2) Clotting enzymes. Rennet and/or cent by weight of the solids, as deter- other clotting enzymes of animal, mined by the methods described in plant, or microbial origin. § 133.5 and the maximum moisture con- (3) Other optional ingredients. (i) tent is 45 percent by weight. Coloring. (ii) Calcium chloride in an amount [48 FR 2744, Jan. 21, 1983] not more than 0.02 percent (calculated § 133.144 Granular and stirred curd as anhydrous calcium chloride) by cheese. weight of the dairy ingredients, used as a coagulation aid. (a) Description. (1) Granular cheese, stirred curd cheese is the food prepared (iii) Enzymes of animal, plant, or mi- by the procedure set forth in paragraph crobial origin, used in curing or flavor (a)(3) of this section or by any other development. procedure which produces a finished (iv) Antimycotic agents, the cumu- cheese having the same physical and lative levels of which shall not exceed chemical properties. The minimum current good manufacturing practice, milkfat content is 50 percent by weight may be added to the surface of the of the solids and the maximum mois- cheese. ture content is 39 percent by weight as (v) Hydrogen peroxide, followed by a determined by the methods described sufficient quantity of catalase prepara- in § 133.5. If the dairy ingredients used tion to eliminate the hydrogen per- are not pasteurized, the cheese is cured oxide. The weight of the hydrogen per- at a temperature of not less than 35 °F oxide shall not exceed 0.05 percent of for at least 60 days. the weight of the dairy ingredients and

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the weight of the catalase shall not ex- level of 2 percent of the weight of the ceed 20 parts per million of the weight finished food. of the dairy ingredients treated. (2) When one variety of cheese is (c) Nomenclature. The name of the used, the minimum milkfat content of food is ‘‘granular cheese’’ or, alter- the food is not more than 1 percent natively, ‘‘stirred curd cheese’’. lower than the minimum prescribed by (d) Label declaration. Each of the in- the standard of identity for that gredients used in the food shall be de- cheese. clared on the label as required by the (3) When two or more varieties of applicable sections of parts 101 and 130 cheese are used, the minimum milkfat of this chapter, except that: content is not more than 1 percent (1) Enzymes of animal, plant, or mi- below the arithmetical average of the crobial origin may be declared as ‘‘en- minimum fat content percentages pre- zymes’’; and scribed by the standards of identity for the varieties of cheese used, and in no (2) The dairy ingredients may be de- case is the milkfat content less than 31 clared, in descending order of predomi- percent. nance, by the use of the terms ‘‘milkfat (4) Milkfat and moisture contents are and nonfat milk’’ or ‘‘nonfat milk and determined by the methods described milkfat’’, as appropriate. in § 133.5. [54 FR 32055, Aug. 4, 1989, as amended at 58 (c) Optional ingredients. The following FR 2893, Jan. 6, 1993] safe and suitable ingredients may be used: § 133.145 Granular cheese for manu- (1) Antimycotics. facturing. (2) Anticaking agents. Granular cheese for manufacturing (3) Spices. conforms to the definition and stand- (4) Flavorings other than those ard of identity prescribed for granular which, singly or in combination with cheese by § 133.144, except that the other ingredients, simulate the flavor dairy ingredients are not pasteurized of cheese of any age or variety. and curing is not required. (d) Nomenclature. (1) The name of the food is ‘‘grated cheese’’ or ‘‘grated [54 FR 32056, Aug. 4, 1989] cheeses’’, as appropriate. The name of the food shall be accompanied by a dec- § 133.146 Grated cheeses. laration of the specific variety of (a) Description. Grated cheeses is the cheese(s) used in the food and by a dec- class of foods prepared by grinding, laration indicating the presence of any grating, shredding, or otherwise added spice or flavoring. comminuting cheese of one variety or a (2) Any cheese varietal names used in mixture of two or more varieties. The the name of the food are those speci- cheese varieties that may be used are fied by applicable standards of iden- those for which there are definitions tity, except that the designation and standards of identity, except that ‘‘American cheese’’ may be used for cream cheese, neufchatel cheese, cot- cheddar, washed curd, colby, or granu- tage cheese, creamed cottage cheese, lar cheese or for any mixture of these cook cheese, and skim milk cheese for cheeses. manufacturing may not be used. All (3) The following terms may be used cheese ingredients used are either in place of the name of the food to de- made from pasteurized milk or held at scribe specific types of grated cheese: a temperature of not less than 35 °F for (i) If only one variety of cheese is at least 60 days. Moisture may be reused, the name of the food is ‘‘grated moved from the cheese ingredients in lll cheese’’, the name of the cheese the manufacture of the finished food, filling the blank. but no moisture is added. One or more (ii) If only parmesan and romano of the optional ingredients specified in cheeses are used and each is present at paragraph (c) of this section may be a level of not less than 25 percent by used. weight of the finished food, the name of (b) Composition. (1) Each cheese ingre- the food is ‘‘grated lll and lll dient used is present at a minimum cheese’’, the blanks being filled with

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the names ‘‘parmesan’’ and ‘‘romano’’ sheep’s milk and nonfat sheep’s milk’’, in order of predominance by weight. etc., as appropriate. The name ‘‘reggiano’’ may be used for [54 FR 32056, Aug. 4, 1989; 54 FR 35756, Aug. 29, ‘‘parmesan’’. 1989, as amended at 58 FR 2893, Jan. 6, 1993] (iii) If a mixture of cheese varieties (not including parmesan or romano) is § 133.147 Grated American cheese used and each variety is present at a food. level of not less than 25 percent of the (a)(1) Grated American cheese food is weight of the finished food, the name of the food prepared by mixing, with or the food is ‘‘grated lll cheese’’, the without the aid of heat, one or more of blank being filled in with the names of the optional cheese ingredients pre- the varieties in order of predominance scribed in paragraph (b) of this section by weight. with one or more of the optional ingre- (iv) If a mixture of cheese varieties in dients prescribed in paragraph (c) of which one or more varieties (not in- this section, into a uniformly blended, cluding parmesan or romano) are each partially dehydrated, powdered, or present at a level of not less than 25 granular mixture. percent by weight of the finished food, (2) Grated American cheese food con- and one or more other varieties (which tains not less than 23 percent of may include parmesan and romano milkfat, as determined by the method cheese) are each present at a level of prescribed in § 133.5(b). not less than 2 percent but in the ag- (b) The optional cheese ingredients gregate not more than 10 percent of the referred to in paragraph (a) of this sec- weight of the finished food, the name of tion are cheddar cheese, washed curd the food is ‘‘grated lll cheese with cheese, colby cheese, and granular other grated cheese’’ or ‘‘grated lll cheese. cheese with other grated cheeses’’, as (c) The other optional ingredients re- appropriate, the blank being filled in ferred to in paragraph (a) of this sec- with the name or names of those tion are: cheese varieties present at levels of not (1) Nonfat dry milk. less than 25 percent by weight of the (2) Dried whey. finished food in order of predominance, (3) An emulsifying agent consisting in letters not more than twice as high of one or any mixture of two or more of as the letters in the phrase ‘‘with other the emulsifying ingredients named in grated cheese(s)’’. § 133.173(e)(1), in such quantity that the (4) The following terms may be used weight of the solids thereof is not more in place of ‘‘grated’’ to describe alter- than 3 percent of the weight of the native forms of cheese: grated American cheese food. (i) ‘‘Shredded’’, if the particles of (4) An acidifying agent consisting of cheese are in the form of cylinders, one or more of the acid-reacting ingre- shreds, or strings. dients named in § 133.173(e)(2). (ii) ‘‘Chipped’’ or ‘‘chopped’’, if the (5) Salt. particles of cheese are in the form of (6) Artificial coloring. chips. (d) The name of the food is ‘‘Grated (e) Label declaration. Each of the in- American cheese food’’. The full name gredients used in the food shall be de- of the food shall appear on the prin- clared on the label as required by the cipal display panel of the label in type applicable sections of parts 101 and 130 of uniform size, style, and color. Wher- of this chapter, except that: ever any word or statement empha- (1) Enzymes of animal, plant, or mi- sizing the name of any ingredient ap- crobial origin may be declared as ‘‘en- pears on the label (other than in an in- zymes’’; and gredient statement as specified in (2) The dairy ingredients may be de- paragraph (e) of this section) so con- clared, in descending order of predomi- spicuously as to be easily seen under nance, by the use of the terms ‘‘milkfat customary conditions of purchase, the and nonfat milk’’ or ‘‘nonfat milk and full name of the food shall immediately milkfat’’, ‘‘milkfat from goat’s milk and conspicuously precede or follow and nonfat goat’s milk’’, ‘‘milkfat from such word or statement in type of at

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least the same size as the type used in cheese may be added during the proce- such word or statement. dure, in such quantity that the weight (e) Each of the ingredients used in of the solids of such preparation is not the food shall be declared on the label more than 0.1 percent of the weight of as required by the applicable sections the milk used. of parts 101 and 130 of this chapter, ex- (c) For the purposes of this section, cept that cheddar cheese, washed curd the word ‘‘milk’’ means cow’s milk or cheese, colby cheese, granular cheese, goat’s milk or sheep’s milk or mixtures or any mixture of two or more of these of two or all of these. Such milk may may be designated ‘‘American cheese’’. be adjusted by separating part of the [42 FR 14366, Mar. 15, 1977, as amended at 49 fat therefrom or (in the case of cow’s FR 10094, Mar. 19, 1984; 58 FR 2893, Jan. 6, milk) by adding one or more of the fol- 1993] lowing: Cream, skim milk, con- § 133.148 Hard grating cheeses. centrated skim milk, nonfat dry milk; (in the case of goat’s milk) the cor- (a) The cheeses for which definitions and standards of identity are pre- responding products from goat’s milk; scribed by this section are hard grating (in the case of sheep’s milk) the cor- cheeses for which specifically applica- responding products from sheep’s milk; ble definitions and standards of iden- water in a quantity sufficient to recon- tity are not prescribed by other sec- stitute any such concentrated or dried tions of this part. They are made from products used. milk and the other ingredients speci- (d) Safe and suitable antimycotic fied in this section, by the procedure agent(s), the cumulative levels of set forth in paragraph (b) of this sec- which shall not exceed current good tion. They contain not more than 34 manufacturing practice, may be added percent of moisture, and their solids to the surface of the cheese. contain not less than 32 percent of (e) The name of each hard grating milkfat, as determined by the methods cheese for which a definition and prescribed in § 133.5 (a), (b), and (d). standard of identity is prescribed by Hard grating cheeses are cured for not this section is ‘‘Hard grating cheese’’, less than 6 months. preceded or followed by: (b) Milk, which may be pasteurized or (1) The specific common or usual clarified or both, and which may be warmed, is subjected to the action of name of such hard grating cheese, if harmless lactic-acid-producing bac- any such name has become generally teria or other harmless flavor-pro- recognized therefor; or ducing bacteria, present in such milk (2) If no such specific common or or added thereto. Sufficient rennet, usual name has become generally rec- rennet paste, extract of rennet paste, ognized therefor, an arbitrary or fan- or other safe and suitable milk-clot- ciful name that is not false or mis- ting enzyme that produces equivalent leading in any particular. curd formation, singly or in any com- (3) When milk other than cow’s milk bination (with or without purified cal- is used, in whole or in part, the state- cium chloride in a quantity not more ment ‘‘made from lll’’, the blank than 0.02 percent, calculated as anhy- being filled in with the name or names drous calcium chloride, of the weight of the milk used, in order of predomi- of the milk) is added to set the milk to nance by weight. a semisolid mass. Harmless artificial (f) Label declaration. Each of the in- coloring may be added. The mass is cut gredients used in the food shall be de- into small particles, stirred, and heat- clared on the label as required by the ed. The curd is separated from the applicable sections of parts 101 and 130 whey, drained, shaped into forms, of this chapter, except that: pressed, salted, and cured. The rind may be colored or rubbed with vege- (1) When milk other than cow’s milk table oil or both. A harmless prepara- is used, in whole or in part, the com- tion of enzymes of animal or plant ori- mon or usual name of each such milk gin capable of aiding in the curing or ingredient shall be declared in order of development of flavor of hard grating predominance by weight; and

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(2) Enzymes of the animal, plant, or during which time small holes, or so- microbial origin may be declared as called eyes, form. The cheese is then ‘‘enzymes’’. stored at a lower temperature for further curing. One or more of the other [42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24, 1983; 49 FR 10094, Mar. 19, optional ingredients specified in para- 1984; 58 FR 2893, Jan. 6, 1993] graph (b)(3) of this section may be added during the procedure. § 133.149 Gruyere cheese. (b) Optional ingredients. The following (a) Description. (1) Gruyere cheese is safe and suitable ingredients may be the food prepared by the procedure set used: forth in paragraph (a)(3) of this section (1) Dairy ingredients. Milk, nonfat or by any other procedure which pro- milk, or cream, as defined in § 133.3, duces a finished cheese having the used alone or in combination. same physical and chemical properties. (2) Clotting enzymes. Rennet and/or It contains small holes or eyes. It has other clotting enzymes of animal, a mild flavor, due in part to the growth plant, or microbial origin. of surface-curing agents. The minimum (3) Other optional ingredients. (i) Cal- milkfat content is 45 percent by weight cium chloride in an amount not more of the solids and the maximum mois- than 0.02 percent (calculated as anhy- ture content is 39 percent by weight, as drous calcium chloride) of the weight determined by the methods described of the dairy ingredients, used as a coin § 133.5. The dairy ingredients used agulation aid. may be pasteurized. The cheese is at (ii) Enzymes of animal, plant, or mi- least 90 days old. crobial origin, used in curing or flavor (2) If pasteurized dairy ingredients development. are used, the phenol equivalent value (iii) Antimycotic agents, applied to of 0.25 gram of gruyere cheese is not the surface of slices or cuts in con- more than 3 micrograms as determined sumer-sized packages. by the method described in § 133.5. (c) Nomenclature. The name of the (3) One or more of the dairy ingredi- food is ‘‘gruyere cheese’’. ents specified in paragraph (b)(1) of (d) Label declaration. Each of the in- this section may be warmed and is sub- gredients used in the food shall be de- jected to the action of lactic acid-pro- clared on the label as required by the ducing and propionic acid-producing applicable sections of parts 101 and 130 bacterial cultures. One or more of the of this chapter, except that: clotting enzymes specified in para- (1) Enzymes of animal, plant, or mi- graph (b)(2) of this section is added to crobial origin may be declared as ‘‘en- set the dairy ingredients to a semisolid zymes’’; and mass. The mass is cut into particles (2) The dairy ingredients may be de- similar in size to wheat kernels. For clared, in descending order of predomi- about 30 minutes the particles are al- nance, by the use of the terms ‘‘milkfat ternately stirred and allowed to settle. and nonfat milk’’ or ‘‘nonfat milk and The temperature is raised to about 126 milkfat’’, as appropriate. °F. Stirring is continued until the curd [48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, becomes firm. The curd is transferred 1983, as amended at 58 FR 2893, Jan. 6, 1993] to hoops or forms, and pressed until the desired shape and firmness are ob- § 133.150 Hard cheeses. tained. The cheese is surface-salted (a) The cheeses for which definitions while held at a temperature of 48° to 54 and standards of identity are pre- °F for a few days. It is soaked for 1 day scribed by this section are hard cheeses in a saturated salt solution. It is then for which specifically applicable defini- held for 3 weeks in a salting cellar and tions and standards of identity are not wiped every 2 days with brine cloth to prescribed by other sections of this insure growth of biological curing part. They are made from milk and the agents on the rind. It is then removed other ingredients specified in this sec- to a heating room and held at progres- tion, by the procedure set forth in sively higher temperatures, finally paragraph (b) of this section. They con- reaching 65 °F with a relative humidity tain not more than 39 percent of mois- of 85 to 90 percent, for several weeks, ture, and their solids contain not less

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than 50 percent of milkfat, as deter- reconstitute any concentrated or dried mined by the methods prescribed in products used. § 133.5 (a), (b), and (d). If the milk used (2) Milk shall be deemed to have been is not pasteurized, the cheese so made pasteurized if it has been held at a tem- is cured at a temperature of not less perature of not less than 143 °F for a than 35 °F for not less than 60 days. period of not less than 30 minutes, or (b) Milk, which may be pasteurized or for a time and at a temperature equiva- clarified or both, and which may be lent thereto in phosphatase destruc- warmed, is subjected to the action of tion. A hard cheese shall be deemed not harmless lactic-acid-producing bac- to have been made from pasteurized teria, with or without other harmless milk if 0.25 gram shows a phenol equiv- flavor-producing bacteria, present in alent of more than 3 micrograms when such milk or added thereto. Harmless tested by the method prescribed in artificial coloring may be added. Suffi- § 133.5(c). cient rennet, rennet paste, extract of (d) Safe and suitable antimycotic rennet paste, or other safe and suitable agent(s), the cumulative levels of milk-clotting enzyme that produces which shall not exceed current good equivalent curd formation, singly or in manufacturing practice, may be added any combination (with or without puri- to the surface of the cheese. fied calcium chloride in a quantity not (e) The name of each hard cheese for more than 0.02 percent, calculated as anhydrous calcium chloride, of the which a definition and standard of weight of the milk) is added to set the identity is prescribed by this section is milk to a semisolid mass. The mass is ‘‘Hard cheese’’, preceded or followed cut into small particles, stirred, and by: heated. The curd is separated from the (1) The specific common or unusual whey, drained, and shaped into forms, name of such hard cheese, if any such and may be pressed. The curd is salted name has become generally recognized at some stage of the manufacturing therefor; or process. The shaped curd may be cured. (2) If no such specific common or The rind may be coated with paraffin usual name has become generally rec- or rubbed with vegetable oil. A harm- ognized, therefor, an arbitrary or fan- less preparation of enzymes of animal ciful name that is not false or mis- or plant origin capable of aiding in the leading in any particular. curing or development of flavor of hard (3) When milk other than cow’s milk cheese may be added during the proce- is used, in whole or in part, the state- dure, in such quantity that the weight ment ‘‘made from lll’’, the blank of the solids of such preparation is not being filled in with the name or names more than 0.1 percent of the weight of of the milk used, in order of predomi- the milk used. Harmless flavor-pro- nance by weight. ducing microorganisms may be added, (f) Label declaration. Each of the in- and curing may be conducted under gredients used in the food shall be de- suitable conditions for the develop- clared on the label as required by the ment of biological curing agents. applicable sections of parts 101 and 130 (c) For the purposes of this section: of this chapter, except that: (1) The word ‘‘milk’’ means cow’s (1) When milk other than cow’s milk milk or goat’s milk or sheep’s milk or is used, in whole or in part, the com- mixtures of two or all of these. Such mon or usual name of each such milk milk may be adjusted by separating ingredient shall be declared in order of part of the fat therefrom, or (in the case of cow’s milk) by adding one or predominance by weight; and more of the following: Cream, skim (2) Enzymes of animal, plant, or mi- milk, concentrated skim milk, nonfat crobial origin may be declared as ‘‘en- dry milk; (in the case of goat’s milk) zymes’’. the corresponding products from goat’s [42 FR 14366, Mar. 15, 1977, as amended at 48 milk; (in the case of sheep’s milk) the FR 49013, Oct. 24, 1983; 49 FR 10094, Mar. 19, corresponding products from sheep’s 1984; 58 FR 2893, Jan. 6, 1993] milk; water in a quantity sufficient to

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§ 133.152 Limburger cheese. a temperature of 89° to 90 °F. after pas- (a) Description. (1) Limburger cheese teurization, and is subjected to the ac- is the food prepared by one of the pro- tion of a lactic acid-producing bac- cedures set forth in paragraph (a)(3) of terial culture. The procedure is then this section, or by any other procedure the same as in paragraph (a)(3)(i) of which produces a finished cheese hav- this section, except that heating is to ° ing the same physical and chemical 94 F. After most of the whey is drained ° properties. The minimum milkfat con- off, salt brine at a temperature of 66 to ° tent is 50 percent by weight of the sol- 70 F is added, so that the pH of the ids and the maximum moisture content curd is about 4.8. The mixed curd, is 50 percent by weight, as determined whey, and brine is dipped into molds, by the methods described in § 133.5. If and the remaining procedure specified the dairy ingredients used are not pas- in paragraph (a)(3)(i) of this section is teurized, the cheese is cured at a tem- followed. perature of not less than 35 °F for at (b) Optional ingredients. The following least 60 days. safe and suitable ingredients may be (2) If pasteurized dairy ingredients used: are used, the phenol equivalent value (1) Dairy ingredients. Milk, nonfat of 0.25 gram of limburger cheese is not milk, or cream, as defined in § 133.3, more than 4 micrograms as determined used alone or in combination. by the method described in § 133.5. (2) Clotting enzymes. Rennet and/or (3) One of the following procedures other clotting enzymes of animal, may be followed for producing lim- plant, or microbial origin. burger cheese: (3) Other optional ingredients. (i) (i) One or more of the dairy ingredi- Coloring. ents, unpasteurized, specified in para- (ii) Calcium chloride in an amount graph (b)(1) of this section is warmed not more than 0.02 percent (calculated to about 92 °F and subjected to the ac- as anhydrous calcium chloride) by tion of a lactic acid-producing bac- weight of the dairy ingredients, used as terial culture. One or more of the clot- a coagulation aid. ting enzymes specified in paragraph (iii) Enzymes of animal, plant, or mi- (b)(2) of this section is added to set the crobial origin, used in curing or flavor dairy ingredients to a semisolid mass. development. The mass is cut into cubes with sides (c) Nomenclature. The name of the approximately one-half inch long. food is ‘‘limburger cheese’’. After a few minutes the mass is stirred (d) Label declaration. Each of the in- and heated, gradually raising the tem- ° ° gredients used in the food shall be de- perature to 96 to 98 F. The curd is clared on the label as required by the then allowed to settle, most of the applicable sections of parts 101 and 130 whey is drained off, and the remaining of this chapter, except that: curd and whey dipped into molds. Dur- (1) Enzymes of animal, plant, or mi- ing drainage the curd may be pressed. crobial origin may be declared as ‘‘en- It is turned at regular intervals. After zymes’’; and drainage the curd is cut into pieces of (2) The dairy ingredients may be de- desired size and dry-salted at intervals clared, in descending order of predomi- for 24 to 48 hours. The cheese is then nance, by the use of the terms ‘‘milkfat cured with frequent applications of a and nonfat milk’’ or ‘‘nonfat milk and weak brine solution to the surface, milkfat’’, as appropriate. until the proper growth of surface-curing organisms is obtained. It is then [48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, wrapped and held in storage for devel- 1983, as amended at 58 FR 2893, Jan. 6, 1993] opment of as much additional flavor as is desired. One or more of the other op- § 133.153 Monterey cheese and mon- tional ingredients specified in para- terey jack cheese. graph (b)(3) of this section may be (a) Description. (1) Monterey cheese, added during the procedure. monterey jack cheese is the food pre- (ii) One or more of the dairy ingredi- pared by the procedure set forth in ents specified in paragraph (b)(1) of paragraph (a)(3) of this section, or by this section is pasteurized, brought to any other procedure which produces a

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finished cheese having the same phys- (v) Vegetable oil, with or without ical and chemical properties. The min- rice flour sprinkled on the surface, imum milkfat content is 50 percent by used as a coating for the rind. weight of the solids, and the maximum (c) Nomenclature. The name of the moisture content is 44 percent by food is ‘‘monterey cheese’’ or alter- weight, as determined by the methods natively, ‘‘monterey jack cheese’’. described in § 133.5. The dairy ingredi- (d) Label declaration. Each of the in- ents used are pasteurized. gredients used in the food shall be de- (2) The phenol equivalent of 0.25 gram clared on the label as required by the of monterey cheese is not more than 3 applicable sections of parts 101 and 130 micrograms, as determined by the of this chapter, except that: method described in § 133.5. (1) Enzymes of animal, plant, or mi- (3) One or more of the dairy ingredi- crobial origin may be declared as ‘‘en- ents specified in paragraph (b)(1) of zymes’’, and this section is subjected to the action (2) The dairy ingredients may be de- of a lactic acid-producing bacterial cul- clared, in descending order of predomi- ture. One or more of the clotting en- nance, by the use of the terms ‘‘milkfat zymes specified in paragraph (b)(2) of and nonfat milk’’ or ‘‘nonfat milk and this section is added to set the dairy milkfat’’, as appropriate. ingredients to a semisolid mass. The [54 FR 32056, Aug. 4, 1989, as amended at 58 mass is so cut, stirred, and heated with FR 2893, Jan. 6, 1993] continued stirring, as to promote and regulate the separation of whey and § 133.154 High-moisture jack cheese. curd. Part of the whey is drained off, High-moisture jack cheese conforms and water or salt brine may be added. to the definition and standard of iden- The curd is drained and placed in a tity and is subject to the requirement muslin or sheeting cloth, formed into a for label statement of ingredients pre- ball, and pressed; or the curd is placed scribed for monterey cheese by § 133.153, in a cheese hoop and pressed. Later, except that its moisture content is the cloth bandage is removed, and the more than 44 percent but less than 50 cheese may be covered with a suitable percent. coating. One or more of the other optional ingredients specified in para- [58 FR 2893, Jan. 6, 1993] graph (b)(3) of this section may be added during the procedure. § 133.155 Mozzarella cheese and (b) Optional ingredients. The following scamorza cheese. safe and suitable ingredients may be (a) Description. (1) Mozzarella cheese, used: scamorza cheese is the food prepared (1) Dairy ingredients. Milk, nonfat from dairy ingredients and other ingre- milk, or cream, as defined in § 133.3, dients specified in this section by the used alone or in combination. procedure set forth in paragraph (a)(3) (2) Clotting enzymes. Rennet and/or of this section, or by any other proce- other clotting enzymes of animal, dure which produces a finished cheese plant, or microbial origin. having the same physical and chemical (3) Other optional ingredients. (i) Cal- properties. It may be molded into var- cium chloride in an amount not more ious shapes. The minimum milkfat than 0.02 percent (calculated as anhy- content is 45 percent by weight of the drous calcium chloride) by weight of solids, and the moisture content is the dairy ingredients, used as a coagu- more than 52 percent but not more lation aid. than 60 percent by weight as deter- (ii) Enzymes of animal, plant, or mi- mined by the methods described in crobial origin, used in curing or flavor § 133.5. The dairy ingredients are pas- development. teurized. (iii) Salt. (2) The phenol equivalent value of (iv) Antimycotic agents, the cumu- 0.25 gram of mozzarella cheese is not lative levels of which shall not exceed more than 3 micrograms as determined current good manufacturing practice, by the method described in § 133.5. may be added to the surface of the (3) One or more of the dairy ingredi- cheese. ents specified in paragraph (b)(1) of

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this section is warmed to approxi- clared on the label as required by the mately 88 °F (31.1 °C) and subjected to applicable sections of parts 101 and 130 the action of a lactic acid-producing of this chapter, except that: bacterial culture. One or more of the (1) Enzymes of animal, plant, or mi- clotting enzymes specified in para- crobial origin may be declared as ‘‘en- graph (b)(2) of this section is added to zymes’’; and set the dairy ingredients to a semisolid (2) The dairy ingredients may be de- mass. The mass is cut, and it may be clared, in descending order of predomi- stirred to facilitate separation of whey nance, by the use of the terms ‘‘milkfat from the curd. The whey is drained, and nonfat milk’’ or ‘‘nonfat milk and and the curd may be washed with cold milkfat’’, ‘‘milkfat from water buffalo water and the water drained off. The milk and nonfat buffalo milk’’ or curd may be collected in bundles for ‘‘nonfat water buffalo milk and milkfat further drainage and for ripening. The from water buffalo milk,’’ as appro- curd may be iced, it may be held under priate. refrigeration, and it may be permitted [53 FR 3743, Feb. 9, 1988, as amended at 58 FR to warm to room temperature and 2893, Jan. 6, 1993] ripen further. The curd may be cut. It is immersed in hot water or heated § 133.156 Low-moisture mozzarella and with steam and is kneaded and scamorza cheese. stretched until smooth and free of (a) Description. (1) Low-moisture moz- lumps. It is then cut and molded. The zarella cheese, low-moisture scamorza molded curd is firmed by immersion in cheese is the food prepared from dairy cold water and drained. One or more of ingredients and other ingredients spec- the other optional ingredients specified ified in this section by the procedure in paragraph (b)(3) of this section may set forth in paragraph (a)(3) of this sec- be added during the procedure. tion, or by any other procedure which (b) Optional ingredients. The following produces a finished cheese having the safe and suitable ingredients may be same physical and chemical properties. used: It may be molded into various shapes. (1) Dairy ingredients. Cow’s milk, non- The minimum milkfat content is 45 fat milk, or cream, as defined in § 133.3, percent by weight of the solids and the or the corresponding products of water moisture content is more than 45 per- buffalo origin, except that cow’s milk cent but not more than 52 percent by products are not combined with water weight as determined by the methods buffalo products. described in § 133.5. The dairy ingredi- (2) Clotting enzymes. Rennet and/or ents are pasteurized. other clotting enzymes of animal, (2) The phenol equivalent value of plant, or microbial origin. 0.25 gram of low-moisture mozzarella (3) Other optional ingredients. (i) Vin- cheese is not more than 3 micrograms egar. as determined by the method described (ii) Coloring to mask any natural yel- in § 133.5. low color in the curd. (3) One or more of the dairy ingredi- (iii) Salt. ents specified in paragraph (b)(1) of (iv) Antimycotics, the cumulative this section may be warmed and is sub- levels of which shall not exceed current jected to the action of a lactic acid- good manufacturing practice, may be producing bacterial culture. One or added to the cheese during the knead- more of the clotting enzymes specified ing and stretching process and/or ap- in paragraph (b)(2) of this action is plied to the surface of the cheese. added to set the dairy ingredients to a (c) Nomenclature. The name of the semisolid mass. The mass is cut, food is ‘‘mozzarella cheese’’ or, alter- stirred, and allowed to stand. It may be natively, ‘‘scamorza cheese’’. When the reheated and again stirred. The whey is food is made with water buffalo milk, drained and the curd may be cut and the name of the food is accompanied by piled to promote further separation of the phrase ‘‘made with water buffalo whey. It may be washed with cold milk’’. water and the water drained off. The (d) Label declaration. Each of the in- curd may be collected in bundles for gredients used in the food shall be de- further drainage and for ripening. The

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curd may be iced, it may be held under (1) Enzymes of animal, plant, or mi- refrigeration, and it may be permitted crobial origin may be declared as ‘‘en- to warm to room temperature and zymes’’; and ripen further. The curd may be cut. It (2) The dairy ingredients may be de- is immersed in hot water or heated clared, in descending order of predomi- with steam and is kneaded and nance, by the use of the terms ‘‘milkfat stretched until smooth and free of and nonfat milk’’ or ‘‘nonfat milk and lumps. It is then cut and molded. In milkfat’’, ‘‘milkfat from water buffalo molding, the curd is kept sufficiently milk and nonfat water buffalo milk’’ or warm to cause proper sealing of the ‘‘nonfat water buffalo) The dairy ingre- surface. The molded curd is firmed by dients may be declared, in descending immersion in cold water and drained. order of predominance, by the use of One or more of the other optional in- the terms ‘‘milkfat and nonfat milk’’ gredients specified in paragraph (b)(3) or ‘‘nonfat milk and milkfat’’, of this section may be added during the ‘‘milkfat from water buffalo milk and procedure. nonfat water buffalo milk’’ or ‘‘nonfat water buffalo milk and milkfat from (b) Optional ingredients. The following water buffalo milk’’, as appropriate. safe and suitable ingredients may be used: [53 FR 3743, Feb. 9, 1988, as amended at 58 FR (1) Dairy ingredients. Cow’s milk, non- 2893, Jan. 6, 1993] fat milk, or cream, as defined in § 133.3, or the corresponding products of water § 133.157 Part-skim mozzarella and scamorza cheese. buffalo origin, except that cow’s milk products are not combined with water Part-skim mozzarella cheese, part- buffalo products. skim scamorza cheese conforms to the (2) Clotting enzymes. Rennet and/or definition and standard of identity as clotting enzymes of animal, plant, or prescribed for mozzarella cheese by microbial origin. § 133.155, except that its milk fat content, calculated on the solids basis, is (3) Other optional ingredients. (i) Vin- less than 45 percent but not less than 30 egar. percent. (ii) Coloring to mask any natural yellow color in the curd. § 133.158 Low-moisture part-skim moz- (iii) Salt. zarella and scamorza cheese. (iv) Calcium chloride in an amount Low-moisture part-skim mozzarella not more than 0.02 percent (calculated cheese and low-moisture part-skim as anhydrous calcium chloride) of the scamorza cheese conform to the defini- weight of the dairy ingredients, used as tion and standard of identity and com- a coagulation aid. ply with the requirements for label (v) Antimycotics, the cumulative lev- declaration of ingredients prescribed els of which shall not exceed current for low-moisture mozzarella cheese and good manufacturing practices, may be low-moisture scamorza cheese by added to the cheese during the knead- § 133.156, except that their milkfat con- ing and stretching process and/or ap- tent, calculated on the solids basis, is plied to the surface of the cheese. less than 45 percent but not less than 30 (c) Nomenclature. The names of the percent. food is ‘‘low-moisture mozzarella [58 FR 2894, Jan. 6, 1993] cheese’’ or, alternatively, ‘‘low-moisture scamorza cheese’’. When the food § 133.160 Muenster and munster is made with water buffalo milk, the cheese. name of the food is accompanied by the (a) Description. (1) Muenster cheese, phrase ‘‘made with water buffalo munster cheese, is the food prepared by milk’’. the procedure set forth in paragraph (d) Label declaration. Each of the in- (a)(3) of this section or by any other gredients used in the food shall be de- procedure which produces a finished clared on the label as required by the cheese having the same physical and applicable sections of parts 101 and 130 chemical properties. The minimum of this chapter, except that: milkfat content is 50 percent by weight

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of the solids and the maximum mois- (c) Nomenclature. The name of the ture content is 46 percent by weight, as food is ‘‘muenster cheese’’ or, alter- determined by the methods decribed in natively, ‘‘munster cheese’’. § 133.5. The dairy ingredients used are (d) Label declaration. Each of the in- pasteurized. gredients used in the food shall be de- (2) The phenol equivalent of 0.25 gram clared on the label as required by the of muenster cheese is not more than 3 applicable sections of parts 101 and 130 micrograms, as determined by the of this chapter, except that: methods described in § 133.5. (1) Enzymes of animal, plant, or mi- (3) One or more of the dairy ingredi- crobial origin may be declared as ‘‘en- ents specified in paragraph (b)(1) of zymes’’; and this section may be warmed and is sub- (2) The dairy ingredients may be de- jected to the action of a harmless lac- clared, in descending order of predomi- tic acid-producing bacterial culture. nance, by the use of the terms ‘‘milkfat One or more of the clotting enzymes and nonfat milk’’ or ‘‘nonfat milk and specified in paragraph (b)(2) of this sec- milkfat’’, as appropriate. tion is added to set the dairy ingredients to a semisolid mass. After coagu- [54 FR 32057, Aug. 4, 1989; 54 FR 35756, Aug. 29, lation the mass is divided into small 1989, as amended at 58 FR 2894, Jan. 6, 1993] portions, stirred, and heated, with or § 133.161 Muenster and munster without dilution with water or salt cheese for manufacturing. brine, so as to promote and regulate the separation of whey and curd. The Muenster cheese for manufacturing curd is transferred to forms permitting conforms to the definition and stand- drainage of the whey. During drainage ard of identity for muenster cheese pre- the curd may be pressed and turned. scribed by § 133.160, except that the After drainage the curd is removed dairy ingredients are not pasteurized. from the forms and is salted. One or [54 FR 32057, Aug. 4, 1989] more of the other optional ingredients specified in paragraph (b)(3) of this sec- § 133.162 Neufchatel cheese. tion may be added during the procedure. (a) Description. (1) Neufchatel cheese is the soft uncured cheese prepared by (b) Optional ingredients. The following the procedure set forth in paragraph safe and suitable ingredients may be (a)(2) of this section or by any other used: procedure which produces a finished (1) Dairy ingredients. Milk, nonfat cheese having the same physical and milk, or cream, as defined in § 133.3, chemical properties. The milkfat con- used alone or in combination. tent is not less than 20 percent but less (2) Clotting enzymes. Rennet and/or than 33 percent by weight of the fin- other clotting enzymes of animal, ished food and the maximum moisture plant, or microbial origin. content is 65 percent by weight, as de- (3) Other optional ingredients. (i) termined by the methods described in Coloring. § 133.5. The dairy ingredients used are (ii) Calcium chloride in an amount pasteurized. not more than 0.02 percent (calculated (2) One or more of the dairy ingredi- as anhydrous calcium chloride) of the ents specified in paragraph (b)(1) of weight of the dairy ingredients, used as this section is subjected to the action a coagulation aid. of a harmless lactic acid-producing (iii) Enzymes of animal, plant, or mi- bacterial culture, with or without one crobial origin used in curing or flavor or more of the clotting enzymes speci- development. fied in paragraph (b)(2) of this section. (iv) Antimycotic agents, the cumu- The mixture is held until the dairy in- lative levels of which shall not exceed gredients coagulate. The coagulated current good manufacturing practice, mass may be warmed and stirred and it may be added to the surface of the is drained. The moisture content may cheese. be adjusted with one of the optional in- (v) Vegetable oil, used as a coating gredients in paragraph (b)(3)(ii) of this for the rind. section. The curd may be pressed,

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chilled, worked, and heated until it be- and the maximum moisture content is comes fluid. It may then be homog- 46 percent by weight, as determined by enized or otherwise mixed. One or more the methods described in § 133.5. The of the dairy ingredients specified in dairy ingredients used may be pasteur- paragraph (b)(1) of this section or the ized. Nuworld cheese is at least 60 days other optional ingredients specified in old. paragraph (b)(3) of this section may be (2) One or more of the dairy ingredi- added during the procedure. ents specified in paragraph (b)(1) of (b) Optional ingredients. The following this section may be warmed and is sub- safe and suitable ingredients may be jected to the action of a lactic acid- used: producing bacterial culture. One or (1) Dairy ingredients. Milk, nonfat more of the clotting enzymes specified milk, or cream, as defined in § 133.3. in paragraph (b)(2) of this section is (2) Clotting enzymes. Rennet and/or added to set the dairy ingredients to a other clotting enzymes of animal, semisolid mass. The mass is cut into plant, or microbial origin. smaller portions and allowed to stand (3) Other optional ingredients. (i) Salt. for a time. The mixed curd and whey is (ii) Cheese whey, concentrated cheese placed into forms permitting further whey, dried cheese whey, or reconsti- drainage. While being placed in forms, tuted cheese whey prepared by addition spores of a white mutant of the mold of water to concentrated cheese whey or dried cheese whey. Penicillium roquefortii are added. The (iii) Stabilizers, in a total amount forms are turned several times during not to exceed 0.5 percent of the weight drainage. When sufficiently drained, of the finished food, with or without the shaped curd is removed from the the addition of dioctyl sodium sulfo- forms and salted with dry salt or brine. succinate in a maximum amount of 0.5 Perforations are then made in the percent of the weight of the sta- shaped curd and it is held at a tempera- ° bilizer(s) used. ture of approximately 50 F at 90 to 95 (c) Nomenclature. The name of the percent relative humidity, until the food is ‘‘neufchatel cheese’’. characteristic mold growth has devel- (d) Label declaration. Each of the in- oped. During storage, the surface of the gredients used in the food shall be de- cheese may be scraped to remove sur- clared on the label as required by the face growth of undesirable microorga- applicable sections of parts 101 and 130 nisms. One or more of the other op- of this chapter, except that: tional ingredients specified in para- (1) Enzymes of animal, plant, or mi- graph (b)(3) of this section may be crobial origin may be declared as ‘‘en- added during the procedure. zymes’’; and (b) Optional ingredients. The following (2) The dairy ingredients may be de- safe and suitable ingredients may be clared, in descending order of predomi- used: nance, by use of the terms ‘‘milkfat (1) Dairy ingredients. Milk, nonfat and nonfat milk’’ or ‘‘nonfat milk and milk, or cream, as defined in § 133.3, milkfat’’, as appropriate. used alone or in combination. [54 FR 32057, Aug. 4, 1989, as amended at 58 (2) Clotting enzymes. Rennet and/or FR 2894, Jan. 6, 1993] other clotting enzymes of animal, plant, or microbial origin. § 133.164 Nuworld cheese. (3) Other optional ingredients. (i) Blue (a) Description. (1) Nuworld cheese is or green color in an amount to neu- the food prepared by the procedure set tralize the natural yellow color of the forth in paragraph (a)(2) of this section curd. or by any other procedure which pro- (ii) Calcium chloride in an amount duces a finished cheese having the not more than 0.02 percent (calculated same physical and chemical properties. as anhydrous calcium chloride) of the It is characterized by the presence of weight of the dairy ingredients, used as creamy-white mold, a white mutant of a coagulation aid. Penicillium roquefortii, throughout the (iii) Enzymes of animal, plant, or mi- cheese. The minimum milkfat content crobial origin, used in curing or flavor is 50 percent by weight of the solids development.

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(c) Nomenclature. The name of the hoops, and pressed. The pressed curd is food is ‘‘nuworld cheese’’. removed and salted in brine, or dry- (d) Label declaration. Each of the in- salted. The cheese is cured in a cool, gredients used in the food shall be de- ventilated room. The rind of the cheese clared on the label as required by the may be coated or colored. A harmless applicable sections of parts 101 and 130 preparation of enzymes of animal or of this chapter, except that: plant origin capable of aiding in the (1) Enzymes of animal, plant, or mi- curing or development of flavor of par- crobial origin may be declared as ‘‘en- mesan cheese may be added during the zymes’’; and procedure, in such quantity that the (2) The dairy ingredients may be declared, in descending order of predomi- weight of the solids of such preparation nance, by the use of the terms ‘‘milkfat is not more than 0.1 percent of the and nonfat milk’’ or ‘‘nonfat milk and weight of the milk used. milkfat’’, as appropriate. (c)(1) For the purposes of this section, the word ‘‘milk’’ means cow’s [54 FR 32058, Aug. 4, 1989, as amended at 58 FR 2894, Jan. 6, 1993] milk, which may be adjusted by separating part of the fat therefrom or by § 133.165 Parmesan and reggiano adding thereto one or more of the fol- cheese. lowing: Cream, skim milk, con- (a) Parmesan cheese, reggiano centrated skim milk, nonfat dry milk, cheese, is the food prepared from milk water in a quantity sufficient to recon- and other ingredients specified in this stitute any concentrated skim milk or section, by the procedure set forth in nonfat dry milk used. paragraph (b) of this section, or by an- (2) Such milk may be bleached by the other procedure which produces a fin- use of benzoyl peroxide or a mixture of ished cheese having the same physical benzoyl peroxide with potassium alum, and chemical properties as the cheese calcium sulfate, and magnesium car- produced when the procedure set forth bonate; but the weight of the benzoyl in paragraph (b) of this section is used. peroxide is not more than 0.002 percent It is characterized by a granular tex- of the weight of the milk bleached, and ture and a hard and brittle rind. It the weight of the potassium alum, cal- grates readily. It contains not more cium sulfate, and magnesium car- than 32 percent of moisture, and its bonate, singly or combined, is not more solids contain not less than 32 percent than six times the weight of the ben- of milkfat, as determined by the methods prescribed in § 133.5 (a), (b), and (d). zoyl peroxide used. If milk is bleached It is cured for not less than 10 months. in this manner, sufficient vitamin A is (b) Milk, which may be pasteurized or added to the curd to compensate for clarified or both, and which may be the vitamin A or its precursors de- warmed, is subjected to the action of stroyed in the bleaching process, and harmless lactic-acid-producing bac- artificial coloring is not used. teria, present in such milk or added (d) Safe and suitable antimycotic thereto. Sufficient rennet, or other safe agent(s), the cumulative levels of and suitable milk-clotting enzyme that which shall not exceed current good produces equivalent curd formation, or manufacturing practice may be added both, with or without purified calcium to the surface of the cheese. chloride in a quantity not more than (e) Label declaration. Each of the in- 0.02 percent (calculated as anhydrous gredients used in the food shall be de- calcium chloride) of the weight of the clared on the label as required by the milk, is added to set the milk to a applicable sections of parts 101 and 130 semisolid mass. Harmless artificial of this chapter, except that enzymes of coloring may be added. The mass is cut animal, plant, or microbial origin may into pieces no larger than wheat ker- be declared as ‘‘enzymes’’. nels, heated, and stirred until the temperature reaches between 115 °F and 125 [42 FR 14366, Mar. 15, 1977, as amended at 48 °F. The curd is allowed to settle and is FR 49014, Oct. 24, 1983; 49 FR 10095, Mar. 19, then removed from the kettle or vat, 1984; 58 FR 2894, Jan. 6, 1993] drained for a short time, placed in

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§ 133.167 Pasteurized blended cheese. cheese, followed by the term ‘‘with lll’’, the blank being filled in with Pasteurized blended cheese conforms the common or usual name or names of to the definition and standard of iden- the fruits, vegetables, or meats used, in tity, and is subject to the requirements order of predominance by weight. for label statement of ingredients, prescribed for pasteurized process cheese [42 FR 14366, Mar. 15, 1977, as amended at 49 by § 133.169, except that: FR 10095, Mar. 19, 1977; 58 FR 2894, Jan. 6, (a) In mixtures of two or more 1993] cheeses, cream cheese or neufchatel § 133.169 Pasteurized process cheese. cheese may be used. (b) None of the ingredients prescribed (a)(1) Pasteurized process cheese is or permitted for pasteurized process the food prepared by comminuting and cheese by § 133.169 (c) and (d)(1) is used. mixing, with the aid of heat, one or (c) In case of mixtures of two or more more cheeses of the same or two or cheeses containing cream cheese or more varieties, except cream cheese, neufchatel cheese, the moisture con- neufchatel cheese, cottage cheese, tent is not more than the arithmetical lowfat cottage cheese, cottage cheese average of the maximum moisture con- dry curd, cook cheese, hard grating tents prescribed by the definitions and cheese, semisoft part-skim cheese, standards of identity for the varieties part-skim spiced cheese, and skim milk cheese for manufacturing with an of cheeses blended, for which such lim- emulsifying agent prescribed by para- its have been prescribed. graph (c) of this section into a homo- (d) The word ‘‘process’’ is replaced by geneous plastic mass. One or more of the word ‘‘blended’’ in the name pre- the optional ingredients designated in scribed by § 133.169(e). paragraph (d) of this section may be [42 FR 14366, Mar. 15, 1977, as amended at 58 used. FR 2894, Jan. 6, 1993] (2) During its preparation, pasteurized process cheese is heated for not § 133.168 Pasteurized blended cheese less than 30 seconds at a temperature with fruits, vegetables, or meats. of not less than 150 °F. When tested for (a) Pasteurized blended cheese with phosphatase by the method prescribed fruits, vegetables, or meats, or mix- in § 133.5(c), the phenol equivalent of tures of these is the food which con- 0.25 gram of pasteurized process cheese forms to the definition and standard of is not more than 3 micrograms. identity, and is subject to the require- (3)(i) The moisture content of a pas- ments for label statement of ingredi- teurized process cheese made from a ents, prescribed for pasteurized blended single variety of cheese is not more cheese by § 133.167, except that: than 1 percent greater than the max- (1) Its moisture content may be 1 per- imum moisture content prescribed by cent more, and the milk fat content of the definition and standard of identity, its solids may be 1 percent less, than if any there be, for the variety of the limits prescribed by § 133.167 for cheese used; but in no case is more moisture and milk fat in the cor- than 43 percent, except that the mois- responding pasteurized blended cheese. ture content of pasteurized process (2) It contains one or any mixture of washed curd cheese or pasteurized two or more of the following: Any prop- process colby cheese is not more than erly prepared cooked, canned, or dried 40 percent; the moisture content of pas- fruit; any properly prepared cooked, teurized process swiss cheese or pas- canned, or dried vegetable; any prop- teurized process gruyere cheese is not erly prepared cooked or canned meat. more than 44 percent; and the moisture (3) When the added fruits, vegetables, content of pasteurized process lim- or meats contain fat, the method pre- burger cheese is not more than 51 per- scribed for the determination of fat by cent. § 133.5(b) is not applicable. (ii) The fat content of the solids of a (b) The name of a pasteurized blended pasteurized process cheese made from a cheese with fruits, vegetables, or meats single variety of cheese is not less than is the name prescribed by § 133.167 for the minimum prescribed by the defini- the applicable pasteurized blended tion and standard of identity, if any

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there be, for the variety of cheese used, cheese, or gorgonzola cheese is not less but in no case is less than 47 percent; than 5 percent of the total weight of except that the fat content of the sol- all, and the weight of limburger cheese ids of pasteurized process swiss cheese is not less than 3 percent of the total is not less than 43 percent, and the fat weight of all. These limits do not apply content of the solids of pasteurized to the quantity of cheddar cheese, process gruyere cheese is not less than washed curd cheese, colby cheese and 45 percent. granular cheese in mixtures which are (4)(i) The moisture content of a pas- designated as ‘‘American cheese’’ as teurized process cheese made from two prescribed in paragraph (e)(2)(ii) of this or more varieties of cheese is not more section. Such mixtures are considered than 1 percent greater than the arith- as one variety of cheese for the pur- metical average of the maximum mois- poses of this paragraph (a)(6). ture contents prescribed by the defini- (7) For the purposes of this section, tions and standards of identity, if any cheddar cheese for manufacturing, there be, for the varieties of cheese washed curd cheese for manufacturing, used; but in no case is the moisture colby cheese for manufacturing, granu- content more than 43 percent, except lar cheese for manufacturing, brick that the moisture content of a pasteur- cheese for manufacturing, muenster ized process cheese made from two or cheese for manufacturing, and swiss more of the varieties cheddar cheese, cheese for manufacturing are consid- washed curd cheese, colby cheese, and ered as cheddar cheese, washed curd granular cheese is not more than 40 cheese, colby cheese, granular cheese, percent, and the moisture content of a brick cheese, muenster cheese, and mixture of swiss cheese and gruyere swiss cheese, respectively. cheese is not more than 44 percent. (b) Pasteurized process cheese may be (ii) The fat content of the solids of a smoked, or the cheese or cheeses from pasteurized process cheese made from which it is made may be smoked, be- two or more varieties of cheese is not fore comminuting and mixing, or it less than the arithmetical average of may contain substances prepared by the minimum fat contents prescribed condensing or precipitating wood by the definitions and standards of smoke. identity, if any there be, for the varieties of cheese used, but in no case is (c) The emulsifying agent referred to less than 47 percent, except that the fat in paragraph (a) of this section is one content of the solids of a pasteurized or any mixture of two or more of the process gruyere cheese made from a following: Monosodium phosphate, di- mixture of swiss cheese and gruyere sodium phosphate, dipotassium phos- cheese is not less than 45 percent. phate, trisodium phosphate, sodium (5) Moisture and fat are determined metaphosphate (sodium by the methods prescribed in § 133.5(a), hexametaphosphate), sodium acid (b), and (d). pyrophosphate, tetrasodium (6) The weight of each variety of pyrophosphate, sodium aluminum cheese in a pasteurized process cheese phosphate, sodium citrate, potassium made from two varieties of cheese is citrate, calcium citrate, sodium tar- not less than 25 percent of the total trate, and sodium potassium tartrate, weight of both, except that the weight in such quantity that the weight of the of blue cheese, nuworld cheese, roque- solids of such emulsifying agent is not fort cheese, or gorgonzola cheese is not more than 3 percent of the weight of less than 10 percent of the total weight the pasteurized process cheese. of both, and the weight of limburger (d) The optional ingredients referred cheese is not less than 5 percent of the to in paragraph (a) of this section are: total weight of both. The weight of (1) An acidifying agent consisting of each variety of cheese in a pasteurized one or any mixture of two or more of process cheese made from three or the following: A vinegar, lactic acid, more varieties of cheese is not less citric acid, acetic acid, and phosphoric than 15 percent of the total weight of acid, in such quantity that the pH of all, except that the weight of blue the pasteurized process cheese is not cheese, nuworld cheese, roquefort below 5.3.

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(2) Cream, anhydrous milkfat, dehy- (ii) In case it is made of cheddar drated cream, or any combination of cheese, washed curd cheese, colby two or more of these, in such quantity cheese, or granular cheese or any mix- that the weight of the fat derived ture of two or more of these, it may be therefrom is less than 5 percent of the designated ‘‘Pasteurized process Amer- weight of the pasteurized process ican cheese’’; or when cheddar cheese, cheese. washed curd cheese, colby cheese, (3) Water. granular cheese, or any mixture of two (4) Salt. or more of these is combined with (5) Harmless artificial coloring. other varieties of cheese in the cheese (6) Spices or flavorings, other than ingredient, any of such cheeses or such any which singly or in combination mixture may be designated as ‘‘Amer- with other ingredients simulate the ican cheese’’. flavor of a cheese of any age or variety. The full name of the food shall appear (7) Pasteurized process cheese in the on the principal display panel of the form of slices or cuts in consumer-sized label in type of uniform size, style, and packages may contain an optional color. Wherever any word or statement mold-inhibiting ingredient consisting emphasizing the name of any ingre- of not more than 0.2 percent by weight dient appears on the label (other than of sorbic acid, potassium sorbate, so- in an ingredient statement as specified dium sorbate, or any combination of in paragraph (g) of this section) so con- two or more of these, or consisting of spicuously as to be easily seen under not more than 0.3 percent by weight of customary conditions of purchase, the sodium propionate, calcium propio- full name of the food shall immediately nate, or a combination of sodium pro- and conspicuously precede or follow pionate and calcium propionate. such word or statement in type of at (8) Pasteurized process cheese in the least the same size as the type used in form of slices or cuts in consumer-sized such word or statement. packages may contain lecithin as an (f) The name of the food shall include optional anti-sticking agent in an a declaration of any flavoring, includ- amount not to exceed 0.03 percent by ing smoke and substances prepared by weight of the finished product. condensing or precipitating wood (9) Safe and suitable enzyme modified smoke, that characterizes the product cheese. as specified in § 101.22 of this chapter (e) The name of a pasteurized process and a declaration of any spice that cheese for which a definition and characterizes the product. standard of identity is prescribed by (g) Each of the ingredients used in this section is as follows: the food shall be declared on the label (1) In case it is made from a single as required by the applicable sections variety of cheese, its name is ‘‘Pas- of parts 101 and 130 of this chapter, ex- teurized process lll cheese’’, the cept that cheddar cheese, washed curd blank being filled in with the name of cheese, colby cheese, granular cheese, the variety of cheese used. or any mixture of two or more of these (2) In case it is made from two or may be designated as ‘‘American more varieties of cheese, its name is cheese’’. ‘‘Pasteurized process lll and lll [42 FR 14366, Mar. 15, 1977, as amended at 49 cheese’’, or ‘‘Pasteurized process lll FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, blended with lll cheese’’, or ‘‘Pas- 1993] teurized process blend of lll and lll cheese’’, the blanks being filled § 133.170 Pasteurized process cheese in with the names of the varieties of with fruits, vegetables, or meats. cheeses used, in order of predominance (a) Unless a definition and standard by weight; except that: of identity specifically applicable is es- (i) In case it is made from gruyere tablished by another section of this cheese and swiss cheese, and the weight part, a pasteurized process cheese with of gruyere cheese is not less than 25 fruits, vegetables, or meats, or mix- percent of the weight of both, it may tures of these is a food which conforms be designated ‘‘Pasteurized process to the definition and standard of iden- gruyere cheese’’; and tity, and is subject to the requirements

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for label statement of ingredients, pre- that the weight of the solids thereof is scribed for pasteurized process cheese not less than 0.2 percent of the weight by § 133.169, except that: of the finished pasteurized process pi- (1) Its moisture content may be 1 per- mento cheese. cent more, and the milk fat content of (e) The optional ingredients des- its solids may be 1 percent less than ignated in § 133.169(b) and (d)(6) are not the limits prescribed by § 133.169 for used. moisture and fat in the corresponding [42 FR 14366, Mar. 15, 1977, as amended at 58 pasteurized process cheese. FR 2894, Jan. 6, 1993] (2) It contains one or any mixture of two or more of the following: Any prop- § 133.173 Pasteurized process cheese erly prepared cooked, canned, or dried food. fruit; any properly prepared cooked, (a)(1) A pasteurized process cheese canned, or dried vegetable; any prop- food is the food prepared by erly prepared cooked or canned meat. comminuting and mixing, with the aid (3) When the added fruits, vegetables, of heat, one or more of the optional or meats contain fat, the method pre- cheese ingredients prescribed in para- scribed for the determination of fat by graph (c) of this section, with one or § 133.5(b) is not applicable. more of the optional dairy ingredients (b) The name of a pasteurized process prescribed in paragraph (d) of this sec- cheese with fruits, vegetables, or meats tion, into a homogeneous plastic mass. is the name prescribed by § 133.169 for One or more of the optional ingredients the applicable pasteurized process specified in paragraph (e) of this sec- cheese, followed by the term ‘‘with tion may be used. lll’’, the blank being filled in with (2) During its preparation, a pasteur- the common or usual name or names of ized process cheese food is heated for the fruits, vegetables, or meats used, in not less than 30 seconds, at a tempera- order of predominance by weight. ture of not less than 150 °F. When test- [42 FR 14366, Mar. 15, 1977, as amended at 49 ed for phosphatase by the method pre- FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, scribed in § 133.5(c), the phenol equiva- 1993] lent of 0.25 gram of pasteurized process cheese food is not more than 3 § 133.171 Pasteurized process pimento micrograms. cheese. (3) The moisture content of a pas- Pasteurized process pimento cheese teurized process cheese food is not is the food which conforms to the defi- more than 44 percent, and the fat con- nition and standard of identity for pas- tent is not less than 23 percent. teurized process cheese with fruits, (4) Moisture and fat are determined vegetables, or meats, and is subject to by the methods prescribed in § 133.5(a) the requirement for label statement of and (b), except that in determining ingredients, except that: moisture the loss in weight which oc- (a) Its moisture content is not more curs in drying for 5 hours, under the than 41 percent, and the fat content of conditions prescribed in such method, its solids is not less than 49 percent. is taken as the weight of the moisture. (b) The cheese ingredient is cheddar (5) The weight of the cheese ingre- cheese, washed curd cheese, colby dient prescribed by paragraph (a)(1) of cheese, granular cheese or any mixture this section constitutes not less than 51 of two or more of these in any propor- percent of the weight of the finished tion. pasteurized process cheese food. (c) For the purposes of this section, (6) The weight of each variety of cheddar cheese for manufacturing, cheese in a pasteurized process cheese washed curd cheese for manufacturing, food made with two varieties of cheese colby cheese for manufacturing, and is not less than 25 percent of the total granular cheese for manufacturing weight of both, except that the weight shall be considered as cheddar cheese, of blue cheese, nuworld cheese, roque- washed curd cheese, colby cheese, and fort cheese, gorgonzola cheese, or lim- granular cheese, respectively. burger cheese is not less than 10 per- (d) The only fruit, vegetable, or meat cent of the total weight of both. The ingredient is pimentos in such quantity weight of each variety of cheese in a

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pasteurized process cheese food made (1) An emulsifying agent consisting with three or more varieties of cheese of one or any mixture of two or more of is not less than 15 percent of the total the following: Monosodium phosphate, weight of all, except that the weight of disodium phosphate, dipotassium phos- blue cheese, nuworld cheese, roquefort phate, trisodium phosphate, sodium cheese, gorgonzola cheese, or limburger metaphosphate (sodium hexametaphos- cheese is not less than 5 percent of the phate), sodium acid pyrophosphate, total weight of all. These limits do not tetrasodium pyrophosphate, sodium apply to the quantity of cheddar aluminum phosphate, sodium citrate, cheese, washed curd cheese, colby potassium citrate, calcium citrate, so- cheese, and granular cheese in mix- dium tartrate, and sodium potassium tures which are designated as ‘‘Amer- tartrate, in such quantity that the ican cheese’’ as prescribed in paragraph weight of the solids of such emulsifying (h)(5) of this section. Such mixtures are agent is not more than 3 percent of the considered as one variety of cheese for weight of the pasteurized process the purposes of this subparagraph. cheese food. (7) For the purposes of this section, (2) An acidifying agent consisting of cheddar cheese for manufacturing, one or any mixture of two or more of washed curd cheese for manufacturing, the following: A vinegar, lactic acid, colby cheese for manufacturing, granu- citric acid, acetic acid, and phosphoric lar cheese for manufacturing, brick acid in such quantity that the pH of cheese for manufacturing, muenster the pasteurized process cheese food is cheese for manufacturing, and swiss not below 5.0. cheese for manufacturing are consid- (3) Water. ered as cheddar cheese, washed curd (4) Salt. cheese, colby cheese, granular cheese, (5) Harmless artificial coloring. brick cheese, muenster cheese, and (6) Spices or flavorings other than swiss cheese, respectively. any which singly or in combination (b) Pasteurized process cheese food with other ingredients simulate the may be smoked, or the cheese or flavor of cheese of any age or variety. cheeses from which it is made may be (7) Pasteurized process cheese food in smoked, before comminuting and mix- the form of slices or cuts in consumer- ing, or it may contain substances pre- sized packages may contain an op- pared by condensing or precipitating tional mold-inhibiting ingredient con- wood smoke. sisting of not more than 0.2 percent by (c) The optional cheese ingredients weight of sorbic acid, potassium sor- referred to in paragraph (a) of this sec- bate, sodium sorbate, or any combination are one or more cheeses of the tion of two or more of these, or con- same or two or more varieties, except sisting of not more than 0.3 percent by cream cheese, neufchatel cheese, cot- weight of sodium propionate, calcium tage cheese, creamed cottage cheese, propionate, or a combination of sodium cook cheese, and skim-milk cheese for propionate and calcium propionate. manufacturing, and except that hard (8) Pasteurized process cheese food in grating cheese, semisoft part skim the form of slices or cuts in consumer- cheese, and part-skim spiced cheese are sized packages may contain lecithin as not used alone or in combination with an optional anti-sticking agent in an each other as the cheese ingredient. amount not to exceed 0.03 percent by (d) The optional dairy ingredients re- weight of the finished product. ferred to in paragraph (a) of this sec- (9) Safe and suitable enzyme modified tion are cream, milk, skim milk, but- cheese. termilk, cheese whey, any of the fore- (f) The name of the food is ‘‘Pasteur- going from which part of the water has ized process cheese food’’. The full been removed, anhydrous milkfat, de- name of the food shall appear on the hydrated cream, albumin from cheese principal display panel of the label in whey, and skim milk cheese for manu- type of uniform size, style, and color. facturing. Wherever any word or statement em- (e) The other optional ingredients re- phasizing the name of any ingredient ferred to in paragraph (a) of this sec- appears on the label (other than in an tion are: ingredient statement as specified in

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paragraph (h) of this section) so con- meats used, in order of predominance spicuously as to be easily seen under by weight. customary conditions of purchase, the (c) If the only vegetable ingredient is full name of the food shall immediately pimento, and no meat or fruit ingre- and conspicuously precede or follow dient is used, the weight of the solids such word or statement in type of at of such pimentos is not less than 0.2 least the same size as the type used in percent of the weight of the finished such word or statement. food. The name of this food is ‘‘Pi- (g) The name of the food shall include mento pasteurized process cheese food’’ a declaration of any flavoring, includ- or ‘‘Pasteurized process pimento cheese ing smoke and substances prepared by food’’. condensing or precipitating wood smoke, that characterizes the product [42 FR 14366, Mar. 15, 1977, as amended at 49 as specified in § 101.22 of this chapter FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, and a declaration of any spice that 1993] characterizes the product. (h) Each of the ingredients used in § 133.175 Pasteurized cheese spread. the food shall be declared on the label Pasteurized cheese spread is the food as required by the applicable sections which conforms to the definition and of parts 101 and 130 of this chapter, ex- standard of identity, and is subject to cept that cheddar cheese, washed curd the requirements for label statement of cheese, colby cheese, granular cheese, ingredients, prescribed for pasteurized or any mixture of two or more of these process cheese spread by § 133.179, ex- may be designated as ‘‘American cept that no emulsifying agent as pre- cheese’’. scribed by § 133.179(e) is used. [42 FR 14366, Mar. 15, 1977, as amended at 49 [58 FR 2894, Jan. 6, 1993] FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, 1993] § 133.176 Pasteurized cheese spread with fruits, vegetables, or meats. § 133.174 Pasteurized process cheese food with fruits, vegetables, or (a) Pasteurized cheese spread with meats. fruits, vegetables, or meats, or mix- (a) Pasteurized process cheese food tures of these is a food which conforms with fruits, vegetables, or meats, or to the definition and standard of iden- mixtures of these is the food which tity, and is subject to the requirements conforms to the definition and stand- for label statement of ingredients, pre- ard of identity, and is subject to the re- scribed for pasteurized cheese spread quirements for label statement of in- by § 133.175, except that: gredients, prescribed for pasteurized (1) It contains one or any mixture of process cheese food by § 133.173, except two or more of the following: Any prop- that: erly prepared cooked, canned, or dried (1) Its milk fat content is not less fruit; any properly prepared cooked, than 22 percent. canned, or dried vegetable; any prop- (2) It contains one or any mixture of erly prepared cooked or canned meat. two or more of the following: Any prop- (2) When the added fruits, vegetables, erly prepared cooked, canned, or dried or meats contain fat, the method pre- fruit; any properly prepared cooked, scribed for the determination of fat by canned, or dried vegetable; any prop- § 133.5(b) is not applicable. erly prepared cooked or canned meat. (b) The name of a pasteurized cheese (3) When the added fruits, vegetables, spread with fruits, vegetables, or meats or meats contain fat, the method pre- is ‘‘Pasteurized cheese spread with scribed for the determination of fat by § 133.5(b) is not applicable. lll’’, the blank being filled in with (b) The name of a pasteurized process the name or names of the fruits, vege- cheese food with fruits, vegetables, or tables, or meats used, in order of pre- meats is ‘‘Pasteurized process cheese dominance by weight. food with lll’’, the blank being filled [42 FR 14366, Mar. 15, 1977, as amended at 49 in with the common or usual name or FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, names of the fruits, vegetables, or 1993]

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§ 133.178 Pasteurized neufchatel (3) An acidifying agent consisting of cheese spread with other foods. one or a mixture of two or more of the (a)(1) Pasteurized neufchatel cheese following: A vinegar, acetic acid, lactic spread with other foods is the class of acid, citric acid, phosphoric acid. foods each of which is prepared by mix- (4) A sweetening agent consisting of ing, with the aid of heat, neufchatel one or a mixture of two or more of the cheese with one or a mixture of two or following: Sugar, dextrose, corn sirup, more properly prepared foods (except corn sirup solids, glucose sirup, glucose other cheeses), such as fresh, cooked, sirup solids, maltose, malt sirup, canned, or dried fruits or vegetables; hydrolyzed lactose. cooked or canned meats; relishes, pick- (5) Cream, milk, skim milk, butter- les or other foods suitable for blending milk, cheese whey, any of the foregoing with neufchatel cheese. It may contain from which part of the water has been one or any mixture of two or more of removed, anhydrous milkfat, dehy- the optional ingredients named in drated cream, and albumin from cheese paragraph (b) of this section. The whey. amount of the added food or foods must (c) The name of the food is ‘‘pasteur- be sufficient to so differentiate the ized Neufchatel cheese spread with blend that it does not simulate neuf- lll’’ or ‘‘pasteurized Neufchatel chatel cheese. It is spreadable at 70 °F. cheese spread and lll’’, the blank (2) During its preparation the mix- being filled in with the common names ture is heated for not less than 30 sec- of the foods added, in order of predomi- onds at a temperature of not less than nance by weight. The full name of the 150 °F. When tested for phosphatase by food shall appear on the principal dis- the method prescribed in § 133.5(c), the play panel of the label in type of uni- phenol equivalent of 0.25 gram of such form size, style, and color. Wherever food is not more than 3 micrograms. any word or statement emphasizing the (3)(i) No water other than that con- name of any ingredient appears on the tained in the ingredients used is added label (other than in an ingredient to this food, but the moisture content statement as specified in paragraph (d) in no case is more than 65 percent. of this section) so conspicuously as to (ii) The milk fat is not less than 20 be easily seen under customary condi- percent by weight of the finished food. tions of purchase, the full name of the (b) The optional ingredients referred food shall immediately and conspicu- to in paragraph (a) of this section are: ously precede or follow such word or (1)(i) One or any mixture of two or statement in type of at least the same more of the following: Gum karaya, size as the type used in such word or gum tragacanth, carob bean gum, gela- statement. tin, algin (sodium alginate), propylene (d) Each of the ingredients used in glycol alginate, guar gum, sodium the food shall be declared on the label carboxymethylcellulose (cellulose as required by the applicable sections gum), carrageenan, oat gum, or xan- of parts 101 and 130 of this chapter. than gum. The total quantity of any [42 FR 14366, Mar. 15, 1977, as amended at 49 such substances, including that con- FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, tained in the neufchatel cheese, is not 1993] more than 0.8 percent by weight of the finished food. § 133.179 Pasteurized process cheese (ii) When one or more of the optional spread. ingredients in paragraph (b)(1)(i) of (a)(1) Pasteurized process cheese this section are used, dioctyl sodium spread is the food prepared by sulfosuccinate complying with the re- comminuting and mixing, with the aid quirements of § 172.810 of this chapter of heat, one or more of the optional may be used in a quantity not in excess cheese ingredients prescribed in para- of 0.5 percent by weight of such ingre- graph (c) of this section, with or with- dients. out one or more of the optional dairy (2) Artificial coloring, unless such ad- ingredients prescribed in paragraph (d) dition conceals damage or inferiority of this section, with one or more of the or makes the finished food appear bet- emulsifying agents prescribed in para- ter or of greater value than it is. graph (e) of this section, and with or

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without one or more of the optional in- colby cheese for manufacturing, granu- gredients prescribed by paragraph (f) of lar cheese for manufacturing, brick this section, into a homogeneous plas- cheese for manufacturing, muenster tic mass, which is spreadable at 70 °F. cheese for manufacturing, and swiss (2) During its preparation, a pasteur- cheese for manufacturing are consid- ized process cheese spread is heated for ered as cheddar cheese, washed curd not less than 30 seconds at a tempera- cheese, colby cheese, granular cheese, ture of not less than 150 °F. When test- brick cheese, muenster cheese, and ed for phosphatase by the method pre- swiss cheese, respectively. scribed in § 133.5(c), the phenol equiva- (b) Pasteurized process cheese spread lent of 0.25 gram of pasteurized process may be smoked, or the cheese or cheese spread is not more than 3 cheeses from which it is made may be micrograms. smoked, before comminuting and mix- (3) The moisture content of a pas- ing, or it may contain substances pre- teurized process cheese spread is more pared by condensing or precipitating than 44 percent but not more than 60 wood smoke. percent, and the milk fat content is (c) The optional cheese ingredients not less than 20 percent. referred to in paragraph (a) of this sec- (4) Moisture and fat are determined tion are one or more cheeses of the by the methods prescribed in § 133.5(a) same or two or more varieties, except and (b), except that in determining that skim-milk cheese for manufac- moisture the loss in weight which oc- turing may not be used, and except curs in drying for 5 hours, under the that cream cheese, neufchatel cheese, conditions prescribed in such method, cottage cheese, creamed cottage is taken as the weight of the moisture. cheese, cook cheese, hard grating (5) The weight of the cheese ingre- cheese, semisoft part-skim cheese, and dient referred to in paragraph (a)(1) of part-skim spiced cheese are not used, this section constitutes not less than 51 alone or in combination with each percent of the weight of the pasteur- other, as the cheese ingredient. ized process cheese spread. (6) The weight of each variety of (d) The optional dairy ingredients re- cheese in a pasteurized process cheese ferred to in paragraph (a) of this sec- spread made with two varieties of tion are cream, milk, skim milk, but- cheese is not less than 25 percent of the termilk, cheese whey, any of the fore- total weight of both, except that the going from which part of the water has weight of blue cheese, nuworld cheese, been removed, anhydrous milkfat, de- roquefort cheese, gorgonzola cheese, or hydrated cream, albumin from cheese limburger cheese is not less than 10 whey, and skim milk cheese for manu- percent of the total weight of both. The facturing. weight of each variety of cheese in a (e) The emulsifying agents prescribed pasteurized process cheese spread made in paragraph (a) of this section are one with three or more varieties of cheese or any mixture of two or more of the is not less than 15 percent of the total following: Monosodium phosphate, di- weight of all, except that the weight of sodium phosphate, dipotassium phos- blue cheese, nuworld cheese, roquefort phate, trisodium phosphate, sodium cheese, gorgonzola cheese, or limburger metaphosphate (sodium hexametaphos- cheese is not less than 5 percent of the phate), sodium acid pyrophosphate, total weight of all. These limits do not tetrasodium pyrophosphate, sodium apply to the quantity of cheddar aluminum phosphate, sodium citrate, cheese, washed curd cheese, colby potassium citrate, calcium citrate, so- cheese, and granular cheese in mix- dium tartrate, and sodium potassium tures which are designated as ‘‘Amer- tartrate, in such quantity that the ican cheese’’ as prescribed in paragraph weight of the solids of such emulsifying (i)(5) of this section. Such mixtures are agent is not more than 3 percent of the considered as one variety of cheese for weight of the pasteurized process the purposes of this paragraph (a)(6). cheese spread. (7) For the purposes of this section, (f) The other optional ingredients re- cheddar cheese for manufacturing, ferred to in paragraph (a) of this sec- washed curd cheese for manufacturing, tion are:

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(1)(i) One or any mixture of two or (10) Safe and suitable enzyme modi- more of the following: Carob bean gum, fied cheese. gum karaya, gum tragacanth, guar (11) Nisin preparation in an amount gum, gelatin, sodium carboxymethyl- which results in not more than 250 cellulose (cellulose gum), carrageenan, parts per million nisin in the food. oat gum, algin (sodium alginate), pro- (g) The name of the food is ‘‘pasteur- pylene glycol alginate, or xanthan ized process cheese spread’’. The full gum. The total weight of such sub- name of the food shall appear on the stances is not more than 0.8 percent of principal display panel of the label in the weight of the finished food. type of uniform size, style, and color. (ii) When one or more of the optional Wherever any word or statement em- ingredients in paragraph (f)(1)(i) of this phasizing the name of any ingredient section are used, dioctyl sodium sulfo- appears on the label (other than in an succinate complying with the require- ingredient statement as specified in ments of § 172.810 of this chapter may paragraph (i) of this section) so con- be used in a quantity not in excess of spicuously as to be easily seen under 0.5 percent by weight of such ingredi- customary conditions of purchase, the ents. full name of the food shall immediately (2) An acidifying agent consisting of and conspicuously precede or follow one or any mixture of two or more of such word or statement in type of at the following: A vinegar, lactic acid, least the same size as the type used in citric acid, acetic acid, and phosphoric such word or statement. acid, in such quantity that the pH of (h) The name of the food shall in- the pasteurized process cheese spread is clude a declaration of any flavoring, not below 4.0. including smoke and substances pre- (3) A sweetening agent consisting of pared by condensing or precipitating one or any mixture of two or more of wood smoke, that characterizes the the following: Sugar, dextrose, corn product as specified in § 101.22 of this sugar, corn sirup, corn sirup solids, chapter and a declaration of any spice glucose sirup, glucose sirup solids, that characterizes the product. maltose, malt sirup, and hydrolyzed (i) Each of the ingredients used in the lactose, in a quantity necessary for food shall be declared on the label as seasoning. required by the applicable sections of (4) Water. parts 101 and 130 of this chapter, except (5) Salt. that cheddar cheese, washed curd (6) Harmless artificial coloring. cheese, colby cheese, granular cheese, (7) Spices or flavorings other than or any mixture of two or more of these any which singly or in combination may be designated as ‘‘American with other ingredients simulates the cheese’’. flavor of a cheese of any age or variety. [42 FR 14366, Mar. 15, 1977, as amended at 49 (8) Pasteurized process cheese spread FR 10095, Mar. 19, 1984; 54 FR 6121, Feb. 8, in consumer-sized packages may con- 1989; 54 FR 22741, May 26, 1989; 58 FR 2895, tain an optional mold-inhibiting ingre- Jan. 6, 1993] dient consisting of sorbic acid, potassium sorbate, sodium sorbate, or any § 133.180 Pasteurized process cheese combination of two or more of these, in spread with fruits, vegetables, or an amount not to exceed 0.2 percent by meats. weight, calculated as sorbic acid or (a) Pasteurized process cheese spread consisting of not more than 0.3 percent with fruits, vegetables, or meats, or by weight of sodium propionate, cal- mixtures of these is a food which con- cium propionate, or a combination of forms to the definition and standard of sodium propionate and calcium propio- identity, and is subject to the require- nate. ments for label statement of ingredi- (9) Pasteurized process cheese spread ents, prescribed for pasteurized process in consumer-sized packages may con- cheese spread by § 133.179, except that: tain lecithin as an optional anti-stick- (1) It contains one or any mixture of ing agent in an amount not to exceed two or more of the following: Any prop- 0.03 percent by weight of the finished erly prepared cooked, canned, or dried product. fruit; any properly prepared cooked,

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canned, or dried vegetable; any prop- proper sealing of the surface. The erly prepared cooked or canned meat. molded curd is then firmed by immer- (2) When the added fruits, vegetables, sion in cold water, salted in brine, and or meats contain fat, the method pre- dried. It is given some additional cur- scribed for the determination of fat by ing. Provolone cheese may be smoked, § 133.5(b) is not applicable. and one or more of the other optional (b) The name of a pasteurized process ingredients specified in paragraph cheese spread with fruits, vegetables, (b)(3) of this section may be added dur- or meats is ‘‘Pasteurized process cheese ing the procedure. spread with lll’’, the blank being (b) Optional ingredients. The following filled in with the name or names of the safe and suitable ingredients may be fruits, vegetables, or meats used, in used: order of predominance by weight. (1) Dairy ingredients. Milk, nonfat [42 FR 14366, Mar. 15, 1977, as amended at 49 milk, or cream, as defined in § 133.3, FR 10095, Mar. 19, 1984; 58 FR 2895, Jan. 6, used alone or in combination. 1993] (2) Clotting enzymes. Rennet and/or other clotting enzymes of animal, § 133.181 Provolone cheese. plant, or microbial origin. (a) Description. (1) Provolone, a pasta (3) Other optional ingredients. (i) Blue filata or stretched curd-type cheese, is or green color in an amount to neu- the food prepared by the procedure set tralize the natural yellow color of the forth in paragraph (a)(3) of this section, curd. or by any other method which produces (ii) Calcium chloride in an amount a finished cheese having the same not more than 0.02 percent (calculated physical and chemical properties. It as anhydrous calcium chloride) by has a stringy texture. The minimum weight of the dairy ingredients, used as milkfat content is 45 percent by weight a coagulation aid. of the solids, as determined by the (iii) Enzymes of animal, plant, or mi- methods described in § 133.5 and the crobial origin, used in curing or flavor maximum moisture content is 45 per- development. cent by weight. If the dairy ingredients (iv) Safe and suitable antimycotic used are not pasteurized, the cheese is agent(s), the cumulative levels of cured at a temperature of not less than which shall not exceed current good 35 °F for at least 60 days. manufacturing practice, may be added (2) If pasteurized dairy ingredients to the cheese during the kneading and are used, the phenol equivalent value stretching process and/or applied to the of 0.25 gram of provolone cheese is not surface of the cheese. more than 3 micrograms as determined (v) Benzoyl peroxide or a mixture of by the method described in § 133.5. benzoyl peroxide with potassium alum, (3) One or more of the dairy ingredi- calcium sulfate, and magnesium car- ents specified in paragraph (b)(1) of bonate used to bleach the dairy ingre- this section may be bleached, warmed, dients. The weight of the benzoyl per- and is subjected to the action of a lac- oxide is not more than 0.002 percent of tic acid-producing bacterial culture. the weight of the milk being bleached, One or more of the clotting enzymes and the weight of the potassium alum, specified in paragraph (b)(2) of this sec- calcium sulfate, and magnesium car- tion is added to set the dairy ingredi- bonate, singly or combined, is not more ents to a semisolid mass. The mass is than six times the weight of the ben- cut, stirred, and heated so as to pro- zoyl peroxide used. If milk is bleached mote and regulate the separation of in this manner, vitamin A is added to whey from the curd. The whey is the curd in such quantity as to com- drained off, and the curd is matted and pensate for the vitamin A or its precur- cut, immersed in hot water, and knead- sors destroyed in the bleaching process, ed and stretched until it is smooth and and artificial coloring is not used. free from lumps. Antimycotics may be (c) Nomenclature. (1) The name of the added to the curd during the kneading food is ‘‘provolone cheese’’. The name and stretching process. Then it is cut of the food may include the common and molded. During the molding the name of the shape of the cheese, such curd is kept sufficiently warm to cause as ‘‘salami provolone’’.

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(2) One of the following terms, in let- drous calcium chloride, of the weight ters not less than one-half the height of the milk) is added to set the milk to of the letters used in the name of the a semisolid mass. Harmless artificial food, shall accompany the name of the coloring may be added. After coagula- food wherever it appears on the prin- tion the mass is so treated as to pro- cipal display panel or panels: mote and regulate the separation of (i) ‘‘Smoked’’ if the food has been whey and curd. Such treatment may smoked. include one or more of the following: (ii) ‘‘Not smoked’’ if the food has not Cutting, stirring, heating, dilution been smoked. with water or brine. The whey, or part (d) Label declaration. Each of the in- of it, is drained off, and the curd is col- gredients used in the food shall be de- lected and shaped. It may be placed in clared on the label as required by the forms, and may be pressed. Harmless applicable sections of parts 101 and 130 flavor-producing microorganisms may of this chapter, except that: be added. It is cured under conditions (1) Enzymes of animal, plant, or mi- suitable for development of biological crobial origin may be declared as ‘‘en- curing agents on the surface of the zymes’’; and cheese, and the curing is conducted so (2) The dairy ingredients may be de- that the cheese cures from the surface clared, in descending order of predomi- toward the center. Salt may be added nance, by the use of the terms ‘‘milkfat during the procedure. A harmless prep- and nonfat milk’’ or ‘‘nonfat milk and aration of enzymes of animal or plant milkfat’’, as appropriate. origin capable of aiding in the curing [48 FR 2745, Jan. 21, 1983, as amended at 48 or development of flavor of soft ripened FR 49014, Oct. 24, 1983; 58 FR 2895, Jan. 6, cheeses may be added, in such quantity 1993] that the weight of the solids of such preparation is not more than 0.1 per- § 133.182 Soft ripened cheeses. cent of the weight of the milk used. (a) The cheeses for which definitions (c) For the purposes of this section: and standards of identity are pre- (1) The word ‘‘milk’’ means cow’s scribed by this section are soft ripened milk or goat’s milk or sheep’s milk or cheeses for which specifically applica- mixtures of two or all of these. Such ble definitions and standards of iden- milk may be adjusted by separating tity are not prescribed by other sec- part of the fat therefrom or (in the case tions of this part. They are made from of cow’s milk) by adding one or more of milk and other ingredients specified in the following: Cream, skim milk, con- this section, by the procedure set forth centrated skim milk, nonfat dry milk; in paragraph (b) of this section. Their (in the case of goat’s milk) the cor- solids contain not less than 50 percent of milkfat, as determined by the meth- responding products from goat’s milk; ods prescribed in § 133.5(a), (b), and (d). (in the case of sheep’s milk) the cor- If the milk used is not pasteurized, the responding products from sheep’s milk; cheese so made is cured at a tempera- water, in a quantity sufficient to re- ture of not less than 35 °F for not less constitute any such concentrated or than 60 days. dried products used. (b) Milk, which may be pasteurized or (2) Milk shall be deemed to have been clarified or both, and which may be pasteurized if it has been held at a tem- warmed, is subjected to the action of perature of not less than 143 °F for a harmless lactic-acid-producing bac- period of not less than 30 minutes, or teria or other harmless flavor-pro- for a time and at a temperature equiva- ducing bacteria, present in such milk lent thereto in phosphatase destruc- or added thereto. Sufficient rennet, tion. rennet paste, extract of rennet paste, (d) The name of each soft ripened or other safe and suitable milk-clot- cheese for which a definition and ting enzyme that produces equivalent standard of identity is prescribed by curd formation, singly or in any com- this section is ‘‘Soft ripened cheese’’, bination (with or without purified cal- preceded or followed by: cium chloride in a quantity not more (1) The specific common or usual than 0.02 percent, calculated as anhy- name of such soft ripened cheese, if any

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such name has become generally recog- milk) is added to set the milk to be a nized therefor; or semisolid mass. The mass is cut into (2) If no such specific common or particles no larger than corn kernels, usual name has become generally rec- stirred, and heated to a temperature of ognized therefor, an arbitrary or fan- about 120 °F. The curd is allowed to ciful name which is not false or mis- settle to the bottom of the kettle or leading in any particular. vat, and is then removed and drained (e) When milk other than cow’s milk for a short time, packed in forms or is used in whole or in part, the name of hoops, and pressed. The pressed curd is the cheese includes the statement salted by immersing in brine for about ‘‘made from lll’’, the blank being 24 hours and is then removed from the filled in with the name or names of the brine and the surface allowed to dry. It milk used, in order of predominance by is then alternately rubbed with salt weight. and washed at intervals. It may be per- (f) Each of the ingredients used in the forated with needles. It is finally food shall be declared on the label as drycured. During curing it is turned required by the applicable sections of and scraped. The surface may be parts 101 and 130 of this chapter. rubbed with vegetable oil. A harmless [42 FR 14366, Mar. 15, 1977, as amended at 49 preparation of enzymes of animal or FR 10095, Mar. 19, 1984; 58 FR 2895, Jan. 6, plant origin capable of aiding in the 1993] curing or development of flavor of romano cheese may be added during the § 133.183 Romano cheese. procedure, in such quantity that the (a) Romano cheese is the food pre- weight of the solids of such preparation pared from cow’s milk or sheep’s milk is not more than 0.1 percent of the or goat’s milk or mixtures of two or all weight of the milk used. of these and other ingredients specified (c)(1) For the purposes of this sec- in this section, by the procedure set tion, the word ‘‘milk’’ means cow’s forth in paragraph (b) of this section, milk or goat’s milk or sheep’s milk or or by another procedure which pro- mixtures of two or all of these. Such duces a finished cheese having the milk may be adjusted by separating same physical and chemical properties part of the fat therefrom or (in the case as the cheese produced when the proce- of cow’s milk) by adding one or more of dure set forth in paragraph (b) of this the following: Cream, skim milk, con- section is used. It grates readily, and centrated skim milk, nonfat dry milk; has a granular texture and a hard and (in the case of goat’s milk) the cor- brittle rind. It contains not more than responding products from goat’s milk; 34 percent of moisture, and its solids (in the case of sheep’s milk) the cor- contain not less than 38 percent of responding products from sheep’s milk; milkfat, as determined by the methods water in a quantity sufficient to recon- prescribed in § 133.5(a), (b), and (d). It is stitute any such concentrated or dried cured for not less than 5 months. products used. (b) Milk, which may be pasteurized or (2) Such milk may be bleached by the clarified or both, and which may be use of benzoyl peroxide or a mixture of warmed, is subjected to the action of benzoyl peroxide with potassium alum, harmless lactic-acid-producing bac- calcium sulfate, and magnesium car- teria present in such milk or added bonate; but the weight of the benzoyl thereto. Harmless artificial blue or peroxide is not more than 0.002 percent green coloring in a quantity which neu- of the weight of the milk bleached, and tralizes any natural yellow coloring in the weight of the potassium alum, cal- the curd may be added. Rennet, rennet cium, sulfate, and magnesium car- paste, extract of rennet paste, or other bonate, singly or combined, is not more safe and suitable milk-clotting enzyme than six times the weight of the ben- that produces equivalent curd forma- zoyl peroxide used. If milk is bleached tion, singly or in any combination in this manner, sufficient vitamin A is (with or without purified calcium chlo- added to the curd to compensate for ride in a quantity not more than 0.02 the vitamin A or its precursors de- percent, calculated as anhydrous cal- stroyed in the bleaching process, and cium chloride, of the weight of the artificial coloring is not used.

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(d) Safe and suitable antimycotic described in § 133.5. The dairy ingredi- agent(s), the cumulative levels of ents used may be pasteurized. Roque- which shall not exceed current good fort cheese is at least 60 days old. manufacturing practice, may be added (2) One or more of the dairy ingredi- to the surface of the cheese. ents specified in paragraph (b)(1) of (e) When romano cheese is made sole- this section may be warmed and is sub- ly from cow’s milk, the name of such jected to the action of a lactic acid- cheese is ‘‘Romano cheese made from producing bacterial culture. One or cow’s milk’’, and may be preceded by more of the clotting enzymes specified the word ‘‘Vaccino’’ (or ‘‘Vacchino’’); in paragraph (b)(2) of this section is when made solely from sheep’s milk, added to set the dairy ingredients to a the name is ‘‘Romano cheese made semisolid mass. The mass is cut into from sheep’s milk’’, and may be pre- smaller portions and allowed to stand ceded by the word ‘‘Pecorino’’; when for a time. The mixed curd and whey is made solely from goat’s milk, the placed into forms permitting further name is ‘‘Romano cheese made from drainage. While being placed in forms, goat’s milk’’, and may be preceded by spores of the mold Penicillium the word ‘‘Caprino’’; and when a mix- roquefortii are added. The forms are ture of two or all of the milks specified turned several times during drainage. in this section is used, the name of the When sufficiently drained, the shaped cheese is ‘‘Romano cheese made from curd is removed from the forms and lll’’, the blank being filled in with salted with dry salt or brine. Perfora- the names of the milks used, in order tions are then made in the shaped curd of predominance by weight. and it is held at a temperature of ap- (f) Label declaration. Each of the in- proximately 50 °F at 90 to 95 percent gredients used in the food shall be de- relative humidity, until the char- clared on the label as required by the acteristic mold growth has developed. applicable sections of parts 101 and 130 During storage, the surface of the of this chapter, except that: cheese may be scraped to remove sur- (1) When milk other than cow’s milk face growth of undesirable microorga- is used, in whole or in part, the com- nisms. One or more of the other op- mon or usual name of each such milk tional ingredients specified in para- ingredient shall be declared in order of graph (b)(3) of this section may be predominance by weight; and added during the procedure. (2) Enzymes of animal, plant, or microbial origin may be declared as ‘‘en- (b) Operational ingredients. The fol- zymes’’. lowing safe and suitable ingredients may be used: [42 FR 14366, Mar. 15, 1977, as amended at 48 (1) Dairy ingredients. Forms of milk, FR 49014, Oct. 24, 1983; 49 FR 10095, Mar. 19, nonfat milk, or cream, as defined in 1984; 58 FR 2895, Jan. 6, 1993] § 133.3, of sheep origin, used alone or in § 133.184 Roquefort cheese, sheep’s combination. milk blue-mold, and blue-mold (2) Clotting enzymes. Rennet and/or cheese from sheep’s milk. other clotting enzymes of animal, (a) Description. (1) Roquefort cheese, plant, or microbial origin. sheep’s milk blue-mold cheese, blue- (3) Other optional ingredients. En- mold cheese from sheep’s milk, is the zymes of animal, plant, or microbial food prepared by the procedure set origin, used in curing or flavor develop- forth in paragraph (a)(2) of this section ment. or by any other procedure which pro- (c) Nomenclature. The name of the duces a finished cheese having the food is ‘‘roquefort cheese’’, or alter- same physical and chemical properties. natively, ‘‘sheep’s milk blue-mold It is characterized by the presence of cheese’’ or ‘‘blue-mold cheese from bluish-green mold, Penicillium roque- sheep’s milk. fortii, throughout the cheese. The min- (d) Label declaration. Each of the in- imum milkfat content is 50 percent by gredients used in the food shall be de- weight of the solids and the maximum clared on the label as required by the moisture content is 45 percent by applicable sections of parts 101 and 130 weight, as determined by the methods of this chapter, except that:

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(1) Enzymes of animal, plant, or mi- tion for about 3 days. The curd is then crobial origin may be declared as ‘‘en- cured at a temperature of from 60° to 70 zymes’’; and °F for 3 to 5 weeks to obtain the desired (2) The dairy ingredients may be de- eye formation. Further curing is con- clared, in descending order of predomi- ducted at a lower temperature. One or nance, by the use of the terms ‘‘milkfat more of the other optional ingredients from sheep’s milk and nonfat sheep’s specified in paragraph (b)(3) of this sec- milk’’ or ‘‘nonfat sheep’s milk and tion may be added during the proce- milkfat from sheep’s milk’’, as appro- dure. priate. (b) Optional ingredients. The following [54 FR 32058, Aug. 4, 1989, as amended at 58 safe and suitable ingredients may be FR 2895, Jan. 6, 1993] used: (1) Dairy ingredients. Milk, nonfat § 133.185 Samsoe cheese. milk, or cream, as defined in § 133.3, (a) Description. (1) Samsoe cheese is used alone or in combination. the food prepared by the procedure set (2) Clotting enzymes. Rennet and/or forth in paragraph (a)(3) of this section other clotting enzymes of animal, or by any other procedure which pro- plant, or microbial origin. duces a finished cheese having the (3) Other optional ingredients. (i) same physical and chemical properties. Coloring. It has a small amount of eye formation (ii) Calcium chloride in an amount of approximately uniform size of about not more than 0.02 percent (calculated five-sixteenths inch (8 millimeters). as anhydrous calcium chloride) by The minimum milkfat content is 45 weight of the dairy ingredients, used as percent by weight of the solids and the a coagulation aid. maximum moisture content is 41 per- (iii) Enzymes of animal, plant, or mi- cent by weight, as determined by the crobial origin, used in curing or flavor methods described in § 133.5. The dairy development. ingredients used may be pasteurized. (iv) Antimycotic agents, applied to Samsoe cheese is cured at not less than the surface of slices or cuts in con- 35 °F for at least 60 days. sumer-sized packages. (2) If pasteurized dairy ingredients (c) Nomenclature. The name of the are used, the phenol equivalent value food is ‘‘samsoe cheese’’. of 0.25 gram of samsoe cheese is not (d) Label declaration. Each of the in- more than 3 micrograms as determined gredients used in the food shall be de- by the method described in § 133.5. clared on the label as required by the (3) One or more of the dairy ingredi- applicable sections of parts 101 and 130 ents specified in paragraph (b)(1) of of this chapter, except that: this section may be warmed and is sub- (1) Enzymes of animal, plant, or mi- jected to the action of a lactic acid- crobial origin may be declared as ‘‘en- producing bacterial culture. One or zymes’’; and more of the clotting enzymes specified (2) The dairy ingredients may be de- in paragraph (b)(2) of this section is clared, in descending order of predomi- added to set the dairy ingredients to a nance, by the use of the terms ‘‘milkfat semisolid mass. After coagulation the and nonfat milk’’ or ‘‘nonfat milk and mass is cut into small cube-shaped milkfat’’, as appropriate. pieces with sides approximately three- eighths inch (1 centimeter). The mass [48 FR 2745, Jan. 21, 1983; 48 FR 11426, Mar. 18, is stirred and heated to about 102 °F, 1983, as amended at 58 FR 2895, Jan. 6, 1993] and so handled by further stirring, heating, dilution with water, and salt- § 133.186 Sap sago cheese. ing as to promote and regulate the sep- (a) Description. (1) Sap sago cheese is aration of curd and whey. When the de- the food prepared by the procedure set sired curd is obtained, it is transferred forth in paragraph (a)(2) of this section to forms permitting drainage of whey. or by any other procedure which pro- During drainage, the curd is pressed. duces a finished cheese having the After drainage, the curd is removed same physical and chemical properties. from the forms and is further salted by The cheese is pale green in color and immersing in a concentrated salt solu- has the shape of a truncated cone. The

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maximum moisture content is 38 per- (b) Milk, which may be pasteurized or cent by weight, as determined by the clarified or both, and which may be method described in § 133.5. Sap sago warmed, is subjected to the action of cheese is not less than 5 months old. harmless lactic-acid-producing bac- (2) One or more of the dairy ingredi- teria or other harmless flavor-pro- ents specified in paragraph (b)(1) of ducing bacteria, present in such milk this section is allowed to become sour, or added thereto. Sufficient rennet, and is heated to boiling temperature, rennet paste, extract of rennet paste, with stirring. Sufficient sour whey is or other safe and suitable milk-clot- added to precipitate the casein. The ting enzyme that produces equivalent curd is removed, spread out in boxes, curd formation, singly or in any com- and pressed, and while under pressure bination (with or without purified cal- is allowed to drain and ferment. It is cium chloride in a quantity not more ripened for not less than 5 weeks. The than 0.02 percent, calculated as anhy- ripened curd is dried and ground; salt drous calcium chloride, of the weight and dried clover of the species Melilotus of the milk) is added to set the milk to coerulea are added. The mixture is a semisolid mass. Harmless artificial shaped into truncated cones and rip- coloring may be added. After coagula- ened. The optional ingredient in para- tion the mass is so treated as to pro- graph (b)(2) of this section may be mote and regulate the separation of added during this procedure. whey and curd. Such treatment may (b) Optional ingredients. The following include one or more of the following: safe and suitable ingredients may be cutting, stirring, heating, dilution with used: water or brine. The whey, or part of it, (1) Dairy ingredients. Nonfat milk, as is drained off, and the curd is collected defined in § 133.3. and shaped. It may be placed in forms, (2) Other optional ingredients. Butter- and may be pressed. Harmless flavor- milk. producing microorganisms may be (c) Nonmenclature. The name of the added. It may be cured in a manner to food is ‘‘sap sago cheese’’. promote the growth of biological cur- (d) Label declaration. Each of the in- ing agents. Salt may be added during gredients used in the food shall be de- the procedure. A harmless preparation clared on the label as required by the of enzymes of animal or plant origin applicable sections of parts 101 and 130 capable of aiding in the curing or de- of this chapter. velopment of flavor of semisoft cheese may be added, in such quantity that [54 FR 32058, Aug. 4, 1989, as amended at 58 the weight of the solids of such prepa- FR 2895, Jan. 6, 1993] ration is not more than 0.1 percent of the weight of the milk used. § 133.187 Semisoft cheeses. (c) For the purposes of this section: (a) The cheeses for which definitions (1) The word ‘‘milk’’ means cow’s and standards of identity are pre- milk or goat’s milk or sheep’s milk or scribed by this section are semisoft mixtures of two or all of these. Such cheeses for which specifically applica- milk may be adjusted by separating ble definitions and standards of iden- part of the fat therefrom, or (in the tity are not prescribed by other sec- case of cow’s milk) by adding one or tions of this part. They are made from more of the following: Cream, skim milk and other ingredients specified in milk, concentrated skim milk, nonfat this section, by the procedure set forth dry milk; (in the case of goat’s milk) in paragraph (b) of this section. They the corresponding products from goat’s contain more than 39 percent, but not milk; (in the case of sheep’s milk) the more than 50 percent, of moisture, and corresponding products from sheep’s their solids contain not less than 50 milk; water in a quantity sufficient to percent of milkfat, as determined by reconstitute any concentrated or dried the methods prescribed in § 133.5 (a), products used. (b), and (d). If the milk used is not pas- (2) Milk shall be deemed to have been teurized, the cheese so made is cured at pasteurized if it has been held at a tem- a temperature of not less than 35 °F for perature of not less than 143 °F for a not less than 60 days. period of not less than 30 minutes, or

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for a time and at a temperature equiva- (g) Label declaration. Each of the in- lent thereto in phosphatase destruc- gredients used in the food shall be de- tion. A semisoft cheese shall be deemed clared on the label as required by the not to have been made from pasteur- applicable sections of parts 101 and 130 ized milk if 0.25 gram shows a phenol of this chapter. equivalent of more than 5 micrograms [42 FR 14366, Mar. 15, 1977, as amended at 49 when tested by the method prescribed FR 10096, Mar. 19, 1984; 58 FR 2895, Jan. 6, in § 133.5(c). 1993] (d) Semisoft cheeses in the form of slices or cuts in consumer-sized pack- § 133.188 Semisoft part-skim cheeses. ages may contain an optional mold-in- (a) The cheeses for which definitions hibiting ingredient consisting of sorbic and standards of identity are pre- acid, potassium sorbate, sodium sor- scribed by this section are semisoft bate, or any combination of two or part-skim cheeses for which specifi- more of these, in an amount not to ex- cally applicable definitions and stand- ceed 0.3 percent by weight, calculated ards of identity are not prescribed by as sorbic acid. other sections of this part. They are (e) The name of each semisoft cheese made from partly skimmed milk and for which a definition and standard of other ingredients specified in this sec- identity is prescribed by this section is tion, by the procedure set forth in ‘‘Semisoft cheese’’, preceded or fol- paragraph (b) of this section. They con- lowed by: tain not more than 50 percent of mois- (1) The specific common or usual ture, and their solids contain not less name of such semisoft cheese, if any than 45 percent, but less than 50 percent, of milkfat, as determined by the such name has become generally recog- methods set forth in § 133.5 (a), (b), and nized therefor; or (d). If the milk used is not pasteurized, (2) If no such specific common or the cheese so made is cured at a tem- usual name has become generally rec- perature of not less than 35 °F, for not ognized therefor, an arbitrary or fan- less than 60 days. ciful name which is not false or mis- (b) Milk, which may be pasteurized or leading in any particular. clarified or both, and which may be (f)(1) When milk other than cow’s warmed, is subjected to the action of milk is used in whole or in part, the harmless lactic-acid-producing bac- name of the cheese includes the state- teria or other harmless flavor-pro- ment ‘‘made from lll’’, the blank ducing bacteria, present in such milk being filled in with the name or names or added thereto. Sufficient rennet, of the milk used, in order of predomi- rennet paste, extract of rennet paste, nance by weight. or other safe and suitable milk-clot- (2) If semisoft cheese in sliced or cut ting enzyme that produces equivalent form contains an optional mold-inhib- curd formation singly or in any com- iting ingredient as specified in para- bination (with or without purified cal- graph (d) of this section, the label shall cium chloride in a quantity not more bear the statement ‘‘lll added to re- than 0.02 percent, calculated as anhy- tard mold growth’’ or ‘‘lll added as drous calcium chloride, of the weight a preservative’’, the blank being filled of the milk) is added to set the milk to in with the common name or names of a semisolid mass. Harmless artificial the mold-inhibiting ingredient or in- coloring may be added. After coagula- gredients used. tion the mass is so treated as to pro- (3) Wherever the name of the food ap- mote and regulate the separation of pears on the label so conspicuously as whey and curd. Such treatment may to be easily seen under customary con- include one or more of the following: ditions of purchase, the words and Cutting, stirring, heating, dilution statements prescribed by this section, with water or brine. The whey, or part showing the optional ingredient used, of it, is drained off, and the curd is col- shall immediately and conspicuously lected and shaped. It may be placed in precede or follow such name, without forms, and it may be pressed. Harmless intervening written, printed, or graph- flavor-producing microorganisms may ic matter. be added. It may be cured in a manner

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to promote the growth of biological ognized therefor, an arbitrary or fan- curing agents. Salt may be added dur- ciful name which is not false or mis- ing the procedure. A harmless prepara- leading in any particular. tion of enzymes of animal or plant ori- (f)(1) When milk other than cow’s gin capable of aiding in the curing or milk is used in whole or in part, the development of flavor of semisoft part- name of the cheese includes the state- skim cheese may be added in such ment ‘‘made from lll’’, the blank quantity that the weight of the solids being filled in with the name or names of such preparation is not more than of the milk used, in order of predomi- 0.1 percent of the weight of the milk nance by weight. used. (2) If semi-soft part-skim cheese in (c) For the purposes of this section: sliced or cut form contains an optional (1) The word ‘‘milk’’ means cow’s mold-inhibiting ingredient as specified milk or goat’s milk or sheep’s milk or in paragraph (d) of this section, the mixtures of two or all of these. Such label shall bear the statement ‘‘lll milk may be adjusted by separating added to retard mold growth’’ or part of the fat therefrom or (in the case ‘‘lll added as a preservative’’, the of cow’s milk) by adding one or more of blank being filled in with the common the following: Cream, skim milk, con- name or names of the mold-inhibiting centrated skim milk, nonfat dry milk; ingredient or ingredients used. (in the case of goat’s milk) the cor- (3) Wherever the name of the food ap- responding products from goat’s milk; pears on the label so conspicuously as (in the case of sheep’s milk) the cor- to be easily seen under customary con- responding products from sheep’s milk; ditions of purchase, the words and water in a quantity sufficient to recon- statements prescribed by this section, stitute any such concentrated or dried showing the optional ingredient used, products used. shall immediately and conspicuously (2) Milk shall be deemed to have been precede or follow such name, without pasteurized if it has been held at a tem- intervening written, printed, or graph- ° perature of not less than 143 F for a ic matter. period of not less than 30 minutes, or (g) Each of the ingredients used in for a time and at a temperature equiva- the food shall be declared on the label lent thereto in phosphatase destruc- as required by the applicable sections tion. A semisoft part-skim cheese shall of parts 101 and 130 of this chapter. be deemed not to have been made from pasteurized milk if 0.25 gram shows a [42 FR 14366, Mar. 19, 1977, as amended at 49 phenol equivalent of more than 5 FR 10096, Mar. 19, 1984; 58 FR 2895, Jan. 6, micrograms when tested by the method 1993] prescribed in § 133.5(c). (d) Semisoft part-skim cheeses in the § 133.189 Skim milk cheese for manufacturing. form of slices or cuts in consumer-sized packages may contain an optional (a) Skim milk cheese for manufac- mold-inhibiting ingredient consisting turing is the food prepared from skim of sorbic acid, potassium sorbate, so- milk and other ingredients specified in dium sorbate, or any combination of this section, by the procedure set forth two or more of these, in an amount not in paragraph (b) of this section, or by to exceed 0.3 percent by weight, cal- another procedure which produces a culated as sorbic acid. finished cheese having the same phys- (e) The name of each semisoft part- ical and chemical properties as the skim cheese for which a definition and cheese produced when the procedure standard of identity is prescribed by set forth in paragraph (b) of this sec- this section is ‘‘Semisoft part-skim tion is used. It contains not more than cheese,’’ preceded or followed by: 50 percent of moisture, as determined (1) The specific common or usual by the method prescribed in § 133.5 (a). name of such semisoft cheese, if any It is coated with blue-colored paraffin such name has become generally recog- or other tightly adhering coating, col- nized therefor; or ored blue. (2) If no such specific common or (b) Skim milk or the optional dairy usual name has become generally rec- ingredients specified in paragraph (c)

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of this section, which may be pasteur- as required by the applicable sections ized, and which may be warmed, are of parts 101 and 130 of this chapter. subjected to the action of harmless lac- [42 FR 14366, Mar. 15, 1977, as amended at 49 tic-acid-producing bacteria, present in FR 10096, Mar. 19, 1984; 58 FR 2895, Jan. 6, such milk or added thereto. Harmless 1993] artificial coloring may be added. Suffi- cient rennet, or other safe and suitable § 133.190 Spiced cheeses. milk-clotting enzyme that produces (a) Description. (1) Spiced cheeses are equivalent curd formation, or both, cheeses for which specifically applica- with or without purified calcium chlo- ble definitions and standards of iden- ride in a quantity not more than 0.02 tity are not prescribed by other sec- percent (calculated as anhydrous cal- tions of this part. The food is prepared cium chloride) of the weight of the by the procedure set forth in paragraph skim milk, is added to set the skim (a)(3) of this section or by any other procedure which produces a finished milk to a semisolid mass. The mass is cheese having the same physical and so cut, stirred, and heated with contin- chemical properties. The minimum ued stirring, as to promote and regu- milkfat content is 50 percent by weight late the separation of whey and curd. of the solids, as determined by the The whey is drained off, and the curd is method described in § 133.5. The food matted into a cohesive mass. Proteins contains spices, in a minimum amount from the whey may be incorporated. of 0.015 ounce per pound of cheese, and The mass is cut into slabs which are so may contain spice oils. If the dairy in- piled and handled as to promote the gredients are not pasteurized, the drainage of whey and the development cheese is cured at a temperature of not of acidity. The slabs are then cut into less than 35 °F for at least 60 days. pieces, which may be rinsed by pouring (2) The phenol equivalent of 0.25 gram or sprinkling water over them, with of spiced cheese is not more than 3 free and continuous drainage; but the micrograms, as determined by the duration of such rinsing is so limited method described in § 133.5. that only the whey on the surface of (3) One or more of the dairy ingredi- such pieces is removed. The curd is ents specified in paragraph (b)(1) of salted, stirred, further drained, and this section may be warmed and is sub- pressed into forms. A harmless prepa- jected to the action of a harmless lac- ration of enzymes of animal or plant tic acid-producing bacterial culture. One or more of the clotting enzymes origin capable of aiding in the curing specified in paragraph (b)(2) of this sec- or development of flavor of skim milk tion is added to set the dairy ingredi- cheese for manufacturing may be added ents to a semisolid mass. The mass is during the procedure, in such quantity divided into smaller portions and so that the weight of the solids of such handled by stirring, heating, and dilut- preparation is not more than 0.1 per- ing with water or salt brine as to pro- cent of the weight of the milk used. mote and regulate the separation of (c) The optional dairy ingredients re- whey and curd. The whey is drained off. ferred to in paragraph (b) of this sec- The curd is removed and may be fur- tion are: Skim milk or concentrated ther drained. The curd is then shaped skim milk or nonfat dry milk or a mix- into forms, and may be pressed. At ture of any two or more of these, with some time during the procedure, spices water in a quantity not in excess of are added so as to be evenly distributed that sufficient to reconstitute any con- throughout the finished cheese. One or centrated skim milk or nonfat dry more of the other optional ingredients milk used. specified in paragraph (b)(3) of this sec- (d) For the purposes of this section, tion may be added during the proce- ‘‘skim milk’’ means cow’s milk from dure. which the milk fat has been separated. (b) Optional ingredients. The following safe and suitable ingredients may be (e) Each of the ingredients used in used: the food shall be declared on the label (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in § 133.3, or

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corresponding products of goat or except that their solids contain less sheep origin, used alone or in combina- than 50 percent, but not less than 20 tion. percent, of milkfat. (2) Clotting enzymes. Rennet and/or other clotting enzymes of animal, [58 FR 2895, Jan. 6, 1993] plant, or microbial origin. (3) Other optional ingredients. (i) § 133.193 Spiced, flavored standardized cheeses. Coloring. (ii) Calcium chloride in an amount (a) Except as otherwise provided for not more than 0.02 percent (calculated herein and in applicable sections in as anhydrous calcium chloride) of the this part, a spiced or flavored standard- weight of the dairy ingredients, used as ized cheese conforms to the applicable a coagulation aid. definitions, standard of identity and re- (iii) Salt. quirements for label statement of in- (iv) Spice oils which do not, alone or gredients prescribed for that specific in combination with other ingredients, natural cheese variety promulgated simulate the flavor of cheese of any age pursuant to section 401 of the Federal or variety. Food, Drug, and Cosmetic Act. In addi- (v) Enzymes of animal, plant, or mi- tion a spiced and/or flavored standard- crobial origin, used in curing or flavor ized cheese shall contain one or more development. safe and suitable spices and/or (vi) Antimycotic agents, applied to flavorings, in such proportions as are the surface of slices or cuts in con- reasonably required to accomplish sumer-sized packages. their intended effect: Provided, That, (c) Nomenclature. The name of the no combination of ingredients shall be food is ‘‘spiced cheese’’. The following used to simulate the flavor of cheese of terms shall accompany the name of the any age or variety. food, as appropriate: (b) The name of a spiced or flavored (1) The specific common or usual standardized cheese shall include in ad- name of the spiced cheese, if any such dition to the varietal name of the nat- name has become generally recognized; ural cheese, a declaration of any flavor or and/or spice that characterizes the (2) An arbitrary or fanciful name food, in the manner prescribed in that is not false or misleading in any § 101.22 of this chapter. particular. (d) Label declaration. Each of the in- [42 FR 14366, Mar. 15, 1977, as amended at 58 gredients used in the food shall be de- FR 2895, Jan. 6, 1993] clared on the label as required by the applicable sections of parts 101 and 130 § 133.195 Swiss and emmentaler of this chapter, except that: cheese. (1) Enzymes of animal, plant, or mi- (a) Description. (1) Swiss cheese, crobial origin may be declared as ‘‘en- emmentaler cheese, is the food pre- zymes’’; and pared by the procedure set forth in (2) The dairy ingredients may be de- paragraph (a)(3) of this section, or by clared, in descending order of predomi- any other procedure which produces a nance, by the use of the terms ‘‘milkfat finished cheese having the same phys- and nonfat milk’’ or ‘‘nonfat milk and ical and chemical properties. It has milkfat’’, or ‘‘milkfat from goat’s milk holes or eyes developed throughout the and nonfat goat’s milk’’, etc., as appro- cheese. The minimum milkfat content priate. is 43 percent by weight of the solids [54 FR 32059, Aug. 4, 1989, as amended at 58 and the maximum moisture content is FR 2895, Jan. 6, 1993] 41 percent by weight, as determined by the methods described in § 133.5. The § 133.191 Part-skim spiced cheeses. dairy ingredients used may be pasteur- Part-skim spiced cheeses conform to ized. Swiss cheese is at least 60 days the definition and standard of identity, old. and are subject to the requirements for (2) If pasteurized dairy ingredients label statement of ingredients pre- are used, the phenol equivalent value scribed for spiced cheeses by § 133.190, of 0.25 gram of swiss cheese is not more

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than 3 micrograms as determined by (iv) Antimycotic agents, the cumu- the method described in § 133.5. lative levels of which shall not exceed (3) One or more of the dairy ingredi- good manufacturing practice, may be ents specified in paragraph (b)(1) of added to the surface of the cheese. this section may be bleached, warmed, (v) Benzoyl peroxide or a mixture of or treated with hydrogen peroxide/cat- benzoyl peroxide with potassium alum, alase, and is subjected to the action of calcium sulfate, and magnesium car- lactic acid-producing and propionic bonate used to bleach the dairy ingre- acid-producing bacterial cultures. One dients. The weight of the benzoyl per- or more of the clotting enzymes speci- oxide is not more than 0.002 percent of fied in paragraph (b)(2) of this section the weight of the milk being bleached, is added to set the dairy ingredients to and the weight of the potassium alum, a semisolid mass. The mass is cut into calcium sulfate, and magnesium car- particles similar in size to wheat ker- bonate, singly or combined, is not more nels. For about 30 minutes the par- than six times the weight of the ben- ticles are alternately stirred and al- zoyl peroxide used. If milk is bleached lowed to settle. The temperature is in this manner, vitamin A is added to raised to about 126 °F. Stirring is con- the curd in such quantity as to com- tinued until the curd becomes firm. pensate for the vitamin A or its precur- The acidity of the whey at this point, sors destroyed in the bleaching process, calculated as lactic acid, does not ex- and artificial coloring is not used. ceed 0.13 percent. The curd is trans- (vi) Hydrogen peroxide, followed by a ferred to hoops or forms and pressed sufficient quantity of catalase prepara- until the desired shape and firmness tion to eliminate the hydrogen per- are obtained. The cheese is then salted oxide. The weight of the hydrogen per- by immersing it in a saturated salt so- oxide shall not exceed 0.05 percent of lution for about 3 days. It is then held the weight of the milk and the weight at a temperature of about 50° to 60 °F. of the catalase shall not exceed 20 parts for a period of 5 to 10 days, after which per million of the weight of the milk it is held at a temperature of about 75 treated. °F. until it is approximately 30 days (c) Nomenclature. The name of the old, or until the so-called eyes form. food is ‘‘swiss cheese’’, or alter- Salt, or a solution of salt in water, is natively, ‘‘emmentaler cheese’’. added to the surface of the cheese at (d) Label declaration. Each of the in- some time during the curing process. gredients used in the food shall be de- The cheese is then stored at a lower clared on the label as required by the applicable sections of parts 101 and 130 temperature for further curing. One or of this chapter, except that: more of the optional ingredients speci- (1) Enzymes of animal, plant, or mi- fied in paragraph (b)(3) of this section crobial origin may be declared as ‘‘en- may be added during the procedure. zymes’’; and (b) Optional ingredients. The following (2) The dairy ingredients may be de- safe and suitable ingredients may be clared, in descending order of predomi- used: nance, by the use of the terms ‘‘milkfat (1) Dairy ingredients. Milk, nonfat and nonfat milk’’ or ‘‘nonfat milk and milk, or cream, as defined in § 133.3, milkfat’’, as appropriate. used alone or in combination. (2) Clotting enzymes. Rennet and/or [48 FR 2746, Jan. 21, 1983; 48 FR 11426, Mar. 18, other clotting enzymes of animal, 1983, as amended at 55 FR 6795, Feb. 27, 1990; plant, or microbial origin. 58 FR 2895, Jan. 6, 1993] (3) Other optional ingredients. (i) § 133.196 Swiss cheese for manufac- Coloring. turing. (ii) Calcium chloride in an amount not more than 0.02 percent (calculated Swiss cheese for manufacturing con- as anhydrous calcium chloride) by forms to the definition and standard of weight of the dairy ingredients, used as identity prescribed for swiss cheese by a coagulation aid. § 133.195, except that the holes, or eyes, (iii) Enzymes of animal, plant, or mi- have not developed throughout the en- crobial origin, used in curing or flavor tire cheese. development. [55 FR 6795, Feb. 27, 1990]

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PART 135—FROZEN DESSERTS food fats, except such as are natural components of flavoring ingredients Subpart A—General Provisions used or are added in incidental amounts to accomplish specific func- Sec. tions. Ice cream is sweetened with safe 135.3 Definitions. and suitable sweeteners and may be Subpart B—Requirements for Specific characterized by the addition of fla- Standardized Frozen Desserts voring ingredients. (2) Ice cream contains not less than 135.110 Ice cream and frozen custard. 1.6 pounds of total solids to the gallon, 135.115 Goat’s milk ice cream. and weighs not less than 4.5 pounds to 135.130 Mellorine. 135.140 Sherbet. the gallon. Ice cream contains not less 135.160 Water ices. than 10 percent milkfat, nor less than 10 percent nonfat milk solids, except AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, that when it contains milkfat at 1 per- 379e. cent increments above the 10 percent minimum, it may contain the fol- Subpart A—General Provisions lowing milkfat-to-nonfat milk solids levels: § 135.3 Definitions. For the purposes of this part, a pas- Minimum percent teurized mix is one in which every par- Percent milkfat nonfat milk ticle of the mix has been heated in solids properly operated equipment to one of the temperatures specified in the table 10 ...... 10 11 ...... 9 in this section and held continuously 12 ...... 8 at or above that temperature for the 13 ...... 7 specified time (or other time/tempera- 14 ...... 6 ture relationship which has been demonstrated to be equivalent thereto in Except that when one or more bulky microbial destruction): flavors are used, the weights of milkfat Temperature Time and total milk solids are not less than 10 percent and 20 percent, respectively, 155 °F ...... 30 min. of the remainder obtained by sub- ° 175 F ...... 25 sec. tracting the weight of the bulky flavors from the weight of the finished [42 FR 19132, Apr. 12, 1977] food; but in no case is the weight of milkfat or total milk solids less than 8 Subpart B—Requirements for Spe- percent and 16 percent, respectively, of cific Standardized Frozen Des- the weight of the finished food. Except serts in the case of frozen custard, ice cream contains less than 1.4 percent egg yolk § 135.110 Ice cream and frozen cus- solids by weight of the food, exclusive tard. of the weight of any bulky flavoring in- (a) Description. (1) Ice cream is a food gredients used. Frozen custard shall produced by freezing, while stirring, a contain 1.4 percent egg yolk solids by pasteurized mix consisting of one or weight of the finished food: Provided, more of the optional dairy ingredients however, That when bulky flavors are specified in paragraph (b) of this sec- added the egg yolk solids content of tion, and may contain one or more of frozen custard may be reduced in pro- the optional caseinates specified in portion to the amount by weight of the paragraph (c) of this section subject to bulky flavors added, but in no case is the conditions hereinafter set forth, the content of egg yolk solids in the one or more of the optional hydrolyzed finished food less than 1.12 percent. A milk proteins as provided for in para- product containing egg yolk solids in graph (d) of this section subject to the excess of 1.4 percent, the maximum set conditions hereinafter set forth, and forth in this paragraph for ice cream, other safe and suitable nonmilk-de- may be marketed if labeled as specified rived ingredients; and excluding other by paragraph (e)(1) of this section.

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(3) When calculating the minimum tribute, singly or in combination, not amount of milkfat and nonfat milk sol- more than 25 percent by weight of the ids required in the finished food, the total nonfat milk solids content of the solids of chocolate or cocoa used shall finished food. The modified skim milk, be considered a bulky flavoring ingre- when adjusted with water to a total dient. In order to make allowance for solids content of 9 percent, is substan- additional sweetening ingredients tially free of lactic acid as determined needed when certain bulky ingredients by titration with 0.1N NaOH, and it has are used, the weight of chocolate or a Ph value in the range of 8.0 to 8.3. cocoa solids used may be multiplied by (c) Optional caseinates. The optional 2.5; the weight of fruit or nuts used caseinates referred to in paragraph (a) may be multiplied by 1.4; and the of this section that may be added to ice weight of partially or wholly dried cream mix containing not less than 20 fruits or fruit juices may be multiplied percent total milk solids are: Casein by appropriate factors to obtain the prepared by precipitation with gums, original weights before drying and this ammonium caseinate, calcium casein- weight may be multiplied by 1.4. ate, potassium caseinate, and sodium (b) Optional dairy ingredients. The op- caseinate. Caseinate may be added in tional dairy ingredients referred to in liquid or dry form, but must be free of paragraph (a) of this section are: excess alkali. Cream; dried cream; plastic cream (d) Optional hydrolyzed milk proteins. (sometimes known as concentrated One or more of the optional hydrolyzed milkfat); butter; butter oil; milk; con- milk proteins referred to in paragraph centrated milk; evaporated milk; (a) of this section may be added as sta- sweetened condensed milk; superheated bilizers at a level not to exceed 3 per- condensed milk; dried milk; skim milk; cent by weight of ice cream mix con- concentrated skim milk; evaporated taining not less that 20 percent total skim milk; condensed skim milk; milk solids, provided that any whey superheated condensed skim milk; and modified whey products used con- sweetened condensed skim milk; sweet- tribute, singly or in combination, not ened condensed part-skim milk; nonfat more than 25 percent by weight of the dry milk; sweet cream buttermilk; con- total nonfat milk solids content of the densed sweet cream buttermilk; dried finished food. Further, when sweet cream buttermilk; skim milk, hydrolyzed milk proteins are used in that may be concentrated, and from the food, the declaration of these ingre- which part or all of the lactose has dients on the food label shall comply been removed by a safe and suitable with the requirements of § 102.22 of this procedure; skim milk in concentrated chapter. or dried form that has been modified by (e) Methods of analysis. The fat con- treating the concentrated skim milk tent shall be determined by the method with calcium hydroxide and disodium prescribed in ‘‘Official Methods of phosphate; and whey and those modi- Analysis of the Association of Official fied whey products (e.g., reduced lac- Analytical Chemists,’’ 13th Ed. (1980), tose whey, reduced minerals whey, and sections 16.287 and 16.059, under ‘‘Fat, whey protein concentrate) that have Roese-Gottlieb Method—Official Final been determined by FDA to be gen- Action,’’ which is incorporated by ref- erally recognized as safe (GRAS) for erence. Copies may be obtained from use in this type of food. Water may be the AOAC INTERNATIONAL, 481 North added, or water may be evaporated Frederick Ave., suite 500, Gaithersburg, from the mix. The sweet cream butter- MD 20877, or may be examined at the milk and the concentrated sweet cream National Archives and Records Admin- buttermilk or dried sweet cream but- istration (NARA). For information on termilk, when adjusted with water to a the availability of this material at total solids content of 8.5 percent, has NARA, call 202–741–6030, or go to: http:// a titratable acidity of not more than www.archives.gov/federallregister/ 0.17 percent, calculated as lactic acid. codeloflfederallregulations/ The term ‘‘milk’’ as used in this sec- ibrllocations.html. tion means cow’s milk. Any whey and (f) Nomenclature. (1) The name of the modified whey products used con- food is ‘‘ice cream’’; except that when

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the egg yolk solids content of the food size and prominence as the words that is in excess of that specified for ice precede and follow it. cream by paragraph (a) of this section, (ii) Wherever the name of the charac- the name of the food is ‘‘frozen cus- terizing flavor appears on the label so tard’’ or ‘‘french ice cream’’ or ‘‘french conspicuously as to be easily seen custard ice cream’’. under customary conditions of pur- (2)(i) If the food contains no artificial chase, the words prescribed by this flavor, the name on the principal dis- paragraph shall immediately and con- play panel or panels of the label shall spicuously precede or follow such be accompanied by the common or name, in a size reasonably related to usual name of the characterizing fla- the prominence of the name of the vor, e.g., ‘‘vanilla’’, in letters not less characterizing flavor and in any event than one-half the height of the letters the size of the type is not less than 6- used in the words ‘‘ice cream’’. point on packages containing less than (ii) If the food contains both a nat- 1 pint, not less than 8-point on pack- ural characterizing flavor and an artifi- ages containing at least 1 pint but less cial flavor simulating it, and if the nat- than one-half gallon, not less than 10- ural flavor predominates, the name on point on packages containing at least the principal display panel or panels of one-half gallon but less than 1 gallon, the label shall be accompanied by the and not less than 12-point on packages common name of the characterizing containing 1 gallon or over: Provided, flavor, in letters not less than one-half however, That where the characterizing the height of the letters used in the flavor and a trademark or brand are words ‘‘ice cream’’, followed by the presented together, other written, word ‘‘flavored’’, in letters not less printed, or graphic matter that is a than one-half the height of the letters part of or is associated with the trade- in the name of the characterizing fla- mark or brand, may intervene if the re- vor, e.g., ‘‘Vanilla flavored’’, or ‘‘Peach quired words are in such relationship flavored’’, or ‘‘Vanilla flavored and with the trademark or brand as to be Strawberry flavored’’. clearly related to the characterizing (iii) If the food contains both a nat- flavor: And provided further, That if the ural characterizing flavor and an artifi- finished product contains more than cial flavor simulating it, and if the ar- one flavor of ice cream subject to the tificial flavor predominates, or if arti- requirements of this paragraph, the ficial flavor is used alone the name on statements required by this paragraph the principal display panel or panels of need appear only once in each state- the label shall be accompanied by the common name of the characterizing ment of characterizing flavors present flavor in letters not less than one-half in such ice cream, e.g., ‘‘Vanilla fla- the height of the letters used in the vored, Chocolate, and Strawberry fla- words ‘‘ice cream’’, preceded by ‘‘arti- vored, artificial flavors added’’. ficial’’ or ‘‘artificially flavored’’, in let- (4) If the food contains both a natural ters not less than one-half the height characterizing flavor and an artificial of the letters in the name of the char- flavor simulating the characterizing acterizing flavor, e.g., ‘‘artificial Va- flavor, any reference to the natural nilla’’, or ‘‘artifically flavored Straw- characterizing flavor shall, except as berry’’ or ‘‘artificially flavored Vanilla otherwise authorized by this para- and artificially flavored Strawberry’’. graph, be accompanied by a reference (3)(i) If the food is subject to the re- to the artificial flavor, displayed with quirements of paragraph (f)(2)(ii) of substantially equal prominence, e.g., this section or if it contains any artifi- ‘‘strawberry and artificial strawberry cial flavor not simulating the charac- flavor’’. terizing flavor, the label shall also bear (5) An artificial flavor simulating the the words ‘‘artificial flavor added’’ or characterizing flavor shall be deemed ‘‘artificial lll flavor added’’, the to predominate: blank being filled with the common (i) In the case of vanilla beans or va- name of the flavor simulated by the ar- nilla extract used in combination with tificial flavor in letters of the same vanillin if the amount of vanillin used

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is greater than 1 ounce per unit of va- an inch. If the food purports to be or is nilla constituent, as that term is de- represented for special dietary use, it fined in § 169.3(c) of this chapter. shall bear labeling in accordance with (ii) In the case of fruit or fruit juice the requirements of part 105 of this used in combination with artificial chapter. fruit flavor, if the quantity of the fruit (g) Label declaration. Each of the in- or fruit juice used is such that, in rela- gredients used shall be declared on the tion to the weight of the finished ice label as required by the applicable sec- cream, the weight of the fruit or fruit tions of parts 101 and 130 of this chap- juice, as the case may be (including ter, except that the sources of milkfat water necessary to reconstitute par- or milk solids not fat may be declared tially or wholly dried fruits or fruit in descending order of predominance juices to their original moisture con- either by the use of all the terms tent) is less than 2 percent in the case ‘‘milkfat and nonfat milk’’ when one or of citrus ice cream, 6 percent in the any combination of two or more of the case of berry or cherry ice cream, and ingredients listed in § 101.4(b)(3), (b)(4), 10 percent in the case of ice cream pre- (b)(8), and (b)(9) of this chapter are pared with other fruits. used or, alternatively, as permitted in (iii) In the case of nut meats used in § 101.4 of this chapter. Under section combination with artificial nut flavor, 403(k) of the Federal Food, Drug, and if the quantity of nut meats used is Cosmetic Act, artificial color need not such that, in relation to the finished be declared in ice cream, except as re- ice cream the weight of the nut meats quired by § 101.22(c) or (k) of this chap- is less than 2 percent. ter. Voluntary declaration of all colors (iv) In the case of two or more fruits used in ice cream and frozen custard is or fruit juices, or nut meats, or both, recommended. used in combination with artificial flavors simulating the natural flavors and [43 FR 4598, Feb. 3, 1978, as amended at 45 FR dispersed throughout the food, if the 63838, Sept. 26, 1980; 46 FR 44433, Sept. 4, 1981; quantity of any fruit or fruit juice or 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. nut meat is less than one-half the ap- 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 6, 1993; 59 FR 47079, Sept. 14, 1994; 63 FR plicable percentage specified in para- 14035, Mar. 24, 1998; 63 FR 14818, Mar. 27, 1998] graph (e)(5) (ii) or (iii) of this section. For example, if a combination ice § 135.115 Goat’s milk ice cream. cream contains less than 5 percent of bananas and less than 1 percent of al- (a) Description. Goat’s milk ice cream monds it would be ‘‘artificially fla- is the food prepared in the same man- vored banana-almond ice cream’’. How- ner prescribed in § 135.110 for ice cream, ever, if it contains more than 5 percent and complies with all the provisions of of bananas and more than 1 percent of § 135.110, except that the only optional almonds it would be ‘‘banana-almond dairy ingredients that may be used are flavored ice cream’’. those in paragraph (b) of this section; (6) If two or more flavors of ice cream caseinates and hydrolyzed milk pro- are distinctively combined in one pack- teins may not be used; and paragraphs age, e.g., ‘‘Neapolitan’’ ice cream, the (f)(1) and (g) of § 135.110 shall not apply. applicable provisions of this paragraph (b) Optional dairy ingredients. The op- shall govern each flavor of ice cream tional dairy ingredients referred to in comprising the combination. paragraph (a) of this section are goat’s (7) Until September 14, 1998, when skim milk, goat’s milk, and goat’s safe and suitable sweeteners other than cream. These optional dairy ingredi- nutritive carbohydrate sweeteners are ents may be used in liquid, con- used in the food, their presence shall be centrated, and/or dry form. declared by their common or usual (c) Nomenclature. (1) The name of the name on the principal display panel of food is ‘‘goat’s milk ice cream’’ or, al- the label as part of the statement of ternatively, ‘‘ice cream made with identity in letters that shall be no less goat’s milk’’, except that when the egg than one-half the size of the type used yolk solids content of the food is in ex- in the term ‘‘ice cream’’ but in any cess of that specified for ice cream in case no smaller than one-sixteenth of paragraph (a) of § 135.110, the name of

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the food is ‘‘goat’s milk frozen cus- than 2.2 percent. The protein to meet tard’’ or, alternatively, ‘‘frozen custard the minimum protein requirements made with goat’s milk’’, or ‘‘goat’s shall be provided by milk solids, not milk french ice cream’’, or, alter- fat and/or other milk-derived ingredi- natively, ‘‘french ice cream made with ents. goat’s milk’’, or ‘‘goat’s milk french (3) When calculating the minimum custard ice cream’’, or, alternatively, amount of milkfat and protein required ‘‘french custard ice cream made with in the finished food, the solids of choc- goat’s milk’’. olate or cocoa used shall be considered (2) Until September 14, 1998, when a bulky flavoring ingredient. In order safe and suitable sweeteners other than to make allowance for additional nutritive carbohydrate sweeteners are sweetening ingredients needed when used in the food, their presence shall be certain bulky ingredients are used, the declared by their common or usual weight of chocolate or cocoa solids name on the principal display panel of used may be multiplied by 2.5; the the label as part of the statement of weight of fruit or nuts used may be identity in letters that shall be no less multiplied by 1.4; and the weight of than one-half the size of the type used partially or wholly dried fruits or fruit in the term ‘‘goat’s milk ice cream’’ juices may be multiplied by appro- but in any case no smaller than one- priate factors to obtain the original sixteenth of an inch. If the food pur- weights before drying and this weight ports to be or is represented for special may be multiplied by 1.4. dietary use, it shall bear labeling in ac- (b) Fortification. Vitamin A is present cordance with the requirements of part in a quantity which will ensure that 40 105 of this chapter. international units (IU) are available (d) Label declaration. Each of the infor each gram of fat in mellorine, with- gredients used in the food shall be de- in limits of good manufacturing prac- clared on the label as required by the tice. applicable sections of parts 101 and 130 (c) Methods of analysis. Fat and proof this chapter. tein content, and the PER shall be de- [47 FR 41526, Sept. 21, 1982, as amended at 58 termined by following the methods FR 2896, Jan. 6, 1993; 59 FR 47080, Sept. 14, contained in ‘‘Official Methods of Anal- 1994] ysis of the Association of Official Ana- lytical Chemists,’’ 13th Ed. (1980), § 135.130 Mellorine. which is incorporated by reference. (a) Description. (1) Mellorine is a food Copies may be obtained from the AOAC produced by freezing, while stirring, a INTERNATIONAL, 481 North Frederick pasteurized mix consisting of safe and Ave., suite 500, Gaithersburg, MD 20877, suitable ingredients including, but not or may be examined at the National limited to, milk-derived nonfat solids Archives and Records Administration and animal or vegetable fat, or both, (NARA). For information on the avail- only part of which may be milkfat. ability of this material at NARA, call Mellorine is sweetened with nutritive 202–741–6030, or go to: http:// carbohydrate sweetener and is charac- www.archives.gov/federallregister/ terized by the addition of flavoring in- codeloflfederallregulations/ gredients. ibrllocations.html. (2) Mellorine contains not less than (1) Fat content shall be determined 1.6 pounds of total solids to the gallon, by the method: ‘‘Fat, Roese-Gottlieb and weighs not less than 4.5 pounds to Method—Official Final Action,’’ sec- the gallon. Mellorine contains not less tion 16.287. than 6 percent fat and 2.7 percent pro- (2) Protein content shall be deter- tein having a protein efficiency ratio mined by one of the following methods: (PER) not less than that of whole milk ‘‘Nitrogen—Official Final Action,’’ protein (108 percent of casein) by Kjeldahl Method, section 16.285, or Dye weight of the food, exclusive of the Binding Method, section 16.286. weight of any bulky flavoring ingredi- (3) PER shall be determined by the ents used. In no case shall the fat con- method: ‘‘Biological Evaluation of Pro- tent of the finished food be less than 4.8 tein Quality—Official Final Action,’’ percent or the protein content be less sections 43.212–43.216.

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(d) Nomenclature. The name of the acterized by a fruit ingredient shall food is ‘‘mellorine’’. The name of the have a titratable acidity, calculated as food on the label shall be accompanied lactic acid, of not less than 0.35 per- by a declaration indicating the pres- cent. ence of characterizing flavoring in the (b) Optional dairy ingredients. The op- same manner as is specified in tional dairy ingredients referred to in § 135.110(c). paragraph (a) of this section are: (e) Label declaration. Each of the in- Cream, dried cream, plastic cream gredients used shall be declared on the (sometimes known as concentrated label as required by the applicable sec- milkfat), butter, butter oil, milk, con- tions of parts 101 and 130 of this chap- centrated milk, evaporated milk, ter, except that sources of milkfat or superheated condensed milk, sweetened milk solids not fat may be declared in condensed milk, dried milk, skim milk, descending order of predominance ei- concentrated skim milk, evaporated ther by the use of the terms ‘‘milkfat skim milk, condensed skim milk, and nonfat milk’’ when one or any sweetened condensed skim milk, sweet- combination of two or more of the in- ened condensed part-skim milk, nonfat gredients listed in § 101.4(b)(3), (b)(4), dry milk, sweet cream buttermilk, con- (b)(8), and (b)(9) of this chapter are densed sweet cream buttermilk, dried used, or alternatively as permitted in sweet cream buttermilk, skim milk § 101.4 of this chapter. that has been concentrated and from [42 FR 19137, Apr. 12, 1977, as amended at 47 which part of the lactose has been re- FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, moved by crystallization, and whey 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, and those modified whey products (e.g., Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] reduced lactose whey, reduced minerals whey, and whey protein concentrate) § 135.140 Sherbet. that have been determined by FDA to (a) Description. (1) Sherbet is a food be generally recognized as safe (GRAS) produced by freezing, while stirring, a for use in this type of food. Water may pasteurized mix consisting of one or be added, or water may be evaporated more of the optional dairy ingredients from the mix. The sweet cream butter- specified in paragraph (b) of this sec- milk and the concentrated sweet cream tion, and may contain one or more of buttermilk or dried sweet cream but- the optional caseinates specified in termilk, when adjusted with water to a paragraph (c) of this section subject to total solids content of 8.5 percent, has the conditions hereinafter set forth, a titratable acidity of not more than and other safe and suitable nonmilk- 0.17 percent calculated as lactic acid. derived ingredients; and excluding The term ‘‘milk’’ as used in this sec- other food fats, except such as are tion means cow’s milk. added in small amounts to accomplish (c) Optional caseinates. The optional specific functions or are natural com- caseinates referred to in paragraph (a) ponents of flavoring ingredients used. of this section which may be added to Sherbet is sweetened with nutritive sherbet mix are: Casein prepared by carbohydrate sweeteners and is charac- precipitation with gums, ammonium terized by the addition of one or more caseinate, calcium caseinate, potas- of the characterizing fruit ingredients sium caseinate, and sodium caseinate. specified in paragraph (d) of this sec- Caseinates may be added in liquid or tion or one or more of the nonfruit- dry form, but must be free of excess al- characterizing ingredients specified in kali, such caseinates are not consid- paragraph (e) of this section. ered to be milk solids. (2) Sherbet weighs not less than 6 (d) Optional fruit-characterizing ingre- pounds to the gallon. The milkfat con- dients. The optional fruit-character- tent is not less than 1 percent nor more izing ingredients referred to in para- than 2 percent, the nonfat milk-derived graph (a) of this section are any ma- solids content not less than 1 percent, ture fruit or the juice of any mature and the total milk or milk-derived sol- fruit. The fruit or fruit juice used may ids content is not less than 2 percent be fresh, frozen, canned, concentrated, nor more than 5 percent by weight of or partially or wholly dried. The fruit the finished food. Sherbet that is char- may be thickened with pectin or other

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optional ingredients. The fruit is pre- names of two or more fruits are in- pared by the removal of pits, seeds, cluded, such names shall be arranged in skins, and cores, where such removal is order of predominance, if any, by usual in preparing that kind of fruit for weight of the respective fruit ingredi- consumption as fresh fruit. The fruit ents used. may be screened, crushed, or otherwise (ii) The name of each nonfruit sher- comminuted. It may be acidulated. In bet is ‘‘lll sherbet’’, the blank being the case of concentrated fruit or fruit filled in with the common or usual juices, from which part of the water is name or names of the characterizing removed, substances contributing fla- flavor or flavors; for example, ‘‘pepper- vor volatilized during water removal mint’’, except that if the character- may be condensed and reincorporated izing flavor used is vanilla, the name of in the concentrated fruit or fruit juice. the food is ‘‘lll sherbet’’, the blank In the case of citrus fruits, the whole being filled in as specified by § 135.110(e) fruit, including the peel but excluding (2) and (5)(i). the seeds, may be used, and in the case (2) When the optional ingredients, ar- of citrus juice or concentrated citrus tificial flavoring, or artificial coloring juices, cold-pressed citrus oil may be are used in sherbet, they shall be added thereto in an amount not exceed- named on the label as follows: ing that which would have been ob- (i) If the flavoring ingredient or in- tained if the whole fruit had been used. gredients consists exclusively of artifi- The quantity of fruit ingredients used cial flavoring, the label designation is such that, in relation to the weight shall be ‘‘artificially flavored’’. of the finished sherbet, the weight of (ii) If the flavoring ingredients are a fruit or fruit juice, as the case may be combination of natural and artificial (including water necessary to reconsti- flavors, the label designation shall be tute partially or wholly dried fruits or ‘‘artificial and natural flavoring fruit juices to their original moisture added’’. content), is not less than 2 percent in (iii) The label shall designate artifi- the case of citrus sherbets, 6 percent in cial coloring by the statement ‘‘artifi- the case of berry sherbets, and 10 per- cially colored’’, ‘‘artificial coloring cent in the case of sherbets prepared added’’, ‘‘with added artificial color- with other fruits. For the purpose of ing’’, or ‘‘lll, an artificial color this section, tomatoes and rhubarb are added’’, the blank being filled in with considered as kinds of fruit. the name of the artificial coloring (e) Optional nonfruit characterizing in- used. gredients. The optimal nonfruit charac- (g) Characterizing flavor(s). Wherever terizing ingredients referred to in para- there appears on the label any rep- graph (a) of this section include but are resentation as to the characterizing not limited to the following: flavor or flavors of the food and such (1) Ground spice or infusion of coffee flavor or flavors consist in whole or in or tea. part of artificial flavoring, the (2) Chocolate or cocoa, including statment required by paragraph (f)(2) sirup. (i) and (ii) of this section, as appro- (3) Confectionery. priate, shall immediately and con- (4) Distilled alcoholic beverage, in- spicuously precede or follow such rep- cluding liqueurs or wine, in an amount resentation, without intervening writ- not to exceed that required for fla- ten, printed, or graphic matter (except voring the sherbet. that the word ‘‘sherbet’’ may inter- (5) Any natural or artificial food fla- vene) in a size reasonably related to voring (except any having a char- the prominence of the name of the acteristic fruit or fruit-like flavor). characterizing flavor and in any event (f) Nomenclature. (1) The name of each the size of the type is not less than 6- sherbet is as follows: point on packages containing less than (i) The name of each fruit sherbet is 1 pint, not less than 8-point on pack- ‘‘lll sherbet’’, the blank being filled ages containing at least 1 pint but less in with the common name of the fruit than one-half gallon, not less than 10- or fruits from which the fruit ingredi- point on packages containing at least ents used are obtained. When the one-half gallon but less than 1 gallon,

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and not less than 12-point on packages Subpart A—General Provisions containing 1 gallon or over. (h) Display of statements required by § 136.3 Definitions. paragraph (f)(2). Except as specified in For purposes of this part, the fol- paragraph (g) of this section, the state- lowing definitions apply: ments required by paragraph (f)(2) of (a) The word bread when used in the this section shall be set forth on the name of the food means the unit principal display panel or panels of the weighs one-half pound or more after label with such prominence and con- cooling. spicuousness as to render them likely (b) The words rolls and buns when to be read and understood by the ordi- used in the name of the food mean the nary individual under customary con- unit weighs less than one-half pound ditions of purchase and use. after cooling. (i) Label declaration. Each of the ingredients used in the food shall be de- Subpart B—Requirements for Spe- clared on the label as required by the applicable sections of parts 101 and 130 cific Standardized Bakery of this chapter. Products [43 FR 4599, Feb. 3, 1978, as amended at 46 FR § 136.110 Bread, rolls, and buns. 44434, Sept. 4, 1981; 58 FR 2896, Jan. 6, 1993] (a) Bread, white bread, and rolls, white rolls, or buns, and white buns are § 135.160 Water ices. the foods produced by baking mixed (a) Description. Water ices are the yeast-leavened dough prepared from foods each of which is prepared from one or more of the farinaceous ingredi- the same ingredients and in the same ents listed in paragraph (c)(1) of this manner prescribed in § 135.140 for sher- section and one or more of the moist- bets, except that the mix need not be ening ingredients listed in paragraphs pasteurized, and complies with all the (c) (2), (6), (7), and (8) of this section provisions of § 135.140 (including the re- and one or more of the leavening quirements for label statement of in- agents provided for by paragraph (c)(3) gredients), except that no milk or of this section. The food may contain milk-derived ingredient and no egg in- additional ingredients as provided for gredient, other than egg white, is used. by paragraph (c) of this section. Each (b) Nomenclature. The name of the of the finished foods contains not less food is ‘‘lll ice’’, the blank being than 62 percent total solids as deter- filled in, in the same manner as speci- mined by the method prescribed in fied in § 135.140(f)(1) (i) and (ii), as ap- paragraph (d) of this section. propriate. (b) All ingredients from which the food is fabricated shall be safe and suit- [42 FR 19132, Apr. 12, 1977, as amended 58 FR 2876, Jan. 6, 1993] able. (c) The following optional ingredients are provided for: PART 136—BAKERY PRODUCTS (1) Flour, bromated flour, phosphated flour, or a combination of two or more Subpart A—General Provisions of these. The potassium bromate in any Sec. bromated flour used and the 136.3 Definitions. monocalcium phosphate in any phosphated flour used are deemed to be Subpart B—Requirements for Specific additional optional ingredients in the Standardized Bakery Products bread, rolls, or buns. All ingredients in any flour, bromated flour, or 136.110 Bread, rolls, and buns. phosphated flour used are deemed to be 136.115 Enriched bread, rolls, and buns. optional ingredients of the bread, rolls, 136.130 Milk bread, rolls, and buns. or buns prepared therefrom. 136.160 Raisin bread, rolls, and buns. (2) Water. 136.180 Whole wheat bread, rolls, and buns. (3) Yeast—any type which produces AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, the necessary leavening effect. 379e. (4) Salt.

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(5) Shortening, in which or in con- flour used. Any calcium propionate junction with which may be used one used as a preservative in bread, rolls, or any combination of two or more of or buns is not subject to the limitation the following: prescribed in this paragraph. (i) Lecithin, hydroxylated lecithin (14)(i) Potassium bromate, calcium complying with the provisions of part bromate, potassium iodate, calcium 172 of this chapter, either of which may iodate, calcium peroxide, or any com- include related phosphatides derived bination of 2 or more of these if the from the corn oil or soybean oil from total quantity, including the potas- which such ingredients were obtained. sium bromate in any bromated flour (ii) Mono- and diglycerides of fat- used, is not more than 0.0075 part for forming fatty acids, diacetyl tartaric each 100 parts by weight of flour used. acid esters of mono- and diglycerides of (ii) Azodicarbonamide, if the total fat-forming fatty acids, propylene gly- quantity, including any quantity in the col mono- and diesters of fat-forming flour used, is not more than 0.0045 part fatty acids, and other ingredients that for each 100 parts by weight of flour perform a similar function. used. (6) Milk and/or other dairy products (15) Dough strengtheners and other in such quantity and composition as dough conditioners not listed or re- not to meet the requirements for milk ferred to in this paragraph, if the total and/or other dairy products prescribed quantities of such ingredients or com- for milk bread by § 136.130. Whenever bination is not more than 0.5 part for nonfat milk solids in any form are each 100 parts by weight of flour used. used, carrageenan or salts of carra- (16) Spices, spice oil, and spice ex- geenan complying with the provisions tract. of part 172 of this chapter may be used (17) Coloring may not be added as in a quantity not in excess of 0.8 per- such or as part of another ingredient cent by weight of such nonfat milk sol- except as permitted by paragraph ids. (c)(16) of this section and except that (7) Egg products. coloring which may be present in but- (8) Nutritive carbohydrate sweet- ter or margarine if the intensity of the eners. butter or margarine color does not ex- (9) Enzyme active preparations. ceed ‘‘medium high’’ (MH) when viewed (10) Lactic-acid-producing bacteria. under diffused light (7400 Kelvin) (11) Nonwheat flours, nonwheat against the Munsell Butter Color Com- meals, nonwheat grits, wheat and parator. The MH designation cor- nonwheat starches, any of which may responds to the Munsell renotation of be wholly or in part dextrinized, 3.8Y7.9/7.6. dextrinized wheat flour, or any com- (18) Other ingredients that do not bination of 2 or more of these, if the change the basic identity or adversely total quantity is not more than 3 parts affect the physical and nutritional for each 100 parts by weight of flour characteristics of the food. used. (d) Total solids are determined by the (12) Ground dehulled soybeans which method prescribed in ‘‘Official Methods may be heat-treated, and from which of Analysis of the Association of Offi- oil may be removed, but which retain cial Analytical Chemists,’’ 13th Ed. enzymatic activity, if the quantity is (1980), section 14.091(a), which is incor- not more than 0.5 part for each 100 porated by reference, except that if the parts by weight of flour used. baked unit weighs 454 grams (1 pound) (13) Yeast nutrients and calcium or more, one entire unit is used for the salts, if the total quantity of such in- determination; if the baked unit gredients, with the exception of weighs less than 454 grams, enough monocalcium phosphate and calcium units to weigh 454 grams or more are propionate, is not more than 0.25 part used. Copies of the material incor- for each 100 parts by weight of flour porated by reference may be obtained used. The quantity of monocalcium from the AOAC INTERNATIONAL, 481 phosphate, including any quantity in North Frederick Ave., suite 500, Gai- the flour used, is not more than 0.75 thersburg, MD 20877, or may be exam- part for each 100 parts by weight of ined at the National Archives and

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Records Administration (NARA). For ents prescribed for bread, rolls or buns information on the availability of this by § 136.110, except that: material at NARA, call 202–741–6030, or (1) Each such food contains in each go to: http://www.archives.gov/ pound 1.8 milligrams of thiamin, 1.1 federallregister/ milligrams of riboflavin, 15 milligrams codeloflfederallregulations/ of niacin, 0.43 milligrams of folic acid, ibrllocations.html. and 12.5 milligrams of iron. (e)(1) The name of the food is (2) Each such food may contain added ‘‘bread’’, ‘‘white bread’’, ‘‘rolls’’, calcium in such quantity that the total ‘‘white rolls’’, ‘‘buns’’, ‘‘white buns’’, as calcium content is 600 milligrams per applicable. When the food contains not pound. If insufficient calcium is added less than 2.56 percent by weight of to meet the 600-milligram level per whole egg solids, the name of the food pound of the finished food, no claim may be ‘‘egg bread’’, ‘‘egg rolls’’, or may be made on the label for calcium ‘‘egg buns’’, as applicable, accompanied as a nutrient except as a part of nutri- by the statement ‘‘Contains ll me- tion labeling. dium-sized egg(s) per pound’’ in the (3) The requirements of paragraphs manner prescribed by § 102.5(c)(3) of (a) (1) and (2) of this section will be this chapter, the blank to be filled in deemed to have been met if reasonable with the number which represents the overages of the vitamins and minerals, whole egg content of the food expressed within the limits of good manufac- to the nearest one-fifth egg but not turing practice, are present to ensure greater than the amount actually that the required levels of the vitamins present. For the purpose of this regula- and minerals are maintained through- tion, whole egg solids are the edible out the expected shelf life of the food contents of eggs calculated on a mois- under customary conditions of dis- ture-free basis and exclusive of any tribution and storage. The quantitative nonegg solids which may be present in content of the following vitamins shall standardized and other commercial egg be calculated in terms of the following products. One medium-sized egg is chemically identifiable reference equivalent to 0.41 ounce of whole egg forms: solids. Reference form (2) When the label bears any rep- Vitamin Molec- resentation, other than in the ingre- Name Empirical formula ular dient listing, of the presence of egg in weight the food, e.g., the word egg or any pho- Thiamine ... Thiamine chlo- C12H17ClN4 337.28 netic equivalent spelling of the word ride hydro- OS·HCl egg, or a picture of an egg, the food chloride. shall contain not less than 2.56 percent Riboflavin .. Riboflavin ...... C17H20N4O6 376.37 Niacin ...... Niacin ...... C H NO 123.11 of whole egg solids. 6 5 2 (f) Label declaration. Each of the in- (4) Each such food may also contain gredients used shall be declared on the wheat germ or partly defatted wheat label as required by the applicable sec- germ, but the total quantity thereof, tions of parts 101 and 130 of this chap- including any wheat germ or partly ter. defatted wheat germ in any enriched [42 FR 14400, Mar. 15, 1977, as amended at 43 flour used, shall not be more than 5 FR 47177, Oct. 13, 1978; 47 FR 11826, Mar. 19, percent of the flour ingredient. 1982; 49 FR 10096, Mar. 19, 1984; 49 FR 13692, (5) Enriched flour may be used, in Apr. 6, 1984; 54 FR 24894, June 12, 1989; 58 FR whole or in part, instead of flour. As 2877, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] used in this section, the term ‘‘enriched flour’’ includes enriched § 136.115 Enriched bread, rolls, and bromated flour. buns. (6) The limitation prescribed by (a) Each of the foods enriched bread, § 136.110(c)(6) on the quantity and com- enriched rolls, and enriched buns con- position of milk and/or other dairy forms to the definition and standard of products does not apply. identity and is subject to the require- (7) The vitamins and minerals added ments for label statement of ingredi- to the food for enrichment purposes

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may be supplied by any safe and suit- sized egg is equivalent to 0.41 ounce of able substances. Niacin equivalents as whole egg solids. derived from tryptophan content shall [42 FR 14400, Mar. 15, 1977, as amended at 43 not be used in determining total niacin FR 38578, Aug. 29, 1978; 46 FR 43413, Aug. 28, content. 1981; 61 FR 8796, Mar. 5, 1996; 61 FR 14245, Apr. (b) The name of the food is ‘‘enriched 1, 1996] bread’’, ‘‘enriched rolls’’, or ‘‘enriched § 136.130 Milk bread, rolls, and buns. buns’’, as applicable. When the food contains not less than 2.56 percent by (a) Each of the foods milk bread, weight of whole egg solids, the name of milk rolls, and milk buns conforms to the food may be ‘‘enriched egg bread’’, the definition and standard of identity ‘‘enriched egg rolls’’, or ‘‘enriched egg and is subject to the requirements for buns’’, as applicable, accompanied by label statement of ingredients prescribed for bread, rolls or buns by the statement ‘‘Contains l medium- § 136.110 except that: sized egg(s) per pound’’ in the manner (1) The only moistening ingredient prescribed by § 102.5(c)(3) of this chap- permitted in the preparation of the ter, the blank to be filled in with the dough is milk or, as an alternative, a number which represents the whole egg combination of dairy products in such content of the food expressed to the a proportion that the weight of the nearest one-fifth egg but not greater nonfat milk solids is not more than 2.3 than the amount actually present. For times and not less than 1.2 times the the purpose of this regulation, whole weight of the milkfat therein, with or egg solids are the edible contents of without water, in a quantity that pro- eggs calculated on a moisture-free vides not less than 8.2 parts milk solids basis and exclusive of any non-egg sol- for each 100 parts by weight of flour. ids which may be present in standard- (2) No buttermilk, buttermilk prod- ized and other commercial egg product, cheese whey, cheese whey product, ucts. One medium-sized egg is equiva- or milk protein is used. lent to 0.41 ounce of whole egg solids. (b) The name of the food is ‘‘milk When the food complies with the re- bread’’, ‘‘milk rolls’’, ‘‘milk buns’’, as quirements for milk and/or other dairy applicable. products content in § 136.130 for milk bread, the name of the food may be § 136.160 Raisin bread, rolls, and buns. ‘‘enriched milk bread’’, ‘‘enriched milk (a) Each of the foods raisin bread, rolls’’, or ‘‘enriched milk buns’’, as ap- raisin rolls, and raisin buns conforms plicable. When the food complies with to the definition and standard of iden- the requirements for both enriched egg tity and is subject to the requirements bread and enriched milk bread in this for label statement of ingredients pre- section, the name of the food may be scribed for bread, rolls or buns by ‘‘enriched milk and egg bread’’, ‘‘en- § 136.110, except that: riched milk and egg rolls’’, or ‘‘en- (1) Not less than 50 parts by weight of riched milk and egg buns’’, as applica- seeded or seedless raisins are used for each 100 parts by weight of flour used. ble accompanied by the statement (2) Water extract of raisins may be ‘‘Contains l medium-sized egg(s) per used, but not to replace raisins. pound’’ in the manner prescribed by (3) The baked units may bear icing or § 102.5(c)(3) of this chapter, the blank to frosting. be filled in with the number which rep- (4) The limitation prescribed by resents the whole egg content of the § 136.110(c)(6) on the quantity and com- food expressed to the nearest one-fifth position of milk and/or other dairy egg but no greater than the amount ac- products does not apply. tually present. For purposes of this (5) The total solids are determined by regulation, whole egg solids are the ed- the method prescribed in § 136.110(d), ible contents of eggs calculated on a except that section 14.091(b) of ‘‘Offi- moisture-free basis and exclusive of cial Methods of Analysis of the Asso- any non-egg solids which may be ciation of Official Analytical Chem- present in standardized or other com- ists,’’ 13th Ed. (1980), which is incor- mercial egg products. One medium- porated by reference, will apply. Copies

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may be obtained from the AOAC an additional optional ingredient in INTERNATIONAL, 481 North Frederick the whole wheat bread, whole wheat Ave., suite 500, Gaithersburg, MD 20877, rolls, or whole wheat buns. or may be examined at the National (2) The limitation prescribed by Archives and Records Administration § 136.110(c)(6) on the quantity and com- (NARA). For information on the avail- position of milk and/or other dairy ability of this material at NARA, call products does not apply. 202–741–6030, or go to: http:// (b) The name of the food is ‘‘whole www.archives.gov/federallregister/ wheat bread’’, ‘‘graham bread’’, ‘‘entire codeloflfederallregulations/ wheat bread’’, ‘‘whole wheat rolls’’, ibrllocations.html. ‘‘graham rolls’’, ‘‘entire wheat rolls’’, (b) The name of the food is ‘‘raisin ‘‘whole wheat buns’’, ‘‘graham buns’’, bread’’, ‘‘raisin rolls’’, ‘‘raisin buns’’, ‘‘entire wheat buns’’, as applicable. as applicable. When the food contains not less than 2.56 percent by weight of PART 137—CEREAL FLOURS AND whole egg solids, the name of the food RELATED PRODUCTS may be ‘‘raisin and egg bread’’, ‘‘raisin and egg rolls’’, or ‘‘raisin and egg Subpart A [Reserved] buns’’, as applicable, accompanied by the statement ‘‘Contains l medium- Subpart B—Requirements for Specific sized egg(s) per pound’’ in the manner Standardized Cereal Flours and Re- prescribed by § 102.5(c)(3) of this chap- lated Products ter, the blank to be filled in with the number which represents the whole egg Sec. content of the food expressed to the 137.105 Flour. nearest one-fifth egg but not greater 137.155 Bromated flour. than the amount actually present. For 137.160 Enriched bromated flour. 137.165 Enriched flour. purposes of this regulation, whole egg 137.170 Instantized flours. solids are the edible contents of eggs 137.175 Phosphated flour. calculated on a moisture-free basis and 137.180 Self-rising flour. exclusive of any nonegg solids which 137.185 Enriched self-rising flour. may be present in standardized and 137.190 Cracked wheat. other commercial egg products. One 137.195 Crushed wheat. medium-sized egg is equivalent to 0.41 137.200 Whole wheat flour. ounce of whole egg solids. 137.205 Bromated whole wheat flour. 137.211 White corn flour. [42 FR 14400, Mar. 15, 1977, as amended at 47 137.215 Yellow corn flour. FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 137.220 Durum flour. 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, 137.225 Whole durum flour. Mar. 24, 1998] 137.250 White corn meal. 137.255 Bolted white corn meal. § 136.180 Whole wheat bread, rolls, and 137.260 Enriched corn meals. buns. 137.265 Degerminated white corn meal. (a) Each of the foods whole wheat 137.270 Self-rising white corn meal. bread, graham bread, entire wheat 137.275 Yellow corn meal. bread, whole wheat rolls, graham rolls, 137.280 Bolted yellow corn meal. entire wheat rolls, whole wheat buns, 137.285 Degerminated yellow corn meal. 137.290 Self-rising yellow corn meal. graham buns, and entire wheat buns 137.300 Farina. conforms to the definition and stand- 137.305 Enriched farina. ard of identity and is subject to the 137.320 Semolina. label statement of ingredients pre- 137.350 Enriched rice. scribed for bread, rolls and buns by AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, § 136.110, except that: 379e. (1) The dough is made from the optional ingredient whole wheat flour, SOURCE: 42 FR 14402, Mar. 15, 1977, unless bromated whole wheat flour, or a com- otherwise noted. bination of these. No flour, bromated EDITORIAL NOTE: Nomenclature changes to flour, or phosphated flour is used. The part 137 appear at 63 FR 14035, Mar. 24, 1998. potassium bromate in any bromated whole wheat flour used is deemed to be Subpart A [Reserved] 554

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Subpart B—Requirements for Spe- value than it is, one or any combina- cific Standardized Cereal tion of two or more of the following op- Flours and Related Products tional bleaching ingredients may be added in a quantity not more than suf- § 137.105 Flour. ficient for bleaching or, in case such ingredient has an artificial aging effect, (a) Flour, white flour, wheat flour, in a quantity not more than sufficient plain flour, is the food prepared by for bleaching and such artificial aging grinding and bolting cleaned wheat, effect: other than durum wheat and red durum (1) Oxides of nitrogen. wheat. To compensate for any natural deficiency of enzymes, malted wheat, (2) Chlorine. malted wheat flour, malted barley (3) Nitrosyl chloride. flour, or any combination of two or (4) Chlorine dioxide. more of these, may be used; but the (5) One part by weight of benzoyl per- quantity of malted barley flour so used oxide mixed with not more than six is not more than 0.75 percent. Harmless parts by weight of one or any mixture preparations of a-amylase obtained of two or more of the following: potas- from Aspergillus oryzae, alone or in a sium alum, calcium sulfate, magne- safe and suitable carrier, may be used. sium carbonate, sodium aluminum sul- When tested for granulation as pre- fate, dicalcium phosphate, tricalcium scribed in paragraph (c)(4) of this sec- phosphate, starch, calcium carbonate. tion, not less than 98 percent of the (6) Acetone peroxides complying with flour passes through a cloth having the provisions of § 172.802 of this chap- openings not larger than those of ter. woven wire cloth designated ‘‘212 μm (7) Azodicarbonamide (complying (No. 70)’’ complying with the specifica- with the requirements of § 172.806 of tions for such cloth set forth in ‘‘Offi- this chapter, including the quan- cial Methods of Analysis of the Asso- titative limit of not more than 45 parts ciation of Official Analytical Chem- per million). ists’’ (AOAC), 13th Ed. (1980), Table 1, (b)(1) Label declaration. Each of the ‘‘Nominal Dimensions of Standard Test ingredients used in the food shall be de- Sieves (U.S.A. Standard Series),’’ under clared on the label as required by the the heading ‘‘Definitions of Terms and applicable sections of parts 101 and 130 Explanatory Notes,’’ which is incor- of this chapter. porated by reference. Copies may be (2) When ascorbic acid is added, the obtained from the AOAC INTER- label shall bear the statement ‘‘Ascor- NATIONAL, 481 North Frederick Ave., bic acid added as a dough conditioner’’. suite 500, Gaithersburg, MD 20877, or When the optional ingredient a-amy- may be examined at the National Ar- lase obtained from Aspergillus oryzae’’ chives and Records Administration is used, it may alternatively be de- (NARA). For information on the avail- clared in the list of ingredients as ability of this material at NARA, call ‘‘Fungal alpha-amylase,’’ ‘‘Fungal a- 202–741–6030, or go to: http:// amylase’’, ‘‘Enzyme’’, or ‘‘Enzyme www.archives.gov/federallregister/ added for improved baking’’. When any codeloflfederallregulations/ optional bleaching ingredient is used, ibrllocations.html. The flour is freed the label shall bear the word from bran coat, or bran coat and germ, ‘‘Bleached’’. Wherever the name of the to such extent that the percent of ash food appears on the label so conspicu- therein, calculated to a moisture-free ously as to be easily seen under cus- basis, is not more than the sum of 1⁄20 of tomary conditions of purchase, the the percent of protein therein, cal- word ‘‘Bleached’’ shall immediately culated to a moisture-free basis, plus and conspicuously precede or follow 0.35. Its moisture content is not more such name, without intervening writ- than 15 percent. It may contain ascor- ten, printed, or graphic matter; except bic acid in a quantity not to exceed 200 that where such name is a part of a parts per million as a dough condi- trademark or brand, other written, tioner. Unless such addition conceals printed, or graphic matter, which is damage or inferiority or makes the also a part of such trademark or brand, flour appear to be better or of greater may so intervene if the word

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‘‘Bleached’’ is in such juxtaposition the residue on the No. 70 sieve and con- with such trademark or brand as to be vert to percentage. conspicuoulsy related to such name. [42 FR 14402, Mar. 15, 1977, as amended at 47 (c) For the purposes of this section: FR 11827, Mar. 19, 1982; 47 FR 24693, June 8, (1) Ash is determined by the method 1982; 47 FR 43363, Oct. 1, 1982; 49 FR 10097, prescribed in the AOAC, 13th Ed. (1980), Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR section 14.006, ‘‘Direct Method—Official 2877, Jan. 6, 1993] Final Action,’’ under the heading ‘‘Ash § 137.155 Bromated flour. (5),’’ which is incorporated by reference. The availability of this incor- Bromated flour conforms to the defi- poration by reference is given in para- nition and standard of identity, and is graph (a) of this section. Ash is cal- subject to the requirements for label culated to a moisture-free basis by sub- statement of ingredients, prescribed tracting the percent of moisture in the for flour by § 137.105, except that potas- flour from 100, dividing the remainder sium bromate is added in a quantity into the percent of ash, and multi- not exceeding 50 parts to each million parts of the finished bromated flour, plying the quotient by 100. and is added only to flours whose bak- (2) Protein is 5.7 times the nitrogen ing qualities are improved by such ad- as determined by the method pre- dition. scribed in section 2.057, ‘‘Improved Kjeldahl Methods for Nitrate-Free [57 FR 2877, Jan. 6, 1993] Samples (20)—Official Final Action,’’ AOAC, 13th Ed. (1980), which is incor- § 137.160 Enriched bromated flour. porated by reference. The availability Enriched bromated flour conforms to of this incorporation by reference is the definition and standard of identity, given in paragraph (a) of this section. and is subject to the requirements for Protein is calculated to a moisture-free label statement of ingredients, pre- basis by subtracting the percent of scribed for enriched flour by § 137.165, moisture in the flour from 100, dividing except that potassium bromate is the remainder into the percent of pro- added in a quantity not exceeding 50 tein, and multiplying the quotient by parts to each million parts of the fin- 100. ished enriched bromated flour, and is added only to enriched flours whose (3) Moisture is determined by the baking qualities are improved by such method prescribed in the AOAC, 13th addition. Ed. (1980), sections 14.002 and 14.003, ‘‘Vacuum Oven Method (2)—Official [58 FR 2877, Jan. 6, 1993] Final Action,’’ under the heading ‘‘Total Solids Moisture, Indirect Meth- § 137.165 Enriched flour. od,’’ which is incorporated by ref- Enriched flour conforms to the defi- erence. The availability of this incor- nition and standard of identity, and is poration by reference is given in para- subject to the requirements for label graph (a) of this section. statement of ingredients, prescribed (4) Granulation is determined as fol- for flour by § 137.105, except that: lows: Use No. 70 sieve complying with (a) It contains in each pound 2.9 mil- the specifications for ‘‘Nominal Dimen- ligrams of thiamin, 1.8 milligrams of sions of Standard Test Sieves (U.S.A. riboflavin, 24 milligrams of niacin, 0.7 Standard Series)’’ prescribed in para- milligrams of folic acid, and 20 milli- graph (a) of this section. Attach bot- grams of iron. tom pan to sieve in Ro-Tap sifter (or an (b) It may contain added calcium in equivalent sifter). Place half of a rub- such quantity that the total calcium content is 960 milligrams per pound. ber ball or other sieving aid in the Enriched flour may be acidified with sieve. Pour 100 grams of the sample in monocalcium phosphate within the the sieve and turn on the sifter with limits prescribed by § 137.175 for knocker. Sift exactly 5 minutes. Weigh phosphated flour, but, if insufficient additional calcium is present to meet the 960 milligram level, no claim may

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be made on the label for calcium as a 137.165, 137.175, 137.180, and 137.185, ex- nutrient; cept that each such flour has been (c) The requirement of paragraphs (a) made by one of the optional procedures and (b) of this section will be deemed set forth in paragraph (b) of this sec- to have been met if reasonable over- tion, and is thereby made readily pour- ages of the vitamins and minerals, able. Such flours will all pass through within the limits of good manufac- a No. 20 mesh U.S. standard sieve (840- turing practice, are present to insure micron opening), and not more than 20 that the required levels of the vitamins percent will pass through a 200 mesh and minerals are maintained through- U.S standard sieve (74-micron opening). out the expected shelf life of the food (b) The optional procedures referred under customary conditions of dis- to in paragraph (a) of this section are: tribution and storage. The quantitative content of the following vitamins shall (1) A selective grinding and bolting be calculated in terms of the following procedure or other milling procedure, chemically identifiable reference whereby controlled techniques are used forms: to obtain a food too fine to meet the granulation specification prescribed in Reference form § 137.300(a) for farina. Vitamin Molec- (2) An agglomerating procedure, Name Empirical formula ular weight whereby flour that originally meets the granulation specification pre- Thiamine ... Thiamine chlo- C12H17ClN4OS·HCl 337 .28 scribed in § 137.105(a) has been modified ride hydro- chloride. by further processing, so that a number Riboflavin .. Riboflavin ...... C17H20N4O6 376.37 of the individual flour particles have Niacin ...... Niacin ...... C6H5NO2 123.11 been combined into agglomerates conforming to the granulation specifica- (d) It may contain not more than 5 tions set out in paragraph (a) of this percent by weight of wheat germ or partly defatted wheat germ; section. (e) In determining whether the ash (c) The name of each product covered content complies with the require- by this section is the name prescribed ments of this section, ash resulting by the definition and standard of iden- from any added iron or salts of iron or tity for the corresponding kind of flour calcium or wheat germ is excluded in as referred to in paragraph (a) of this calculating ash content. section, preceded immediately and con- (f) All ingredients from which the spicuously by the words ‘‘Instantized’’, food is fabricated shall be safe and suit- ‘‘Instant blending’’, or ‘‘Quick-mix- able. The vitamins and minerals added ing’’. to the food for enrichment purposes [42 FR 14402, Mar. 15, 1977, as amended at 58 may be supplied by any safe and suit- FR 2877, Jan. 6, 1993] able substance. Niacin equivalents as derived from tryptophan content shall § 137.175 Phosphated flour. not be used in determining total niacin content. Phosphated flour, phosphated white flour, and phosphated wheat flour, con- [42 FR 14402, Mar. 15, 1977, as amended at 43 form to the definition and standard of FR 38578, Aug. 29, 1978; 46 FR 43414, Aug. 28, identity, and are subject to the re- 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] quirements for label declaration of ingredients, prescribed for flour by § 137.170 Instantized flours. § 137.105, except that: (a) Instantized flours, instant blend- (a) Monocalcium phosphate is added ing flours, and quick-mixing flours, are in a quantity not less than 0.25 percent the foods each of which conforms to and not more than 0.75 percent of the the definition and standard of identity weight of the finished phosphated and is subject to the requirement for flour; and label statement of ingredients pre- (b) In determining whether the ash scribed for the corresponding kind of content complies with the require- flour by §§ 137.105, 137.155, 137.160, ments of this section allowance is

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made for the added monocalcium phos- dure is substituted for the procedure phate. specified in the AOAC, under section [42 FR 14402, Mar. 15, 1977, as amended at 58 8.004, ‘‘Determination’’: FR 2877, Jan. 6, 1993] (1) Weigh 17 grams of the official sample into flask A, add 15–20 glass § 137.180 Self-rising flour. beads (4–6 mm. diameter), and connect (a) Self-rising flour, self-rising white this flask with the apparatus (fig. 22). flour, self-rising wheat flour, is an inti- Open stopcock C and by means of the mate mixture of flour, sodium bicar- leveling bulb E bring the displacement bonate, and one or more of the acid-re- solution to the 25 cc. graduation above acting substances monocalcium phos- the zero mark. (This 25 cc. is a partial phate, sodium acid pyrophosphate, and allowance for the volume of acid to be sodium aluminum phosphate. It is sea- used in the decomposition.) Allow the soned with salt. When it is tested by apparatus to stand 1–2 minutes to in- the method prescribed in paragraph (c) sure that the temperature and pressure of this section not less than 0.5 percent within the apparatus are the same as of carbon dioxide is evolved. The acid- those of the room. Close the stopcock, reacting substance is added in suffi- lower the leveling bulb somewhat to re- cient quantity to neutralize the sodium duce the pressure within the apparatus, bicarbonate. The combined weight of and slowly run into the decomposition such acid-reacting substance and so- flask from burette F 45 cc. of sulfuric dium bicarbonate is not more than 4.5 acid (1 + 5). To prevent the liberated parts to each 100 parts of flour used. carbon dioxide from escaping through Subject to the conditions and restric- the acid burette into the air, keep the tions prescribed by § 137.105(a), the displacement solution in the leveling bleaching ingredients specified in such bulb at all times during the decomposi- section may be added as optional ingre- tion at a lower level than that in the dients. If the flour used in making the gas-measuring tube. Rotate and then self-rising flour is bleached, the op- vigorously agitate the decomposition tional bleaching ingredient used there- flask for three minutes to mix the con- in (see § 137.105(a)) is also an optional tents intimately. Allow to stand for 10 ingredient of the self-rising flour. (b) Label declaration. Each of the in- minutes to bring to equilibrium. Equal- gredients used in the food, shall be de- ize the pressure in the measuring tube clared on the label as required by the by means of the leveling bulb and read applicable sections of parts 101 and 130 the volume of gas from the zero point of this chapter. on the tube. Deduct 20 cc. from this (c) The method referred to in para- reading (this 20 cc. together with pre- graph (a) of this section is the method vious allowance of 25 cc. compensates prescribed in ‘‘Official Methods of for the 45 cc. acid used in the decompo- Analysis of the Association of Official sition). Observe the temperature of the Analytical Chemists’’ (AOAC), 13th Ed. air surrounding the apparatus and also (1980), section 8.002, ‘‘Reagent (Dis- the barometric pressure and multiply placement soln.),’’ and section 8.003, the number of mL of gas evolved by the ‘‘Chittick apparatus,’’ under the head- factor given in section 52.007, ‘‘Correc- ing ‘‘Total Carbon Dioxide (1)—Official tion factors for gasometric determina- Final Action,’’ which is incorporated tion of carbon dioxide,’’ AOAC, 13th Ed. by reference. Copies may be obtained (1980), which is incorporated by ref- from the AOAC INTERNATIONAL, 481 erence (the availability of this incorpo- North Frederick Ave., suite 500, Gai- ration by reference is given in para- thersburg, MD 20877, or may be exam- graph (c) of this section), for the tem- ined at the National Archives and perature and pressure observed. Divide Records Administration (NARA). For the corrected reading by 100 to obtain information on the availability of this the apparent percent by weight of car- material at NARA, call 202–741–6030, or bon dioxide in the official sample. go to: http://www.archives.gov/ (2) Correct the apparent percent of federallregister/ carbon dioxide to compensate for vary- codeloflfederallregulations/ ing atmospheric conditions by imme- ibrllocations.html.The following proce- diately assaying a synthetic sample by

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the same method in the same appa- that the required levels of the vitamins ratus. and minerals are maintained through- (3) Prepare the synthetic sample with out the expected shelf life of the food 16.2 grams of flour, 0.30 gram of under customary conditions of dis- monocalcium phosphate, 0.30 gram of tribution and storage. The quantitative salt, and a sufficient quantity of so- content of the following vitamins shall dium bicarbonate U.S.P. (dried over be calculated in terms of the following sulfuric acid) to yield the amount of chemically identifiable reference carbon dioxide recovered in assay of of- forms: ficial sample. Determine this quantity by multiplying weight of carbon diox- Referemce form ide recovered in assay of official sam- Vitamin Molec- Name Empirical formula ular ple by 1.91. weight (4) Divide the weight of carbon dioxide recovered from synthetic sample by Thiamine ... Thiamine chlo- C12H17ClN4OS·HCl 337 .28 weight of carbon dioxide contained in ride hydro- chloride. sodium bicarbonate used. Riboflavin .. Riboflavin ...... C17H20N4O6 376.37 (5) Divide the quotient into the ap- Niacin ...... Niacin ...... C6H5NO2 123.11 parent percent of carbon dioxide in official sample to obtain percent of car- (d) It may contain not more than 5 bon dioxide evolved from the official percent by weight of wheat germ or sample. partly defatted wheat germ; (e) When calcium is added as [42 FR 14402, Mar. 15, 1977, as amended at 47 dicalcium phosphate, such dicalcium FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, phosphate is also considered to be an Jan. 6, 1993] acid-reacting substance; (f) When calcium is added as car- § 137.185 Enriched self-rising flour. bonate, the method set forth in Enriched self-rising flour conforms to § 137.180(c) does not apply as a test for the definition and standard of identity, carbon dioxide evolved; but in such and is subject to the requirements for case the quantity of carbon dioxide label statement of ingredients, pre- evolved under ordinary conditions of scribed for self-rising flour by § 137.180, use of the enriched self-rising flour is except that: not less than 0.5 percent of the weight (a) It contains in each pound 2.9 mil- thereof; ligrams of thiamin, 1.8 milligrams of (g) All ingredients from which the riboflavin, 24 milligrams of niacin, 0.7 food is fabricated shall be safe and suit- milligrams of folic acid, and 20 milli- able. The vitamins and minerals added grams of iron. to the food for enrichment purposes (b) It contains added calcium in such may be supplied by any safe and suit- quantity that the total calcium con- able substances. Niacin equivalents as tent is 960 milligrams per pound. If a derived from tryptophan content shall calcium compound is added for tech- not be used in determining total niacin nical purposes to give self-rising char- content. acteristics to the flour, the amount of [42 FR 14402, Mar. 15, 1977, as amended at 43 calcium per pound of flour may exceed FR 38578, Aug. 29, 1978; 46 FR 43414, Aug. 28, 960 milligrams provided that the excess 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. is no greater than necessary to accom- 5, 1996] plish the intended effect. However, if such calcium is insufficient to meet § 137.190 Cracked wheat. the 960-milligram level, no claim may Cracked wheat is the food prepared be made on the label for calcium as a by so cracking or cutting into angular nutrient. fragments cleaned wheat other than (c) The requirements of paragraphs durum wheat and red durum wheat (a) and (b) of this section will be that, when tested by the method pre- deemed to have been met if reasonable scribed in § 137.200(c)(2), not less than 90 overages of the vitamins and minerals, percent passes through a No. 8 sieve within the limits of good manufac- and not more than 20 percent passes turing practice, are present to insure through a No. 20 sieve. The proportions

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of the natural constituents of such codeloflfederallregulations/ wheat, other than moisture, remain ibrllocations.html. unaltered. Cracked wheat contains not [42 FR 14402, Mar. 15, 1977, as amended at 47 more than 15 percent of the moisture FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, as determined by the method pre- 1984; 54 FR 24894, June 12, 1989] scribed in ‘‘Official Methods of Anal- ysis of the Association of Official Ana- § 137.200 Whole wheat flour. lytical Chemists,’’ 13th Ed. (1980), sec- (a) Whole wheat flour, graham flour, tion 7.002 under ‘‘Preparation of Sam- entire wheat flour is the food prepared ple—Official Final Action,’’ and section by so grinding cleaned wheat, other 7.003 under ‘‘Moisture—Official Final than durum wheat and red durum ° Action. I. Drying in Vacuo at 95–100 wheat, that when tested by the method (2),’’ which is incorporated by ref- prescribed in paragraph (c)(2) of this erence. Copies may be obtained from section, not less than 90 percent passes the AOAC INTERNATIONAL, 481 North through a 2.36 mm (No. 8) sieve and not Frederick Ave., suite 500, Gaithersburg, less than 50 percent passes through a MD 20877, or may be examined at the 850 μm (No. 20) sieve. The proportions National Archives and Records Admin- of the natural constituents of such istration (NARA). For information on wheat, other than moisture, remain the availability of this material at unaltered. To compensate for any nat- NARA, call 202–741–6030, or go to: http:// ural deficiency of enzymes, malted www.archives.gov/federallregister/ wheat, malted wheat flour, malted bar- codeloflfederallregulations/ ley flour, or any combination of two or ibrllocations.html. more of these, may be used; but the [42 FR 14402, Mar. 15, 1977, as amended at 47 quantity of malted barley flour so used FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, is not more than 0.75 percent. It may 1984; 54 FR 24894, June 12, 1989] contain harmless preparations of a-amylase obtained from Aspergillus oryzae, § 137.195 Crushed wheat. alone or in a safe and suitable carrier. Crushed wheat, coarse ground wheat, The moisture content of whole wheat is the food prepared by so crushing flour is not more than 15 percent. It cleaned wheat other than durum wheat may contain ascorbic acid in a quan- and red durum wheat that, when tested tity not to exceed 200 parts per million by the method prescribed in as a dough conditioner. Unless such ad- § 137.200(c)(2), 40 percent or more passes dition conceals damage or inferiority through a No. 8 sieve and less than 50 or makes the whole wheat flour appear percent passes through a No. 20 sieve. to be better or of greater value than it The proportions of the natural con- is, the optional bleaching ingredient stituents of such wheat, other than azodicarbonamide (complying with the moisture, remain unaltered. Crushed requirements of § 172.806 of this chap- wheat contains not more than 15 per- ter, including the quantitative limit of cent of moisture as determined by the not more than 45 parts per million) or method prescribed in ‘‘Official Methods chlorine dioxide, or chlorine, or a mix- of Analysis of the Association of Offi- ture of nitrosyl chloride and chlorine, cial Analytical Chemists,’’ 13th Ed. may be added in a quantity not more (1980), section 7.002 under ‘‘Preparation than sufficient for bleaching and artifi- of Sample—Official Final Action,’’ and cial aging effects. section 7.003 under ‘‘Moisture—Official (b)(1) Label declaration. Each of the Final Action. I. Drying in Vacuo at 95– ingredients used in the food shall be de- 100° (2),’’ which is incorporated by ref- clared on the label as required by the erence. Copies may be obtained from applicable sections of parts 101 and 130 the AOAC INTERNATIONAL, 481 North of this chapter. Frederick Ave., suite 500, Gaithersburg, (2) When ascorbic acid is added, the MD 20877, or may be examined at the label shall bear the statement ‘‘Ascor- National Archives and Records Admin- bic acid added as a dough conditioner’’. istration (NARA). For information on When the optional ingredient ‘‘a’’-amy- the availability of this material at lase obtained from Aspergillus oryzae’’ NARA, call 202–741–6030, or go to: http:// is used, it may alternatively be de- www.archives.gov/federallregister/ clared in the list of ingredients as

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‘‘Fungal alpha-amylase,’’ ‘‘Fungal a- sition with one hand. Shake the sieves amylase’’, ‘‘Enzyme’’, or ‘‘Enzyme by striking the sides against the other added for improved baking’’. When any hand with an upward stroke, at the optional bleaching ingredient is used, rate of about 150 times per minute. the label shall bear the word Turn the sieves about one-sixth of a ‘‘Bleached’’. Wherever the name of the revolution each time in the same direc- food appears on the label so conspicu- tion, after each 25 strokes. Continue ously as to be easily seen under cus- shaking for 2 minutes. Weigh the mate- tomary conditions of purchase, the rial which fails to pass through the No. word ‘‘Bleached’’ shall immediately 8 sieve and the material which passes and conspicuously precede or follow through the No. 20 sieve. such name, without intervening writ- [42 FR 14402, Mar. 15, 1977, as amended at 47 ten, printed, or graphic matter; except FR 11827, Mar. 19, 1982; 47 FR 24693, June 8, that where such name is a part of a 1982; 47 FR 43364, Oct. 1, 1982; 49 FR 10097, trademark or brand, other written, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR printed or graphic matter, which is 2877, Jan. 6, 1993] also a part of such trademark or brand, may so intervene if the word § 137.205 Bromated whole wheat flour. ‘‘Bleached’’ is in such juxtaposition Bromated whole wheat flour con- with such trademark or brand as to be forms to the definition and standard of conspicuously related to such name. identity, and is subject to the require- (c) For the purposes of this section: ments for label statement of ingredi- (1) Moisture is determined by the ents, prescribed for whole wheat flour method prescribed in ‘‘Official Methods by § 137.200, except that potassium bro- of Analysis of the Association of Offi- mate is added in a quantity not exceed- cial Analytical Chemists’’ (AOAC), 13th ing 75 parts to each million parts of Ed. (1980), section 14.002. ‘‘Vacuum finished bromated whole wheat flour. Oven Method—Official Final Action,’’ and section 14.003, ‘‘Determination,’’ [58 FR 2877, Jan. 6, 1993] which is incorporated by reference. Copies may be obtained from the AOAC § 137.211 White corn flour. INTERNATIONAL, 481 North Frederick (a) White corn flour is the food pre- Ave., suite 500, Gaithersburg, MD 20877, pared by so grinding and bolting or may be examined at the National cleaned white corn that when tested by Archives and Records Administration the method prescribed in paragraph (NARA). For information on the avail- (b)(2) of this section, not less than 98 ability of this material at NARA, call percent passes through a No. 50 sieve 202–741–6030, or go to: http:// and not less than 50 percent passes www.archives.gov/federallregister/ through No. 70 woven-wire cloth. Its codeloflfederallregulations/ moisture content is not more than 15 ibrllocations.html. percent. In its preparation, part of the (2) The method referred to in para- ground corn may be removed, but in graph (a) of this section is as follows: any such case, the content (on a mois- Use No. 8 and No. 20 sieves, having ture-free basis) of neither the crude standard 8-inch full-height frames, fiber nor fat in the finished white corn complying with the specifications set flour exceeds the content (on a mois- forth in the AOAC, Table 1, ‘‘Nominal ture-free basis) of such substance in Dimensions of Standard Test Sieves the cleaned corn from which it was (U.S.A. Standard Series),’’ under the ground. heading ‘‘Definitions of Terms and Ex- (b)(1) For the purpose of this section, planatory Notes,’’ which is incor- moisture, fat, and crude fiber are deter- porated by reference. The availability mined by methods therefore referred to of this incorporation by reference is in § 137.250(b)(1). given in paragraph (c)(1) of this sec- (2) The method referred to in para- tion. Fit a No. 8 sieve into a No. 20 graph (a) of this section is as follows: sieve. Attach bottom pan to the No. 20 Weigh 5 grams of sample into a tared sieve. Pour 100 gm. of the sample into truncated metal cone (top diameter 5 the No. 8 sieve. Attach cover and hold centimeters, bottom diameter 2 centi- the assembly in a slightly inclined po- meters, height 4 centimeters), fitted at

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bottom with 70-mesh wire cloth com- § 137.220 Durum flour. plying with the specifications for No. (a) Durum flour is the food prepared 70 wire cloth in ‘‘Official Methods of by grinding and bolting cleaned durum Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), wheat. When tested for granulation as Table 1, ‘‘Nominal Dimensions of prescribed in § 137.105(c)(4), not less Standard Test Sieves (U.S.A. Standard than 98 percent of such flour passes Series),’’ under the heading ‘‘Defini- through the No. 70 sieve. It is freed tions of Terms and Explanatory from bran coat, or bran coat and germ, Notes,’’ which is incorporated by ref- to such extent that the percent of ash erence. Copies may be obtained from therein, calculated to a moisture-free the AOAC INTERNATIONAL, 481 North basis, is not more than 1.5 percent. Its Frederick Ave., suite 500, Gaithersburg, moisture content is not more than 15 MD 20877, or may be examined at the percent. National Archives and Records Admin- (b) For the purpose of this section, istration (NARA). For information on ash, moisture, and granulation are de- the availability of this material at termined by the methods prescribed in NARA, call 202–741–6030, or go to: http:// § 137.105(c). www.archives.gov/federallregister/ codeloflfederallregulations/ § 137.225 Whole durum flour. ibrllocations.html.Attach cone to a suc- Whole durum wheat flour conforms tion flask. Wash with 150 ml. of petro- to the definition and standard of iden- leum ether applied in a small stream tity, and is subject to the requirements without suction, while gently stirring for label statement of ingredients, pre- the sample with a small glass rod. scribed for whole wheat flour by Apply suction for 2 minutes after wash- § 137.200, except that cleaned durum ing is completed, then shake the cone wheat, instead of cleaned wheat other for 2 minutes with a vigorous hori- than durum wheat and red durum zontal motion, striking the side against the hand, and then weigh. The wheat, is used in its preparation. decrease in weight of sample, cal- [58 FR 2877, Jan. 6, 1993] culated as percent by weight of sample shall be considered the percent passing § 137.250 White corn meal. through No. 70 wire cloth. Transfer the (a) White corn meal is the food pre- residue from cone to a No. 50 sieve hav- pared by so grinding cleaned white ing a standard 20.3 centimeter (8-inch) corn that when tested by the method diameter full-height frame, complying prescribed in paragraph (b)(2) of this with the specifications for wire cloth section not less than 95 percent passes and sieve frame in ‘‘Nominal Dimen- through a No. 12 sieve, not less than 45 sions of Standard Test Sieves (U.S.A. Standard Series).’’ Shake for 2 minutes percent through a No. 25 sieve, but not with a vigorous horizontal motion, more than 35 percent through a No. 72 striking the side against the hand; re- grits gauze. Its moisture content is not move and weigh the residue; calculate more than 15 percent. In its prepara- the weight of residue as percent by tion coarse particles of the ground corn weight of sample, and subtract from 100 may be separated and discarded, or re- percent to obtain the percent of sample ground and recombined with all or part passing through the No. 50 sieve. of the material from which they were separated, but in any such case the [42 FR 14402, Mar. 15, 1977, as amended at 47 crude fiber content of the finished corn FR 11827, Mar. 19, 1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989] meal is not less than 1.2 percent and not more than that of the cleaned corn § 137.215 Yellow corn flour. from which it was ground, and its fat Yellow corn flour conforms to the content does not differ more than 0.3 definition and standard of identity pre- percent from that of such corn. The scribed by § 137.211 for white corn flour contents of crude fiber and fat in all except that cleaned yellow corn is used the foregoing provisions relating there- instead of clean white corn. to are on a moisture-free basis.

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(b)(1) For the purposes of this sec- into the No. 12 sieve, attach cover and tion, moisture, fat, and crude fiber con- hold the assembly in a slightly inclined tent will be determined by the fol- position and shake the assembly of lowing methods of analysis from ‘‘Offi- sieves by striking the sides against one cial Methods of Analysis of the Asso- hand with an upward stroke, at the ciation of Official Analytical Chem- rate of about 150 times per minute. ists,’’ 13th Ed. (1980), which is incor- Turn the assembly of sieves about one- porated by reference (copies may be ob- sixth of a revolution, each time in the tained from the AOAC INTER- same direction, after each 25 strokes. NATIONAL, 481 North Frederick Ave., Continue shaking for 2 minutes. Weigh suite 500, Gaithersburg, MD 20877, or separately the material remaining on may be examined at the National Ar- each sieve and in the pan, and cal- chives and Records Administration culate each weight as percent of sam- (NARA). For information on the avail- ple. Sometimes when meals are tested, ability of this material at NARA, call fine particles clog the sieve openings. 202–741–6030, or go to: http:// If any sieve is clogged by fine material www.archives.gov/federallregister/ smaller than its openings, empty the codeloflfederallregulations/ contents onto a piece of paper. Remove ibrllocations.html): the entrapped material on the bottom (i) Moisture content—sections 14.062 of the sieve by a hair brush and add to and 14.063 (Official Final Action). the sieve below. In like manner, clean (ii) Fat content—sections 14.062 and the adhering material from inside the 14.067 (Official Final Action). sieve and add to the material on the (iii) Crude fiber content—sections paper. Return mixture on the paper to 14.062 and 14.065 (Official Final Action). the sieve, reassemble the sieves, and (2) The method referred to in para- shake in the same manner as before for graph (a) of this section is as follows: 1 minute. Repeat cleaning procedure if Use No. 12 and No. 25 sieves, having necessary until a 5-gram or less loss in standard 20.3 centimeter (8-inch) di- weight occurs in any sieve during a 1- ameter full-height frames, complying minute shaking. The percent of sample with the specifications for wire cloth passing through No. 12 sieve shall be and sieve frames in ‘‘Nominal Dimen- determined by subtracting from 100 sions of Standard Test Sieves (U.S.A. percent, the percent of material re- Standard Series)’’ prescribed in maining on the No. 12 sieve. The per- § 137.105(a), which is incorporated by cent passing through a No. 25 sieve reference. Copies may be obtained from shall be determined by adding the per- the AOAC INTERNATIONAL, 481 North cents remaining on the No. 72 sieve and Frederick Ave., suite 500, Gaithersburg, the percent in pan. The percent in the MD 20877, or may be examined at the pan shall be considered as the percent National Archives and Records Admin- passing through a No. 72 XXX grits istration (NARA). For information on gauze. the availability of this material at [42 FR 14402, Mar. 15, 1977, as amended at 47 NARA, call 202–741–6030, or go to: http:// FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, www.archives.gov/federallregister/ 1984; 54 FR 24894, June 12, 1989] codeloflfederallregulations/ ibrllocations.html. A sieve with frame § 137.255 Bolted white corn meal. of the same dimensions as the Nos. 12 (a) Bolted white corn meal is the food and 25 and fitted with 72 XXX grits prepared by so grinding and sifting gauze is used as the third sieve. It is re- cleaned white corn that: ferred to hereafter as the No. 72 sieve. (1) Its crude fiber content is less than The 72 XXX grits gauze has openings 1.2 percent but its fat content is not equivalent in size with those of No. 70 less than 2.25 percent; and woven-wire cloth, complying with spec- (2) When tested by the method pre- ifications for such cloth contained in scribed in § 137.250(b)(2), except that a such ‘‘Standard Specifications for No. 20 standard sieve is used instead of Sieves.’’ Attach bottom pan to No. 72 the No. 12 sieve, not less than 95 per- sieve. Fit the No. 25 sieve into the No. cent passes through a No. 20 sieve, not 72 sieve and the No. 12 sieve into the less than 45 percent through a No. 25 No. 25 sieve. Pour 100 grams of sample sieve, but not more than 25 percent

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through No. 72 XXX grits gauze. Its ceeding 1.5 percent by weight of the moisture content is not more than 15 finished food may be used. percent. In its preparation particles of (b) The name of each kind of enriched ground corn which contain germ may corn meal is the word ‘‘Enriched’’ fol- be separated, reground, and recombined lowed by the name of the kind of corn with all or part of the material from meal used which is prescribed in the which it was separated, but in any such definition and standard of identity case the fat content of the finished therefor. bolted white corn meal does not exceed (c) Label declaration. Each of the in- by more than 0.3 percent the fat con- gredients used in the food shall be de- tent of the cleaned corn from which it clared on the label as required by the was ground. The contents of crude fiber applicable sections of parts 101 and 130 and fat in all the foregoing provisions of this chapter. relating thereto are on a moisture-free [42 FR 14402, Mar. 15, 1977, as amended at 58 basis. FR 2878, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] (b) For the purposes of this section, moisture, fat and crude fiber are deter- § 137.265 Degerminated white corn mined by the methods therefor referred meal. to in § 137.250(b)(1). (a) Degerminated white corn meal, degermed white corn meal, is the food § 137.260 Enriched corn meals. prepared by grinding cleaned white (a) Enriched corn meals are the corn and removing bran and germ so foods, each of which conforms to the that: definition and standard of identity pre- (1) On a moisture-free basis, its crude scribed for a kind of corn meal by fiber content is less than 1.2 percent §§ 137.250, 137.255, 137.265, 137.270, 137.275, and its fat content is less than 2.25 per- 137.280, 137.285, and 137.290, except that: cent; and (1) It contains in each pound not less (2) When tested by the method pre- than 2.0 milligrams (mg) and not more scribed in § 137.250(b)(2), except that a than 3.0 mg of thiamin, not less than No. 20 standard sieve is used instead of 1.2 mg and not more than 1.8 mg of ri- a No. 12 sieve, not less than 95 percent boflavin, not less than 16 mg and not passes through a No. 20 sieve, not less more than 24 mg of niacin or niacina- than 45 percent through a No. 25 sieve, mide, not less than 0.7 mg and not but not more than 25 percent through more than 1.0 mg of folic acid, and not No. 72 XXX grits gauze. Its moisture less than 13 mg and not more than 26 content is not more than 15 percent. mg of iron (Fe); (b) For the purposes of this section, (2) It may contain in each pound not moisture, fat and crude fiber are deter- less than 250 U.S.P. units and not more mined by methods therefor referred to than 1,000 U.S.P. units of vitamin D; in § 137.250(b)(1). and (3) It may contain in each pound not § 137.270 Self-rising white corn meal. less than 500 milligrams and not more (a) Self-rising white corn meal is an than 750 milligrams of calcium (Ca); intimate mixture of white corn meal, Provided, however, That enriched self- sodium bicarbonate, and one or both of rising corn meals shall contain in each the acid-reacting substances pound not more than 1,750 milligrams monocalcium phosphate and sodium of calcium (Ca). Iron and calcium may aluminum phosphate. It is seasoned be added only in forms which are harm- with salt. When it is tested by the less and assimilable. The substances re- method prescribed in paragraph (b) of ferred to in this paragraph (a)(3) and in this section, not less than 0.5 percent paragraphs (a) (1) and (2) of this section of carbon dioxide is evolved. The acid- may be added in a harmless carrier reacting substance is added in suffi- which does not impair the enriched cient quantity to neutralize the sodium corn meal; such carrier is used only in bicarbonate. The combined weight of the quantity necessary to effect an in- such acid-reacting substance and so- timate and uniform admixture of such dium bicarbonate is not more than 4.5 substances with the kind of corn meal parts to each 100 parts of white corn used. Dried yeast in quantities not ex- meal used.

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(b) The method referred to in para- allowance of 25 cc. compensates for the graph (a) of this section is the method 45 cc. acid used in the decomposition). prescribed in ‘‘Official Methods of Observe the temperature of the air sur- Analysis of the Association of Official rounding the apparatus and also the Analytical Chemists’’ (AOAC), 13th Ed. barometric pressure and multiply the (1980), section 8.002, ‘‘Reagent (Dis- number of mL of gas evolved by the placement soln.),’’ and section 8.003, factor given in the AOAC, 13th Ed. ‘‘Chittick apparatus,’’ under the head- (1980), section 52.007 under Reference ing ‘‘Total Carbon Dioxide (1)—Official Tables for the temperature and pres- Final Action,’’ which is incorporated sure observed, which is incorporated by by reference. Copies may be obtained reference. The availability of this in- from the AOAC INTERNATIONAL, 481 corporation by reference is given in North Frederick Ave., suite 500, Gai- paragraph (b) of this section. Divide thersburg, MD 20877, or may be exam- the corrected reading by 100 to obtain ined at the National Archives and the apparent percent by weight of car- Records Administration (NARA). For bon dioxide in the official sample. information on the availability of this (2) Correct the apparent percent of material at NARA, call 202–741–6030, or carbon dioxide to compensate for vary- go to: http://www.archives.gov/ ing atmospheric conditions by imme- federallregister/ diately assaying a synthetic sample by codeloflfederallregulations/ the same method in the same appa- ibrllocations.html. The following proce- ratus. dure is substituted for the procedure (3) Prepare the synthetic sample with specified in the AOAC, under section 16.2 grams of corn meal, 0.30 gram of 8.004, ‘‘Determination’’: monocalcium phosphate, 0.30 gram of (1) Weigh 17 grams of the official salt, and a sufficient quantity of so- sample into flask A, add 15–20 glass dium bicarbonate U.S.P. (dried over beads (4–6 mm. diameter), and connect sulfuric acid) to yield the amount of this flask with the apparatus (fig. 25). carbon dioxide recovered in assay of of- Open stopcock C and by means of the ficial sample. Determine this quantity leveling bulk E bring the displacement by multiplying weight of carbon diox- solution to the 25 cc. graduation above ide recovered in assay of official sam- the zero mark. (This 25 cc. is a partial ple by 1.91. allowance for the volume of acid to be (4) Divide the weight of carbon diox- used in the decomposition.) Allow the ide recovered from synthetic sample by apparatus to stand 1–2 minutes to in- weight of carbon dioxide contained in sure that the temperature and pressure sodium bicarbonate used. within the apparatus are the same as (5) Divide the quotient into the ap- those of the room. Close the stopcock, parent percent of carbon dioxide in of- lower the leveling bulb somewhat to re- ficial sample to obtain percent of car- duce the pressure within the apparatus, bon dioxide evolved from the official and slowly run into the decomposition sample. flask from burette F 45 cc. of sulfuric (c) Label declaration. Each of the in- acid (1 + 5). To prevent the liberated gredients used in the food shall be de- carbon dioxide from escaping through clared on the label as required by the the acid burette into the air keep the applicable sections of parts 101 and 130 displacement solution in the leveling of this chapter. bulb at all times during the decomposition at a lower level than that in the [42 FR 14402, Mar. 15, 1977, as amended at 47 gas-measuring tube. Rotate and then FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, vigorously agitate the decomposition 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, flask for 3 minutes to mix the contents Jan. 6, 1993] intimately. Allow to stand for 10 minutes to bring to equilibrium. Equalize § 137.275 Yellow corn meal. the pressure in the measuring tube by Yellow corn meal conforms to the means of the leveling bulb and read the definition and standard of identity pre- volume of gas from the zero point on scribed by § 137.250 for white corn meal the tube. Deduct 20 cc. from this read- except that cleaned yellow corn is used ing (this 20 cc. together with previous instead of cleaned white corn.

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§ 137.280 Bolted yellow corn meal. obtained from the AOAC INTER- Bolted yellow corn meal conforms to NATIONAL, 481 North Frederick Ave., the definition and standard of identity suite 500, Gaithersburg, MD 20877, or prescribed by § 137.255 for bolted white may be at the National Archives and corn meal except that cleaned yellow Records Administration (NARA). For corn is used instead of cleaned white information on the availability of this corn. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 137.285 Degerminated yellow corn federallregister/ meal. codeloflfederallregulations/ Degerminated yellow corn meal, ibrllocations.html. Fit a No. 20 sieve degermed yellow corn meal, conforms into a No. 100 sieve. Attach bottom pan to the definition and standard of iden- to the No. 100 sieve. Pour 100 grams of tity prescribed by § 137.265 for the sample into the No. 20 sieve. At- degerminated white corn meal except tach cover and hold the assembly in a that cleaned yellow corn is used in- slightly inclined position with one stead of cleaned white corn. hand. Shake the sieves by striking the sides against the other hand with an § 137.290 Self-rising yellow corn meal. upward stroke, at the rate of about 150 times per minute. Turn the sieves Self-rising yellow corn meal con- about one-sixth of a revolution, each forms to the definition and standard of time in the same direction, after each identity prescribed by § 137.270 for self- 25 strokes. Continue shaking for 2 min- rising white corn meal except that yel- utes. Weigh the material which fails to low corn meal is used instead of white corn meal. pass through the No. 20 sieve and the material which passes through the No. § 137.300 Farina. 100 sieve. (a) Farina is the food prepared by [42 FR 14402, Mar. 15, 1977, as amended at 47 grinding and bolting cleaned wheat, FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, other than durum wheat and red durum 1984; 54 FR 24894, June 12, 1989] wheat, to such fineness that, when § 137.305 Enriched farina. tested by the method prescribed in paragraph (b)(2) of this section, it (a) Enriched farina conforms to the passes through a No. 20 sieve, but not definition and standard of identity pre- more than 3 percent passes through a scribed for farina by § 137.300, except No. 100 sieve. It is freed from bran coat, that: or bran coat and germ, to such extent (1) It contains in each pound not less that the percent of ash therein, cal- than 2.0 milligrams (mg) and not more culated to a moisture-free basis, is not than 2.5 mg of thiamin, not less than more than 0.6 percent. Its moisture 1.2 mg and not more than 1.5 mg of ri- content is not more than 15 percent. boflavin, not less than 16.0 mg and not (b) For the purposes of this section: more than 20.0 mg of niacin or niacina- (1) Ash and moisture are determined mide, not less than 0.7 mg and not by the methods therefor referred to in more than 0.87 mg of folic acid, and not § 137.105(c). less than 13.0 mg of iron (Fe). (2) The method referred to in para- (2) Vitamin D may be added in such graph (a) of this section is as follows: quantity that each pound of the fin- Use No. 20 and No. 100 sieves, having ished enriched farina contains not less standard 20.3 centimeter (8-inch) full- than 250 U.S.P. units of the optional in- height frames, complying with the gredient vitamin D. specifications for such cloth set forth (3) Calcium may be added in such in ‘‘Official Methods of Analysis of the quantity that each pound of the fin- Association of Official Analytical ished enriched farina contains not less Chemists,’’ 13th Ed. (1980), Table 1, than 500 milligrams of the optional in- ‘‘Nominal Dimensions of Standard Test gredient calcium (Ca). Sieves (U.S.A. Standard Series),’’ under (4) It may contain not more than 8 the heading ‘‘Definitions of Terms and percent by weight of the optional in- Explanatory Notes,’’ which is incor- gredient wheat germ or partly defatted porated by reference. Copies may be wheat germ.

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(5)(i) It may contain not less than 0.5 also a part of the trademark or brand percent and not more than 1 percent by may so intervene, if such statement is weight of the optional ingredient diso- in such juxtaposition with the trade- dium phosphate; or mark or brand as to be conspicuously (ii) It may be treated with one of the related to the name of the food. proteinase enzymes papain or pepsin to [42 FR 14402, Mar. 15, 1977, as amended at 58 reduce substantially the time required FR 2878, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] for cooking. In such treatment papain or pepsin, in an amount not to exceed § 137.320 Semolina. 0.1 percent by weight, is added to the (a) Semolina is the food prepared by farina, which is moistened, warmed, grinding and bolting cleaned durum and subsequently heated sufficiently to wheat to such fineness that, when test- inactivate the enzyme and to dry the ed by the method prescribed in product to comply with the limit for § 137.300(b)(2), it passes through a No. 20 moisture prescribed by § 137.300(a). sieve, but not more than 3 percent (6) In determining whether the ash passes through a No. 100 sieve. It is content complies with the require- freed from bran coat, or bran coat and ments of this section allowance is germ, to such extent that the percent made for ash resulting from any added of ash therein, calculated to a mois- iron or salts of iron or calcium, or from ture-free basis, is not more than 0.92 any added disodium phosphate, or from percent. Its moisture content is not any added wheat germ or partly more than 15 percent. defatted wheat germ. (b) For the purpose of this section, Iron and calcium may be added only in ash and moisture are determined by forms which are harmless and assimi- the methods therefor referred to in lable. Dried irradiated yeast may be § 137.105(c). used as a source of vitamin D. The substances referred to in paragraphs (a) (1) § 137.350 Enriched rice. and (2) of this section may be added in (a) The foods for which definitions a harmless carrier which does not im- and standards of identity are pre- pair the enriched farina; such carrier is scribed by this section are forms of used only in the quantity necessary to milled rice (except rice coated with effect an intimate and uniform admix- talc and glucose and known as coated ture of such substances with the farina. rice), to which nutrients have been (b)(1) Label declaration. Each of the added so that each pound of the rice ingredients used in the food shall be de- contains: clared on the label as required by the (1) Not less than 2.0 milligrams (mg) applicable sections of parts 101 and 130 and not more than 4.0 mg of thiamin, of this chapter. not less than 1.2 mg and not more than (2)(i) When the optional ingredient 2.4 mg of riboflavin, not less than 16 mg disodium phosphate is used, the label and not more than 32 mg of niacin or shall bear the statement ‘‘Disodium niacinamide, not less than 0.7 mg and phosphate added for quick cooking’’. not more than 1.4 mg of folic acid, and (ii) When the proteinase enzyme not less than 13 mg and not more than treatment is used, the label shall bear 26 mg of iron (Fe). the statement ‘‘Enzyme treated for (2) Each pound may contain not less quicker cooking’’. than 250 U.S.P. units and not more (3) Wherever the name of the food ap- than 1,000 U.S.P. units of vitamin D. pears on the label so conspicuously as (3) Each pound may contain not less to be easily seen under customary con- than 500 milligrams and not more than ditions of purchase, the statements 1,000 milligrams of calcium (Ca). Cal- prescribed by paragraph (b)(2) of this cium carbonate derived from the use of section shall immediately and con- this substance in milling rice, when spicuously precede or follow such name present in quantities that furnish less without intervening written, printed, than 500 milligrams of calcium (Ca) per or graphic matter; except that where pound, is considered a normal ingre- the name of the food is a part of a dient of the milled rice used and not an trademark or brand, then other writ- optional ingredient of the enriched rice ten, printed, or graphic matter that is unless such enriched rice is labeled to

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show it contains the optional ingre- riched’’ as, for example, ‘‘Enriched dient calcium. Iron and calcium may rice’’ or ‘‘Enriched parboiled rice’’. be added only in forms that are harm- (e) The method referred to in para- less and assimilable. The vitamins re- graph (c) of this section is as follows: ferred to in paragraphs (a) (1) and (2) of Mix the contents of one or more con- this section may be combined with tainers and transfer 1⁄2 pound thereof to harmless substances to render them in- a 4-liter flask containing 2 liters of dis- soluble in water, if the water-insoluble tilled water at room temperature (but products are assimilable. not below 20 °C). Stopper the flask and (4) In the case of enriched parboiled swirl it moderately for 1⁄2 minute so rice, butylated hydroxytoluene may be that the rice is in motion and in uni- added as an optional ingredient in an form suspension. Allow the rice to set- amount not to exceed 0.0033 percent by tle for 1⁄2 minute, then pour off 1,600 weight of the finished food. milliliters of the water, together with (b) The substances referred to in any floating and suspended matter, and paragraphs (a) (1), (2), and (3) of this discard. To the contents of the flask, section may be added in a harmless add 1,600 milliliters of distilled water carrier. Such carrier is used only in the and 20 milliliters of 10 N hydrochloric quantity necessary to effect an inti- acid. Agitate vigorously and wash mate and uniform mixture of such sub- down the sides of the flask with 150 stances with the rice. milliliters of 0.1 N hydrochloric acid. In (c) Unless the label of the food bears order to avoid excess foaming during the statement ‘‘To retain vitamins do the extraction, heat the mixture slowly not rinse before or drain after cooking’’ ° immediately preceding or following the to about 100 C, agitate if necessary, name of the food and in letters not less and maintain at this temperature until than one-fourth the point size of type air is expelled. Again wash down the used for printing the name of the food sides of the flask with 150 milliliters of (but in no case less than 8-point type) 0.1 N hydrochloric acid. Heat the mix- ° ° and the label bears no cooking direc- ture in an autoclave at 120 C to 123 C tions calling for washing or draining or for 30 minutes, remove and cool to unless the food is precooked and it is room temperature. Dilute the mixture packaged in consumer packages which with distilled water so that the total are conspicuously and prominently la- volume is 2,500 milliliters. Swirl the beled with directions for preparation flask, and while the solids are in uni- which, if followed, will avoid washing form suspension pour off about 250 mil- away or draining off enriching ingredi- liliters of the mixture for later deter- ents, the substances named in para- mination of iron (and calcium, if this is graphs (a) (1), (2), and (3) of this section to be determined). With filter paper shall be present in such quantity or in that has been shown not to adsorb thi- such form that when the enriched rice amine, riboflavin, or niacin, filter is washed as prescribed in paragraph (e) enough of the remaining mixture for of this section, the washed rice con- determination of thiamine, riboflavin, tains not less than 85 percent of the and niacin. (In the case of a mixture minimum quantities of the substances difficult to filter, centrifuging or fil- named in paragraph (a)(1) of this sec- tering through fritted glass, or both, tion, as required for enriched rice; and using a suitable analytical filter-aid, in case any optional ingredients named may be substituted for, or may pre- in paragraphs (a) (2) and (3) of this sec- cede, filtering through paper.) Dilute tion are used, the washed rice also con- an aliquot of filtrate with 0.1 N hydro- tains not less than 85 percent of the chloric acid, so that each milliliter minimum quantity specified for the contains about 0.2 microgram of thi- substance or substances used. amine, and determine thiamine by the (d) The name specified for each food ‘‘Rapid Fluorometric Method—Official for which a definition and standard of Final Action,’’ in section 43.034 of ‘‘Of- identity is prescribed by this section is ficial Methods of Analysis of the Asso- the common name of the kind of milled ciation of Official Analytical Chem- rice to which the enriching substances ists’’ (AOAC), 13th Ed. (1980), which is are added, preceded by the word ‘‘en- incorporated by reference. Copies may

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be obtained from the AOAC INTER- taken disposing of the objections, after pub- NATIONAL, 481 North Frederick Ave., lic hearing thereon. suite 500, Gaithersburg, MD 20877, or [42 FR 14402, Mar. 15, 1977, as amended at 47 may be examined at the National Ar- FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, chives and Records Administration 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, (NARA). For information on the avail- Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] ability of this material at NARA, call 202–741–6030, or go to: http:// PART 139—MACARONI AND www.archives.gov/federallregister/ NOODLE PRODUCTS codeloflfederallregulations/ ibrllocations.html.With a suitable ali- Subpart A [Reserved] quot determine riboflavin by the method prescribed in section 43.041(a) by the Subpart B—Requirements for Specific ‘‘Fluorometric Method—Official Final Standardized Macaroni and Noodle Action,’’ AOAC, 13th Ed. (1980), begin- Products ning with the third sentence of the second paragraph, ‘‘Adjust, with vigorous Sec. 139.110 Macaroni products. agitation * * *.’’ Determine niacin in a 139.115 Enriched macaroni products. 200-milliliter aliquot of the filtrate by 139.117 Enriched macaroni products with the ‘‘Colorimetric Method—Official fortified protein. Final Action,’’ in section 43.045, AOAC, 139.120 Milk macaroni products. 13th Ed. (1980), beginning with the sixth 139.121 Nonfat milk macaroni products. sentence of the first paragraph, ‘‘Ad- 139.122 Enriched nonfat milk macaroni just to pH 4.5 with * * *.’’ Evaporate to products. dryness a 100-milliliter aliquot of the 139.125 Vegetable macaroni products. nonfiltered material withdrawn while 139.135 Enriched vegetable macaroni products. agitating, and determine iron using the 139.138 Whole wheat macaroni products. method ‘‘Iron—Official Final Action,’’ 139.140 Wheat and soy macaroni products. in sections 14.011, 14.012, and 14.013, 139.150 Noodle products. AOAC, 13th Ed. (1980), and, if required, 139.155 Enriched noodle products. determine calcium as directed in sec- 139.160 Vegetable noodle products. tion 14.014 under the heading ‘‘Cal- 139.165 Enriched vegetable noodle products. cium—Official Final Action,’’ AOAC, 139.180 Wheat and soy noodle products. 13th Ed. (1980). AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, (f) When the optional ingredient 379e.

specified in paragraph (a)(4) of this sec- SOURCE: 42 FR 14409, Mar. 15, 1977, unless tion is added, the statement otherwise noted. ‘‘Butylated hydroxytoluene added as a preservative’’ shall be placed on the Subpart A Reserved label prominently and with such con- [ ] spicuousness (as compared with other words, statements, designs, or devices Subpart B—Requirements for Spe- in the label) as to render it likely to be cific Standardized Macaroni read and understood by the ordinary and Noodle Products individual under customary conditions of purchase. § 139.110 Macaroni products. (g) Label declaration. Each of the in- (a) Macaroni products are the class of gredients used in the food shall be de- food each of which is prepared by dry- clared on the label as required by the ing formed units of dough made from applicable sections of parts 101 and 130 semolina, durum flour, farina, flour, or of this chapter. any combination of two or more of NOTE: The Order of the Commissioner of these, with water and with or without Food and Drugs appearing at 23 FR 1170, Feb. one or more of the optional ingredients 25, 1958, amending paragraphs (a)(1) and (c) specified in paragraphs (a) (1) to (6), in- provides in part as follows: The regulations clusive, of this section. in § 137.350 (formerly § 15.525) are stayed insofar as they require each pound of the food to (1) Egg white, frozen egg white, dried contain not less than 1.2 milligrams and not egg white, or any two or all of these, in more than 2.4 milligrams of riboflavin. This such quantity that the solids thereof stay shall continue until final action is are not less than 0.5 percent and not

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more than 2.0 percent of the weight of and sizes specified in paragraph (b), (c), the finished food. or (d), respectively, of this section. (2) Disodium phosphate, in a quantity (f)(1) When disodium phosphate is not less than 0.5 percent and not more used the label shall bear the statement than 1.0 percent of the weight of the ‘‘Disodium phosphate added for quick finished food. cooking’’. (3) Onions, celery, garlic, bay leaf, or (2) When any ingredient specified in any two or more of these, in a quantity paragraph (a)(3) of this section is used which seasons the food. the label shall bear the statement (4) Salt, in a quantity which seasons ‘‘Seasoned with lll’’, the blank the food. being filled in with the common name (5) Gum gluten, in such quantity that of the ingredient; or in the case of bay the protein content of the finished food leaves the statement ‘‘Spiced’’, ‘‘Spice is not more than 13 percent by weight. added’’, or ‘‘Spiced with bay leaves’’. The finished macaroni product con- (3) When the ingredient specified in tains not less than 87 percent of total paragraph (a)(6) of this section is used, solids as determined by the method the label shall bear the statement prescribed in ‘‘Official Methods of ‘‘Glyceryl monostearate added’’ or the Analysis of the Association of Official statement ‘‘With added glyceryl mono- Analytical Chemists,’’ 13th Ed. (1980), stearate’’. in section 14.133, under the heading (4) Wherever the name of the food ap- ‘‘Vacuum Oven Method—Official Final pears on the label so conspicuously as Action,’’ which is incorporated by ref- to be easily seen under customary con- erence. Copies may be obtained from ditions of purchase, the words and the AOAC INTERNATIONAL, 481 North statements prescribed in this section, Frederick Ave., suite 500, Gaithersburg, showing the optional ingredients used, MD 20877, or may be examined at the shall immediately and conspicuously National Archives and Records Admin- precede or follow, or in part precede istration (NARA). For information on and in part follow, such name, without the availability of this material at intervening written, printed, or graph- NARA, call 202–741–6030, or go to: http:// ic matter. www.archives.gov/federal register/ l (g) Label declaration. Each of the in- codeloflfederallregulations/ gredients used in the food shall be de- ibrllocations.html. clared on the label as required by the (6) Concentrated glyceryl monostea- applicable sections of parts 101 and 130 rate (containing not less than 90 per- of this chapter. cent monoester), in a quantity not exceeding 2 percent by weight of the fin- [42 FR 14409, Mar. 15, 1977, as amended at 47 ished food. FR 11828, Mar. 19, 1982; 49 FR 10099, Mar. 19, (b) Macaroni is the macaroni product 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, the units of which are tube-shaped and Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] more than 0.11 inch but not more than 0.27 inch in diameter. § 139.115 Enriched macaroni products. (c) Spaghetti is the macaroni product (a) Description. Enriched macaroni the units of which are tube-shaped or products are the class of food each of cord-shaped (not tubular) and more which conforms to the definition and than 0.06 inch but not more than 0.11 standard of identity and is subject to inch in diameter. the requirements for label statement of (d) Vermicelli is the macaroni prod- ingredients, prescribed for macaroni uct the units of which are cord-shaped products by § 139.110(a), (f), and (g), ex- (not tubular) and not more than 0.06 cept that: inch in diameter. (1) Each such food contains in each (e) The name of each food for which a pound not less than 4.0 milligrams (mg) definition and standard of identity is and not more than 5.0 mg of thiamin, prescribed by this section is ‘‘Macaroni not less than 1.7 mg and not more than product’’; or alternatively, the name is 2.2 mg of riboflavin, not less than 27 mg ‘‘Macaroni’’, ‘‘Spaghetti’’, or and not more than 34 mg of niacin or ‘‘Vermicelli’’, as the case may be, when niacinamide, not less than 0.9 mg and the units of the food are of the shapes not more than 1.2 mg of folic acid, and

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not less than 13 mg and not more than prescribed by this section is ‘‘Enriched 16.5 mg of iron (Fe); Macaroni product’’; or alternatively, (2) Each such food may also contain the name is ‘‘Enriched macaroni’’, as an optional ingredient added vita- ‘‘Enriched spaghetti’’, or ‘‘Enriched min D in such quantity that each vermicelli’’, as the case may be, when pound of the finished food contains not the units of the food comply with the less than 250 U.S.P. units and not more requirements of paragraphs (b), (c), or than 1000 U.S.P. units of vitamin D. (d) respectively of this section. (3) Each such food may also contain [42 FR 14409, Mar. 15, 1977, as amended at 58 as an optional ingredient added cal- FR 2878, Jan. 6, 1993; 61 FR 8797, Mar. 5, 1996] cium in such quantity that each pound of the finished food contains not less § 139.117 Enriched macaroni products than 500 mg. and not more than 625 mg. with fortified protein. of calcium (Ca); (a)(1) Each of the foods for which a (4) Each such food may also contain standard of identity is prescribed by as an optional ingredient partly this section is produced by drying defatted wheat germ but the amount formed units of dough made with one thereof does not exceed 5 percent of the or more of the milled wheat ingredi- weight of the finished food; ents designated in §§ 139.110(a) and (5) Each such food may be supplied, 139.138(a), and other ingredients to en- wholly or in part, with the prescribed able the finished food to meet the pro- quantity of any substance referred to tein requirements set out in paragraph in paragraphs (a) (1), (2), and (3) of this (a)(2)(i) of this section. Edible protein section through the use of dried yeast, sources, including food grade flours or dried torula yeast, partly defatted meals made from nonwheat cereals or wheat germ, enriched farina, or en- from oilseeds, may be used. Vitamin riched flour, or through the direct ad- and mineral enrichment nutrients are ditions of any of the substances pre- added to bring the food into conformity scribed in paragraphs (a) (1), (2), and (3) with the requirements of paragraph (b) of this section. of this section. Safe and suitable ingre- Iron and calcium may be added only in dients, as provided for in paragraph (c) forms which are harmless and assimi- of this section, may be added. The pro- lable. The substances referred to in portion of the milled wheat ingredient paragraphs (a) (1) and (2) of this section is larger than the proportion of any may be added in a harmless carrier other ingredient used. which does not impair the enriched (2) Each such finished food, when macaroni product, such carrier being tested by the methods described in the used only in the quantity reasonably cited sections of ‘‘Official Methods of necessary to effect an intimate and Analysis of the Association of Official uniform distribution of such sub- Analytical Chemists,’’ 13th Ed. (1980), stances in the finished enriched maca- which is incorporated by reference roni product. (copies may be obtained from the (b) Enriched macaroni is the enriched AOAC INTERNATIONAL, 481 North macaroni product the units of which Frederick Ave., suite 500, Gaithersburg, conform to the specifications of shape MD 20877, or may be examined at the and size prescribed for macaroni by National Archives and Records Admin- § 139.110(b). istration (NARA). For information on (c) Enriched spaghetti is the enriched the availability of this material at macaroni product the units of which NARA, call 202–741–6030, or go to: http:// conform to the specifications of shape www.archives.gov/federallregister/ and size prescribed for spaghetti by codeloflfederallregulations/ § 139.110(c). ibrllocations.html.), meets the fol- (d) Enriched vermicelli is the en- lowing specifications: riched macaroni product the units of (i) The protein content (N × 6.25) is which conform to the specifications of not less than 20 percent by weight (on shape and size prescribed for vermicelli a 13 percent moisture basis) as deter- by § 139.110(d). mined by the method in section 14.142. (e) The name of each food for which a The protein quality is not less than 95 definition and standard of identity is percent that of casein as determined on

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the cooked food by the method in sec- the word ‘‘Macaroni’’, ‘‘Spaghetti’’, or tions 43.212 through 43.216 of the offi- ‘‘Vermicelli’’, as appropriate, may be cial methods. used if the units conform in shape and (ii) The total solids content is not size to the requirements of § 139.110 (b), less than 87 percent by weight as deter- (c), or (d). mined by the method in section 14.133 (2) When any ingredient, not des- of the official methods. ignated in the part of the name pre- (b)(1) Each food covered by this sec- scribed in paragraph (d)(1) of this section contains in each pound 5 milli- tion, is added in such proportion as to grams of thiamin, 2.2 milligrams of ri- contribute 10 percent or more of the boflavin, 34 milligrams of niacin or nia- quantity of protein contained in the cinamide, and 16.5 milligrams of iron. finished food, the name shall include (2) Each pound of such food may also the statement ‘‘Made with lll’’, the contain 625 milligrams of calcium. blank being filled in with the name of (3) Iron and calcium may be added each such ingredient, e.g., ‘‘Made with only in forms which are harmless and nonfat milk’’. assimilable. The enrichment nutrients (3) When, in conformity with para- may be added in a harmless carrier graph (d) (1) or (2) of this section, two used only in a quantity necessary to ef- or more ingredients are listed in the fect a uniform distribution of the nu- name, their designations shall be ar- trients in the finished food. The re- ranged in descending order of predomi- quirements of paragraphs (b) (1) and (2) nance by weight. of this section shall be deemed to have (4) In the case of a food made to com- been met if reasonable overages, within ply with another section of this part, the limits of good manufacturing prac- but which also meets the tice, are present to assure that the pre- compositional requirements of this sec- scribed levels of the vitamins and min- tion, it may alternatively bear the eral(s) are maintained throughout the name set out in that other section. expected shelf life of the food under (e) Label declaration. Each of the in- customary conditions of distribution. gredients used in the food shall be de- (c) The safe and suitable ingredients clared on the label as required by the referred to in paragraph (a) of this sec- applicable sections of parts 101 and 130 tion are ingredients that serve a useful of this chapter. purpose, e.g., to fortify the protein or facilitate production of the food, but [42 FR 14409, Mar. 15, 1977, as amended at 47 they do not include color additives, ar- FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, tificial flavorings, artificial sweet- 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] eners, chemical preservatives, or starches. Ingredients deemed suitable EFFECTIVE DATE NOTE: Section 139.117 was for use by this paragraph are added in stayed in its entirety at 43 FR 11695, Mar. 21, amounts that are not in excess of those 1978. reasonably required to achieve their intended purposes. Ingredients are § 139.120 Milk macaroni products. deemed to be safe if they are not food (a) Milk macaroni products are the additives within the meaning of section class of food, each of which conforms to 201(s) of the Federal Food, Drug, and the definition and standard of identity Cosmetic Act, or in case they are food and is subject to the requirements for additives, if they are used in con- label statement of ingredients pre- formity with regulations established scribed for macaroni products by pursuant to section 409 of the act. § 139.110(a), (f)(2), (f)(3), and (g), except (d)(1) The name of any food covered that: by this section is ‘‘Enriched Wheat (1) Milk is used as the sole moist- lll Macaroni Product—with For- ening ingredient in preparing the tified Protein’’, the blank being filled dough; or in lieu of milk one or more of in with appropriate word(s) such as the milk ingredients specified in para- ‘‘Soy’’ to show the source of any flours graph (f) of this section is used, with or or meals used that were made from without water, in such quantity that nonwheat cereals or from oilseeds. In the weight of milk solids therein is not lieu of the words ‘‘Macaroni Product’’ less than 3.8 percent of the weight of

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the finished milk macaroni product; statement of ingredients, prescribed and for macaroni products by § 139.110(a), (2) None of the optional ingredients (f)(2), (f)(3), (f)(4), and (g), except that: permitted by § 139.110(a) (1) and (2) is (1)(i) In preparing the dough, nonfat used. When the optional ingredient dry milk or concentrated skim milk, or gum gluten (§ 139.110(a)(5)) is added, the a mixture of these, is used in an quantity is such that the protein de- amount such that the finished maca- rived therefrom, together with the pro- roni product made with nonfat milk tein derived from semolina, durum contains by weight not less than 12 per- flour, farina, flour, or any combination cent and not more than 25 percent of of these used, does not exceed 13 per- milk solids-not-fat. Carrageenan or cent of the weight of the finished food. salts of carrageenan conforming to the (b) Milk macaroni is the milk maca- requirements of §§ 172.620 and 172.626 of roni product the units of which con- this chapter may be used in a quantity form to the specifications of shape and not in excess of 0.833 percent by weight size prescribed for macaroni by of the milk solids-not-fat used. § 139.110(b). (ii) When the ingredient carrageenan (c) Milk spaghetti is the milk maca- or the salts of carrageenan specified in roni product the units of which con- paragraph (a)(1)(i) of this section is form to the specifications of shape and used, the label shall bear the state- size prescribed for spaghetti by ment, ‘‘Carrageenan added’’ or ‘‘Salts § 139.110(c). of carrageenan added’’ or the state- (d) Milk vermicelli is the milk maca- ment ‘‘With added carrageenan’’ or roni product the units of which con- ‘‘With added salts of carrageenan’’, in form to the specifications of shape and the manner further prescribed by size prescribed for vermicelli by § 139.110(f)(4). § 139.110(d). (2) None of the optional ingredients (e) The name of each food for which a permitted by § 139.110(a) (1), (2), and (5) definition and standard of identity is are used. prescribed by this section is ‘‘Milk (b) The name of each food for which Macaroni Product’’; or alternatively, a definition and standard of identity is the name is ‘‘Milk macaroni’’, ‘‘Milk prescribed by this section is ‘‘Macaroni spaghetti’’, or ‘‘Milk vermicelli’’, as products made with nonfat milk’’ or, the case may be, when the units of the alternatively, the name is ‘‘Macaroni food comply with the requirements of made with nonfat milk’’, ‘‘Spaghetti paragraph (b), (c), or (d), respectively, made with nonfat milk’’ or ‘‘Vermicelli of this section. made with nonfat milk’’, as the case (f) The milk ingredients referred to may be when the units of the food con- in paragraph (a)(1) of this section are form to the specifications of shape and concentrated milk, evaporated milk, size prescribed by § 139.110 (b), (c), or dried milk, and a mixture of butter (d), respectively. with skim milk, concentrated skim [42 FR 14409, Mar. 15, 1977, as amended at 58 milk, evaporated skim milk, nonfat FR 2878, Jan. 6, 1993] dry milk (dried skim milk), or any two or more of these, in such proportion § 139.122 Enriched nonfat milk maca- that the weight of nonfat milk solids in roni products. such mixture is not more than 2.275 (a) Each of the enriched macaroni times the weight of milk fat therein. products made with nonfat milk for [42 FR 14409, Mar. 15, 1977, as amended at 58 which a definition and standard of FR 2878, Jan. 6, 1993] identity is prescribed by this section conforms to the definition and stand- § 139.121 Nonfat milk macaroni prod- ard of identity, and is subject to the re- ucts. quirements for label statement of in- (a) Each of the macaroni products gredients, prescribed for macaroni made with nonfat milk for which a def- products by § 139.110(a), (f)(2), (f)(3), inition and standard of identity is pre- (f)(4), and (g), except that: scribed by this section conforms to the (1)(i) In preparing the dough, nonfat definition and standard of identity, and dry milk or concentrated skim milk, or is subject to the requirements for label a mixture of these, is used in an

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amount such that the finished enriched nonfat milk’’, or ‘‘Enriched vermicelli macaroni product made with nonfat made with nonfat milk,’’ as the case milk contains by weight not less than may be when the units of the food con- 12 percent and not more than 25 perform to the specifications of shape and cent of milk solids-not-fat. Carra- size prescribed by § 139.110 (b), (c), or geenan or the salts of carrageenan con- (d), respectively. forming to the requirements of § 172.620 and § 172.626 of this chapter may be [42 FR 14409, Mar. 15, 1977, as amended at 58 used in a quantity not in excess of 0.833 FR 2878, Jan. 6, 1993] percent by weight of the milk solids- § 139.125 Vegetable macaroni prod- not-fat used. ucts. (ii) When the ingredient carrageenan or the salts of carrageenan specified in (a) Vegetable macaroni products are paragraph (a)(1)(i) of this section is the class of food each of which con- used, the label shall bear the state- forms to the definition and standard of ment, ‘‘Carrageenan added’’ or ‘‘Salts identity and is subject to the require- of carrageenan added’’ or the statements for label statement of ingredi- ment ‘‘With added carrageenan’’ or ents prescribed for macaroni products ‘‘With added salts of carrageenan’’, in by § 139.110(a), (f)(2), (f)(3), and (g), ex- the manner further prescribed by cept that: § 139.110(f)(4). (1) Tomato (of any red variety), arti- (2) None of the optional ingredients choke, beet, carrot, parsley, or spinach permitted by § 139.110(a) (1), (2), and (5) is added in such quantity that the sol- are used. ids thereof are not less than 3 percent (3) Each such food contains in each by weight of the finished vegetable pound not less than 4.0 milligrams (mg) macaroni product (the vegetable used and not more than 5.0 mg of thiamin, may be fresh, canned, dried, or in the not less than 1.7 mg and not more than form of puree or paste); and 2.2 mg of riboflavin, not less than 27 mg (2) None of the optional ingredients and not more than 34 mg of niacin or permitted by § 139.110(a) (1) and (2) is niacinamide, not less than 0.9 mg and used. When the optional ingredient not more than 1.2 mg of folic acid, and gum gluten (§ 139.110(a)(5)) is added, the not less than 13 mg and not more than quantity is such that the protein de- 16.5 mg of iron (Fe). These substances rived therefrom, together with the pro- may be added through direct addition tein derived from the semolina, durum or wholly or in part through the use of flour, farina, flour or any combination dried yeast, dried torula yeast, partly of these used, does not exceed 13 per- defatted wheat germ (as provided for in cent of the weight of the finished food. paragraph (a)(4) of this section), en- (b) Vegetable macaroni is the vege- riched farina, or enriched flour. They table macaroni product the units of may be added in a harmless carrier, such carrier being used only in the which conform to the specifications of quantity reasonably necessary to effect shape and size prescribed for macaroni an intimate and uniform distribution by § 139.110(b). of such substances in the finished food. (c) Vegetable spaghetti is the vege- Iron may be added only in a form that table macaroni product the units of is harmless and assimilable. which conform to the specifications of (4) Each such food may also contain shape and size prescribed for spaghetti as an optional ingredient partly by § 139.110(c). defatted wheat germ, but the amount (d) Vegetable vermicelli is the vege- thereof does not exceed 5 percent by table macaroni product, the units of weight of the finished food. which conform to the specifications of (b) The name of each food for which shape and size prescribed for vermicelli a definition and standard of identity is by § 139.110(d). prescribed by this section is ‘‘Enriched (e) The name of each food for which a macaroni product made with nonfat definition and standard of identity is milk’’ or, alternatively, the name is prescribed by this section is ‘‘lll ‘‘Enriched macaroni made with nonfat macaroni product’’, the blank being milk’’, ‘‘Enriched spaghetti made with filled in with the name whereby the

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vegetable used is designated in para- § 139.138 Whole wheat macaroni prod- graph (a) of this section; or alter- ucts. natively, the name is ‘‘lll maca- (a) Whole wheat macaroni products roni’’, ‘‘lll spaghetti’’, or ‘‘lll are the class of food each of which con- vermicelli’’, as the case may be, when forms to the definition and standard of the units of the food comply with the identity and is subject to the require- requirements of paragraph (b), (c), or ments for label statement of ingredi- (d) of this section, respectively, the ents, prescribed for macaroni products blank in each instance being filled in by § 139.110(a), (f)(2), (f)(3), and (g), ex- with the name whereby the vegetable cept that: used is designated in paragraph (a) of (1) Whole wheat flour or whole durum this section. wheat flour or both are used as the sole wheat ingredient; and [42 FR 14409, Mar. 15, 1977, as amended at 58 (2) None of the optional ingredients FR 2878, Jan. 6, 1993] permitted by § 139.110(a) (1), (2), and (5) is used. § 139.135 Enriched vegetable macaroni (b) Whole wheat macaroni is the products. whole wheat macaroni product the (a) Each of the macaroni products for units of which conform to the speci- which a definition and standard of fications of shape and size prescribed identity is prescribed by this section for macaroni by § 139.110(b). conforms to the definition and stand- (c) Whole wheat spaghetti is the ard of identity and is subject to the re- whole wheat macaroni product the quirements for label statement of in- units of which conform to the speci- gredients prescribed for macaroni prod- fications of shape and size prescribed for spaghetti by § 139.110(c). ucts by § 139.110(a), (f), and (g), and in (d) Whole wheat vermicelli is the addition is enriched to meet the re- whole wheat macaroni product the quirements prescribed for enriched units of which conform to the speci- macaroni products by § 139.115 and con- fications of shape and size prescribed tains a vegetable ingredient in compli- for vermicelli by § 139.110(d). ance with the requirements prescribed (e) The name of each food for which a for vegetable macaroni products by definition and standard of identity is § 139.125. prescribed by this section is ‘‘Whole (b) The name of each food for which wheat macaroni product’’; or alter- a definition and standard of identity is natively, the name is ‘‘Whole wheat prescribed by this section is ‘‘Enriched macaroni’’, ‘‘Whole wheat spaghetti’’, lll macaroni product’’, or, alter- or ‘‘Whole wheat vermicelli’’, as the natively, the name is ‘‘Enriched lll case may be, when the units of the food macaroni’’, ‘‘Enriched lll spa- comply with the requirements of para- ghetti’’, or ‘‘Enriched lll graph (b), (c), or (d), respectively, of vermicelli’’, when the units comply this section. with the shape and size requirements [42 FR 14409, Mar. 15, 1977, as amended at 58 prescribed for macaroni, spaghetti, or FR 2878, Jan. 6, 1993] vermicelli in § 139.110 (b), (c), or (d). § 139.140 Wheat and soy macaroni The blank in each instance is filled in products. with the name of the vegetable used, as specified in § 139.125(a). For example, (a) Wheat and soy macaroni products are the class of food each of which con- the name of an enriched macaroni forms to the definition and standard of product containing the prescribed identity and is subject to the require- amount of spinach and made in units ments for label statement of ingredi- not conforming in shape and size to the ents, prescribed for macaroni products requirements for macaroni, spaghetti, by § 139.110(a), (f)(2), (f)(3), and (g), ex- or vermicelli is ‘‘Enriched spinach cept that: macaroni product’’. (1) Soy flour is added in a quantity [42 FR 14409, Mar. 15, 1977, as amended at 58 not less than 12.5 percent of the com- FR 2878, Jan. 6, 1993] bined weight of the wheat and soy ingredients used (the soy flour used is

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made from heat-processed, dehulled whereby the wheat ingredient used is soybeans, with or without the removal designated in § 139.110(a). of fat therefrom); and [42 FR 14409, Mar. 15, 1977, as amended at 58 (2) None of the optional ingredients FR 2878, Jan. 6, 1993] permitted by § 139.110(a) (1) and (2) is used. When the optional ingredient § 139.150 Noodle products. gum gluten (§ 139.110(a)(5)) is added, the (a) Noodle products are the class of quantity is such that the protein de- food each of which is prepared by dry- rived therefrom, together with the pro- ing formed units of dough made from tein derived from semolina, durum semolina, durum flour, farina, flour, or flour, farina, flour or any combination any combination of two or more of of these used, does not exceed 13 per- these, with liquid eggs, frozen eggs, cent of the weight of the finished food. dried eggs, egg yolks, frozen yolks, (b) Wheat and soy macaroni is the dried yolks, or any combination of two wheat and soy macaroni product the or more of these, with or without water units of which conform to the speci- and with or without one or more of the fications of shape and size prescribed optional ingredients specified in paragraphs (a) (1) to (4) of this section infor macaroni by § 139.110(b). clusive: (c) Wheat and soy spaghetti is the (1) Onions, celery, garlic, bay leaf, or wheat and soy macaroni product the any two or more of these, in a quantity units of which conform to the speci- which seasons the food. fications of shape and size prescribed (2) Salt, in a quantity which seasons for spaghetti by § 139.110(c). the food. (d) Wheat and soy vermicelli is the (3) Gum gluten, in such quantity that wheat and soy macaroni product the the protein derived therefrom, together units of which conform to the speci- with the protein derived from semo- fications of shape and size prescribed lina, durum flour, farina, flour or any for vermicelli by § 139.110(d). combination of these used, does not ex- (e) The name of each food for which a ceed 13 percent of the weight of the fin- definition and standard of identity is ished food. prescribed by this section is ‘‘Wheat (4) Concentrated glyceryl monostea- and soy macaroni product’’, ‘‘Wheat rate (containing not less than 90 per- and soybean macaroni product’’, cent monoester) in a quantity not ex- ‘‘lll and soy macaroni product’’, or ceeding 3 percent by weight of the fin- ‘‘lll and soybean macaroni prod- ished food. The finished noodle product contains uct’’, the blank in each instance being not less than 87 percent of total solids filled in with the name whereby the as determined by the method pre- wheat ingredient used is designated in scribed in ‘‘Official Methods of Anal- § 139.110(a); or alternatively, the name ysis of the Association of Official Ana- is ‘‘Wheat and soy macaroni’’, ‘‘Wheat lytical Chemists,’’ 13th Ed. (1980), in and soybean macaroni’’, ‘‘lll and section 14.133, under the heading ‘‘Vac- soy macaroni’’, or ‘‘lll and soybean uum Oven Method—Official Final Ac- macaroni’’ when the units of the food tion,’’ which is incorporated by ref- comply with the requirements of para- erence. Copies may be obtained from graph (b) of this section; or ‘‘Wheat and the AOAC INTERNATIONAL, 481 North soy spaghetti’’, ‘‘Wheat and soybean Frederick Ave., suite 500, Gaithersburg, spaghetti’’, ‘‘lll and soy spaghetti’’, MD 20877, or may be examined at the or ‘‘lll and soybean spaghetti’’ when National Archives and Records Admin- such units comply with the require- istration (NARA). For information on ments of paragraph (c) of this section; the availability of this material at or ‘‘Wheat and soy vermicelli’’, ‘‘Wheat NARA, call 202–741–6030, or go to: http:// and soybean vermicelli’’, ‘‘lll and www.archives.gov/federallregister/ soy vermicelli’’, or ‘‘lll and soybean codeloflfederallregulations/ vermicelli’’ when such units comply ibrllocations.html. The total solids of with the requirements of paragraph (d) noodle products contains not less than of this section, the blank in each in- 5.5 percent by weight of the solids of stance being filled in with the name egg, or egg yolk.

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(b) Noodles, egg noodles, is the noo- applicable sections of parts 101 and 130 dle product the units of which are rib- of this chapter. bon-shaped. [42 FR 14409, Mar. 15, 1977, as amended at 47 (c) Egg macaroni is the noodle prod- FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, uct the units of which are tube-shaped 1984; 54 FR 24894, June 12, 1989; 58 FR 2879, and more than 0.11 inch but not more Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] than 0.27 inch in diameter. § 139.155 Enriched noodle products. (d) Egg spaghetti is the noodle product the units of which are tube-shaped (a) Enriched noodle products are the or cord-shaped (not tubular) and more class of food each of which conforms to than 0.06 inch but not more than 0.11 the definition and standard of identity, and is subject to the requirements for inch in diameter. label statement of ingredients, pre- (e) Egg vermicelli is the noodle prod- scribed for noodle products by § 139.150 uct the units of which are cord-shaped (a), (g), and (i), except that: (not tubular) and not more than 0.06 (1) Each such food contains in each inch in diameter. pound not less than 4 milligrams (mg) (f) The name of each food for which a and not more than 5 mg of thiamin, not definition and standard of identity is less than 1.7 mg and not more than 2.2 prescribed by this section is ‘‘Noodle mg of riboflavin, not less than 27 mg product’’ or ‘‘Egg noodle product’’; or and not more than 34 mg of niacin or alternatively, the name is ‘‘Noodles’’ niacinamide, not less than 0.9 mg and or ‘‘Egg noodles’’, ‘‘Egg macaroni’’, not more than 1.2 mg of folic acid, and ‘‘Egg spaghetti’’, or ‘‘Egg vermicelli’’, not less than 13 mg and not more than as the case may be, when the units of 16.5 mg of iron (Fe); the food are of the shapes and sizes (2) Each such food may also contain specified in paragraph (b), (c), (d), or as an optional ingredient added vitamin D in such quantity that each (e), respectively, of this section. pound of the finished food contains not (g)(1) When any ingredient specified less than 250 U.S.P. units and not more in paragraph (a)(1) of this section is than 1000 U.S.P. units of vitamin D; used, the label of the noodle product (3) Each such food may also contain shall bear the statement ‘‘Seasoned as an optional ingredient added cal- with lll’’, the blank being filled in cium in such quantity that each pound with the common name of the ingre- of the finished food contains not less dient; or in the case of bay leaves, the than 500 mg. and not more than 625 mg. statement ‘‘Spiced’’, ‘‘Spice added’’, or of calcium (Ca); ‘‘Spiced with bay leaves’’. (4) Each such food may also contain (2) When the ingredient specified in as an optional ingredient partly paragraph (a)(4) of this section is used, defatted wheat germ, but the amount the label shall bear the statement thereof does not exceed 5 percent of the ‘‘Glyceryl monostearate added’’ or the weight of the finished food; statement ‘‘With added glyceryl mono- (5) Each such food may be supplied, stearate’’. wholly or in part, with the prescribed quantity of any substance referred to (h) Wherever the name of the food ap- in paragraphs (a) (1), (2), and (3) of this pears on such label so conspicuously as section through the use of dried yeast, to be easily seen under customary con- dried torula yeast, partly defatted ditions of purchase, the words and wheat germ, enriched farina, or en- statements prescribed in this section, riched flour, or through the direct ad- showing the ingredients used shall im- ditions of any of the substances pre- mediately and conspicuously precede scribed in paragraphs (a) (1), (2), and (3) or follow, or in part precede and in part of this section. follow, such name without intervening Iron and calcium may be added only in written, printed, or other graphic mat- forms which are harmless and assimi- ter. lable. The substances referred to in (i) Label declaration. Each of the in- paragraphs (a) (1) and (2) of this section gredients used in the food shall be de- may be added in a harmless carrier clared on the label as required by the which does not impair the enriched

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noodle product, such carrier being used uct the units of which are ribbon- only in the quantity reasonably nec- shaped. essary to effect an intimate and uni- (c) Vegetable egg macaroni is the form distribution of such substances in vegetable noodle product the units of the finished enriched noodle product. which conform to the specifications of (b) Enriched noodles, enriched egg shape and size prescribed for egg maca- noodles are the enriched noodle prod- roni by § 139.150(c). ucts the units of which conform to the (d) Vegetable egg spaghetti is the specifications of shape and size pre- vegetable noodle product the units of scribed for noodles in § 139.150(b). which conform to the specifications of (c) Enriched egg macaroni is the en- shape and size prescribed for egg spa- riched noodle product the units of ghetti by § 139.150(d). which conform to the specifications of (e) Vegetable egg vermicelli is the shape and size prescribed for egg maca- vegetable noodle product the units of roni in § 139.150(c). which conform to the specifications of (d) Enriched egg spaghetti is the en- shape and size prescribed for egg riched noodle product the units of vermicelli by § 139.150(e). which conform to the specifications of (f) The name of each food for which a shape and size prescribed for egg spa- definition and standard of identity is ghetti in § 139.150(d). prescribed by this section is ‘‘lll (e) Enriched egg vermicelli is the en- noodle product’’ or ‘‘lll egg noodle riched noodle product the units of product’’, the blank being filled in with which conform to the specifications of the name whereby the vegetable used is shape and size prescribed for egg designated in paragraph (a) of this sec- vermicelli in § 139.150(e). tion; or alternatively, the name is (f) The name of each food for which a ‘‘lll noodles’’ or ‘‘lll egg noo- definition and standard of identity is dles’’, ‘‘lll egg macaroni’’, ‘‘lll prescribed by this section is ‘‘Enriched egg spaghetti’’, or ‘‘lll egg noodle product’’ or ‘‘Enriched egg noo- vermicelli’’, as the case may be, when dle product’’; or alternatively, the the units of the food comply with the name is ‘‘Enriched noodles’’, or ‘‘En- requirements of paragraph (b), (c), (d), riched egg noodles’’, ‘‘Enriched egg or (e) of this section, respectively, the macaroni’’, ‘‘Enriched egg spaghetti’’, blank in each instance being filled in or ‘‘Enriched egg vermicelli’’, as the with the name whereby the vegetable case may be, when the units of the food is designated in paragraph (a) of this comply with the requirements of para- section. graph (b), (c), (d), or (e) respectively of [42 FR 14409, Mar. 15, 1977, as amended at 58 this section. FR 2879, Jan. 6, 1993] [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] § 139.165 Enriched vegetable noodle products. § 139.160 Vegetable noodle products. (a) Each of the noodle products for (a) Vegetable noodle products are the which a definition and standard of class of food each of which conforms to identity is prescribed by this section the definition and standard of identity, conforms to the definition and stand- and is subject to the requirements for ard of identity and is subject to the relabel statement of ingredients, pre- quirements for label declaration of in- scribed for noodle products by gredients prescribed for noodle prod- § 139.150(a), (g), and (i), except that to- ucts by § 139.150 (a), (g), (h), and (i), and mato (of any red variety), artichoke, in addition is enriched to meet the re- beet, carrot, parsley, or spinach is quirements prescribed for enriched added in such quantity that the solids noodle products by § 139.155 and, except thereof are not less than 3 percent by as hereinafter provided, contains a veg- weight of the finished vegetable noodle etable ingredient in compliance with product (the vegetable used may be the requirements prescribed for vege- fresh, canned, dried, or in the form of table noodle products by § 139.160. Be- puree or paste). cause they are apt to impart an egg- (b) Vegetable noodles, vegetable egg yolk color, carrots are not used in en- noodles, is the vegetable noodle prod- riched vegetable noodle products.

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(b) The name of each food for which soy egg noodle product’’, ‘‘Wheat and a definition and standard of identity is soybean noodle product’’, ‘‘Wheat and prescribed by this section is ‘‘Enriched soybean egg noodle product’’, ‘‘lll lll noodle product’’, ‘‘Enriched and soy noodle product’’, ‘‘lll and lll egg noodle product’’, or, alter- soy egg noodle product’’, ‘‘lll and natively, the name is ‘‘Enriched lll soybean noodle product’’, or ‘‘lll noodles’’, or ‘‘Enriched lll egg noo- and soybean egg noodle product’’, the dles’’, ‘‘Enriched lll egg macaroni’’, blank in each instance being filled in ‘‘Enriched lll egg spaghetti’’, or with the name whereby the wheat in- ‘‘Enriched lll egg vermicelli’’, when gredient used is designated in the units comply with the size and § 139.150(a); or alternatively, the name shape requirements for noodles, maca- is ‘‘Wheat and soy noodles’’, ‘‘Wheat roni, spaghetti, or vermicelli in § 139.150 and soy egg noodles’’, ‘‘Wheat and soy- (b), (c), (d), or (e). The blank in each in- bean noodles’’, ‘‘Wheat and soybean stance is filled in with the name of the egg noodles’’, ‘‘lll and soy noodles’’, vegetable used, as specified in ‘‘lll and soy egg noodles’’, ‘‘lll § 139.160(a). and soybean noodles’’, or ‘‘lll and [42 FR 14409, Mar. 15, 1977, as amended at 58 soybean egg noodles’’ when the units of FR 2879, Jan. 6, 1993] the food comply with the requirements of paragraph (b) of this section; or § 139.180 Wheat and soy noodle prod- ‘‘Wheat and soy egg macaroni’’, ucts. ‘‘Wheat and soybean egg macaroni’’, (a) Wheat and soy noodle products ‘‘lll and soy egg macaroni’’, or are the class of food each of which con- ‘‘lll and soybean egg macaroni’’ forms to the definition and standard of when such units comply with the re- identity and is subject to the require- quirements of paragraph (c) of this sec- ments for label statement of ingredi- tion; or ‘‘Wheat and soy egg spa- ents prescribed for noodle products by ghetti’’, ‘‘Wheat and soybean egg spa- § 139.150(a), (g), and (i), except that soy ghetti’’, ‘‘lll and soy egg spaghetti’’, flour is added in a quantity not less or ‘‘lll and soybean egg spaghetti’’ than 12.5 percent of the combined when such units comply with the re- weight of the wheat and soy ingredi- quirements of paragraph (d) of this sec- ents used (the soy flour used is made tion; or ‘‘Wheat and soy egg from heat-processed, dehulled soy- vermicelli’’, ‘‘Wheat and soybean egg beans, with or without the removal of vermicelli’’, ‘‘lll and soy egg fat therefrom). vermicelli’’, or ‘‘lll and soybean egg (b) Wheat and soy noodles, wheat and vermicelli’’, when such units comply soy egg noodles, is the wheat and soy with the requirements of paragraph (e) noodle product the units of which are of this section, the blank in each in- ribbon-shaped. stance being filled in with the name (c) Wheat and soy egg macaroni is whereby the wheat ingredient used is the wheat and soy noodle product the designated in § 139.150(a). units of which conform to the speci- [42 FR 14409, Mar. 15, 1977, as amended at 58 fications of shape and size prescribed FR 2879, Jan. 6, 1993] for egg macaroni by § 139.150(c). (d) Wheat and soy egg spaghetti is the wheat and soy noodle product the PART 145—CANNED FRUITS units of which conform to the specifications of shape and size prescribed Subpart A—General Provisions for egg spaghetti by § 139.150(d). Sec. (e) Wheat and soy egg vermicelli is 145.3 Definitions. the wheat and soy noodle product the units of which conform to the speci- Subpart B—Requirements for Specific fications of shape and size prescribed Standardized Canned Fruits for egg vermicelli by § 139.150(e). 145.110 Canned applesauce. (f) The name of each food for which a 145.115 Canned apricots. definition and standard of identity is 145.116 Artificially sweetened canned apri- prescribed by this section is ‘‘Wheat cots. and soy noodle product’’, ‘‘Wheat and 145.120 Canned berries.

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145.125 Canned cherries. odorless, and flavorless, except for 145.126 Artificially sweetened canned cher- sweetness. ries. (f) The term sugar means refined su- 145.130 Canned figs. crose. 145.131 Artificially sweetened canned figs. (g) The terms edible organic acid and 145.134 Canned preserved figs. 145.135 Canned fruit cocktail. edible organic salt refer to any edible or- 145.136 Artificially sweetened canned fruit ganic acid and any edible organic salt cocktail. added for the purpose of flavor en- 145.140 Canned seedless grapes. hancement that either is not a food ad- 145.145 Canned grapefruit. ditive as defined in section 201(s) of the 145.170 Canned peaches. Federal Food, Drug, and Cosmetic Act 145.171 Artificially sweetened canned peach- or, if it is a food additive as so defined, es. is used in conformity with regulations 145.175 Canned pears. established pursuant to section 409 of 145.176 Artificially sweetened canned pears. 145.180 Canned pineapple. the act. 145.181 Artificially sweetened canned pine- (h) The term water means, in addition apple. to water, any mixture of water and 145.185 Canned plums. fruit juice in which the fruit juice(s) is 145.190 Canned prunes. less than 50 percent of such mixture, including any water contributed by the AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. use of liquid nutritive carbohydrate sweeteners. SOURCE: 42 FR 14414, Mar. 15, 1977, unless (i) The term fruit juice(s) and water otherwise noted. means any mixture of fruit juice as herein defined and water, including any Subpart A—General Provisions water contributed by the use of liquid nutritive carbohydrate sweeteners, in § 145.3 Definitions. which the fruit juice(s) is 50 percent, or For the purposes of this part: more, of such mixture except that (a) The term corn sirup means a clari- water used in preparing equivalent sin- fied, concentrated aqueous solution of gle strength juice(s) from con- the products obtained by the incom- centrate(s) shall not be considered to plete hydrolysis of cornstarch, and in- be a mixture of fruit juice and water. cludes dried corn sirup. The solids of (j) The term fruit juice(s) means sin- corn sirup and of dried corn sirup con- gle strength expressed juice(s) of tain not less than 40 percent by weight sound, mature fruit(s). It may be fresh, of reducing sugars calculated as anhy- frozen, canned, or made from con- drous dextrose. centrate(s). However, if it is made from (b) The term dextrose means the hy- concentrate(s), the juice(s) shall be re- drated or anhydrous, refined constituted with water to not less than monosaccharide obtained from the soluble solids that such fruit juice hydrolyzed starch. had before concentration. Fruit juice(s) (c) The term dried glucose sirup means may be used singly or in combination. the product obtained by drying ‘‘glu- If a fruit juice(s) is used which is regu- cose sirup.’’ lated by a standard of identity of this (d) The term glucose sirup means a chapter, it shall conform to the clarified, concentrated, aqueous solu- compositional requirements prescribed tion of the products obtained by the in- by such standard prior to the addition complete hydrolysis of any edible of any sweetener which may be used. starch. The solids of glucose sirup con- (k) The term clarified juice means the tain not less than 40 percent by weight liquid expressed wholly or in part from of reducing sugars calculated as anhy- fruit peelings, fruit shells, fruit cores, drous dextrose. or from the fruit flesh or parts thereof, (e) The term invert sugar sirup means which is clarified and may be further an aqueous solution of inverted or refined or concentrated. partly inverted, refined or partly re- (l) The term solid pack means the fined sucrose, the solids of which con- product contains practically all fruit tain not more than 0.3 percent by with only the very little free flowing weight of ash, and which is colorless, liquid that is expressed from the fruit

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and to which no packing media have fall on the sieve with cups or cavities been added. up. Cups or cavities in soft products (m) The procedure for determining may be drained by tilting sieve. With- the densities of the packing media out further shifting the material on means the following: The density of the the sieve, incline the sieve at an angle packing medium, when measured 15 of 17° to 20° to facilitate drainage. Two days or more after packing, or the den- minutes after the drainage begins, sity of the blended homogenized slurry weigh the sieve and drained fruit. The of the comminuted entire contents of weight so found, less the weight of the the container, when measured less than sieve, shall be considered to be the 15 days after canning, is determined ac- weight of the drained fruit. cording to ‘‘Official Methods of Anal- (o) Compliance means the following: ysis of the Association of Official Ana- Unless otherwise provided in a stand- lytical Chemists,’’ 13th Ed. (1980), ard, a lot of canned fruits shall be which is incorporated by reference, sec- deemed in compliance for the following tion 31.6F011 (Solids) ‘‘By Means of the factors, to be determined by the sam- Refractometer—Official Final Action’’ pling and acceptance procedure as pro- (and sections 52.012 and 52.015) with re- vided in paragraph (p) of this section, sult expressed as percent by weight of namely: sucrose (degrees Brix) with correction (1) Packing medium density. A lot shall for temperature to the equivalent at 20 be deemed to be in compliance for °C, but without correction for invert packing medium density based on the sugar or other substances. Copies of average sucrose value for all samples the material incorporated by reference analyzed according to the sampling may be obtained from the AOAC plans, but no container may have a su- INTERNATIONAL, 481 North Frederick crose value lower than that of the next Ave., suite 500, Gaithersburg, MD 20877, lower category or 2 percent by weight or may be examined at the National sucrose (degrees Brix) lower if no lower Archives and Records Administration category exists. (NARA). For information on the avail- (2) Quality. The quality of a lot shall ability of this material at NARA, call be considered acceptable when the 202–741–6030, or go to: http:// number of defectives does not exceed www.archives.gov/federallregister/ the acceptance number in the sampling codeloflfederallregulations/ plans. ibrllocations.html. (3) Fill of container. A lot shall be (n) The procedure for determining deemed to be in compliance for fill of drained weight is as follows: Tilt the container (packing medium and fruit opened container so as to distribute ingredient) when the number of the contents evenly over the meshes of defectives does not exceed the accept- a circular sieve which has previously ance number (c) in the sampling plans. been weighed. The diameter of the (4) Drained weight. A lot shall be sieve is 20.3 centimeters (8 inches) if deemed to be in compliance for drained the quantity of contents of the con- weight based on the average value of tainer is less than 1.4 kilograms (3 all samples analyzed according to the pounds) and 30.5 centimeters (12 inches) sampling plans. The sample unit shall if such quantity is 1.4 kilograms (3 be the entire contents of the container. pounds) or more. The bottom of the (p) The sampling and acceptance pro- sieve is woven-wire cloth which com- cedure means the following: plies with the specifications for the No. (1) Definitions—(i) Lot. A collection of 8 sieve set forth in the ‘‘Definitions of primary containers or units of the Terms and Explanatory Notes’’ of the same size, type, and style manufac- ‘‘Official Methods of Analysis of the tured or packed under similar condi- Association of Official Analytical tions and handled as a single unit of Chemists,’’ 13th Ed. (1980), which is in- trade. corporated by reference. The avail- (ii) Lot size. The number of primary ability of this incorporation by ref- containers or units in the lot. erence is given in paragraph (m) of this (iii) Sample size. The total number of section. Carefully invert by hand all sample units drawn for examination fruits having cups or cavities if they from a lot.

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(iv) Sample unit. A container, a por- Subpart B—Requirements for Spe- tion of the contents of a container, or cific Standardized Canned a composite mixture of product from Fruits small containers that is sufficient for the examination or testing as a single § 145.110 Canned applesauce. unit. (a) Identity—(1) Definition. Canned ap- (v) Defective. Any sample unit shall plesauce is the food prepared from be regarded as defective when the sam- comminuted or chopped apples (Malus ple unit does not meet the criteria set domestica Borkhausen), which may or forth in the standards. may not be peeled and cored, and which (vi) Acceptance number (c). The max- may have added thereto one or more of imum number of defective sample units the optional ingredients specified in permitted in the sample in order to paragraph (a)(2) of this section. The consider the lot as meeting the speci- apple ingredient is heated and, in ac- fied requirements. cordance with good manufacturing (vii) Acceptable quality level (AQL). practices, bruised apple particles, peel, The maximum percent of defective seed, core material, carpel tissue, and sample units permitted in a lot that other coarse, hard, or extraneous mate- will be accepted approximately 95 per- rials are removed. The food is sealed in cent of the time. containers. It is so processed by heat, (2) Sampling plans: either before or after sealing, as to prevent spoilage. The soluble solids con- Size in container tent, measured by refractometer and Lot size (primary containers) expressed as percent sucrose (degrees n 1 c 2 Brix) with correction for temperature NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) to the equivalent at 20 °C (68 °F), is not less than 9 percent (exclusive of the 4,800 or less ...... 13 2 solids of any added optional nutritive 4,801 to 24,000 ...... 21 3 24,001 to 48,000 ...... 29 4 carbohydrate sweeteners) as deter- 48,001 to 84,000 ...... 48 6 mined by the method prescribed in 84,001 to 144,000 ...... 84 9 ‘‘Official Methods of Analysis of the 144,001 to 240,000 ...... 126 13 Association of Official Analytical Over 240,000 ...... 200 19 Chemists,’’ 13th Ed. (1980), section 22.024, ‘‘Soluble Solids by Refractom- NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN 4.5 KG (10 LB) eter in Fresh and Canned Fruits, Jams, Marmalades, and Preserves—Official 2,400 or less ...... 13 2 First Action,’’ which is incorporated by 2,401 to 15,000 ...... 21 3 reference, but without correction for 15,001 to 24,000 ...... 29 4 24,001 to 42,000 ...... 48 6 invert sugar or other substances. Cop- 42,001 to 72,000 ...... 84 9 ies may be obtained from the AOAC 72,001 to 120,000 ...... 126 13 INTERNATIONAL, 481 North Frederick Over 120,000 ...... 200 19 Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National NET WEIGHT GREATER THAN 4.5 KG (10 LB) Archives and Records Administration 600 or less ...... 13 2 (NARA). For information on the avail- 601 to 2,000 ...... 21 3 ability of this material at NARA, call 2,001 to 7,200 ...... 29 4 202–741–6030, or go to: http:// 7,201 to 15,000 ...... 48 6 www.archives.gov/federallregister/ 15,001 to 24,000 ...... 84 9 codeloflfederallregulations/ 24,001 to 42,000 ...... 126 13 Over 42,000 ...... 200 19 ibrllocations.html. (2) Optional ingredients. The following 1 n = number of primary containers in sample. 2 c = acceptance number. safe and suitable optional ingredients may be used: [42 FR 14414, Mar. 15, 1977, as amended at 47 (i) Water. FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, (ii) Apple juice. 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, (iii) Salt. Mar. 24, 1998] (iv) Any organic acid added for the purpose of acidification. (Organic acids

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generally recognized as having a pre- (b) [Reserved] servative effect are not permitted in (c) Fill of container. (1) The standard applesauce except as provided for in of fill of container for canned apple- paragraph (a)(2)(viii) of this section.) sauce is a fill of not less than 90 per- (v) Nutritive carbohydrate sweet- cent of the total capacity of the con- eners. tainer, as determined by the general (vi) Spices. method for fill of containers prescribed (vii) Natural and artificial flavoring. in § 130.12(b) of this chapter; except (viii) Either of the following: that in the case of glass containers (a) Erythorbic acid or ascorbic acid having a total capacity of 192 ml (61⁄2 as an antioxidant preservative in an fluid ounces) or less, the fill is not less amount not to exceed 150 parts per mil- than 85 percent. lion; or (b) Ascorbic acid (vitamin C) in a (2) Sampling and acceptance proce- quantity such that the total vitamin C dure: A lot will be deemed to fall below in each 113 g (4 ounces) by weight of the standard of fill when the number of the finished food amounts to 60 mg. ‘‘defectives’’ exceeds the acceptance This requirement will be deemed to number ‘‘c’’ in the sampling plans pre- have been met if a reasonable overage scribed in paragraph (c)(2)(ii) of this of the vitamin, within limits of good section. manufacturing practice, is present to (i) Definitions of terms to be used in insure that the required level is main- the sampling plans in paragraph tained throughout the expected shelf (c)(2)(ii) of this section are as follows: life of the food under customary condi- (a) Lot. A collection of primary con- tions of distribution. tainers or units of the same size, type, (ix) Color additives in such quantity and style manufactured or packed as to distinctly characterize the food under similar conditions and handled unless such addition conceals damage as a single unit of trade. or inferiority or makes the finished (b) Lot size. The number of primary food appear better or of greater value containers or units in the lot. than it is. (c) Sample size ‘‘n.’’ The total number (3) Nomenclature. The name of the food is ‘‘applesauce’’. The name of the of sample units drawn for examination food shall include a declaration indi- from a lot as indicated in paragraph cating the presence of any flavoring (c)(2)(ii) of this section. that characterizes the product as speci- (d) Sample unit. A container, the en- fied in § 101.22 of this chapter and a dec- tire contents of a container, a portion laration of any spice that characterizes of the contents of a container, or a the product. If a nutritive sweetener as composite mixture of product from provided for in paragraph (a)(2)(v) of small containers that is sufficient for this section is added and the soluble examination or testing as a single unit. solids content of the finished food is (e) Defective. A container that falls not less than 16.5 percent as deter- below the requirement for minimum mined by the method referred to in fill prescribed in paragraph (c)(1) of paragraph (a)(1) of this section, the this section is considered a ‘‘defec- name may include the word ‘‘sweet- tive.’’ ened’’. If no such sweetener is added, (f) Acceptable number ‘‘c.’’ The max- the name may include the word ‘‘un- imum number of defective sample units sweetened’’. permitted in the sample in order to (4) Label declaration. Each of the in- consider the lot as meeting the speci- gredients used in the food shall be de- fied requirements. clared on the label as required by the applicable sections of parts 101 and 130 (g) Acceptable quality level (AQL). The of this chapter. However, when ascor- maximum percent of defective sample bic acid (vitamin C) is added as pro- units permitted in a lot that will be ac- vided for in paragraph (a)(2)(viii)(b) of cepted approximately 95 percent of the this section, after the application of time. heat to the apples, preservative label- (ii) Sampling and acceptance: ing requirements do not apply.

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ACCEPTABLE QUALITY LEVEL (AQL) 6.5 (iv) Apricot pits, except in the cases of unpeeled whole apricots and peeled Size of container Lot size (primary containers) whole apricots, in a quantity not more n 1 c 2 than 1 apricot pit to each 227 grams (8 ounces) of finished canned apricots. NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) (v) Apricot kernels, except in the 4,800 or less ...... 13 2 cases of unpeeled whole apricots and 4,801 to 24,000 ...... 21 3 peeled whole apricots, and except when 24,001 to 48,000 ...... 29 4 optional ingredient under paragraph 48,001 to 84,000 ...... 48 6 84,001 to 144,000 ...... 84 9 (a)(4) of this section is used. 144,001 to 240,000 ...... 126 13 (vi) Ascorbic acid in an amount no Over 240,000 ...... 200 19 greater than necessary to preserve color. NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN 4.5 KG (10 LB) Such food is sealed in a container and 2,400 or less ...... 13 2 before or after sealing is so processed 2,401 to 15,000 ...... 21 3 by heat as to prevent spoilage. 15,001 to 24,000 ...... 29 4 (2) Optional styles of the apricot ingre- 24,001 to 42,000 ...... 48 6 dient. The optional styles of the apricot 42,001 to 72,000 ...... 84 9 72,001 to 120,000 ...... 126 13 ingredient referred to in paragraph (a) Over 120,000 ...... 200 19 of this section are peeled or unpeeled: (i) Whole. NET WEIGHT GREATER THAN 4.5 KG (10 LB) (ii) Halves. 600 or less ...... 13 2 (iii) Quarters. 601 to 2,000 ...... 21 3 (iv) Slices. 2,001 to 7,200 ...... 29 4 (v) Pieces or irregular pieces. 7,201 to 15,000 ...... 48 6 15,001 to 24,000 ...... 84 9 Each such ingredient, except in the 24,001 to 42,000 ...... 126 13 cases of unpeeled whole apricots and Over 42,000 ...... 200 19 peeled whole apricots, is pitted. 1 n = number of primary containers in sample. (3) Packing media. (i) The optional 2 c = acceptance number. packing media referred to in paragraph (3) If canned applesauce falls below (a)(1) of this section, as defined in the standard of fill of container pre- § 145.3 are: scribed in paragraph (c)(1) of this sec- (a) Water. tion, the label shall bear the general (b) Fruit juice(s) and water. statement of substandard fill specified (c) Fruit juice(s). in § 130.14(b) of this chapter, in the Such packing media may be used as manner and form therein specified. such or any one or any combination of [42 FR 14414, Mar. 15, 1977, as amended at 47 two or more safe and suitable nutritive FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, carbohydrate sweetener(s) may be 1984; 54 FR 24894, June 12, 1989; 58 FR 2879, added. Sweeteners defined in § 145.3 Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] shall be as defined therein, except that a nutritive carbohydrate sweetener for § 145.115 Canned apricots. which a standard of identity has been (a) Identity—(1) Ingredients. Canned established in part 168 of this chapter apricots is the food prepared from ma- shall comply with such standard in lieu ture apricots of one of the optional of any definition that may appear in styles specified in paragraph (a)(2) of § 145.3. this section, which may be packed as (ii) When a sweetener is added as a solid pack or in one of the optional part of any such liquid packing me- packing media specified in paragraph dium, the density range of the result- (a)(3) of this section. Such food may ing packing medium expressed as per- also contain one, or any combination cent by weight of sucrose (degrees of two or more of the following safe Brix) as determined by the procedure and suitable optional ingredients: prescribed in § 145.3(m) shall be des- (i) Natural and artificial flavors. ignated by the appropriate name for (ii) Spice. the respective density ranges, namely: (iii) Vinegar, lemon juice, or organic (a) When the density of the solution acids. is 10 percent or more but less than 16

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percent, the medium shall be des- ceded or followed by ‘‘Unpeeled’’ or ignated as ‘‘slightly sweetened water’’; ‘‘Peeled’’, as the case may be. ‘‘Halves’’ or ‘‘extra light sirup’’; ‘‘slightly sweet- may be alternatively designated ened fruit juice(s) and water’’; or ‘‘Halved’’, ‘‘Quarters’’ as ‘‘Quartered’’ ‘‘slightly sweetened fruit juice(s)’’, as and ‘‘Slices’’ as ‘‘Sliced’’. When the the case may be. packing medium is prepared with a (b) When the density of the solution sweetener(s) which imparts a taste, fla- is 16 percent or more but less than 21 vor or other characteristic to the fin- percent, the medium shall be des- ished food in addition to sweetness, the ignated as ‘‘light sirup’’; ‘‘lightly name of the packing medium shall be sweetened fruit juice(s) and water’’; or accompanied by the name of such ‘‘lightly sweetened fruit juice(s)’’, as sweetener(s), as for example in the case the case may be. of a mixture of brown sugar and honey, (c) When the density of the solution an appropriate statement would be is 21 percent or more but less than 25 ‘‘lll sirup of brown sugar and percent, the medium shall be des- honey’’ the blank to be filled in with ignated as ‘‘heavy sirup’’; ‘‘heavily the word ‘‘light’’, ‘‘heavy’’, or ‘‘extra sweetened fruit juice(s) and water’’; or heavy’’ as the case may be. When the ‘‘heavily sweetened fruit juice(s)’’, as liquid portion of the packing media the case may be. provided for in paragraphs (a)(3) (i) and (d) When the density of the solution (ii) of this section consists of fruit is 25 percent or more but not more juice(s), such juice(s) shall be des- than 40 percent, the medium shall be ignated in the name of the packing me- designated as ‘‘extra heavy sirup’’; dium as: ‘‘extra heavily sweetened fruit juice(s) (a) In the case of a single fruit juice, and water’’; or ‘‘extra heavily sweet- the name of the juice shall be used in ened fruit juice(s)’’, as the case may be. lieu of the word ‘‘fruit’’. (4) Labeling requirements. (i) The name (b) In the case of a combination of of the food is ‘‘apricots’’. The name of two or more fruit juices, the names of the food shall also include a declara- the juices in the order of predominance tion of any flavoring that characterizes by weight shall either be used in lieu of the product as specified in § 101.22 of the word ‘‘fruit’’ in the name of the this chapter and a declaration of any packing medium, or be declared on the spice or seasoning that characterizes label as specified in paragraph the product; for example, ‘‘Spice (a)(4)(iii) of this section, and Added’’, or in lieu of the word ‘‘Spice’’, (c) In the case of a single fruit juice the common name of the spice, ‘‘Sea- or a combination of two or more fruit soned with Vinegar’’ or ‘‘Seasoned with juices any of which are made from con- Apricot Kernels’’. When two or more of centrate(s), the words ‘‘from con- the optional ingredients specified in centrate(s)’’ shall follow the word paragraphs (a)(1) (ii) through (iv), in- ‘‘juice(s)’’ in the name of the packing clusive, of this section are used, such medium and in the name(s) of such words may be combined as for example, juice(s) when declared as specified in ‘‘Seasoned with Cider Vinegar, Cloves, paragraph (a)(4)(iii) of this section. Cinnamon Oil and Apricot Kernels’’. (iii) Whenever the names of the fruit (ii) The style of the apricot ingre- juices used do not appear in the name dient as provided in paragraph (a)(2) of of the packing medium as provided in this section and the name of the pack- paragraph (a)(4)(ii)(b) of this section, ing medium as used in paragraphs such names and the words ‘‘from con- (a)(3)(i) and (ii) of this section, pre- centrate,’’ as specified in paragraph ceded by ‘‘In’’ or ‘‘Packed in’’ or the (a)(4)(ii)(c) of this section, shall appear words ‘‘solid pack’’, where applicable, in an ingredient statement pursuant to shall be included as part of the name or the requirements of § 101.3(d) of this in close proximity to the name of the chapter. food, except that pieces or irregular (iv) Label declaration. Each of the in- pieces shall be designated ‘‘Pieces’’, gredients used in the food shall be de- ‘‘Irregular pieces’’, or ‘‘Mixed pieces of clared on the label as required by the irregular sizes and shapes’’. The style applicable sections of parts 101 and 130 of the apricot ingredient shall be pre- of this chapter.

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(b) Quality. (1) The standard of qual- The rod is held vertically by a support ity for canned apricots is as follows: through which it can freely move up- (i) All units tested in accordance ward or downward. The lower end of with the method prescribed in para- the rod is a plane surface to which the graph (b)(2) of this section are pierced vertical axis of the rod is perpen- by a weight of not more than 300 dicular. Adjust the combined weight of grams. the rod and device to 100 grams. Set (ii) In the cases of whole apricots, the receptacle so that the surface of halves, and quarters, the weight of the the test piece is held horizontally. largest unit in the container is not Lower the end of the rod to the approx- more than twice the weight of the imate center of such surface, and add smallest unit therein. weight to the device at a uniform, con- (iii) Not more than 20 percent of the tinuous rate of 12 grams per second units in the container are blemished until the rod pierces the test piece. with scab, hail injury, discoloration, or Weigh the rod and weighted device. other abnormalities. Test all units in containers of 50 units (iv) In the cases of whole apricots, or less, except those units too small for halves, and quarters, all units are testing or too soft for trimming. Test untrimmed, or are so trimmed as to at least 50 units, taken at random, in preserve normal shape. containers of more than 50 units; but if (v) Except in the case of mixed pieces less than 50 units are of sufficient size of irregular sizes and shapes, not more and firmness for testing, test those than 5 percent of the units in a con- which are of sufficient size and firm- tainer of 20 or more units, and not ness. more than 1 unit in a container of less (3) If the quality of canned apricots than 20 units, are crushed or broken. (A falls below the standard prescribed in unit which has lost its normal shape paragraph (b)(1) of this section, the because of ripeness and which bears no label shall bear the general statement mark of crushing shall not be consid- of substandard quality specified in ered to be crushed or broken.) § 130.14(a) of this chapter, in the man- (2) Canned apricots shall be tested by ner and form therein specified; but in the following method to determine lieu of such general statement of sub- whether or not they meet the require- standard quality, the label may bear ments of paragraph (b)(1)(i) of this sec- the alternative statement ‘‘Below tion: So trim a test piece from the unit standard in quality lll’’, the blank as to fit, with peel surface up, into a to be filled in with the words specified supporting receptacle. If the unit is of after the corresponding number of each different firmness in different parts of subparagraph of paragraph (b)(1) of this its peel surface, trim the piece from section which such canned apricots fail the firmest part. If the piece is to meet, as follows: unpeeled, remove the peel. The top of (i) ‘‘Not tender’’; the receptacle is circular in shape, of (ii) ‘‘Mixed sizes’’; 11⁄8 inches inside diameter, with (iii) ‘‘Blemished’’; vertical sides; or rectangular in shape, (iv) ‘‘Unevenly trimmed’’; 3⁄4 inch by 1 inch inside measurements, (v) ‘‘Partly crushed or broken’’. with ends vertical and sides sloping Such alternative statement shall im- downward and joining at the center at mediately and conspicuously precede a vertical depth of 3⁄4 inch. Use the cir- or follow, without intervening written, cular receptacle for testing units of printed, or graphic matter, the name such size that a test piece can be ‘‘apricots’’ and any words and state- trimmed therefrom to fit it. Use the ments required or authorized to appear rectangular receptacle for testing with such name by § 145.115(a)(2). other units. Test no unit from which a (c) Fill of container. (1) The standard test piece with rectangular peel surface of fill of container for canned apricots at least 1⁄2 inch by 1 inch cannot be is the maximum quantity of the op- trimmed. Test the piece by means of a tional apricot ingredient that can be round metal rod 3⁄16 inch in diameter. sealed in the container and processed To the upper end of the rod is affixed a by heat to prevent spoilage, without device to which weight can be added. crushing or breaking such ingredient.

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(2) If canned apricots fall below the any combination of two or more of the standard of fill of container prescribed safe and suitable optional ingredients in paragraph (c)(1) of this section, the specified in paragraph (a)(4) of this sec- label shall bear the general statement tion. Such food is sealed in a container of substandard fill specified in and before or after sealing is so proc- § 130.14(b) of this chapter, in the man- essed by heat to prevent spoilage. ner and form therein specified. (2) Varietal types. The optional berry ingredients referred to in paragraph [42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] (a)(1) of this section are prepared from stemmed fruit of the following optional § 145.116 Artificially sweetened canned varietal types of berry ingredient; apricots. namely: (a) Artificially sweetened canned (i) Raspberry varieties conforming to apricots is the food which conforms to the characteristics of Rubus idaeus L. the definition and standard of identity or Rubus occidentalis L. prescribed for canned apricots by (ii) Blackberries. § 145.115(a), except that in lieu of a (iii) Blueberries. packing medium specified in (iv) Boysenberries. § 145.115(a)(3), the packing medium used (v) Dewberries. is water artificially sweetened with (vi) Gooseberries. saccharin, sodium saccharin, or a com- (vii) Huckleberries. bination of both. Such packing medium (viii) Loganberries. may be thickened with pectin and may (ix) Strawberry varieties conforming contain any mixture of any edible or- to the characteristics of Fragaria. ganic salt or salts and any edible or- (x) Youngberries. ganic acid or acids as a flavor-enhanc- (3) Packing media. (i) The optional ing agent, in a quantity not more than packing media referred to in paragraph is reasonably required for that purpose. (a)(1) of this section as defined in § 145.3 (b)(1) The specified name of the food are: is ‘‘artificially sweetened lll’’, the (a) Water. blank being filled in with the name (b) Fruit juice(s) and water. prescribed by § 145.115(a) for canned (c) Fruit juice(s). apricots having the same optional apri- Such packing media may be used as cot ingredient. such or any one or any combination of (2) The artificially sweetened food is two or more safe and suitable nutritive subject to the requirements for label carbohydrate sweeteners may be added. statement of ingredients used, as pre- Sweeteners listed in § 145.3 shall be as scribed for canned apricots by defined therein, except that a nutritive § 145.115(a). If the packing medium is carbohydrate sweetener for which a thickened with pectin, the label shall standard of identity has been estab- bear the statement ‘‘thickened with lished in part 168 of this chapter shall pectin’’. When any organic salt or acid comply with such standard in lieu of or any mixture of two or more of these any definition that may appear in is added, the label shall bear the com- § 145.3. mon or usual name of each such ingre- (ii) When a sweetener is added as a dient. part of any such liquid packing me- [42 FR 14414, Mar. 15, 1977, as amended at 58 dium, the four density ranges of the re- FR 2879, Jan. 6, 1993] sulting packing media hereinafter specified for each berry ingredient, ex- § 145.120 Canned berries. pressed as percent by weight of sucrose (a) Identity—(1) Ingredients. Canned (degrees Brix) as determined by the berries is the food prepared from any procedure described in § 145.3(m), shall suitable variety of one of the optional be designated by the appropriate name berry ingredients specified in para- for each of the respective density graph (a)(2) of this section, which may ranges for each berry ingredient as: be packed in one of the optional pack- (a) ‘‘Slightly sweetened water’’; or ing media specified in paragraph (a)(3) ‘‘extra light sirup’’; ‘‘slightly sweet- of this section, and may contain one or ened fruit juice(s) and water’’; or

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‘‘slightly sweetened fruit juice(s)’’, as sweetened fruit juice(s)’’, as the case the case may be. may be. (b) ‘‘Light sirup’’, when the liquid (d) ‘‘Extra heavy sirup’’, when the used is water, ‘‘lightly sweetened fruit liquid used is water; or ‘‘extra heavily juice(s) and water’’; or ‘‘lightly sweet- sweetened fruit juice(s) and water’’; or ened fruit juice(s)’’, as the case may be. ‘‘extra heavily sweetened fruit (c) ‘‘Heavy sirup’’, when the liquid juice(s)’’, as the case may be. used is water; or ‘‘heavily sweetened The density ranges referred to herein fruit juice(s) and water’’; or ‘‘heavily are:

Density ranges

(a) (b) (c) (d) Optional berry ingredient Max- Max- Max- Max- imum Min- imum Min- imum Min- imum Min- not imum less imum less imum less imum more than than than than

Blackberries ...... 14 14 19 19 24 24 35 Blueberries ...... 15 15 20 20 25 25 35 Boysenberries ...... 14 14 19 19 24 24 35 Dewberries ...... 14 14 19 19 24 24 35 Gooseberries ...... 14 14 20 20 25 25 35 Huckleberries ...... 15 15 20 20 25 25 35 Loganberries ...... 14 14 19 19 24 24 35 Raspberries ...... 11 15 15 20 20 27 27 35 Strawberries ...... 10 14 14 19 19 27 27 35 Youngberries ...... 14 14 19 19 24 24 35 (a) ‘‘Slightly sweetened water.’’ (b) ‘‘Light sirup.’’ (c) ‘‘Heavy sirup.’’ (d) ‘‘Extra heavy sirup.’’

(4) Optional ingredients. The optional (a) In the cases of a single fruit juice, ingredients referred to in paragraph the name of the juice shall be used in (a)(1) of this section are: lieu of the word ‘‘fruit’’; (i) Natural and artificial flavors. (b) In the case of a combination of (ii) Calcium salts as firming agents two or more fruit juices, the names of provided that the calcium added is no the juices in the order of predominance more than 0.035 percent, calculated as by weight shall either be used in lieu of calcium, of the weight of the finished the word ‘‘fruit’’ in the name of the canned berries. packing medium, or be declared on the (iii) Organic acids. label as specified in paragraph (a)(3) of (5) Labeling requirements. (i) The name this section; and of the food is the appropriate name of (c) In the case of a single fruit juice the berry ingredient specified in para- or a combination of two or more fruit graph (a)(2) of this section. juices any of which are made from con- (ii) The name of the packing medium, centrate(s), the words ‘‘from con- as used in paragraph (a)(3)(i) of this centrate(s)’’ shall follow the word section preceded by ‘‘In’’ or ‘‘Packed ‘‘juice(s)’’ in the name of the packing in.’’ as provided in paragraph (a)(3) of medium and in the name(s) of such this section and, in the case of raspberries other than red raspberries pro- juice(s) when declared as specified in vided for in paragraph (a)(2) of this sec- paragraph (a)(5)(iii) of this section. tion, the name of such packing medium (iii) Whenever the names of the fruit and the color of such raspberry shall be juices used do not appear in the name included as part of the name or in close of the packing medium as provided in proximity to the name of the food. paragraph (a)(5)(ii)(b) of this section, When the liquid portion of the packing such names and the words ‘‘from con- media provided for in paragraphs (a)(3) centrate’’, as specified in paragraph (i) and (ii) of this section consists of (a)(5)(ii)(c) of this section, shall appear fruit juice(s), such juice(s) shall be des- in an ingredient statement pursuant to ignated in the name of the packing me- the requirements of § 101.3(d) of this dium as: chapter.

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(iv) Label declaration. Each of the in- cent by weight of sucrose (degrees gredients used in the food shall be de- Brix) as determined by the procedure clared on the label as required by the prescribed in § 145.3(m) shall be des- applicable sections of parts 101 and 130 ignated by the appropriate name for of this chapter. the respective density ranges, namely: (b) [Reserved] (a) In the case of sweet cherries: [46 FR 2339, Jan. 9, 1981; 47 FR 6426, Feb. 12, (i) When the density of the solution is 1982, as amended at 48 FR 2748, Jan. 21, 1983; less than 16 percent, the medium shall 58 FR 2879, Jan. 6, 1993] be designated as ‘‘slightly sweetened water’’; or ‘‘extra light sirup’’; ‘‘slight- § 145.125 Canned cherries. ly sweetened fruit juice(s) and water’’; (a) Identity—(1) Ingredients. Canned or ‘‘slightly sweetened fruit juice(s)’’, cherries is the food prepared from one as the case may be. of the optional fresh or previously (ii) When the density of the solution canned cherry ingredients specified in is 16 percent or more but less than 20 paragraph (a)(2) of this section, which percent, the medium shall be des- may be packed in one of the optional ignated as ‘‘light sirup’’; ‘‘lightly packing media specified in paragraph sweetened fruit juice(s) and water’’; or (a)(3) of this section. Such food may ‘‘lightly sweetened fruit juice(s)’’, as also contain one, or any combination the case may be. of two or more, of the following safe (iii) When the density of the solution and suitable optional ingredients: is 20 percent or more but less than 25 (i) Natural and artificial flavors. percent, the medium shall be des- (ii) Spice. ignated as ‘‘heavy sirup’’; ‘‘heavily (iii) Vinegar, lemon juice, or organic sweetened fruit juice(s) and water’’; or acids. Such food is sealed in a con- ‘‘heavily sweetened fruit juice(s)’’, as tainer and before or after sealing is so the case may be. processed by heat as to prevent spoil- (iv) When the density of the solution age. is 25 percent or more but not more (2) Varietal types and styles. The op- than 35 percent, the medium shall be tional cherry ingredients referred to in designated as ‘‘extra heavy sirup’’; paragraph (a)(1) of this section are pre- ‘‘extra heavily sweetened fruit juice(s) pared from mature pitted or unpitted and water’’; or ‘‘extra heavily sweet- cherries of the red tart or alter- ened fruit juice(s)’’, as the case may be. natively, red sour, light sweet or dark (b) In the case of red tart cherries: sweet varietal group. (i) When the density of the solution is (3) Packing media. (i) The optional less than 18 percent, the medium shall packing media referred to in paragraph be designated as ‘‘slightly sweetened (a)(1) of this section, as defined in water’’; ‘‘slightly sweetened fruit § 145.3 are: juice(s) and water’’; or ‘‘slightly sweet- (a) Water. ened fruit juice(s)’’, as the case may be. (b) Fruit juice(s) and water. (ii) When the density of the solution (c) Fruit juice(s). is 18 percent or more but less than 22 Such packing media may be used as percent, the medium shall be des- such or any one or any combination of ignated as ‘‘light sirup’’; ‘‘lightly two or more safe and suitable nutritive sweetened fruit juice(s) and water’’; or carbohydrate sweetener(s) may be ‘‘lightly sweetened fruit juice(s)’’, as added. Sweeteners defined in § 145.3 the case may be. shall be as defined therein, except that (iii) When the density of the solution a nutritive carbohydrate sweetener for is 22 percent or more but less than 28 which a standard of identity has been percent, the medium shall be des- established in part 168 of this chapter ignated as ‘‘heavy sirup’’; ‘‘heavily shall comply with such standard in lieu sweetened fruit juice(s) and water’’; or of any definition that may appear in ‘‘heavily sweetened fruit juice(s)’’, as § 145.3. the case may be. (ii) When a sweetener is added as a (iv) When the density of the solution part of any such liquid packing me- is 28 percent or more but not more dium, the density range of the result- than 45 percent, the medium shall be ing packing medium expressed as per- designated as ‘‘extra heavy sirup’’;

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‘‘extra heavily sweetened fruit juice(s) the word ‘‘fruit’’ in the name of the and water’’; or ‘‘extra heavily sweet- packing medium, or be declared on the ened fruit juice(s)’’, as the case may be. label as specified in paragraph (4) Labeling requirements. (i) The name (a)(4)(iii) of this section; and of the food is ‘‘cherries’’. The optional (c) In the case of a single fruit juice varietal type as set forth in paragraph or a combination of two or more fruit (a)(2) of this section, preceded or fol- juices any of which are made from con- lowed by the word ‘‘pitted’’ when this centrate(s), the words ‘‘from con- is the fact, shall be a part of the name. centrate(s)’’ shall follow the word The name of the food shall also include ‘‘juice(s)’’ in the name of the packing a declaration of any flavoring that medium and in the name(s) of such characterizes the product as specified juice(s) when declared as specified in in § 101.22 of this chapter and a declara- paragraph (a)(4)(iii) of this section. tion of any spice or seasoning that (iii) Whenever the names of the fruit characterizes the product; for example, juices used do not appear in the name ‘‘Spice added’’, or in lieu of the word of the packing medium as provided in ‘‘Spice’’, the common name of the paragraph (a)(4)(ii)(b) of this section, spice, or ‘‘Seasoned with lemon juice’’. such names and the words ‘‘from con- When two or more of the optional in- centrate’’, as specified in paragraph gredients specified in paragraph (a)(1) (a)(4)(ii)(c) of this section, shall appear (ii) and (iii) of this section are used, in an ingredient statement pursuant to such words may be combined as for ex- the requirements of § 101.3(d) of this ample, ‘‘Seasoned with cider vinegar, chapter. cloves, and cinnamon oil’’. (iv) Label declaration. Each of the in- (ii) The color type and style of the gredients used in the food shall be de- cherry ingredient as provided in para- clared on the label as required by the graph (a)(2) of this section and the applicable sections of parts 101 and 130 name of the packing medium specified of this chapter. in paragraphs (a)(3) (i) and (ii) of this section, preceded by ‘‘In’’ or ‘‘Packed (b) Quality. (1) The standard of qual- in’’ or the words ‘‘solid pack’’, where ity for canned cherries is as follows: applicable, shall be included as part of (i) In the case of pitted cherries, not the name or in close proximity to the more than 1 pit is present in each 20 name of the food. When the packing ounces of canned cherries, as deter- medium is prepared with a sweetener(s) mined by the method prescribed in which imparts a taste, flavor or other paragraph (b)(2)(i) of this section. characteristic to the finished food in (ii) In the case of unpitted cherries, addition to sweetness, the name of the the weight of each cherry in the con- packing medium shall be accompanied tainer is not less than 1⁄10 ounce. by the name of such sweetener(s), as (iii) In the case of unpitted cherries, for example in the case of a mixture of the weight of the largest cherry in the brown sugar and honey, an appropriate container is not more than twice the statement would be ‘‘lll sirup of weight of the smallest cherry therein. brown sugar and honey’’ the blank to (iv) In the case of unpitted cherries, be filled in with the word ‘‘light’’, the total weight of pits is not more ‘‘heavy’’, or ‘‘extra heavy’’ as the case than 12 percent of the weight of may be. When the liquid portion of the drained cherries, as determined by the packing media provided for in para- method prescribed in paragraph graphs (a)(3) (i) and (ii) of this section (b)(2)(ii) of this section. consists of fruit juice(s), such juice(s) (v) Not more than 15 percent by shall be designated in the name of the count of the cherries in the container packing medium as: are blemished with scab, hail injury, (a) In the case of a single fruit juice, discoloration, scar tissue or other ab- the name of the juice shall be used in normality. A cherry showing skin dis- lieu of the word ‘‘fruit’’; coloration (other than scald) having an (b) In the case of a combination of aggregate area exceeding that of a cir- two or more fruit juices, the names of cle 9⁄32 inch in diameter is considered to the juices in the order of predominance be blemished. A cherry showing discol- by weight shall either be used in lieu of oration of any area but extending into

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the fruit tissue is also considered to be www.archives.gov/federallregister/ blemished. codeloflfederallregulations/ (2)(i) Pitted canned cherries shall be ibrllocations.html. Without shifting the tested by the following method to de- cherries, so incline the sieve as to fa- termine whether or not they comply cilitate drainage. Two minutes from with the requirements of paragraph the time drainage begins, weigh the (b)(1)(i) of this section: Take at random sieve and drained cherries. The weight such number of containers as to have a so found, less the weight of the sieve, total quantity of contents of at least 24 shall be considered to be the weight of pounds. Open the containers and weigh drained cherries. Pit the cherries and the contents. Count the pits and pieces wash the pits free from adhering flesh. of pit shell in such total quantity. Drain and weigh the pits by the meth- Count a piece of pit shell equal to or od prescribed above. Divide the weight smaller than one-half pit shell as one- half pit, and a piece of pit shell larger of pits so found by the weight of than one-half pit shell as one pit; but drained cherries, and multiply by 100. when two or more pieces of pit shell (3) If the quality of canned cherries are within or attached to a single cher- falls below the standard prescribed in ry, count such pieces as one-half pit if paragraph (b)(1) of this section, the their combined size is equivalent to label shall bear the general statement that of one-half pit shell or less, and as of substandard quality specified in one pit if their combined size is equiva- § 130.14(a) of this chapter, in the man- lent to that of more than one-half pit ner and form therein specified; but in shell. From the total number of pits so lieu of such general statement of sub- counted and the combined weight of standard quality, the label may bear the contents of all the containers, cal- the alternative statement ‘‘Below culate the number of pits present in Standard in Quality lll’’, the blank each 20 ounces of canned cherries. to be filled in with the words specified (ii) Unpitted canned cherries shall be after the corresponding number of each tested by the following method to de- subparagraph of paragraph (b)(1) of this termine whether or not they comply section which such canned cherries fail with the requirements of paragraph to meet, as follows: (b)(1)(iv) of this section: Tilt the (i) ‘‘Partially pitted’’; opened container so as to distribute (ii) ‘‘Small’’; the contents over the meshes of a circular sieve which has previously been (iii) ‘‘Mixed sizes’’; weighed. The diameter of the sieve is 8 (iv) ‘‘Thin-fleshed’’; inches if the quantity of the contents (v) ‘‘Blemished’’. of the container is less than 3 pounds, Such alternative statement shall im- or 12 inches if such quantity is 3 pounds mediately and conspicuously precede or more. The bottom of the sieve is No. or follow, without intervening written, 8 woven-wire cloth that complies with printed, or graphic matter, the name the specifications for such cloth set ‘‘Cherries’’ and any words and state- forth in the ‘‘Official Methods of Anal- ysis of the Association of Official Ana- ments required or authorized to appear lytical Chemists,’’ 13th Ed. (1980), with such name by § 145.125(a)(2). Table 1, ‘‘Nominal Dimensions of (c) Fill of container. (1) The standard Standard Test Sieves (U.S.A. Standard of fill of container for canned cherries Series),’’ under the heading ‘‘Defini- is the maximum quantity of the options of Terms and Explanatory tional cherry ingredient that can be Notes,’’ which is incorporated by ref- sealed in the container and processed erence. Copies may be obtained from by heat to prevent spoilage, without the AOAC INTERNATIONAL, 481 North crushing such ingredient. Frederick Ave., suite 500, Gaithersburg, (2) If canned cherries fall below the MD, 20877–2504, or may be examined at standard of fill of container prescribed the National Archives and Records Ad- in paragraph (c)(1) of this section, the ministration (NARA). For information label shall bear the general statement on the availability of this material at of substandard fill specified in NARA, call 202–741–6030, or go to: http://

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§ 130.14(b) of this chapter, in the man- of two or more of the following safe ner and form therein specified. and suitable optional ingredients: (1) Natural and artificial flavoring. [42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, (2) Spice. 1984; 54 FR 24895, June 12, 1989; 58 FR 2879, (3) Vinegar. Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] (4) Unpeeled segments of citrus fruits. § 145.126 Artificially sweetened canned (5) Salt. cherries. (a) Artificially sweetened canned Such food is sealed in a container and cherries is the food which conforms to before or after sealing is so processed the definition and standard of identity by heat as to prevent spoilage. prescribed for canned cherries by (b) Varietal types. The optional fig in- § 145.125(a), except that in lieu of a gredients referred to in paragraph (a) packing medium specified in of this section are prepared from ma- § 145.125(a)(3), the packing medium used ture figs of the light or dark varieties. is water artificially sweetened with Figs (or whole figs), split figs (or bro- saccharin, sodium saccharin, or a com- ken figs), or any combination thereof bination of both. Such packing medium are optional fig ingredients. A ‘‘whole may be thickened with pectin and may fig’’ is one which is whole, but may be contain any mixture of any edible or- slightly cracked, provided it retains its ganic salt or salts and any edible or- natural conformation without exposing ganic acid or acids as a flavor-enhanc- the interior. A ‘‘split’’ or ‘‘broken’’ fig ing agent, in a quantity not more than is one that is open to such an extent is reasonably required for that purpose. that the seed cavity is exposed. The (b)(1) The specified name of the food shape of the fruit may be distorted, and is ‘‘artificially sweetened lll’’, the the fruit may or may not be broken blank being filled in with the name apart into entirely separate pieces. prescribed by § 145.125(a) for canned (c) Packing media. (1) The optional cherries having the same optional cher- packing media referred to in paragraph ry ingredient. (a) of this section, as defined in § 145.3 (2) The artificially sweetened food is are: subject to the requirements for label (i) Water. statement of ingredients used, as pre- (ii) Fruit juice(s) and water. scribed for canned cherries by (iii) Fruit juice(s). § 145.125(a). If the packing medium is Such packing media may be used as thickened with pectin, the label shall such or any one or any combination of bear the statement ‘‘thickened with two or more safe and suitable nutritive pectin’’. When any organic salt or acid carbohydrate sweetener(s) may be or any mixture of two or more of these added. Sweeteners defined in § 145.3 is added, the label shall bear the com- shall be as defined therein, except that mon or usual name of each such ingre- a nutritive carbohydrate sweetener for dient. which a standard of identity has been [42 FR 14414, Mar. 15, 1977, as amended at 58 established in part 168 of this chapter FR 2879, Jan. 6, 1993] shall comply with such standard in lieu of any definition that may appear in § 145.130 Canned figs. § 145.3. (a) Ingredients. Canned figs is the food (2) When a sweetener is added as a prepared from one of the optional fig part of any such liquid packing me- ingredients specified in paragraph (b) dium, the density range of the result- of this section and one of the optional ing packing medium expressed as per- packing media specified in paragraph cent by weight of sucrose (degrees (c) of this section, to which lemon Brix) as determined by the procedure juice, concentrated lemon juice or or- prescribed in § 145.3(m) shall be des- ganic acid(s) is added, when necessary ignated by the appropriate name for to reduce the pH of the finished prod- the respective density ranges, namely: uct to pH 4.9 or below. Such food may (i) When the density of the solution also contain one, or any combination is 11 percent or more but less than 16

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percent, the medium shall be des- than sweetness, as for example, a mix- ignated as ‘‘slightly sweetened water’’; ture of brown sugar and honey, the or ‘‘extra light syrup’’; ‘‘slightly sweet- statement ‘‘lll sirup of brown sugar ened fruit juice(s) and water’’; or and honey’’ the blank to be filled in ‘‘slightly sweetened fruit juice(s)’’, as with the word ‘‘light’’, ‘‘heavy’’, or the case may be. ‘‘extra heavy’’, as the case may be, (ii) When the density of the solution shall be included as part of the name or is 16 percent or more but less than 21 in close proximity to the name of the percent, the medium shall be des- food. When the liquid portion of the ignated as ‘‘light sirup’’; ‘‘lightly packing media provided for in para- sweetened fruit juice(s) and water’’; or graphs (c) (1) and (2) of this section ‘‘lightly sweetened fruit juice(s)’’, as consists of fruit juice(s), such juice(s) the case may be. shall be designated in the name of the (iii) When the density of the solution packing medium as: is 21 percent or more but less than 26 (i) In the case of a single fruit juice, percent, the medium shall be des- the name of the juice shall be used in ignated as ‘‘heavy sirup’’; ‘‘heavily lieu of the word ‘‘fruit’’; sweetened fruit juice(s) and water’’; or (ii) In the case of a combination of ‘‘heavily sweetened fruit juice(s)’’, as two or more fruit juices, the names of the case may be. the juices in the order of predominance (iv) When the density of the solution by weight shall either be used in lieu of is 26 percent or more but not more than the word ‘‘fruit’’ in the name of the 35 percent, the medium shall be des- packing medium, or be declared on the ignated as ‘‘extra heavy sirup’’; ‘‘extra label as specified in paragraph (d)(3) of heavily sweetened fruit juice(s) and this section; and water’’; or ‘‘extra heavily sweetened (iii) In the case of a single fruit juice fruit juice(s)’’, as the case may be. or a combination of two or more fruit (d) Labeling requirements. (1) The juices any of which are made from con- name of the food is ‘‘figs’’. The words centrate(s), the words ‘‘from con- ‘‘broken’’ or ‘‘split’’ shall be a part of centrate(s)’’ shall follow the word the name when the optional fig ingre- ‘‘juice(s)’’ in the name of the packing dient is a broken or split fig. The name medium and in the name(s) of such of the food shall also include a declara- juice(s) when declared as specified in tion of any flavoring that characterizes paragraph (d)(3) of this section. the product as specified in § 101.22 of (3) Whenever the names of the fruit this chapter and a declaration of any juices used do not appear in the name spice or seasoning that characterizes of the packing medium as provided in the product; for example, ‘‘Spice paragraph (d)(2)(ii) of this section, such added’’, or in lieu of the word ‘‘Spice’’, names and the words ‘‘from contrate’’, the common name of the spice, ‘‘Sea- as specified in paragraph (d)(2)(iii) of soned with vinegar’’ or ‘‘Seasoned with this section, shall appear in an ingre- unpeeled segments of citrus fruits’’. dient statement pursuant to the re- When two or more of the optional in- quirements of § 101.3(d) of this chapter. gredients specified in paragraphs (a) (2) (4) Label declaration. Each of the in- through (5), inclusive, of this section gredients used in the food shall be de- are used, such words may be combined clared on the label as required by the as for example, ‘‘Seasoned with cider applicable sections of parts 101 and 130 vinegar, cloves, cinnamon oil and of this chapter. unpeeled segments of citrus fruits.’’ (2) The name of the packing medium [42 FR 14414, Mar. 15, 1977, as amended at 58 as used in paragraph (c)(1) of this sec- FR 2879, Jan. 6, 1993] tion, preceded by ‘‘In’’ or ‘‘Packed in’’, as provided in paragraph (c) of this sec- § 145.131 Artificially sweetened canned tion, shall be included as part of the figs. name or in close proximity to the name (a) Artificially sweetened canned figs of the food. When the packing medium is the food which conforms to the defi- is prepared with a sweetener(s) which nition and standard of identity pre- imparts a taste, flavor or other char- scribed for canned figs by § 145.130, ex- acteristic to the finished food other cept that in lieu of a packing medium

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specified in § 145.130(c), the packing me- (iii) Any mixture of optional sweet- dium used is water artificially sweetening ingredients designated in para- ened with saccharin, sodium saccharin, graphs (c)(1) (i) and (ii) of this section. or a combination of both. Such packing (iv) Any of the optional sweetening medium may be thickened with pectin ingredients designated in paragraphs and may contain any mixture of any (c)(1) (i), (ii), and (iii) of this section edible organic salt or salts and any edi- with dextrose: Provided, That the ble organic acid or acids as a flavor-en- weight of the solids of dextrose does hancing agent, in a quantity not more not exceed one-third of the total than is reasonably required for that weight of the solids of the combined purpose. sweetening ingredients. (b)(1) The specified name of the food (v) Any of the optional sweetening is ‘‘artificially sweetened lll’’, the ingredients designated in paragraphs blank being filled in with the name (c)(1) (i), (ii), and (iii) of this section prescribed by § 145.130 for canned figs with corn sirup or with dried corn sirup having the same optional fig ingre- or with glucose sirup or with dried glu- dient. cose sirup, or with any two or more of (2) The artificially sweetened food is these: Provided, That the weight of the subject to the requirements for label solids of corn sirup, dried corn sirup, statement of ingredients used, as pre- glucose sirup, dried glucose sirup or scribed for canned figs by § 145.130. If the sum of the weights of the solids of the packing medium is thickened with corn sirup, dried corn sirup, glucose pectin, the label shall bear the state- sirup, and dried glucose sirup, in case ment ‘‘thickened with pectin’’. When two or more of these are used, does not any organic salt or acid or any mixture exceed one-fourth of the total weight of of two or more of these is added, the the solids of the combined sweetening label shall bear the common or usual ingredients. name of each such ingredient. (vi) Any mixture of the optional ingredients designated in paragraphs [42 FR 14414, Mar. 15, 1977, as amended at 58 (c)(1) (iv) and (v) of this section. FR 2880, Jan. 6, 1993] (2) The density of the packing me- § 145.134 Canned preserved figs. dium described in paragraph (c)(1) of this section, as measured on the Brix (a) Canned preserved figs is the food hydrometer 15 days or more after the prepared from one of the optional fig figs are canned, is not less than 50° and ingredients specified in paragraph (b) not more than 55°. of this section and the packing medium (d)(1) The name of the food is ‘‘Pre- specified in paragraph (c) of this sec- served Figs—Precooked in Sirup’’. For tion, to which citric acid or lemon the purpose of label declaration, the juice or concentrated lemon juice is words ‘‘Precooked in Sirup’’ may ap- added, if necessary, in such quantity as pear immediately below the words to reduce the pH of the finished prod- ‘‘Preserved Figs’’, but there shall be no uct to 4.9 or below. The figs are intervening written, printed, or graph- precooked in the packing medium, ic matter, and the letters used for the sealed in a container, and so processed words ‘‘Precooked in Sirup’’ shall be of by heat, either before or after sealing, the same type style and not less than as to prevent spoilage. one-half the height of the letters in the (b) The optional fig ingredients re- words ‘‘Preserved Figs’’. ferred to in paragraph (a) of this sec- (2) The label shall indicate which option are whole mature figs of the light tional fig ingredient specified in para- or dark varieties that may be either graph (b) of this section is used. peeled or unpeeled. (e) Wherever the name of the food ap- (c)(1) The packing medium referred pears on the label so conspicuously as to in paragraph (a) of this section is to be easily seen under customary con- prepared from water and one of the fol- ditions of purchase, the words herein lowing optional sweetening ingredi- specified, showing the optional fig in- ents: gredient used, shall immediately and (i) Sugar. conspicuously precede or follow such (ii) Invert sugar sirup. name without intervening written,

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printed, or graphic matter, except that labrusca L., not less than 6 percent and the varietal name of the figs may so in- not more than 20 percent. tervene. (v) Cherries. Approximate halves or (f) Label declaration. Each of the in- whole pitted cherries of the species gredients used in the food shall be de- Prunus cerasus L., not less than 2 per- clared on the label as required by the cent and not more than 6 percent, of applicable sections of parts 101 and 130 the following types: of this chapter. (a) Cherries of any light, sweet vari- [42 FR 14414, Mar. 15, 1977, as amended at 58 ety; FR 2880, Jan. 6, 1993] (b) Cherries artificially colored red; or § 145.135 Canned fruit cocktail. (c) Cherries artificially colored red (a) Identity—(1) Ingredients. Canned and flavored, natural or artificial. fruit cocktail, canned cocktail fruits, 1 canned fruits for cocktail, is the food Provided, That each 127.5 grams (4 ⁄2 prepared from the mixture of fresh, fro- ounces avoirdupois) of the finished zen, or previously canned fruit ingredi- canned fruit cocktail and each fraction ents of mature fruits in the forms and thereof greater than 56.7 grams (2 proportions as provided in paragraph ounces avoirdupois) contain not less (a)(2) of this section, and one of the op- than 2 sectors or 3 dice of pineapple tional packing media specified in para- and not less than 1 approximate half of graph (a)(3) of this section. Such food the optional cherry ingredient. may also contain one, or any combina- (3) Packing media. (i) The optional tion of two or more, of the following packing media referred to in paragraph safe and suitable optional ingredients: (a)(1) of this section, as defined in (i) Natural and artificial flavors. § 145.3 are: (ii) Spice. (a) Water. (iii) Vinegar, lemon juice, or organic (b) Fruit juice(s) and water. acids. (c) Fruit juice(s). (iv) Ascorbic acid in an amount no greater than necessary to preserve Such packing media may be used as color. Such food is sealed in a con- such or any one or any combination of tainer and before or after sealing is so two or more safe and suitable nutritive processed by heat as to prevent spoil- carbohydrate sweetener(s) may be age. added. Sweeteners defined in § 145.3 (2) Varietal types and styles. The fruit shall be as defined therein, except that ingredients referred to in paragraph a nutritive carbohydrate sweetener for (a)(1) of this section, the forms of each, which a standard of identity has been and the percent by weight of each in established in part 168 of this chapter the mixture of drained fruit from the shall comply with such standard in lieu finished canned fruit cocktail are as of any definition that may appear in follows: § 145.3. (i) Peaches. Any firm yellow variety (ii) When a sweetener is added as a of the species Prunus persica L., exclud- part of any such liquid packing me- ing nectarine varieties, which are pit- dium, the density range of the result- ted, peeled, and diced, not less than 30 ing packing medium expressed as per- percent and not more than 50 percent. cent by weight of sucrose (degrees (ii) Pears. Any variety, of the species Brix) as determined by the procedure Pyrus communis L. or Pyrus sinensis L., prescribed in § 145.3(m) shall be des- which are peeled, cored, and diced, not ignated by the appropriate name for less than 25 percent and not more than the respective density ranges, namely: 45 percent. (a) When the density of the solution (iii) Pineapples. Any variety, of the is 10 percent or more, but less than 14 species Ananas comosus L., which are percent, the medium shall be des- peeled, cored, and cut into sectors or ignated as ‘‘slightly sweetened water’’; into dice, not less than 6 percent and or ‘‘extra light sirup’’; ‘‘slightly sweet- not more than 16 percent. ened fruit juice(s) and water’’; or (iv) Grapes. Any seedless variety, of ‘‘slightly sweetened fruit juice(s)’’, as the species Vitis vinifera L., or Vitis the case may be.

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(b) When the density of the solution tion of the packing media provided for is 14 percent or more but less than 18 in paragraphs (a)(3) (i) and (ii) of this percent, the medium shall be des- section consists of fruit juice(s), such ignated as ‘‘light sirup’’; ‘‘lightly juice(s) shall be designated in the pack- sweetened fruit juice(s) and water’’; or ing medium as: ‘‘lightly sweetened fruit juice(s)’’, as (a) In the case of a single fruit juice, the case may be. the name of the juice shall be used in (c) When the density of the solution lieu of the word ‘‘fruit’’; is 18 percent or more but less than 22 (b) In the case of a combination of percent, the medium shall be des- two or more fruit juices, the names of ignated as ‘‘heavy sirup’’; ‘‘heavily the juices in the order of predominance sweetened fruit juice(s) and water’’; or by weight shall either be used in lieu of ‘‘heavily sweetened fruit juice(s)’’, as the word ‘‘fruit’’ in the name of the the case may be. packing medium, or be declared on the (d) When the density of the solution label as specified in paragraph is 22 percent or more but not more (a)(4)(iii) of this section; and than 35 percent, the medium shall be (c) In the case of a single fruit juice designated as ‘‘extra heavy sirup’’; or a combination of two or more fruit ‘‘extra heavily sweetened fruit juice(s) juices any of which are made from con- and water’’; or ‘‘extra heavily sweet- centrate(s), the words ‘‘from con- ened fruit juice(s)’’, as the case may be. centrate(s)’’ shall follow the word (4) Labeling requirements. (i) The name ‘‘juice(s)’’ in the name of the packing of the food is ‘‘fruit cocktail’’, ‘‘cock- medium and in the name(s) of such tail fruits’’, or ‘‘fruits for cocktail’’. juice(s) when declared as specified in The name of the food shall also include paragraph (a)(4)(iii) of this section. a declaration of any flavoring that characterizes the product as specified (iii) Whenever the names of the fruit in § 101.22 of this chapter and a declara- juices used do not appear in the name tion of any spice or seasoning that of the packing medium as provided in characterizes the product; for example, paragraph (a)(4)(ii)(b) of this section, ‘‘Spice added’’, or in lieu of the word such names and the words ‘‘from con- ‘‘Spice’’, the common name of the centrate’’, as specified in paragraph spice, ‘‘Seasoned with vinegar’’ or (a)(4)(ii)(c) of this section, shall appear ‘‘Seasoned with lemon juice’’. When in an ingredient statement pursuant to two or more of the optional ingredients the requirements of § 101.3(d) of this specified in paragraphs (a)(1) (ii) and chapter. (iii) of this section are used, such words (iv) Label declaration. Each of the in- may be combined as for example, gredients used in the food shall be de- ‘‘Seasoned with cider vinegar, cloves, clared on the label as required by the cinnamon oil and lemon juice’’. applicable sections of parts 101 and 130 (ii) The name of the packing medium of this chapter. as used in paragraphs (a)(3) (i) and (ii) (b) Quality. (1) The standard of qual- of this section, preceded by ‘‘In’’ or ity for canned fruit cocktail is as fol- ‘‘Packed in’’ shall be included as part lows: of the name or in close proximity to (i) Not more than 20 percent by the name of the food. When the pack- weight of the units in the container of ing medium is prepared with a sweet- peach or pear, or of pineapple if the ener(s) which imparts a taste, flavor or units thereof are diced, are more than other characteristic to the finished 3⁄4 inch in greatest edge dimension, or food in addition to sweetness, the name pass through the meshes of a sieve des- of the packing medium shall be accom- ignated as 5⁄16 inch that complies with panied by the name of such sweet- the specifications for such cloth set ener(s), as for example, in the case of a forth in the ‘‘Official Methods of Anal- mixture of brown sugar and honey, an ysis of the Association of Official Ana- appropriate statement would be ‘‘lll lytical Chemists,’’ 13th Ed. (1980), sirup of brown sugar and honey’’ the Table 1, ‘‘Nominal Dimensions of blank to be filled in with the word Standard Test Sieves (U.S.A. Standard ‘‘light’’, ‘‘heavy’’, or ‘‘extra heavy’’ as Series),’’ under the heading ‘‘Defini- the case may be. When the liquid portions of Terms and Explanatory

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Notes,’’ which is incorporated by ref- termined by the method prescribed in erence. Copies may be obtained from paragraph (c) of this section. the AOAC INTERNATIONAL, 481 North (vi) Not more than 15 percent of the Frederick Ave., suite 500, Gaithersburg, units of cherry ingredient, and not MD 20877, or may be examined at the more than 20 percent of the units of National Archives and Records Admin- peach, pear, or grape, in the container istration (NARA). For information on are blemished with scab, hail injury, the availability of this material at scar tissue or other abnormality. NARA, call 202–741–6030, or go to: http:// (vii) If the cherry ingredient is artifi- www.archives.gov/federallregister/ cially colored, the color of not more codeloflfederallregulations/ than 15 percent of the units thereof in ibrllocations.html. If the units of pine- a container containing more than six apple are in the form of sectors, not units and of not more than one unit in more than 20 percent of such sectors in a container containing six units or the container fail to conform to the less, is other than evenly distributed in following dimensions: The length of the the unit or other than uniform with outside arc is not more than 3⁄4 inch but the color of the other units of the cher- is more than 3⁄8 inch; the thickness is ry ingredient. not more than 1⁄2 inch but is more than (2) If the quality of canned fruit 5⁄16 inch; the length (measured along cocktail falls below the standard pre- the radius from the inside arc to the scribed in paragraph (b)(1) of this sec- outside arc) is not more than 11⁄4 inches tion, the label shall bear the general but is more than 3⁄4 inch. statement of substandard quality spec- (ii) Not more than 10 percent of the ified in § 130.14(a) of this chapter, in the grapes in a container containing 10 manner and form therein specified. grapes or more, and not more than 1 (c) Fill of container. (1) The standard grape in a container containing less of fill of container for canned fruit than 10 grapes, are cracked to the ex- cocktail is a fill such that the total tent of being severed into two parts or weight of drained fruit is not less than are crushed to the extent that their 65 percent of the water capacity of the normal shape is destroyed. container, as determined by the gen- (iii) Not more than 10 percent of the eral method for water capacity of con- grapes in a container containing 10 tainers prescribed in § 130.12(a) of this grapes or more, and not more than a chapter. Such total weight of drained grape in a container containing less fruit is determined by the following than 10 grapes, have the cap stem at- method: Tilt the opened container so tached. as to distribute the contents evenly (iv) There is present in the finished over the meshes of a circular sieve canned fruit cocktail not more than 1 which has been previously weighed. square inch of pear peel per each 1 The diameter of the sieve is 8 inches if pound of drained weight of units of the quantity of contents of the con- pear plus the weight of a proportion of tainer is less than 3 pounds, and 12 the packing medium which is the same inches if such quantity is 3 pounds or proportion as the drained weight of the more. The bottom of the sieve is units of pear bears to the drained woven-wire cloth that complies with weight of the entire contents of the the specifications for such cloth set can. Such drained weights shall be de- forth under ‘‘2.38 mm (No. 8)’’ in Table termined by the method prescribed in 1, ‘‘Nominal Dimensions of Standard paragraph (c) of this section. Test Sieves (U.S.A. Standard Series),’’ (v) There is present in the finished prescribed in paragraph (b)(1)(i) of this canned fruit cocktail not more than 1 section, which is incorporated by ref- square inch of peach peel per each 1 erence. The availability of this incor- pound of drained weight of units of poration by reference is given in para- peach plus the weight of a proportion graph (b)(1)(i) of this section. Without of the packing medium which is the shifting the material on the sieve so in- same proportion as the drained weight cline the sieve as to facilitate drain- of units of peach bears to the drained age. Two minutes from the time drain- weight of the entire contents of the age begins, weigh the sieve and drained can. Such drained weights shall be de- fruit. The weight so found, less the

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weight of the sieve, shall be considered one, or any combination of two or to be the total weight of drained fruit. more, of the following safe and suitable (2) If canned fruit cocktail falls below optional ingredients: the standard of fill of container pre- (1) Natural and artificial flavors. scribed in paragraph (c)(1) of this sec- (2) Spice. tion, the label shall bear the general (3) Vinegar, lemon juice, or organic statement of substandard fill specified acids. in § 130.14(b) of this chapter, in the manner and form therein prescribed. Such food is sealed in a container and before or after sealing is so processed [42 FR 14414, Mar. 15, 1977, as amended at 47 by heat as to prevent spoilage. FR 11829, Mar. 19, 1982; 49 FR 10100, Mar. 19, (b) Varietal types and styles. The op- 1984; 54 FR 24895, June 12, 1989; 58 FR 2880, tional grape ingredients referred to in Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] paragraph (a) of this section are pre- § 145.136 Artificially sweetened canned pared from stemmed grapes of the light fruit cocktail. or dark seedless varieties or from (a) Artificially sweetened canned unstemmed clusters of such grapes. For fruit cocktail is the food which con- the purposes of paragraph (d) of this forms to the definition and standard of section, the names of such optional identity prescribed for canned fruit grape ingredients are ‘‘light seedless cocktail by § 145.135(a), except that in grapes’’ or ‘‘dark seedless grapes’’, as lieu of a packing medium specified in the case may be, preceded by the words § 145.135(a)(3), the packing medium used ‘‘unstemmed clusters’’ where applica- is water artificially sweetened with ble. saccharin, sodium saccharin, or a com- (c) Packing media. (1) The optional bination of both. Such packing medium packing media referred to in paragraph may be thickened with pectin and may (a) of this section, as defined in § 145.3 contain any mixture of any edible or- are: ganic salt or salts and any edible or- (i) Water. ganic acid or acids as a flavor-enhanc- (ii) Fruit juice(s) and water. ing agent, in a quantity not more than (iii) Fruit juice(s). is reasonably required for that purpose. Such packing media may be used as (b)(1) The specified name of the food such or any one or any combination of is ‘‘artificially sweetened fruit cock- two or more safe and suitable nutritive tail’’. carbohydrate sweetener(s) may be (2) The artificially sweetened food is added. Sweeteners defined in § 145.3 subject to the requirements for label shall be as defined therein, except that statement of ingredients used, as pre- a nutritive carbohydrate sweetener for scribed for canned fruit cocktail by which a standard of identity has been § 145.135(a). If the packing medium is established in part 168 of this chapter thickened with pectin, the label shall shall comply with such standard in lieu bear the statement ‘‘thickened with of any definition that may appear in pectin’’. When any organic salt or acid § 145.3. or any mixture of two or more of these (2) When a sweetener is added as a is added, the label shall bear the com- part of any such liquid packing me- mon or usual name of each such ingre- dium, the density range of the result- dient. ing packing medium expressed as per- [42 FR 14414, Mar. 15, 1977, as amended at 58 cent by weight of sucrose (degrees FR 2880, Jan. 6, 1993] Brix) as determined by the procedure prescribed in § 145.3(m) shall be des- § 145.140 Canned seedless grapes. ignated by the appropriate name for (a) Ingredients. Canned seedless the respective density ranges, namely: grapes is the food prepared from one of (i) When the density of the solution the fresh or previously canned optional is less than 14 percent, the medium grape ingredients specified in para- shall be designated as ‘‘slightly sweet- graph (b) of this section which may be ened water’’; or ‘‘extra light sirup’’; packed in one of the optional packing ‘‘slightly sweetened fruit juice(s) and media specified in paragraph (c) of this water’’; or ‘‘slightly sweetened fruit section. Such food may also contain juice(s)’’, as the case may be.

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(ii) When the density of the solution ‘‘heavy’’, or ‘‘extra heavy’’ as the case is 14 percent or more but less than 18 may be. When the liquid portion of the percent, the medium shall be des- packing media provided for in para- ignated as ‘‘light sirup’’; ‘‘lightly graphs (c) (1) and (2) of this section sweetened fruit juice(s) and water’’; or consists of fruit juice(s), such juice(s) ‘‘lightly sweetened fruit juice(s)’’, as shall be designated in the packing me- the case may be. dium as: (iii) When the density of the solution (i) In the case of a single fruit juice, is 18 percent or more but less than 22 the name of the juice shall be used in percent, the medium shall be des- lieu of the word ‘‘fruit’’; ignated as ‘‘heavy sirup’’; ‘‘heavily (ii) In the case of a combination of sweetened fruit juice(s) and water’’; or two or more fruit juices, the names of ‘‘heavily sweetened fruit juice(s)’’, as the juices in the order of predominance the case may be. by weight shall either be used in lieu of (iv) When the density of the solution the word ‘‘fruit’’ in the name of the is 22 percent or more but not more packing medium, or be declared on the than 35 percent, the medium shall be label as specified in paragraph (d)(3) of designated as ‘‘extra heavy sirup’’; this section; and ‘‘extra heavily sweetened fruit juice(s) (iii) In the case of a single fruit juice and water’’; or ‘‘extra heavily sweet- or a combination of two or more fruit ened fruit juice(s)’’, as the case may be. juices any of which are made from con- (d) Labeling requirements. (1) The centrate(s), the words ‘‘from con- name of the food is ‘‘seedless grapes.’’ centrate(s)’’ shall follow the word The name of the food shall also include ‘‘juice(s)’’ in the name of the packing a declaration of any flavoring that medium and in the name(s) of such characterizes the product as specified juice(s) when declared as specified in in § 101.22 of this chapter and a declara- paragraph (d)(3) of this section. tion of any spice or seasoning that (3) Whenever the names of the fruit characterizes the product; for example, juices used do not appear in the name ‘‘Spice added’’, or in lieu of the word of the packing medium as provided in ‘‘Spice’’, the common name of the paragraph (d)(2)(ii) of this section, such spice, or ‘‘Seasoned with lemon juice’’. names and the words ‘‘from con- When two or more of the optional in- centrate’’, as specified in paragraph gredients specified in paragraphs (a) (2) (d)(2)(iii) of this section, shall appear and (3) of this section are used, such in an ingredient statement pursuant to words may be combined as for example, the requirements of § 101.3(d) of this ‘‘Seasoned with cider vinegar, cloves, chapter. and cinnamon oil’’. (4) Label declaration. Each of the in- (2) The color type and style of the gredients used in the food shall be de- grape ingredient as provided in para- clared on the label as required by the graph (b) of this section and the name applicable sections of parts 101 and 130 of the packing medium specified in of this chapter. paragraphs (c) (1) and (2) of this sec- [42 FR 14414, Mar. 15, 1977, as amended at 58 tion, preceded by ‘‘In’’ or ‘‘Packed in’’ FR 2880, Jan. 6, 1993] or the words ‘‘solid pack’’, where applicable, shall be included as part of the § 145.145 Canned grapefruit. name or in close proximity to the name (a) Identity—(1) Product identification. of the food. When the packing medium Canned grapefruit is the food prepared is prepared with a sweetener(s) which from one of the optional grapefruit in- imparts a taste, flavor or other char- gredients specified in paragraph (a)(2) acteristic to the finished food in addi- of this section and one of the optional tion to sweetness, the name of the packing media specified in paragraph packing medium shall be accompanied (a)(3) of this section. Such food may by the name of such sweetener(s), as also contain one or more of the fol- for example in the case of a mixture of lowing safe and suitable optional ingre- brown sugar and honey, an appropriate dients: statement would be ‘‘lll sirup of (i) Spices. brown sugar and honey’’ the blank to (ii) Natural and artificial flavoring. be filled in with the word ‘‘light’’, (iii) Lemon juice.

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(iv) Citric acid. (f) Heavy sirup. (v) Calcium chloride or calcium lac- (g) Slightly sweetened grapefruit tate or a mixture of the two calcium juice and water. salts in a quantity reasonably nec- (h) Lightly sweetened grapefruit essary to firm the grapefruit sections, juice and water. but in no case in a quantity such that (i) Heavily sweetened grapefruit juice the calcium contained in such calcium and water. salt or mixture is more than 0.035 per- (j) Slightly sweetened grapefruit cent by weight of the finished food. juice. (k) Lightly sweetened grapefruit Such food is sealed in a container and, juice. before or after sealing, is so processed (l) Heavily sweetened grapefruit by heat as to prevent spoilage. juice. (2) Optional grapefruit ingredient. The optional grapefruit ingredients referred As used in paragraph (a)(3)(i) of this to in paragraph (a)(1) of this section section, the optional packing medium are prepared from sound, mature grape- ‘‘water’’ means, in addition to water, fruit (Citrus paradisi Macfadyen) of the any mixture of water and grapefruit color types white—produced from juice in which there is less than 50 per- white-fleshed grapefruit, and pink— cent grapefruit juice; the optional produced from pink or red-fleshed packing medium ‘‘grapefruit juice and grapefruit and are in the following water’’ means the liquid packing me- forms of units: Whole sections or bro- dium in which juice of mature grape- ken sections. Each such form of units fruit and water are combined as a liq- or a mixture of such forms of units pre- uid packing medium with not less than pared from a single varietal group 50 percent grapefruit juice and the (color type) is an optional grapefruit term ‘‘grapefruit juice’’ means single ingredient. The core, seeds, and major strength expressed juice of sound, ma- portions of membrane of such ingre- ture fruit. It may be fresh, canned, or dient are removed. For the purpose of made from concentrate. However, if it this section, a grapefruit section is is made from concentrate, the juice considered whole when the unit is in- shall be reconstituted with water to tact or an intact portion of such unit is not less than the soluble solids the not less than 75 percent of its apparent grapefruit juice had before concentra- original size and is not excessively tion. trimmed. (ii) Each of the packing media in (i) For the purpose of paragraph (a)(4) paragraph (a)(3)(i) (d) to (l) of this sec- of this section, the name of the option is prepared with a liquid ingre- tional grapefruit ingredient is: dient and one or more safe and suitable (a) ‘‘Section’’ or ‘‘segments’’, if 50 nutritive carbohydrate sweeteners. percent or more of the drained weight Water is the liquid ingredient from of the food consists of whole sections. which packing media in paragraph (b) ‘‘Broken sections’’ or ‘‘broken (a)(3)(i) (d) to (f) of this section are pre- segments’’, if less than 50 percent of pared. Grapefruit juice and water are the drained weight of the food consists the liquid ingredients from which the of whole sections. packing media in paragraph (a)(3)(i) (g) (ii) The drained weight is determined to (i) of this section are prepared. by the method prescribed in the stand- Grapefruit juice is the liquid ingre- ard of fill of container for canned dient from which the packing media in grapefruit set forth in paragraph (c)(2) paragraph (a)(3)(i) (j) to (l) of this sec- of this section. tion are prepared. If one or more liquid (3) Packing media. (i) The optional nutritive carbohydrate sweeteners and packing media referred to in paragraph grapefruit juice are combined as a liq- (a)(1) of this section are: uid packing medium with not less than (a) Water. 50 percent grapefruit juice, the packing (b) Grapefruit juice and water. medium is as set forth in paragraph (c) Grapefruit juice. (a)(3)(i) (g) to (i) of this section. (d) Slightly sweetened sirup or (iii) The respective densities of pack- slightly sweetened water. ing media in paragraph (a)(3)(i) (d) to (e) Light sirup. (i) of this section as measured on the

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refractometer, expressed as percent by tion of any spice or seasoning that weight sucrose (degrees Brix) with cor- characterizes the product; for example, rection for temperature to the equiva- ‘‘with added spice’’. Whenever the word lent at 20 °C (68 °F), 15 days or more ‘‘sirup’’ is used, it may be alternatively after the grapefruit are canned or the spelled ‘‘syrup’’. When two or more of blended homogenized slurry of the the optional ingredients specified in comminuted entire contents of the con- paragraphs (a)(1) (i), (ii), and (iii) of tainer if canned for less than 15 days, this section are used, such words may according to the ‘‘Official Methods of be combined; for example, ‘‘with added Analysis of the Association of Official cloves and cinnamon oil’’. Analytical Chemists’’ (AOAC), 13th Ed. (ii) The form and style of the grape- (1980), section 31.011 under ‘‘Solids By fruit ingredient as provided for in para- Means of Refractometer—Official Final graph (a)(2) of this section and the Action,’’ and Reference Tables, section name of the packing medium as used in 52.012 (Refractive indices (n) of sucrose paragraph (a)(3) of this section pre- solutions at 20°) and section 52.015 (Re- ceded by ‘‘In’’ or ‘‘Packed in’’ shall be fractive indices of invert sugar solu- included as part of the name. When the tions), which is incorporated by ref- packing medium is prepared from con- erence (copies may be obtained from centrated grapefruit juice, the words the AOAC INTERNATIONAL, 481 North ‘‘from concentrate’’ shall follow the Frederick Ave., suite 500, Gaithersburg, words ‘‘grapefruit juice’’ in the name of MD 20877, or may be examined at the the packing medium. National Archives and Records Admin- (iii) Label declaration. Each of the in- istration (NARA). For information on gredients used in the food shall be de- the availability of this material at clared on the label as required by the NARA, call 202–741–6030, or go to: http:// applicable sections of parts 101 and 130 www.archives.gov/federallregister/ of this chapter. codeloflfederallregulations/ (b) Quality. (1) The standard of qual- ibrllocations.html), but without correc- ity for canned grapefruit is as follows: tion for invert sugar or other substances, are as follows: (i) The food is free from extraneous material such as leaves, portions of (a) Packing media in paragraph leaves, and pieces of peel. (a)(3)(i) (d), (g), and (j) of this section: Twelve percent or more but less than (ii) The finished food contains per 500 16 percent. grams (17.6 ounces) not more than: (b) Packing media in paragraph (a) An aggregate area of 20 square (a)(3)(i) (e), (h), and (k) of this section: centimeters (3.1 square inches) of tough Sixteen percent or more but less than membrane or albedo on the units. 18 percent. (b) Four developed seeds. A seed is (c) Packing media in paragraph considered a developed seed when it (a)(3)(i) (f), (i), and (l) of this section: measures more than 9.0 millimeters Eighteen percent or more. A lot shall (0.35 inches) in any dimension. be deemed to be in compliance for (iii) Not more than 15 percent by packing medium density based on the weight of the drained grapefruit may average value for all the samples ana- be blemished units. A blemished unit is lyzed according to paragraph (b)(2) of a grapefruit section or any portion this section but no container may have thereof which is damaged by lye peel- a value lower than that of the next ing, by discoloration, or by other visi- lower category or 2 percent by weight ble injury. The drained weight is deter- sucrose (degrees Brix) lower if no lower mined by the method prescribed in the category exists. standard of fill of container for canned (4) Labeling requirements. (i) The name grapefruit set forth in paragraph (c)(2) of the food is ‘‘grapefruit’’ or ‘‘pink of this section. grapefruit’’, as appropriate for the (2) Sampling and acceptance procedure. color type of the grapefruit used. The A lot is to be considered acceptable name of the food shall also include a when the number of ‘‘defectives’’ does declaration of any flavoring that char- not exceed the acceptance number in acterizes the product as specified in the sampling plans given in paragraph § 101.22 of this chapter and a declara- (b)(2)(ii) of this section.

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(i) Definitions of terms to be used in Size of container the sampling plans in paragraph Lot size (primary containers) n 1 c 2 (b)(2)(ii) of this section are as follows: (a) Lot. A collection of primary con- NET WEIGHT GREATER THAN 4.5 KG (10 LB) tainers or units of the same size, type 600 or less ...... 13 2 and style manufactured or packed 601–2,000 ...... 21 3 under similar conditions and handled 2,001–7,200 ...... 29 4 as a single unit of trade. 7,201–15,000 ...... 48 6 (b) Lot size. The number of primary 15,001–24,000 ...... 84 9 containers or units in the lot. 24,001–42,000 ...... 126 13 Over 42,000 ...... 200 19 (c) Sample size (n). The total number of sample units drawn for examination 1 n = number of primary containers in sample 2 c = acceptance number from a lot. (d) Sample unit. A container, the en- (3) If the quality of canned grapefruit tire contents of a container, a portion falls below the standard prescribed in of the contents of a container, or a paragraph (b)(1) of this section, the composite mixture of product from label shall bear the general statement small containers that is sufficient for of substandard quality specified in the examination or testing as a single § 130.14(a) of this chapter, in the man- unit. ner and form therein specified; how- (e) Defective. Any sample unit shall be ever, if the quality of the canned grape- regarded as defective when any of the fruit falls below standard with respect defects or conditions specified in the to only one of the factors of quality quality standard (paragraph (b)(1) of specified by paragraph (b)(1) (i), (ii), or this section) and paragraph (c)(3)(i) of (iii) of this section, there may be sub- this section for minimum fill of constituted for the second line of such gen- tainer are present in excess of the stat- eral statement of substandard quality, ed tolerances. ‘‘Good Food—Not High Grade’’, a new (f) Accepted number (c). The maximum line as specified after the cor- number of defective sample units per- responding designation of paragraph mitted in the sample in order to con- (b)(1) of this section which the canned sider the lot as meeting the specified grapefruit fail to meet: requirements. (i) ‘‘Contains extraneous material’’. (g) Acceptable quality level (AQL). The (ii)(a) ‘‘Excessive tough membrane’’. maximum percent of defective sample (b) ‘‘Excessive seeds’’. units permitted in a lot that will be ac- (iii) ‘‘Excessive blemished units’’. cepted approximately 95 percent of the (c) Fill of container. (1) The standard time. of fill of container for canned grape- (ii) Sampling plans and acceptance fruit is: procedure: (i) The fill of grapefruit and packing Size of container medium, as determined by the general Lot size (primary containers) method for fill of container prescribed 1 2 n c in § 130.12(b) of this chapter, is not less NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) than 90 percent of the total capacity of the container. 4,800 or less ...... 13 2 4,801–24,000 ...... 21 3 (ii) The drained weight of grapefruit 24,001–48,000 ...... 29 4 ingredient is not less than 50 percent of 48,001–84,000 ...... 48 6 the water capacity of the container, as 84,001–144,000 ...... 84 9 144,001–240,000 ...... 126 13 determined by the method prescribed Over 240,000 ...... 200 19 in paragraph (c)(2) of this section and the general method for water capacity NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN 4.5 KG (10 LB) of containers prescribed in § 130.12(a) of this chapter. 2,400 or less ...... 13 2 (2) Drained weight is determined by 2,401–15,000 ...... 21 3 15,001–24,000 ...... 29 4 the following method: Tilt the opened 24,001–42,000 ...... 48 6 container so as to distribute the con- 42,001–72,000 ...... 84 9 tents evenly over the meshes of a cir- 72,001–120,000 ...... 126 13 Over 120,000 ...... 200 19 cular sieve which has previously been weighed. The diameter of the sieve is

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20.3 centimeters (8 inches) if the quan- varieties, specified in paragraph (a)(2) tity of contents of the container is less of this section, which may be packed as than 1.4 kilograms (3 pounds) and 30.5 a solid pack or in one of the optional centimeters (12 inches) if such quantity packing media specified in paragraph is 1.4 kilograms (3 pounds) or more. (a)(3) of this section. Such food may The bottom of the sieve is woven-wire also contain one, or any combination cloth that complies with the specifica- of two or more, of the following safe tions for the No. 8 sieve set forth in the and suitable optional ingredients: ‘‘Definitions of Terms and Explanatory (i) Natural and artificial flavors. Notes’’ of the AOAC, 13th Ed. (1980), (ii) Spice. Table 1, which is incorporated by ref- (iii) Vinegar, lemon juice, or organic erence. The availability of this incor- acids. poration by reference is given in para- (iv) Peach pits, except in the cases of graph (a)(3)(iii) of this section. Without peeled whole peaches, in a quantity not shifting the material on the sieve, in- more than 1 peach pit to each 227 ° ° cline the sieve at an angle of 17 to 20 grams (8 ounces) of finished canned to facilitate drainage. Two minutes peaches. after the drainage begins, weigh the (v) Peach kernels, except in the cases sieve and drained grapefruit. The of peeled whole peaches and except weight so found, less the weight of the when the optional ingredient in para- sieve, shall be considered to be the graph (a)(1)(iv) of this section is used. weight of the drained grapefruit. (3)(i) A container that falls below the (vi) Ascorbic acid in an amount no requirement for minimum fill pre- greater than necessary to preserve scribed in paragraph (c)(1)(i) of this color. Such food is sealed in a con- section shall be considered a ‘‘defec- tainer and before or after sealing is so tive’’. The food will be deemed to fall processed by heat as to prevent spoil- below the standard of fill when the age. number of defectives exceeds the ac- (2) Varietal types and styles. The op- ceptance number (c) in the sampling tional peach ingredients referred to in plans prescribed in paragraph (b)(2) of paragraph (a)(1) of this section are pre- this section. pared from mature peaches of the fol- (ii) Canned grapefruit will be deemed lowing optional varietal and color to fall below the standard of fill when types and styles of peach ingredients; the average drained weight of all con- namely: tainers analyzed when sampled accord- (i) The optional varietal types. (a) ing to the sampling plans prescribed in Freestone is the distinct varietal type paragraph (b)(2) of this section is less where the pit separates readily from than that prescribed in paragraph the flesh. (c)(1)(ii) of this section. (b) Clingstone is the distinct varietal (4) If canned grapefruit falls below type where the pit adheres to the flesh. the standard of fill of container pre- (ii) The optional color types—(a) Yel- scribed in paragraph (c)(1) of this sec- low—the varietal types in which the tion, the label shall bear the statement predominant color ranges from pale of substandard fill specified in yellow to rich red orange. § 130.14(b) of this chapter, in the man- (b) White—the varietal types in which ner and form therein specified. the predominant color ranges from white to yellow-white. [42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19, 1982; 49 FR 10100, Mar. 19, (c) Red—the varietal types in which 1984; 54 FR 24895, June 12, 1989; 58 FR 2880, the predominant color ranges from pale Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] yellow to orange red and with varie- gated red coloring other than that as- § 145.170 Canned peaches. sociated with the pit cavity. (a) Identity—(1) Ingredients. Canned (d) Green—varietal types in which the peaches is the food prepared from one flesh has a green tint even when ma- of the fresh, frozen, or previously ture. canned optional peach ingredients (iii) The optional styles of the peach in- Prunus persica L., of commercial can- gredients—(a) Whole—consisting of ning varieties, but excluding nectarine whole peeled unpitted peaches.

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(b) Halves—consisting of peeled pitted (b) When the density of the solution peaches cut into two approximately is 14 percent or more but less than 18 equal parts. percent, the medium shall be des- (c) Halves and pieces—consisting of a ignated as ‘‘light sirup’’; ‘‘lightly mixture in which the peeled pitted sweetened fruit juice(s) and water’’; or peach halves are more than 50 percent ‘‘lightly sweetened fruit juice(s)’’, as by weight. the case may be. (d) Quarters—consisting of peeled pit- (c) When the density of the solution ted peaches cut into four approxi- is 18 percent or more but less than 22 mately equal parts. percent, the medium shall be des- (e) Slices—consisting of peeled pitted ignated as ‘‘heavy sirup’’; ‘‘heavily peaches cut into wedge-shaped sectors. sweetened fruit juice(s) and water’’; or ( ) —consisting of peeled pitted f Dice ‘‘heavily sweetened fruit juice(s)’’, as peaches cut into cube-like parts. the case may be. (g) Chunky—consisting of peeled pitted peaches cut into parts 13 millime- (d) When the density of the solution ters (0.5 inch) or greater in the small- is 22 percent or more but not more est dimension and 44 millimeters (1.75 than 35 percent, the medium shall be inches) or less in the largest dimen- designated as ‘‘extra heavy sirup’’; sion. ‘‘extra heavily sweetened fruit juice(s) (h) Pieces or irregular pieces—con- and water’’; or ‘‘extra heavily sweet- sisting of peeled pitted peaches cut ened fruit juice(s)’’ as the case may be. into parts of irregular shapes and sizes. (4) Labeling requirements. (i) The name (3) Packing media. (i) The optional of the food is ‘‘peaches’’. The optional packing media referred to in paragraph varietal type as set forth in paragraph (a)(1) of this section, as defined in (a)(2)(i) of this section shall be a part § 145.3 are: of the name. The name of the food shall (a) Water. also include a declaration of any fla- (b) Fruit juice(s) and water. voring that characterizes the product (c) Fruit juice(s). as specified in § 101.22 of this chapter Such packing media may be used as and a declaration of any spice or sea- such or any one or any combination of soning that characterizes the product; two or more safe and suitable nutritive for example, ‘‘Spice added’’, or in lieu carbohydrate sweetener(s) may be of the word ‘‘Spice’’, the common name added. Sweeteners defined in § 145.3 of the spice, ‘‘Seasoned with vinegar’’ shall be as defined therein, except that or ‘‘Seasoned with peach kernels’’. a nutritive carbohydrate sweetener for When two or more of the optional in- which a standard of identity has been gredients specified in paragraphs (a)(1) established in part 168 of this chapter (ii) through (v) of this section are used, shall comply with such standard in lieu such words may be combined as for ex- of any definition that may appear in ample, ‘‘Seasoned with cider vinegar, § 145.3. cloves, cinnamon oil and peach ker- (ii) When a sweetener is added as a nels’’. part of any such liquid packing me- (ii) The color type and style of the dium, the density range of the result- peach ingredient as provided for in ing packing medium, expressed as per- paragraphs (a)(2) (ii) and (iii) of this cent by weight of sucrose (degrees section and the name of the packing Brix) as determined by the procedure medium specified in paragraphs (a)(3) prescribed in § 145.3(m), shall be des- (i) and (ii) of this section, preceded by ignated by the appropriate name for ‘‘In’’ or ‘‘Packed in’’ or the words the respective density ranges, namely: ‘‘Solid pack’’, where applicable, shall (a) When the density of the solution be included as part of the name or in is 10 percent or more but less than 14 close proximity to the name of the percent, the medium shall be des- food, except that ‘‘Halves’’ may be al- ignated as ‘‘slightly sweetened water’’; ternately designated as ‘‘Halved’’, or ‘‘extra light sirup’’; ‘‘slightly sweet- ‘‘Halves and pieces’’ as ‘‘Halved and ened fruit juice(s) and water’’; or pieces’’, ‘‘Quarters’’ as ‘‘Quartered’’, ‘‘slightly sweetened fruit juice(s)’’, as ‘‘Slices’’ as ‘‘Sliced’’, and ‘‘Dice’’ as the case may be. ‘‘Diced’’. Pieces or irregular pieces

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shall be designated ‘‘Pieces’’, ‘‘Irreg- applicable sections of parts 101 and 130 ular pieces’’, or ‘‘Mixed pieces of irreg- of this chapter. ular sizes and shapes’’. ‘‘Chunky’’ may (b) Quality. (1) The standard of qual- be designated as ‘‘Chunks’’. The terms ity for canned peaches is as follows: ‘‘Cling’’ and ‘‘Free’’ may be used as op- (i) Maturity. All units tested in ac- tional designations for ‘‘Clingstone’’ cordance with the method prescribed in and ‘‘Freestone’’, respectively. When paragraph (b)(2) of this section are the packing medium is prepared with a pierced by weight of not more than 300 sweetener(s) which imparts a taste, fla- grams (10.6 ounces). vor, or other characteristic to the fin- (ii) Minimum size. In the case of ished food in addition to sweetness, the halves and quarters styles, the weight name of the packing medium shall be of each unit is not less than 17 grams accompanied by the name of such (0.6 ounce) and 8.5 grams (0.3 ounce), re- sweetener(s); as for example in the case spectively. of a mixture of brown sugar and honey, (iii) Uniformity of size—(a) Whole, an appropriate statement would be halves, and quarters. In the case of ‘‘lll sirup of brown sugar and whole, halves, and quarters styles, the honey’’ the blank to be filled in with diameter (width) of the largest unit is the word ‘‘light’’, ‘‘heavy’’, or ‘‘extra not more than 1.5 centimeters (0.6 inch) heavy’’ as the case may be. When the greater than the diameter (width) of liquid portion of the packing media the smallest unit. In containers with provided for in paragraphs (a)(3) (i) and more than 20 units, 2 units may be dis- (ii) of this section consists of fruit regarded in making the determination. juices(s), such juice(s) shall be des- Where a unit has broken in the con- ignated in the name of the packing me- tainer, the combined broken pieces are dium as: to be reassembled to approximate a (a) In the case of a single fruit juice, single unit of the appropriate style. the name of the juice shall be used in (b) Chunky. In the case of chunky lieu of the word ‘‘fruit’’; style, not more than 25 percent of the (b) In the case of a combination of drained weight of the contents of the two or more fruit juices, the names of container consists of units that will the juices in the order of predominance pass through an opening 13 millimeters by weight shall either be used in lieu of (0.5 inch) wide or that are more than 44 the word ‘‘fruit’’ in the name of the millimeters (1.75 inches) along the packing medium, or be declared on the longest cut edge. label as specified in paragraph (iv) Peel. Not more than 15 square (a)(4)(iii) of this section; and centimeters aggregate area of peel per (c) In the case of a single fruit juice 1,000 grams (1.05 square inches per 16 or a combination of two or more fruit ounces) of net weight. Include any peel juices any of which are made from con- adhering to the peach or loose in the centrate(s), the words ‘‘from con- container. centrate(s)’’ shall follow the word (v) Blemished units. Not more than 20 ‘‘juices(s)’’ in the name of the packing percent by count of the units in the medium and in the name(s) of such container are blemished, e.g., with juice(s) when declared as specified in scab, hail injury, discoloration, or paragraph (a)(4)(iii) of this section. other abnormalities. Blemished units (iii) Whenever the names of the fruit are units which contain surface discol- juices used do not appear in the name orations that definitely contrast with of the packing medium as provided in the overall color and may penetrate paragraph (a)(4)(ii)(b) of this section, into the flesh. such names and the words ‘‘from con- (vi) Trimmed units. In the case of centrate’’, as specified in paragraph whole, halves, quarters, and slices (a)(4)(ii)(c) of this section, shall appear styles, all units are untrimmed or are in an ingredient statement pursuant to so trimmed as to preserve normal the requirements of § 101.3(d) of this shape of the units. chapter. (vii) Crushed or broken units. In the (iv) Label declaration. Each of the in- case of whole, halves, halves and gredients used in the food shall be de- pieces, quarters, slices, dice and clared on the label as required by the chunky styles, not more than 5 percent

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by count of the units in containers of the piece by means of a round metal 20 or more units and not more than 1 rod 4 millimeters (0.16 inch) in diame- unit in containers of fewer than 20 ter. To the upper end of the rod is af- units are crushed or broken. A unit fixed a device to which weight can be that has lost its normal shape because added. The rod is held vertically by a of ripeness and bears no mark of crush- support through which it can freely ing shall not be considered crushed or move upward or downward. The lower broken. end of the rod is a plane surface to (viii) Pits and pieces of pit. In the case which the vertical axis of the rod is of all styles, except whole peaches and perpendicular. Adjust the combined when whole peach pits or peach kernels weight of the rod and device to 100 are used as seasoning ingredients, grams (3.53 ounces). Set the receptacle there is not more than one loose pit or so that the surface of test piece is held one loose large hard piece of pit (10 horizontally. Lower the end of the rod millimeters (3⁄8 inch) or larger) or one to the approximate center of such sur- unit of peach (e.g., peach half or peach face, and add weight to the device at a slice) to which one or more large hard uniform, continuous rate of 12 grams pieces of pit are attached per 5.67 kilo- (0.45 ounce) per second until the rod grams (200 ounces) net weight. In addi- pierces the test piece. Weigh the rod tion, there is not more than three of and weighted device. Test all units in any one or any combination of two or containers of 50 units or less, except more, per 2.83 kilograms (100 ounces) those units too small for testing or too net weight of the following: (a) A unit soft for trimming. Test at least 50 to which one or more small hard pieces units, taken at random, in containers of pit less than 10 millimeters (3⁄8 inch) of more than 50 units; but if less than but not less than 1.6 millimeters (1⁄16 50 units are of sufficient size and firm- inch) are attached, (b) a unit to which ness for testing, test those which are of three or more small pieces of pit less sufficient size and firmness. than 1.6 millimeters (1⁄16 inch) are at- (3) Determine compliance as specified tached, or (c) a loose small hard piece in § 145.3(o) except that a lot shall be of pit less than 10 millimeters (3⁄8 inch). deemed to be in compliance for peel, (2) Canned peaches shall be tested by pits, and pieces of pit based on the av- the following method to determine erage of all samples analyzed according whether or not they meet the require- to the sampling plans set out in ments of paragraph (b)(1)(i) of this sec- § 145.3(p). tion: So trim a test piece from the unit (4) If the quality of canned peaches as to fit, with peel surface up, into a falls below the standard prescribed in supporting receptacle. If the unit is of paragraph (b)(1) of this section, the different firmness in different parts of label shall bear the general statement its peel surface, trim the piece from of substandard quality defined in the firmest part. If the piece is § 130.14(a) of this chapter, in the man- unpeeled, remove the peel. The top of ner and form therein specified; how- the receptacle is circular in shape, of 29 ever, if the quality of the canned millimeters (1.125 inches) inside diame- peaches falls below standard with re- ter, with vertical sides; or rectangular spect to only one of the factors of qual- in shape, 19 millimeters (0.75 inch) by ity specified in paragraph (b)(1) (i) 25 millimeters (1 inch) inside measure- through (viii) of this section, there ments, with ends vertical and sides may be substituted for the second line sloping downward and joining at the of such general statement of sub- center at a vertical depth of 19 milli- standard quality (‘‘Good Food—Not meters (0.75 inch). Use the circular re- High Grade’’) a new line, as specified ceptacle for testing units of such size after the corresponding designation of that a test piece can be trimmed there- paragraph (b)(1) of this section which from to fit it. Use the rectangular re- the canned peaches fail to meet, as fol- ceptacle for testing other units. Test lows: (i) ‘‘Not tender’’; (ii) ‘‘Small no unit from which a test piece with a halves’’ or ‘‘Small quarters’’ as the rectangular peel surface at least 13 case may be; (iii) (a) ‘‘Mixed sizes’’; (b) millimeters (0.51 inch) by 25 millime- ‘‘Undersized and/or oversized pieces’’, ters (1 inch) cannot be trimmed. Test (iv) ‘‘Excess peel’’; (v) ‘‘Blemished’’;

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(vi) ‘‘Unevenly trimmed’’; (vii) ‘‘Partly thickened with pectin, the label shall crushed or broken’’; (viii) ‘‘Contains bear the statement ‘‘thickened with pits or pit fragments’’. Such alter- pectin’’. When any organic salt or acid native statement shall immediately or any mixture of two or more of these and conspicuously precede or follow, is added, the label shall bear the com- without intervening written, printed, mon or usual name of each such ingre- or graphic matter, the name ‘‘peaches’’ dient. and any words and statements required [42 FR 14414, Mar. 15, 1977, as amended at 58 or authorized to appear with such FR 2880, Jan. 6, 1993] name by paragraph (a)(2) of this section. § 145.175 Canned pears. (c) Fill of container. (1) The standard (a) Identity—(1) Ingredients. Canned of fill of container for canned peaches pears is the food prepared from one of is the maximum quantity of the op- the fresh or previously canned optional tional peach ingredient that can be pear ingredients Pyrus communis or sealed in the container and processed Pyrus sinensis specified in paragraph by heat to prevent spoilage, without (a)(2) of this section which may be crushing or breaking such ingredient. packed in one of the optional packing (2) If canned peaches fall below the media specified in paragraph (a)(3) of standard of fill of container prescribed this section. Such food may also con- in paragraph (c)(1) of this section, the tain one, or any combination of two or label shall bear the general statement more, of the following safe and suitable of substandard fill specified in optional ingredients. § 130.14(b) of this chapter, in the man- (i) Natural and artificial flavors. ner and form therein specified. (ii) Spice. [42 FR 14414, Mar. 15, 1977, as amended at 46 (iii) Vinegar, lemon juice, or organic FR 33028, June 26, 1981; 50 FR 34677, Aug. 27, acids. 1985; 51 FR 11434, Apr. 3, 1986; 58 FR 2880, Jan. (iv) Artificial colors. 6, 1993] Such food is sealed in a container and § 145.171 Artificially sweetened canned before or after sealing is so processed peaches. by heat as to prevent spoilage. (a) Artificially sweetened canned (2) Styles and forms of units. The op- peaches is the food which conforms to tional pear styles and forms of units the definition and standard of identity referred to in paragraph (a)(1) of this prescribed for canned peaches by section are: § 145.170(a), except that in lieu of a (i) Whole—consisting of peeled or packing medium specified in unpeeled pears with cores removed or § 145.170(a)(3), the packing medium used left in. is water artificially sweetened with (ii) Halves—consisting of peeled or saccharin, sodium saccharin, or a com- unpeeled pears with cores removed and bination of both. Such packing medium cut into two approximately equal may be thickened with pectin and may parts. contain any mixture of any edible or- (iii) Quarters—consisting of peeled ganic salt or salts and any edible or- pears with cores removed and cut into ganic acid or acids as a flavor-enhanc- four approximately equal parts. ing agent, in a quantity not more than (iv) Slices—consisting of peeled pears is reasonably required for that purpose. with cores removed and cut into wedge- (b)(1) The specified name of the food shaped sectors. is ‘‘artificially sweetened lll’’, the (v) Dice—consisting of peeled pears blank being filled in with the name with cores removed and cut into cube- prescribed by § 145.170(a) for canned like parts. peaches having the same optional (vi) Pieces or irregular pieces—con- peach ingredient. sisting of peeled pears with cores re- (2) The artificially sweetened food is moved and cut into parts of irregular subject to the requirements for label shapes and sizes. statement of ingredients used, as pre- (vii) Chunky—consisting of peeled scribed for canned peaches by pears with cores removed and cut into § 145.170(a). If the packing medium is parts 13 millimeters (0.51 inch) or

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greater in the smallest dimension and ‘‘heavily sweetened fruit juice(s)’’, as 44 millimeters (1.75 inches) or less in the case may be. the largest dimension. (d) When the density of the solution (3) Packing media. (i) The optional is 22 percent or more but not more packing media referred to in paragraph than 35 percent, the medium shall be (a)(1) of this section, as defined in designated as ‘‘extra heavy sirup’’; § 145.3 are: ‘‘extra heavily sweetened fruit juice(s) (a) Water. and water’’; or ‘‘extra heavily sweet- (b) Fruit juice(s) and water. ened fruit juice(s)’’, as the case may be. (c) Fruit juice(s). (4) Labeling requirements. (i) The name (d) Clarified juice. of the food is ‘‘pears’’. The name of the food shall also include a declaration of Such packing media may be used as any flavoring that characterizes the such or any one or any combination of product as specified in § 101.22 of this two or more safe and suitable nutritive chapter and a declaration of any spice carbohydrate sweetener(s) may be or seasoning that characterizes the added. Sweeteners defined in § 145.3 product; for example, ‘‘Spice added’’, or shall be as defined therein, except that in lieu of the word ‘‘Spice’’, the com- a nutritive carbohydrate sweetener for mon name of the spice, ‘‘Seasoned with which a standard of identity has been vinegar’’. When two or more of the op- established in part 168 of this chapter tional ingredients specified in para- shall comply with such standard in lieu graphs (a)(1) (ii) and (iii) of this section of any definition that may appear in are used, such words may be combined § 145.30. as for example, ‘‘Seasoned with cider (ii) If the concentration of clarified vinegar, cloves, and cinnamon oil’’. juice is such that the packing medium (ii) The style and forms of units of forms to the density range for one of the pear ingredient as provided in para- the sirups under paragraph (a)(3)(ii) (a), graph (a)(2) of this section and the (b), (c), or (d) of this section, the con- name of the packing medium specified centrated clarified juice is considered in paragraph (a)(3) (i) and (ii) of this to be light sirup, heavy sirup, or extra section, preceded by ‘‘In’’ or ‘‘Packed heavy sirup, as the case may be. When in’’ or the words ‘‘Solid pack’’, where a sweetener is added as a part of any applicable, shall be included as part of such liquid packing medium, the den- the name or in close proximity to the sity range of the resulting packing me- name of the food, except that ‘‘Halves’’ dium expressed as percent by weight of may be alternatively designated as sucrose (degrees Brix) as determined by ‘‘Halved’’, ‘‘Quarters’’ as ‘‘Quartered’’, the procedure in § 145.3(m) shall be des- ‘‘Slices’’ as ‘‘Sliced’’, and ‘‘Dice’’ as ignated by the appropriate name for ‘‘Diced’’. ‘‘Pieces’’ or ‘‘Irregular the respective density ranges, namely: pieces’’ shall be designated as (a) When the density of the solution ‘‘Pieces’’, ‘‘Irregular pieces’’, or ‘‘Mixed is less than 14 percent, the medium pieces of irregular sizes and shapes’’. shall be designated as ‘‘slightly sweet- ‘‘Chunky’’ may be designated as ened water’’; or ‘‘extra light sirup’’; ‘‘Chunks’’. The style of the pear ingre- ‘‘slightly sweetened fruit juice(s) and dient shall be preceded or followed by water’’; or ‘‘slightly sweetened fruit ‘‘Unpeeled’’ when the units are whole juice(s)’’, as the case may be. or halves and are unpeeled. When the (b) When the density of the solution packing medium is prepared with a is 14 percent or more but less than 18 sweetener(s) which imparts a taste, fla- percent, the medium shall be des- vor or other characteristic to the fin- ignated as ‘‘light sirup’’; ‘‘lightly ished food in addition to sweetness, the sweetened fruit juice(s) and water’’; or name of the packing medium shall be ‘‘lightly sweetened fruit juice(s)’’ as accompanied by the name of such the case may be. sweetener(s), as for example in the case (c) When the density of the solution of a mixture of brown sugar and honey, is 18 percent or more but less than 22 an appropriate statement would be percent, the medium shall be des- ‘‘lll sirup of brown sugar and ignated as ‘‘heavy sirup’’; ‘‘heavily honey’’ the blank to be filled in with sweetened fruit juice(s) and water’’; or the word ‘‘light’’, ‘‘heavy’’, or ‘‘extra

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heavy’’, as the case may be. When the container that are most uniform in liquid portion of the packing media size, the weight of the largest unit is provided for in paragraphs (a)(3) (i) and not more than twice the weight of the (ii) of this section consists of fruit smallest unit. In containers with fewer juice(s), such juice(s) shall be des- than 20 units, 1 unit may be dis- ignated in the name of the packing me- regarded in making the determination. dium as: Where a unit has broken in the con- (a) In the case of a single fruit juice, tainer, reassemble the broken pieces to the name of the juice shall be used in approximate a single unit of the appro- lieu of the word ‘‘fruit’’; priate style. (b) In the case of a combination of (b) Chunky. In the case of chunky two or more fruit juices, the names of style, not more than 25 percent of the the juices in the order of predominance drained weight of the contents of the by weight shall either be used in lieu of container consists of units that will the word ‘‘fruit’’ in the name of the pass through an opening 13 millimeters packing medium, or be declared on the (0.51 inch) wide or that are more than label as specified in paragraph 44 millimeters (1.75 inches) along the (a)(4)(iii) of this section; and longest cut edge. (c) In the case of a single fruit juice (iv) Peel (except unpeeled style). Not or a combination of two or more fruit more than 10 square centimeters (1.6 juices any of which are made from con- square inches) of peel adhering to pears centrate(s), the words ‘‘from con- or loose in the container per kilogram centrate(s)’’ shall follow the word (35.3 ounces) of net weight. ‘‘juice(s)’’ in the name of the packing (v) Blemished units. Not more than 20 medium and in the name(s) of such percent by count of the units in the juice(s) when declared as specified in container are blemished with scab, hail paragraph (a)(4)(iii) of this section. injury, discoloration, or other abnor- (iii) Whenever the names of the fruit mality aggregating the area of a circle juices used do not appear in the name more than 6.5 millimeters (0.25 inch) in of the packing medium as provided in diameter; corky or hard spots on outer paragraph (a)(4)(ii)(b) of this section, surfaces aggregating the area of a cir- such names and the words ‘‘from con- cle more than 13 millimeters (0.51 inch) centrate’’, as specified in paragraph in diameter; or dark brown areas ag- (a)(4)(ii)(c) of this section, shall appear gregating the area of a circle less than in an ingredient statement pursuant to 6.5 millimeters (0.25 inch) in diameter the requirements of § 101.3(d) of this which penetrate into the flesh or affect chapter. the appearance of the unit. (iv) Label declaration. Each of the in- (vi) Trimmed units. In the case of gredients used in the food shall be de- whole, halves, and quarters styles, all clared on the label as required by the units are untrimmed or are so trimmed applicable sections of parts 101 and 130 as to preserve normal shape of the of this chapter. unit. (b) Quality. (1) The standard of qual- (vii) Crushed or broken units. In the ity for canned pears is as follows: case of whole, halves, quarter, slices, (i) Maturity. All units tested in ac- dice, and chunky styles, not more than cordance with the method prescribed in 10 percent by count of the units in con- paragraph (b)(2) of this section are tainers of 10 or more units and not pierced by a weight of not more than more than 1 unit in containers of less 300 grams (10.6 ounces). than 10 units are crushed or broken. A (ii) Minimum size. In the case of unit that lost its normal shape because halves and quarters styles, the weight of ripeness and bears no mark of crush- of each unit is not less than 17 grams ing shall not be considered to be (0.6 ounce) and 8.5 grams (0.3 ounce), re- crushed or broken. spectively. (viii) Loose core material in all styles (iii) Uniformity of size—(a) Whole, except uncored whole style. Not more halves, and quarters. In the case of than two units of loose core material whole, halves, and quarters styles, per kilogram (35.3 ounces) of net among those units comprising 95 per- weight. A unit of such material is de- cent by count of those present in the fined as a portion of loose core, with or

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without seeds, aggregating approxi- so that the surface of the test piece is mately one-half of a pear core. held horizontally. Lower the end of the (ix) Partially cored units in all styles rod to the approximate center of such except uncored whole style. Not more surface, and add weight to the device than 40 percent by count partially at a uniform, continuous rate of 12 cored units in halves, quarters, slices, grams (0.42 ounce) per second until the and pieces or irregular pieces styles rod pierces the test piece. Weigh the and not more than 5 percent by weight rod and weighted device. Test all units in dice style. A partially cored unit is in containers of 50 units or less except a unit of pear that contains an at- those units too small for testing or too tached portion of the seed cell cavity. soft for trimming. Test at least 50 (x) Seeds in all styles except whole units, taken at random in containers of uncored style. Not more than 8 seeds or more than 50 units; but if less than 50 the equivalent in pieces of seeds per units are of sufficient size and firmness kilogram (35.3 ounces) of net weight. for testing, test those which are of suf- Seeds included as cored material in ficient size and firmness. paragraph (b)(1) (viii) and (ix) of this (3) Determine compliance as specified section shall not be counted a second in § 145.3(o) except that a lot shall be time. deemed to be in compliance for peel in (2) Canned pears shall be tested by all styles except unpeeled styles and the following method to determine seeds in all styles except whole uncored whether they meet the requirements of style based on the average of all sam- paragraph (b)(1)(i) of this section: So ples analyzed according to the sam- trim a test piece from the unit as to pling plans set out in § 145.3(p). fit, with peel surface up, into a sup- (4) If the quality of canned pears falls porting receptacle. If the unit is of dif- below the standard prescribed in para- ferent firmness in different parts of its graph (b)(1) of this section, the label peel surface, trim the piece from the shall bear the general statement of firmest part. If the piece is unpeeled, substandard quality specified in remove the peel. The top of the recep- § 130.14(a) of this chapter, in the man- tacle is circular in shape, of 28.6 milli- ner and form therein specified; how- meters (1.12 inches) inside diameter, ever, if the quality of the canned pears with vertical sides; or rectangular in falls below standard with respect to shape, 19 millimeters (0.75 inch) by 25.4 only one of the factors of quality speci- millimeters (1 inch) inside measure- fied in paragraph (b)(1) (i) through (x) ments, with ends vertical and sides of this section, there may be sub- sloping downward and joining at the stituted for the second line of such gen- center at a vertical depth of 19 milli- eral statement of substandard quality meters (0.75 inch). Use the circular re- (‘‘Good Food—Not High Grade’’) a new ceptacle for testing units of such size line, as specified after the cor- that a test piece can be trimmed there- responding designation of paragraph from to fit it. Use the rectangular re- (b)(1) of this section which the canned ceptacle for testing other units. Test pears fail to meet, as follows: no unit from which a test piece with (i) ‘‘Not tender’’; rectangular peel surface at least 13 (ii) ‘‘Small halves’’ or ‘‘small quar- millimeters (0.51 inch) by 25.4 millimeters’’, as the case may be; ters (1 inch) cannot be trimmed. Test (iii)(a) ‘‘Mixed sizes’’; the piece by means of a round metal (b) ‘‘Undersized and/or oversized rod 4 millimeters (0.16 inch) in diame- pieces’’; ter. To the upper end of the rod is af- (iv) ‘‘Excessive peel’’; fixed a device to which weight can be (v) ‘‘Blemished’’; added. The rod is held vertically by the (vi) ‘‘Unevenly trimmed’’; support through which it can freely (vii) ‘‘Partly crushed or broken’’; move upward or downward. The lower (viii) ‘‘Excessive core’’; end of the rod is a plane surface to (ix) ‘‘Excessive core’’; which the vertical axis of the rod is (x) ‘‘Excessive seeds’’. perpendicular. Adjust the combined Such alternative statement shall im- weight of the rod and device to 100 mediately and conspicuously precede grams (3.5 ounces). Set the receptacle or follow, without intervening written,

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printed, or graphic matter, the name added, the label shall bear the common ‘‘pears’’ and any words and statements or usual name of each such ingredient. required or authorized to appear with [42 FR 14414, Mar. 15, 1977, as amended at 58 such name by paragraph (a)(2) of this FR 2880, Jan. 6, 1993] section. (c) Fill of container. (1) The standard § 145.180 Canned pineapple. of fill of container for canned pears is (a) Identity—(1) Ingredients. Canned the maximum quantity of the optional pineapple is the food prepared from pear ingredient that can be sealed in mature, fresh or previously canned, the container and processed by heat to pineapple conforming to the character- prevent spoilage, without crushing or istics of Ananas comosus (L.) Merrill breaking such ingredient. and from which peel and core have been (2) If canned pears fall below the removed. The food consists of one of standard of fill of container prescribed the optional styles of the pineapple in- in paragraph (c)(1) of this section, the gredient specified in paragraph (a)(2) of label shall bear the general statement this section and may be packed in one of substandard fill specified in of the optional packing media specified § 130.14(b) of this chapter, in the man- in paragraph (a)(3) of this section, ex- ner and form therein specified. cept water is not a suitable packing medium for crushed style. Crushed [42 FR 14414, Mar. 15, 1977, as amended at 47 style additionally may be packed as FR 41528, 41530, Sept. 21, 1982; 58 FR 2880, Jan. heavy or solid pack as specified in 6, 1993] paragraph (a)(4) of this section. The food may also contain one, or any com- § 145.176 Artificially sweetened canned bination of two or more, of the fol- pears. lowing safe and suitable optional ingre- (a) Artificially sweetened canned dients: pears is the food which conforms to the (i) Natural fruit flavors. definition and standard of identity pre- (ii) Mint flavor. scribed for canned pears by § 145.175(a) (iii) Spices, spice oils. except that in lieu of a packing me- (iv) Vinegar or organic acids. dium specified in § 145.175(a)(3), the (v) Dimethylpolysiloxane in an packing medium used is water artifi- amount not greater than 10 milligrams/ cially sweetened with saccharin, so- kilogram (10 parts per million) by dium saccharin, or a combination of weight of the finished food as a defoam- both. Such packing medium may be ing agent. thickened with pectin and may contain any mixture of any edible organic salt The food is sealed in a container and, before or after sealing, is so processed or salts and any edible organic acid or by heat as to prevent spoilage. acids as a flavor-enhancing agent, in a (2) Styles of pack. The optional styles quantity not more than is reasonably of the pineapple ingredients referred to required for that purpose. in paragraph (a)(1) of this section are: (b)(1) The specified name of the food (i) Slices or whole slices or rings—con- is ‘‘artificially sweetened lll’’, the sisting of uniformly cut circular slices blank being filled in with the name or rings cut across the axis of the prescribed by § 145.175(a) for canned peeled, cored pineapple cylinders. pears having the same optional pear in- (ii) Half slices—consisting of uni- gredient. formly cut, approximately semi- (2) The artificially sweetened food is circular halves of slices. subject to the requirements for label (iii) Quarter slices—consisting of uni- statement of ingredients used, as pre- formly cut, one-fourth portions of scribed for canned pears by § 145.175(a). slices. If the packing medium is thickened (iv) Broken slices—consisting of arc- with pectin, the label shall bear the shaped portions which may not be uni- statement ‘‘thickened with pectin’’. form in size and/or shape. When any organic salt or acid or any (v) Spears or fingers—consisting of mixture of two or more of these is long, slender pieces cut radially and

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lengthwise of the cored pineapple cyl- (a)(3)(ii)(a), (b), and (c) of this section inder, predominantly 65 millimeters with dextrose, as long as the weight of (2.5 inches) or longer. the solids of dextrose does not exceed (vi) Tidbits—consisting of reasonably one-third of the total weight of the sol- uniform, wedge-shaped sectors cut ids of the combined sweetening ingredi- from slices or portions thereof, pre- ents. dominantly from 8 millimeters (0.31 (e) Any of the optional sweetening in- inch) to 13 millimeters (0.51 inch) gredients designated in paragraph thick. (a)(3)(ii)(a), (b), and (c) of this section (vii) Chunks—consisting of short, with corn sirup or with dried corn sirup thick pieces cut from thick slices and/ or with glucose sirup or with dried glu- or from peeled cored pineapple and pre- cose sirup, or with any two or more of dominantly more than 13 millimeters these, as long as the weight of the sol- (0.51 inch) in both thickness and width, ids of corn sirup, dried corn sirup, glu- and less than 38 millimeters (1.5 inches) cose sirup, dried glucose sirup, or the in length and does not include large sum of the weights of the solids of corn cubes. sirup, dried corn sirup, glucose sirup, (viii) Small cubes or dice—consisting and dried glucose sirup, in case two or of reasonably uniform, cube-shaped more of these are used, does not exceed pieces, predominately 14 millimeters one-fourth of the total weight of the (0.55 inch) or less in the longest edge solids of the combined sweetening in- dimensions. gredients. (ix) Pieces or irregular pieces—con- (f) Any mixture of the optional ingre- sisting of irregular shapes and sizes not dients designated in paragraph identifiable as a specific style and does (a)(3)(ii)(d) and (e) of this section. not include chunks. (iii) If the concentration of clarified (x) Crushed—consisting of finely cut pineapple juice is such that the pack- or finely shredded or grated or diced ing medium conforms to the density pieces of pineapple. range for one of the sirups provided for (xi) Large cubes—consisting of reason- in paragraph (a)(3)(iv)(b), (c), or (d) of ably uniform, cube-shaped pieces, this section, the concentrated clarified longer than 14 millimeters (0.55 inch) juice is considered to be light sirup, along any edge, but predominately 25 heavy sirup, or extra heavy sirup, as millimeters (1 inch) or less in the long- the case may be. est edge dimensions. (iv) When a sweetener is added as a (3) Packing media. (i) The optional part of any liquid packing medium as packing media referred to in paragraph provided for in paragraph (a)(3)(i)(a), (a)(1) of this section and defined in (b), and (c) of this section, the density § 145.3 are: range of the resulting packing medium, (a) Water. expressed as percent by weight of su- (b) Pineapple juice and water. crose (degrees Brix) as determined by (c) Pineapple juice. the procedure in § 145.3(m), shall be des- (d) Clarified pineapple juice. ignated by the appropriate name for Such packing media may be used as the respective density ranges, namely: such, or any one of the optional sweet- (a) When the density of the solution ening ingredients specified in para- is 10 percent or more but less than 14 graph (a)(3)(ii) of this section may be percent, the medium shall be des- added. ignated as ‘‘slightly sweetened water’’ (ii) The optional sweetening ingredi- or ‘‘extra light sirup’’; ‘‘slightly sweet- ents referred to in paragraph (a)(3)(i) of ened pineapple juice and water’’; or this section are: ‘‘slightly sweetened pineapple juice’’, (a) Sugar. as the case may be. (b) Invert sugar sirup. (b) When the density of the solution (c) Any mixture of optional sweet- is 14 percent or more but less than 18 ening ingredients designated in para- percent, the medium shall be des- graph (a)(3)(ii)(a) and (b) of this sec- ignated as ‘‘light sirup’’; ‘‘lightly tion. sweetened pineapple juice and water’’; (d) Any of the optional sweetening or ‘‘lightly sweetened pineapple juice,’’ ingredients designated in paragraph as the case may be.

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(c) When the density of the solution cluded as part of the name or in close is 18 percent or more but less than 22 proximity to the name of the food. The percent, the medium shall be des- word ‘‘slices’’ may be alternatively designated as ‘‘heavy sirup’’; ‘‘heavily ignated ‘‘sliced,’’ ‘‘dice’’ as ‘‘diced,’’ sweetened pineapple juice and water’’; and ‘‘pieces’’ or ‘‘irregular pieces’’ as or ‘‘heavily sweetened pineapple ‘‘mixed pieces of irregular sizes and juice’’, as the case may be. shapes.’’ Whenever pineapple juice, as (d) When the density of the solution provided for in paragraph (a)(3)(i)(c) of is 22 percent or more but not more this section, is used, the declaration than 35 percent, the medium shall be may be preceded by an appropriate designated as ‘‘extra heavy sirup’’; statement such as ‘‘unsweetened’’. ‘‘extra heavily sweetened pineapple (iii) Label declaration. Each of the juice and water’’; or ‘‘extra heavily ingredients used in the food shall be de- sweetened pineapple juice’’, as the case clared on the label as required by the may be. applicable sections of parts 101 and 130 (v) Determine compliance as speci- of this chapter. fied in § 145.3(o). (b) Quality. (1) The standard of qual- (4) Types of pack. The optional types ity for canned pineapple is as follows: of pack for crushed style referred to in (i) Core material. In the case of all paragraph (a)(1) of this section are as styles, not more than 7 percent of the follows: drained weight of the contents of the (i) Heavy pack. Crushed style with or container consists of core material as without sweetening ingredients and determined by the method prescribed containing at least 73 percent drained in paragraph (b)(3)(ii) of this section. fruit weight, as determined by the pro- (ii) Uniformity of weight and shape— cedure set forth in § 145.3(n). (a) Slices. The drained weight of the (ii) Solid pack. Crushed style with or largest unit in the container is not without sweetening ingredients and more than 1.4 times the drained weight containing at least 78 percent drained of the smallest unit. fruit weight, as determined by the pro- (b) Half slices and quarter slices. The cedure set forth in § 145.3(n). drained weight of the largest unit in a (5) Labeling requirements. (i) The name container is not more than 1.75 times of the food is ‘‘pineapple’’. The name of the drained weight of the smallest the food shall also include a declara- unit, except for an occasional broken tion of any flavoring that characterizes piece due to splitting or an occasional the product as specified in § 101.22 of whole slice not completely cut this chapter and a declaration of any through. spice or seasoning that characterizes (c) Broken slices. (1) Not more than 10 the product; for example, ‘‘Spice percent of the drained weight of the added’’, or, in lieu of the word ‘‘Spice’’, contents of the container consists of the common name of the spice; or pieces having an arc of less than 90°. ‘‘Seasoned with vinegar’’ or, in lieu of (2) Not more than 5 percent of the the word ‘‘vinegar’’, the name of the drained weight of the contents of the vinegar used. When two or more of the container: optional ingredients specified in para- (i) Consists of pieces that measure in graph (a)(1)(i) through (iv) of this sec- thickness less than 8 millimeters (0.31 tion are used, such words may be com- inch) or more than 25 millimeters (1 bined, as, for example, ‘‘Seasoned with inch); or cider vinegar, cloves, and cinnamon (ii) Consists of pieces that measure oil’’. less than 19 millimeters (0.75 inch) in (ii) The style of the pineapple ingre- width as measured from the outer edge dient as provided for in paragraph (a)(2) to the inner edge. of this section and the name of the (3) Not more than 5 percent of the packing medium as specified in para- drained weight of the contents of the graph (a)(3)(i) and (ii) of this section, container consists of broken slices hav- preceded by ‘‘In’’ or ‘‘Packed in’’ or the ing an outside diameter differing by as words ‘‘Heavy pack’’ or ‘‘Solid pack’’ much as 9.5 millimeters (0.37 inch) from as specified in paragraph (a)(4) of this that of those present in greatest pro- section, where applicable, shall be in- portion by weight.

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(d) Spears. The drained weight of the tents of the container consists of frag- largest unit in the container is not ments bearing blemishes. more than 1.4 times the drained weight (iv) Excessively trimmed. Slices, half of the smallest unit. slices, and quarter slices are considered (e) Tidbits. Not more than 15 percent excessively trimmed if the portion of the drained weight of the contents of trimmed away exceeds 5 percent of the the container consists of units each of apparent physical bulk of the perfectly which weighs less than three-fourths as formed unit and if the trimming de- much as the average drained weight of stroys the normal circular shape of the all the untrimmed units in the con- outer or inner edge of the unit. Broken tainer. slices, spears, and tidbits are exces- (f) Chunks. Not more than 15 percent sively trimmed if the trimming de- of the drained weight of the contents of stroys the normal shape of the unit. the container consists of pieces weigh- (a) Slices, half slices, and quarter slices. ing less than 5 grams (0.18 ounce) each. Not more than 7.5 percent by count of (g) Cubes. (1) Not more than 10 per- the units in the container may be ex- cent of the drained weight of the con- cessively trimmed, but in containers tents of the container consists of pieces having not more than 10 units, 1 unit that will pass through a screen with may be excessively trimmed; and in square openings of 8 millimeters (0.31 inch) in the case of the small cubes or containers having more than 10 units, large cubes. but not more than 27 units, 2 units may (2) Not more than 15 percent of the be excessively trimmed. drained weight consists of pieces (b) Broken slices and spears. Not more weighing more than 3 grams (0.11 than 15 percent by count of the total ounce) each for small cubes and 18 units in the container may be exces- grams (0.63 ounce) each for large cubes. sively trimmed. (h) Pieces. Not more than 20 percent (c) Tidbits. Not more than 15 percent of the drained weight of the contents of of the drained weight of the contents of the container consists of units that the container consists of excessively will pass through a screen with square trimmed units. openings of 8 millimeters (0.31 inch). (v) Mashed. A unit that has lost its (iii) Blemishes. Blemishes consist of normal shape because of ripeness that surface areas and spots that contrast bears no mark of mechanical injury is strongly in color or texture with the not to be considered mashed. normal pineapple tissue or that may (a) Slices, half slices, and quarter slices. penetrate the flesh. Blemishes are nor- Not more than one unit in containers mally removed in preparation of pine- of 25 units or less, and not more than 3 apple for culinary use and include any units in containers of more than 25 of the following, if in excess of 1.6 mil- units, are mashed. limeters (0.06 inch) in the longest di- (b) Broken slices. Not more than 5 per- mension on the exposed surface of the cent by count of the units in the con- unit: deep fruit eyes, pieces of shell, tainer are mashed. brown spots, bruised portions, and (c) Spears. Not more than 1 unit in other abnormalities. the container is mashed. (a) Slices, half slices, quarter slices, broken slices, spears, tidbits, chunks, cubes, (d) Tidbits. Not more than 3 units in and pieces. Not more than 12.5 percent containers of less than 150 units, and by count of the units in the container not more than 2 percent of the units in may be blemished; but in containers containers of 150 units or more, are having not more than 5 units, 1 unit mashed. may be blemished; in containers having (e) Chunks. Not more than 3 units in more than 5 units, but not more than containers of less than 70 units, and 10 units, 2 units may be blemished and not more than 5 percent of the units in in containers having more than 10 containers of 70 units or more, are units, but not more than 32 units, 4 mashed. units may be blemished. (vi) Acidity. In the case of all styles, (b) Crushed. Not more than 1.5 per- not more than 1.35 grams of acid, cal- cent of the drained weight of the con- culated as anhydrous citric acid, is

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contained in 100 milliliters of the liq- (vii) Except in the case of chunks, uid drained from the product 15 days or cubes, pieces, and crushed pineapple, more after the pineapple is canned. inspect all the units in the container to (vii) Excessive liquid. The drained determine those that have been exces- weight of crushed pineapple is not less sively trimmed, as defined in para- than 63 percent of the net weight of the graph (b)(1)(iv) of this section. contents of the container. (viii) Except in the case of cubes, (2) Sampling and acceptance. Deter- pieces, and crushed pineapple, count mine compliance as specified in the total units in the container and the § 145.3(o). number of mashed units to determine (3) Methodology. The method to be compliance with paragraph (b)(1)(v) of employed to determine whether canned this section. pineapple meets the requirements of (ix) Determine the total acidity of paragraph (b)(1) (i) through (vi) of this the drained liquid by titration, using section are as follows: the following method: Measure with a pipette 10 milliliters of the unfiltered (i) Determine the drained weight of drained liquid into a 250-milliliter Er- the canned pineapple by the procedure lenmeyer flask. Add 25 milliliters of prescribed in § 145.3(n). distilled or deionized water and 0.3 mil- (ii) Identify and separate any core liliter of 1-percent phenolphthalein so- material cleanly from each of the units lution. Titrate with one-tenth normal in the container, and weigh the aggre- sodium hydroxide solution to a faint, gate of the core material. Calculate the permanently pink coloration. Multiply percent core material to determine the number of milliliters of one-tenth compliance with paragraph (b)(1)(i) of normal sodium hydroxide required by this section. 0.064 to calculate the number of grams (iii) In the case of slices, half slices, of anhydrous citric acid per 100 milli- quarter slices, spears, tidbits, chunks, liters of drained liquid to determine and pieces, check the weight of the compliance with paragraph (b)(3)(vi) of units against the requirements of para- this section. graph (b)(1)(ii) (a), (b), (d), (e), (f), and (4) If the quality of canned pineapple (h) of this section. falls below the standard prescribed in (iv) In the case of broken slices, paragraph (b)(1) of this section, the check the dimensions of each unit label shall bear the general statement against the requirements of paragraph of substandard quality specified in (b)(1)(ii)(c) of this section. § 130.14(a) of this chapter, in the man- (v) In the case of cubes, and pieces, ner and form specified in that section; determine compliance with paragraph however, if the quality of the canned (b)(1)(ii) (g) and (h) of this section by pineapple falls below standard with re- placing the units, a few at a time, on spect to only one of the factors of qual- the mesh of a U.S. Standard No. 8 sieve ity specified in paragraph (b)(1)(i) (8-millimeter (0.31 inch)) mesh. After through (vii) of this section, there may shaking gently, remove those units be substituted for the second line of that remain on the sieve before testing the general statement of substandard the next portion. Continue portion- quality (‘‘Good Food—Not High wise until all units are tested, then de- Grade’’) one of the following new lines, termine the aggregate weight of those placed after the corresponding designa- units that have passed through the tion of paragraph (b)(1) of this section sieve. that the canned pineapple fails to (vi) Except in the case of crushed meet: pineapple, segregate and count each (i) ‘‘Poorly cored’’ or ‘‘Excessive unit that is blemished as defined in core’’. paragraph (b)(1)(iii) of this section. In (ii) ‘‘Mixed sizes’’ or ‘‘Irregular small the case of crushed pineapple, seg- pieces’’, as appropriate. regate each fragment of crushed pine- (iii) ‘‘Blemished’’ or ‘‘Contains blem- apple bearing a blemish and determine ished pieces’’. the aggregate weight of such fragments (iv) ‘‘Excessively trimmed’’. to determine compliance with para- (v) ‘‘Mashed units’’ or ‘‘Contains graph (b)(1)(iii)(b) of this section. mashed units’’.

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(vi) ‘‘Excessively tart’’. son varieties conforming to the charac- (vii) ‘‘Contains excess liquid’’. teristics of Prunus insititia L., or cherry (c) Fill of Container. (1) The standard varieties conforming to the character- of fill of container for canned crushed istics of Prunus cerasifera Ehrh. The pineapple is a fill of not less than 90 food consists of one of the optional percent of the total capacity of the styles of the plum ingredient, specified container, as determined by the gen- in paragraph (a)(2) of this section, and eral method for fill of container pre- one of the optional packing media scribed in § 130.12(b) of this chapter. specified in paragraph (a)(3) of this sec- (2) If canned crushed pineapple falls tion. Such food may also contain one, below the standard of fill of container or any combination of two or more of prescribed in paragraph (c)(1) of this the following safe and suitable optional section, the label shall bear the general ingredients: statement of substandard fill specified (i) Natural and artificial flavors. in § 130.14(b) of this chapter, in the (ii) Spice. manner and form therein specified. (iii) Vinegar, lemon juice, or organic [42 FR 14414, Mar. 15, 1977, as amended at 44 acids. FR 40279, July 10, 1979; 45 FR 43391 and 43392, (iv) Artificial coloring. June 27, 1980; 46 FR 57475, Nov. 24, 1981; 48 FR 39916, Sept. 2, 1983; 58 FR 2880, Jan. 6, 1993] Such food is sealed in a container and before or after sealing is so processed § 145.181 Artificially sweetened canned by heat so as to prevent spoilage. pineapple. (2) Optional styles of the plum ingre- (a) Artificially sweetened canned dient. The optional plum ingredients pineapple is the food that conforms to specified in paragraph (a)(1) of this sec- the definition and standard of identity tion are peeled or unpeeled: prescribed for canned pineapple by (i) Whole. § 145.180(a), except that in lieu of a packing medium specified in (ii) Halves. § 145.180(a)(2), the packing medium used Peeled or unpeeled whole plums are is water artificially sweetened with pitted or, alternatively, unpitted. saccharin, sodium saccharin, or a com- Peeled or unpeeled plum halves are pit- bination of both. Such packing medium ted. may be thickened with pectin. (3) Packing media. (i) The optional (b)(1) The specified name of the food packing media referred to in paragraph is ‘‘artificially sweetened lll’’, the (a)(1) of this section, as defined in blank being filled in with the name § 145.3 are: prescribed by § 145.180(a) for canned (a) Water. pineapple having the same optional pineapple ingredient. (b) Fruit juice(s) and water. (2) The artificially sweetened food is (c) Fruit juice(s). subject to the requirements for label Such packing media may be used as statement of ingredients used, as pre- such or any one or any combination of scribed for canned pineapple by two or more safe and suitable nutritive § 145.180(a). If the packing medium is carbohydrate sweetener(s) may be thickened with pectin, the label shall added. Sweeteners defined in § 145.3 bear the statement ‘‘thickened with shall be as defined therein, except that pectin’’. a nutritive carbohydrate sweetener for [42 FR 14414, Mar. 15, 1977, as amended at 58 which a standard of identity has been FR 2880, Jan. 6, 1993] established in part 168 of this chapter shall comply with such standard in lieu § 145.185 Canned plums. of any definition that may appear in (a) Identity—(1) Ingredients. Canned § 145.3. plums is the food prepared from clean, (ii) When a sweetener is added as a sound, and mature fruit of plum vari- part of any such liquid packing me- eties conforming to the characteristics dium, the density range of the result- of Prunus domestica L., greengage vari- ing packing medium expressed as per- eties conforming to the characteristics cent by weight of sucrose (degrees of Prunus italica L., mirabelle or dam- Brix) as determined by the procedure

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prescribed in § 145.3(m) shall be des- ‘‘In’’ or ‘‘Packed in’’ shall be included ignated by the appropriate name for as part of the name or in close prox- the respective density ranges, namely: imity to the name of the food. The (a) When the density of the solution style of the plum ingredient shall be is 11 percent or more but less than 15 preceded or followed by ‘‘Peeled’’ when percent, the medium shall be des- the plums are peeled and by ‘‘Pitted’’ ignated as ‘‘slightly sweetened water’’, in the case of whole pitted plums. or ‘‘extra light sirup’’, ‘‘slightly sweet- ‘‘Halves’’ may be alternatively des- ened fruit juice(s) and water’’ or ignated ‘‘Halved’’. When the packing ‘‘slightly sweetened fruit juice(s)’’, as medium is prepared with a sweetener(s) the case may be. which imparts a taste, flavor or other (b) When the density of the solution characteristics to the finished food in is 15 percent or more, but less than 19 addition to sweetness, the name of the percent, the medium shall be des- packing medium shall be accompanied ignated as ‘‘light sirup’’, ‘‘lightly by the name of such sweetener(s), as sweetened fruit juice(s) and water’’, or for example, in the case of a mixture of ‘‘lightly sweetened fruit juice(s)’’, as brown sugar and honey, an appropriate the case may be. (c) When the density of the solution statement would be ‘‘lll sirup of is 19 percent or more, but less than 25 brown sugar and honey’’, the blank to percent, the medium shall be des- be filled in with the word ‘‘light’’, ignated as ‘‘heavy sirup’’, ‘‘heavily ‘‘heavy’’, or ‘‘extra heavy’’, as the case sweetened fruit juice(s) and water’’, or may be. When the liquid portion of the ‘‘heavily sweetened fruit juice(s)’’, as packing media provided for in para- the case may be. graphs (a)(3) (i) and (ii) of this section (d) When the density of the solution consists of fruit juice(s), such juice(s) is 25 percent or more, but less than 35 shall be designated in the name of the percent, the medium shall be des- packing medium as: ignated as ‘‘extra heavy sirup’’, ‘‘extra (a) In the case of a single fruit juice, heavily sweetened fruit juice(s) and the name of the juice shall be used in water’’, or ‘‘extra heavily sweetened lieu of the word ‘‘fruit’’, fruit juice(s)’’, as the case may be. (b) In the case of a combination of (4) Labeling requirements. (i) The name two or more fruit juices, the names of of the food is ‘‘plums’’ accompanied by the juices in the order of predominance the color designation ‘‘yellow’’ or by weight shall either be used in lieu of ‘‘golden’’ or ‘‘red’’ or ‘‘purple’’, as ap- the word ‘‘fruit’’ in the name of the propriate, or the specific name of the packing medium, or be declared on the variety or ‘‘Greengage plums’’, ‘‘Dam- label as specified in paragraph son plums’’, ‘‘Cherry plums’’, (a)(4)(iii) of this section, and ‘‘Mirabelle plums’’. The name of the (c) In the case of a single fruit juice food shall also include a declaration of or a combination of two or more fruit any flavoring that characterizes the juices any of which are made from con- product as specified in § 101.22 of this centrate(s), the words ‘‘from con- chapter and a declaration of any spice or seasoning that characterizes the centrate(s)’’ shall follow the word product; for example, ‘‘Spice added’’, or ‘‘juice(s)’’ in the name of the packing in lieu of the word ‘‘Spice’’, the com- medium and in the name(s) of such mon name of the spice; ‘‘Seasoned with juice(s) when declared as specified in vinegar’’. When two or more of the op- paragraph (a)(4)(iii) of this section. tional ingredients specified in para- (iii) Whenever the names of the fruit graphs (a)(1) (ii) and (iii) of this section juices used do not appear in the name are used, such words may be combined of the packing medium as provided in as for example, ‘‘Seasoned with cider paragraph (a)(4)(ii)(b) of this section, vinegar, cloves, and cinnamon oil’’. such names and the words ‘‘from con- (ii) The style of the plum ingredient centrate’’, as specified in paragraph as provided in paragraph (a)(2) of this (a)(4)(ii)(c) of this section, shall appear section and the name of the packing in an ingredient statement pursuant to medium specified in paragraphs (a)(3) the requirements of § 101.3(d) of this (i) and (ii) of this section, preceded by chapter.

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(iv) Label declaration. Each of the in- (3) If the quality of canned plums gredients used in the food shall be de- falls below the standard prescribed in clared on the label as required by the paragraph (b)(1) of this section, the applicable sections of parts 101 and 130 label shall bear the general statement of this chapter. of substandard quality specified in (b) Quality. (1) The standard of qual- § 130.14(a) of this chapter, in the man- ity for canned plums is as follows: ner and form therein specified; how- (i) Blemishes (damaged). After drain- ever, if the quality of the canned plums ing in accordance with the procedure falls below standard with respect to set out in § 145.3(n) not more than 30 only one of the factors of quality speci- percent by weight of the drained plums fied in paragraphs (b)(1) (i) through (vi) consists of plums which have been of this section, there may be sub- blemished or damaged by any of the stituted for the second line of such gen- following factors either singly or in eral statement of substandard quality combination: Damaged by insects; ap- (‘‘Good Food—Not High Grade’’) a new pearance or eating quality materially line, as specified after the cor- affected by friction, disease, external responding designation of paragraph stone gum or discoloration. (b)(1) of this section which the canned plums fail to meet, as follows: (ii) Crushed or broken units in whole (i) ‘‘Blemished’’; In the case of the and halves styles. (ii) ‘‘Partly crushed or broken’’; whole styles, not more than 25 percent (iii) ‘‘Blemished and partly crushed by weight of the drained plums are de- or broken’’; formed or broken to an extent that the (iv) ‘‘Contains extraneous plant ma- normal shape of the fruit is seriously terial’’; affected. In the case of the halves style, (v) ‘‘Contains loose pits’’; or not more than 25 percent by weight of (vi) ‘‘Contains pits’’ or ‘‘Contains the drained plums are damaged or torn pieces of pits’’. to such an extent that they are smaller (c) Fill of container. (1) The standard than 50 percent of a plum half. of fill of container for canned plums is: (iii) Blemishes and crushed or broken (i) The fill of the plums and packing units. Not more than 35 percent by medium, as determined by the general weight of the drained plums consist of method for fill of container prescribed both blemishes as specified in para- in § 130.12(b) of this chapter, is not less graph (b)(1)(i) of this section and than 90 percent of the total capacity of crushed or broken units in the case of the container. the whole and halves styles as specified (ii) The drained weight of the plum in paragraph (b)(2)(ii) of this section. ingredient as determined by the meth- (iv) Extraneous plant material. Not od prescribed in § 145.3(n) is not less more than one piece of stalk or stem than 50 percent for whole styles and 55 from the plum tree or other harmless percent for halves styles based on the extraneous plant material per 200 water capacity of containers as deter- grams (7 ounces) of drained plums. mined in § 130.12(a) of this chapter. (v) Loose pits in whole style. Not more (2) Determine compliance for fill of than three loose pits per 500 grams (17.6 container as specified in § 145.3(o). ounces) of drained plums. (3) If canned plums fall below the (vi) Pits or pieces of pits in whole pitted standard of fill of container prescribed and halves styles. Not more than two in paragraph (c)(1) of this section, the pits or pieces of pits per 500 grams (17.8 label shall bear the statement of sub- ounces) of drained plums. standard fill specified in § 130.14(b) of (2) Determine compliance as specified this chapter, in the manner and form in § 145.3(o) except that a lot shall be therein specified. If canned plums fall deemed to be in compliance for extra- below the standard of fill of container neous plant material, loose pits in in respect to drained weight, the words whole style, and pits or pieces of pits in ‘‘Low drained weight’’ shall follow the whole pitted and halves styles based on general statement of substandard fill the average of all samples analyzed ac- on the label. cording to the sampling plans set out [42 FR 14414, Mar. 15, 1977, as amended at 58 in § 145.3(p). FR 2880, Jan. 6, 1993]

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§ 145.190 Canned prunes. ‘‘lightly sweetened fruit juice(s)’’, as (a) Ingredients. Canned prunes is the the case may be. food prepared from dried prunes, which (iii) When the density of the solution may be packed as a solid pack or in one is 24 percent or more but less than 30 of the optional packing media specified percent, the medium shall be des- in paragraph (b) of this section. Such ignated as ‘‘heavy sirup’’; ‘‘heavily food may also contain one, or any com- sweetened fruit juice(s) and water’’; or bination of two or more, of the fol- ‘‘heavily sweetened fruit juice(s)’’, as lowing safe and suitable optional ingre- the case may be. dients: (iv) When the density of the solution (1) Natural and artificial flavors. is 30 percent or more but not more (2) Spice. than 45 percent, the medium shall be (3) Vinegar, lemon juice, or organic designated as ‘‘extra heavy sirup’’; acids. ‘‘extra heavily sweetened fruit juice(s) (4) Unpeeled pieces of citrus fruits. and water’’; or ‘‘extra heavily sweet- Such food is sealed in a container and ened fruit juice(s)’’, as the case may be. before or after sealing is so processed (c) Labeling requirements. (1) The by heat as to prevent spoilage. name of the food is ‘‘prunes—prepared (b) Packing media. (1) The optional from dried prunes’’. The words ‘‘pre- packing media referred to in paragraph pared from dried prunes’’ shall be in (a) of this section, as defined in § 145.3 close proximity to the word ‘‘prunes’’ are: and shall be of the same style and not (i) Water. less than 1⁄2 of the point size of the type (ii) Fruit juice(s) and water. used for the word ‘‘prunes’’. The name (iii) Fruit juice(s). of the food shall also include a declara- Such packing media may be used as tion of any flavoring that characterizes such or any one or any combination of the product as specified in § 101.22 of two or more safe and suitable nutritive this chapter and a declaration of any carbohydrate sweetener(s) may be spice or seasoning that characterizes added. Sweeteners defined in § 145.3 the product; for example, ‘‘Spice shall be as defined therein, except that added’’, or in lieu of the word ‘‘Spice’’, a nutritive carbohydrate sweetener for the common name of the spice, ‘‘Sea- which a standard of identity has been soned with vinegar’’ or ‘‘Seasoned with established in part 168 of this chapter unpeeled pieces of citrus fruit’’. When shall comply with such standard in lieu of any definition that may appear in two or more of the optional ingredients § 145.3. specified in paragraphs (a) (2) through (2) When a sweetener is added as a (4) of this section are used, such words part of any such liquid packing me- may be combined as for example, dium, the density range of the result- ‘‘Seasoned with cider vinegar, cloves, ing packing medium expressed as per- cinnamon oil and unpeeled pieces of cent by weight of sucrose (degrees citrus fruit.’’ Brix) as determined by the procedure (2) When the food is prepared with a prescribed in § 145.3(m) shall be des- packing medium, the name of the ignated by the appropriate name for packing medium specified in para- the respective density ranges, namely: graphs (b) (1) and (2) of this section, (i) When the density of the solution preceded by ‘‘In’’ or ‘‘Packed in’’ and is less than 20 percent, the medium the words ‘‘cooked’’, ‘‘stewed’’, or shall be designated as ‘‘slightly sweet- ‘‘prepared’’, shall be included as part of ened water’’; or ‘‘extra light sirup’’; the name or in close proximity to the ‘‘slightly sweetened fruit juice(s) and name of the food. When no packing me- water’’; or ‘‘slightly sweetened fruit dium is used, the words ‘‘solid pack’’ or juice(s)’’, as the case may be. ‘‘moist pack’’ or the word ‘‘moistened’’ (ii) When the density of the solution followed by the words ‘‘without sirup’’ is 20 percent or more but less than 24 shall be included as part of the name or percent, the medium shall be designated as ‘‘light sirup’’; ‘‘lightly in close proximity to the name of the sweetened fruit juice(s) and water’’; or

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food. When the packing medium is pre- PART 146—CANNED FRUIT JUICES pared with a sweetener(s) which imparts a taste, flavor or other char- Subpart A—General Provisions acteristic to the finished food in addition to sweetness, the name of the Sec. packing medium shall be accompanied 146.3 Definitions. by the name of such sweetener(s), as Subpart B—Requirements for Specific for example in the case of a mixture of Standardized Canned Fruit Juices and brown sugar and honey, an appropriate Beverages statement would be ‘‘lll sirup of brown sugar and honey’’, the blank to 146.114 Lemon juice. be filled in with the word ‘‘light’’, 146.120 Frozen concentrate for lemonade. ‘‘heavy’’, or ‘‘extra heavy’’ as the case 146.121 Frozen concentrate for artificially may be. When the liquid portion of the sweetened lemonade. 146.126 Frozen concentrate for colored lem- packing media provided for in para- onade. graphs (b) (1) and (2) of this section 146.132 Grapefruit juice. consists of fruit juice(s), such juice(s) 146.135 Orange juice. shall be designated in the name of the 146.137 Frozen orange juice. packing medium as: 146.140 Pasteurized orange juice. (i) In the case of a single fruit juice, 146.141 Canned orange juice. the name of the juice shall be used in 146.145 Orange juice from concentrate. lieu of the word ‘‘fruit’’, 146.146 Frozen concentrated orange juice. 146.148 Reduced acid frozen concentrated or- (ii) In the case of a combination of ange juice. two or more fruit juices, the names of 146.150 Canned concentrated orange juice. the juices in the order of predominance 146.151 Orange juice for manufacturing. by weight shall either be used in lieu of 146.152 Orange juice with preservative. the word ‘‘fruit’’ in the name of the 146.153 Concentrated orange juice for manu- packing medium, or be declared on the facturing. label as specified in paragraph (c)(3) of 146.154 Concentrated orange juice with preservative. this section, and 146.185 Pineapple juice. (iii) In the case of the single fruit 146.187 Canned prune juice. juice or a combination of two or more fruit juices any of which are made from AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. concentrate(s), the words ‘‘from concentrate(s)’’ shall follow the word SOURCE: 42 FR 14433, Mar. 15, 1977, unless ‘‘juice(s)’’ in the name of the packing otherwise noted. medium and in the name(s) of such juice(s) when declared as specified in Subpart A—General Provisions paragraph (c)(3) of this section. (3) Whenever the names of the fruit § 146.3 Definitions. juices used do not appear in the name For the purposes of this part: of the packing medium as provided in (a) The term corn sirup means a clari- paragraph (c)(2)(ii) of this section, such fied, concentrated, aqueous solution of names and the words ‘‘from con- the products obtained by the incom- centrate’’, as specified in paragraph plete hydrolysis of cornstarch, and in- (c)(2)(iii) of this section, shall appear in cludes dried corn sirup. The solids of an ingredient statement pursuant to corn sirup and of dried corn sirup con- the requirements of § 101.3(d) of this tain not less than 40 percent by weight chapter. of reducing sugars calculated as anhydrous dextrose. (4) Label declaration. Each of the in- (b) The term dextrose means the hy- gredients used in the food shall be de- drated or anhydrous, refined clared on the label as required by the monosaccharide obtained from applicable sections of parts 101 and 130 hydrolyzed starch. of this chapter. (c) The term dried glucose sirup means [42 FR 14414, Mar. 15, 1977, as amended at 58 the product obtained by drying glucose FR 2880, Jan. 6, 1993] sirup.

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(d) The term glucose sirup means a (vi) Acceptance number (c). The max- clarified, concentrated, aqueous solu- imum number of defective sample units tion of the products obtained by the in- permitted in the sample in order to complete hydrolysis of any edible consider the lot as meeting the speci- starch. The solids of glucose sirup con- fied requirements. tain not less than 40 percent by weight (vii) Acceptable quality level (AQL). of reducing sugars calculated as anhy- The maximum percent of defective drous dextrose. sample units permitted in a lot that (e) The term invert sugar sirup means will be accepted approximately 95 per- an aqueous solution of inverted or cent of the time. partly inverted, refined or partly re- (2) Sampling plans: fined sucrose, the solids of which contain not more than 0.3 percent by Size of container Lot size (primary containers) weight of ash, and which is colorless, n 1 c 2 odorless, and flavorless, except for sweetness. NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) (f) The term sugar means refined su- 4,800 or less ...... 13 2 crose. 4,801 to 24,000 ...... 21 3 (g) Compliance means the following: 24,001 to 48,000 ...... 29 4 Unless otherwise provided in a stand- 48,001 to 84,000 ...... 48 6 ard, a lot of canned fruits shall be 84,001 to 144,000 ...... 84 9 144,001 to 240,000 ...... 126 13 deemed in compliance for the following Over 240,000 ...... 200 19 factors, to be determined by the sampling and acceptance procedure as pro- NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN vided in paragraph (h) of this section, 4.5 KG (10 LB) namely: 2,400 or less ...... 13 2 (1) Quality. The quality of a lot shall 2,401 to 15,000 ...... 21 3 be considered acceptable when the 15,001 to 24,000 ...... 29 4 number of defectives does not exceed 24,001 to 42,000 ...... 48 6 42,001 to 72,000 ...... 84 9 the acceptance number in the sampling 72,001 to 120,000 ...... 126 13 plans. Over 120,000 ...... 200 19 (2) Fill of container. A lot shall be deemed to be in compliance for fill of NET WEIGHT GREATER THAN 4.5 KG (10 LB) container when the number of 600 or less ...... 13 2 defectives does not exceed the accept- 601 to 2,000 ...... 21 3 ance number (c) in the sampling plans. 2,001 to 7,200 ...... 29 4 (h) The sampling and acceptance pro- 7,201 to 15,000 ...... 48 6 cedure means the following: 15,001 to 24,000 ...... 84 9 24,001 to 42,000 ...... 126 13 (1) Definitions—(i) Lot. A collection of Over 42,000 ...... 200 19 primary containers or units of the 1 n = number of primary containers in sample. same size, type, and style manufac- 2 c = acceptance number. tured or packed under similar conditions and handled as a single unit of Subpart B—Requirements for Spe- trade. (ii) Lot size. The number of primary cific Standardized Canned containers or units in the lot. Fruit Juices and Beverages (iii) Sample size. The total number of sample units drawn for examination § 146.114 Lemon juice. from a lot. (a) Identity—(1) Description. Lemon (iv) Sample unit. A container, a por- juice is the unfermented juice, ob- tion of the contents of a container, or tained by mechanical process, from a composite mixture of product from sound, mature lemons (Citrus limon (L.) small containers that is sufficient for Burm. f.), from which seeds (except em- the examination or testing as a single bryonic seeds and small fragments of unit. seed which cannot be separated by good (v) Defective. Any sample unit shall manufacturing practice) and excess be regarded as defective when the sam- pulp are removed. The juice may be ad- ple unit does not meet the criteria set justed by the addition of the optional forth in the standards. concentrated lemon juice ingredient

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specified in paragraph (a)(2) of this sec- (ii) Water and/or lemon juice to re- tion in such quantity so that the in- constitute concentrated lemon juice in crease in acidity, calculated as anhy- the manufacture of lemon juice from drous citric acid, does not exceed 15 concentrate. percent of the acidity of the finished (iii) Preservatives. food. The lemon oil and lemon essence (3) Labeling. (i) The name of the food (derived from lemons) content may be is: adjusted in accordance with good man- (a) ‘‘Lemon juice’’ (1) if the food is ufacturing practice. The juice may prepared from unconcentrated, undi- have been concentrated and later re- luted liquid extracted from mature constituted. When prepared from con- lemons; or (2) if the food is prepared centrated lemon juice, the finished from unconcentrated, undiluted liquid food contains not less than 6 percent, extracted from mature lemons to by weight, of soluble solids taken as which concentrated lemon juice is the refractometric sucrose value (of added to adjust acidity as provided for the filtrate), corrected to 20 °C, but unin paragraph (a)(1) of this section. corrected for acidity, in accordance (b) ‘‘Lemon juice from concentrate’’ with the ‘‘International Scale of Re- or ‘‘reconstituted lemon juice’’ (1) if fractive Indices of Sucrose Solutions’’ the food is prepared from concentrated lemon juice and water and/or lemon in section 52.012 of ‘‘Official Methods of juice; or (2) if the food is prepared from Analysis of the Association of Official lemon juice from concentrate and Analytical Chemists,’’ 13th Ed. (1980), lemon juice. The words ‘‘from con- which is incorporated by reference, and centrate’’ or ‘‘reconstituted’’ shall be has a titratable acidity content of not shown in letters not less than one-half less than 4.5 percent, by weight, cal- the height of the letters in the word culated as anhydrous citrus acid. Cop- ‘‘lemon juice.’’ ies of the incorporation by reference (ii) Label declaration. Each of the in- may be obtained from the AOAC gredients used in the food shall be de- INTERNATIONAL, 481 North Frederick clared on the label as required by the Ave., suite 500, Gaithersburg, MD 20877, applicable sections of parts 101 and 130 or may be examined at the National of this chapter. Archives and Records Administration (b) [Reserved] (NARA). For information on the avail- (c) Fill of container. (1) The standard ability of this material at NARA, call of fill of container for lemon juice, ex- 202–741–6030, or go to: http:// cept when the food is frozen, is not less www.archives.gov/federallregister/ than 90 percent of the total capacity of codeloflfederallregulations/ the container as determined by the ibrllocations.html. The food may con- general method for fill of container tain one or any combination of the safe prescribed in § 130.12(b) of this chapter, and suitable optional ingredients speci- except fied in paragraph (a)(2) of this section. (i) When the food is frozen or Lemon juice, as defined in this para- (ii) When the food is packaged in in- graph, may be preserved by heat steri- dividual serving-size packages, con- lization (canning), refrigeration, freez- taining 1⁄2 fluid ounce or less, for use as ing, or by the addition of safe and suit- described in § 1.24(a)(3) of this chapter. able preservatives. When sealed in a (2) Compliance is determined as spec- container to be held at ambient tem- ified in § 146.3(g)(2). peratures, it is preserved by the addi- (3) If the lemon juice fails to meet tion of safe and suitable preservatives the standard of fill as prescribed in or so processed by heat, before or after paragraph (c) (1) and (2) of this section, sealing, as to prevent spoilage. the label shall bear the general state- (2) Optional ingredients. The optional ment of substandard fill specified in safe and suitable ingredients referred § 130.14(b) of this chapter, in the man- to in paragraph (a)(1) of this section ner and form therein prescribed. are: [45 FR 7786, Feb. 5, 1980, as amended at 47 FR (i) Concentrated lemon juice (lemon 11830, Mar. 19, 1982; 49 FR 10100, Mar. 19, 1984; juice from which part of the water has 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 6, been removed). 1993; 63 FR 14035, Mar. 24, 1998]

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§ 146.120 Frozen concentrate for lem- lemon oil in accordance with good onade. manufacturing practice, and the lemon (a) Frozen concentrate for lemonade pulp in the juice as expressed may be is the frozen food prepared from one or left in the juice or may be separated. both of the lemon juice ingredients Lemon pulp that has been separated, specified in paragraph (b) of this sec- which may have been preserved by tion together with one or any mixture freezing, may be added in preparing of safe and suitable nutritive carbo- frozen concentrate for lemonade, pro- hydrate sweeteners. The product con- vided that the amount of pulp added tains not less than 48.0 percent by does not raise the proportion of pulp in weight of soluble solids taken as the the finished food to a level in excess of sucrose value determined by refrac- that which would be present by using tometer and corrected for acidity pre- lemon juice ingredients from which scribed in ‘‘Official Methods of Anal- pulp has not been separated. The lemon ysis of the Association of Official Ana- juice ingredients may be treated by lytical Chemists,’’ 13th Ed. (1980), sec- heat, either before or after the other tion 22.025, ‘‘Frozen Concentrate for ingredients are added, to reduce the en- Lemonade (12),’’ under the heading zymatic activity and the number of ‘‘Soluble Solids by Refractometer—Of- viable microorganisms. ficial First Action,’’ which is incor- (c) Label declaration. Each of the in- porated by reference. Copies may be gredients used in the food shall be de- obtained from the AOAC INTER- clared on the label as required by the NATIONAL, 481 North Frederick Ave., applicable sections of parts 101 and 130 suite 500, Gaithersburg, MD 20877, or of this chapter. may be examined at the National Ar- [42 FR 14433, Mar. 15, 1977, as amended at 47 chives and Records Administration FR 11830, Mar. 19, 1982; 49 FR 10100, Mar. 19, (NARA). For information on the avail- 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, ability of this material at NARA, call Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 146.121 Frozen concentrate for artifi- codeloflfederallregulations/ cially sweetened lemonade. ibrllocations.html When the product is (a) Frozen concentrate for artifi- diluted according to directions for cially sweetened lemonade conforms to making lemonade which shall appear the definition and standard of identity on the label, the acidity of the lem- prescribed for frozen concentrate for onade, calculated as anhydrous citric lemonade by § 146.120, except that in acid, shall be not less than 0.70 gram lieu of nutritive sweeteners it is sweet- per 100 milliliters, and the soluble sol- ened with one or more of the artificial ids, measured as described for the con- sweetening ingredients listed in and centrate, shall be not less than 10.5 per- complying with the requirements of cent by weight. parts 172, 180 or 184 of this chapter, and (b) The lemon juice ingredients re- the soluble solids specifications preferred to in paragraph (a) of this sec- scribed in § 146.120(a) do not apply. tion are: When the product is diluted according (1) Lemon juice or frozen lemon juice to directions which shall appear on the or a mixture of these. label, the acidity of the artificially (2) Concentrated lemon juice or fro- sweetened lemonade, calculated as an- zen concentrated lemon juice or a mix- hydrous citric acid, shall be not less ture of these. than 0.70 gram per 100 milliliters. It For the purposes of this section, lemon may contain one or more safe and suit- juice is the undiluted juice expressed able dispersing ingredients serving the from mature lemons of an acid variety; function of distributing the lemon oil and concentrated lemon juice is lemon throughout the food. It may also con- juice from which part of the water has tain one or more safe and suitable been removed. In the preparation of the thickening ingredients. Such dis- lemon juice ingredients, the lemon oil persing and thickening ingredients are content may be adjusted by the addi- not food additives as defined in section tion of lemon oil or concentrated 201(s) of the Federal Food, Drug, and

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Cosmetic Act; or if they are food addi- scribing the color: for example, ‘‘Fro- tives as so defined, they are used in zen concentrate for pink lemonade’’. conformity with regulations estab- (c) Label declaration. Each of the in- lished pursuant to section 409 of the gredients used in the food shall be de- act. clared on the label as required by the (b) [Reserved] applicable sections of parts 101 and 130 (c) The name of the food is ‘‘Frozen of this chapter. concentrate for artificially sweetened [42 FR 14433, Mar. 15, 1977, as amended at 58 lemonade’’. The words ‘‘artificially FR 2881, Jan. 6, 1993] sweetened’’ shall be of the same size and style of type as the word ‘‘lem- § 146.132 Grapefruit juice. onade’’. (a) Identity—(1) Description. Grape- (d) If an optional thickening or dis- fruit juice is the unfermented juice, in- persing ingredient referred to in para- tended for direct consumption, ob- graph (a) of this section is used, the tained by mechanical process from label shall bear the statement ‘‘lll sound, mature grapefruit (Citrus added’’ or ‘‘with added lll’’, the paradisi Macfadyen) from which seeds blank being filled in with the common and peel (except embryonic seeds and name of the thickening or dispersing small fragments of seeds and peel agent used. Such statement shall be set which cannot be separated by good forth on the label with such promi- manufacturing practice) and excess nence and conspicuousness as to render pulp are removed and to which may be it likely to be read and understood by added not more than 10 percent by vol- the ordinary individual under cus- ume of the unfermented juice obtained tomary conditions of purchase. from mature hybrids of grapefruit. The (e) Frozen concentrate for artificially juice may be adjusted by the addition sweetened lemonade is labeled to con- of the optional concentrated grapefruit form to the labeling requirements pre- juice ingredients specified in paragraph scribed for foods which purport to be or (a)(2) of this section, but the quantity are represented for special dietary use of such concentrated grapefruit juice by regulations promulgated pursuant ingredient added shall not contribute to section 403(j) of the act. more than 15 percent of the grapefruit (f) Label declaration. Each of the in- juice soluble solids in the finished food. gredients used in the food shall be de- The grapefruit pulp, grapefruit oil, and clared on the label as required by the grapefuit essence (components derived applicable sections of parts 101 and 130 from grapefruit) content may be ad- of this chapter. justed in accordance with good manufacturing practice. The juice may have [42 FR 14433, Mar. 15, 1977, as amended at 58 been concentrated and later reconsti- FR 2881, Jan. 6, 1993] tuted with water suitable for the purpose of maintaining essential composi- § 146.126 Frozen concentrate for col- tion and quality factors of the juice. It ored lemonade. may be sweetened with the dry nutri- (a) Frozen concentrate for colored tive sweeteners referred to in para- lemonade conforms to the definition graph (a)(2)(iii) of this section. If the and standard of identity prescribed for grapefruit juice is prepared from con- frozen concentrate for lemonade by centrate, such sweeteners, in liquid § 146.120, except that it is colored with a form, referred to in paragraph (a)(2)(iii) safe and suitable fruit juice, vegetable of this section, also may be used. When juice, or any such juice in concentrated prepared from concentrated grapefruit form, or with any other color additive juice, exclusive of added sweeteners, ingredient suitable for use in food, in- the finished food contains not less than cluding artificial coloring, used in con- 10 percent, by weight, of soluble solids formity with regulations established taken as the refractometric sucrose pursuant to section 721 of the Federal value (of the filtrate), corrected to 20 Food, Drug, and Cosmetic Act. °C, and corrected for acidity by adding (b) The name of the food is ‘‘Frozen (0.012 + 0.193x–0.0004x2), where x equals concentrate for lll lemonade’’, the the percent anhydrous citric acid in blank being filled in with the word de- the sample, to the refractometrically

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obtained sucrose value by the first water and/or grapefruit juice; or (2) if method prescribed in ‘‘Correction of the food is prepared from grapefuit Refractometer Sucrose Readings for juice from concentrate and grapefruit Citric Acid Content for Lemonade,’’ by juice. The words ‘‘from concentrate’’ Yeatman, Senzel, and Springer, ‘‘Jour- shall be shown in letters not less than nal of the Association of Official Ana- one-half the height of the letters in the lytical Chemists,’’ vol. 59 p. 368 (1976). words ‘‘grapefruit juice.’’ Copies are available from the AOAC (ii) If any nutritive sweetener is INTERNATIONAL, 481 North Frederick added, the principal display panel of Ave., suite 500, Gaithersburg, MD 20877, the label shall bear the statement or available for inspection at the Na- ‘‘Sweetener added.’’ If no sweetener is tional Archives and Records Adminis- added, the word ‘‘unsweetened’’ may tration (NARA). For information on immediately precede or follow the the availability of this material at words ‘‘Grapefruit Juice’’ or ‘‘Grape- NARA, call 202–741–6030, or go to: http:// fruit Juice from Concentrate.’’ www.archives.gov/federallregister/ (iii) Label declaration. Each of the in- codeloflfederallregulations/ gredients used in the food shall be de- ibrllocations.html. The food may con- clared on the label as required by the tain one or any combination of the op- applicable sections of parts 101 and 130 tional ingredients specified in para- of this chapter. graph (a)(2) of this section. Grapefruit (b) [Reserved] juice, as defined in this paragraph, may (c) Fill of container. (1) The standard be preserved by heat sterlization (can- of fill of container for grapefruit juice, ning), refrigeration, or freezing. When except when the food is frozen, is not sealed in a container to be held at am- less than 90 percent of the total capac- bient temperatures, it is so processed ity of the container as determined by by heat, before or after sealing, as to the general method for fill of container prevent spoilage. prescribed in § 130.12(b) of this chapter. (2) Optional ingredients. The optional (2) Compliance is determined as spec- ingredients referred to in paragraph ified in § 146.3(g)(2). (a)(1) of this section are: (i) Concentrated grapefruit juice (3) If the grapefruit juice fails to (grapefruit juice from which part of the meet the standard of fill as prescribed water has been removed). in paragraphs (c) (1) and (2) of this sec- (ii) Water and/or grapefruit juice to tion, the label shall bear the general reconstitute concentrated grapefruit statement of substandard fill specified juice in the manufacture of grapefruit in § 130.14(b) of this chapter, in the juice from concentrate. manner and form therein prescribed. (iii) One or any combination of two [46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, or more of the dry or liquid forms of 1981; 46 FR 26300, May 12, 1981, as amended at sugar, invert sugar sirup, dextrose, glu- 47 FR 11830, Mar. 19, 1982; 47 FR 24287, June cose sirup, and fructose. Sweeteners de- 4, 1982; 47 FR 43364, Oct. 1, 1982; 58 FR 2881, fined in part 168 of this chapter shall be Jan. 6, 1993; 66 FR 17359, Mar. 30, 2001] as defined therein. (3) Labeling. (i) The name of the food § 146.135 Orange juice. is: (a) Orange juice is the unfermented (a) ‘‘Grapefruit juice’’ (1) if the food juice obtained from mature oranges of is prepared from unconcentrated, undi- the species Citrus sinensis or of the cit- luted liquid extracted from mature rus hybrid commonly called grapefruit; or (2) if the food is prepared ‘‘Ambersweet’’ (1⁄2 Citrus sinensis X 3⁄8 from unconcentrated, undiluted liquid Citrus reticulata X 1⁄8 Citrus paradisi extracted from mature grapefruit to (USDA Selection:1–100–29: 1972 which concentrated grapefruit juice is Whitmore Foundation Farm)). Seeds added to adjust soluble solids as pro- (except embryonic seeds and small vided for in paragraph (a)(1) of this sec- fragments of seeds that cannot be sepa- tion. rated by current good manufacturing (b) ‘‘Grapefruit juice from con- practice) and excess pulp are removed. centrate’’ (1) if the food is prepared The juice may be chilled, but it is not from concentrated grapefruit juice and frozen.

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(b) The name of the food is ‘‘orange number of viable microorganisms. Ei- juice’’. The name ‘‘orange juice’’ may ther before or after such heat treat- be preceded on the label by the varietal ment, all or a part of the product may name of the oranges used, and if the or- be frozen. The finished pasteurized oranges grew in a single State, the name ange juice contains not less than 10.5 of such State may be included in the percent by weight of orange juice solu- name, as for example, ‘‘California Va- ble solids, exclusive of the solids of any lencia orange juice’’. added optional sweetening ingredients, [42 FR 14433, Mar. 15, 1977, as amended at 57 and the ratio of the Brix hydrometer FR 57667, Dec. 7, 1992] reading to the grams of anhydrous citric acid per 100 milliliters of juice is § 146.137 Frozen orange juice. not less than 10 to 1. (a) Frozen orange juice is orange (b) The optional concentrated orange juice as defined in § 146.135, except that juice ingredients referred to in para- it is frozen. graph (a) of this section are frozen con- (b) The name of the food is ‘‘Frozen centrated orange juice as specified in orange juice’’. Such name may be pre- § 146.146 and concentrated orange juice ceded on the label by the varietal name for manufacturing as specified in of the oranges used, and if the oranges § 146.153 when made from mature or- grew in a single State, the name of anges; but the quantity of such con- such State may be included in the centrated orange juice ingredients name, as for example, ‘‘California Va- added shall not contribute more than lencia frozen orange juice’’. one-fourth of the total orange juice solids in the finished pasteurized orange § 146.140 Pasteurized orange juice. juice. (a) Pasteurized orange juice is the (c) The optional sweetening ingredi- food prepared from unfermented juice ents referred to in paragraph (a) of this obtained from mature oranges as speci- section are sugar, invert sugar, dex- fied in § 146.135, to which may be added trose, dried corn sirup, dried glucose not more that 10 percent by volume of sirup. the unfermented juice obtained from (d)(1) The name of the food is ‘‘Pas- mature oranges of the species Citrus teurized orange juice’’. If the food is reticulata or Citrus reticulata hybrids filled into containers and preserved by (except that this limitation shall not freezing, the label shall bear the name apply to the hybrid species described in ‘‘Frozen pasteurized orange juice’’. The § 146.135). Seeds (except embryonic words ‘‘pasteurized’’ or ‘‘frozen pas- seeds and small fragments of seeds that teurized’’ shall be shown on labels in cannot be separated by good manufacturing practice) are removed, and pulp letters not less than one-half the and orange oil may be adjusted in ac- height of the letters in the words ‘‘or- cordance with good manufacturing ange juice’’. practice. If the adjustment involves the (2) If the pasteurized orange juice is addition of pulp, then such pulp shall filled into containers and refrigerated, not be of the washed or spent type. The the label shall bear the name of the solids may be adjusted by the addition food, ‘‘chilled pasteurized orange of one or more of the optional con- juice’’. If it does not purport to be ei- centrated orange juice ingredients ther canned orange juice or frozen pas- specified in paragraph (b) of this sec- teurized orange juice, the word tion. One or more of the optional ‘‘chilled’’ may be omitted from the sweetening ingredients listed in para- name. The words ‘‘pasteurized’’ or graph (c) of this section may be added ‘‘chilled pasteurized’’ shall be shown in in a quantity reasonably necessary to letters not less than one-half the raise the Brix or the Brix-acid ratio to height of the letters in the words ‘‘or- any point within the normal range usu- ange juice’’. ally found in unfermented juice ob- (e)(1) If a concentrated orange juice tained from mature oranges as speci- ingredient specified in paragraph (b) of fied in § 146.135. The orange juice is so this section is used in adjusting the or- treated by heat as to reduce substan- ange juice solids of the pasteurized or- tially the enzymatic activity and the ange juice, the label shall bear the

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statement ‘‘prepared in part from con- this section may be added, in a quan- centrated orange juice’’ or ‘‘with added tity reasonably necessary to raise the concentrated orange juice’’ or ‘‘con- Brix or the Brix-acid ratio to any point centrated orange juice added’’. within the normal range usually found (2) If one or more of the sweetening in unfermented juice obtained from ingredients specified in paragraph (c) mature oranges as specified in § 146.135. of this section are added to the pas- The food is sealed in containers and so teurized orange juice, the label shall processed by heat, either before or bear the statement ‘‘ added’’, the lll after sealing, as to prevent spoilage. blank being filled in with the name or The finished canned orange juice tests an appropriate combination of the ° names of the sweetening ingredients not less than 10 Brix, and the ratio of used. However, for the purpose of this the Brix hydrometer reading to the section, the name ‘‘sweetener’’ may be grams of anhydrous citric acid per 100 used in lieu of the specific name or milliliters of juice is not less than 9 to names of the sweetening ingredients. 1. (f) Wherever the name of the food ap- (b) The optional sweetening ingredi- pears on the label so conspicuously as ents referred to in paragraph (a) of this to be easily seen under customary con- section are sugar, invert sugar, dex- ditions of purchase, the statements trose, dried corn sirup, dried glucose specified in this section for naming the sirup. optional ingredients used shall imme- (c) The name of the food is ‘‘Canned diately and conspicuously precede or orange juice’’. All the words in the follow the name of the food, without name shall appear in the same size, intervening written, printed, or graph- color, and style of type and on the ic matter. same color-contrasting background. If (g) Label declaration. Each of the in- the food is not sold under refrigeration gredients used in the food shall be declared on the label as required by the and if it does not purport to be chilled applicable sections of parts 101 and 130 pasteurized orange juice or frozen pas- of this chapter. teurized orange juice, the word ‘‘canned’’ may be omitted from the [42 FR 14433, Mar. 15, 1977, as amended at 57 name. FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] (d) If one or more of the sweetening § 146.141 Canned orange juice. ingredients specified in paragraph (b) (a) Canned orange juice is the food of this section are added to the canned prepared from orange juice as specified orange juice, the label shall bear the in § 146.135 or frozen orange juice as statement ‘‘lll added’’, the blank specified in § 146.137, or a combination being filled in with the name or an ap- of both, to which may be added not propriate combination of the names of more than 10 percent by volume of the the sweetening ingredients used. How- unfermented juice obtained from ma- ever, for the purpose of this section, ture oranges of the species Citrus the name ‘‘sweetener’’ may be used in reticulata or Citrus reticulata hybrids lieu of the specific name or names of (except that this limitation shall not the sweetening ingredients. apply to the hybrid species described in (e) Wherever the name of the food ap- § 146.135). Seeds (except embryonic pears on the label so conspicuously as seeds and small fragments of seeds that to be easily seen under customary con- cannot be separated by good manufac- ditions of purchase, the statement turing practice) are removed. Orange specified in this section for naming the oil and pulp may be adjusted in accord- optional ingredients used shall imme- ance with good manufacturing prac- diately and conspicuously precede or tice. The adjustment of pulp referred to follow the name of the food, without in this paragraph does not permit the intervening written, printed, or graph- addition of washed or spent pulp. Liq- ic matter. uid condensate recovered from the deoiling operation may be added back. (f) Label declaration. Each of the in- One or more of the optional sweetening gredients used in the food shall be de- ingredients named in paragraph (b) of clared on the label as required by the

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applicable sections of parts 101 and 130 specific name or names of the sweet- of this chapter. ening ingredients. (e) Wherever the name of the food ap- [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] pears on the label so conspicuously as to be easily seen under customary con- § 146.145 Orange juice from conditions of purchase, the statements centrate. specified in this section for naming the optional ingredients used shall imme- (a) Orange juice from concentrate is diately and conspicuously precede or the food prepared by mixing water with follow the name of the food, without frozen concentrated orange juice as de- intervening written, printed, or graph- fined in § 146.146 or with concentrated ic matter. orange juice for manufacturing as defined in § 146.153 (when made from ma- (f) Label declaration. Each of the in- ture oranges), or both. To such mixture gredients used in the food shall be de- may be added orange juice as defined in clared on the label as required by the § 146.135, frozen orange juice as defined applicable sections of parts 101 and 130 in § 146.137, pasteurized orange juice as of this chapter. defined in § 146.140, orange juice for [42 FR 14433, Mar. 15, 1977, as amended at 58 manufacturing as defined in § 146.151 FR 2881, Jan. 6, 1993] (when made from mature oranges and preserved by chilling or freezing but § 146.146 Frozen concentrated orange not by canning), orange oil, orange juice. pulp, and one or more of the sweet- (a) Frozen concentrated orange juice ening ingredients listed in paragraph is the food prepared by removing water (b) of this section. The finished orange from the juice of mature oranges as juice from concentrate contains not provided in § 146.135, to which may be less than 11.8 percent orange juice solu- added unfermented juice obtained from ble solids, exclusive of solids of any mature oranges of the species Citrus added optional sweetening ingredients. reticulata, other Citrus reticulata hy- It may be so treated by heat as to re- brids, or of Citrus aurantium, or both. duce substantially the enzymatic ac- However, in the unconcentrated blend, tivity and the number of viable micro- the volume of juice from Citrus organisms. reticulata or Citrus reticulata hybrids (b) The sweetening ingredients re- shall not exceed 10 percent (except that ferred to in paragraph (a) of this sec- this limitation shall not apply to the tion are sugar, sugar sirup, invert hybrid species described in § 146.135) sugar, invert sugar sirup, dextrose, and from Citrus aurantium shall not ex- corn sirup, dried corn sirup, glucose ceed 5 percent. The concentrate so ob- sirup, dried glucose sirup. tained is frozen. In its preparation, (c) The name of the food is ‘‘Orange seeds (except embryonic seeds and juice from concentrate’’. The words small fragments of seeds that cannot ‘‘from concentrate’’ shall be shown in be separated by good manufacturing letters not less than one-half the practice) and excess pulp are removed, height of the letters in the words ‘‘or- and a properly prepared water extract ange juice’’. of the excess pulp so removed may be (d) When orange juice from con- added. Orange oil, orange pulp, orange centrate contains any optional sweet- essence (obtained from orange juice), ening ingredient as listed in paragraph orange juice and other orange juice (b) of this section, whether added di- concentrate as provided in this section rectly as such or indirectly as an added or concentrated orange juice for manu- ingredient of any orange juice product facturing provided in § 146.153 (when used, the label shall bear the statement made from mature oranges), water, and ‘‘lll added’’, the blank being filled one or more of the optional sweetening in with the name or an appropriate ingredients specified in paragraph (b) combination of the names of the sweet- of this section may be added to adjust ening ingredients added. However, for the final composition. The juice of Cit- the purposes of this section the name rus reticulata and Citrus aurantium, as ‘‘sweetener’’ may be used in lieu of the permitted by this paragraph, may be

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added in single strength or con- ‘‘frozen concentrated orange juice, centrated form prior to concentration lll plus 1’’ or ‘‘frozen orange juice of the Citrus sinensis juice, or in con- concentrate, lll plus 1’’, the blank centrated form during adjustment of being filled in with the whole number the composition of the finished food. showing the dilution ratio; for exam- The addition of concentrated juice ple, ‘‘frozen orange juice concentrate, 4 from Citrus reticulata or Citrus plus 1’’. However, where the label bears aurantium, or both, shall not exceed, on directions for making 1 quart of orange a single-strength basis, the 10 percent juice from concentrate (or multiples of maximum for Citrus reticulata and the 5 a quart), the blank in the name may be percent maximum for Citrus aurantium filled in with a mixed number; for ex- prescribed by this paragraph. Any of ample, ‘‘frozen orange juice con- the ingredients of the finished concentrate, 41⁄3 plus 1’’. For containers centrate may have been so treated by larger than 1 pint, the dilution ratio in heat as to reduce substantially the en- the name may be replaced by the con- zymatic activity and the number of centration of orange juice soluble sol- viable microorganisms. The finished ids in degrees Brix; for example, a 62° food is of such concentration that when Brix concentrate in 31⁄2-gallon cans diluted according to label directions may be named on the label ‘‘frozen con- the diluted article will contain not less centrated orange juice, 62° Brix’’. than 11.8 percent by weight of orange (e) Wherever the name of the food ap- juice soluble solids, exclusive of the pears on the label so conspicuously as solids of any added optional sweetening to be easily seen under customary con- ingredients. The dilution ratio shall be ditions of purchase, the statements not less than 3 plus 1. For the purposes specified in this section for naming the of this section and § 146.150, the term optional ingredients used shall imme- ‘‘dilution ratio’’ means the whole num- diately and conspicuously precede or ber of volumes of water per volume of follow the name of the food, without frozen concentrate required to produce intervening written, printed, or graph- orange juice from concentrate having ic matter. orange juice soluble solids of not less (f) Nothing in this section is intended than 11.8 percent by weight exclusive of to interfere with the adoption and en- the solids of any added optional sweet- forcement by any State, in regulating ening ingredients. the production of frozen concentrated (b) The optional sweetening ingredi- orange juice in such State, of State ents referred to in paragraph (a) of this standards, consistent with this section, section are sugar, sugar sirup, invert but which impose higher or more re- sugar, invert sugar sirup, dextrose, strictive requirements than those set corn sirup, dried corn sirup, glucose forth in this section. sirup, and dried glucose sirup. (g) Label declaration. Each of the in- (c) If one or more of the sweetening gredients used in the food shall be de- ingredients specified in paragraph (b) clared on the label as required by the of this section are added to the frozen applicable sections of parts 101 and 130 concentrated orange juice, the label of this chapter. shall bear the statement ‘‘lll [42 FR 14433, Mar. 15, 1977, as amended at 57 added’’, the blank being filled in with FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] the name or an appropriate combination of names of the sweetening ingre- § 146.148 Reduced acid frozen con- dients used. However, for the purpose centrated orange juice. of this section, the name ‘‘sweetener’’ (a) Reduced acid frozen concentrated may be used in lieu of the specific orange juice is the food that complies name or names of the sweetening in- with the requirements for composition gredients. and label declaration of ingredients (d) The name of the food con- prescribed for frozen concentrated or- centrated to a dilution ratio of 3 plus 1 ange juice by § 146.146, except that it is ‘‘frozen concentrated orange juice’’ may not contain any added sweetening or ‘‘frozen orange juice concentrate’’. ingredient. A process involving the use The name of the food concentrated to a of anionic ion-exchange resins per- dilution ratio greater than 3 plus 1 is mitted by § 173.25 of this chapter is used

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to reduce the acidity of the food so § 146.151 Orange juice for manufac- that the ratio of the Brix reading to turing. the grams of acid, expressed as anhy- (a) Orange juice for manufacturing is drous citric acid, per 100 grams of juice the food prepared for further manufac- is not less than 21 to 1 or more than 26 turing use. It is prepared from to 1. unfermented juice obtained from or- (b) The name of the food is ‘‘Reduced anges as provided in § 146.135, except acid frozen concentrated orange juice’’. that the oranges may deviate from the standards for maturity in that they are [45 FR 12414, Feb. 26, 1980, as amended at 58 below the minimum for Brix and Brix- FR 2881, Jan. 6, 1993] acid ratio for such oranges, and to which juice may be added not more § 146.150 Canned concentrated orange than 10 percent by volume of the juice. unfermented juice obtained from or- (a) Canned concentrated orange juice anges of the species Citrus reticulata or is the food that complies with the re- Citrus reticulata hybrids (except that quirements of composition, definition this limitation shall not apply to the of dilution ratio, and labeling of ingre- hybrid species described in § 146.135). dients prescribed for frozen con- Seeds (except embryonic seeds and centrated orange juice by § 146.146, ex- small fragments of seeds that cannot cept that it is not frozen and it is be separated by good manufacturing sealed in containers and so processed practice) are removed, and pulp and or- by heat, either before or after sealing, ange oil may be adjusted in accordance so as to prevent spoilage. with good manufacturing practice. If pulp is added it shall be other than (b) The name of the food when con- washed or spent pulp. The juice or por- centrated to a dilution ratio of 3 plus 1 tions thereof may be so treated by heat is ‘‘Canned concentrated orange juice’’ as to reduce substantially the enzy- or ‘‘Canned orange juice concentrate’’. matic activity and number of viable The name of the food when con- microorganisms, and it may be chilled centrated to a dilution ratio greater or frozen, or it may be so treated by than 3 plus 1 is ‘‘Canned concentrated heat, either before or after sealing in orange juice, lll plus 1’’ or ‘‘Canned containers, as to prevent spoilage. orange juice concentrate, lll plus (b) The name of the food is ‘‘Orange 1’’, the blank being filled in with the juice for manufacturing’’. whole number showing the dilution [42 FR 14433, Mar. 15, 1977, as amended at 57 ratio; for example, ‘‘Canned orange FR 57667, Dec. 7, 1992] juice concentrate, 4 plus 1’’. However, where the label bears directions for § 146.152 Orange juice with preserva- making 1 quart of single-strength ditive. luted product (or multiples of a quart) (a) Orange juice with preservative is the blank in the name may be filled in the food prepared for further manufac- with a mixed number; for example, turing use. It complies with the re- ‘‘Canned orange juice concentrate, 41⁄3 quirements for composition of orange plus 1’’. For containers larger than 1 juice for manufacturing as provided for pint, the dilution ratio in the name in § 146.151, except that a preservative may be replaced by the concentration is added to inhibit spoilage. It may be of orange juice soluble solids in degrees heat-treated to reduce substantially the enzymatic activity and the number Brix; for example, a 62° Brix con- of viable microorganisms. centrate in 1-gallon cans may be named (b) The preservatives referred to in on the label ‘‘canned concentrated or- paragraph (a) of this section are any ° ange juice, 62 Brix’’. If the food does safe and suitable preservatives or com- not purport to be frozen concentrated binations thereof. orange juice, the word ‘‘canned’’ may (c) The name of the food is ‘‘Orange be omitted from the name. juice with preservative’’. [42 FR 14433, Mar. 15, 1977, as amended at 58 (d) Label declaration. Each of the in- FR 2881, Jan. 6, 1993] gredients used in the food shall be declared on the label as required by the

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applicable sections of parts 101 and 130 turing by § 146.153, except that a pre- of this chapter. In addition, the name servative is added to inhibit spoilage. of each preservative shall be proceeded (b) The preservatives referred to in by a statement of the percent by paragraph (a) of this section are any weight of the preservative used. If the safe and suitable preservatives or com- food is packed in container sizes that binations thereof. are less than 19 liters (5 gallons), the (c) The name of the food is ‘‘Con- label shall bear a statement indicating centrated orange juice with preserva- that the food is for further manufac- tive, lll’’, the blank being filled in turing use only. with the figure showing the concentra- (e) Wherever the name of the food ap- tion of orange juice soluble solids in pears on the label so conspicuously as degrees Brix. to be easily seen under customary con- (d) Label declaration. Each of the in- ditions of purchase, the statement gredients used in the food shall be de- specified in paragraph (d) of this sec- clared on the label as required by the tion for naming the preservative ingre- applicable sections of parts 101 and 130 dient used shall immediately and con- of this chapter. In addition, the name spicuously precede or follow the name of each preservative shall be preceded of the food, without intervening writ- by a statement of the percent by ten, printed, or graphic matter. weight of the preservative used. If the food is packed in container sizes that [42 FR 14414, Mar. 15, 1977, as amended at 44 are less than 19 liters (5 gallons), the FR 36378, June 22, 1979; 58 FR 2881, Jan. 6, label shall bear a statement indicating 1993] that the food is for further manufacturing use only. § 146.153 Concentrated orange juice for manufacturing. (e) Wherever the name of the food appears on the label so conspicuously as (a) Concentrated orange juice for to be easily seen under customary con- manufacturing is the food that com- ditions of purchase, the statement plies with the requirements of com- specified in paragraph (d) of this sec- position and label declaration of ingre- tion for naming the preservative ingredients prescribed for frozen con- dient used shall immediately and concentrated orange juice by § 146.146, ex- spicuously precede or follow the name cept that it is either not frozen or is of the food, without intervening writ- less concentrated, or both, and the or- ten, printed, or graphic matter. anges from which the juice is obtained may deviate from the standards for [42 FR 14414, Mar. 15, 1977, as amended at 44 maturity in that they are below the FR 36378, June 22, 1979; 58 FR 2882, Jan. 6, 1993] minimum Brix and Brix-acid ratio for such oranges: Provided, however, that § 146.185 Pineapple juice. the concentration of orange juice soluble solids is not less than 20° Brix. (a) Identity. (1) Pineapple juice is the juice, intended for direct consumption, (b) The name of the food is ‘‘Con- obtained by mechanical process from centrated orange juice for manufac- the flesh or parts thereof, with or with- turing, lll’’ or ‘‘lll orange juice out core material, of sound, ripe pine- concentrate for manufacturing’’, the apple (Ananas comosus L. Merrill). The blank being filled in with the figure juice may have been concentrated and showing the concentration of orange later reconstituted with water suitable juice soluble solids in degrees Brix. for the purpose of maintaining essen- [42 FR 14433, Mar. 15, 1977, as amended at 58 tial composition and quality factors of FR 2881, Jan. 6, 1993] the juice. Pineapple juice may contain finely divided insoluble solids, but it § 146.154 Concentrated orange juice does not contain pieces of shell, seeds, with preservative. or other coarse or hard substances or (a) Concentrated orange juice with excess pulp. It may be sweetened with preservative complies with the require- any safe and suitable dry nutritive car- ments for composition and labeling of bohydrate sweetener. However, if the optional ingredients prescribed for con- pineapple juice is prepared from concentrated orange juice for manufac- centrate, such sweeteners, in liquid

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form, also may be used. It may contain (iii) The ratio of the degrees Brix to added vitamin C in a quantity such total acidity, as determined by the that the total vitamin C in each 4 fluid method prescribed in paragraph ounces of the finished food amounts to (b)(2)(iii) of this section, is not less not less than 30 milligrams and not than 12. more than 60 milligrams. In the proc- (iv) The quantity of finely divided essing of pineapple juice, dimethyl- ‘‘insoluble solids’’, as determined by polysiloxane complying with the re- the method prescribed in paragraph quirements of § 173.340 of this chapter (b)(2)(iv) of this section, is not less may be employed as a defoaming agent than 5 percent nor more than 30 per- in an amount not greater than 10 parts cent. per million by weight of the finished (2) The methods referred to in para- food. Such food is prepared by heat graph (b)(1) of this section are as fol- sterilization, refrigeration, or freezing. lows: When sealed in a container to be held (i) Determine the degrees Brix of the at ambient temperatures, it is so proc- pineapple juice by the method pre- essed by heat, before or after sealing, scribed in ‘‘Official Methods of Anal- as to prevent spoilage. ysis of the Association of Official Ana- (2) The name of the food is ‘‘Pine- lytical Chemists,’’ 13th Ed. (1980), sec- apple juice’’ if the juice from which it tion 31.009, ‘‘Solids by Means of Spin- is prepared has not been concentrated dle—Official Final Action,’’ which is and/or diluted with water. The name of incorporated by reference. Copies may the food is ‘‘Pineapple juice from con- be obtained from the AOAC INTER- centrate’’ if the finished juice has been NATIONAL, 481 North Frederick Ave., made from pineapple juice concentrate suite 500, Gaithersburg, MD 20877, or as specified in paragraph (a) of this sec- may be examined at the National Ar- tion. If a nutritive sweetener is added, chives and Records Administration the label shall bear the statement (NARA). For information on the avail- ‘‘Sweetener added.’’ If no sweetener is ability of this material at NARA, call added, the word ‘‘Unsweetened’’ may 202–741–6030, or go to: http:// immediately precede or follow the www.archives.gov/federallregister/ words ‘‘Pineapple juice’’ or ‘‘Pineapple codeloflfederallregulations/ juice from concentrate.’’ ibrllocations.html. (3) Label declaration. Each of the in- (ii) Determine the total acidity of gredients used in the food shall be de- the pineapple juice by titration by the clared on the label as required by the method prescribed in § 145.180(b)(2)(ix) applicable sections of parts 101 and 130 of this chapter. of this chapter. (iii) Divide the degrees Brix deter- (b) Quality. (1) The standard of qual- mined as prescribed in paragraph ity for pineapple juice is as follows: (b)(2)(i) of this section by the grams of (i) The soluble solids content of pine- anhydrous citric acid per 100 milliliters apple juice (exclusive of added sugars) of juice, determined as prescribed in without added water shall not be less paragraph (b)(2)(ii) of this section, and than 10.5° Brix as determined by refrac- report the results as ratio of degrees tometer at 20 °C uncorrected for acid- Brix to total acidity. ity and read as degrees Brix on Inter- (iv) Determine the quantity of ‘‘in- national Sucrose Scales. Where the soluble solids’’ in pineapple juice as juice has been obtained using con- follows: Measure 50 milliliters of thor- centrated juice with addition of water, oughly stirred pineapple juice into a the soluble pineapple juice solids con- cone-shaped graduated tube of the tent (exclusive of added sugars) shall long-cone type, measuring approxi- be not less than 12.8° Brix, uncorrected mately 43⁄16 inches from tip to top cali- for acidity and read as degrees Brix on bration and having a capacity of 50 the International Sucrose Scales. milliliters. Place the tube in a suitable (ii) The acidity, as determined by the centrifuge the approximate speed of method prescribed in paragraph which is related to diameter of swing (b)(2)(ii) of this section, is not more in accordance with the table imme- than 1.35 grams of anhydrous citric diately below. The word ‘‘diameter’’ acid per 100 milliliters of the juice. means the over-all distance between

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the tips of opposing centrifuge tubes in percent by weight of water-soluble sol- operating position. ids extracted from dried prunes. The quantity of prune solids may be ad- Approxi- mate revo- justed by the concentration, dilution, Diameter (inches) lutions per or both, of the water extract or ex- minute tracts made. Such food may contain 10 ...... 1,609 one or more of the optional acidifying 101⁄2 ...... 1,570 ingredients specified in paragraph 11 ...... 1,534 (b)(1) of this section, in a quantity suf- 111⁄2 ...... 1,500 12 ...... 1,468 ficient to render the food slightly tart; 121⁄2 ...... 1,438 it may contain honey added within the 13 ...... 1,410 quantitative limits prescribed by para- 131⁄2 ...... 1,384 14 ...... 1,359 graph (b)(2) of this section; and it may 141⁄2 ...... 1,336 contain added vitamin C in a quantity 15 ...... 1,313 prescribed by paragraph (b)(3) of this 151⁄2 ...... 1,292 16 ...... 1,271 section. Such food is sealed in a con- 161⁄2 ...... 1,252 tainer and so processed by heat, before 17 ...... 1,234 or after sealing, as to prevent spoilage. 171⁄2 ...... 1,216 18 ...... 1,199 (b) The optional ingredients referred 181⁄2 ...... 1,182 to in paragraph (a) of this section are: 19 ...... 1,167 (1) One or any combination of two or 191⁄2 ...... 1,152 20 ...... 1,137 more of the following acidifying ingredients: The milliliter reading at the top of the (i) Lemon juice. layer of ‘‘insoluble solids,’’ after (ii) Lime juice. centrifuging 3 minutes, is multiplied (iii) Citric acid. by two to obtain the percentage of (2) Honey, in a quantity not less than ‘‘insoluble solids.’’ 2 percent and not more than 3 percent (3) If the quality of pineapple juice by weight of the finished food. falls below the standard prescribed in (3) Vitamin C, in a quantity such paragraph (b)(1) of this section, the that the total vitamin C in each 6 fluid label shall bear the general statement ounces of the finished food amounts to of substandard quality specified in not less than 30 milligrams and not § 130.14 (a) of this chapter, in the man- more than 50 milligrams. ner and form therein specified. (c)(1) The name of the food is ‘‘Prune (c) Fill of container. (1) The standard juice—a water extract of dried prunes’’. of fill of container for pineapple juice, For the purposes of the Federal Food, except when the food is frozen, is not Drug, and Cosmetic Act concerning the less than 90 percent of the total capac- label declaration of the name of the ity of the container, as determined by food, the explanatory statement ‘‘A the general method for fill of container water extract of dried prunes’’ may ap- prescribed in § 130.12(b) of this chapter. pear immediately below the words (2) If pineapple juice falls below the ‘‘prune juice’’, but there shall be no in- standard of fill of container prescribed tervening written, printed, or graphic in paragraph (c)(1) of this section, the matter, and the type used for the words label shall bear the statement of sub- ‘‘A water extract of dried prunes’’ shall standard fill specified in § 130.14(b) of be of the same style and not less than this chapter, in the manner and form half the print size of the type used for therein specified. the words ‘‘prune juice’’. [42 FR 14433, Mar. 15, 1977, as amended at 47 (2)(i) When one or more of the FR 11831, Mar. 19, 1982; 47 FR 52694, Nov. 23, acidifying ingredients specified in 1982; 49 FR 10101, Mar. 19, 1984; 50 FR 19524, paragraph (b)(1) of this section are May 9, 1985; 54 FR 24895, June 12, 1989; 58 FR used, the label shall bear the statement 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] ‘‘lll added’’ or ‘‘with added lll’’, the blank being filled in with the name § 146.187 Canned prune juice. or names of the optional ingredients (a) Canned prune juice is the food used. prepared from a water extract of dried (ii) When honey, as specified in para- prunes and contains not less than 18.5 graph (b)(2) of this section, is used the

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label shall bear the statement ‘‘with Subpart B—Requirements for Spe- lll honey’’ or ‘‘lll honey added’’, cific Standardized Fruit But- the blank to be filled in with the per- ters, Jellies, Preserves, and cent by weight of the honey in the finished food or with the statement ‘‘be- Related Products tween 2 and 3%’’. § 150.110 Fruit butter. (iii) When one or more of the ingredi- (a) The fruit butters for which defini- ents designated in paragraph (b)(1) of tions and standards of identity are pre- this section and the ingredient des- scribed by this section are the smooth, ignated in paragraph (b)(2) of this sec- semisolid foods each of which is made tion are used, the statements specified from a mixture of one or a permitted in paragraphs (c)(2) (i) and (ii) of this combination of the optional fruit in- section may be combined, as for exam- gredients specified in paragraph (b) of ple, ‘‘with lemon juice and between 2 this section and one or any combina- and 3% honey added’’. tion of the optional ingredients speci- (iv) When vitamin C is added as pro- fied in paragraph (c) of this section, vided in paragraph (b)(3) of this sec- which meets the specifications in para- tion, it shall be designated on the label graph (d) of this section, and which is as ‘‘vitamin C added’’ or ‘‘with added labeled in accordance with paragraph vitamin C’’. (e) of this section. Such mixture is con- (3) Wherever the name of the food ap- centrated with or without heat. The pears on the label so conspicuously as volatile flavoring materials or essence to be easily seen under customary con- from such mixture may be captured ditions of purchase, the words specified during concentration, separately con- in this paragraph, showing the optional centrated, and added back to any such ingredients used, shall immediately mixture, together with any con- and conspicuously precede or follow centrated essence accompanying any such name, without intervening writ- optional fruit ingredient. ten, printed, or graphic matter. (b)(1) Each of the optional fruit in- (d) Label declaration. Each of the ingredients referred to in paragraph (a) gredients used in the food shall be de- of this section is prepared by cooking clared on the label as required by the one of the following fresh, frozen, applicable sections of parts 101 and 130 canned, and/or dried (evaporated) ma- of this chapter. ture fruits, with or without added water, and screening out skins, seeds, [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993] pits, and cores:

FACTOR REFERRED TO IN PARAGRAPH (D)(2) OF PART 150—FRUIT BUTTERS, JELLIES, THIS SECTION PRESERVES, AND RELATED PROD- UCTS Name of fruit Apple ...... 7.5 Subpart A [Reserved] Apricot ...... 7.0 Grape ...... 7.0 Peach ...... 8.5 Subpart B—Requirements for Specific Pear ...... 6.5 Standardized Fruit Butters, Jellies, Pre- Plum (other than prune) ...... 7.0 serves, and Related Products Prune ...... 7.0 Quince ...... 7.5 Sec. 150.110 Fruit butter. (2) The permitted combinations are 150.140 Fruit jelly. of two, three, four, and five of the fruit 150.160 Fruit preserves and jams. ingredients specified in paragraph (b)(1) of this section; the weight of each AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, is not less than one-fifth of the weight 379e. of the combination. Each such fruit in- SOURCE: 42 FR 14445, Mar. 15, 1977, unless gredient in any such combination is an otherwise noted. optional ingredient. (c) The following safe and suitable Subpart A [Reserved] optional ingredients may be used: 634

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(1) Nutritive carbohydrate sweet- erence, except that no correction is eners. made for water-insoluble solids. Copies (2) Spice. may be obtained from the AOAC (3) Flavoring (other than artificial INTERNATIONAL, 481 North Frederick flavoring). Ave., suite 500, Gaithersburg, MD 20877, (4) Salt. or may be examined at the National (5) Acidifying agents. Archives and Records Administration (6) Fruit juice or diluted fruit juice (NARA). For information on the avail- or concentrated fruit juice, in a quan- ability of this material at NARA, call tity not less than one-half the weight 202–741–6030, or go to: http:// of the optional fruit ingredient. www.archives.gov/federallregister/ (7) Preservatives. codeloflfederallregulations/ (8) Antifoaming agents except those ibrllocations.html. derived from animal fats. (4) The weight of any nutritive carbo- (9) Pectin, in a quantity which rea- hydrate sweetener means the weight of sonably compensates for deficiency, if the solids of such ingredient. any, of the natural pectin content of (5) The weight of fruit juice or di- the fruit ingredient. luted fruit juice or concentrated fruit (d) For the purposes of this section: juice (optional ingredient, paragraph (1) The mixture referred to in para- (c)(6)) from a fruit specified in paragraph (a) of this section shall contain graph (b)(1) of this section is the not less than five parts by weight of weight of such juice, as determined by the fruit ingredient as measured in ac- the method prescribed in paragraph cordance with paragraph (d)(2) of this (d)(2) of this section, except that the section to each two parts by weight of percent of soluble solids is determined nutritive carbohydrate sweetener as by the method prescribed in the AOAC, measured in accordance with para- 13th Ed. (1980), section 31.011, under graph (d)(4) of this section. ‘‘Solids by Means of Refractometer— (2) Any requirement with respect to Official Final Action,’’ which is incor- the weight of any optional fruit ingre- porated by reference; the weight of di- dient, whether concentrated, luted concentrated juice from any unconcentrated, or diluted, means the other fruits is the original weight of weight determined by the following the juice before it was diluted or con- method: (i) Determine the percent of centrated. The availability of this insoluble solids in the optional fruit incorporation by reference is given in gredient by the method for soluble sol- paragraph (d)(3) of this section. ids referred to in paragraph (d)(3) of (e)(1) Label declaration. Each of the this section; (ii) multiply the percent ingredients used in the food shall be de- so found by the weight of such fruit in- clared on the label as required by the gredient; (iii) divide the result by 100; applicable sections of parts 101 and 130 (iv) subtract from the quotient the of this chapter, except that: weight of any nutritive sweetener sol- (i) In case the fruit butter is made ids or other added solids; and (v) mul- from a single fruit ingredient, the tiply the remainder by the factor for name is ‘‘Butter’’, preceded by the such ingredient prescribed in para- name where by such fruit is designated graph (b)(1) of this section. The result in paragraph (b)(1) of this section. is the weight of the optional fruit in- (ii) In case the fruit butter is made gredient. from a combination of two, three, four, (3) The soluble solids content of the or five fruit ingredients, the name is finished fruit butter is not less than 43 ‘‘Butter’’, preceded by the words percent, as determined by the method ‘‘Mixed fruit’’ or by the names whereby prescribed in ‘‘Official Methods of such fruits are designated in paragraph Analysis of the Association of Official (b)(1) of this section, in the order of Analytical Chemists’’ (AOAC), 13th Ed. predominance, if any, of the weight of (1980), section 22.024, under ‘‘Soluble such fruit ingredients in the combina- Solids by Refractometer in Fresh and tion. Canned Fruits, Fruit Jellies, Mar- (2) Each of the optional ingredients malades, and Preserves—Official Final specified in paragraphs (b) and (c) of Action,’’ which is incorporated by ref- this section shall be declared on the

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label as required by the applicable sec- FACTOR REFERRED TO IN PARAGRAPH (D)(2) OF tions of part 101 of this chapter, except THIS SECTION that: (i) Other than in the case of dried Name of fruit (evaporated) fruit the name(s) of the Apple ...... 7.5 fruit or fruits used may be declared Apricot ...... 7.0 without specifying the particular form Blackberry (other than dewberry) ...... 10.0 of the fruit or fruits used. When the op- Black raspberry ...... 9.0 Boysenberry ...... 10.0 tional fruit ingredient is prepared in Cherry ...... 7.0 whole or in part from dried fruit, the Crabapple ...... 6.5 label shall bear the words ‘‘prepared Cranberry ...... 9.5 from’’ or ‘‘prepared in part from’’, as Damson, damson plum ...... 7.0 Dewberry (other than boysenberry, loganberry, and the case may be, followed by the word youngberry) ...... 10.0 ‘‘evaporated’’ or ‘‘dried’’, followed by Fig ...... 5.5 the name whereby such fruit is des- Gooseberry ...... 12.0 ignated in paragraph (c) of this section. Grape ...... 7.0 When two or more such optional fruit Grapefruit ...... 11.0 Greengage, greengage plum ...... 7.0 ingredients are used, such names, each Guava ...... 13.0 preceded by the word ‘‘evaporated’’ or Loganberry ...... 9.5 ‘‘dried’’, shall appear in the order of Orange ...... 8.0 predominance, if any, of the weight of Peach ...... 8.5 Pineapple ...... 7.0 such ingredients in the combination. Plum (other than damson, greengage, and prune) ...... 7.0 (ii) [Reserved] Pomegranate ...... 5.5 Prickly pear ...... 11.0 [42 FR 14445, Mar. 15, 1977, as amended at 47 Quince ...... 7.5 FR 11831, Mar. 19, 1982; 49 FR 10101, Mar. 19, Raspberry, red raspberry ...... 9.5 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Red currant, currant (other than black currant) ...... 9.5 Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] Strawberry ...... 12.5 Youngberry ...... 10.0 § 150.140 Fruit jelly. (a) The jellies for which definitions (2) The permitted combinations are and standards of identity are pre- of two, three, four, or five of the fruit scribed by this section are the jelled juice ingredients specified in paragraph foods each of which is made from a (b)(1) of this section, the weight of each mixture of one or a permitted combina- is not less than one-fifth of the weight tion of the fruit juice ingredients speci- of the combination. Each such fruit fied in paragraph (b) of this section and juice ingredient in any such combina- one or any combination of the optional tion is an optional ingredient. ingredients specified in paragraph (c) (c) The following safe and suitable of this section, which meets the speci- optional ingredients may be used: fications in paragraph (d) of this sec- (1) Nutritive carbohydrate sweet- tion and which is labeled in accordance eners. with paragraph (e) of this section. Such (2) Spice. mixture is concentrated with or with- (3) Acidifying agents. out heat. The volatile flavoring mate- (4) Pectin, in a quantity which rea- rials or essence from such mixture may sonably compensates for deficiency, if be captured during concentration, sep- any, of the natural pectin content of arately concentrated, and added back the fruit juice ingredient. to any such mixture, together with any (5) Buffering agents. concentrated essence accompanying (6) Preservatives. any optional fruit ingredient. (7) Antifoaming agents except those (b)(1) Each of the fruit juice ingredi- derived from animal fats. ents referred to in paragraph (a) of this (8) Mint flavoring and artificial green section is the filtered or strained liquid coloring, in case the fruit juice ingre- extracted with or without the applica- dient or combination of fruit juice in- tion of heat and with or without the gredients is extracted from apple, addition of water, from one of the fol- crabapple, pineapple, or two or all of lowing mature, properly prepared such fruits. fruits which are fresh, frozen and/or (9) Cinnamon flavoring, other than canned: artificial flavoring, and artificial red

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coloring in case the fruit juice ingre- (e)(1) The name of each jelly for dient or combination of fruit juice in- which a definition and standard of gredients is extracted from apple or identity is prescribed by this section is crabapple or both such fruits. as follows: (d) For the purposes of this section: (i) In case the jelly is made with a (1) The mixture referred to in para- single fruit juice ingredient, the name graph (a) of this section shall contain is ‘‘Jelly’’, preceded or followed by the not less than 45 parts by weight of the name or synonym whereby the fruit fruit juice ingredients as measured in from which such fruit juice ingredient accordance with paragraph (d)(2) of was extracted is designated in para- this section to each 55 parts by weight graph (b) of this section. of saccharine ingredient as measured in (ii) In case the jelly is made with a accordance with paragraph (d)(4) of combination of two, three, four, or five this section. fruit juice ingredients, the name is ‘‘Jelly’’, preceded or followed by the (2) Any requirement with respect to words ‘‘Mixed fruit’’ or by the names or the weight of any fruit juice ingre- synonyms whereby the fruits from dient, whether prepared from con- which the fruit juice ingredients were centrated, unconcentrated, or diluted extracted are designated in paragraph fruit juice means the weight deter- (b) of this section, in the order of pre- mined by the following method: (i) De- dominance, if any, of the weights of termine the percent of soluble solids in any such fruit juice ingredients in the such fruit juice ingredient by the combination. method for soluble solids referred to in (2) Label declaration. Each of the in- paragraph (d)(3) of this section; (ii) gredients used in the food shall be de- multiply the percent so found by the clared on the label as required by the weight of such fruit juice ingredient; applicable sections of parts 101 and 130 (iii) divide the result by 100; (iv) sub- of this chapter, except that: tract from the quotient the weight of (i) The name(s) of the fruit or fruits any added saccharine ingredient solids used may be declared without speci- or other added solids; and (v) multiply fying the particular form of the fruit or the remainder by the factor for such fruits used. fruit juice ingredient prescribed in (ii) When the optional ingredients paragraph (b) of this section. The re- listed in paragraphs (c) (3), (4), and (5) sult is the weight of the fruit juice in- of this section are declared on the gredient. label, the declaration may be followed (3) The soluble-solids content of the by the statement ‘‘Used as needed’’ on finished jelly is not less than 65 per- all jellies to which they are custom- cent, as determined by the method pre- arily, but not always, added to com- scribed in ‘‘Official Methods of Anal- pensate for natural variations in the ysis of the Association of Official Ana- fruit juice ingredients used. lytical Chemists,’’ 13th Ed. (1980), sec- [42 FR 14445, Mar. 15, 1977, as amended at 47 tion 31.011, under ‘‘Solids by Means of FR 11831, Mar. 19, 1982; 49 FR 10101, Mar. 19, Refractometer—Official Final Action,’’ 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, which is incorporated by reference. Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick § 150.160 Fruit preserves and jams. Ave., suite 500, Gaithersburg, MD 20877, (a) The preserves or jams for which or may be examined at the National definitions and standards of identity Archives and Records Administration are prescribed by this section are the (NARA). For information on the avail- viscous or semi-solid foods, each of ability of this material at NARA, call which is made from a mixture com- 202–741–6030, or go to: http:// posed of one or a permitted combina- www.archives.gov/federallregister/ tion of the fruit ingredients specified codeloflfederallregulations/ in paragraph (b) of this section and one ibrllocations.html. or any combination of the optional in- (4) The weight of any optional sac- gredients specified in paragraph (c) of charine ingredient means the weight of this section which meets the specifica- the solids of such ingredient. tions in paragraph (d) of this section,

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and which is labeled in accordance with (1) Nutritive carbohydrate sweet- paragraph (e) of this section. Such mix- eners. ture, with or without added water, is (2) Spice. concentrated with or without heat. The (3) Acidifying agents. volatile flavoring material from such (4) Pectin, in a quantity which rea- mixture may be captured during con- sonably compensates for deficiency, if centration, separately concentrated, any, of the natural pectin content of and added back to any such mixture, the fruit ingredient. together with any concentrated es- (5) Buffering agents. sence accompanying any optional fruit (6) Preservatives. ingredient. (7) Antifoaming agents, except those (b)(1) The fruit ingredients referred derived from animal fat. to in paragraph (a) of this section are (d) For the purposes of this section: the following mature, properly pre- (1) The mixture referred to in para- pared fruits which are fresh, con- graph (a) of this section shall be com- centrated, frozen and/or canned: posed of not less than: (i) In the case of a fruit ingredient consisting of a Group GROUP I I fruit or a permitted combination ex- Blackberry (other than dewberry), Black clusively of Group I fruits, 47 parts by raspberry, Blueberry, Boysenberry, Cherry, weight of the fruit ingredient to each Crabapple, Dewberry (other than boysenberry, loganberry, and youngberry) Elder- 55 parts by weight of the saccharine in- berry, Grape, Grapefruit, Huckleberry, Lo- gredient; and (ii) in all other cases, 45 ganberry, Orange, Pineapple, Raspberry, red parts by weight of the fruit ingredient raspberry, Rhubarb, Strawberry, Tangerine, to each 55 parts by weight of the sac- Tomato, Yellow tomato, Youngberry charine ingredient. The weight of the fruit ingredient shall be determined in GROUP II accordance with paragraph (d)(2) of Apricot, Cranberry, Damson, damson plum, this section, and the weight of the sac- Fig, Gooseberry, Greengage, greengage plum, charine ingredient shall be determined Guava, Nectarine, Peach, Pear, Plum (other in accordance with paragraph (d)(5) of than greengage plum and damson plum), Quince, Red currant, currant (other than this section. black currant) (2) Any requirement with respect to the weight of any fruit, combination of (2) The following combinations of fruits, or fruit ingredient means: fruit ingredients may be used: (i) The weight of fruit exclusive of (i) Any combination of two, three, the weight of any sugar, water, or four, or five of such fruits in which the other substance added for any proc- weight of each is not less than one-fifth essing or packing or canning, or other- of the weight of the combination; ex- wise added to such fruit. cept that the weight of pineapple may (ii) In the case of fruit prepared by be not less than one-tenth of the the removal, in whole or in part, of weight of the combination. pits, seeds, skins, cores, or other parts; (ii) Any combination of apple and the weight of such fruit, exclusive of one, two, three, or four of such fruits in the weight of all such substances re- which the weight of each is not less moved therefrom. than one-fifth and the weight of apple (iii) In the cases of apricots, cherries, is not more than one-half of the weight grapes, nectarines, peaches, and all va- of the combination; except that the rieties of plums, whether or not pits weight of pineapple may be not less and seeds are removed therefrom; the than one-tenth of the weight of the weight of such fruit, exclusive of the combination. weight of such pits and seeds. In any combination of two, three, four, (iv) In the case of concentrated fruit, or five fruits, each such fruit is an op- the weight of the properly prepared tional ingredient. For the purposes of fresh fruit used to produce such con- this section the word ‘‘fruit’’ includes centrated fruit. the vegetables specified in this para- (3) The term concentrated fruit means graph. a concentrate made from the properly (c) The following safe and suitable prepared edible portion of mature fresh optional ingredients may be used: or frozen fruits by removal of moisture

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with or without the use of heat or vac- synonyms whereby such fruits are des- uum, but not to the point of drying. ignated in paragraph (b) of this section, Such concentrate is canned or frozen in the order of predominance, if any, of without the addition of sugar or other the weights of such fruits in the com- sweetening agents and is identified to bination. show or permit the calculation of the (2) Label declaration. Each of the in- weight of the properly prepared fresh gredients used in the food shall be de- fruit used to produce any given quan- clared on the label as required by the tity of such concentrate. The volatile applicable sections of parts 101 and 130 flavoring material or essence from of this chapter, except that: such fruits may be captured during (i) The name(s) of the fruit or fruits concentration and separately con- used may be declared without speci- centrated for subsequent addition to fying the particular form of the fruit or the concentrated fruit either directly fruits used. or during manufacture of the preserve (ii) When the optional ingredients or jam, in the original proportions listed in paragraphs (c) (3), (4), and (5) present in the fruit. of this section are declared on the (4) The weight of any optional sac- label, the declaration may be followed charine ingredient means the weight of by the statement ‘‘used as needed’’ on the solids of such ingredient. all preserves or jams to which they are (5) The soluble-solids content of the customarily, but not always, added to finished jam or preserve is not less compensate for natural variations in than 65 percent, as determined by the the fruit ingredients used. method prescribed in ‘‘Official Methods of Analysis of the Association of Offi- [42 FR 14445, Mar. 15, 1977, as amended at 47 cial Analytical Chemists,’’ 13th Ed. FR 11831, Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, (1980), section 22.024, under ‘‘Soluble Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] Solids by Refractometer in Fresh and Canned Fruits, Jellies, Marmalades, and Preserves—Official Final Action,’’ PART 152—FRUIT PIES which is incorporated by reference, except that no correction is made for AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, water-insoluble solids. Copies may be 379e. obtained from the AOAC INTER- NATIONAL, 481 North Frederick Ave., Subpart A [Reserved] suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar- chives and Records Administration Subpart B—Requirements for (NARA). For information on the avail- Specific Standardized Fruit Pies ability of this material at NARA, call 202–741–6030, or go to: http:// § 152.126 Frozen cherry pie. www.archives.gov/federallregister/ (a) Identity. (1) Frozen cherry pie (ex- codeloflfederallregulations/ cluding baked and then frozen) is the ibrllocations.html. food prepared by incorporating in a (e)(1) The name of each preserve or filling contained in a pastry shell ma- jam for which a definition and standard ture, pitted, stemmed cherries that are of identity is prescribed by this section fresh, frozen, and/or canned. The top of is as follows: the pie may be open or it may be whol- (i) If the fruit ingredient is a single ly or partly covered with pastry or fruit, the name is ‘‘Preserve’’ or other suitable topping. Filling, pastry, ‘‘Jam’’, preceded or followed by the and topping components of the food name or synonym whereby such fruit is consist of optional ingredients as pre- designated in paragraph (b) of this sec- scribed by paragraph (a)(2) of this section. tion. The finished food is frozen. (ii) If the fruit ingredient is a com- (2) The optional ingredients referred bination of two, three, four, or five to in paragraph (a)(1) of this section fruits, the name is ‘‘Preserve’’ or consist of suitable substances that are ‘‘Jam’’, preceded or followed by the not food additives as defined in section words ‘‘Mixed fruit’’ or by the names or 201(s) of the Federal Food, Drug, and

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Cosmetic Act or color additives as de- section, is determined by the following fined in section 201(t) of the act; or if procedure: they are food additives or color addi- (i) Select a random sample from a tives as so defined, they are used in lot: conformity with regulations estab- (a) At least 24 containers if they bear lished pursuant to section 409 or 721 of a weight declaration of 16 ounces or the act. Ingredients that perform a use- less. ful function in the formulation of the (b) Enough containers to provide a filling, pastry, and topping compo- total quantity of declared weight of at nents, when used in amounts reason- least 24 pounds if they bear a weight ably required to accomplish their in- declaration of more than 16 ounces. tended effect, are regarded as suitable (ii) Determine net weight of each fro- except that artificial sweeteners are zen pie. not suitable ingredients of frozen cher- (iii) Temper the pie until the top ry pie. crust can be removed. (3) The name of the food for which a (iv) Remove the filling and cherries definition and standard of identity is from the pie and transfer to the surface established by this section is frozen of a previously weighed 12-inch diame- cherry pie; however, if the maximum ter U.S. No. 8 sieve (0.094-inch open- diameter of the food (measured across ings) stacked on a U.S. No. 20 sieve opposite outside edges of the pastry (0.033-inch openings). shell) is not more than 4 inches, the (v) Distribute evenly over the surface food alternatively may be designated and wash with a gentle spray of water ° ° by the name frozen cherry tart. The at 70 –75 F to free the cherries and word ‘‘frozen’’ may be omitted from cherry fragments from the adhering the name on the label if such omission material. is not misleading. (vi) Remove the U.S. No. 8 sieve and (4)(i) Label declaration. Each of the in- examine the U.S. No. 20 sieve and gredients used in the food shall be de- transfer all cherry fragments to the clared on the label as required by the U.S. No. 8 sieve. applicable sections of parts 101 and 130 (vii) Drain the cherry contents on the No. 8 sieve for 2 minutes in an inclined of this chapter. position (15°–30° slope). Weigh the U.S. (ii) The label shall not bear any mis- No. 8 sieve and the washed and drained leading pictorial representation of the cherries to the nearest 0.01 ounce. cherries in the pie. (viii) The weight of the washed and (b) Quality. (1) The standard of qual- drained cherries is the weight of the ity for frozen cherry pie is as follows: sieve and the cherry material less the (i) The fruit content of the pie is such weight of the sieve. Calculate the per- that the weight of the washed and cent of the cherry content of each pie drained cherry content is not less than with the following formula, and then 25 percent of the weight of the pie when calculate the average percent of the determined by the procedure prescribed entire random sample: by paragraph (b)(2) of this section. (ii) Not more than 15 percent by Percent of the cherry content of the pie = count of the cherries in the pie are [(Weight of washed and drained cherries) / × blemished with scab, hail injury, dis- (Net weight of pie)] 100. coloration, scar tissue, or other abnor- (3) If the quality of the frozen cherry mality. A cherry showing skin discol- pie falls below the standard of quality oration (other than scald) having an prescribed by paragraph (b)(1) of this aggregate area exceeding that of a cir- section, the label shall bear the general cle nine thirty-seconds of an inch in di- statement of substandard quality spec- ameter is considered to be blemished. ified in § 130.14(a) of this chapter, in the A cherry showing discoloration of any manner and form specified therein; but area but extending into the fruit tissue in lieu of the words prescribed for the is also considered to be blemished. second line inside the rectangle, the (2) Compliance with the requirement label may bear the alternative state- for the weight of the washed and ment ‘‘Below standard in quality drained cherry content of the pie, as llllll’’, the blank being filled in prescribed by paragraph (b)(1)(i) of this with the following words, as applicable:

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‘‘too few cherries’’, or ‘‘blemished cher- deemed in compliance for the following ries’’. Such alternative statement shall factors, to be determined by the sam- immediately and conspicuously pre- pling and acceptance procedure as pro- cede or follow, without intervening vided in paragraph (c) of this section, written, printed, or graphic matter, the namely: name of the food as prescribed by para- (1) Quality. The quality of a lot shall graph (a) of this section. be considered acceptable when the [42 FR 14449, Mar. 15, 1977, as amended at 58 number of defectives does not exceed FR 2882, Jan. 6, 1993] the acceptance number (c) in the sampling plans. PART 155—CANNED VEGETABLES (2) Fill of container. A lot shall be deemed to be in compliance for fill of Subpart A—General Provisions container (packing medium and vegetable ingredient) when the number of Sec. defectives does not exceed the accept- 155.3 Definitions. ance number (c) in the sampling plans. Subpart B—Requirements for Specific (3) Drained weight. A lot shall be Standardized Canned Vegetables deemed to be in compliance for drained weight based on the average value of 155.120 Canned green beans and canned wax all samples analyzed according to the beans. sampling plans. 155.130 Canned corn. 155.131 Canned field corn. (c) The sampling and acceptance proce- 155.170 Canned peas. dure means the following: 155.172 Canned dry peas. (1) Definitions—(i) Lot. A collection of 155.190 Canned tomatoes. primary containers or units of the 155.191 Tomato concentrates. same size, type, and style manufac- 155.194 Catsup. tured or packed under similar condi- 155.200 Certain other canned vegetables. 155.201 Canned mushrooms. tions and handled as a single unit of trade. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. (ii) Lot size. The number of primary containers or units in the lot. SOURCE: 42 FR 14449, Mar. 15, 1977, unless (iii) Sample size. The total number of otherwise noted. sample units drawn for examination from a lot. Subpart A—General Provisions (iv) Sample unit. A container, a por- § 155.3 Definitions. tion of the contents of a container, or a composite mixture of product from For the purposes of this part: small containers that is sufficient for (a) The procedure for determining the examination or testing as a single drained weight is set forth in the ‘‘Of- unit. For fill of container, the sample ficial Methods of Analysis of the Asso- unit shall be the entire contents of the ciation of Official Analytical Chem- container. ists,’’ 13th Ed. (1980), sections 32.001– (v) Defective. Any sample unit shall 32.003, which is incorporated by ref- be regarded as defective when the sam- erence. Copies are available from the AOAC INTERNATIONAL, 481 North ple unit does not meet the criteria set Frederick Ave., suite 500, Gaithersburg, forth in the standards. MD 20877, or available for inspection at (vi) Acceptance number (c). The max- the National Archives and Records Ad- imum number of defective sample units ministration (NARA). For information permitted in the sample in order to on the availability of this material at consider the lot as meeting the speci- NARA, call 202–741–6030, or go to: http:// fied requirements. www.archives.gov/federallregister/ (vii) Acceptable quality level (AQL). codeloflfederallregulations/ The maximum percent of defective ibrllocations.html. sample units permitted in a lot that (b) Compliance means the following: will be accepted approximately 95 per- Unless otherwise provided in a stand- cent of the time. ard, a lot of canned vegetables shall be (2) Sampling plans.

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Size of container ning the Munsell color discs in the Lot size (primary containers n 1 c 2 combination as set out above. (e) Tomato soluble solids means the su- NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) crose value as determined by the meth- 4,800 or less ...... 13 2 od prescribed in the ‘‘Official Methods 4,801 to 24,000 ...... 21 3 of Analysis of the Association of Offi- 24,001 to 48,000 ...... 29 4 48,001 to 84,000 ...... 48 6 cial Analytical Chemists,’’ 13th Ed., 84,001 to 144,000 ...... 84 9 1980, sections 32.014 to 32.016 and 52.012, 144,001 to 240,000 ...... 126 13 under the headings ‘‘Soluble Solids in Over 240,000 ...... 200 19 Tomato Products Official Final Ac- NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN tion’’ and ‘‘Refractive Indices (n) of Su- 4.5 KG (10 LB) crose Solutions at 20°,’’ which is incor- 2,400 or less ...... 13 2 porated by reference. Copies are avail- 2,401 to 15,000 ...... 21 3 able from the AOAC INTER- 15,001 to 24,000 ...... 29 4 24,001 to 42,000 ...... 48 6 NATIONAL, 481 North Frederick Ave., 42,001 to 72,000 ...... 84 9 suite 500, Gaithersburg, MD 20877, or 72,001 to 120,000 ...... 126 13 are available for inspection at the Na- Over 120,000 ...... 200 19 tional Archives and Records Adminis- NET WEIGHT GREATER THAN 4.5 KG (10 LB) tration (NARA). For information on the availability of this material at 600 or less ...... 13 2 601 to 2,000 ...... 21 3 NARA, call 202–741–6030, or go to: http:// 2,001 to 7,200 ...... 29 4 www.archives.gov/federallregister/ 7,201 to 15,000 ...... 48 6 15,001 to 24,000 ...... 84 9 codeloflfederallregulations/ 24,001 to 42,000 ...... 126 13 ibrllocations.html. If no salt has been Over 42,000 ...... 200 19 added, the sucrose value obtained from 1 n = number of primary containers in sample. the referenced tables shall be consid- 2 c = acceptance number. ered the percent of tomato soluble sol- (d) Strength and redness of color means ids. If salt has been added either inten- at least as much red as is obtained by tionally or through the application of comparison of the prepared product, the acidified break, determine the per- with the blended color produced by cent of such added sodium chloride as spinning a combination of the fol- specified in paragraph (f) of this sec- lowing concentric Munsell color discs tion. Subtract the percentage so found of equal diameter, or the color equiva- from the percentage of total soluble lent of such discs: solids found (sucrose value from the re- Disc 1—Red (5R 2.6/13) (glossy finish) fractive index tables) and multiply the Disc 2—Yellow (2.5 YR 5/12) (glossy finish) difference by 1.016. The resultant value Disc 3—Black (N1) (glossy finish) is considered the percent of ‘‘tomato Disc 4—Grey (N4) (mat finish) soluble solids.’’ Such comparison is to be made in full (f) Salt means sodium chloride, deter- diffused daylight or under a diffused mined as chloride and calculated as light source of approximately 2691 lux percent sodium chloride, by the meth- (250 footcandles) and having a spectral od prescribed in ‘‘Official Methods of quality approximating that of daylight Analysis of the Association of Official under a moderately overcast sky, with Analytical Chemists,’’ 13th Ed., 1980, a correlated color temperature of 7,500 sections 32.025 to 32.030, under the head- degrees Kelvin ±200 degrees. With the ing ‘‘Method III (Potentiometric Meth- light source directly over the disc and od),’’ which is incorporated by ref- product, observation is made at an erence. angle of 45 degrees from a distance of about 24 inches from the product. Elec- [45 FR 43398, June 27, 1980, as amended at 47 tronic color meters may be used as an FR 11831, Mar. 19, 1982; 48 FR 3954, Jan. 28, alternate means of determining the 1983; 54 FR 24895, June 12, 1989; 63 FR 14035, color of tomato concentrates. Such me- Mar. 24, 1998] ters shall be calibrated to indicate that the color of the product is as red or more red than that produced by spin-

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Subpart B—Requirements for Spe- (f) Diagonal short cuts. Pods cut in cific Standardized Canned lengths as specified in paragraph Vegetables (a)(2)(iii)(d) of this section, except the pods are cut at an angle approximately ° § 155.120 Canned green beans and 45 to the longitudinal axis. canned wax beans. (g) Mixture. Any mixture of two or more of the styles specified in para- (a) —(1) Canned Identity Definition. graph (a)(2)(iii)(a) to (f), inclusive, of green beans and canned wax 4eans are this section. the foods prepared from succulent pods (3) Optional ingredients. In addition to of fresh green bean or wax bean plants the optional packing media listed in conforming to the characteristics of paragraph (a)(1) of this section and the Phaseolus vulgaris L. and Phaseolus optional types and styles of beans in- coccineus L. The optional color and va- gredient listed in paragraph (a)(2) of rietal types and styles of the bean in- this section, the following safe and gredient are set forth in paragraph suitable optional ingredients may be (a)(2) of this section. The product is used: packed with water or other suitable (i) Salt. aqueous liquid medium to which may (ii) Monosodium glutamate. be added one or more of the other op- (iii) Disodium inosinate. tional ingredients set forth in para- (iv) Disodium guanylate. graph (a)(3) of this section. Such food is (v) Hydrolyzed vegetable protein. so processed by heat, in an appropriate (vi) Autolyzed yeast extract. manner before or after being sealed in (vii) Nutritive carbohydrate sweet- a container, as to prevent spoilage. eners. (2) Optional color and varietal types (viii) Spice. and styles of pack. The optional color (ix) Flavoring (except artificial). and varietal types and styles of the (x) Pieces of green or red peppers or bean ingredient referred to in para- mixtures of both, either of which may graph (a)(1) of this section are: be dried, or other vegetables not ex- (i) Optional color types. The beans ceeding in total 15 percent by weight of shall be one of the following distinct the finished product. color types: (a) Green; or (b) Wax. (xi) Vinegar. (ii) Optional varietal types—(a) Round. (xii) Lemon juice or concentrated Beans having a width not greater than lemon juice. 11⁄2 times the thickness of the bean; or (xiii) Glucono delta-lactone. (b) Flat. Beans having a width greater (xiv) Mint leaves. than 11⁄2 times the thickness of the (xv) Butter or margarine in a quan- bean. tity of not less than 3 percent by (iii) Optional styles of pack—(a) Whole. weight of the finished product. When Whole pods of any length. butter or margarine is added, emulsi- (b) Shoestring or sliced lengthwise or fiers or stabilizers, or both, may be French style. Pods sliced lengthwise. added. No spice or flavoring simulating (c) Cuts. Transversely cut pods not the color or flavor imparted by butter less than 19 mm (0.75 in) long as meas- or margarine is used. ured along the longitudinal axis, which (4) Labeling. (i) The name of the food may contain the shorter end pieces is ‘‘green beans’’ or ‘‘wax beans’’ as ap- that result from cutting such pods. propriate. Wax beans may be addition- (d) Short cuts. Pieces of pods cut ally designated ‘‘golden’’ or ‘‘yellow’’. transversely of which 75 percent, by (ii) The following shall be included as count, or more are less than 19 mm part of the name or in conjunction (0.75 in) in length and not more than 1 with the name of the food: percent by count are more than 32 mm (a) A declaration of any flavoring (11⁄4 in) in length. that characterizes the product as speci- (e) Diagonal cuts. Pods cut in lengths fied in § 101.22 of this chapter. as specified in paragraph (a)(2)(iii)(c) of (b) A declaration of any spice, sea- this section, except the pods are cut at soning, or garnishing that character- an angle approximately 45° to the lon- izes the product, e.g., ‘‘with added gitudinal axis. spice’’, or, in lieu of the word ‘‘spice’’,

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the common name of the spice, e.g., clared on the label as required by the ‘‘seasoned with green peppers’’. applicable sections of parts 101 and 130 (c) The words ‘‘vacuum pack’’ or of this chapter. ‘‘vacuum packed’’ when the weight of (b) Quality. (1) When tested by the the liquid in the container, as deter- method prescribed in paragraph (b)(2) mined by the method prescribed in of this section: paragraph (b)(2)(i) of this section is not (i) In the case of cut beans and diago- more than 25 percent of the net weight, nal cut beans under paragraphs and the container is closed under con- (a)(2)(iii) (c) and (d) of this section and ditions creating a high vacuum in the mixtures of two or more optional forms container. under paragraph (a)(2)(iii)(g) of this (d) The name of the optional style of section, not more than 60 units per 340 bean ingredient as set forth in para- g (12 oz) drained weight are less than 13 graph (a)(2)(iii) of this section or, if a mm (0.50 in) long: Provided, That where product consists of a mixture of such the number of units per 340 g (12 oz) styles, the words ‘‘mixture of ’’ drained weight exceeds 240, not more the blank to be filled in with the names than 25 percent by count of the total of the styles present, arranged in the units are less than 13 mm (0.50 in) long. order of decreasing predominance, if (ii) In case there are present pods or any, by weight of such ingredients. If pieces of pods 10.7 mm (27⁄64-inch) or the product consists of whole beans and more in diameter, there are not more the pods are packed parallel to the than 12 strings per 340 gm (12 ounces) of sides of the container, the word drained weight which will support 227 ‘‘whole’’ may be preceded or followed gm (one-half pound) for 5 seconds or by the words ‘‘vertical pack’’, or if the longer. pods are cut at both ends and are of substantially equal lengths, the words (iii) The deseeded pods contain not ‘‘asparagus style’’ may be used in lieu more than 0.15 percent by weight of fi- of the words ‘‘vertical pack’’. If the brous material. product consists of short cuts or diago- (iv) There are not more than 10 per- nal short cuts, a numerical expression cent by weight of blemished units of indicating the predominate length of which amount not more than one-half cut in the finished food may be used in may be materially damaged by insect or pathological injury. A unit is con- lieu of the word ‘‘short’’, e.g., ‘‘1⁄2 inch cut’’. sidered blemished when the aggregate (iii) The following may be included in blemished area exceeds the area of a 1 the name of the food: circle 3 mm ( ⁄8 in) in diameter. Materi- (a) The word ‘‘stringless’’ where the ally damaged means that the unit is beans are in fact stringless. damaged to the extent that the appear- (b) The name of the optional varietal ance or eating quality of the unit is se- type as specified in paragraph (a)(2)(ii) riously affected. of this section, or the specific varietal (v) There are not more than 8 name, e.g., ‘‘Blue Lake Green Beans’’, unstemmed units per 340 g (12 oz) or both. drained weight. (iv) If a term designating diameter is (vi) The combined number of leaves, used, it shall be supported by an exact detached stems, and other extraneous graphic representation of the cross sec- vegetable matter shall not average tion of the bean pod or by a statement more than 3 pieces per 340 g (12 oz) of the maximum diameter in common drained beans. or decimal fractions of an inch and, op- (2) Canned beans shall be tested by tionally, by the millimeter equivalent the following method to determine stated parenthetically. The diameter of whether they meet the requirements of a whole, cut, diagonal cut, or short cut paragraph (b)(1) of this section: is determined by measuring the thick- (i) Determine the gross weight of the est portion of the pod at the shorter di- container. Open and distribute the con- ameter of the bean perpendicular to tents of the container over the meshes the longitudinal axis. of a U.S. No. 8 circular sieve with open- (5) Label declaration. Each of the in- ings of 2.36 mm (0.0937 in), which has gredients used in the food shall be de- been previously weighed. The diameter

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of the sieve is 20.3 cm (8 in) if the quan- in.) long. If the number of units per 340 tity of contents of the container is less g (12 oz.) is 240 or less, divide the num- than 1.36 kg (3 lb) and 30.5 cm (12 in) if ber of units which are less than 13 mm such quantity is 1.36 kg (3 lb) or more. (0.50 in.) by the drained weight re- The bottom of the sieve is woven-wire corded in paragraph (b)(2)(i) of this sec- cloth that complies with the specification and multiply by 340 to obtain the tions of such cloth set forth in ‘‘Offi- number of such units per 340 g (12 oz.) cial Methods of Analysis of the Asso- drained weight. If the number of units ciation of Official Analytical Chem- per 340 g (12 oz.) exceeds 240, divide the ists,’’ 15th ed. (1990), vol. 2, p. xii, Table number of units less than 13 mm (0.50 1, ‘‘Nominal Dimensions of Standard in.) long by the total number of units Test Sieves (USA Standard Series),’’ and multiply by 100 to determine the under the heading ‘‘Definitions of percentage by count of the total units Terms and Explanatory Notes,’’ which which are less than 13 mm (0.50 in.) is incorporated by reference in accord- long. ance with 5 U.S.C. 552(a) and 1 CFR (a) Divide the weight of blemished part 51. Copies may be obtained from units by the drained weight recorded in the AOAC INTERNATIONAL, 481 North paragraph (b)(2)(i) of this section and Frederick Ave., suite 500, Gaithersburg, multiply by 100 to obtain the percent- MD 20877, or may be examined at the age by weight of blemished units in the National Archives and Records Admin- container. istration (NARA). For information on (b) Divide the number of unstemmed the availability of this material at units by the drained weight recorded in NARA, call 202–741–6030, or go to: http:// paragraph (b)(2)(i) of this section and www.archives.gov/federallregister/ multiply by 340 to obtain the number codeloflfederallregulations/ of unstemmed units per 340 g (12 oz.) of Without shifting the ibrllocations.html. drained weight. material on the sieve, incline the sieve (iv) Remove from the tray the extra- 17 to 20° to facilitate drainage. Two neous vegetable material, count, minutes after drainage begins, weigh the sieve and the drained material. record count, and return to tray. Record in grams (ounces) the weight so (v) Remove from the tray one or found, less the weight of the sieve, as more representative samples of 99 to 1 the drained weight. Dry and weigh the 113 g (3 ⁄2 to 4 ounces) covering each empty container and subtract this sample as taken to prevent evapo- weight from the gross weight to obtain ration. the net weight. Calculate the percent (vi) From each representative sample of drained liquid in the net weight. selected in paragraph (b)(2)(v) of this (ii) Pour the drained material from section, discard any loose seed and ex- the sieve into a flat tray and spread it traneous vegetable material and de- in a layer of fairly uniform thickness. tach and discard any attached stems. Count the total number of units. For Except with optional style of ingre- the purpose of this count, loose seeds, dient specified in paragraph pieces of seed, loose stems, and extra- (a)(2)(iii)(b) of this section (pods sliced neous material are not to be included. lengthwise), trim off, as far as the end Divide the number of units by the of the space formerly occupied by the drained weight recorded in paragraph seed, any portion of pods from which (b)(2)(i) of this section and multiply by the seed has become separated. Remove 340 to obtain the number of units per and discard any portions of seed from 340 g (12 oz) drained weight. the trimmings and reserve the trim- (iii) Examine the drained material in mings for paragraph (b)(2)(viii) of this the tray, weigh and record weight of section. Weigh and record the weight of blemished units, count and record the the trimmed pods. Deseed the trimmed number of unstemmed units; and, in pods and reserve the deseeded pods for case the material consists of the op- paragraph (b)(2)(viii) of this section. tional ingredient specified in para- Remove strings from the pods during graph (a)(2)(iii) (c), (d) or (f) of this sec- the deseeding operation. Reserve these tion, count and record the number of strings for testing as prescribed in units which are less than 13 mm (0.50 paragraph (b)(2)(vii) of this section. In

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the case of pods sliced lengthwise, remove seed and pieces of seed and reserve the deseeded pods for use as prescribed in paragraph (b)(2)(viii) of this section. (vii) If strings have been removed for testing, as prescribed in paragraph (b)(2)(vi) of this section, test them as follows: Fasten clamp, weighted to 250 g (8.8 oz.), to one end of the string, grasp the other end with the fingers (a cloth may be used to aid in holding the string), and lift gently. Count the string as tough if it supports the 250 g (8.8 oz.) weight for at least 5 seconds. If the string breaks before 5 seconds, test such parts into which it breaks as are 13 mm (1⁄2 in.) or more in length; and if any such part of the string supports the 250 g (8.8 oz.) weight for at least 5 seconds, count the Transfer the material from the cup to string as tough. Divide the number of tough a previously weighed 30-mesh monel strings by the weight of the sample recorded metal screen having a diameter of in paragraph (b)(2)(v) of this section and about 9–10 cm (31⁄2 to 4 in.) and side multiply by 340 to obtain the number of walls about 2.5 cm (1 in.) high, and tough strings per 340 g (12 oz.) drained wash fiber on the screen with a stream weight. of water using a pressure not exceeding (viii) Combine the deseeded pods with a head (vertical distance between upper the trimmings reserved in paragraph level of water and outlet of glass tube) (b)(2)(vi) of this section, and, if strings of 152 cm (60 in.), delivered through a were tested as prescribed in paragraph glass tube 7.6 cm (3 in.) long and 3 mm (b)(2)(vii) of this section, add such (1⁄8 in.) inside diameter inserted into a strings broken or unbroken. Weigh and rubber tube of 6 mm (1⁄4 in.) inside di- record weight of combined material. ameter. Wash the pulpy portion of the Transfer to the metal cup of a malted- material through the screen and con- milk stirrer and mash with a pestle. tinue washing until the remaining fi- Wash material adhering to the pestle brous material, moistened with phenol- back into cup with 200 cc of boiling phthalein solution, does not show any water. Bring mixture nearly to a boil, red color after standing 5 minutes. add 25 cc of 50 percent (by weight) so- Again wash to remove phenolphthalein. dium hydroxide solution and bring to a Dry the screen containing the fibrous material for 2 hours at 100 °C, cool, boil. (If foaming is excessive, 1 cc of weigh, and deduct weight of screen. Di- capryl alcohol may be added.) Boil for vide the weight of fibrous material by 5 minutes, then stir for 5 minutes with the weight of combined deseeded pods, a malted-milk stirrer capable of a no- trimmings, and strings and multiply by load speed of at least 7,200 rpm. Use a 100 to obtain the percentage of fibrous rotor with two scalloped buttons material. shaped as shown in exhibit 1 as follows: (ix) If the drained weight recorded in paragraph (b)(2)(i) of this section was less than 340 g (12 oz.), open and examine separately for extraneous material, as directed in paragraph (b)(2)(iv) of this section, additional containers until a total of not less than 340 g (12 oz.) of drained material is obtained. To determine the number of pieces of extraneous vegetable material per 340 g (12 oz.) of drained weight, total the

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number of pieces of extraneous vege- tion of two or more, of the optional in- table material found in all containers gredients set forth in paragraph (a)(3) opened, divide this sum by the sum of of this section. Such food is processed the drained weights in these containers by heat, in an appropriate manner, be- and multiply by 340. fore or after being sealed in a con- (3) Determine compliance as specified tainer, so as to prevent spoilage. in § 155.3(b) except that a lot shall be (2) Styles. The optional styles referred deemed to be in compliance for extra- to in paragraph (a)(1) of this section neous plant material based on an aver- consist of succulent sweet corn of the age of all containers examined. yellow (golden) or white color type, (4) If the quality of the canned green conforming to Zea mays L. having the beans or canned wax beans falls below sweet corn characteristic as follows: the standard of quality prescribed by (i) Whole kernel or whole grain or cut paragraph (b)(1) of this section, the kernel consisting of whole or substan- label shall bear the general statement tially whole cut kernels packed with a of substandard quality specified in liquid medium. § 130.14(a) of this chapter, in the man- (ii) Cream style consisting of whole ner and form therein specified; but in or partially whole cut kernels packed lieu of the words prescribed for the sec- in a creamy component from the corn ond line inside the rectangle the fol- kernels and other liquid or other ingre- lowing words may be used, when the dients to form a product of creamy quality of canned green beans or consistency. canned wax beans falls below the (3) Optional ingredients. The following standard in one only of the following safe and suitable optional ingredients respects: may be used: (i) ‘‘Excessive number very short (i) Salt. pieces’’, if the canned green beans or (ii) Monosodium glutamate. canned wax beans fail to meet the re- (iii) Disodium inosinate. quirements of paragraph (b)(1)(i) of this (iv) Disodium guanylate. section. (v) Hydrolyzed vegetable protein. (ii) ‘‘Excessive number blemished units’’, if they fail to meet the require- (vi) Autolyzed yeast extract. ments of paragraph (b)(1)(iv) of this (vii) Nutritive carbohydrate sweet- section. eners. (iii) ‘‘Excessive number unstemmed (viii) Spice. units’’, if they fail to meet the require- (ix) Flavoring (except artificial). ments of paragraph (b)(1)(v) of this sec- (x) Citric acid. tion. (xi) Starch or food starch-modified in (iv) ‘‘Excessive foreign material’’, if cream style corn when necessary to en- they fail to meet the requirements of sure smoothness. paragraph (b)(1)(vi) of this section. (xii) Seasonings and garnishes. (a) Mint leaves. [42 FR 14449, Mar. 15, 1977, as amended at 42 (b) Pieces of green peppers or red pep- FR 30359, 30360, June 14, 1977; 45 FR 43398, June 27, 1980; 47 FR 11831, Mar. 19, 1982; 49 FR pers, or mixtures of both, either of 10101, Mar. 19, 1984; 57 FR 34245, Aug. 4, 1992; which may be sweet or hot and may be 58 FR 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, dried, or other vegetables, not exceed- 1998] ing 15 percent by weight of the finished food. § 155.130 Canned corn. (c) Lemon juice or concentrated (a) Identity—(1) Definition. Canned lemon juice. sweet corn is the product prepared (d) Butter or margarine in a quantity from clean, sound kernels of sweet corn not less than 3 percent by weight of the packed with a suitable liquid packing finished food. When butter or mar- medium which may include water and garine is added, emulsifiers or stabi- the creamy component from corn ker- lizers, or both, may be added. When nels. The tip caps are removed. The butter or margarine is added, no spice, product is of the optional styles speci- or flavoring simulating the color or fied in paragraph (a)(2) of this section. flavor imparted by butter or margarine It may contain one, or any combina- is used.

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(4) Labeling. The name of the food is (a) Contains not more than 10 brown ‘‘corn’’ or ‘‘sweet corn’’ or ‘‘sugar or black discolored kernels or pieces of corn’’ and shall include a declaration of kernel per 600 g. (21.4 ounces) of net any flavoring that characterizes the weight; product as specified in § 101.22 of this (b) Contains not more than 1 cubic chapter and a declaration of any spice, centimeter of pieces of cob per 600 g. seasoning or garnishing that character- (21.4 ounces) of net weight; izes the product; for example, ‘‘With (c) Contains not more than 7 square added spice’’, ‘‘Seasoned with red pep- centimeters (1.1 square inch) of husk pers’’, ‘‘Seasoned with butter’’. The per 600 g. (21.4 ounces) of net weight; name of the food shall also include the (d) Contains not more than 150 mm. following: (6 inches) of silk for each 28 g. (1 ounce) (i) The optional style of the corn in- of net weight; and gredient as specified in paragraph (a)(2) (e) Has a consistency such that the of this section. average diameter of the approximately (ii) The words ‘‘vacuum pack’’ or circular area over which the prescribed ‘‘vacuum packed’’ when the corn ingre- sample spreads does not exceed 30.5 cm. dient is as specified in paragraph (12 inches), except that when the (a)(2)(i) of this section and the weight washed drained material contains more of the liquid in the container, as deter- than 20 percent of alcohol-insoluble mined by the method prescribed in solids, the average diameter of the ap- paragraph (b)(2)(i) of this section, is proximately circular area over which not more than 20 percent of the net the prescribed sample spreads does not weight, and the container is closed exceed 25.4 cm. (10 inches). under conditions creating a high vacu- (iii)(a) The weight of the alcohol-in- um in the container. soluble solids of whole-kernel corn (iii) The color type used only when (paragraph (a)(2)(i) of this section) does the product consists of white corn. not exceed 27 percent of the drained (iv) The color type used only when weight, when tested by the method pre- the product consists of white corn. scribed in paragraph (b)(2) of this sec- (5) Label declaration. Each of the in- tion. gredients used in the food shall be de- (b) The weight of the alcohol-insol- clared on the label as required by the uble solids of the washed drained mate- applicable sections of parts 101 and 130 rial of cream style corn (paragraph of this chapter. (a)(2)(ii) of this section) does not ex- (b) Quality. (1) The standard of qual- ceed 27 percent of the drained weight of ity for canned corn is as follows: such material, when tested by the (i) When tested by the method pre- method prescribed in paragraph (b)(3) scribed in paragraph (b)(2) of this sec- of this section. tion, canned whole-kernel corn (para- (2) The method referred to in paragraph (a)(2)(i) of this section): graph (b)(1) of this section for testing (a) Contains not more than seven whole-kernel corn (paragraph (a)(2)(i) brown or black discolored kernels or of this section) is as follows: pieces of kernel per 400 g. (14 ounces) of (i) Determine the gross weight of the drained weight; container. Open and distribute the con- (b) Contains not more than 1 cubic tents of the container over the meshes centimeter of pieces of cob for each 400 of a U.S. No. 8 circular sieve which has g. (14 ounces) of drained weight; previously been weighed. The diameter (c) Contains not more than 7 square of the sieve is 20.3 cm. (8 inches) if the centimeters (1.1 square inch) of husk quantity of the contents of the con- per 400 g. (14 ounces) of drained weight; tainer is less than 1.36 kg. (3 pounds), and and 30.5 cm. (12 inches) if such quantity (d) Contains not more than 180 mm. is 1.36 kg. (3 pounds) or more. The bot- (7 inches) of silk per 28 g. (1 ounce) of tom of the sieve is woven-wire cloth drained weight. that complies with the specifications (ii) When tested by the method pre- for such sieve set forth in the ‘‘Defini- scribed in paragraph (b)(3) of this sections of Terms and Explanatory Notes’’ tion, canned cream style corn (para- prescribed in ‘‘Official Methods of graph (a)(2)(ii) of this section): Analysis of the Association of Official

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Analytical Chemists,’’ 13th Ed. (1980), water is used to facilitate this oper- Table 1, ‘‘Nominal Dimensions of ation. Weigh to nearest 0.01 g. a por- Standard Test Sieves (U.S.A. Standard tion of the comminuted material Series),’’ under the heading ‘‘Defini- equivalent to approximately 10 g. of tions of Terms and Explanatory the drained corn into a 600 cubic centi- Notes,’’ which is incorporated by ref- meter beaker. Add 300 cubic centi- erence. Copies may be obtained from meters of 80 percent alcohol (by vol- the AOAC INTERNATIONAL, 481 North ume), stir, cover beaker, and bring to a Frederick Ave., suite 500, Gaithersburg, boil. Simmer slowly for 30 minutes. Fit MD 20877, or may be examined at the a Buchner funnel with a previously pre- National Archives and Records Admin- pared filter paper of such sizes that its istration (NARA). For information on edges extend 12.7 mm. (one-half inch) the availability of this material at or more up the vertical sides of the NARA, call 202–741–6030, or go to: http:// funnel. The previous preparation of the www.archives.gov/federallregister/ filter paper consists of drying it in a codeloflfederallregulations/ flat-bottomed dish for 2 hours at 100 °C, ibrllocations.html. Without shifting the covering the dish with a tight fitting material on the sieve, so incline the cover, cooling it in a desiccator, and sieve at approximately 17–20° angle to promptly weighing to the nearest 0.001 facilitate drainage. Two minutes from g. After the filter paper is fitted to the the time drainage begins, weigh the funnel, apply suction and transfer the sieve and the drained material. Record, contents of the beaker to the funnel. in g. (ounces), the weight so found, less Do not allow any of the material to run the weight of the sieve, as the drained over the edge of the paper. Wash the weight. Dry and weigh the empty con- material on the filter with 80 percent tainer and subtract this weight from alcohol (by volume) until the washings the gross weight to obtain the net are clear and colorless. Transfer the fil- weight. Calculate the percent of ter paper with the material retained drained liquid in the net weight. thereon to the dish used in preparing (ii) Pour the drained material from the filter paper. Dry the material in a the sieve into a flat tray and spread it ventilated oven, without covering the in a layer of fairly uniform thickness. dish, for 2 hours at 100 °C. Place the Count, but do not remove, the brown or cover on the dish, cool it in a desic- black discolored kernels or pieces of cator, and promptly weigh to the near- kernel and calculate the number per est 0.001 g. From this weight subtract 400 g. (14 ounces) of drained material. the weight of the dish, cover, and paper Remove pieces of silk more than 12.7 as previously found. Calculate the re- mm. (one-half inch) long, husk, cob, mainder to percentage. and any pieces of material other than (3) The method referred to in para- corn. Measure the aggregate length of graph (b)(1) of this section for testing such pieces of silk and calculate the cream-style corn (paragraph (a)(2)(ii) of length of silk per 28 g. (1 ounce) of this section) is as follows: drained weight. Spread the husk flat, (i) Allow the container to stand at measure its aggregate area, and cal- least 24 hours at a temperature of 68 °F culate the area of husk per 400 g. (14 to 85 °F. Determine the gross weight, ounces) of drained weight. Place all open, transfer the contents into a pan, pieces of cob under a measured amount and mix thoroughly in such a manner of water in a cylinder which is so grad- as not to incorporate air bubbles. (If uated that the volume can be measured the net contents of a single container to 0.1 cubic centimeter. Take the in- is less than 510 g. (18 ounces) determine crease in volume as the aggregate vol- the gross weight, open, and mix the ume of the cob and calculate the vol- contents of the least number of con- ume of cob per 400 g. (14 ounces) of tainers necessary to obtain 510 g. (18 drained weight. ounces). Fill level full a hollow, trun- (iii) Comminute representative 100 g. cated cone so placed on a polished hori- sample of the drained corn from which zontal plate as to prevent leakage. The the silk, husk, cob, and other material cone has an inside bottom diameter of which is not corn (i.e., peppers) have 7.62 cm. (3 inches), inside top diameter been removed. An equal amount of of 5.08 cm. (2 inches), and height of

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12.30 cm. (427⁄32 inches). As soon as the (4) Determine compliance as specified cone is filled, lift it vertically. Deter- in § 155.3(b). mine the average of the longest and (5) If the quality of canned corn falls shortest diameters of the approxi- below the standard prescribed in para- mately circular area on the plate cov- graph (b)(1) of this section, the label ered by the sample 30 seconds after lift- shall bear the general statement of ing the cone. Dry and weigh each substandard quality specified in empty container and subtract the § 130.14(a) of this chapter, in the man- weight so found from the gross weight ner and form therein specified; how- to obtain the net weight. ever, if the quality of the canned corn (ii) Transfer the material from the falls below standard with respect to plate, cone, and pan onto a U.S. No. 8 only one of the factors of quality speci- sieve as prescribed in paragraph (b)(2)(i) of this section. The diameter of fied by paragraphs (b)(1)(i) (a) to (d) of the sieve is 20.3 cm. (8 inches) if the this section, or by paragraphs (b)(1)(ii) quantity of the contents of the con- (a) to (e) of this section, there may be tainer is less than 1.36 kg. (3 pounds), substituted for the second line of such and 30.5 cm. (12 inches) if such quantity general statement of substandard qual- is 1.36 kg. (3 pounds) or more. Set the ity, ‘‘Good food—not high grade’’, a sieve in a pan. Add enough water to new line as specified after the cor- bring the level within 9.53 mm. (three- responding subdivision designation of eighth inch) to 6.35 mm. (one-fourth paragraph (b)(1) of this section, which inch) of the top of the sieve. Gently the canned corn fails to meet: wash the material on the sieve by com- (i)(a) or (ii)(a) ‘‘Excessive discolored ker- bined up-and-down and circular motion nels’’. for 30 seconds. Repeat washing with a (i)(b) or (ii)(b) ‘‘Excessive cob’’. second portion of water. Remove sieve (i)(c) or (ii)(c) ‘‘Excessive husk’’. from pan, incline to facilitate drain- (i)(d) or (ii)(d) ‘‘Excessive silk’’. age, and drain for 2 minutes. (ii)(e) ‘‘Excessively liquid’’. (iii) From the material remaining on the U.S. No. 8 sieve, count, but do not (c) Fill of container. (1) The standard remove, the brown or black discolored of fill of container for canned corn is: kernels or pieces of kernel and cal- (i) Except in the case of vacuum pack culate the number per 600 g. (21.4 corn the fill of the corn ingredient and ounces) of net weight. Remove pieces packing medium, as determined by the of silk more than 12.7 mm. (one-half general method for fill of container inch) long, husk, cob, and other mate- prescribed in § 130.12(b) of this chapter, rial which is not corn (i.e., peppers). is not less than 90 percent of the total Measure aggregate length of such capacity of the container. pieces of silk and calculate the length (ii) In whole kernel corn, the drained per 28 g. (ounce) of net weight. Spread weight of the corn ingredient, deter- the husk flat and measure its aggre- mined by the procedure set forth in gate area and calculate the area per 600 § 155.3, shall not be less than 61 percent g. (21.4 ounces) of net weight. Place all of the water capacity of the container. pieces of cob under a measured amount (2) Determine compliance as specified of water in a cylinder which is so grad- in § 155.3(b). uated that the volume may be measured to 0.1 cubic centimeter. Take the (3) If canned corn falls below the increase in volume as the aggregate standard of fill of container prescribed volume of the cob and calculate the in paragraphs (c)(1) and (2) of this sec- volume of cob per 600 g. (21.4 ounces) of tion, the label shall bear the general net weight. Take a representative 100 statement of substandard fill specified g. sample of the material remaining on in § 130.14(b) of this chapter, in the the U.S. No. 8 sieve (if such material manner and form therein specified. weighs less than 100 g. take all of it) [42 FR 14449, Mar. 15, 1977, as amended at 45 and determine the alcohol-insoluble FR 43398, June 27, 1980; 47 FR 11831, 11832, solids as prescribed in paragraph Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984; 54 FR (b)(2)(iii) of this section for whole ker- 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 nel corn. FR 14035, Mar. 24, 1998]

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§ 155.131 Canned field corn. (x) Color additives. (a) Identity. (1) Canned field corn con- (xi) Calcium salts, the total amount forms to the definition and standard of of which added to firm the peas shall identity, and is subject to the require- not result in more than 350 milligrams/ ments for label declaration of ingredi- kilogram (0.01 ounce/2.2 pounds) of cal- ents, prescribed for canned corn by cium in the finished food. § 155.130(a), except that the corn ingre- (xii) Magnesium hydroxide, magne- dient consists of succulent field corn or sium oxide, magnesium carbonate, or a mixture of succulent field corn and any mixture or combination of these in succulent sweet corn. such quantity that the pH of the fin- (2) The name of the food conforms to ished canned peas is not more than 8, the name specified in § 155.130(a)(5), ex- as determined by the glass electrode cept that the words ‘‘Corn’’, ‘‘Sweet method for the hydrogen ion con- corn’’, and ‘‘Sugar corn’’ are replaced centration. by the words ‘‘Field corn’’, and the (xiii) Seasonings and garnishes: term ‘‘Golden field corn’’ is not used. (a) Pieces of green or red peppers or (b) [Reserved] mixtures of both, either of which may (c) Fill of container. Canned cream- be dried, or other vegetables not ex- style field corn conforms to the stand- ceeding in total 15 percent of the ard of fill of container and label state- drained weight of the finished food. ment of substandard fill prescribed for (b) Lemon juice or concentrated canned cream-style corn by § 155.130(c). lemon juice. [42 FR 14449, Mar. 15, 1977, as amended at 58 (c) Mint leaves. FR 2882, Jan. 6, 1993] (d) Butter or margarine in a quantity not less that 3 percent by weight of the § 155.170 Canned peas. finished food, or other vegetable or ani- (a) Identity—(1) Definition. Canned mal fats or oils in a quantity not less peas is the food prepared from fresh or than 2.4 percent by weight of the fin- frozen succulent seeds of the pea plant ished foods. When butter, margarine, or of the species Pisum sativum L. but ex- other vegetable or animal fats or oils cluding the subspecies macrocarpum. are added, emulsifiers or stabilizers or Only sweet wrinkled varieties, smooth- both may be added, but no color, spice, skin varieties, or hybrids thereof may or flavoring simulating the color or be used. The product is packed with flavor imparted by butter or margarine water or other suitable aqueous liquid may be used. medium to which may be added one or more of the other optional ingredients (3) Labeling. (i) The name of the food set forth in paragraph (a)(2) of this sec- is ‘‘peas’’ and may include the designation. Such food is sealed in a container tion ‘‘green.’’ The term ‘‘early,’’ and, before or after sealing, is so proc- ‘‘June,’’ or ‘‘early June’’ shall precede essed by heat as to prevent spoilage. or follow the name in the case of (2) Optional ingredients. In addition to smooth-skin peas or substantially the optional packing media provided smooth-skin peas, such as Alaska-type for in paragraph (a)(1) of this section, peas or hybrids having similar charac- the following safe and suitable optional teristics. Where the peas are of sweet ingredients may be used: green wrinkled varieties or hybrids (i) Salt. having similar characteristics, the (ii) Monosodium glutamate. name may include the designation (iii) Disodium inosinate. ‘‘sweet,’’ ‘‘wrinkled,’’ or any combina- (iv) Disodium guanylate. tion thereof. The term ‘‘petit pois’’ (v) Hydrolyzed vegetable protein. may be used in conjunction with the (vi) Autolyzed yeast extract. name of the food when an average of 80 (vii) One or any combination of two percent or more of the peas will pass or more of the dry or liquid forms of through a circular opening of a diame- sugar, invert sugar sirup, dextrose, glu- ter of 7.1 millimeters (0.28 inch). If any cose sirup, and fructose. color additive has been added, the (viii) Spice. name of the food shall include the term (ix) Flavoring (except artificial). ‘‘artificially colored.’’

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(ii) The following shall be included as (vi) Alcohol-insoluble solids. The alco- part of the name or in close proximity hol-insoluble solids of smooth-skin or to the name of the food: substantially smooth-skin peas, such (a) A declaration of any flavoring as Alaska-type peas or hybrids having that characterizes the food, as specified similar characteristics, may not be in § 101.22 of this chapter. more than 23.5 percent and, of sweet (b) A declaration of any spice, sea- green wrinkled varieties or hybrids soning, or garnishing that character- having similar characteristics, not izes the product, e.g., ‘‘seasoned with more than 21 percent based on the pro- green peppers’’, ‘‘seasoned with but- cedure set forth in the ‘‘Official Meth- ter’’, ‘‘seasoned with lll oil’’, the ods of Analysis of the Association of blank to be filled in with the common Official Analytical Chemists,’’ 13th Ed. or usual name of the oil, ‘‘with added (1980), section 30.012, which is incor- spice’’, or, in lieu of the word spice, the porated by reference. Copies are avail- common or usual name of the spice. able from the AOAC INTER- (c) The words ‘‘vacuum pack’’ or NATIONAL, 481 North Frederick Ave., ‘‘vacuum packed’’ when the weight of suite 500, Gaithersburg, MD 20877, or the liquid in the container, as deter- available for inspection at the National mined by the method prescribed in Archives and Records Administration § 155.3(a) is not more than 20 percent of (NARA). For information on the avail- the net weight, and the container is ability of this material at NARA, call closed under conditions creating a high 202–741–6030, or go to: http:// vacuum in the container. www.archives.gov/federallregister/ codeloflfederallregulations/ (4) Label declaration. Each of the in- ibrllocations.html. gredients used in the food shall be de- (vii) Limitation. The sum of the pea clared on the label as required by the material described in paragraphs (b)(1) applicable sections of parts 101 and 130 (i), (ii), (iii), (iv), and (v) of this section of this chapter. shall not exceed 12 percent. (b) (1) The standard of qual- Quality. (2) Determine compliance as specified ity for canned peas is as follows: in § 155.3(b). (i) Blond and yellow peas. Not more (3) If the quality of canned peas falls than 2 percent of the drained weight is below the standard prescribed in para- blond and/or yellow peas, i.e., white or graph (b)(1) of this section, the label yellow but edible peas. shall bear the general statement of (ii) Blemished peas. Not more than 5 substandard quality specified in percent of the drained weight is blem- § 130.14(a) of this chapter, in the man- ished peas, i.e., slightly stained or ner and form therein specified; but in spotted peas. lieu of such general statement of sub- (iii) Seriously blemished peas. Not standard quality when the quality of more than 1 percent of the drained canned peas falls below the standard in weight is seriously blemished peas, i.e., only one respect, the label may bear peas that are hard, shrivelled, spotted, the alternative statement, ‘‘Below discolored, or otherwise blemished to standard in quality ’’, the blank an extent that the appearance or eat- to be filled in with the words specified ing quality is seriously affected. after the corresponding paragraph (iv) Pea fragments. Not more than 10 under paragraph (b)(1) of this section percent of the drained weight is pea which such canned peas fail to meet, as fragments, i.e., portions of peas, sepa- follows: (i) ‘‘Excessive blond and/or yel- rated or individual cotyledons, low peas’’; (ii) ‘‘Excessive blemished crushed, partial or broken cotyledons, peas’’; (iii) ‘‘Excessive seriously blem- and loose skins, but excluding entire ished peas’’; (iv) ‘‘Excessive pea frag- intact peas with skins detached. ments’’; (v) ‘‘Excessive vegetable mate- (v) Extraneous vegetable material. Not rial’’; (vi) ‘‘Excessive mealy’’. Such al- more than 0.5 percent of the drained ternative statement shall immediately weight is extraneous vegetable mate- and conspicuously precede or follow rial, i.e., vine or leaf or pod material without intervening written, printed, from the pea plant or other such mate- or graphic matter, the name ‘‘peas’’ rial. and any words and statements required

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or authorized to appear with such (3) The name of the food is ‘‘cooked name by paragraph (a)(3) of this sec- dry peas’’ or ‘‘soaked dry peas’’. The tion. optional terms specified by (c) Fill of container. (1) Except in the § 155.170(a)(3), ‘‘early’’, ‘‘June’’, case of vacuum pack peas, the fill of ‘‘sweet’’, ‘‘green’’, ‘‘wrinkled’’, or any pea ingredient and packing medium, as combination thereof, shall not be used determined by the general method for on the labels. fill of container prescribed in § 130.12(b) (b) Quality. (1) The standard of qual- of this chapter, is not less than 90 per- ity for canned dry peas is that specified cent of the total capacity of the con- for canned peas by § 155.170(b) except tainer. that: (2) When the peas and liquid are re- (i) The alcohol-insoluble solids maxi- moved from the container and returned mums specified in § 155.170(b)(1)(vi) do thereto, the leveled peas (irrespective not apply. of the quantity of the liquid), 15 sec- (ii) The skins of not more than 25 onds after they are so returned, com- percent by count of the peas in the con- pletely fill the container. A container tainer are ruptured to a width of 1.6 with lid attached by double seam shall millimeters (0.06 inch) or more. be considered to be completely filled (2) If the quality of canned dry peas when it is filled to 5 millimeters (0.2 falls below the standard of quality pre- inch) vertical distance below the top of scribed by paragraph (b)(1) of this sec- the double seam; and a glass container tion, the label shall bear the statement shall be considered to be completely of substandard quality in the manner filled when it is filled to 13 millimeters and form specified in § 155.170(b)(3) for (0.5 inch) vertical distance below the canned peas, except that the words top of the container. ‘‘Excessively mealy’’ shall not be used. (3) Determine compliance for fill of (c) Fill of container. (1) The standard container as specified in § 155.3(b). of fill of container for canned dry peas (4) If canned peas fall below the is that prescribed for canned peas by standard of fill of container prescribed § 155.170(c). in paragraph (c)(1) and/or (2) of this (2) If canned dry peas fall below the section, the label shall bear the general standard of fill of container prescribed statement of substandard fill specified by paragraph (c)(1) of this section, the in § 130.14(b) of this chapter, in the label shall bear the general statement manner and form therein specified. of substandard fill specified in § 130.14(b) of this chapter, in the man- [45 FR 43398, June 27, 1980, as amended at 47 ner and form therein specified. FR 11832, Mar. 19, 1982; 48 FR 15241, Apr. 8, 1983; 54 FR 24895, June 12, 1989; 58 FR 2882, [45 FR 43399, June 27, 1980, as amended at 48 Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] FR 15241, Apr. 8, 1983; 58 FR 2883, Jan. 6, 1993] EFFECTIVE DATE NOTE: In § 155.170, those § 155.190 Canned tomatoes. portions of paragraph (a)(2) pertaining to the deletion of magnesium, hydroxide, magne- (a) Identity—(1) Description. (i) Canned sium oxide, and magnesium carbonate were tomatoes is the food prepared from ma- stayed until further notice at 46 FR 35086, ture tomatoes conforming to the char- July 1, 1981, effective June 30, 1981. acteristics of the fruit Lycopersicum esculentum P. Mill, of red or reddish va- § 155.172 Canned dry peas. rieties. The tomatoes may or may not (a) Identity. Canned dry peas con- be peeled, but shall have had the stems forms to the definition and standard of and calicies removed and shall have identity, and is subject to the require- been cored, except where the internal ments for label declaration of ingredi- core is insignificant to texture and ap- ents, prescribed for canned peas by pearance. § 155.170(a), except that: (ii) Canned tomatoes may contain (1) The optional pea ingredient is the one or more of the safe and suitable op- dry seeds of the pea plant of the species tional ingredients specified in para- Pisum sativum L. but excluding the sub- graph (a)(2) of this section, be packed species macrocarpum. without any added liquid or in one of (2) The optional ingredients specified the optional packing media specified in in § 155.170(a)(2)(xii) shall not be used. paragraph (a)(3) of this section and be

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prepared in one of the styles specified (a) A declaration of any flavoring in paragraph (a)(4) of this section. Such that characterizes the product as speci- food is sealed in a container and before fied in § 101.22 of this chapter. or after sealing is so processed by heat (b) A declaration of any added spice, as to prevent spoilage. seasoning, or vegetable ingredient that (2) Optional ingredients. One or more characterizes the product, (e.g., ‘‘with of the following safe and suitable ingre- added lll’’ or, ‘‘with lll’’ the dients may be used: blank to be filled in with the word(s) (i) Calcium salts in a quantity rea- ‘‘spice(s)’’, ‘‘seasoning(s)’’, or the sonably necessary to firm the toma- name(s) of the vegetable(s) used or in toes, but the amount of calcium in the lieu of the word(s) ‘‘spice(s)’’ or ‘‘sea- finished canned tomatoes is not more soning (s)’’ the common or usual than 0.045 percent of the weight, except name(s) of the spice(s) or seasoning(s) that when the tomatoes are prepared in used) except that no declaration of the one of the styles specified in para- presence of onion, peppers, and celery graphs (a)(4) (ii) to (iv) of this section is required for stewed tomatoes. the amount of calcium is not more (c) The word ‘‘stewed’’ if the toma- than 0.08 percent of the weight of the toes contain characterizing amounts of food. at least the three optional vegetables (ii) Organic acids for the purpose of listed in paragraph (a)(2)(vii) of this acidification. section. (iii) Dry nutritive carbohydrate (d) The styles: ‘‘Diced’’, ‘‘sliced’’, or sweeteners whenever any organic acid ‘‘wedges’’ as appropriate. provided for in paragraph (a)(2)(ii) of (e) The name of the packing medium: this section is used, in a quantity rea- ‘‘tomato paste’’, ‘‘tomato puree’’, or sonably necessary to compensate for ‘‘tomato pulp’’ as provided in para- the tartness resulting from such added graph (a)(3)(iv) of this section, or acid. ‘‘strained residual tomato material (iv) Salt. from preparation for canning’’ as pro- (v) Spices, spice oils. vided for in paragraph (a)(3)(ii) of this (vi) Flavoring and seasoning. section, as appropriate. The name of (vii) Vegetable ingredients such as the packing medium shall be preceded onion, peppers, and celery, that may be by the word ‘‘with’’. fresh or preserved by physical means, in a quantity not more than 10 percent (iii) The following may be included as by weight of the finished food. part of the name or in close proximity to the name: (3) Packing media. (i) The liquid draining from the tomatoes during or after (a) The word ‘‘whole’’ if the tomato peeling or coring. ingredient is whole or almost whole, (ii) The liquid strained from the res- and the weight of such ingredient is idue from preparing tomatoes for cannot less than 80 percent of the drained ning consisting of peels and cores with weight of the finished food as deter- or without tomatoes or pieces thereof. mined in accordance with the method (iii) The liquid strained from mature prescribed in paragraph (b)(2) of this tomatoes (tomato juice). section. (iv) Tomato paste, or tomato puree, (b) The words ‘‘solid pack’’ when or tomato pulp complying with the none of the optional packing media compositional requirements of § 155.191. specified in paragraph (a)(3) of this sec- (4) Styles. (i) Whole. tion are used. (ii) Diced. (c) The words ‘‘in tomato juice’’ if (iii) Sliced. the packing medium specified in para- (iv) Wedges. graph (a)(3)(iii) of this section is used. (5) Name of the food. (i) The name of (6) Label declaration. The name of the food is ‘‘tomatoes’’, except that each ingredient used shall be declared when the tomatoes are not peeled the on the label as required by the applica- name is ‘‘unpeeled tomatoes’’. ble sections of parts 101 and 130 of this (ii) The following shall be included as chapter. part of the name or in close proximity (b) Quality. (1) The standard of qual- to the name of the food: ity for canned tomatoes is as follows:

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(i) The drained weight, as determined as to facilitate drainage of the liquid. by the method prescribed in paragraph Two minutes from the time drainage (b)(2)(i) of this section, is not less than begins, weigh the sieve and drained to- 50 percent of the weight of water re- matoes. The weight so found, less the quired to fill the container, as deter- weight of the sieve, shall be considered mined by the general method for water to be the drained weight. capacity of containers prescribed in (ii) Remove from the sieve the § 130.12(a) of this chapter; drained tomatoes, cut out and seg- (ii) The strength and redness of color regate successively those portions of as determined by the method pre- least redness until 50 percent of the scribed in paragraph (b)(2) of this sec- drained weight has been so segregated. tion, are not less than that of the Comminute the segregated portions to blended color of any combination of a uniform mixture without removing the color discs described in such meth- or breaking the seeds. Fill the mixture od in which one-third the area of disc 1, into a black container to a depth of at and not more than one-third the area least 25.4 mm (1 inch). Free the mix- of disc 2, is exposed; ture from air bubbles, and skim off or (iii) Peel per kilogram (2.2 pounds) of press below the surface all visible the finished food covers an area of not seeds. Compare the color of the mix- more than 15 cm2 (2.3 square inches) ture, in full diffused daylight or its which is equivalent to 6.8 cm2 (1.06 equivalent, with the blended color of square inches) per pound based on an combinations of the following concen- average of all containers examined pro- tric Munsell color discs of equal diame- vided, however, that the area of peel is ter, or the color equivalent of such not a factor of quality for canned discs: unpeeled tomatoes labeled in accord- (a) Red—Munsell 5 R 2.6/13 (glossy ance with paragraph (a)(5)(i) of this finish). section; and (b) Yellow—Munsell 2.5 YR 5/12 (iv) Blemishes per kilogram (2.2 (glossy finish). pounds) of the finished food cover an (c) Black—Munsell N 1/ (glossy fin- area of not more than 3.5 cm2 (0.54 ish). square inch) which is equivalent to 1.6 (d) Grey—Munsell N 4 (mat finish). cm2 (0.25 square inch) per pound based (3) Determine compliance as specified on an average of all containers exam- in § 155.3(b). ined. (4) If the quality of canned tomatoes (2) Canned tomatoes shall be tested falls below the standard prescribed in by the following method to determine paragraph (b)(1) of this section, the whether or not they meet the require- label shall bear the general statement ments of paragraphs (b)(1) (i) and (ii) of of substandard quality specified in this section: § 130.14(a) of this chapter in the manner (i) Remove lid from container, but in and form therein specified; if, however, the case of a container with lid at- the quality of canned tomatoes falls tached by double seam, do not remove below standard with respect to only or alter the height of the double seam. one of the factors of quality specified Tilt the opened container so as to dis- by paragraphs (b)(1) (i) to (iii) of this tribute the contents over the meshes of section, there may be substituted for a circular sieve which has previously the second line of such general state- been weighed. The diameter of the ment of substandard quality (‘‘Good sieve used is 20.3 centimeters (8 inches) Food—Not High Grade’’) a new line, ap- if the quantity of the contents of the propriate for the corresponding sub- container is less than 1.4 kilograms (3 paragraph designation of paragraph pounds) or 30.5 centimeters (12 inches) (b)(1) of this section which the canned if such quantity is 1.4 kilograms (3 tomatoes fail to meet, to read as fol- pounds) or more. The meshes of such lows: sieve are made by so weaving wire of (i) ‘‘Poor color’’ or 1.4 mm (0.054 inch) diameter as to form (ii) ‘‘Excessive peel’’ or square openings 11.3 mm by 11.3 mm (iii) ‘‘Excessive blemishes’’. (0.446 inch by 0.446 inch). Without shift- (c) Fill of container. (1) The standard ing the tomatoes, so incline the sieve of fill of container for canned tomatoes

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is a fill of not less than 90 percent of (2) Optional ingredients. One or any the total capacity of the container, as combination of two or more of the fol- determined by the general method for lowing safe and suitable ingredients fill of containers prescribed in may be used in the foods: § 130.12(b) of this chapter. (i) Salt (sodium chloride formed dur- (2) Determine compliance as specified ing acid neutralization shall be consid- in § 155.3(b). ered added salt). (3) If canned tomatoes fall below the (ii) Lemon juice, concentrated lemon standard of fill of container prescribed juice, or organic acids. in paragraph (c)(1) of this section, the (iii) Sodium bicarbonate. label shall bear the general statement (iv) Water, as provided for in para- of substandard fill specified in graph (a)(1) of this section. § 130.14(b) of this chapter, in the man- (v) Spices. ner and form therein specified. (vi) Flavoring. [42 FR 14449, Mar. 15, 1977, as amended at 43 (3) Labeling. (i) The name of the food FR 12858, Mar. 28, 1978; 43 FR 30274, July 14, is: 1978; 45 FR 43400, June 27, 1980; 58 FR 17103, (a) ‘‘Tomato puree’’ or ‘‘tomato Apr. 1, 1993; 59 FR 15051, Mar. 31, 1994] pulp’’ if the food contains not less than 8.0 percent but less than 24.0 percent § 155.191 Tomato concentrates. tomato soluble solids. (a) Identity—(1) Definition. Tomato (b) ‘‘Tomato paste’’ if the food con- concentrates are the class of foods each tains not less than 24.0 percent tomato of which is prepared by concentrating soluble solids. one or any combination of two or more (c) The name ‘‘tomato concentrate’’ of the following optional tomato ingre- may be used in lieu of the name ‘‘to- dients: mato puree,’’ ‘‘tomato pulp,’’ or ‘‘to- (i) The liquid obtained from mature mato paste’’ whenever the concentrate tomatoes of the red or reddish varieties complies with the requirements of such (Lycopersicum esculentum P. Mill). foods; except that the label shall bear (ii) The liquid obtained from the res- the statement ‘‘for remanufacturing idue from preparing such tomatoes for purposes only’’ when the concentrate is canning, consisting of peelings and packaged in No. 10 containers (3.1 kilo- cores with or without such tomatoes or grams or 109 avoirdupois ounces total pieces thereof. water capacity) or containers that are (iii) The liquid obtained from the res- smaller in size. idue from partial extraction of juice (d) ‘‘Concentrated tomato juice’’ if from such tomatoes. the food is prepared from the optional Such liquid is obtained by so straining tomato ingredient described in para- the tomatoes, with or without heating, graph (a)(1)(i) of this section and is of as to exclude skins (peel), seeds, and such concentration that upon diluting other coarse or hard substances in ac- the food according to label directions cordance with good manufacturing as set forth in paragraph (a)(3)(iii) of practice. Prior to straining, food-grade this section, the diluted article will hydrochloric acid may be added to the contain not less than 5.0 percent by tomato material in an amount to ob- weight tomato soluble solids. tain a pH no lower than 2.0. Such acid (ii) The following shall be included as is then neutralized with food-grade so- part of the name or in close proximity dium hydroxide so that the treated to- to the name of the food: mato material is restored to a pH of (a) The statement ‘‘Made from’’ or 4.2±0.2. Water may be added to adjust ‘‘Made in part from,’’ as the case may the final composition. The food con- be, ‘‘residual tomato material from tains not less than 8.0 percent tomato canning’’ if the optional tomato ingre- soluble solids as defined in § 155.3(e). dient specified in paragraph (a)(1)(ii) of The food is preserved by heat steriliza- this section is present. tion (canning), refrigeration, or freez- (b) The statement ‘‘Made from’’ or ing. When sealed in a container to be ‘‘Made in part from,’’ as the case may held at ambient temperatures, it is so be, ‘‘residual tomato material from processed by heat, before or after seal- partial extraction of juice’’ if the oping, as to prevent spoilage. tional tomato ingredient specified in

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paragraph (a)(1)(iii) of this section is Munsell color discs in the following present. combination: (c) A declaration of any flavoring 53 percent of the area of Disc 1; that characterizes the product as speci- 28 percent of the area of Disc 2; and fied in § 101.22 of this chapter and a dec- 19 percent of the area of either Disc 3 or Disc laration of any spice that characterizes 4; or the product, e.g., ‘‘Seasoned with 91⁄2 percent of the area of Disc 3 and 91⁄2 per- lll,’’ the blank to be filled in with cent of the area of Disc 4, whichever most the words ‘‘added spice’’ or, in lieu of nearly matches the appearance of the sam- the word ‘‘spice,’’ the common name of ple. the spice. (ii) Not more than one whole seed per (iii) The label of concentrated to- 600 grams (21 ounces). mato juice shall bear adequate direc- (iii) Not more than 36 of the fol- tions for dilution to result in a diluted lowing defects, either singly or in com- article containing not less than 5.0 per- bination, per 100 grams (3.5 ounces) of cent by weight tomato soluble solids; the product when diluted with water to except that alternative methods may 8.1±0.1 percent tomato soluble solids: be used to convey adequate dilution di- (a) Pieces of peel 5 millimeters (0.20 rections for containers that are larger inch) or greater in length (without un- than No. 10 containers (3.1 kilograms rolling). or 109 avoirdupois ounces total water (b) Pieces of seed (seed particles) 1 capacity). millimeter (0.039 inch) or greater in (iv) Label declaration. Each of the in- length. gredients used in the food shall be de- (c) Blemishes, such as dark brown or clared on the label as required by the black particles (specks)—not more applicable sections of parts 101 and 130 than four exceed 1.6 millimeters (0.0625 of this chapter; except that water need inch) in length of which not more than not be declared in the ingredient state- one exceeds 3.2 millimeters (0.125 inch) ment when added to adjust the tomato and none exceed 6.4 millimeters (0.25 soluble solids content of tomato con- inch). centrates within the range of soluble (2) Methodology. Dilute with water, if solids levels permitted for these foods. necessary, to 8.1±0.1 percent tomato (v) Determine percent tomato soluble soluble solids. (i) Determine strength solids as specified in § 155.3(e). Deter- and redness of color as prescribed in mine compliance as specified in § 155.3(d). § 155.3(b). A lot shall be deemed to be in (ii) Whole seeds—Weigh out 600 grams compliance for tomato soluble solids as (21 ounces) of the well-mixed, diluted follows: concentrate; place a U.S. No. 12 screen (a) The sample average meets or ex- (1.68 millimeters (0.066 inch) openings) ceeds the required minimum. over the sink drain; transfer the prod- (b) The number of sample units that uct sample onto the screen; rinse con- are more than 1 percent tomato soluble tainer thoroughly with water and pour solids below the minimum required through screen; flush sample through does not exceed the acceptance number screen by using an adequate spray of in the sampling plans set forth in water; check screen for whole seeds; § 155.3(c)(2). apply the appropriate allowance. (b) Quality. (1) The standard of qual- (iii) Peel, pieces of seed, and blem- ity for tomato concentrate (except for ishes—Spread the prepared concentrate concentrated tomato juice, which when evenly on a large white tray and re- diluted to 5.0 percent tomato soluble move the individual defects, identify, solids shall conform to the standard of classify, and measure. quality for tomato juice set forth in (3) Sampling and acceptance. Deter- § 156.145 of this chapter) is as follows: mine compliance as specified in (i) The strength and redness of color § 155.3(b). of the food, when diluted with water (if (4) If the quality of the tomato con- necessary) to 8.1±0.1 percent tomato centrate falls below the standard pre- soluble solids is not less than the com- scribed in paragraph (b) (1) and (3) of posite color produced by spinning the this section, the label shall bear the

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general statement of substandard qual- cores with or without such tomatoes or ity specified in § 130.14(a) of this chap- pieces thereof. ter, in the manner and form therein (iv) The liquid obtained from the res- specified, but in lieu of such general idue from partial extraction of juice statement of substandard quality when from such tomatoes. the quality of the tomato concentrate falls below the standard in one or more Such liquid is strained so as to exclude respects, the label may bear the alter- skins, seeds, and other coarse or hard native statement, ‘‘Below Standard in substances in accordance with current Quality lll,’’ the blank to be filled good manufacturing practice. Prior to in with the words specified after the straining, food-grade hydrochloric acid corresponding paragraph(s) under para- may be added to the tomato material graph (b)(1) of this section which such in an amount to obtain a pH no lower tomato concentrate fails to meet, as than 2.0. Such acid is then neutralized follows: with food-grade sodium hydroxide so (i) ‘‘Poor color.’’ that the treated tomato material is re- ± (ii) ‘‘Excessive seeds.’’ stored to a pH of 4.2 0.2. The final com- (iii)(a) ‘‘Excessive pieces of peel.’’ position of the food may be adjusted by (b) ‘‘Excessive pieces of seed.’’ concentration and/or by the addition of (c) ‘‘Excessive blemishes.’’ water. The food may contain salt (so- (c) Fill of container. (1) The standard dium chloride formed during acid neu- of fill of container for tomato con- tralization shall be considered added centrate, as determined by the general salt) and is seasoned with ingredients method for fill of container prescribed as specified in paragraph (a)(2) of this in § 130.12(b) of this chapter, is not less section. The food is preserved by heat than 90 percent of the total capacity, sterilization (canning), refrigeration, except when the food is frozen. or freezing. When sealed in a container (2) Determine compliance as specified to be held at ambient temperatures, it in § 155.3(b). is so processed by heat, before or after (3) If the tomato concentrate falls sealing, as to prevent spoilage. below the standard of fill prescribed in (2) Ingredients. One or any combina- paragraph (c) (1) and (2) of this section, tion of two or more of the following the label shall bear the general state- safe and suitable ingredients in each of ment of substandard fill specified in the following categories is added to the § 130.14(b) of this chapter, in the man- tomato ingredients specified in para- ner and form therein prescribed. graph (a)(1) of this section: (i) Vinegars. [48 FR 3954, Jan. 28, 1983, as amended at 49 FR 15073, Apr. 17, 1984; 58 FR 2883, Jan. 6, (ii) Nutritive carbohydrate sweet- 1993; 58 FR 17104, Apr. 1, 1993] eners. Such sweeteners if defined in part 168 of this chapter shall be as de- § 155.194 Catsup. fined therein. (a) Identity—(1) Definition. Catsup, (iii) Spices, flavoring, onions, or gar- ketchup, or catchup is the food pre- lic. pared from one or any combination of (3) Labeling. (i) The name of the food two or more of the following optional is ‘‘Catsup,’’ ‘‘Ketchup,’’ or ‘‘Catchup.’’ tomato ingredients: (ii) The following shall be included as (i) Tomato concentrate as defined in part of the name or in close proximity § 155.191(a)(1), except that lemon juice, to the name of the food: concentrated lemon juice, or safe and (a) The statement ‘‘Made from’’ or suitable organic acids may be used in ‘‘Made in part from,’’ as the case may quantities no greater than necessary to be, ‘‘residual tomato material from adjust the pH, and in compliance with canning’’ if the optional tomato ingre- § 155.191(b). dient specified in paragraph (a)(1)(iii) (ii) The liquid derived from mature of this section or tomato concentrate tomatoes of the red or reddish varieties containing the ingredient specified in Lycopersicum esculentum P. Mill. § 155.191(a)(1)(ii) is present. (iii) The liquid obtained from the res- (b) The statement ‘‘Made from’’ or idue from preparing such tomatoes for ‘‘Made in part from,’’ as the case may canning, consisting of peelings and be, ‘‘residual tomato material from

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partial extraction of juice’’ if the op- tained. Report the average of two or tional tomato ingredient specified in more readings, excluding any that ap- paragraph (a)(1)(iv) of this section or pear to be abnormal. tomato concentrate containing the in- (2) Determine compliance as specified gredient specified in § 155.191(a)(1)(iii) is in § 155.3(b). present. (3) If the quality of catsup falls below (iii) Label declaration. Each of the in- the standard prescribed in paragraphs gredients used in the food shall be de- (b) (1) and (2) of this section, the label clared on the label as required by the shall bear the general statement of applicable sections of parts 101 and 130 substandard quality specified in of this chapter; except that the name § 130.14(a) of this chapter, in the man- ‘‘tomato concentrate’’ may be used in ner and form therein specified, but in lieu of the names ‘‘tomato puree,’’ lieu of such general statement of sub- ‘‘tomato pulp,’’ or ‘‘tomato paste’’ and standard quality when the quality of when tomato concentrates are used, the catsup falls below the standard, the the labeling requirements of label may bear the alternative state- § 155.191(a)(3)(ii)(a) and (a)(3)(ii)(b) do ment, ‘‘Below Standard in Quality— not apply. Low Consistency.’’ (b) Quality. (1) The standard of qual- (c) Fill of container. (1) The standard ity for catsup is as follows: The con- of fill of container for catsup, as deter- sistency of the finished food is such mined by the general method for fill of that its flow is not more than 14 centi- container prescribed in § 130.12(b) of meters in 30 seconds at 20 °C when test- this chapter, is not less than 90 percent ed in a Bostwick Consistometer in the of the total capacity except: following manner: Check temperature (i) When the food is frozen, or of mixture and adjust to 20±1 °C. The (ii) When the food is packaged in in- trough must also be at a temperature dividual serving-size packages con- close to 20 °C. Adjust end-to-end level taining 56.7 grams (2 ounces) or less. of Bostwick Consistometer by means of (2) Determine compliance as specified the spirit level placed in trough of in- in § 155.3(b). strument. Side-to-side level may be ad- (3) If the catsup falls below the stand- justed by means of the built-in spirit ard of fill prescribed in paragraphs (c) level. Transfer sample to the dry sam- (1) and (2) of this section, the label ple chamber of the Bostwick shall bear the general statement of Consistometer. Fill the chamber substandard fill as specified in slightly more than level full, avoiding § 130.14(b) of this chapter, in the man- air bubbles as far as possible. Pass a ner and form therein specified. straight edge across top of chamber [48 FR 3956, Jan. 28, 1983, as amended at 49 starting from the gate end to remove FR 15073, Apr. 17, 1984; 58 FR 2883, Jan. 6, excess product. Release gate of instru- 1993] ment by gradual pressure on lever, holding the instrument down at the § 155.200 Certain other canned vegeta- same time to prevent its movement as bles. the gate is released. Immediately start (a) The canned vegetables for which the stop watch or interval timer, and definitions and standards of identity after 30 seconds read the maximum dis- are prescribed by this section are those tance of flow to the nearest 0.1 centi- named in column I of the table set meter. Clean and dry the instrument forth in paragraph (b) of this section. and repeat the reading on another por- The vegetable ingredient in each such tion of sample. Do not wash instru- canned vegetable is obtained by proper ment with hot water if it is to be used preparation from the succulent vege- immediately for the next determina- table prescribed in column II of such tion, as this may result in an increase table. If two or more forms of such in- in temperature of the sample. For gredient are designated in column III highest accuracy, the instrument of such table, the vegetable in each should be maintained at a temperature such form is an optional ingredient. To of 20±1 °C. If readings vary more than the vegetable ingredient additional in- 0.2 centimeter, repeat a third time or gredients as required or permitted by until satisfactory agreement is ob- paragraph (c) of this section are added,

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and the food is sealed in a container (b) The table referred to in paragraph and so processed by heat as to prevent (a) of this section is as follows: spoilage.

I—Name or synonym of canned vegetable II—Source III—Optional forms of vegetable ingredient

Artichokes ...... Flower buds of the artichoke plant ...... Whole; half or halves or halved; whole hearts; halved hearts; quartered hearts. Asparagus ...... Edible portions of sprouts of the asparagus plant, as follows:. 3 and 3⁄4 in or more of upper end ...... Stalks or spears. 3 and 3⁄4 in or more of peeled upper end ...... Peeled stalks or peeled spears. Not less than 2 and 3⁄4 in but less than 3 and Tips. 3⁄4 in of upper end. Less than 2 and 3⁄4 in of upper end ...... Points. Sprouts cut in pieces ...... Cut stalks or cut spears. Sprouts from which the tip has been re- Bottom cuts or cuts—tips removed. moved, cut in pieces. Bean sprouts ...... Sprouts of the Mung bean. Shelled beans ...... Seed shelled from green or wax bean pods, with or without snaps (pieces of immature unshelled pods). Lima beans or butter beans ...... Seed shelled from the pods of the lima bean plant. Beets ...... Root of the beet plant ...... Whole; slices or sliced; quarters or quartered; dice or diced; cut; shoestring or French style or julienne. Beet greens ...... Leaves, or leaves and immature root, of the beet plant. Broccoli ...... Heads of the broccoli plant. Brussels sprouts ...... Sprouts of the brussels sprouts plant. Cabbage ...... Cut pieces of the heads of the cabbage plant. Carrots ...... Root of the carrot plant ...... Do. Cauliflower ...... Cut pieces of the head of the cauliflower plant. Celery ...... Stalks of the celery plant ...... Cut; hearts. Collards ...... Leaves of the collard plant. Dandelion greens ...... Leaves of the dandelion plant. Kale ...... Leaves of the kale plant. Mustard greens ...... Leaves of the mustard plant. Okra ...... Pods of the okra plant ...... Whole; cut. Onions ...... Bulb of the onion plant ...... Do. Parsnips ...... Root of the parsnip plant ...... Whole; quarters or quartered; slices or sliced; cut; shoestring or French style or julienne. Black-eye peas or black-eyed Seed shelled from pods of the black-eye pea peas. plant, with or without snaps (pieces of immature unshelled pods). Field peas ...... Seed shelled from pods of the field pea plant (other than the black-eye pea plant), with or without snaps (pieces of immature unshelled pods). Green sweet peppers ...... Green pods of the sweet pepper plant ...... Whole; halves or halved; pieces; dice or diced; strips; chopped. Red sweet peppers ...... Red-ripe pods of the sweet pepper plant ...... Do. Pimientos or pimentos ...... Red-ripe pods of the pimiento, pimento, pep- Whole; halves or halved; pieces; dice or per plant. diced; slices or sliced; chopped. Potatoes ...... Tuber of the potato plant ...... Whole; slices or sliced; dice or diced; pieces; shoestring or French style or julienne; French fry cut. Rutabagas ...... Root of the rutabaga plant ...... Whole; quarters or quartered; slices or sliced; dice or diced; cut. Salsify ...... Root of the salsify plant. Spinach ...... Leaves of the spinach plant ...... Whole leaf; cut leaf or sliced; chopped. Sweet potatoes ...... Tuber of the sweet potato plant ...... Whole; mashed; pieces or cuts or cut (longi- tudinally cut halves may be named on labels as halves or halved in lieu of pieces or cuts or cut). Swiss chard ...... Leaves of the Swiss chard plant. Truffles ...... Fruit of the truffle. Turnip greens ...... Leaves of the turnip plant. Turnips ...... Root of the turnip plant ...... Whole; quarters or quartered; slices or sliced; dice or diced; cut.

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(c) Water is added to the vegetable emulsifiers or stabilizers, or both, may ingredient, except that pimientos may be added. When butter or margarine is be canned with or without added water, added, no spice or flavoring simulating and sweet potatoes in mashed form are the color or flavor imparted by butter canned without added water. Aspar- or margarine is used. agus may be canned with added water, (4) In the case of all vegetables, the asparagus juice, or a mixture of both. following optional ingredients may be For the purposes of this section, aspar- added: agus juice is the clear, unfermented (i) Salt. liquid expressed from the washed and (ii) Monosodium glutamate. heated sprouts or parts of sprouts of (iii) Disodium inosinate complying the asparagus plant, and mixtures of with the provisions of § 172.535 of this asparagus juice and water are consid- chapter. ered to be water when such mixtures (iv) Disodium guanylate complying are used as a packing medium for with the provisions of § 172.530 of this canned asparagus. In the case of arti- chapter. chokes, a vinegar or any safe and suit- (v) Hydrolyzed vegetable protein. able organic acid, which either is not a (vi) Autolyzed yeast extract. food additive as defined in section (5) In the case of all vegetables fla- 201(s) of the Federal Food, Drug, and voring (except artificial) may be added. Cosmetic Act, or if it is a food additive (6) In the case of bean sprouts, lima as so defined, is used in conformity beans, carrots, green sweet peppers, red with regulations established pursuant sweet peppers, and potatoes, any safe to section 409 of the act, is added in and suitable calcium salts may be such quantity as to reduce the pH of added as a firming agent. the finished canned vegetable to 4.5 or (7) In the case of canned artichokes below. The following optional ingredi- packed in glass containers, ascorbic ents, in the case of the vegetables spec- acid may be added in a quantity not to ified, may be added: exceed 32 milligrams per 100 grams of (1) An edible vegetable oil, in the the finished food. cases of artichokes and pimientos. (8) In the case of canned asparagus, (2) Snaps, in the cases of shelled ascorbic acid, erythorbic acid, or the beans, black-eyed peas, and field peas. sodium salts of ascorbic acid or (3) In the case of all vegetables (ex- erythorbic acid may be added in an cept canned mashed sweet potatoes as amount necessary to preserve color in regards the seasonings listed in para- the ‘‘white’’ and ‘‘green-tipped and graph (c)(3)(iii) of this section) one or white’’ color types. more of the following optional sea- (9) In the case of canned asparagus soning ingredients may be added in a packed in glass containers, stannous quantity sufficient to season the food. chloride may be added in a quantity (i) Refined sugar (sucrose). not to exceed 15 parts per million cal- (ii) Refined corn sugar (dextrose). culated as tin (Sn), except that in the (iii) Corn sirup, glucose sirup. case of asparagus packed in glass con- (iv) Dried corn sirup, dried glucose tainers with lids lined with an inert sirup. material the quantity of stannous chlo- (v) Spice. ride added may exceed 15 parts per mil- (vi) A vinegar. lion but not 20 parts per million cal- (vii) Green peppers or red peppers culated as tin (Sn). which may be dried. (10) In the case of canned black-eyed (viii) Mint leaves. peas, disodium EDTA may be added in (ix) Onions, which may be dried. a quantity not to exceed 145 parts per (x) Garlic, which may be dried. million. (xi) Horseradish. (11) In the case of potatoes, calcium (xii) Lemon juice or concentrated disodium EDTA may be added in a lemon juice. quantity not to exceed 110 parts per (xiii) Butter or margarine in a quan- million. tity not less than 3 percent by weight (12) A vinegar or any safe and suit- of the finished food. When butter or able organic acid for all vegetables (ex- margarine is added, safe and suitable cept artichokes, in which the quantity

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of such optional ingredient is pre- precede or follow such name, without scribed by the introductory text of intervening written, printed, or graph- paragraph (c) of this section) in a quan- ic matter, except that the varietal tity which, together with the amount name of the vegetable may so inter- of any lemon juice or concentrated vene. lemon juice that may be added, is not (h) Label declaration. Each of the in- more than sufficient to permit effec- gredients used in the food shall be de- tive processing by heat without discol- clared on the label as required by the oration or other impairment of the ar- applicable sections of parts 101 and 130 ticle. of this chapter. (d) The name of each canned vegetable for which a definition and stand- [42 FR 14449, Mar. 15, 1977, as amended at 42 FR 30358, June 14, 1977; 46 FR 56410, Nov. 17, ard of identity is prescribed by this 1981; 48 FR 10813, Mar. 15, 1983; 49 FR 6711, section is the name or any synonym Feb. 23, 1984; 58 FR 2883, Jan. 6, 1993; 59 FR thereof whereby such vegetable is des- 15052, Mar. 31, 1994] ignated in column I of the table in paragraph (b) of this section. § 155.201 Canned mushrooms. (e) When two or more forms of the (a) Identity—(1) Definition. Canned vegetable are specified in column III of mushrooms is the food properly pre- the table in paragraph (b) of this sec- pared from the caps and stems of suction, the label shall bear the specified culent mushrooms conforming to the word or words, or in case synonyms are characteristics of the species Agaricus so specified, one of such synonyms, (Psalliota) bisporus or A. bitorquis, in one showing the form of the vegetable in- of the optional styles specified in para- gredient present; except that in the graph (a)(2) of this section, packed with case of canned spinach, if the whole a suitable liquid medium which may leaf is the optional form used, the word include water; and may contain one or ‘‘spinach’’ unmodified may be used in more safe and suitable optional ingre- lieu of the words ‘‘whole leaf spinach’’. dients specified in paragraph (a)(3) of (f)(1) If the optional ingredient speci- this section. The food is sealed in a fied in paragraph (c)(1) of this section container and, before or after sealing, is present, the label shall bear the is so processed by heat as to prevent statement ‘‘lll oil added’’ or ‘‘With spoilage. added lll oil’’, the blank being filled in with the common or usual name of (2) Styles. The optional styles of the the oil. mushroom ingredient referred to in (2) If asparagus juice is used as a paragraph (a)(1) of this section are: packing medium in canned asparagus, (i) Buttons—consisting of whole the label shall bear the statement mushrooms with attached stems not ‘‘Packed in asparagus juice’’. exceeding 5 millimeters (0.2 inch) in (3) If the optional ingredient speci- length, measured from the bottom of fied in paragraph (c)(2) of this section the veil. is present, the label shall bear the (ii) Whole—consisting of whole mush- statement ‘‘With snaps’’. rooms with attached stems cut to a (g) The name of the food shall include length not exceeding the diameter of a declaration of any flavoring that the cap, measured from the bottom of characterizes the product as specified the veil. in § 101.22 of this chapter, and a dec- (iii) Quarters—consisting of buttons laration of any spice or seasoning that or whole style cut into four approxi- characterizes the product; for example, mately equal parts. ‘‘with added spice’’, ‘‘seasoned with red (iv) Slices or sliced—consisting of but- peppers’’, ‘‘seasoned with butter’’. tons or whole style of which not less Wherever the name of the vegetable ap- than 50 percent are cut parallel to the pears on the label so conspicuously as longitudinal axis of the stem and 2 mil- to be easily seen under customary con- limeters to 8 millimeters (0.08 inch to ditions of purchase, the words and 0.32 inch) in thickness. statements specified in paragraphs (e) (v) Random sliced—consisting of but- and (f) (1) through (3) of this section tons or whole style sliced in a random shall immediately and conspicuously manner.

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(vi) Pieces and stems—consisting of cent of the water capacity of the con- pieces of caps and stems of irregular tainer. shapes and sizes. (iii) Determine drained weight as (3) Optional ingredients. One or any specified in § 155.3(a). combination of two or more of the fol- (2) Determine compliance for min- lowing safe and suitable optional ingre- imum fill and drained weight as speci- dients as provided for in paragraph fied in § 155.3(b). (a)(1) of this section may be used: (3) If the canned mushrooms fall (i) Salt. below the standard of fill prescribed in (ii) Monosodium glutamate. paragraph (c)(1) (i) and/or (ii) and (2) of (iii) Disodium inosinate complying this section, the label shall bear the with the provisions of § 172.535 of this general statement of substandard fill chapter. specified in § 130.14(b) of this chapter, in (iv) Disodium guanylate complying the manner and form therein pre- with the provisions of § 172.530 of this scribed. chapter. [48 FR 10813, Mar. 15, 1983, as amended at 58 (v) Hydrolyzed vegetable protein. FR 2883, Jan. 6, 1993] (vi) Autolyzed yeast extract. (vii) Ascorbic acid (vitamin C) in a PART 156—VEGETABLE JUICES quantity not to exceed 132 milligrams for each 100 grams (37.5 milligrams for Subpart A—General Provisions each ounce) of drained weight of mushrooms. Sec. 156.3 Definitions. (viii) Organic acids (except no vinegar is permitted), only where the in- Subpart B—Requirements for Specific side metal of the container is fully Standardized Vegetable Juices enamel-lined and in glass containers with fully enamel-lined caps. Ascorbic 156.145 Tomato juice. acid as provided for in paragraph AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371. (a)(3)(vii) of this section. (ix) Calcium disodium ethylene- Subpart A—General Provisions diaminetetraacetate (CaNa2 EDTA) in a quantity not to exceed 200 parts per § 156.3 Definitions. million for use to promote color reten- For the purpose of this part: tion. (a) Strength and redness of color means (4) (i) The name Labeling requirements. at least as much red as obtained by of the food is mushrooms. The style as comparison of the prepared product, provided for in paragraph (a)(2) of this with the blended color produced by section shall be included as part of the spinning a combination of the fol- name or in close proximity to the name lowing concentric Munsell color discs of the food. of equal diameter, or the color equiva- (ii) Label declaration. Each of the in- lent of such discs: gredients used in the food shall be declared on the label as required by the Disc 1—Red (5R 2.6/13) (glossy finish) applicable sections of parts 101 and 130 Disc 2—Yellow (2.5 YR 5/12) (glossy finish) of this chapter. Disc 3—Black (N1) (glossy finish) Disc 4—Grey (N4) (mat finish) (b) [Reserved] (c) Fill of container. (1) The standard Such comparison is to be made in full of fill of container for canned mush- diffused daylight or under a diffused rooms is: light source of approximately 2691 lux (i) The fill of the mushroom ingre- (250 footcandles) and having a spectral dient and packing medium, as deter- quality approximating that of daylight mined by the general method for fill of under a moderately overcast sky, with container prescribed in § 130.12(b) of a correlated color temperature of 7,500 this chapter, is not less than 90 percent degrees Kelvin ±200 degrees. With the of the total capacity of the container. light source directly over the disc and (ii) The drained weight of the mush- product, observation is made at an room ingredient is not less than 56 per- angle of 45 degrees from a distance of

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about 24 inches from the product. Elec- shall be deemed in compliance for the tronic color meters may be used as an following factors, to be determined by alternate means of determining the the sampling and acceptance procedure color of tomato juice. Such meters as provided in paragraph (e) of this sec- shall be calibrated to indicate that the tion, namely: color of the product is as red or more (1) Quality. The quality of a lot shall red than that produced by spinning the be considered acceptable when the Munsell color discs in the combination number of defectives does not exceed as set out above. the acceptance number (c) in the sam- (b) Tomato soluble solids means the su- pling plans. crose value as determined by the meth- (2) Fill of container. A lot shall be od prescribed in ‘‘Official Methods of deemed to be in compliance for fill of Analysis of the Association of Official container when the number of Analytical Chemists,’’ 13th Ed., 1980, defectives does not exceed the accept- sections 32.014 to 32.016 and 52.012, ance number (c) in the sampling plans. under the headings ‘‘Soluble Solids in (e) Sampling and acceptance procedure Tomato Products Official Final Ac- means the following: tion’’ and ‘‘Refractive Indices (n) of Su- (1) Definitions—(i) Lot. A collection of crose Solutions at 20°,’’ which is incor- primary containers or units of the porated by reference. Copies are avail- same size, type, and style manufac- able from the AOAC INTER- tured or packed under similar condi- NATIONAL, 481 North Frederick Ave., tions and handled as a single unit of suite 500, Gaithersburg, MD 20877, or trade. available for inspection at the National (ii) Lot size. The number of primary Archives and Records Administration containers or units in the lot. (NARA). For information on the avail- (iii) Sample size (n). The total number ability of this material at NARA, call of sample units drawn for examination 202–741–6030, or go to: http:// from a lot. www.archives.gov/federallregister/ (iv) Sample unit. A container, a por- codeloflfederallregulations/ tion of the contents of a container, or ibrllocations.html. If no salt has been a composite mixture of product from added, the sucrose value obtained from small containers that is sufficient for the referenced tables shall be consid- the examination or testing as a single ered the percent of tomato soluble sol- unit. For fill of container, the sample ids. If salt has been added, either inten- unit shall be the entire contents of the tionally or through the application of container. the acidified break, determine the per- (v) Defective. Any sample unit shall cent of such added sodium chloride as be regarded as defective when the sam- specified in paragraph (c) of this sec- ple unit does not meet the criteria set tion. Subtract the percentage so found forth in the standards. from the percentage of tomato soluble (vi) Acceptance number (c). The max- solids found (sucrose value from the re- imum number of defective sample units fractive index tables) and multiply the permitted in the sample in order to difference by 1.016. The resultant value consider the lot as meeting the speci- is considered the percent of ‘‘tomato fied requirements. soluble solids.’’ (vii) Acceptable quality level (AQL). (c) Salt means sodium chloride, deter- The maximum percent of defective mined as chloride and calculated as sample units permitted in a lot that percent sodium chloride, by the meth- will be accepted approximately 95 per- od prescribed in ‘‘Official Methods of cent of the time. Analysis of the Association of Official (2) Sampling plans: Analytical Chemists,’’ 13th Ed., 1980, ACCEPTABLE QUALITY LEVEL (AQL) 6.5 sections 32.025 to 32.030, under the heading ‘‘Method III (Potentiometric Meth- Size of container Lot size (primary containers) od),’’ which is incorporated by ref- n c erence. (d) Compliance means the following: NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) Unless otherwise provided in a stand- 4,800 or less ...... 13 2 ard, a lot of canned vegetable juice 4,801 to 24,000 ...... 21 3

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ACCEPTABLE QUALITY LEVEL (AQL) 6.5— soluble solids content of not less than Continued 5.0 percent by weight as determined by the method prescribed in § 156.3(b). The Size of container Lot size (primary containers) food is preserved by heat sterilization n c (canning), refrigeration, or freezing. When sealed in a container to be held 24,001 to 48,000 ...... 29 4 48,001 to 84,000 ...... 48 6 at ambient temperatures, it is so proc- 84,001 to 144,000 ...... 84 9 essed by heat, before or after sealing, 144,001 to 240,000 ...... 126 13 as to prevent spoilage. Over 240,000 ...... 200 19 (2) Labeling. (i) The name of the food NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN is: 4.5 KG (10 LB) (a) ‘‘Tomato juice’’ if it is prepared 2,400 or less ...... 13 2 from unconcentrated undiluted liquid 2,401 to 15,000 ...... 21 3 extracted from mature tomatoes of 15,001 to 24,000 ...... 29 4 reddish varieties. 24,001 to 42,000 ...... 48 6 42,001 to 72,000 ...... 84 9 (b) ‘‘Tomato juice from concentrate’’ 72,001 to 120,000 ...... 126 13 if the finished juice has been prepared Over 120,000 ...... 200 19 from concentrated tomato juice as

NET WEIGHT GREATER THAN 4.5 KG (10 LB) specified in paragraph (a)(1) of this section or if the finished juice is a mixture 600 or less ...... 13 2 of tomato juice and tomato juice from 601 to 2,000 ...... 21 3 2,001 to 7,200 ...... 29 4 concentrate. 7,201 to 15,000 ...... 48 6 (ii) Label declaration. Each of the in- 15,001 to 24,000 ...... 84 9 gredients used in the food shall be de- 24,001 to 42,000 ...... 126 13 Over 42,000 ...... 200 19 clared on the label as required by the applicable sections of parts 101 and 130 n = number of primary containers in sample. c = acceptance number. of this chapter. (b) Quality. (1) The standard of qual- [48 FR 3956, Jan. 28, 1983, as amended at 54 ity for tomato juice is as follows: FR 24895, June 12, 1989; 63 FR 14035, Mar. 24, (i) The strength and redness of color 1998] is not less than the composite color produced by spinning the Munsell color Subpart B—Requirements for Spe- discs in the following combination: 53 cific Standardized Vegetable percent of the area of Disc 1; 28 percent Juices of the area of Disc 2; and 19 percent of the area of either Disc 3 or Disc 4; or § 156.145 Tomato juice. 91⁄2 percent of the area of Disc 3 and 91⁄2 (a) Identity—(1) Definition. Tomato percent of the area of Disc 4, whichever juice is the food intended for direct most nearly matches the appearance of consumption, obtained from the the tomato juice. unfermented liquid extracted from ma- (ii) Not more than two defects for ture tomatoes of the red or reddish va- peel and blemishes, either singly or in rieties of Lycopersicum esculentum P. combination, in addition to three de- Mill, with or without scalding followed fects for seeds or pieces of seeds, de- by draining. In the extraction of such fined as follows, per 500 milliliters (16.9 liquid, heat may be applied by any fluid ounces): method which does not add water (a) Pieces of peel 3.2 millimeters thereto. Such juice is strained free (0.125 inch) or greater in length. from peel, seeds, and other coarse or (b) Blemishes such as dark brown or hard substances, but contains finely di- black particles (specks) greater than vided insoluble solids from the flesh of 1.6 millimeters (0.0625 inch) in length. the tomato in accordance with current (c) Seeds or pieces of seeds 3.2 milli- good manufacturing practice. Such meters (0.125 inch) or greater in length. juice may be homogenized, may be sea- (2) Methodology. (i) Determine soned with salt, and may be acidified strength and redness of color as speci- with any safe and suitable organic fied in § 156.3(a). acid. The juice may have been con- (ii) Examine a total of 500 milliliters centrated and later reconstituted with for peel, blemishes, and seeds. Divide water and/or tomato juice to a tomato the 500-milliliter sample into two 250-

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milliliter aliquots and pour each ali- Subpart B—Requirements for Specific quot onto separate 30.5 × 45.7 centi- Standardized Frozen Vegetables meters (12 × 18 inches) white grading 158.170 Frozen peas. trays. Remove defects and evaluate for color and size as defined in paragraph AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371. (b)(1)(ii) of this section. (3) Determine compliance as specified Subpart A—General Provisions in § 156.3(d). § 158.3 Definitions. (4) If the quality of the tomato juice falls below the standard prescribed in For the purposes of this part the fol- paragraph (b)(1) and (3) of this section, lowing definitions shall apply: the label shall bear the general state- (a) Lot. A collection of primary containers or units of the same size, type ment of substandard quality specified and style manufactured or packed in § 130.14(a) of this chapter, in the under similar conditions and handled manner and form therein specified, but as a single unit of trade. in lieu of such general statement of (b) Lot size. The number of primary substandard quality when the quality containers or units (pounds when in of the tomato juice falls below the bulk) in the lot. standard in one or more respects, the (c) Sample size. The total number of label may bear the alternative state- sample units drawn for examination ment, ‘‘Below Standard in Quality from a lot. lll’’, the blank to be filled in with (d) Sample unit. A container, a por- the words specified after the cor- tion of the contents of a container, or responding paragraph (s) under para- a composite mixture of product from graph (b)(1) of this section which such small containers that is sufficient for tomato juice fails to meet, as follows: the examination or testing as a single (i) ‘‘Poor color’’. unit. (ii)(a) ‘‘Excessive pieces of peel’’. (e) Defective. Any sample unit shall (b) ‘‘Excessive blemishes’’. be regarded as defective when the sample unit does not meet the criteria set (c) ‘‘Excessive seeds’’ or ‘‘excessive forth in the standards. pieces of seed’’. (f) Acceptance number. The maximum (c) Fill of container. (1) The standard number of defective sample units per- of fill of container for tomato juice, as mitted in the sample in order to con- determined by the general method for sider the lot as meeting the specified fill of container prescribed in § 130.12(b) requirements. The following accept- of this chapter, is not less than 90 per- ance numbers shall apply: cent of the total capacity, except when the food is frozen. Size container Lot size (primary container) (2) Determine compliance as specified n 1 c 2 in § 156.3(d). NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) (3) If the tomato juice falls below the standard of fill prescribed in paragraph 4,800 or less ...... 13 2 4,801 to 24,000 ...... 21 3 (c)(1) and (2) of this section, the label 24,001 to 48,000 ...... 29 4 shall bear the general statement of 48,001 to 84,000 ...... 48 6 substandard fill specified in § 130.14(b) 84,001 to 144,000 ...... 84 9 144,001 to 240,000 ...... 126 13 of this chapter, in the manner and form Over 240,000 ...... 200 19 therein prescribed. NET WEIGHT GREATER THAN 1 KG (2.2 LB) [48 FR 3957, Jan. 28, 1983, as amended at 58 FR 2883, Jan. 6, 1993] Number of Pounds 20,000 or less ...... 13 2 More than 20,000 to 100,000 ...... 21 3 PART 158—FROZEN VEGETABLES More than 100,000 to 200,000 ...... 29 4 More than 200,000 to 400,000 ...... 48 6 More than 400,000 to 600,000 ...... 84 9 Subpart A—General Provisions More than 600,000 to 1,000,000 ...... 126 13 More than 1,000,000 ...... 200 19 Sec. 1 n = number of sample units. 158.3 Definitions. 2 c = acceptance number.

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(g) Acceptable quality level (AQL). The Round hole sieve size through maximum percent of defective sample Size designation which peas will pass units permitted in a lot that will be ac- Millimeters Inch cepted approximately 95 percent of the time. Medium ...... Up to 10.2 ...... 40 Large ...... Over 10.2 ...... 40 [42 FR 14461, Mar. 15, 1977] (3) Labeling. The name of the product Subpart B—Requirements for Spe- is ‘‘peas’’. The term ‘‘early’’, ‘‘June’’, cific Standardized Frozen or ‘‘early June’’ shall precede or follow Vegetables the name in the case of smooth-skin or substantially smooth-skin peas, such § 158.170 Frozen peas. as Alaska-type peas. Where the peas (a) Identity—(1) Product definition. are of sweet green wrinkled varieties, Frozen peas is the food in ‘‘package’’ the name may include the designation form as that term is defined in § 1.20 of ‘‘sweet’’, ‘‘green’’, ‘‘wrinkled’’, or any this chapter, prepared from the suc- combination thereof. The label shall culent seed of the pea plant of the spe- contain the words ‘‘frozen’’ or ‘‘quick cies Pisum sativum L. Any suitable vari- frozen’’. The name of the food shall in- ety of pea may be used. It is blanched, clude a declaration of any flavoring drained, and preserved by freezing in that characterizes the product as speci- such a way that the range of tempera- fied in § 101.22 of this chapter and a dec- ture of maximum crystallization is laration of any condiment such as passed quickly. The freezing process spices and mint leaves that character- shall not be regarded as complete until izes the product, e.g., ‘‘Spice added’’. the product temperature has reached Where a statement of pea size is made, ¥18 °C (0 °F) or lower at the thermal such statement shall indicate either center, after thermal stabilization. the size designation as specified in Such food may contain one, or any paragraph (a)(2) of this section or the combination of two or more, of the fol- applicable sieve size. However, the op- lowing safe and suitable optional ingre- tional descriptive words ‘‘petite’’ or dients: ‘‘tiny’’ may be used in conjunction (i) Natural and artificial flavors. with the product name when an aver- (ii) Condiments such as spices and age of 80 percent or more of the peas mint leaves. will pass through a circular opening of (iii) Dry nutritive carbohydrate a diameter of 8.75 mm (0.34 in) or less sweeteners. for sweet green wrinkled peas and 8.2 (iv) Salt. mm (0.32 in) for smooth-skin or sub- (v) Monosodium glutamate and other stantially smooth-skin peas, such as glutamic acid salts. Alaska-type peas. (2) Size specifications. If size graded, (4) Label declaration. Each of the in- frozen peas shall contain not less than gredients used in the food shall be de- 80 percent by weight of peas of the size clared on the label as required by the declared or of smaller sizes. The sam- applicable sections of parts 101 and 130 ple unit may not contain more than 20 of this chapter. percent by weight of peas of the next (b) Quality. (1) The standard of qual- two larger sizes, of which not more ity for frozen peas is as follows: than one quarter by weight of such (i) Not more than 4 percent by weight peas may be of the larger of these two blond peas, i.e., yellow or white but ed- sizes, and may contain no peas larger ible peas; than the next two larger sizes, if such (ii) Not more than 10 percent by there be. The following sizes and des- weight blemished peas, i.e., slightly ignations shall apply: stained or spotted peas; Round hole sieve size through (iii) Not more than 2 percent by Size designation which peas will pass weight seriously blemished peas, i.e., Millimeters Inch peas that are hard, shrivelled, spotted, discolored or otherwise blemished to an Extra small ...... Up to 7.5 ...... 0.295 Very small ...... Up to 8.2 ...... 32 extent that the appearance or eating Small ...... Up to 8.75 ...... 34 quality is seriously affected.

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(iv) Not more than 15 percent by (b) A mixture of 95 parts of formula weight pea fragments, i.e., portions of 3A denatured alcohol and five parts of peas, separated or individual isopropanol v/v. cotyledons, crushed, partial or broken (ii) Eighty percent alcohol (8 liters of cotyledons and loose skins, but exclud- extracting solutions, specified in para- ing entire intact peas with skins de- graph (b)(3)(i) (a) or (b) of this section, tached; diluted to 9.5 liters with water). (v) Not more than 0.5 percent by (iii) Drying dish—a flat-bottom dish weight, or more than 12 sq cm (2 sq in) with a tight fitting cover. in area, extraneous vegetable material, (iv) Drying oven—a properly venti- i.e., vine or leaf or pod material from lated oven thermostatically controlled the pea plant or other such material at 100±2 °C. per sample unit as defined in paragraph (v) Procedure—Transfer frozen con- (b) of this section. tents of package to plastic bag; tie bag (vi) The sum of the pea material de- securely and immerse in water bath scribed in paragraphs (b)(1) (i), (ii), with continuous flow at room tempera- (iii), and (iv) of this section shall not ture. Avoid agitation of bag during exceed 15 percent. thawing by using clamps or weights. (vii) For peas that meet the When sample completely thaws, re- organoleptic and analytical character- move bag, blot off adhering water, and istics of sweet green wrinkled vari- transfer peas to U.S. No. 8 sieve, using eties: (20 cm.) size for container of less than (a) The alcohol-insoluble solids may 3 lb. net weight and (30.5 cm.) for larger not be more than 19 percent based on quantities. Without shifting peas, in- the procedure set forth in paragraph cline sieve to aid drainage, drain 2 min- (b)(3) of this section. utes. With cloth wipe surplus water (b) Not more than 15 percent by from lower screen surface. Weigh 250 g. count of the peas may sink in a solu- of peas into high-speed blender, add 250 tion containing 16 percent salt by g. of water and blend to smooth paste. weight according to the brine flotation For less than 250 g. sample, use entire test set forth in paragraph (b)(4) of this sample with equal weight of water. section; Weight 20 g.±10 mg. of the paste into (viii) For smooth-skin or substan- 250 ml. distillation flask, add 120 ml. of tially smooth-skin varieties the alco- extracting solutions specified in para- hol insoluble solids may not be more graph (b)(3)(i) (a) or (b) of this section, than 23 percent based on the procedure and reflux 30 minutes on steam or set forth in paragraph (b)(3) of this sec- water bath or hotplate. Fit into a tion. buchner funnel a filter paper of appro- (ix) The quality of a lot shall be con- priate size (previously prepared by dry- sidered acceptable when the number of ing in flatbottom dish for 2 hours in defectives does not exceed the accept- drying oven, covering, cooling in desic- ance number in the sampling plans set cator, and weighing). Apply vacuum to forth in § 158.3(f). buchner funnel and transfer contents of (2) The sample unit for determining beaker so as to avoid running over edge compliance with the requirements of of paper. Aspirate to dryness and wash paragraph (b)(1) of this section other material on filter with 80 percent alco- than those of paragraphs (b)(1)(vii)(a) hol until washings are clear and color- and (b)(1)(viii) of this section, shall be less. Transfer paper and alcohol-insol- 500 g (17.6 oz). For the determination of uble solids to drying dish used to pre- alcohol-insoluble solids as specified in pare paper, dry uncovered for 2 hours paragraph (b)(3) of this section, the in drying oven, cover, cool in desic- container may be the sample unit. cator, and weigh at once. From this (3) Alcohol-insoluble solids determina- weight deduct weight of dish, cover, tion. (i) Extracting solutions: and paper. Calculate percent by weight (a) One hundred parts of ethanol de- of alcohol-insoluble solids. natured with five parts of methanol (4) Brine flotation test. (i) Expla- volume to volume (formula 3A dena- nation—The brine flotation test uti- tured alcohol), or lizes salt solutions of various specific

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gravities to separate the peas accord- 160.115 Liquid eggs. ing to maturity. The brine solutions 160.140 Egg whites. are based on the percentage by weight 160.145 Dried egg whites. of pure salt (NaCl) in solution at 20 °C. 160.150 Frozen egg whites. In making the test the brine solutions 160.180 Egg yolks. are standardized to the proper specific 160.185 Dried egg yolks. 160.190 Frozen egg yolks. gravity equivalent to the specified ‘‘percent of salt solutions at 20 °C’’ by AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, using a salometer spindle accurately 379e. calibrated at 20 °C. A 250 ml glass beak- SOURCE: 42 FR 14462, Mar. 15, 1977, unless er or similar receptacle is filled with otherwise noted. the brine solution to a depth of approximately 50 mm. The brine solution Subpart A [Reserved] and sample (100 peas per container) must be at the same temperature and should closely approximate 20 °C. Subpart B—Requirements for Spe- (ii) Procedure—After carefully re- cific Standardized Eggs and moving the skins from the peas, place Egg Products the peas into the solution. Pieces of peas and loose skins should not be used § 160.100 Eggs. in making the brine flotation test. If No regulation shall be promulgated cotyledons divide, use both cotyledons fixing and establishing a reasonable in the test and consider the two sepa- definition and standard of identity for rated cotyledons as 1 pea; and, if an the food commonly known as eggs. odd cotyledon sinks, consider it as one pea. Only peas that sink to the bottom § 160.105 Dried eggs. of the receptacle within 10 seconds (a) Dried eggs, dried whole eggs are after immersion are counted as ‘‘peas prepared by drying liquid eggs that that sink’’. conform to § 160.115, with such pre- (5) If the quality of the frozen peas cautions that the finished food is free falls below the standard prescribed in of viable Salmonella microorganisms. paragraph (b)(1) of this section, the They may be powdered. Before drying, label shall bear the general statement the glucose content of the liquid eggs of substandard quality specified in the may be reduced by one of the optional Code of Federal Regulations but in lieu procedures set forth in paragraph (b) of of the words prescribed in the second this section. Either silicon dioxide line of the rectangle the following complying with the provisions of words may be used where the frozen § 172.480 of this chapter or sodium peas fall below the standard in only silicoaluminate may be added as an op- one respect: ‘‘Below standard in qual- tional anticaking ingredient, but the ity lll’’, the blank to be filled in amount of silicon dioxide used is not with the specific reason for sub- more than 1 percent and the amount of standard quality as listed in the stand- sodium silicoaluminate used is less ard. than 2 percent by weight of the fin- [42 FR 14461, Mar. 15, 1977, as amended at 42 ished food. The finished food shall con- FR 15673, Mar. 22, 1977; 58 FR 2883, Jan. 6, tain not less than 95 percent by weight 1993] total egg solids. (b) The optional glucose-removing PART 160—EGGS AND EGG procedures are: PRODUCTS (1) Enzyme procedure. A glucose-oxidase-catalase preparation and hydro- Subpart A [Reserved] gen peroxide solution are added to the liquid eggs. The quantity used and the Subpart B—Requirements for Specific time of reaction are sufficient to sub- Standardized Eggs and Egg Products stantially reduce the glucose content Sec. of the liquid eggs. The glucose-oxidase- 160.100 Eggs. catalase preparation used is one that is 160.105 Dried eggs. generally recognized as safe within the 160.110 Frozen eggs. meaning of section 201(s) of the Federal

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Food, Drug, and Cosmetic Act. The hy- finished food is free of viable Salmonella drogen peroxide solution used shall microorganisms. comply with the specifications of the (b) Monosodium phosphate or United States Pharmacopeia, except monopotassium phosphate may be that it may exceed the concentration added either directly or in a water car- specified therein and it does not con- rier, but the amount added does not ex- tain a preservative. ceed 0.5 percent of the weight of the (2) Yeast procedure. The pH of the liq- frozen eggs. If a water carrier is used, uid eggs is adjusted to the range of 6.0 it shall contain not less than 50 percent to 7.0, if necessary, by the addition of by weight of such monosodium phos- dilute, chemically pure hydrochloric phate or monopotassium phosphate. acid, and controlled fermentation is (c) When one of the optional ingredi- maintained by adding food-grade ents specified in paragraph (b) of this baker’s yeast (Saccharomyces cerevisiae). section is used, the label shall bear the The quantity of yeast used and the statement ‘‘Monosodium phosphate (or time of reaction are sufficient to sub- monopotassium phosphate) added to stantially reduce the glucose content preserve color’’, or, in case the optional of the liquid eggs. ingredient used is added in a water car- (c) The name of the food for which a rier, the statement shall be ‘‘Mono- definition and standard of identity is sodium phosphate (or monopotassium prescribed by this section is ‘‘Dried phosphate), with l percent water as a eggs’’ or ‘‘Dried whole eggs’’ and if the carrier, added to preserve color’’, the glucose content was reduced, as pro- blank being filled in to show the per- vided in paragraph (b) of this section, cent by weight of water used in propor- the name shall be followed imme- tion to the weight of the finished food. diately by the statement ‘‘Glucose re- The statement declaring the optional moved for stability’’ or ‘‘Stabilized, ingredient used shall appear on the glucose removed’’. principal display panel or panels with (d)(1) When either of the optional such prominence and conspicuousness anticaking ingredients specified in as to render it likely to be read and un- paragraph (a) of this section is used, derstood under customary conditions the label shall bear the statement ‘‘Not of purchase. more than 1 percent silicon dioxide (d) Label declaration. Each of the in- added as an anticaking agent’’ or ‘‘Less gredients used in the food shall be de- than 2 percent sodium silicoaluminate clared on the label as required by the added as an anticaking agent’’, which- applicable sections of parts 101 and 130 ever is applicable. of this chapter. (2) The name of any optional ingre- [42 FR 14462, Mar. 15, 1977, as amended at 58 dient used, as provided in paragraph FR 2883, Jan. 6, 1993] (d)(1) of this section, shall be listed on the principal display panel or panels of § 160.115 Liquid eggs. the label with such prominence and (a) Liquid eggs, mixed eggs, liquid conspicuousness as to render such whole eggs, mixed whole eggs are eggs statement likely to be read and under- of the domestic hen broken from the stood by the ordinary individual under shells and with yolks and whites in customary conditions of purchase. their natural proportion as so broken. (e) Label declaration. Each of the in- They may be mixed, or mixed and gredients used in the food shall be de- strained, and they are pasteurized or clared on the label as required by the otherwise treated to destroy all viable applicable sections of parts 101 and 130 Salmonella microorganisms. Pasteuriza- of this chapter. tion or such other treatment is deemed [42 FR 14462, Mar. 15, 1977, as amended at 58 to permit the adding of safe and suit- FR 2883, Jan. 6, 1993] able substances (other than chemical preservatives) that are essential to the § 160.110 Frozen eggs. method of pasteurization or other (a) Frozen eggs, frozen whole eggs, treatment used. For the purposes of frozen mixed eggs is the food prepared this paragraph, safe and suitable sub- by freezing liquid eggs that conform to stances are those that perform a useful § 160.115, with such precautions that the function in the pasteurization or other

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treatment to render the liquid eggs clared on the label as required by the free of viable Salmonella microorga- applicable sections of parts 101 and 130 nisms, and that are not food additives of this chapter. as defined in section 201(s) of the Fed- [42 FR 14462, Mar. 15, 1977, as amended at 58 eral Food, Drug, and Cosmetic Act; or, FR 2883, Jan. 6, 1993] if they are food additives, they are used in conformity with regulations estab- § 160.145 Dried egg whites. lished pursuant to section 409 of the (a) The food dried egg whites, egg act. white solids, dried egg albumen, egg al- (b) Label declaration. Each of the in- bumen solids is prepared by drying liq- gredients used in the food shall be de- uid egg whites conforming to the re- clared on the label as required by the quirements of § 160.140 (or deviating applicable sections of parts 101 and 130 from that section only by not being of this chapter. Salmonella free). As a preliminary step [42 FR 14462, Mar. 15, 1977, as amended at 58 to drying, the lysozyme and avidin con- FR 2883, Jan. 6, 1993] tents may be reduced. If lysozyme and avidin levels are reduced, cation ex- § 160.140 Egg whites. change resins regulated for use under (a) Egg whites, liquid egg whites, liq- § 173.25 of this chapter shall be used. As uid egg albumen is the food obtained a further preliminary step to drying, from eggs of the domestic hen, broken the glucose content of the liquid egg from the shells and separated from whites is reduced by adjusting the pH, yolks. The food may be mixed, or where necessary, with food-grade acid mixed and strained, and is pasteurized and by following one of the optional or otherwise treated to destroy all via- procedures set forth in paragraph (b) of ble Salmonella microorganisms. Pas- this section. If the food is prepared teurization or such other treatment is from liquid egg whites conforming in deemed to permit the adding of safe all respects to the requirements of and suitable substances (other than § 160.140, drying shall be done with such chemical preservatives) that are essen- precautions that the finished food is tial to the method of pasteurization or free of viable Salmonella microorga- other treatment used. Safe and suit- nisms. If the food is prepared from liq- able substances that aid in protecting uid egg whites that are not Salmonella or restoring the whipping properties of free, the dried product shall be so liquid egg whites may be added. For treated by heat or otherwise as to the purposes of this paragraph, safe render the finished food free of viable and suitable substances are those that Salmonella microorganisms. Dried egg perform a useful function as whipping whites may be powdered. aids or in the pasteurization or other (b) The optional glucose-removing treatment to render liquid egg whites procedures are: free of viable Salmonella microorga- (1) Enzyme procedure. A glucose-oxi- nisms and that are not food additives dase-catalase preparation and hydro- as defined in section 201(s) of the Fed- gen peroxide solution are added to liq- eral Food, Drug, and Cosmetic Act; or, uid egg whites. The quantity used and if they are food additives, they are used the time of reaction are sufficient to in conformity with regulations estab- substantially reduce the glucose con- lished pursuant to section 409 of the tent. The glucose-oxidase-catalase act. preparation used is one that is gen- (b) Any optional ingredients used as erally recognized as safe within the whipping aids, as provided for in para- meaning of section 201(s) of the Federal graph (a) of this section, shall be Food, Drug, and Cosmetic Act. The hy- named on the principal display panel or drogen peroxide solution used shall panels of labels with such prominence comply with the specifications of the and conspicuousness as to render such United States Pharmacopeia, except names likely to be read and understood that it may exceed the concentration by ordinary individuals under cus- specified therein and it does not con- tomary conditions of purchase. tain a preservative. (c) Label declaration. Each of the in- (2) Controlled fermentation proce- gredients used in the food shall be de- dures—(i) Yeast procedure. Food-grade

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baker’s yeast (Saccharomyces cerevisiae) the principal display panel or panels of is added to the liquid egg whites and the label with such prominence and controlled fermentation is maintained. conspicuousness as to render the names The quantity of yeast used and the likely to be read and understood by or- time of reaction are sufficient to sub- dinary individuals under customary stantially reduce the glucose content. conditions of purchase. (ii) Bacterial procedure. The liquid egg (e) The name of the food for which a whites are subjected to the action of a definition and standard of identity is culture of glucose-fermenting bacteria prescribed in this section is alter- either generally recognized as safe natively ‘‘Dried egg whites’’, Egg white within the meaning of section 201(s) of solids’’, ‘‘Dried egg albumen’’, or ‘‘Egg the Federal Food, Drug, and Cosmetic albumen solids’’. If the lysozyme and Act or the subject of a regulation es- avidin content is reduced as provided tablished pursuant to section 409 of the in paragraph (a) of this section, the act, and the culture is used in con- name shall be immediately preceded or formity with such regulation. The followed by the statement ‘‘lysozyme quantity of the culture used is suffi- and avidin reduced’’ when the dried egg cient to predominate in the fermenta- whites are sold as such. When the dried tion and the time and temperature of egg whites are used in a fabricated reaction are sufficient to substantially food, the statement ‘‘lysozyme and avi- reduce the glucose content. din reduced’’ may be omitted from any (c)(1) Dried egg whites in which the declaration of ingredients required lysozyme and avidin have been reduced under § 101.4 of this chapter. shall not be nutritionally inferior, as (f) Label declaration. Each of the in- defined in § 101.3(e)(4)(i) of this chapter, gredients used in the food shall be de- and shall be considered nutritionally clared on the label as required by the equivalent to untreated egg whites if applicable sections of parts 101 and 130 they meet the conditions that the bio- of this chapter. logical quality of the protein contained [42 FR 14462, Mar. 15, 1977, as amended at 51 is equal to or greater than that of un- FR 11435, Apr. 3, 1986; 51 FR 25362, July 14, treated egg white from the same batch 1986; 54 FR 24895, June 12, 1989; 58 FR 2883, of liquid egg white. Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] (2) Compliance with the biological § 160.150 Frozen egg whites. quality of protein requirement of paragraph (c)(1) of this section shall be de- (a) Frozen egg whites, frozen egg al- termined by the analytical method pre- bumen is the food prepared by freezing scribed in ‘‘Official Methods of Anal- liquid egg whites that conform to ysis of the Association of Official Ana- § 160.140, with such precautions that the lytical Chemists,’’ 14th Ed. (1984), sec- finished food is free of viable Salmonella tion 43.253–43.257, ‘‘Protein Efficiency microorganisms. Ratio, Rat Bioassay, Final Action,’’ (b) When frozen egg whites are pre- which is incorporated by reference. pared from liquid egg whites con- Copies may be obtained from the AOAC taining any optional ingredients added INTERNATIONAL, 481 North Frederick as whipping aids, as provided for in Ave., suite 500, Gaithersburg, MD 20877, § 160.140(a), the common names of such or may be examined at the National optional ingredients shall be listed on Archives and Records Administration the principal display panel or panels of (NARA). For information on the avail- the label with such prominence and ability of this material at NARA, call conspicuousness as to render such 202–741–6030, or go to: http:// names likely to be read and understood www.archives.gov/federallregister/ by ordinary individuals under cus- codeloflfederallregulations/ tomary conditions of purchase. ibrllocations.html. (c) Label declaration. Each of the in- (d) When the dried egg whites are gredients used in the food shall be de- prepared from liquid egg whites con- clared on the label as required by the taining any optional ingredients added applicable sections of parts 101 and 130 as whipping aids, as provided for in of this chapter. § 160.140(a), the common names of such [42 FR 14462, Mar. 15, 1977, as amended at 58 optional ingredients shall be listed on FR 2883, Jan. 6, 1993]

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§ 160.180 Egg yolks. cautions that the finished food is free (a) Egg yolks, liquid egg yolks, yolks, of viable Salmonella microorganisms. liquid yolks are yolks of eggs of the do- Before drying, the glucose content of mestic hen so separated from the the liquid egg yolks may be reduced by whites thereof as to contain not less one of the optional procedures set forth than 43 percent total egg solids, as de- in paragraph (b) of this section. Either termined by the method prescribed in silicon dioxide complying with the pro- ‘‘Official Methods of Analysis of the visions of § 172.480 of this chapter or so- Association of Official Analytical dium silicoaluminate may be added as Chemists,’’ 13th Ed. (1980), sections an optional anticaking ingredient, but 17.006 and 17.007 under ‘‘Total Solids, the amount of silicon dioxide used is Vacuum Method (3)—Official Final Ac- not more than 1 percent and the tion,’’ which is incorporated by ref- amount of sodium silicoaluminate used erence. Copies may be obtained from is less than 2 percent by weight of the the AOAC INTERNATIONAL, 481 North finished food. The finished food shall Frederick Ave., suite 500, Gaithersburg, contain not less than 95 percent by MD 20877, or may be examined at the weight total egg solids. National Archives and Records Admin- (b) The optional glucose-removing istration (NARA). For information on procedures are: the availability of this material at (1) Enzyme procedure. A glucose-oxi- NARA, call 202–741–6030, or go to: http:// dase-catalase preparation and hydro- www.archives.gov/federallregister/ gen peroxide solution are added to the codeloflfederallregulations/ liquid egg yolks. The quantity used and ibrllocations.html. They may be mixed, the time of reaction are sufficient to or mixed and strained, and they are substantially reduce the glucose con- pasteurized or otherwise treated to de- tent of the liquid egg yolks. The glu- stroy all viable Salmonella microorga- cose-oxidase-catalase preparation used nisms. Pasteurization or such other is one that is generally recognized as treatment is deemed to permit the add- safe within the meaning of section ing of safe and suitable substances 201(s) of the Federal Food, Drug, and (other than chemical preservatives) Cosmetic Act. The hydrogen peroxide that are essential to the method of pas- solution used shall comply with the teurization or other treatment used. specification of the United States For the purposes of this paragraph, Pharmacopeia, except that it may ex- safe and suitable substances are those ceed the concentration specified there- that perform a useful function in the pasteurization or other treatment to in and it does not contain a preserva- render the egg yolks free of viable Sal- tive. monella microorganisms, and that are (2) Yeast procedure. The pH of the liq- not food additives as defined in section uid egg yolks is adjusted to the range 201(s) of the Federal Food, Drug, and of 6.0 to 7.0, if necessary, by the addi- Cosmetic Act; or, if they are food addition of dilute, chemically pure hydro- tives, they are used in conformity with chloric acid, and controlled fermenta- regulations established pursuant to tion is maintained by adding food- section 409 of the act. grade baker’s yeast (Saccharomyces (b) Label declaration. Each of the in- cerevisiae). The quantity of yeast used gredients used in the food shall be de- and the time of reaction are sufficient clared on the label as required by the to substantially reduce the glucose applicable sections of parts 101 and 130 content of the liquid egg yolks. of this chapter. (c) The name of the food for which a [42 FR 14462, Mar. 15, 1977, as amended at 47 definition and standard of identity is FR 11832, Mar. 19, 1982; 49 FR 10102, Mar. 19, prescribed by this section is ‘‘Dried egg 1984; 54 FR 24895, June 12, 1989; 58 FR 2883, yolks’’, or ‘‘Dried yolks’’, and if the Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] glucose content was reduced, as provided in paragraph (b) of this section, § 160.185 Dried egg yolks. the name shall be followed imme- (a) Dried egg yolks, dried yolks is the diately by the statement ‘‘Glucose re- food prepared by drying egg yolks that moved for stability’’ or ‘‘Stabilized, conform to § 160.180, with such pre- glucose removed’’.

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(d)(1) When either of the optional AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, anticaking ingredients specified in 379e. paragraph (a) of this section is used, SOURCE: 42 FR 14464, Mar. 15, 1977, unless the label shall bear the statement ‘‘Not otherwise noted. more than 1 percent silicon dioxide added as an anticaking agent’’ or ‘‘Less EDITORIAL NOTE: Nomenclature changes to part 161 appear at 81 FR 49896, July 29, 2016. than 2 percent sodium silicoaluminate added as an anticaking agent’’, whichever is applicable. Subpart A—General Provisions (2) The name of any optional ingredient used, as provided in paragraph § 161.30 Declaration of quantity of contents on labels for canned oysters. (d)(1) of this section, shall be listed on the principal display panel or panels of (a) For many years packers of canned the label with such prominence and oysters in the Gulf area of the United conspicuousness as to render such States have labeled their output with a statement likely to be read and under- declaration of the drained weight of stood by the ordinary individual under oysters in the containers. Packers in customary conditions of purchase. other areas have marketed canned oys- (e) Label declaration. Each of the in- ters with a declaration of the total gredients used in the food shall be de- weight of the contents of the con- clared on the label as required by the tainer. Investigation reveals that applicable sections of parts 101 and 130 under present-day practice consumers of this chapter. generally do not discard the liquid packing medium, but use it as a part of [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] the food. Section 403(e)(2) of the Fed- eral Food, Drug, and Cosmetic Act and § 160.190 Frozen egg yolks. the regulations thereunder require food (a) Frozen egg yolks, frozen yolks is in package form to bear an accurate the food prepared by freezing egg yolks label statement of the quantity of food that conform to § 160.180, with such pre- in the container. cautions that the finished food is free (b) It is concluded that compliance of viable Salmonella microorganisms. with the label declaration of quantity (b) Label declaration. Each of the in- of contents requirement will be met by gredients used in the food shall be de- an accurate declaration of the total clared on the label as required by the weight of the contents of the can. The applicable sections of parts 101 and 130 requirements of § 161.145(c), estab- of this chapter. lishing a standard of fill of container for canned oysters and specifying the [42 FR 14462, Mar. 15, 1977, as amended at 58 statement of substandard fill for those FR 2884, Jan. 6, 1993] canned oysters failing to meet that standard remain unaffected by this in- PART 161—FISH AND SHELLFISH terpretation.

Subpart A—General Provisions Subpart B—Requirements for Spe- Sec. cific Standardized Fish and 161.30 Declaration of quantity of contents Shellfish on labels for canned oysters. § 161.130 Oysters. Subpart B—Requirements for Specific Standardized Fish and Shellfish (a) Oysters, raw oysters, shucked oysters, are the class of foods each of 161.130 Oysters. which is obtained by shucking shell 161.136 Olympia oysters. oysters and preparing them in accord- 161.145 Canned oysters. ance with the procedure prescribed in 161.170 Canned Pacific salmon. paragraph (b) of this section. The name 161.173 Canned wet pack shrimp in transparent or nontransparent containers. of each such food is the name specified 161.175 Frozen raw breaded shrimp. in the applicable definition and stand- 161.176 Frozen raw lightly breaded shrimp. ard of identity prescribed in §§ 161.131 161.190 Canned tuna. to 161.140, inclusive.

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(b) If water, or salt water containing moved so that when the oysters are less than 0.75 percent salt, is used in tested within 15 minutes after packing any vessel into which the oysters are by draining a representative gallon of shucked the combined volume of oys- oysters on a skimmer of the dimen- ters and liquid when such oysters are sions and in the manner described in emptied from such vessel is not less paragraph (c)(2)(i) of this section for 2 than four times the volume of such minutes, not more than 5 percent of water or salt water. Any liquid accu- liquid by weight is removed by such mulated with the oysters is removed. draining. The oysters are washed, by blowing or otherwise, in water or salt water, or § 161.136 Olympia oysters. both. The total time that the oysters Olympia oysters, raw Olympia oys- are in contact with water or salt water ters, shucked Olympia oysters, are of after leaving the shucker, including the species Ostrea lurida and conform the time of washing, rinsing, and any to the definition and standard of iden- other contact with water or salt water tity prescribed for oysters in § 161.130. is not more than 30 minutes. In com- puting the time of contact with water § 161.145 Canned oysters. or salt water, the length of time that (a) Identity. (1) Canned oysters is the oysters are in contact with water or food prepared from one or any mixture salt water that is agitated by blowing of two or all of the forms of oysters or otherwise, shall be calculated at specified in paragraph (a)(2) of this sec- twice its actual length. Any period of tion, and a packing medium of water, time that oysters are in contact with or the watery liquid draining from oys- salt water containing not less than 0.75 ters before or during processing, or a percent salt before contact with oys- mixture of such liquid and water. The ters, shall not be included in com- food may be seasoned with salt. It is puting the time that the oysters are in sealed in containers and so processed contact with water or salt water. Be- by heat as to prevent spoilage. fore packing into the containers for (2) The forms of oysters referred to in shipment or other delivery for con- paragraph (a)(1) of this section are pre- sumption the oysters are thoroughly pared from oysters which have been re- drained and are packed without any moved from their shells and washed added substance. and which may be steamed while in the (c) For the purposes of this section: shell or steamed or blanched or both (1) Shell oysters means live oysters of after removal therefrom, and are as fol- any of the species, Ostrea virginica, lows: Ostrea gigas, Ostrea lurida, in the shell, (i) Whole oysters with such broken which, after removal from their beds, pieces of oysters as normally occur in have not been floated or otherwise held removing oysters from their shells, under conditions which result in the washing, and packing. addition of water. (ii) Pieces of oysters obtained by seg- (2) Thoroughly drained means one of regating pieces of oysters broken in the following: shucking, washing, or packing whole (i) The oysters are drained on a oysters. strainer or skimmer which has an area (iii) Cut oysters obtained by cutting of not less than 300 square inches per whole oysters. gallon of oysters, drained, and has per- (3)(i) When the form of oysters speci- forations of at least 1⁄4 of an inch in di- fied in paragraph (a)(2)(i) of this sec- ameter and not more than 11⁄4 inches tion is used, the name of the food is apart, or perforations of equivalent ‘‘Oysters’’ or ‘‘Cove oysters’’, if of the areas and distribution. The oysters are species Ostrea virginica; ‘‘Oysters’’ or distributed evenly over the draining ‘‘Pacific oysters’’, if of the species surface of the skimmer and drained for Ostrea gigas; ‘‘Oysters’’ or ‘‘Olympia not less than 5 minutes; or oysters’’, if of the species Ostrea lurida. (ii) The oysters are drained by any (ii) When the form of oysters speci- method other than that prescribed by fied in paragraph (a)(2)(ii) of this sec- paragraph (c)(2)(i) of this section tion is used, the name of the food is whereby liquid from the oysters is re- ‘‘Pieces of lll’’, the blank being

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filled in with the name ‘‘Oysters’’ or Sieves (U.S.A. Standard Series),’’ under ‘‘Cove oysters’’, if of the species Ostrea the heading ‘‘Definitions of Terms and virginica; ‘‘Oysters’’ or ‘‘Pacific oys- Explanatory Notes,’’ which is incor- ters’’, if of the species Ostrea gigas; porated by reference. Copies may be ‘‘Oysters’’ or ‘‘Olympia oysters’’, if of obtained from the AOAC INTER- the species Ostrea lurida. NATIONAL, 481 North Frederick Ave., (iii) When the form of oysters speci- suite 500, Gaithersburg, MD 20877, or fied in paragraph (a)(2)(iii) of this sec- may be examined at the National Ar- tion is used, the name of the food is chives and Records Administration ‘‘Cut lll, the blank being filled in (NARA). For information on the avail- with the name ‘‘Oysters’’ or ‘‘Cove oys- ability of this material at NARA, call ters’’, if of the species Ostrea virginica; 202–741–6030, or go to: http:// ‘‘Oysters’’ or ‘‘Pacific oysters’’, if of www.archives.gov/federallregister/ the species Ostrea gigas; ‘‘Oysters’’ or codeloflfederallregulations/ ‘‘Olympia oysters’’, if of the species ibrllocations.html. Without shifting the Ostrea lurida. material on the sieve, so incline the (iv) In case a mixture of two or all sieve as to facilitate drainage. Two such forms of oysters is used, the name minutes from the time drainage begins, is a combination of the names specified weigh the sieve and the drained oys- in this paragraph (a)(3) of the forms of ters. The weight so found, less the oysters used, arranged in order of their weight of the sieve, shall be considered predominance by weight. to be the drained weight of the oysters. (4) Label declaration. Each of the in- (4) If canned oysters fall below the gredients used in the food shall be de- standard of fill of container prescribed clared on the label as required by the in paragraph (a) of this section, the applicable sections of parts 101 and 130 label shall bear the general statement of this chapter. of substandard fill specified in (b) [Reserved] § 130.14(b) of this chapter in the manner (c) Fill of container. (1) The standard and form therein specified, followed by of fill of container for canned oysters is the statement, ‘‘A can of this size a fill such that the drained weight of should contain lll oz. of oysters. oysters taken from each container is This can contains only lll oz.’’, the not less than 59 percent of the water blanks being filled in with the applica- capacity of the container. ble figures. (2) Water capacity of containers is determined by the general method pro- [42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982; 49 FR 10102, Mar. 19, vided in § 130.12(a) of this chapter. 1984; 54 FR 24895, June 12, 1989; 58 FR 2884, (3) Drained weight is determined by Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] the following method: Keep the unopened canned oyster container at a § 161.170 Canned Pacific salmon. ° temperature of not less than 68 or (a) Identity. (1) Canned Pacific salm- ° more than 95 Fahrenheit for at least 12 on is the food prepared from one of the hours immediately preceding the deter- species of fish enumerated in paragraph mination. After opening, tilt the con- (a)(2) of this section, prepared in one of tainer so as to distribute its contents the forms of pack specified in para- evenly over the meshes of a circular graph (a)(3) of this section, and to sieve which has been previously which may be added one or more of the weighed. The diameter of the sieve is 8 optional ingredients specified in para- inches if the quantity of the contents graph (a)(4) of this section. The food is of the container is less than 3 pounds, packed in hermetically sealed con- and 12 inches if such quantity is 3 tainers and so processed by heat as to pounds or more. The bottom of the prevent spoilage and soften bones. The sieve is woven-wire cloth that complies food is labeled in accordance with para- with the specifications for such cloth graph (a)(5) of this section. set forth under ‘‘2.38 mm (No. 8)’’ in (2)(i) The species of fish which may ‘‘Official Methods of Analysis of the be used in this food are: Association of Official Analytical Oncorhynchus Chinook, king, spring. Chemists,’’ 13th Ed. (1980), Table 1, tshawytscha. ‘‘Nominal Dimensions of Standard Test Oncorhynchus nerka ...... Blueback, red, sockeye

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Oncorhynchus kisutch ..... Coho, Cohoe, medium in letters of the same style of type and red, silver not less in height than those used for Oncorhynchus gorbuscha Pink Oncorhynchus keta ...... Chum, keta the word ‘‘salmon’’. Oncorhynchus masou ...... Masou, cherry (ii) Whenever the form of pack is that (ii) For the purpose of paragraph described in paragraph (a)(3) (ii), (iii), (a)(5)(i) of this section, the common or or (iv) of this section, the word or usual name or names of each species of words describing the form of pack shall fish enumerated in paragraph (a)(2)(i) immediately precede or follow the of this section is (are) the name(s) im- name of the food without intervening mediately following the scientific written, printed, or graphic matter in name of each species. the manner prescribed in § 101.3(c) of (3) The optional forms of canned Pa- this chapter; for example, ‘‘red salm- cific salmon are processed from fish on’’ as the name of the food followed by prepared by removing the head, gills, ‘‘skinless and backbone removed’’. and tail, and the viscera, blood, fins, (iii) Label declaration. Each of the in- and damaged or discolored flesh to the gredients used in the food shall be de- greatest extent practicable in accord- clared on the label as required by the ance with good manufacturing prac- applicable sections of parts 101 and 130 tice; and then washing. Canned Pacific of this chapter. salmon is prepared in one of the fol- (b) [Reserved] lowing forms of pack: (c) Fill of container. (1) The standard (i) ‘‘Regular’’ consists of sections or of fill of container for canned salmon is steaks which are cut transversely from a fill including all the contents of the the fish and filled vertically into the container and is not less than the min- can. In preparation, segments of skin imum net weight specified for the cor- or large backbone may be removed. responding can size in the following The sections or steaks are so packed table: that the cut surfaces approximately I. Can size II. Minimum net weight parallel the ends of the container. A small portion of salmon may be added 603 × 405 ...... 1.814 kg (64 oz). × if necessary to complete the fill of the 301 411 ...... 454 g (16 oz). 301 × 408 ...... 439 g (151⁄2 oz). container. 401 × 211 ...... 439 g (151⁄2 oz). (ii) ‘‘Skinless and backbone re- 607 × 406 × 108 ...... 439 g (151⁄2 oz). moved’’ consists of the regular form of 301 × 308 ...... 340 g (12 oz). × 3 canned salmon set forth in paragraph 307 200.25 ...... 220 g (7 ⁄4 oz). 513 × 307 × 103 ...... 220 g (73⁄4 oz). (a)(3)(i) of this section from which the 307 × 113 ...... 191 g (63⁄4 oz). × 3 skin and vertebrae have been removed 301 106 ...... 106 g (3 ⁄4 oz). × × 3 in accordance with good manufacturing 407 213 015 ...... 106 g (3 ⁄4 oz). practices. (iii) ‘‘Minced salmon’’ consists of If the can size in question is not listed, salmon which has been minced or calculate the value for Column II as ground. follows: From the list, select as the (iv) ‘‘Salmon tips or tidbits’’ consists comparable can size, that one having of small pieces of salmon. the nearest water capacity of the can (v) ‘‘No salt added’’ consists of size in question, multiply the net canned salmon to which no salt has weight listed in Column II by the water been added. capacity of the can size in question, (4) One or more of the following op- and divide by the water capacity of the tional ingredients may be added to the comparable can size. Water capacities food: are determined by the general method (i) Salt. provided in § 130.12(a) of this chapter. (ii) Edible salmon oil comparable in (2) Sampling and acceptance proce- color, viscosity, and flavor to the oil dure: The sample size of the sample which would occur naturally in the representing the lot will be selected in species of salmon canned. accordance with the sampling plan (5)(i) The name of the food is ‘‘salm- shown in paragraph (c)(2)(ii) of this sec- on’’ together with the common or tion. A lot is to be considered accept- usual name or names of the species. At able when the average net weight of all least one species name shall be printed the sample units is not less than the 677

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minimum net weight stated in para- § 161.173 Canned wet pack shrimp in graph (c)(1) of this section for the cor- transparent or nontransparent con- responding can size. tainers. (i) Definitions of terms to be used in (a) Identity. (1) Canned wet pack the sampling plans in paragraph shrimp is the food consisting of the (c)(2)(ii) of this section are as follows: processed meat of peeled shrimp, free (a) Lot. A collection of primary con- of heads and, to the extent practicable tainers or units of the same size, type, under good manufacturing practice, and style manufactured or packed free of shells, legs, and antennae; in under similar conditions and handled one or any combination of species enu- as a single unit of trade. merated in paragraph (a)(2) of this sec- (b) Lot size. The number of primary tion; prepared in one of the styles specified in paragraph (a)(3) of this section, containers or units in the lot. in sufficient water or other suitable ( ) ( ). The total number c Sample size n aqueous packing medium to fill the in- of sample units drawn for examination terstices and permit proper processing from a lot. in accordance with good manufacturing (d) Sample unit. A container, the en- practice. Canned shrimp may contain tire contents of a container, a portion one or more of the optional ingredients of the contents of a container, or a specified in paragraph (a)(4) of this sec- composite mixture of product from tion. It is packed in hermetically small containers that is sufficient for sealed transparent or nontransparent examination or testing as a single unit. containers and so processed by heat as (ii) Sampling plans: to prevent spoilage. (2) The species of shrimp that may be Size of used in the food are of the families: Lot size (primary containers) container 1 (n) Penaeidae, Pandalidae, Crangonidae, and Palaemonidae. 4,800 or less ...... 13 (3) Styles. Canned shrimp is prepared 4,801 to 24,000 ...... 21 in one of the following styles: 24,001 to 48,000 ...... 29 48,001 to 84,000 ...... 48 (i) Shrimp with readily visible dark 84,001 to 144,000 ...... 84 vein (dorsal tract, back vein, or sand 144,001 to 240,000 ...... 126 vein). Over 240,000 ...... 200 (ii) Deveined shrimp containing not 1 Net weight equal to or less than 1 kg. (2.2 lb). less than 95 percent by weight of shrimp prepared by removing the dark Size of vein from the first five segments by de- Lot size (primary containers) container 1 (n) liberate cutting action. (iii) Shrimp, other than ‘‘deveined’’ 2,400 or less ...... 13 as described in paragraph (a)(3)(ii) of 2,401 to 15,000 ...... 21 this section, containing not less than 15,001 to 24,000 ...... 29 95 percent by weight of shrimp with no 24,001 to 42,000 ...... 48 42,001 to 72,000 ...... 84 readily visible dark vein within the 72,001 to 120,000 ...... 126 first five segments. Over 120,000 ...... 200 (iv) Broken shrimp, consisting of less than four segments and otherwise con- n-number of primary containers in sample. 1 Net weight greater than 1 kg (2.2 lb) but not more than 4.5 forming to one of the styles described kgs (10 lb). in paragraph (a)(3)(i), (ii), or (iii) of (3) If canned salmon falls below the this section. standard of fill of container prescribed (4) Optional ingredients. The following in paragraph (c)(1) of this section, the safe and suitable optional ingredients label shall bear the general statement may be used: of substandard fill specified in (i) Salt. (ii) Lemon juice. § 130.14(b) of this chapter, in the man- (iii) Organic acids. ner and form therein specified. (iv) Nutritive carbohydrate sweet- [42 FR 14464, Mar. 15, 1977, as amended at 58 eners. FR 2884, Jan. 6, 1993; 80 FR 41436, July 15, (v) Spices or spice oils or spice ex- 2015] tracts.

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(vi) Flavorings. (deveined),’’ or ‘‘deveined’’ may be de- (vii) Sodium bisulfite. clared on the label. (viii) Calcium disodium EDTA (cal- (iii) When the food is of the style de- cium disodium ethylenediaminetetra- scribed in paragraph (a)(3)(iii) of this acetate), complying with the provi- section, the words ‘‘contain no dark sions of § 172.120 of this chapter. veins’’ or their equivalent may be de- (5) Labeling. (i) The name of the food clared on the label. is ‘‘shrimp’’ or ‘‘shrimps.’’ The word (iv) When the food is whole shrimp ‘‘prawns’’ may appear on the label in parentheses immediately after the within a size range designated in table word ‘‘shrimp’’ or ‘‘shrimps’’ if the I as ‘‘extra large,’’ ‘‘large,’’ ‘‘medium,’’ shrimp are of large or extra large size or ‘‘small’’ and does not contain bro- as designated in paragraph (a)(5)(iv) of ken shrimp as defined in paragraph this section. (a)(3)(iv) of this section in excess of the (ii) When the food is of the style de- amount listed in table II for the appli- scribed in paragraph (a)(3)(ii) of this cable size, the appropriate size designa- section, the words ‘‘cleaned,’’ ‘‘cleaned tion may be declared on the label.

TABLE I

Number of shrimp per 28.4 g (1 oz) of drained Number of shrimp per 100 g (3.5 oz) of drained product product Size Other than deveined Other than deveined style Deveined style style Deveined style

Extra large or jumbo Less than 3.5 ...... Less than 3.8 ...... Less than 12.3 ...... Less than 13.4. Large ...... 3.5 to 5.0 inclusive ...... 3.8 to 5.4 inclusive ...... 12.3 to 17.7 inclusive .... 13.4 to 19.1 inclusive. Medium ...... More than 5.0 but not More than 5.4 but not More than 17.7 but not More than 19.1 but not more than 9.0. more than 9.8. more than 31.8. more than 34.6. Small ...... More than 9.0 but not More than 9.8 but not More than 31.8 but not More than 34.6 but not more than 17.0. more than 18.4. more than 60.0. more than 65.3. Tiny ...... More than 17.0 ...... More than 18.4 ...... More than 60.0 ...... More than 65.3.

TABLE II accompanied by the word ‘‘broken’’ or ‘‘pieces’’ rather than the word ‘‘tiny,’’ Maximum percent by in type size equal to that used in the Size weight of name of the food. broken shrimp a (vii) When the food consists wholly or in part of sizes other than tiny, as des- Extra large or jumbo ...... 5 ignated in table I in paragraph Large ...... 5 Medium ...... 5 (a)(5)(iv) of this section and contains Small ...... 10 more than 10 percent by weight of bro- Tiny ...... 15 ken shrimp as defined in paragraph a Grams of broken shrimp per 100 g of cut-out weight as (a)(3)(iv) of this section, the name of determined in § 161.173(c) of this section. the food on the label shall be accom- (v) When the food consists of tiny panied by the word ‘‘broken’’ or shrimp, as designated in table I in ‘‘pieces’’ in type size equal to that used paragraph (a)(5)(iv) of this section and in the name of the food. does not contain broken shrimp as de- (viii) The name of the food shall in- fined in paragraph (a)(3)(iv) of this sec- clude a declaration of any flavoring tion in excess of 15 percent by weight, that characterizes the food, as specified the name of the food on the label shall in § 101.22 of this chapter, and the term be accompanied by the word ‘‘tiny’’ in ‘‘spiced’’ if spice characterizes the type size equal to that used in the food. name of the food. (ix) Label declaration. Each of the in- (vi) When the food consists of tiny gredients used in the food shall be de- shrimp, as designated in table I in clared on the label as required by the paragraph (a)(5)(iv) of this section and applicable sections of parts 101 and 130 contains more than 15 percent by of this chapter. weight of broken shrimp as defined in (6) Sampling and acceptance procedure. paragraph (a)(3)(iv) of this section, the A lot is to be considered acceptable name of the food on the label shall be when the number of defectives does not

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exceed the acceptance number in the ACCEPTABLE QUALITY LEVEL 6.5—Continued sampling plans given in paragraph Size of container (a)(6)(ii) of this section. Lot size (primary containers) (i) Definitions of terms to be used in n 1 c 2 the sampling plans in paragraph NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN (a)(6)(ii) of this section are as follows: 4.5 KG (10 LB) (a) Lot. A collection of primary con- 2,400 or less ...... 13 2 tainers or units of the same size, type, 2,401 to 15,000 ...... 21 3 and style manufactured or packed 15,001 to 24,000 ...... 29 4 under similar conditions and handled 24,001 to 42,000 ...... 48 6 42,001 to 72,000 ...... 84 9 as a single unit of trade. 72,001 to 120,000 ...... 126 13 (b) Lot size. The number of primary Over 120,000 ...... 200 19 containers or units in the lot. 1 n = Number of primary containers in sample. (c) Sample size (n). The total number 2 c = Acceptance number. of sample units drawn for examination (b) [Reserved] from a lot. (c) Fill of container. (1) The standard (d) Sample unit. A container, the en- of fill of transparent or nontransparent tire contents of a container, a portion containers for canned wet pack shrimp of the contents of a container, or a is a fill such that the cut-out weight of composite mixture of product from shrimp taken from each container is small containers that is sufficient for not less than 60 percent of the weight the examination or testing as a single of the water required to fill the con- unit. tainer. The weight of the water re- (e) Defective. Any sample unit shall be quired to fill the container is deter- regarded as defective when it fails to mined by the general method provided meet the minimum requirements in in § 130.12(a) of this chapter. Cut-out paragraph (a)(3) (ii) or (iii) of this sec- weight is determined by the following tion for the applicable style, when it method: Keep the unopened canned exceeds the tolerances in paragraph shrimp container at a temperature of (a)(5)(iv) of this section for the applica- not less than 68° nor more than 75 ble size, or when the labeling fails to °Fahrenheit for at least 12 hours imme- meet the requirements of paragraph diately preceding the determination. (a)(5) (v), (vi), or (vii) of this section of After opening, distribute the shrimp the applicable size. evenly over the meshes of a circular (f) Acceptance number (c). The max- sieve that has been previously weighed. imum number of defective sample units The diameter of the sieve is 20.3 centi- permitted in the sample in order to meters (8 inches) if the quantity of the consider the lot as meeting the speci- contents of the container is less than fied requirements. 1.36 kilograms (3 pounds), and 30.5 cen- (g) Acceptable quality level (AQL). The timeters (12 inches), if such quantity is maximum percent of defective sample 1.36 kilograms (3 pounds) or more. The units permitted in a lot that will be ac- bottom of the sieve is woven-wire cloth cepted approximately 95 percent of the that complies with the specifications time. for such cloth set forth as a 2.38 mm (ii) Sampling plans: (No. 8) sieve in the ‘‘Definitions of Terms and Explanatory Notes’’ of the ACCEPTABLE QUALITY LEVEL 6.5 ‘‘Official Methods of Analysis of the Association of Official Analytical Size of container Chemists,’’ 13th Ed. (1980), which is in- Lot size (primary containers) n 1 c 2 corporated by reference. Copies may be obtained from the AOAC INTER- NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) NATIONAL, 481 North Frederick Ave., 4,800 or less ...... 13 2 suite 500, Gaithersburg, MD 20877, or 4,801 to 24,000 ...... 21 3 may be examined at the National Ar- 24,001 to 48,000 ...... 29 4 chives and Records Administration 48,001 to 84,000 ...... 48 6 (NARA). For information on the avail- 84,001 to 144,000 ...... 84 9 ability of this material at NARA, call 144,001 to 240,000 ...... 126 13 Over 240,000 ...... 200 19 202–741–6030, or go to: http:// www.archives.gov/federallregister/

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codeloflfederallregulations/ posite units, each shrimp unit is indi- ibrllocations.html. Without shifting the vidually coated. The optional forms of material on the sieve, incline the sieve shrimp are: at an angle of approximately 17° to 20° (1) Fantail or butterfly: Prepared by to facilitate drainage. Allow the splitting the shrimp; the shrimp are shrimp to drain for 2 minutes, meas- peeled, except that tail fins remain at- ured from the moment the product is tached and the shell segment imme- poured onto the sieve. Weigh the sieve diately adjacent to the tail fins may be and the drained shrimp. The weight so left attached. found, less the weight of the sieve, (2) Butterfly, tail off: Prepared by shall be considered to be the cut-out splitting the shrimp; tail fins and all weight of the shrimp. shell segments are removed. (2) Sampling and acceptance proce- (3) Round: Round shrimp, not split; dure: A container that falls below the the shrimp are peeled, except that tail requirement for minimum fill pre- fins remain attached and the shell seg- scribed in paragraph (c)(1) of this sec- ment immediately adjacent to the tail tion is considered a ‘‘defective.’’ Deter- fins may be left attached. mine compliance with paragraph (c)(1) (4) Round, tail off: Round shrimp, not of this section as specified in paragraph split; tail fins and all shell segments (a)(6) of this section except that the are removed. sample unit shall be the entire con- (5) Pieces: Each unit consists of a tents of the container. piece or a part of a shrimp; tail fins (3) If canned wet pack shrimp in and all shell segments are removed. transparent or nontransparent con- (6) Composite units: Each unit containers falls below the applicable sists of two or more whole shrimp or standard of fill of container prescribed pieces of shrimp, or both, formed and in paragraph (c)(1) of this section, the pressed into composite units prior to label shall bear the general statement coating; tail fins and all shell segments of substandard fill provided in are removed; large composite units, § 130.14(b) of this chapter, in the man- prior to coating, may be cut into ner and form therein specified. smaller units. [43 FR 19840, May 9, 1978; 43 FR 25423, June 13, (d) The batter and breading ingredi- 1978, as amended at 47 FR 11833, Mar. 19, 1982; ents referred to in paragraph (a) of this 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June section are the fluid constituents and 12, 1989; 58 FR 2884, Jan. 6, 1994; 63 FR 14035, the solid constituents of the coating Mar. 24, 1998] around the shrimp. These ingredients EFFECTIVE DATE NOTE: Paragraphs (a) and consist of suitable substances which (c) of § 161.173 were stayed until further no- are not food additives as defined in sec- tice by a document published at 44 FR 50328, tion 201(s) of the Federal Food, Drug, Aug. 28, 1979. and Cosmetic Act; or if they are food additives as so defined, they are used in § 161.175 Frozen raw breaded shrimp. conformity with regulations estab- (a) Frozen raw breaded shrimp is the lished pursuant to section 409 of the food prepared by coating one of the op- act. Batter and breading ingredients tional forms of shrimp specified in that perform a useful function are re- paragraph (c) of this section with safe garded as suitable, except that artifi- and suitable batter and breading ingre- cial flavorings, artificial sweeteners, dients as provided in paragraph (d) of artificial colors, and chemical preserv- this section. The food is frozen. atives, other than those provided for in (b) The food tests not less than 50 this paragraph, are not suitable ingre- percent of shrimp material as deter- dients of frozen raw breaded shrimp. mined by the method prescribed in Chemical preservatives that are suit- paragraph (g) of this section, except able are: that if the shrimp are composite units (1) Ascorbic acid, which may be used the method prescribed in paragraph (h) in a quantity sufficient to retard devel- of this section is used. opment of dark spots on the shrimp; (c) The term shrimp means the tail and portion of properly prepared shrimp of (2) The antioxidant preservatives commercial species. Except for com- listed in subpart D of part 182 of this

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chapter that may be used to retard de- name. If ascorbic acid is used to retard velopment of rancidity of the fat con- development of dark spots on the tent of the food, in amounts within the shrimp, it shall be designated as limits prescribed by that section. ‘‘Ascorbic acid added as a preserva- (e) The label shall name the food, as tive’’ or ‘‘Ascorbic acid added to retard prepared from each of the optional discoloration of shrimp’’. If any other forms of shrimp specified in paragraph antioxidant preservative, as provided (c) (1) to (6), inclusive, of this section, in paragraph (d) of this section, is used, and following the numbered sequence such preservative shall be designated of such subparagraph, as follows: by its common name followed by the (1) ‘‘Breaded fantail shrimp.’’ The statement ‘‘Added as a preservative’’. word ‘‘butterfly’’ may be used in lieu of (g) The method for determining per- ‘‘fantail’’ in the name. centage of shrimp material for those (2) ‘‘Breaded butterfly shrimp, tail forms specified in paragraphs (c) (1) off.’’ through (5) of this section is as follows: (3) ‘‘Breaded round shrimp.’’ (1) Equipment needed. (i) Two-gallon (4) ‘‘Breaded round shrimp, tail off.’’ container, approximately 9 inches in (5) ‘‘Breaded shrimp pieces.’’ diameter. (6) Composite units: (ii) Two-vaned wooden paddle, each (i) If the composite units are in a 3 vane measuring approximately 1 ⁄4 shape similar to that of breaded fish inches by 33⁄4 inches. sticks the name is ‘‘Breaded shrimp (iii) Stirring device capable of rotat- sticks’’; if they are in the shape of ing the wooden paddle at 120 r.p.m. meat cutlets, the name is ‘‘Breaded (iv) Balance accurate to 0.01 ounce shrimp cutlets’’. (or 0.1 gram). (ii) If prepared in a shape other than (v) U.S. Standard Sieve No. 20, 30.5 that of sticks or cutlets, the name is centimeter (12 inch) diameter. The ‘‘Breaded shrimp lll’’, the blank to sieves shall comply with the specifica- be filled in with the word or phrase tions for such cloth set forth in ‘‘Offi- that accurately describes the shape, cial Methods of Analysis of the Asso- but which is not misleading. ciation of Official Analytical Chem- In the case of the names specified in ists’’ (AOAC), 13th Ed. (1980), Table 1, paragraphs (e) (1) through (5) of this ‘‘Nominal Dimensions of Standard Test section, the words in each name may Sieves (U.S.A. Standard Series),’’ under be arranged in any order, provided they the heading ‘‘Definitions of Terms and are so arranged as to be accurately de- Explanatory Notes,’’ which is incor- scriptive of the food. The word porated by reference. Copies may be ‘‘prawns’’ may be added in parentheses obtained from the AOAC INTER- immediately after the word ‘‘shrimp’’ NATIONAL, 481 North Frederick Ave., in the name of the food if the shrimp suite 500, Gaithersburg, MD 20877, or are of large size; for example, ‘‘Fantail may be examined at the National Ar- breaded shrimp (prawns)’’. If the chives and Records Administration shrimp are from a single geographical (NARA). For information on the avail- area, the adjectival designation of that ability of this material at NARA, call area may appear as part of the name; 202–741–6030, or go to: http:// for example, ‘‘Breaded Alaskan shrimp www.archives.gov/federallregister/ sticks’’. codeloflfederallregulations/ (f) The names of the optional ingredi- ibrllocations.html. ents used, as provided for in paragraph (vi) U.S. Standard sieve, 1⁄2-inch sieve (d) of this section, shall be listed on the opening, 12-inch diameter. principal display panel or panels of the (vii) Forceps, blunt points. label with such prominence and con- (viii) Shallow baking pans. spicuousness as to render them likely (ix) Rubber-tipped glass stirring rod. to be read and understood by the ordi- (2) Procedure. (i) Weigh the sample to nary individual under customary con- be debreaded. Fill the container three- ditions of purchase. If a spice that also fourths full of water at 70°–80 °F. Sus- imparts color is used, it shall be des- pend the paddle in the container, leav- ignated as ‘‘spice and coloring’’, unless ing a clearance of at least 5 inches the spice is designated by its specific below the paddle vanes, and adjust

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speed to 120 r.p.m. Add shrimp and stir still frozen shrimp material (between for 10 minutes. Stack the sieves, the 1⁄2- 10 seconds to 80 seconds for composite inch mesh over the No. 20, and pour the units held in storage at 0 °F). If the contents of the container onto them. composite units were prepared using Set the sieves under a faucet, pref- batters that are difficult to remove erably with spray attached, and rinse after one dipping, redip them for up to shrimp with no rubbing of flesh, being 5 seconds after the initial debreading careful to keep all rinsings over the and remove residual batter materials. sieves and not having the stream of NOTE: Several preliminary trials may be water hit the shrimp on the sieve di- necessary to determine the exact dip time rectly. Lay the shrimp out singly on required for ‘‘debreading’’ the composite the sieve as rinsed. Inspect each shrimp units in a sample. For these trials only, a saturated solution of copper sulfate (1 pound and use the rubber-tipped rod and the of copper sulfate in 2 liters of tap water) is spray to remove the breading material necessary. The correct dip time is the min- that may remain on any of them, being imum time of immersion in the copper sul- careful to avoid undue pressure or rub- fate solution required before the breading bing, and return each shrimp to the can easily be scraped off: Provided, That the sieve. Remove the top sieve and drain ‘‘debreaded’’ units are still solidly frozen and on a slope for 2 minutes, then remove only a slight trace of blue color is visible on the surface of the ‘‘debreaded’’ shrimp mate- the shrimp to weighing pan. Rinse con- rial. tents of the No. 20 sieve onto a flat pan (iii) Remove the unit from the bath; and collect any particles other than blot lightly with double thickness of breading (i.e., flesh and tail fins) and paper toweling; and scrape off or pick add to shrimp on balance pan and out coating from the shrimp material weigh. with the spatula or nut picker. (ii) Calculate percent shrimp mate- (iv) Weigh all the ‘‘debreaded’’ rial: shrimp material. Percent shrimp material = (Weight of (v) Calculate the percentage of debreaded sample) / (Weight of sam- shrimp material in the sample, using ple) × 100 + 2 the following formula: (h) The method for determining per- Percent shrimp material = (Weight of de- centage of shrimp material for com- breaded shrimp sample) / Weight of sam- × posite units, specified in paragraph ple 100 (c)(6) of this section, is as follows: (i) Label declaration. Each of the in- (1) Equipment needed. (i) Water bath gredients used in the food shall be de- (for example a 3–liter to 4–liter beak- clared on the label as required by the er). applicable sections of parts 101 and 130 (ii) Balance accurate to 0.1 gram. of this chapter. (iii) Clip tongs of wire, plastic, or [42 FR 14464, Mar. 15, 1977, as amended at 47 glass. FR 11833, Mar. 19, 1982; 49 FR 10102, Mar. 19, (iv) Stop-watch or regular watch 1984; 54 FR 24896, June 12, 1989; 58 FR 2884, readable to a second. Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] (v) Paper towels. (vi) Spatula, 4–inch blade with round- § 161.176 Frozen raw lightly breaded ed tip. shrimp. (vii) Nut picker. Frozen raw lightly breaded shrimp (viii) Thermometer (immersion type) complies with the provisions of accurate to ±2 °F. § 161.175, except that it contains not (ix) Copper sulfate crystals less than 65 percent of shrimp material, (CuSo4·5H2O). as determined by the method pre- (2) Procedure. (i) Weigh all composite scribed in § 161.175 (g) or (h), as appro- units in the sample while they are still priate, and that in the name prescribed hard frozen. the word ‘‘lightly’’ immediately pre- (ii) Place each composite unit indi- cedes the words ‘‘breaded shrimp’’. vidually in a water bath that is maintained at 63 °F–86 °F, and allow to re- § 161.190 Canned tuna. main until the breading becomes soft (a) Identity. (1) Canned tuna is the and can easily be removed from the food consisting of processed flesh of

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fish of the species enumerated in para- mined in accordance with the methods graph (a)(2) of this section, prepared in prescribed in paragraph (c)(2) of this one of the optional forms of pack speci- section. fied in paragraph (a)(3) of this section, (i) Solid or solid pack consists of conforming to one of the color designa- loins freed from any surface tissue dis- tions specified in paragraph (a)(4) of colored by diffused hemolyzed blood, this section, in one of the optional cut in transverse segments to which no packing media specified in paragraph free fragments are added. In containers (a)(5) of this section, and may contain of 1 pound or less of net contents, such one or more of the seasonings and segments are cut in lengths suitable flavorings specified in paragraph (a)(6) for packing in one layer. In containers of this section. For the purpose of in- of more than 1 pound net contents, hibiting the development of struvite such segments may be cut in lengths crystals, sodium acid pyrophosphate suitable for packing in one or more may be added in a quantity not in ex- layers of equal thickness. Segments are cess of 0.5 percent by weight of the fin- placed in the can with the planes of ished food. It is packed in hermetically their transverse cut ends parallel to sealed containers and so processed by the ends of the can. A piece of a seg- heat as to prevent spoilage. It is la- ment may be added if necessary to fill beled in accordance with the provisions a container. The proportion of free of paragraph (a)(8) of this section. flakes broken from loins in the canning (2) The fish included in the class operation shall not exceed 18 percent. known as tuna fish are: (ii) Chunk, chunks, chunk style con- Thunnus thynnus (Linnaeus, 1758)—Northern sists of a mixture of pieces of tuna in bluefin tuna which the original muscle structure is Thunnus maccoyii (Castelnau, 1872)—South- retained. The pieces may vary in size, ern bluefin tuna but not less than 50 percent of the Thunnus alalunga (Bonnaterre, 1788)—Alba- core weight of the pressed contents of a con- Thunnus atlanticus (Lesson, 1830)—Blackfin tainer is retained on a 1⁄2-inch-mesh tuna screen. Thunnus obesus (Lowe, 1839)—Bigeye tuna (iii) Flake or flakes consist of a mix- Thunnus albacares (Bonnaterre, 1788)—Yel- ture of pieces of tuna in which more lowfin tuna than 50 percent of the weight of the Thunnus tonggol (Bleeker, 1851)—Longtail tuna pressed contents of the container will Katsuwonus pelamis (Linnaeus, 1758)—Skip- pass through a 1⁄2-inch-mesh screen, but jack tuna in which the muscular structure of the Euthynnus alletteratus (Rafinesque, 1810)— flesh is retained. Spotted tunny (iv) Grated consists of a mixture of Euthynnus lineatus Kishinouye, 1920—Black particles of tuna that have been re- skipjack tuna Euthynnus affinis (Cantor, 1849)—Kawakawa duced to uniform size, that will pass Allothunnus fallai Serventy, 1948—Slender through a 1⁄2-inch-mesh screen, and in tuna which the particles are discrete and do Auxis rochei (Risso, 1810)—Bullet tuna not comprise a paste. Auxis thazard (Lacepede, 1800)—Frigate tuna (v) Any of the specified forms of pack (3) The optional forms of processed of canned tuna may be smoked. Canned tuna consist of loins and other striated smoked tuna shall be labeled in accord- muscular tissue of the fish. The loin is ance with the provisions of paragraph the longitudinal quarter of the great (a)(8)(v) of this section. lateral muscle freed from skin, scales, (4) Canned tuna, in any of the forms visible blood clots, bones, gills, viscera of pack specified in paragraph (a)(3) of and from the nonstriated part of such this section, falls within one of the fol- muscle, which part (known anatomi- lowing color designations, measured by cally as the median superficial muscle) visual comparison with matte surface is highly vascular in structure, dark in neutral reflectance standards cor- color because of retained blood, and responding to the specified Munsell granular in form. Canned tuna is pre- units of value, determined in accord- pared in one of the following forms of ance with paragraph (a)(7) of this sec- pack, the identity of which is deter- tion.

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(i) White. This color designation is ing 0.005 percent by weight of the fin- limited to the species Thunnus alalunga ished food. A substance used in accord- (albacore), and is not darker than ance with this paragraph is deemed to Munsell value 6.3. be suitable if it is used in an amount (ii) Light. This color designation in- no greater than necessary to achieve cludes any tuna not darker than the intended flavor effect, and is Munsell value 5.3. deemed to be safe if it is not a food ad- (iii) Dark. This color designation in- ditive as defined in section 201(s) of the cludes all tuna darker than Munsell Federal Food, Drug, and Cosmetic Act value 5.3. (the act), or if it is a food additive as so (iv) Blended. This color designation defined, it is used in conformity with may be applied only to tuna flakes regulations established pursuant to specified in paragraph (a)(3)(iii) of this section 409 of the act. section, consisting of a mixture of tuna (viii) Edible vegetable oil or partially flakes of which not less than 20 percent hydrogenated vegetable oil, excluding by weight meet the color standard for olive oil, used alone or in combination either white tuna or light tuna, and the in an amount not to exceed 5 percent of remainder of which fall within the the volume capacity of the container, color standard for dark tuna. The color with or without any suitable form of designation for blended tuna is deter- emulsifying and suspending ingredients mined in accordance with paragraph that has been affirmed as GRAS or ap- (a)(7) of this section. proved as a food additive to aid in dis- (5) Canned tuna is packed in one of persion of the oil, as seasoning in the following optional packing media: canned tuna packed in water. (i) Any edible vegetable oil other (7) For determination of the color than olive oil, or any mixture of such designations specified in paragraph oils not containing olive oil. (a)(4) of this section, the following (ii) Olive oil. method shall be used: Recombine the (iii) Water. separations of pressed cake resulting (6) Canned tuna may be seasoned or from the method prescribed in para- flavored with one or more of the fol- graph (c)(2) of this section. Pass the lowing: combined portions through a sieve (i) Salt. fitted with woven-wire cloth of 1⁄4-inch (ii) Monosodium glutamate. mesh complying with the specifica- (iii) Hydrolyzed protein declared in tions for such cloth set forth in ‘‘Offi- accordance with the applicable provi- cial Methods of Analysis of the Asso- sions of § 101.22. ciation of Official Analytical Chem- (iv) Spices or spice oils or spice exists,’’ 13th Ed. (1980), Table 1, ‘‘Nominal tracts. Dimensions of Standard Test Sieves (v) Vegetable broth in an amount not (U.S.A. Standard Series),’’ under the in excess of 5 percent of the volume ca- heading ‘‘Definitions of Terms and Ex- pacity of the container, such broth to planatory Notes,’’ which is incor- consist of a minimum of 0.5 percent by porated by reference. Copies may be weight of vegetable extractives and to obtained from the AOAC INTER- be prepared from two or more of the NATIONAL, 481 North Frederick Ave., following vegetables: Beans, cabbage, suite 500, Gaithersburg, MD 20877, or carrots, celery, garlic, onions, parsley, may be examined at the National Ar- peas, potatoes, green bell peppers, red chives and Records Administration bell peppers, spinach, and tomatoes. (NARA). For information on the avail- (vi) Garlic. ability of this material at NARA, call (vii) Lemon flavoring to be prepared 202–741–6030, or go to: http:// from lemon oil and citric acid together www.archives.gov/federallregister/ with safe and suitable carriers for the codeloflfederallregulations/ lemon oil which are present at non- ibrllocations.html. Mix the sieved ma- functional and insignificant levels in terial and place a sufficient quantity the finished canned food. When lemon into a 307 × 113 size container (bearing flavoring is added, a safe and suitable a top seam and having a false bottom solubilizing and dispersing ingredient approximately 1⁄2-inch deep and painted may be added in a quantity not exceed- flat black inside and outside) so that

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after tamping and smoothing the sur- one lamp and using, in the other, a face of the sample the material will be similar 150-watt bulb connected with 1⁄8-inch to 1⁄4-inch below the top of the the power source through a suitable container. Within 10 minutes after rheostat. The stand is equipped with sieving through the 1⁄4-inch mesh non-glossy black curtains on the side woven-wire cloth, determine the of the observer, to exclude variation in Munsell value of sample surface. extraneous light reflected from the (i) Determine the Munsell value of person of the observer. the sample surface so prepared. The (ii) To adjust the comparator, place a following method may be used, employ- pair of matte surface standards of ing an optical comparator, consisting Munsell value 5.3, mounted as de- of a lens and prism system which scribed in paragraph (a)(7)(iv) of this brings two beams of light, reflected section, in position in the comparator from equal areas of sample surface and base, and adjust the intensity of the standard surface, respectively, to- variable lamp until the two halves of gether, within an eyepiece, so as to the optical field, viewed through the show an equally divided optical field. eyepiece, are of equal brightness. Then The scanned areas of sample and stand- remove one of the standards and re- ard surface are not smaller than 2 place it with the prepared sample. square inches. Light reaching the eye Without altering any other adjust- is rendered sufficiently diffuse, by de- ments, observe through the eyepiece sign of eyepiece and comparator, so whether the sample appears lighter or that detail of the sample surface will darker than the standard. In case of ex- remain undefined, to a degree such as amination of albacore designated to avoid visual confusion in observa- ‘‘white’’, conduct the procedure using tion of a match of over-all intensity of standards of Munsell value 6.3. reflected light. The eyepiece contains a (iii) The standards with which com- color filter centering at a wavelength parisons are made are essentially neu- between 550 mμ and 560 mμ. The filter tral matte-finish standards, equivalent does not pass appreciable visible radi- in luminous reflectance of light of 555μ ation of wavelengths below 540 mμ or wavelength to 33.7 percent of the lumi- above 570 mμ. The passed wavelength nous reflectance of magnesium oxide band is of a monochromaticity suffi- (for Munsell value 6.3) and 22.6 percent cient to cause a sample and a neutral of the luminous reflectance of magne- standard of equal reflectance to appear sium oxide (for Munsell value 5.3), as of the same hue. The comparator is rig- given by the relationship between idly mounted on a vertical stand at- Munsell value and luminous reflec- tached to a base in which arrangement tance derived by a subcommittee of the is provided for securely and accurately Optical Society of America and pub- positioning two cans of size 307 × 113 in lished in the ‘‘Journal of the Optical the two fields of view. Mounted on the Society of America,’’ Vol. 33, page 406 base are two shaded lamps, which di- (1943), which is incorporated by ref- rect the center of their beams of light erence. Copies are available from the at about a 45° angle to the plane of the Center for Food Safety and Applied Nu- sample and standard surfaces. The trition (HFS–150), Food and Drug Ad- lamps are so positioned that light from ministration, 5001 Campus Dr., College one bears mainly upon the sample sur- Park, MD 20740, or available for inspec- face and light from the other mainly tion at the National Archives and on the standard surface, and are so Records Administration (NARA). For placed in relation to sample and stand- information on the availability of this ard that no shadows, as from the can material at NARA, call 202–741–6030, or rims, appear in the fields of view. The go to: http://www.archives.gov/ lamps are strong enough to furnish federallregister/ adequate and convenient illumination codeloflfederallregulations/ through eyepiece and filter. Means are ibrllocations.html. provided to alter the light intensity of (iv) These standards shall be cut in one lamp in relation to the other, as circles 31⁄4 inches in diameter and shall may conveniently be achieved by using be mounted in 307 × 113 size containers, a 100-watt tungsten filament bulb in bearing a top seam and painted flat

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black inside and outside, so that the for in paragraph (a)(6) of this section, surfaces of the standards are 3⁄16 inch the label shall bear the statement below the top of the containers in ‘‘Seasoned with lll’’, the blank which they are mounted. being filled in with the name or names (v) In the case of blended tuna, the of the ingredient or ingredients used, foregoing method shall be varied by except that if the ingredient designated first separating the tuna flakes of the in paragraph (a)(6)(v) of this section is two different colors before passing used, the blank shall be filled in with them through the 1⁄4-inch mesh sieve, the term ‘‘vegetable broth’’, and if the then proceeding with each portion sep- ingredients designated in paragraph arately for the determination of its (a)(6)(viii) of this section are used, the color value, employing, if necessary, a blank may be filled in with the term sample container with false bottom ‘‘oil’’, and if the ingredient designated greater than 1⁄2 inch deep. in paragraph (a)(6)(iv) of this section is (8)(i) The specified names of the used alone, the label may alternatively canned tuna for which definitions and bear either the statement ‘‘spiced’’ or standards of identity are prescribed by the statement ‘‘with added spice’’; and this section, except where water is the if salt is the only seasoning ingredient packing medium or where the tuna is used, the label may alternatively bear smoked, are formed by combining the any of the statements ‘‘salted’’, ‘‘with designation of form of pack with the added salt’’, or ‘‘salt added’’. If the fla- color designation of the tuna; for ex- voring ingredients designated in para- ample, ‘‘Solid pack white tuna’’, graph (a)(6)(vii) of this section are ‘‘Grated dark tuna’’, etc. In the case of used, the words ‘‘lemon flavored’’ or blended tuna, there shall be used both ‘‘with lemon flavoring’’ shall appear as applicable color designations of the part of the name on the label; for ex- blended flakes, in precedence deter- ample, ‘‘lemon flavored chunk light mined in accordance with the predomi- tuna’’. Citric acid and any optional nating portion found in the container; solubilizing and dispersing agent used for example, ‘‘Blended white and dark as specified in paragraph (a)(6)(vii) of tuna flakes’’, ‘‘Blended dark and light this section in connection with lemon tuna flakes’’. flavoring ingredients or emulsifying (ii) The specified name of canned and suspending ingredients used as tuna when water is used as the packing specified in paragraph (a)(6)(viii) of medium is formed as described in para- this section shall be designated on the graph (a)(8)(i) of this section, followed label by their common or usual name. by the words ‘‘in water’’; for example, (vii) Where the canned tuna contains ‘‘Grated light tuna in water’’. the optional ingredient sodium acid (iii) When the packing medium is pyrophosphate as provided in para- vegetable oil or olive oil, the label graph (a)(1) of this section, the label shall bear the name of the optional shall bear the statement packing medium used, as specified in ‘‘pyrophosphate added’’ or ‘‘with added paragraph (a)(5) of this section, pre- pyrophosphate’’. ceded by the word ‘‘in’’ or the words (viii) Wherever the name of the food ‘‘packed in’’. In case of the optional in- appears on the label so conspicuously gredient specified in paragraph (a)(5)(i) as to be easily seen under customary of this section, the name or names of conditions of purchase, the names of the oil used may be stated, or the gen- the optional ingredients used, as speci- eral term ‘‘vegetable oil’’ may be used. fied in paragraphs (a)(8)(iii), (vi), and (iv) In case solid pack tuna is packed (vii) of this section (except if lemon in olive oil, the designation ‘‘Tonno’’ flavoring is added, this subparagraph may also appear. applies only to the terms ‘‘lemon fla- (v) In case any of the specified forms vored’’ or ‘‘with lemon flavoring’’, not of canned tuna are smoked, the word to the constituent ingredients of that ‘‘smoked’’ shall appear as a part of the flavoring or to any optional solubi- name on the label; for example, lizing or dispersing ingredient used in ‘‘Smoked light tuna flakes’’. connection with lemon flavoring ingre- (vi) Where the canned tuna contains dients), shall immediately and con- one or more of the ingredients provided spicuously precede or follow such name

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without intervening, written, printed, listed in column II for the same form of or graphic matter except that the com- tuna ingredient by the water capacity mon name of the species of tuna fish of the can size in question, and divided may so intervene; but the species name by the water capacity of the com- ‘‘albacore’’ may be employed only for parable can size. Water capacities are canned tuna of that species which determined by the general method pro- meets the color designation ‘‘white’’ as vided in § 130.12(a) of this chapter. For prescribed by paragraph (a)(4)(i) of this the purposes of this section, cans of di- section. mensions 211 × 109 shall be deemed to (ix) Statements of optional ingredi- have a water capacity at 68 °F of 3.55 ents present required by paragraph avoirdupois ounces of water; cans of di- (a)(8)(vi) of this section, but not sub- mensions 307 × 113, a water capacity of ject to the provisions of paragraph 7.05 avoirdupois ounces of water; cans (a)(8)(viii) of this section shall be set of dimensions 401 × 206, a water capac- forth on the label with such promi- ity of 13.80 avoirdupois ounces of water; nence and conspicuousness as to render and cans of dimensions 603 × 408, a them likely to be read and understood water capacity of 68.15 avoirdupois by the ordinary individual under cus- ounces of water. tomary conditions of purchase. (2) The methods referred to in para- (b) [Reserved] graph (c)(1) of this section for deter- (c) Fill of container. (1) The standard mining the weight of the pressed cake of fill of container for canned tuna is a and referred to in paragraph (a)(3)(i) of fill such that the average weight of the this section for determining the per- pressed cake from 24 cans, as deter- cent of free flakes and the percent of mined by the method prescribed by pieces that pass through a 1⁄2-inch-mesh paragraph (c)(2) of this section, is not sieve are as follows: less than the minimum value specified (i) Have each of the 24 cans and con- for the corresponding can size and form tents at a temperature of 75 °F within of tuna ingredient in the following ±5 °F. Test each can in turn as follows: table: (ii) Cut out the top of the can (code end), using a can opener that does not II. Minimum value for remove nor distort the double seam. weights of (iii) With the cut top held on the can pressed I. Can size and form of tuna ingredient cake (aver- contents, invert the can, and drain the age of 24 free liquid by gentle finger pressure on cans) (in ounces) the cut lid so that most of the free liquid drains from the can. 211 × 109: Solid ...... 2.25 (iv) With the cut lid still in place, cut Chunks ...... 1.98 out the bottom of the can with the can Flakes ...... 1.98 opener, then turn the can upright and Grated ...... 2.00 307 × 113: remove the cut can top (code end). Solid ...... 4.47 Scrape off any adhering tuna particles Chunks ...... 3.92 into the tuna mass in the can. Flakes ...... 3.92 Grated ...... 3.96 (v) Place the proper size of press cyl- 401 × 206: inder as provided in paragraph (c)(3)(i) Solid ...... 8.76 of this section in a horizontal position Chunks ...... 7.68 Flakes ...... 7.68 on a table; then, using the cut bottom Grated ...... 7.76 of the can as a pusher, gently force the 603 × 408: can contents from the can into the cyl- Solid ...... 43.2 inder so that the flat side of the can Chunks ...... 37.9 Flakes ...... 37.9 contents lies in contact with the bot- Grated ...... 38.3 tom of the cylinder. Remove the bottom of the can that was used as the If the can size in question is not listed, pusher and scrape any adhering par- calculate the value for column II as ticles from the can body and bottom of follows: From the list select as the the can, and put them in the cylinder. comparable can size that one having (vi) Place the cylinder plunger on top nearest the water capacity of the can of the can contents in the cylinder. Re- size in question, multiply the value move the eyebolt and put the cylinder

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and plunger in position on the press der of the 24 cans and determine the (paragraph (c)(3)(iii) of this section). average weight of pressed cake for the (vii) Begin the operation of the press purpose of paragraph (c)(1) of this sec- and as soon as liquid is observed com- tion. ing from the cylinder start timing the (xi) Determination of free flakes: If operation. Apply pressure to the plung- the optional form of tuna ingredient is er slowly and at a uniform rate, so that solid pack, determine the percent of a full minute is used to reach a pres- free flakes. Any flakes resulting from sure of 384 pounds per square inch of the operations described in this para- plunger face in contact with the can graph (c)(2)(xi) or in other parts of this contents. Hold this pressure for 1 addi- paragraph are to be weighed as free tional minute and then release the flakes. Only fragments that were bro- pressure and disengage the plunger ken in the canning procedure are con- from the press shaft. Tip the press cyl- sidered to be free flakes. If the can is of inder so that any free liquid is drained such size that its entire drained con- out. tents were pressed as described in para- (viii) Remove press cylinder with graphs (c)(2)(i) to (viii) of this section, plunger from the press, insert eyebolt inclusive, examine the pressed cake in plunger and withdraw it from the carefully for free flakes. Using a spat- cylinder. Loosen the pressed cake from ula, scrape free flakes gently from the the cylinder with a thin blade and re- outside of the cake. Weigh the aggre- move the entire pressed cake as gently gate free flakes that were broken from as possible, to keep the mass in a sin- the loin segments in the canning proce- gle cake during this operation. Place dure and calculate their percentage of the pressed cake and any pieces that the total weight of pressed cake. If the adhered to the plunger and cylinder in a tared receiving pan and determine can is of such size that a core was cut the weight of the pressed material. for pressing as described in paragraph (ix) For cans larger than 401 × 206, cut (c)(2)(ix) of this section, make the ex- out the top of the can and drain off free amination for free flakes on a weighed liquid from the can contents as in oper- portion of the drained material re- ations described in paragraphs (c)(2)(ii) maining after the core was removed. and (iii) of this section. Determine the The weight of the portion examined gross weight of the can and remaining should approximately equal the weight contents. Using a tared core cutter as of the core before pressing. Calculate provided for in paragraph (c)(3)(ii) of the weight of the free flakes that were this section, cut vertically a core of broken from the loins in the canning the drained material in the can. Deter- procedure as a percentage of the weight mine the weight of the core. With a of the portion examined. thin spatula transfer the core to the (xii) Determination of particle size: If pressing cylinder for 401 × 206 cans. De- the optional form of tuna ingredient is termine the weight of the pressed cake chunks, flakes, or grated, the pressed as in the operations described in para- cake resulting from the operations de- graphs (c)(2)(v) through (viii) of this scribed in paragraphs (c)(2)(i) to (ix) of section. Remove the remaining drained this section, inclusive, is gently sepa- contents of the can, reserving the con- rated by hand, care being taken to tents for the determination of free avoid breaking the pieces. The sepa- flakes (paragraph (c)(2)(xi) of this sec- rated pieces are evenly distributed over tion), weigh the empty can, and cal- the top sieve of the screen separation culate the weight of the total drained equipment described in paragraph material. Calculate the weight of (c)(3)(iv) of this section. Beginning pressed cake on the entire can basis by with the top sieve, lift and drop each multiplying the weight of the pressed sieve by its open edge three times. cake of the core by the ratio of the Each time, the open edge of the sieve is weight of the drained contents of the lifted the full distance permitted by can to the weight of the core before the device. Combine and weigh the ma- pressing. terial remaining on the three top (x) Repeat the determination of sieves (11⁄2-inch, 1-inch, 1⁄2-inch weight of pressed cake on the remain- screens), and determine the combined

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percentage retention by weight in rela- 300 × 407 can. The cover, including the tion to the total weight of the pressed top seam, is cut out. The edge is cake. smoothed and sharpened. A small hole (3)(i) The press cylinder and plunger to permit passage of air is made in the referred to in paragraph (c)(2) of this bottom. section are made of stainless steel. The (iii) The hydraulic press referred to press cylinders are made with a lip to in paragraph (c)(2) (vi) to (x) of this facilitate drainage of the liquid. Plung- section, inclusive, is made by so ers have a threaded center hole, about mounting a hydraulic jack, in a strong half as deep as the thickness of the plunger, for receiving a ringbolt to as- frame, that it will press horizontally sist in removing the plunger from the against the center of the plunger in the press cylinder. Dimensions for press press cylinder used. The frame is so cylinders and plungers are as follows: braced that it does not change shape when pressure is applied. The gauge on For can size 211 × 109 the hydraulic jack is so calibrated that it will indicate, for the plunger being Press cylinder: Inside depth, approximately 33⁄4 inches. used, when the plunger is pressing Inside diameter, 2.593 inches. against the contents of the press cyl- Wall thickness, approximately 3⁄8 inch. inder with a pressure of 384 pounds per Plunger: square inch of plunger face. Thickness, approximately 1 inch. Diameter, 2.568 inches. (iv) The sieving device referred to in paragraph (c)(2)(xii) of this section con- For can size 307 × 113 sists of three sieves, each approxi- Press cylinder: mately 1 foot square, loosely mounted, Inside depth, approximately 4 inches. one above the other, in a metal frame. Inside diameter, 3.344 inches. The mesh in the top sieve complies 3 Wall thickness, approximately ⁄8 inch. 1 Plunger: with the specifications for 1 ⁄2-inch Thickness, approximately 11⁄4 inches. woven-wire cloth as prescribed in para- Diameter, 3.319 inches. graph (a)(7) of this section. The meshes in the sieves below comply with similar For can size 401 × 206 specifications for 1-inch and 1⁄2-inch Press cylinder: woven-wire cloth as set forth in the 1 Inside depth, approximately 4 ⁄8 inches. same publication. The sides of each Inside diameter, 3.969 inches. Wall thickness, approximately 1⁄2 inch. sieve are formed, in a raised rim, from Plunger: 3⁄4-inch × 1⁄8-inch metal strap. The 1 Thickness, approximately 1 ⁄4 inches. frame has tracks made of 3⁄8-inch angle Diameter, 3.944 inches. metal to support each sieve under each For can sizes where the diameter is side. The tracks are so positioned as to greater than 401, the core cutter de- permit each sieve a free vertical travel scribed in paragraph (c)(3)(ii) of this of 13⁄4 inches. section shall be used and the resulting (4) If canned tuna falls below the ap- core pressed in the press cylinder for plicable standard of fill of container can size 401 × 206. For can sizes dif- prescribed in paragraph (c)(1) of this fering from those specified in this para- section, the label shall bear the general graph (c)(3)(i), special press cylinders statement of substandard fill provided and plungers may be used. Special in § 130.14(b) of this chapter, in the press less than the outside diameters, manner and form therein specified. at the cylinders have inside diameters [42 FR 14464, Mar. 15, 1977, as amended at 47 1⁄10-inch double seam, for the can sizes for which the cylinders are used; plung- FR 11833, Mar. 19, 1982; 49 FR 10102, Mar. 19, er diameters are 0.025-inch less than 1984; 54 FR 24896, June 12, 1989; 55 FR 45797, Oct. 31, 1990; 56 FR 6263, Feb. 15, 1991; 58 FR the inside diameters of the press cyl- 2884, Jan. 6, 1993; 61 FR 14480, Apr. 2, 1996; 63 inders. FR 14035, Mar. 24, 1998; 66 FR 56035, Nov. 6, (ii) The core cutter referred to in 2001] paragraph (c)(2) (ix) and (xi) of this section and paragraph (c)(3)(i) of this section is made from a previously sealed

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PART 163—CACAO PRODUCTS Cacao Products—Soxhlet Extraction Method—Final Action, 1973,’’ pp. 770– Subpart A—General Provisions 771. Sec. [58 FR 29529, May 21, 1993, as amended at 63 163.5 Methods of analysis. FR 14035, Mar. 24, 1998]

Subpart B—Requirements for Specific Subpart B—Requirements for Spe- Standardized Cacao Products cific Standardized Cacao 163.110 Cacao nibs. Products 163.111 Chocolate liquor. 163.112 Breakfast cocoa. § 163.110 Cacao nibs. 163.113 Cocoa. 163.114 Lowfat cocoa. (a) Description. (1) Cacao nibs is the 163.117 Cocoa with dioctyl sodium sulfo- food prepared by removing the shell succinate for manufacturing. from cured, cleaned, dried, and cracked 163.123 Sweet chocolate. cacao beans. The cacao shell content is 163.124 White chocolate. 163.130 Milk chocolate. not more than 1.75 percent by weight, 163.135 Buttermilk chocolate. calculated on an alkali free basis, as 163.140 Skim milk chocolate. determined by the method prescribed 163.145 Mixed dairy product chocolates. in § 163.5(a). 163.150 Sweet cocoa and vegetable fat coat- (2) The cacao nibs, or the cacao beans ing. from which they are prepared, may be 163.153 Sweet chocolate and vegetable fat coating. processed by heating with one or more 163.155 Milk chocolate and vegetable fat of the optional alkali ingredients speci- coating. fied in paragraph (b)(1) of this section. AUTHORITY: 21 U.S.C. 321, 331, 341, 343, 348, (3) The cacao nibs, or the cacao beans 371, 379e. from which they are prepared, as appropriate, may be further processed SOURCE: 58 FR 29529, May 21, 1993, unless otherwise noted. with one or more of the optional neutralizing agents specified in paragraph Subpart A—General Provisions (b)(2) of this section. (b) Optional ingredients. The following § 163.5 Methods of analysis. safe and suitable ingredients may be Shell and cacao fat content in cacao used: products shall be determined by the (1) Alkali ingredients. Ammonium, following methods of analysis pre- potassium, or sodium bicarbonate, car- scribed in ‘‘Official Methods of Anal- bonate, or hydroxide, or magnesium ysis of the Association of Official Ana- carbonate or oxide, added as such, or in lytical Chemists,’’ which are incor- aqueous solution. For each 100 parts by porated by reference in accordance weight of cacao nibs, used as such, or with 5 U.S.C. 552(a) and 1 CFR part 51. before shelling from the cacao beans, Copies may be obtained from the AOAC the total quantity of alkali ingredients INTERNATIONAL, 481 North Frederick used is not greater in neutralizing Ave., suite 500, Gaithersburg, MD 20877, value (calculated from the respective or may be examined at the National combined weights of the alkali ingredi- Archives and Records Administration ents used) than the neutralizing value (NARA). For information on the avail- of 3 parts by weight of anhydrous po- ability of this material at NARA, call tassium carbonate. 202–741–6030, or go to: http:// (2) Neutralizing agents. Phosphoric www.archives.gov/federallregister/ acid, citric acid, and L-tartaric acid, codeloflfederallregulations/ added as such, or in aqueous solution. ibrllocations.html. For each 100 parts by weight of cacao (a) Shell content—12th ed. (1975), nibs, used as such, or before shelling methods 13.010–13.014, under the head- from the cacao beans, the total quan- ing ‘‘Shell in Cacao Nibs—Official tity of phosphoric acid used is not Final Action,’’ pp. 208–210. greater than 0.5 part by weight, ex- (b) Fat content—15th ed. (1990), meth- pressed as P2O5. The total amount, sin- od 963.15, under the heading ‘‘Fat in gly or in combination, of citric acid

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and L-tartaric acid is not greater than (3) Optional neutralizing agents spec- 1.0 part by weight. ified in paragraph (b)(3) of this section (c) Nomenclature. The name of the may be used as such in the preparation food is ‘‘cacao nibs’’, ‘‘cocoa nibs’’, or of the chocolate liquor under the condi- ‘‘cracked cocoa’’. (1) When the cacao tions and limitations specified in nibs, or the cacao beans from which § 163.110(b)(2). they are prepared, are processed with (4) Chocolate liquor may be spiced, alkali ingredients specified in para- flavored, or seasoned with one or more graph (b)(1) of this section, the name of of the ingredients listed in paragraphs the food shall be accompanied by the (b)(4), (b)(5), and (b)(6) of this section. statement ‘‘Processed with alkali’’ or (b) Optional ingredients. The following ‘‘Processed with lll’’, the blank safe and suitable ingredients may be being filled in with the common or used: usual name of the specific alkali ingre- (1) Cacao fat and cocoas (breakfast dient used in the food. cocoa, cocoa, or lowfat cocoa); (2) When the cacao nibs, or the cacao (2) Alkali ingredients. Ammonium, beans from which they are prepared, potassium, or sodium bicarbonate, car- are processed with neutralizing agents bonate, or hydroxide, or magnesium specified in paragraph (b)(2) of this sec- carbonate or oxide, added as such, or in tion, the name of the food shall be ac- aqueous solution; companied by the statement ‘‘Proc- (3) Neutralizing agents. Phosphoric essed with neutralizing agent’’ or acid, citric acid, and L-tartaric acid, ‘‘Processed with lll’’, the blank added as such, or in aqueous solution; being filled in with the common or (4) Spices, natural and artificial usual name of the specific neutralizing flavorings, ground whole nut meats, agent used in the food. ground coffee, dried malted cereal ex- (3) Whenever the name of the food ap- tract, and other seasonings that do not pears on the label so conspicuously as either singly or in combination impart to be easily seen under customary con- a flavor that imitates the flavor of ditions of purchase, the statements chocolate, milk, or butter; prescribed in paragraphs (c)(1) and (5) Butter or milkfat; or (c)(2) of this section shall precede or (6) Salt. follow the name without intervening (c) Nomenclature. The name of the printed or graphic matter. food is ‘‘chocolate liquor’’, ‘‘choco- (d) Label declaration. Each of the in- late’’, ‘‘unsweetened chocolate’’, ‘‘bit- gredients used in the food shall be deter chocolate’’, ‘‘baking chocolate’’, clared on the label as required by the ‘‘cooking chocolate’’, ‘‘chocolate coat- applicable sections of parts 101 and 130 ing’’, or ‘‘unsweetened chocolate coat- of this chapter. ing’’. (1) When any optional alkali ingre- § 163.111 Chocolate liquor. dient specified in paragraph (b)(2) of (a) Description. (1) Chocolate liquor is this section is used, including those the solid or semiplastic food prepared used in the preparation of the cacao by finely grinding cacao nibs. The fat nibs and cocoas from which the choco- content of the food may be adjusted by late liquor was prepared, the name of adding one or more of the optional in- the food shall be accompanied by the gredients specified in paragraph (b)(1) statement ‘‘Processed with alkali’’ or of this section to the cacao nibs. Choc- ‘‘Processed with lll’’, the blank olate liquor contains not less than 50 being filled in with the common or percent nor more than 60 percent by usual name of the specific alkali ingre- weight of cacao fat as determined by dient used in the food. the method prescribed in § 163.5(b). (2) When any optional neutralizing (2) Optional alkali ingredients speci- agent specified in paragraph (b)(3) of fied in paragraph (b)(2) of this section this section is used, including those may be used as such in the preparation used in the preparation of the cacao of chocolate liquor under the condi- nibs and cocoas from which the choco- tions and limitations specified in late liquor was prepared, the name of § 163.110(b)(1). the food shall be accompanied by the

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statement ‘‘Processed with neutral- (4) Breakfast cocoa may be spiced, izing agent’’ or ‘‘Processed with flavored, or seasoned with one or more lll’’, the blank being filled in with of the ingredients listed in paragraphs the common or usual name of the spe- (b)(3) and (b)(4) of this section. cific neutralizing ingredient used in (b) Optional ingredients. The following the food. safe and suitable ingredients may be (3) When one or more spices, used: flavorings, or seasonings specified in (1) Alkali ingredients. Ammonium, paragraphs (b)(4) and (b)(5) of this sec- potassium, or sodium bicarbonate, car- tion are used in the chocolate liquor, bonate, or hydroxide, or magnesium the label shall bear an appropriate carbonate or oxide, used as such, or in statement, e.g., ‘‘Spice added’’, ‘‘Fla- aqueous solution; vored with lll’’, ‘‘Seasoned with (2) Neutralizing agents. Phosphoric lll’’, or ‘‘With lll added’’, the acid, citric acid and L-tartaric acid, blank being filled in with the common used as such, or in aqueous solution; or usual name of the spice, flavoring, (3) Spices, natural and artificial or seasoning used, in accordance with flavorings, and other seasonings that § 101.22 of this chapter. do not either singly or in combination (4) When two or more of the state- impart a flavor that imitates the flavor ments set forth in this paragraph are of chocolate, milk, or butter; or required, such statements may be com- (4) Salt. bined in a manner that is appropriate, (c) Nomenclature. The name of the but not misleading. food is ‘‘breakfast cocoa’’, or ‘‘high fat (5) Whenever the name of the food ap- cocoa’’. pears on the label so conspicuously as (1) When any optional alkali ingre- to be easily seen under customary con- dient specified in paragraph (b)(1) of ditions of purchase, the statements this section is used, including those prescribed in this section, showing op- used in the preparation of the cacao tional ingredients used, shall precede nibs from which the breakfast cocoa or follow the name without intervening was prepared, the name of the food printed or graphic matter. shall be accompanied by the statement ‘‘Processed with alkali’’, or ‘‘Processed (d) Label declaration. Each of the in- with lll’’, the blank being filled in gredients used in the food shall be de- with the common or usual name of the clared on the label as required by the specific alkali ingredient used in the applicable sections of parts 101 and 130 food. of this chapter. (2) When any optional neutralizing agent specified in paragraph (b)(2) of § 163.112 Breakfast cocoa. this section is used, including those (a) Description. (1) Breakfast cocoa is used in the preparation of the cacao the food prepared by pulverizing the nibs from which the breakfast cocoa material remaining after part of the was prepared, the name of the food cacao fat has been removed from shall be accompanied by the statement ground cacao nibs. Breakfast cocoa ‘‘Processed with neutralizing agent’’ or contains not less than 22 percent by ‘‘Processed with lll’’, the blank weight of cacao fat as determined by being filled in with the common or the method prescribed in § 163.5(b). usual name of the specific neutralizing (2) Optional alkali ingredients speci- agent used in the food. fied in paragraph (b)(1) of this section (3) When one or more of the spices, may be used as such in the preparation flavorings, or seasonings specified in of breakfast cocoa under the conditions paragraph (b)(3) of this section are used and limitations specified in in the breakfast cocoa, the label shall § 163.110(b)(1). bear an appropriate statement, e.g., (3) Optional neutralizing agents spec- ‘‘Spice added’’, ‘‘Flavored with lll’’, ified in paragraph (b)(2) of this section or ‘‘With lll added’’, the blank being may be used as such in the preparation filled in with the common or usual of the breakfast cocoa under the condi- name of the spice, flavoring, or sea- tions and limitations specified in soning used, in accordance with § 101.22 § 163.110(b)(2). of this chapter.

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(4) When two or more of the state- dium sulfosuccinate (complying with ments set forth in this paragraph are the requirements of § 172.810 of this required, such statements may be com- chapter, including the limit of not bined in a manner that is appropriate, more than 0.4 percent by weight of the but not misleading. finished food additive). (5) Whenever the name of the food ap- (b) Nomenclature. The name of the pears on the label so conspicuously as food additive is ‘‘cocoa with dioctyl so- to be easily seen under customary con- dium sulfosuccinate for manufac- ditions of purchase, the statements turing’’ to which is added any modifier prescribed in this paragraph showing of the word ‘‘cocoa’’ required by the optional ingredients used shall precede definition and standard of identity to or follow the name without intervening which the food additive otherwise con- printed or graphic matter. forms. When the food additive is used (d) Label declaration. Each of the in- in a fabricated food, the phrase ‘‘for gredients used in the food shall be declared on the label as required by the manufacturing’’ may be omitted from applicable sections of parts 101 and 130 any declaration of ingredients required of this chapter. under § 101.4 of this chapter.

§ 163.113 Cocoa. § 163.123 Sweet chocolate. (a) Description. Cocoa is the food that (a) Description. (1) Sweet chocolate is conforms to the definition and stand- the solid or semiplastic food prepared ard of identity, and is subject to the re- by intimately mixing and grinding quirements for label declaration of in- chocolate liquor with one or more op- gredients for breakfast cocoa in tional nutritive carbohydrate sweet- § 163.112, except that the cacao fat con- eners, and may contain one or more of tent is less than 22 percent, but not less the other optional ingredients specified than 10 percent by weight, as deter- in paragraph (b) of this section. mined by the method prescribed in (2) Sweet chocolate contains not less § 163.5(b). than 15 percent by weight of chocolate (b) Nomenclature. The name of the liquor complying with the require- food is ‘‘cocoa’’ or ‘‘medium fat cocoa’’. ments of § 163.111, as calculated by subtracting from the weight of the choco- § 163.114 Lowfat cocoa. late liquor used the weight of the cacao (a) Description. Lowfat cocoa is the fat therein and the weights therein of food that conforms to the definition any alkali, neutralizing, and seasoning and standard of identity, and is subject ingredients, and multiplying the re- to the requirements for label declara- mainder by 2.2, dividing the result by tion of ingredients for breakfast cocoa the weight of the finished sweet choco- in § 163.112, except that the cacao fat late, and multiplying the quotient by content is less than 10 percent by 100. The finished sweet chocolate con- weight, as determined by the method tains less than 12 percent by weight of prescribed in § 163.5(b). total milk solids based on those dairy (b) Nomenclature. The name of the ingredients specified in paragraph food is ‘‘lowfat cocoa’’. (b)(4) of this section, exclusive of any § 163.117 Cocoa with dioctyl sodium added sweetener or other dairy derived sulfosuccinate for manufacturing. ingredient that is added beyond that (a) Description. Cocoa with dioctyl so- amount that is normally present in the dium sulfosuccinate for manufacturing specified dairy ingredient. is the food additive complying with the (3) Semisweet chocolate or bitter- provisions prescribed in § 172.520 of this sweet chocolate is sweet chocolate that chapter. It conforms to the definition contains not less than 35 percent by and standard of identity, and is subject weight of chocolate liquor complying to the requirements for label declara- with the requirements of § 163.111 and tion of ingredients, for breakfast cocoa calculated in the same manner as set in § 163.112, or for cocoa in § 163.113, or forth in paragraph (a)(2) of this section. for lowfat cocoa in § 163.114, except that (4) Cacao fat is determined by the the food additive contains dioctyl so- method prescribed in § 163.5(b).

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(b) Optional ingredients. The following or ‘‘With lll added’’, the blank being safe and suitable ingredients may be filled in with the common or usual used: name of the spice, flavoring, or sea- (1) Cacao fat; soning used, in accordance with § 101.22 (2) Nutritive carbohydrate sweet- of this chapter. eners; (4) When two or more of the state- (3) Spices, natural and artificial ments set forth in this paragraph are flavorings, ground whole nut meats, required, such statements may be com- ground coffee, dried malted cereal ex- bined in a manner that is appropriate, tract, salt, and other seasonings that but not misleading. do not either singly or in combination (5) Whenever the name of the food ap- impart a flavor that imitates the flavor pears on the label so conspicuously as of chocolate, milk, or butter; to be easily seen under customary con- (4) Dairy ingredients: ditions of purchase, the statements (i) Cream, milkfat, butter; prescribed in this paragraph showing (ii) Milk, concentrated milk, evapo- optional ingredients used shall precede rated milk, sweetened condensed milk, or follow such name without inter- dried milk; vening printed or graphic matter. (iii) Skim milk, concentrated skim (d) Label declaration. Each of the in- milk, evaporated skim milk, sweetened gredients used in the food shall be de- condensed skim milk, nonfat dry milk; clared on the label as required by the (iv) Concentrated buttermilk, dried applicable sections of parts 101 and 130 buttermilk; and of this chapter. (v) Malted milk; or (5) Emulsifying agents, used singly or § 163.124 White chocolate. in combination, the total amount of (a) Description. (1) White chocolate is which does not exceed 1.0 percent by the solid or semiplastic food prepared weight. by intimately mixing and grinding (c) Nomenclature. The name of the cacao fat with one or more of the op- food is ‘‘sweet chocolate’’, ‘‘sweet choc- tional dairy ingredients specified in olate coating’’, ‘‘semisweet chocolate’’, paragraph (b)(2) of this section and one ‘‘semisweet chocolate coating’’, ‘‘bit- or more optional nutritive carbo- tersweet chocolate’’, or ‘‘bittersweet hydrate sweeteners and may contain chocolate coating’’, as appropriate. one or more of the other optional in- (1) When optional alkalizing ingredi- gredients specified in paragraph (b) of ents are used in the preparation of the this section. White chocolate shall be chocolate liquor or the cacao nibs from free of coloring material. which the chocolate was prepared, the (2) White chocolate contains not less label shall bear the statement ‘‘Proc- than 20 percent by weight of cacao fat essed with alkali’’, or ‘‘Processed with as calculated by subtracting from the lll’’, the blank being filled in with weight of the total fat the weight of the common or usual name of the spe- the milkfat, dividing the result by the cific alkali ingredient used in the food. weight of the finished white chocolate, (2) When optional neutralizing agents and multiplying the quotient by 100. are used in the preparation of the choc- The finished white chocolate contains olate liquor or the cacao nibs from not less than 3.5 percent by weight of which the chocolate was prepared, the milkfat and not less than 14 percent by label shall bear the statement ‘‘Proc- weight of total milk solids, calculated essed with neutralizing agents’’, or by using only those dairy ingredients ‘‘Processed with lll’’, the blank specified in paragraph (b)(2) of this sec- being filled in with the common or tion, and not more than 55 percent by usual name of the specific neutralizing weight nutritive carbohydrate sweet- agent used in the food. ener. (3) When one or more of the spices, (b) Optional ingredients. The following flavorings, or seasonings specified in safe and suitable ingredients may be paragraph (b)(3) of this section are used used: in the breakfast cocoa, the label shall (1) Nutritive carbohydrate sweet- bear an appropriate statement, e.g., eners; ‘‘Spice added’’, ‘‘Flavored with lll’’, (2) Dairy ingredients:

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(i) Cream, milkfat, butter; ments of § 163.111 as calculated by sub- (ii) Milk, dry whole milk, con- tracting from the weight of the choco- centrated milk, evaporated milk, late liquor used the weight of cacao fat sweetened condensed milk; therein and the weights of alkali, neu- (iii) Skim milk, concentrated skim tralizing and seasoning ingredients, milk, evaporated skim milk, sweetened multiplying the remainder by 2.2, di- condensed skim milk, nonfat dry milk; viding the result by the weight of the (iv) Concentrated buttermilk, dried finished milk chocolate, and multi- buttermilk; and plying the quotient by 100. The finished (v) Malted milk; milk chocolate contains not less than (3) Emulsifying agents, used singly or 3.39 percent by weight of milkfat and in combination, the total amount of not less than 12 percent by weight of which does not exceed 1.5 percent by total milk solids based on those dairy weight; ingredients specified in paragraph (4) Spices, natural and artificial (b)(4) of this section, exclusive of any flavorings, ground whole nut meats, added sweetener or other dairy-derived ground coffee, dried malted cereal ex- ingredient that is added beyond that tract, salt, and other seasonings that amount that is normally present in the do not either singly or in combination specified dairy ingredient. impart a flavor that imitates the flavor (b) Optional ingredients. The following of chocolate, milk, or butter; safe and suitable ingredients may be (5) Antioxidants; and used: (6) Whey or whey products, the total (1) Cacao fat; amount of which does not exceed 5 percent by weight. (2) Nutritive carbohydrate sweet- (c) Nomenclature. The name of the eners; food is ‘‘white chocolate’’ or ‘‘white (3) Spices, natural and artificial chocolate coating.’’ When one or more flavorings, ground whole nut meats, of the spices, flavorings, or seasonings ground coffee, dried malted cereal ex- specified in paragraph (b)(4) of this sec- tract, salt, and other seasonings that tion are used, the label shall bear an do not either singly or in combination appropriate statement, e.g., ‘‘Spice impart a flavor that imitates the flavor added’’, ‘‘Flavored with lll ’’, or of chocolate, milk, or butter; ‘‘With lll added’’, the blank being (4) Dairy ingredients: filled in with the common or usual (i) Cream, milkfat, butter; name of the spice, flavoring, or sea- (ii) Milk, concentrated milk, evapo- soning used, in accordance with § 101.22 rated milk, sweetened condensed milk, of this chapter. dried milk; and (d) Label declaration. Each of the in- (iii) Skim milk, concentrated skim gredients used in the food shall be de- milk, evaporated skim milk, sweetened clared on the label as required by the condensed skim milk, nonfat dry milk; applicable sections of parts 101 and 130 or of this chapter. (5) Emulsifying agents, used singly or [67 FR 62177, Oct. 4, 2002] in combination, the total amount of which does not exceed 1.0 percent by § 163.130 Milk chocolate. weight. (a) Description. (1) Milk chocolate is (c) Nomenclature. The name of the the solid or semiplastic food prepared food is ‘‘milk chocolate’’ or ‘‘milk by intimately mixing and grinding chocolate coating’’. chocolate liquor with one or more of (1) When optional alkali ingredients the optional dairy ingredients and one are used in the preparation of the choc- or more optional nutritive carbo- olate liquor or the cacao nibs from hydrate sweeteners, and may contain which the milk chocolate was prepared, one or more of the other optional in- the label shall bear the statement gredients specified in paragraph (b) of ‘‘Processed with alkali’’, or ‘‘Processed this section. with lll’’, the blank being filled in (2) Milk chocolate contains not less with the common or usual name of the than 10 percent by weight of chocolate specific alkali ingredient used in the liquor complying with the require- food.

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(2) When optional neutralizing agents sweetener or other dairy-derived ingre- are used in the preparation of the choc- dient that is added beyond that olate liquor or the cacao nibs from amount that is normally present in the which the milk chocolate was prepared, specified dairy ingredient. the label shall bear the statement (b) Nomenclature. The name of the ‘‘Processed with neutralizing agents’’, food is ‘‘buttermilk chocolate’’, ‘‘but- or ‘‘Processed with lll’’, the blank termilk chocolate coating’’, ‘‘sweet being filled in with the common or buttermilk chocolate’’, ‘‘sweet butter- usual name of the specific neutralizing milk chocolate coating’’, ‘‘sweet cream agent used in the food. buttermilk chocolate’’, or ‘‘sweet (3) When one or more of the spices, cream buttermilk chocolate coating’’. flavorings, or seasonings specified in paragraph (b)(3) of this section are used § 163.140 Skim milk chocolate. in the breakfast cocoa, the label shall (a) Description. Skim milk chocolate bear an appropriate statement, e.g., is the food that conforms to the stand- ‘‘Spice added’’, ‘‘Flavored with lll’’, ard of identity, and is subject to the re- or ‘‘With lll added’’, the blank being quirements for label declaration of in- filled in with the common or usual gredients for milk chocolate in name of the spice, flavoring, or sea- § 163.130, except that: soning used, in accordance with § 101.22 (1) The optional dairy ingredients are of this chapter. limited to skim milk, evaporated skim (4) When two or more of the state- milk, concentrated skim milk, sweet- ments set forth in this paragraph are ened condensed skim milk, nonfat dry required, such statements may be com- milk, and any combination of these; bined in a manner that is appropriate, and but not misleading. (2) The finished skim milk chocolate (5) Whenever the name of the food ap- contains less than 3.39 percent by pears on the label so conspicuously as weight of milkfat and not less than 12 to be easily seen under customary con- percent by weight of skim milk solids ditions of purchase, the statements based on those dairy ingredients speci- prescribed in this paragraph showing fied in paragraph (a)(1) of this section, optional ingredients used shall precede exclusive of any added sweetener or or follow such name without inter- other dairy-derived ingredient that is vening printed or graphic matter. added beyond that amount that is nor- (d) Label declaration. Each of the in- mally present in the specified dairy ingredients used in the food shall be de- gredient. clared on the label as required by the (b) Nomenclature. The name of the applicable sections of parts 101 and 130 food is ‘‘skim milk chocolate’’, ‘‘skim of this chapter. milk chocolate coating’’, ‘‘sweet skim milk chocolate’’, or ‘‘sweet skim milk § 163.135 Buttermilk chocolate. chocolate coating’’. (a) Description. Buttermilk chocolate is the food that conforms to the stand- § 163.145 Mixed dairy product choco- ard of identity, and is subject to the relates. quirements for label declaration of in- (a) Description. Mixed dairy product gredients for milk chocolate in chocolates are the foods that conform § 163.130, except that: to the standard of identity, and are (1) The optional dairy ingredients are subject to the requirements for label limited to sweet cream buttermilk, declaration of ingredients for milk concentrated sweet cream buttermilk, chocolate in § 163.130, except that: dried sweet cream buttermilk, and any (1) The optional dairy ingredients for combination of these; and each of the foods are mixtures of two (2) The finished buttermilk chocolate or more of the following: contains less than 3.39 percent by (i) Any dairy ingredients specified in weight of milkfat and not less than 12 § 163.130; percent by weight of sweet cream but- (ii) Any dairy ingredients specified in termilk solids based on those dairy in- § 163.135; gredients specified in paragraph (a)(1) (iii) Any dairy ingredients specified of this section, exclusive of any added in § 163.140; or

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(iv) Malted milk; and (5) Safe and suitable bulking agents, (2) The finished mixed dairy product formulation aids, humectants, and chocolates shall contain not less than texturizers. 12 percent by weight of total milk sol- (c) Nomenclature. The name of the ids derived from those dairy products food is ‘‘sweet cocoa and vegetable fat referred to in paragraph (a)(1) of this coating’’. Alternatively, the common section, exclusive of any added sweet- or usual name of the vegetable derived ener or other dairy-derived ingredient fat ingredient may be used in the name that is added beyond that amount that of the food, e.g., ‘‘sweet cocoa and is normally present in the specified lll oil coating’’, the blank being dairy product, and may contain less filled in with the common or usual than 3.39 percent by weight of milkfat. name of the specific vegetable fat used. The quantity of each component used in any such mixture is such that no § 163.153 Sweet chocolate and vege- component contributes less than one table fat coating. third of the weight of the total milk (a) Description. Sweet chocolate and solids contributed by that component vegetable fat coating is the food that which is used in the largest proportion. conforms to the definition and stand- (b) Nomenclature. The name of the ard of identity, and is subject to the re- food is ‘‘chocolate’’, or ‘‘chocolate quirements for label declaration of in- coating’’, preceded by the designation gredients for sweet chocolate in of the type of milk ingredients used as § 163.123, except that one or more op- prescribed in paragraph (a) of this sectional ingredients specified in para- tion in order of predominance by graph (b) of this section are used. Com- weight, e.g., ‘‘milk and skim milk pliance with the requirement in chocolate’’. § 163.123(a)(2) limiting the total milk solids content to less than 12 percent § 163.150 Sweet cocoa and vegetable by weight shall be calculated by in- fat coating. cluding only those dairy ingredients re- (a) Description. Sweet cocoa and vege- ferred to in § 163.123(b)(4), exclusive of table fat coating is the food that con- any added sweetener or other dairy-de- forms to the definition and standard of rived ingredient that is added beyond identity, and is subject to the require- that amount that is normally present ments for label declaration of ingredi- in the specified dairy ingredient. ents for sweet chocolate in § 163.123, ex- (b) Optional ingredients. (1) Safe and cept that: suitable vegetable derived fats, oils, (1) In the preparation of the product, and stearins other than cacao fat. The cocoa or a mixture of cocoa and choco- fats, oils, and stearins may be hydro- late liquor is used in such quantity genated; that the finished food contains not less (2) Safe and suitable dairy-derived in- than 6.8 percent by weight of nonfat gredients; and cacao solids, calculated on a moisture- (3) Safe and suitable bulking agents, free basis; formulation aids, humectants, and (2) One or more optional ingredients texturizers. specified in paragraph (b) of this sec- (c) Nomenclature. The name of the tion are used; and food is ‘‘sweet chocolate and vegetable (3) The requirement in § 163.123(a)(2) fat coating’’. Alternatively, the com- limiting the total milk solids content mon or usual name of the vegetable de- to less than 12 percent by weight does rived fat ingredient may be used in the not apply. name of the food, e.g., ‘‘sweet choco- (b) Optional ingredients. (1) Breakfast late and lll oil coating’’, the blank cocoa, cocoa, lowfat cocoa; being filled in with the common or (2) Chocolate liquor; usual name of the specific vegetable fat (3) Safe and suitable vegetable de- used. rived fats, oils, and stearins other than cacao fat. The fats, oils, and stearins § 163.155 Milk chocolate and vegetable may be hydrogenated; fat coating. (4) Safe and suitable dairy-derived in- (a) Description. Milk chocolate and gredients; and vegetable fat coating is the food that

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conforms to the standard of identity, Subpart A [Reserved] and is subject to the requirements for label declaration of ingredients for milk chocolate in § 163.130 or skim milk Subpart B—Requirements for Spe- chocolate in § 163.140, except that one cific Standardized Tree Nut or more optional ingredients specified and Peanut Products in paragraph (b) of this section are used. Compliance with the requirement § 164.110 Mixed nuts. in § 163.130(a)(2) that the product con- (a) Mixed nuts is the food consisting tains not less than 12 percent by weight of a mixture of four or more of the op- of nonfat milk solids shall be cal- tional shelled tree nut ingredients, culated using only those dairy ingredi- with or without one or more of the op- ents referred to in § 163.130(b)(4), exclu- tional shelled peanut ingredients, of sive of any added sweetener or other the kinds prescribed by paragraph (b) dairy-derived ingredient that is added of this section; except that when 2 beyond that amount that is normally ounces or less of the food is packed in present in the specified dairy ingre- transparent containers, three or more dient. of the optional tree nut ingredients (b) Optional ingredients. (1) Safe and shall be present. Each such kind of nut suitable vegetable derived oils, fats, ingredient when used shall be present and stearins other than cacao fat. The in a quantity not less than 2 percent oils, fats, and stearins may be hydro- and not more than 80 percent by weight genated; of the finished food. For purposes of (2) Safe and suitable dairy-derived in- this section, each kind of tree nut and gredients; and peanut is an optional ingredient that (3) Safe and suitable bulking agents, may be prepared by any suitable meth- formulation aids, humectants, and od in accordance with good manufac- texturizers. turing practice. The finished food may (c) Nomenclature. The name of the contain one or more of the optional food is ‘‘milk chocolate and vegetable nonnut ingredients provided for in fat coating’’ or ‘‘skim milk chocolate paragraph (c) of this section. and vegetable fat coating’’, as appro- (b) The optional shelled nut ingredi- priate. Alternatively, the common or ents referred to in paragraph (a) of this usual name of the vegetable derived fat section are: ingredient may be used in the name of the food, e.g., ‘‘milk chocolate and (1) Almonds, black walnuts, Brazil lll oil coating’’, the blank being nuts, cashews, English walnuts (alter- filled in with the common or usual natively ‘‘walnuts’’), filberts, pecans, name of the specific vegetable fat used. and other suitable kinds of tree nuts. (2) Peanuts of the Spanish, Valencia, Virginia, or similar varieties, or any PART 164—TREE NUT AND PEANUT combination of two or more such vari- PRODUCTS eties. (c) The optional nonnut ingredients Subpart A [Reserved] referred to in paragraph (a) of this sec- Subpart B—Requirements for Specific tion consist of suitable substances that Standardized Tree Nut and Peanut are not food additives as defined in sec- Products tion 201(s) of the Federal Food, Drug, and Cosmetic Act; or if they are food Sec. additives as so defined, they are used in 164.110 Mixed nuts. conformity with regulations estab- 164.120 Shelled nuts in rigid or semirigid lished pursuant to section 409 of the containers. act. Nonnut ingredients that perform a 164.150 Peanut butter. useful function are regarded as suit- AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, able, except that color additives are 379e. not suitable ingredients of the food. SOURCE: 42 FR 14475, Mar. 15, 1977, unless (d) The name of the food is ‘‘mixed otherwise noted. nuts’’. If the percentage of a single tree

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nut ingredient or the total peanut con- with the labeling requirements of this tent by weight of the finished food ex- paragraph. ceeds 50 percent but not 60 percent, the (e) Label declaration. Each of the instatement ‘‘contains up to 60% lll’’ gredients used in the food shall be de- or ‘‘contains 60% lll’’ or ‘‘60% clared on the label as required by the lll’’ shall immediately follow the applicable sections of parts 101 and 130 name ‘‘mixed nuts’’ and shall appear on of this chapter, except that: the same background, be of the same (1) If the Spanish variety of peanuts color or, in the case of multicolors, in is used, it shall be declared as ‘‘Spanish the color showing distinct contrast peanuts’’. Other varieties of peanuts with the background, and be in letters shall be declared as ‘‘peanuts’’, or al- not less than one-half the height of the ternatively ‘‘lll peanuts’’, the blank largest letter in the words ‘‘mixed being filled in with the varietal name nuts’’. The blank is to be filled in with of the peanuts used. the appropriate name of the predomi- (2) If the peanut ingredient or ingre- nant nut ingredient; for example, dients as provided for in paragraph ‘‘contains up to 60% pecans’’ or ‘‘con- (b)(2) of this section are unblanched, tains up to 60% Spanish peanuts’’. The the label shall show that fact by such numbers ‘‘70’’ or ‘‘80’’ shall be sub- statement as ‘‘Peanuts unblanched’’, stituted for the number ‘‘60’’ when the ‘‘Peanuts skins on’’, or words of simi- percentage of the predominant nut in- lar import, unless the vignette clearly gredient exceeds 60 but not 70, or ex- depicts peanuts with skins on. ceeds 70 but not 80, respectively. Com- (f) The words and statements speci- pliance with the requirements for per- fied in paragraph (e) of this section centage of nut ingredients of this sec- showing the ingredients present shall tion and the fill of container require- be listed on the principal display panel ments of § 164.120(c) will be determined or panels or any appropriate informa- by the following procedure: tion panel without obscuring design, (1) Take at random from a lot, in the vignettes, or crowding. The declaration case of containers bearing a weight shall appear in conspicuous and easily declaration of 16 ounces or less, at legible letters of boldface print or type least 24 containers, and for containers the size of which shall be not less than bearing a weight declaration of more one-half of that required by part 101 of than 16 ounces, enough containers to this chapter for the statement of net provide a total quantity of at least 24 quantity of contents appearing on the pounds of nuts. label, but in no case less than one-six- (2) If compliance with § 164.120(c) is to teenth of an inch in height. The entire be determined, first follow the proce- ingredient statement shall appear on dure set forth therein. at least one panel of the label. If the (3) Determine the percent by weight label bears any pictorial representa- of each nut ingredient present in each tion of the mixture of nuts, it shall de- container separately. Calculate the av- pict the relative proportions of the nut erage percentage of each nut ingredient ingredients of the food. If the label present. If the average percent found bears a pictorial representation of only for each nut ingredient present is 2 per- one of each nut ingredient present, the cent or more and none of the individual nuts shall be depicted in the order of nut ingredients exceeds 80 percent by decreasing predominance by weight. A weight of the finished food, the lot will factual statement that the food does be deemed to be in compliance with the not contain a particular nut ingredient percentage requirements of paragraph or ingredients may be shown on the (a) of this section. If the average per- label if the statement is not misleading cent found for a single nut ingredient and does not result in an insufficiency exceeds 50 percent by weight of the fin- of label space for the proper declara- ished food and the average percent tion of information required by or found is within the range indicated by under authority of the act to appear on the number declared on the label in ac- the label. cordance with this paragraph, the lot [42 FR 14475, Mar. 15, 1977, as amended at 58 will be deemed to be in compliance FR 2885, Jan. 6, 1993]

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§ 164.120 Shelled nuts in rigid or method for water capacity of con- semirigid containers. tainers as prescribed in § 130.12(a) of (a)–(b) [Reserved] this chapter and determine the con- (c) Fill of container. (1) The standard tainer volume, considering the water of fill for shelled nuts in rigid or capacity in grams to be numerically semirigid containers is a fill such that equivalent to volume in cubic centi- the average volume of nuts, from the meters, or the water capacity in ounces number of containers specified in (avoirdupois) to be equivalent to 28.35 § 164.110(d)(1), is not less than 85 per- cubic centimeters per ounce. cent of the container volume as deter- (b) For box-shaped containers (that mined by the method in paragraph is, with opposite sides parallel), meas- (c)(2) of this section. ure the inside height, width, and depth (2) The method for determining the and calculate the volume as the prod- percent of fill is as follows: uct of these three dimensions. For such (i) For the shelled nuts in each con- containers used to enclose vacuum tainer, determine the loose volume, the packs and containing 4 ounces or less settled volume, and the average vol- of the product, consider the height to ume in cubic centimeters. For the pur- be the inside height minus three- poses of this subparagraph, consider eighths inch. volume in milliliters to be numerically (c) For cylindrical containers, cal- equal to volume in cubic centimeters. culate the container volume in cubic Open the container and pour the nuts centimeters as the product of the loosely into a vertical graduated cyl- height times the square of the diame- inder (do not tilt) of appropriate size ter, both measured in inches, times fitted with a funnel which has been 12.87; or as the product of the height modified, if necessary, to provide a times the square of the diameter, both minimum opening of 11⁄2-inch diameter. measured in centimeters, times 0.7854. (If the loose volume of the nuts is less For containers that do not have in- than 500 milliliters, use a 500–milliliter dented ends, use the inside height and cylinder with an inside diameter of ap- inside diameter as the dimensions. For proximately 17⁄8 inches; but if the loose metal cans with indented ends (that is, volume is 500 milliliters or more, use a metal cans with ends attached by dou- 1,000–milliliter cylinder with an inside ble seams), consider the height to be diameter of approximately 21⁄4 inches.) the outside height at the double seam Without shaking the cylinder, estimate minus three-eighths inch (0.953 centi- the location of a horizontal plane rep- meter) and the diameter to be the out- resenting the average height of the side diameter at the double seam product, read the volume of the nuts, minus one-eighth inch (0.318 centi- and record as the loose volume. Raise meter). For fiber-bodied containers the cylinder 2 inches and allow it a free with indented ends (that is, fiber-bod- vertical drop onto a level, firm, but re- ied cans with metal ends attached by silient surface (do not tamp) for a total double seams), consider the height to of 5 times and observe the volume as be the outside height at the double above. Repeat in successive five-drop seam minus three-eighths inch (0.953 increments until the nuts have so set- centimeter) and the diameter to be the tled that the volume decreases less outside diameter at the double seam than 2 percent in the last five-drop in- minus three-sixteenths inch (0.476 cen- crement. Read the last volume in the timeter). manner described above and record as (iii) Calculate the percent fill of the the settled volume. The arithmetical container as follows: Divide the aver- average of the loose volume and the age volume of nuts found according to settled volume equals the average vol- paragraph (c)(2)(i) of this section by ume of nuts. the appropriate container volume (ii) Classify the container by shape found according to paragraph (c)(2)(ii) and determine its volume in cubic cen- of this section and multiply by 100. The timeters according to one of the fol- result shall be considered to be the per- lowing methods as appropriate: cent fill of the container. (a) For containers of irregular shape, (3) If shelled nuts fall below the including glass jars, follow the general standard of fill of container prescribed

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in paragraph (c)(1) of this section, the lizing ingredients that perform a useful label shall bear the general statement function are regarded as suitable, ex- of substandard fill specified in cept that artificial flavorings, artifi- § 130.14(b) of this chapter, in the man- cial sweeteners, chemical preserva- ner and form therein specified. tives, and color additives are not suitable ingredients in peanut butter. Oil § 164.150 Peanut butter. products used as optional stabilizing (a) Peanut butter is the food prepared ingredients shall be hydrogenated veg- by grinding one of the shelled and etable oils. For the purposes of this roasted peanut ingredients provided for section, hydrogenated vegetable oil by paragraph (b) of this section, to shall be considered to include partially which may be added safe and suitable hydrogenated vegetable oil. seasoning and stabilizing ingredients (d) If peanut butter is prepared from provided for by paragraph (c) of this unblanched peanuts as specified in section, but such seasoning and stabi- paragraph (b)(2) of this section, the lizing ingredients do not in the aggre- name shall show that fact by some gate exceed 10 percent of the weight of such statement as ‘‘prepared from the finished food. To the ground pea- unblanched peanuts (skins left on).’’ nuts, cut or chopped, shelled, and Such statement shall appear promi- roasted peanuts may be added. During nently and conspicuously and shall be processing, the oil content of the pea- in type of the same style and not less nut ingredient may be adjusted by the than half of the point size of that used addition or subtraction of peanut oil. for the words ‘‘peanut butter.’’ This The fat content of the finished food statement shall immediately precede shall not exceed 55 percent when deter- or follow the words ‘‘peanut butter,’’ mined as prescribed in ‘‘Official Meth- without intervening written, printed, ods of Analysis of the Association of or graphic matter. Official Analytical Chemists,’’ 13th Ed. (e) Label declaration. Each of the in- (1980), section 27.006(a) under ‘‘Crude gredients used in the food shall be de- Fat—Official First Action, Direct clared on the label as required by the Method,’’ in paragraph (a), which is in- applicable sections of parts 101 and 130 corporated by reference. Copies may be of this chapter. obtained from the AOAC INTER- NATIONAL, 481 North Frederick Ave., [42 FR 14475, Mar. 15, 1977, as amended at 47 suite 500, Gaithersburg, MD 20877, or FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, may be examined at the National Ar- Jan. 6, 1993; 61 FR 9325, Mar. 8, 1996; 63 FR chives and Records Administration 14035, Mar. 24, 1998] (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// PART 165—BEVERAGES www.archives.gov/federallregister/ codeloflfederallregulations/ Subpart A—General Provisions ibrllocations.html. Sec. (b) The peanut ingredients referred to 165.3 Definitions. in paragraph (a) of this section are: (1) Blanched peanuts, in which the Subpart B—Requirements for Specific germ may or may not be included. Standardized Beverages (2) Unblanched peanuts, including the skins and germ. 165.110 Bottled water. (c) The seasoning and stabilizing in- AUTHORITY: 21 U.S.C. 321, 341, 343, 343–1, 348, gredients referred to in paragraph (a) 349, 371, 379e. of this section are suitable substances which are not food additives as defined SOURCE: 60 FR 57124, Nov. 13, 1995, unless otherwise noted. in section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act), or if they are food additives as so defined, Subpart A—General Provisions they are used in conformity with regulations established pursuant to section § 165.3 Definitions. 409 of the act. Seasoning and stabi- (a) A lot is:

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(1) For purposes of determining qual- above the top of the aquifer is ‘‘arte- ity factors related to manufacture, sian water’’ or ‘‘artesian well water.’’ processing, or packing, a collection of Artesian water may be collected with primary containers or units of the the assistance of external force to en- same size, type, and style produced hance the natural underground pres- under conditions as nearly uniform as sure. On request, plants shall dem- possible and usually designated by a onstrate to appropriate regulatory offi- common container code or marking, or cials that the water level stands at in the absence of any common con- some height above the top of the aqui- tainer code or marking, a day’s produc- fer. tion. (ii) The name of water from a sub- (2) For purposes of determining qual- surface saturated zone that is under a ity factors related to distribution and pressure equal to or greater than at- storage, a collection of primary con- mospheric pressure is ‘‘ground water.’’ tainers or units transported, stored, or Ground water must not be under the di- held under conditions as nearly uni- rect influence of surface water as de- form as possible. fined in 40 CFR 141.2. (b) A sample consists of 10 subsamples (iii) The name of water containing (consumer units), one taken from each not less than 250 parts per million of 10 different randomly chosen ship- (ppm) total dissolved solids (TDS), ping cases to be representative of a coming from a source tapped at one or given lot, unless otherwise specified in more bore holes or springs, originating a specific standard in this part. from a geologically and physically pro- (c) An analytical unit is the portion(s) tected underground water source, may of food taken from a subsample of a be ‘‘mineral water.’’ Mineral water sample for the purpose of analysis. shall be distinguished from other types of water by its constant level and rel- Subpart B—Requirements for ative proportions of minerals and trace Specific Standardized Beverages elements at the point of emergence from the source, due account being § 165.110 Bottled water. taken of the cycles of natural fluctua- (a) Identity—(1) Description. Bottled tions. No minerals may be added to water is water that is intended for this water. human consumption and that is sealed (iv) The name of water that has been in bottles or other containers with no produced by distillation, deionization, added ingredients except that it may reverse osmosis, or other suitable proc- optionally contain safe and suitable esses and that meets the definition of antimicrobial agents. Fluoride may be ‘‘purified water’’ in the United States optionally added within the limitations Pharmacopeia, 23d Revision, January 1, established in § 165.110(b)(4)(ii). Bottled 1995, which is incorporated by reference water may be used as an ingredient in in accordance with 5 U.S.C. 551(a) and 1 beverages (e.g., diluted juices, flavored CFR part 51. (Copies may be obtained bottled waters). It does not include from the United States Pharmacopial those food ingredients that are de- Convention, Inc., 12601 Twinbrook clared in ingredient labeling as Pkwy., Rockville, MD 20852 and may be ‘‘water,’’ ‘‘carbonated water,’’ ‘‘dis- examined at the Food and Drug Admin- infected water,’’ ‘‘filtered water,’’ istration’s Main Library, 10903 New ‘‘seltzer water,’’ ‘‘soda water,’’ ‘‘spar- Hampshire Ave., Bldg. 2, Third Floor, kling water,’’ and ‘‘tonic water.’’ The Silver Spring, MD 20993, 301–796–2039, or processing and bottling of bottled at the National Archives and Records water shall comply with applicable reg- Administration (NARA). For informa- ulations in part 129 of this chapter. tion on the availability of this mate- (2) Nomenclature. The name of the rial at NARA, call 202–741–6030, or go food is ‘‘bottled water,’’ ‘‘drinking to: http://www.archives.gov/ water,’’ or alternatively one or more of federallregister/ the following terms as appropriate: codeloflfederallregulations/ (i) The name of water from a well ibrllocations.html.), may be ‘‘purified tapping a confined aquifer in which the water’’ or ‘‘demineralized water.’’ Al- water level stands at some height ternatively, the water may be called

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‘‘deionized water’’ if the water has been Rockville, MD 20852 and may be exam- processed by deionization, ‘‘distilled ined at the Food and Drug Administra- water’’ if it is produced by distillation, tion’s Main Library, 10903 New Hamp- ‘‘reverse osmosis water’’ if the water shire Ave., Bldg. 2, Third Floor, Silver has been processed by reverse osmosis, Spring, MD 20993, 301–796–2039, or at the and ‘‘lll drinking water’’ with the National Archives and Records Admin- blank being filled in with one of the de- istration (NARA). For information on fined terms describing the water in this the availability of this material at paragraph (e.g., ‘‘purified drinking NARA, call 202–741–6030, or go to: http:// water’’ or ‘‘deionized drinking water’’). www.archives.gov/federallregister/ (v) The name of water that, after codeloflfederallregulations/ treatment and possible replacement of ibrllocations.html.), may be ‘‘sterile carbon dioxide, contains the same water.’’ Alternatively, the water may amount of carbon dioxide from the be called ‘‘sterilized water.’’ source that it had at emergence from (viii) The name of water from a hole the source may be ‘‘sparkling bottled bored, drilled, or otherwise constructed water.’’ in the ground which taps the water of (vi) The name of water derived from an aquifer may be ‘‘well water.’’ an underground formation from which (3) Other label statements. (i) If the water flows naturally to the surface of TDS content of mineral water is below the earth may be ‘‘spring water.’’ 500 ppm, or if it is greater than 1,500 Spring water shall be collected only at ppm, the statement ‘‘low mineral con- the spring or through a bore hole tap- tent’’ or the statement ‘‘high mineral ping the underground formation feed- content’’, respectively, shall appear on ing the spring. There shall be a natural the principal display panel following force causing the water to flow to the the statement of identity in type size surface through a natural orifice. The at least one-half the size of the state- location of the spring shall be identi- ment of identity but in no case of less fied. Spring water collected with the than one-sixteenth of an inch. If the use of an external force shall be from TDS of mineral water is between 500 the same underground stratum as the and 1,500 ppm, no additional statement spring, as shown by a measurable hy- need appear. draulic connection using a (ii) When bottled water comes from a hydrogeologically valid method be- community water system, as defined in tween the bore hole and the natural 40 CFR 141.2, except when it has been spring, and shall have all the physical treated to meet the definitions in para- properties, before treatment, and be of graphs (a)(2)(iv) and (a)(2)(vii) of this the same composition and quality, as section and is labeled as such, the label the water that flows naturally to the shall state ‘‘from a community water surface of the earth. If spring water is system’’ or, alternatively, ‘‘from a mu- collected with the use of an external nicipal source’’ as appropriate, on the force, water must continue to flow nat- principal display panel or panels. This urally to the surface of the earth statement shall immediately and con- through the spring’s natural orifice. spicuously precede or follow the name Plants shall demonstrate, on request, of the food without intervening writ- to appropriate regulatory officials, ten, printed, or graphic matter, other using a hydrogeologically valid meth- than statements required by paragraph od, that an appropriate hydraulic con- (c) of this section, in type size at least nection exists between the natural ori- one-half the size of the statement of fice of the spring and the bore hole. identity but in no case of less than one- (vii) The name of water that meets sixteenth of an inch. the requirements under ‘‘Sterility (iii) When the label or labeling of a Tests’’ <71>in the United States Phar- bottled water product states or implies macopeia, 23d Revision, January 1, (e.g., through label statements or vi- 1995, which is incorporated by reference gnettes with references to infants) that in accordance with 5 U.S.C. 552(a) and 1 the bottled water is for use in feeding CFR 51. (Copies may be obtained from infants, and the product is not com- the United States Pharmacopeial Con- mercially sterile under § 113.3(e)(3)(i) of vention, Inc., 12601 Twinbrook Pkwy., this chapter, the product’s label shall

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bear conspicuously and on the prin- (2) Membrane filter (MF) method. Not cipal display panel the statement ‘‘Not more than one of the analytical units sterile. Use as directed by physician or in the sample shall have 4.0 or more by labeling directions for use of infant coliform organisms per 100 milliliters formula.’’ and the arithmetic mean of the coli- (4) Label declaration. Each of the inform density of the sample shall not gredients used in the food shall be de- exceed one coliform organism per 100 clared on the label as required by the milliliters. applicable sections of parts 101 and 130 (B) E. coli. If E. coli is present, then of this chapter. the bottled water will be deemed adul- (b) Quality. The standard of quality terated under paragraph (d) of this sec- for bottled water, including water for tion. use as an ingredient in beverages (ex- (ii) Analyses conducted to determine cept those described in the labeling as compliance with paragraphs (b)(2)(i)(A) ‘‘water,’’ ‘‘carbonated water,’’ ‘‘dis- and (b)(2)(i)(B) of this section and infected water,’’ ‘‘filtered water,’’ § 129.35(a)(3)(i) of this chapter shall be ‘‘seltzer water,’’ ‘‘soda water,’’ ‘‘spar- made in accordance with the multiple- kling water,’’ and ‘‘tonic water’’), is as tube fermentation (MTF) or the mem- follows: brane filter (MF) methods described in (1) Definitions. (i) Trihalomethane the applicable sections of ‘‘Standard (THM) means one of the family of or- Methods for the Examination of Water ganic compounds, named as derivatives and Wastewater,’’ 21st Ed. (2005), Amer- of methane, wherein three of the four ican Public Health Association. The hydrogen atoms in methane are each Director of the Federal Register ap- substituted by a halogen atom in the proves this incorporation by reference molecular structure. in accordance with 5 U.S.C. 552(a) and 1 (ii) Total trihalomethanes (TTHM) CFR part 51. You may obtain a copy means the sum of the concentration in from the American Public Health Asso- milligrams per liter of the ciation, 800 I St. NW., Washington, DC trihalomethane compounds (trichloro- 20001, 202–777–2742 (APHA). You may in- methane, dibromochloromethane, spect a copy at the Food and Drug Ad- bromodichloromethane, and ministration’s Main Library, 10903 New tribromomethane), rounded to two sig- Hampshire Ave., Bldg. 2, Third Floor, nificant figures. Silver Spring, MD 20993, 301–796–2039, or (iii) Haloacetic acids (five) (HAA5) at the National Archives and Records means the sum of the concentrations in Administration (NARA). For informa- milligrams per liter of the haloacetic tion on the availability of this mate- acid compounds (monochloroacetic rial at NARA, call 202–741–6030, or go acid, dichloroacetic acid, to: http://www.archives.gov/ trichloroacetic acid, monobromoacetic federallregister/ acid, and dibromoacetic acid), rounded codeloflfederallregulations/ to two significant figures after addi- ibrllocations.html. tion. (3) Physical quality. Bottled water (2) Microbiological quality. (i) Bottled shall, when a composite of analytical water shall, when a sample consisting units of equal volume from a sample is of analytical units of equal volume is examined by the method described in examined by the methods described in applicable sections of ‘‘Standard Meth- paragraph (b)(2)(ii) of this section, ods for the Examination of Water and meet the following standards of micro- Wastewater,’’ 15th Ed. (1980), American biological quality: Public Health Association, which is in- (A) Total coliform—(1) Multiple-tube corporated by reference in accordance fermentation (MTF) method. Not more with 5 U.S.C. 552(a) and 1 CFR part 51 than one of the analytical units in the (copies may be obtained from the sample shall have a most probable American Public Health Association, number (MPN) of 2.2 or more coliform 800 I St. NW., Washington, DC 20001, organisms per 100 milliliters and no an- 202–777–2742 (APHA), or a copy may be alytical unit shall have an MPN of 9.2 examined at the National Archives and or more coliform organisms per 100 Records Administration (NARA), or at milliliters; or the Food and Drug Administration’s

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Main Library, 10903 New Hampshire of this section are incorporated by ref- Ave., Bldg. 2, Third Floor, Silver erence in accordance with 5 U.S.C. Spring, MD 20993, 301–796–2039, for infor- 552(a) and 1 CFR part 51 and are de- mation on the availability of this ma- scribed in ‘‘Standard Methods for Ex- terial at NARA, call 202–741–6030, or go amination of Water and Wastewater,’’ to: http://www.archives.gov/ 15th Ed. (1980). Copies may be obtained federallregister/ from the American Public Health Asso- codeloflfederallregulations/ ciation, 800 I St. NW., Washington DC ibrllocations.html), meet the following 20001, and examined at the National Ar- standards of physical quality: chives and Records Administration (i) The turbidity shall not exceed 5 (NARA) , or the Food and Drug Admin- units. istration’s Main Library, 10903 New (ii) The color shall not exceed 15 Hampshire Ave., Bldg. 2, Third Floor, units. 1 Silver Spring, MD 20993, 301–796–2039. (iii) The odor shall not exceed thresh- For information on the availability of old odor No. 3. 1 this material at NARA, call 202–741– (4) Chemical quality. (i)(A) Bottled 6030, or go to: http://www.archives.gov/ water shall, when a composite of ana- federallregister/ lytical units of equal volume from a codeloflfederallregulations/ sample is examined by the methods de- ibrllocations.html. The methods in scribed in paragraph (b)(4)(i)(B) of this paragraphs (b)(4)(i)(C)(3) and (C)(4) are section, meet standards of chemical cross-referenced in 40 CFR part 141, quality and shall not contain chemical subpart C, appendix C. substances in excess of the following (1) ‘‘Methods for Organochlorine Pes- concentrations: ticides in Industrial Effluents;’’ Concentration in (2) ‘‘Methods for Chlorinated Substance milligrams per liter Phenoxy Acid Herbicides in Industrial Effluents,’’ November 28, 1973; Chloride1 ...... 250.0 Iron1 ...... 0 .3 (3) ‘‘Part I: The Analysis of Manganese1 ...... 0.05 Trihalomethanes in Finished Waters by Phenols ...... 0 .001 the Purge and Trap Method;’’ which is Total dissolved solids1 ...... 500.0 Zinc 1 ...... 5 .0 cross-referenced in 40 CFR part 141, subpart C, appendix C; 1 Mineral water is exempt from allowable level. The exemptions are aesthetically based allowable levels and do not re- (4) ‘‘Part II: The Analysis of late to a health concern. Trihalomethanes in Drinking Water by (B) Analyses conducted to determine Liquid/Liquid Extraction,’’ which is compliance with paragraph (b)(4)(i)(A) cross-referenced in 40 CFR part 141, of this section shall be made in accord- subpart C, appendix C; ance with the methods described in the (ii)(A) Bottled water packaged in the applicable sections of ‘‘Standard Meth- United States to which no fluoride is ods for the Examination of Water and added shall not contain fluoride in ex- Wastewater,’’ 15th Ed. (1980), or cess of the levels in Table 1 and these ‘‘Methods for Chemical Analysis of levels shall be based on the annual av- Water and Wastes,’’ Environmental erage of maximum daily air tempera- Monitoring and Support Laboratory tures at the location where the bottled (EMSL), EPA–600/4–79–020, March 1983, water is sold at retail. U.S. Environmental Protection Agency (EPA), both of which are incorporated TABLE 1 by reference in accordance with 5 Annual average of maximum daily air tem- Fluoride con- U.S.C. 552(a) and 1 CFR part 51. peratures (°F) centration in mil- (C) Analyses for organic substances ligrams per liter shall be determined by the appropriate 53.7 and below ...... 2.4 methods set forth below. The methods 53.8–58.3 ...... 2.2 in paragraphs (b)(4)(i) (C)(1) and (C)(2) 58.4–63.8 ...... 2.0 63.9–70.6 ...... 1.8 70.7–79.2 ...... 1.6 1 Mineral water is exempt from allowable 79.3–90.5 ...... 1.4 level. The exemptions are aesthetically based allowable levels and do not relate to a (B) Imported bottled water to which health concern. no fluoride is added shall not contain

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fluoride in excess of 1.4 milligrams per (B) The allowable levels for volatile liter. organic chemicals (VOC’s) are as fol- (C) Bottled water packaged in the lows: United States to which fluoride is Contaminant Concentration in added shall not contain fluoride in ex- (CAS Reg. No.) milligrams per liter cess of levels in Table 2 and these levels shall be based on the annual aver- Benzene (71–43–2) ...... 0 .005 Carbon tetrachloride (56–23–5) ...... 0 .005 age of maximum daily air tempera- o- Dichlorobenzene (95–50–1) ...... 0 .6 tures at the location where the bottled p- Dichlorobenzene (106–46–7) ...... 0 .075 water is sold at retail. 1,2-Dichloroethane (107–06–2) ...... 0.005 1,1-Dichloroethylene (75–35–4) ...... 0 .007 cis-1,2-Dichloroethylene (156–59–2) ...... 0.07 TABLE 2 trans-1,2-Dichloroethylene (156–60–5) ... 0 .1 Dichloromethane (75–09–2) ...... 0 .005 Annual average of maximum daily air tem- Fluoride con- 1,2-Dichloropropane (78–87–5) ...... 0 .005 peratures (°F) centration in mil- Ethylbenzene (100–41–4) ...... 0 .7 ligrams per liter Monochlorobenzene (108–90–7) ...... 0 .1 Styrene (100–42–5) ...... 0 .1 53.7 and below ...... 1.7 Tetrachloroethylene (127–18–4) ...... 0 .005 53.8–58.3 ...... 1.5 Toluene (108–88–3) ...... 1 58.4–63.8 ...... 1.3 1,2,4–Trichlorobenzene (120–82–1) ...... 0.07 63.9–70.6 ...... 1.2 1,1,1-Trichloroethane (71–55–6) ...... 0.20 70.7–79.2 ...... 1.0 1,1,2–Trichloroethane (79–00–5) ...... 0 .005 79.3–90.5 ...... 0.8 Trichloroethylene (79–01–6) ...... 0 .005 Vinyl chloride (75–01–4) ...... 0 .002 (D) Imported bottled water to which Xylenes (1330–20–7) ...... 10 fluoride is added shall not contain fluo- (C) The allowable levels for pesticides ride in excess of 0.8 milligram per liter. and other synthetic organic chemicals (iii) Having consulted with EPA as (SOC’s) are as follows: required by section 410 of the Federal Food, Drug, and Cosmetic Act, the Contaminant Concentration in Food and Drug Administration has de- (CAS Reg. No.) milligrams per liter termined that bottled water, when a Alachlor (15972–60–8) ...... 0 .002 composite of analytical units of equal Atrazine (1912–24–9) ...... 0 .003 volume from a sample is examined by Benzo(a)pyrene (50–32–8) ...... 0.0002 Carbofuran (1563–66–2) ...... 0.04 the methods listed in paragraphs Chlordane (57–74–9) ...... 0 .002 (b)(4)(iii)(E) through (b)(4)(iii)(F), and Dalapon (75–99–0) ...... 0.2 (b)(4)(iii)(G) of this section, shall not 1,2-Dibromo-3-chloropropane (96–12–8) 0 .0002 2,4-D (94–75–7) ...... 0 .07 contain the following chemical con- Di(2-ethylhexyl)adipate (103–23–1) ...... 0.4 taminants in excess of the concentra- Di(2-ethylhexyl)phthalate (117–81–7) ..... 0 .006 tions specified in paragraphs Dinoseb (88–85–7) ...... 0 .007 (b)(4)(iii)(A) through (b)(4)(iii)(D) of Diquat (85–00–7) ...... 0 .02 Endothall (145–73–3) ...... 0 .1 this section. Endrin (72–20–8) ...... 0 .002 (A) The allowable levels for inorganic Ethylene dibromide (106–93–4) ...... 0 .00005 substances are as follows: Glyphosate (1071–53–6) ...... 0 .7 Heptachlor (76–44–8) ...... 0 .0004 Heptachlor epoxide (1024–57–3) ...... 0 .0002 Concentration in milli- Contaminant grams per liter (or as Hexachlorobenzene (118–74–4) ...... 0 .001 specified) Hexachlorocyclopentadiene (77–47–4) ... 0 .05 Lindane (58–89–9) ...... 0 .0002 Arsenic ...... 0 .010 Methoxychlor (72–43–5) ...... 0 .04 Antimony ...... 006 Oxamyl (23135–22–0) ...... 0 .2 Barium ...... 2 Pentachlorophenol (87–86–5) ...... 0 .001 Beryllium ...... 0 .004 PCB’s (as decachlorobiphenyl) (1336– Cadmium ...... 0 .005 36–3) ...... 0 .0005 Chromium ...... 0 .1 Picloram (1918–02–1) ...... 0.5 Simazine (122–34–9) ...... 0 .004 Copper ...... 1 .0 2,3,7,8-TCDD (Dioxin) (1746–01–6) ...... 3 × 10¥8 Cyanide ...... 0 .2 Toxaphene (8001–35–2) ...... 0 .003 Lead ...... 0 .005 2,4,5-TP (Silvex) (93–72–1) ...... 0 .05 Mercury ...... 0 .002 Nickel ...... 0 .1 Nitrate ...... 10 (as nitrogen) (D) The allowable levels for certain Nitrite ...... 1 (as nitrogen) chemicals for which EPA has estab- Total Nitrate and Nitrite ...... 10 (as nitrogen) lished secondary maximum contami- Selenium ...... 0 .05 nant levels in its drinking water regu- Thallium ...... 0 .002 lations (40 CFR part 143) are as follows:

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Concentration in DC 20460, (EPA/600/4–91/010), June 1991, Contaminant milligrams per which is incorporated by reference in liter accordance with 5 U.S.C. 552(a) and 1 Aluminum ...... 0.2 CFR part 51. Copies of this publication Silver ...... 0.1 Sulfate 1 ...... 250.0 are available from the National Tech- nical Information Service, U.S. Depart- 1 Mineral water is exempt from allowable level. The exemptions are aesthetically based allowable levels and do not re- ment of Commerce, 5285 Port Royal late to a health concern. Rd., Springfield, VA 22161, or may be (E) Analyses to determine compli- examined at the Food and Drug Admin- ance with the requirements of para- istration’s Main Library, 10903 New graph (b)(4)(iii)(A) of this section shall Hampshire Ave., Bldg. 2, Third Floor, be conducted in accordance with an ap- Silver Spring, MD 20993, 301–796–2039, or plicable method and applicable revi- at the National Archives and Records sions to the methods listed in para- Administration (NARA). For informa- graphs (b)(4)(iii)(E)(1) through tion on the availability of this mate- (b)(4)(iii)(E)(14) of this section and de- rial at NARA, call 202–741–6030, or go scribed, unless otherwise noted, in to: http://www.archives.gov/ ‘‘Methods for Chemical Analysis of federallregister/ Water and Wastes,’’ U.S. EPA Environ- codeloflfederallregulations/ mental Monitoring and Support Lab- ibrllocations.html. oratory (EMSL), Cincinnati, OH 45258 (iii) Method 200.9—‘‘Determination of (EPA–600/4–79–020), March 1983, which is Trace Elements by Stabilized Tempera- incorporated by reference in accord- ture Graphite Furnace Atomic Absorp- ance with 5 U.S.C. 552(a) and 1 CFR tion Spectrometry,’’ Rev. 1.2, April part 51. Copies of this publication are 1991, U.S. EPA, EMSL. The revision is available from the National Technical contained in the manual entitled Information Service (NTIS), U.S. De- ‘‘Methods for the Determination of partment of Commerce, 5825 Port Metals in Environmental Samples,’’ Of- Royal Rd., Springfield, VA 22161, or fice of Research and Development, may be examined at the Food and Drug Washington, DC 20460, (EPA/600/4–91/ Administration’s Main Library, 10903 010), June 1991, which is incorporated New Hampshire Ave., Bldg. 2, Third by reference in accordance with 5 Floor, Silver Spring, MD 20993, 301–796– U.S.C. 552(a) and 1 CFR part 51. The 2039, or at the National Archives and availability of this incorporation by Records Administration (NARA). For reference is given in paragraph information on the availability of this (b)(4)(iii)(E)(1)(ii) of this section. material at NARA, call 202–741–6030, or (iv) Method D–3697–92—‘‘Standard go to: http://www.archives.gov/ Test Method for Antimony in Water,’’ federallregister/ contained in the Annual Book of ASTM codeloflfederallregulations/ Standards, vols. 11.01 and 11.02, 1995, ibrllocations.html. American Society for Testing and Ma- (1) Antimony shall be measured using terials, 100 Barr Harbor Dr., West the following methods: Conshohocken, PA 19428, which is in- (i) Method 204.2—‘‘Atomic Absorp- corporated by reference in accordance tion; furnace technique,’’ which is in- with 5 U.S.C. 552(a) and 1 CFR part 51. corporated by reference in accordance Copies of this publication are available with 5 U.S.C. 552(a) and 1 CFR part 51. from American Society for Testing and The availability of this incorporation Materials, 100 Barr Harbor Dr., West by reference is given in paragraph Conshohocken, PA 19428, or may be ex- (b)(4)(iii)(E) of this section. amined at the Food and Drug Adminis- (ii) Method 200.8—‘‘Determination of tration’s Main Library, 10903 New Trace Elements in Water and Wastes Hampshire Ave., Bldg. 2, Third Floor, by Inductively Coupled Plasma-Mass Silver Spring, MD 20993, 301–796–2039, or Spectrometry,’’ Rev. 4.4, April 1991, at the National Archives and Records U.S. EPA, EMSL. The revision is con- Administration (NARA). For informa- tained in the manual entitled ‘‘Meth- tion on the availability of this mate- ods for the Determination of Metals in rial at NARA, call 202–741–6030, or go Environmental Samples,’’ Office of Re- to: http://www.archives.gov/ search and Development, Washington, federallregister/

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codeloflfederallregulations/ (iii) Method 200.8—‘‘Determination of ibrllocations.html. Trace Elements in Water and Wastes (2) Barium shall be measured using by Inductively Coupled Plasma-Mass the following methods: Spectrometry,’’ Rev. 4.4, April 1991, (i) Method 208.2—‘‘Atomic Absorp- U.S. EPA, EMSL. The revision is con- tion; furnace technique,’’ which is in- tained in the manual entitled ‘‘Meth- corporated by reference in accordance ods for the Determination of Metals in with 5 U.S.C. 552(a) and 1 CFR part 51, Environmental Samples,’’ Office of Re- or search and Development, Washington, (ii) Method 208.1—‘‘Atomic Absorp- DC 20460, (EPA/600/4–91/010), June 1991, tion; direct aspiration,’’ which is incor- which is incorporated by reference in porated by reference in accordance accordance with 5 U.S.C. 552(a) and 1 with 5 U.S.C. 552(a) and 1 CFR part 51. CFR part 51. The availability of this in- The availability of this incorporation corporation by reference is given in by reference is given in paragraph paragraph (b)(4)(iii)(E)(1)(ii) of this sec- (b)(4)(iii)(E) of this section. tion. (iii) Method 200.7—‘‘Determination of (iv) Method 200.9—‘‘Determination of Metals and Trace Elements in Water Trace Elements by Stabilized Tempera- and Wastes by Inductively Coupled ture Graphite Furnace Atomic Absorp- Plasma-Atomic Emission Spectrom- tion Spectrometry,’’ Rev. 1.2, April etry,’’ Rev. 3.3, April 1991, U.S. EPA, 1991, U.S. EPA, EMSL. The revision is EMSL. The revision is contained in the contained in the manual entitled manual entitled ‘‘Methods for the De- ‘‘Methods for the Determination of termination of Metals in Environ- Metals in Environmental Samples,’’ Of- mental Samples,’’ Office of Research fice of Research and Development, and Development, Washington, DC Washington, DC 20460, (EPA/600/4–91/ 20460, (EPA/600/4–91/010), June 1991, 010), June 1991, which is incorporated which is incorporated by reference in by reference in accordance with 5 accordance with 5 U.S.C. 552(a) and 1 U.S.C. 552(a) and 1 CFR part 51. The CFR part 51. The availability of this in- availability of this incorporation by corporation by reference is given in reference is given in paragraph paragraph (b)(4)(iii)(E)(1)(ii) of this sec- (b)(4)(iii)(E)(1)(ii) of this section. tion. (3) Beryllium shall be measured using (4) Cadmium shall be measured using the following methods: the following methods: (i) Method 210.2—‘‘Atomic Absorp- (i) Method 213.2—‘‘Atomic Absorp- tion; Furnace Technique,’’ which is in- tion; Furnace Technique,’’ which is incorporated by reference in accordance corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation The availability of this incorporation by reference is given in paragraph by reference is given in paragraph (b)(4)(iii)(E) of this section. (b)(4)(iii)(E) of this section. (ii) Method 200.7—‘‘Determination of (ii) Method 200.7—‘‘Determination of Metals and Trace Elements in Water Metals and Trace Elements in Water and Wastes by Inductively Coupled and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrom- Plasma-Atomic Emission Spectrom- etry,’’ Rev. 3.3, April 1991, U.S. EPA, etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the EMSL. The revision is contained in the manual entitled ‘‘Methods for the De- manual entitled ‘‘Methods for the De- termination of Metals in Environ- termination of Metals in Environ- mental Samples,’’ Office of Research mental Samples,’’ Office of Research and Development, Washington, DC and Development, Washington, DC 20460, (EPA/600/4–91/010), June 1991, 20460, (EPA/600/4–91/010), June 1991, which is incorporated by reference in which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this in- CFR part 51. The availability of this incorporation by reference is given in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec- paragraph (b)(4)(iii)(E)(1)(ii) of this section. tion.

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(5) Chromium shall be measured (iv) Method 200.8—‘‘Determination of using the following methods: Trace Elements in Water and Wastes (i) Method 218.2—‘‘Atomic Absorp- by Inductively Coupled Plasma-Mass tion; furnace technique,’’ which is in- Spectrometry,’’ Rev. 4.4, April 1991, corporated by reference in accordance U.S. EPA, EMSL. The revision is con- with 5 U.S.C. 552(a) and 1 CFR part 51. tained in the manual entitled ‘‘Meth- The availability of this incorporation ods for the Determination of Metals in by reference is given in paragraph Environmental Samples,’’ Office of Re- (b)(4)(iii)(E) of this section. search and Development, Washington, (ii) Method 200.7—‘‘Determination of DC 20460, (EPA/600/4–91/010), June 1991, Metals and Trace Elements in Water which is incorporated by reference in and Wastes by Inductively Coupled accordance with 5 U.S.C. 552(a) and 1 Plasma-Atomic Emission Spectrom- CFR part 51. The availability of this in- etry,’’ Rev. 3.3, April 1991, U.S. EPA, corporation by reference is given in EMSL. The revision is contained in the paragraph (b)(4)(iii)(E)(1)(ii) of this sec- manual entitled ‘‘Methods for the De- tion. termination of Metals in Environ- (v) Method 200.9—‘‘Determination of mental Samples,’’ Office of Research Trace Elements by Stabilized Tempera- and Development, Washington, DC ture Graphite Furnace Atomic Absorp- 20460, (EPA/600/4–91/010), June 1991, tion Spectrometry,’’ Rev. 1.2, April which is incorporated by reference in 1991, U.S. EPA, EMSL. The revision is accordance with 5 U.S.C. 552(a) and 1 contained in the manual entitled CFR part 51. The availability of this in- ‘‘Methods for the Determination of corporation by reference is given in Metals in Environmental Samples,’’ Of- paragraph (b)(4)(iii)(E)(1)(ii) of this sec- fice of Research and Development, tion. Washington, DC 20460, (EPA/600/4–91/ 010), June 1991, which is incorporated (6) Copper shall be measured as total by reference in accordance with 5 recoverable metal without filtration U.S.C. 552(a) and 1 CFR part 51. The using the following methods: availability of this incorporation by (i) Method 220.2—‘‘Atomic Absorp- reference is given in paragraph tion; furnace technique,’’ which is in- (b)(4)(iii)(E)(1)(ii) of this section. corporated by reference in accordance (7) Cyanide shall be measured using with 5 U.S.C. 552(a) and 1 CFR part 51, the following methods: or (i) Method 335.1—‘‘Titrimetric; (ii) Method 220.1—‘‘Atomic Absorp- Spectrophotometric’’ which is incor- tion; direct aspiration,’’ which is incorporated by reference in accordance porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, with 5 U.S.C. 552(a) and 1 CFR part 51. or The availability of these incorporation (ii) Method 335.2—‘‘Titrimetric; by reference is given in paragraph Spectrophotometric’’ which is incor- (b)(4)(iii)(E) of this section. porated by reference in accordance (iii) Method 200.7—‘‘Determination of with 5 U.S.C. 552(a) and 1 CFR part 51, Metals and Trace Elements in Water or and Wastes by Inductively Coupled (iii) Method 335.3—‘‘Colorimetric, Plasma-Atomic Emission Spectrom- Automated UV,’’ which is incorporated etry,’’ Rev. 3.3, April 1991, U.S. EPA, by reference in accordance with 5 EMSL. The revision is contained in the U.S.C. 552(a) and 1 CFR part 51. The manual entitled ‘‘Methods for the De- availability of these incorporation by termination of Metals in Environ- reference is given in paragraph mental Samples,’’ Office of Research (b)(4)(iii)(E) of this section. and Development, Washington, DC (iv) Method D–2036–91—‘‘Standard 20460, (EPA/600/4–91/010), June 1991, Test Methods for Cyanides in Water,’’ which is incorporated by reference in contained in the Annual Book of ASTM accordance with 5 U.S.C. 552(a) and 1 Standards, vols. 11.01 and 11.02, 1995, CFR part 51. The availability of this in- American Society for Testing and Ma- corporation by reference is given in terials, 100 Barr Harbor Dr., West paragraph (b)(4)(iii)(E)(1)(ii) of this sec- Conshohocken, PA 19428, which is in- tion. corporated by reference in accordance

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with 5 U.S.C. 552(a) and 1 CFR part 51. (9) Mercury shall be measured using Copies of this publication are available the following methods: from American Society for Testing and (i) Method 245.1—‘‘Manual cold vapor Materials, 100 Barr Harbor Dr., West technique,’’ which is incorporated by Conshohocken, PA 19428, or may be ex- reference in accordance with 5 U.S.C. amined at the Food and Drug Adminis- 552(a) and 1 CFR part 51, or tration’s Main Library, 10903 New (ii) Method 245.2—‘‘Automated cold Hampshire Ave., Bldg. 2, Third Floor, vapor technique,’’ which is incor- Silver Spring, MD 20993, 301–796–2039, or porated by reference in accordance at the National Archives and Records with 5 U.S.C. 552(a) and 1 CFR part 51. Administration (NARA). For informa- The availability of these incorporation tion on the availability of this mate- by reference is given in paragraph rial at NARA, call 202–741–6030, or go (b)(4)(iii)(E) of this section. to: http://www.archives.gov/ (10) Nickel shall be measured using federallregister/ the following methods: codeloflfederallregulations/ (i) Method 249.1—‘‘Atomic Absorp- ibrllocations.html. tion; direct aspiration,’’ which is incor- (8) Lead shall be measured as total porated by reference in accordance recoverable metal without filtration with 5 U.S.C. 552(a) and 1 CFR part 51, using the following methods: or (i) Method 239.2—‘‘Atomic Absorp- tion; furnace technique,’’ which is in- (ii) Method 249.2—‘‘Atomic Absorp- corporated by reference in accordance tion; furnace technique,’’ which is in- with 5 U.S.C. 552(a) and 1 CFR part 51. corporated by reference in accordance The availability of this incorporation with 5 U.S.C. 552(a) and 1 CFR part 51. by reference is given in paragraph The availability of these incorporation (b)(4)(iii)(E) of this section. by reference is given in paragraph (ii) Method 200.8—‘‘Determination of (b)(4)(iii)(E) of this section. Trace Elements in Water and Wastes (iii) Method 200.7—‘‘Determination of by Inductively Coupled Plasma-Mass Metals and Trace Elements in Water Spectrometry,’’ Rev. 4.4, April 1991, and Wastes by Inductively Coupled U.S. EPA, EMSL. The revision is con- Plasma-Atomic Emission Spectrom- tained in the manual entitled ‘‘Meth- etry,’’ Rev. 3.3, April 1991, U.S. EPA, ods for the Determination of Metals in EMSL. The revision is contained in the Environmental Samples,’’ Office of Re- manual entitled ‘‘Methods for the De- search and Development, Washington, termination of Metals in Environ- DC 20460, (EPA/600/4–91/010), June 1991, mental Samples,’’ Office of Research which is incorporated by reference in and Development, Washington, DC accordance with 5 U.S.C. 552(a) and 1 20460, (EPA/600/4–91/010), June 1991, CFR part 51. The availability of this in- which is incorporated by reference in corporation by reference is given in accordance with 5 U.S.C. 552(a) and 1 paragraph (b)(4)(iii)(E)(1)(ii) of this sec- CFR part 51. The availability of this in- tion. corporation by reference is given in (iii) Method 200.9—‘‘Determination of paragraph (b)(4)(iii)(E)(1)(ii) of this sec- Trace Elements by Stabilized Tempera- tion. ture Graphite Furnace Atomic Absorp- (iv) Method 200.8—‘‘Determination of tion Spectrometry,’’ Rev. 1.2, April Trace Elements in Water and Wastes 1991, U.S. EPA, EMSL. The revision is by Inductively Coupled Plasma-Mass contained in the manual entitled Spectrometry,’’ Rev. 4.4, April 1991, ‘‘Methods for the Determination of U.S. EPA, EMSL. The revision is con- Metals in Environmental Samples,’’ Of- tained in the manual entitled ‘‘Meth- fice of Research and Development, ods for the Determination of Metals in Washington, DC 20460, (EPA/600/4–91/ Environmental Samples,’’ Office of Re- 010), June 1991, which is incorporated search and Development, Washington, by reference in accordance with 5 DC 20460, (EPA/600/4–91/010), June 1991, U.S.C. 552(a) and 1 CFR part 51. The which is incorporated by reference in availability of this incorporation by accordance with 5 U.S.C. 552(a) and 1 reference is given in paragraph CFR part 51. The availability of this in- (b)(4)(iii)(E)(1)(ii) of this section. corporation by reference is given in

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paragraph (b)(4)(iii)(E)(1)(ii) of this sec- (12) Selenium shall be measured tion. using the following methods: (v) Method 200.9—‘‘Determination of (i) Method 270.2—‘‘Atomic Absorp- Trace Elements by Stabilized Tempera- tion; furnace technique,’’ which is in- ture Graphite Furnace Atomic Absorp- corporated by reference in accordance tion Spectrometry,’’ Rev. 1.2, April with 5 U.S.C. 552(a) and 1 CFR part 51, 1991, U.S. EPA, EMSL. The revision is or contained in the manual entitled (ii) Method 270.3—‘‘Atomic Absorp- ‘‘Methods for the Determination of tion; gaseous hydride,’’ which is incor- Metals in Environmental Samples,’’ Of- porated by reference in accordance fice of Research and Development, with 5 U.S.C. 552(a) and 1 CFR part 51. Washington, DC 20460, (EPA/600/4–91/ The availability of this incorporation 010), June 1991, which is incorporated by reference is given in paragraph by reference in accordance with 5 (b)(4)(iii)(E) of this section. U.S.C. 552(a) and 1 CFR part 51. The (13) Thallium shall be measured using availability of this incorporation by the following methods: reference is given in paragraph (i) Method 279.2—‘‘Atomic Absorp- (b)(4)(iii)(E)(1)(ii) of this section. tion; furnace technique,’’ which is in- (11) Nitrate and/or nitrite shall be corporated by reference in accordance measured using the following methods: with 5 U.S.C. 552(a) and 1 CFR part 51. (i) Method 300.0—‘‘The Determination The availability of this incorporation of Inorganic Anions in Water by Ion by reference is given in paragraph Chromatography—Method 300.0,’’ EPA, (b)(4)(iii)(E) of this section. EMSL (EPA–600/4–84–017), March 1984, (ii) Method 200.8—‘‘Determination of which is incorporated by reference in Trace Elements in Water and Wastes accordance with 5 U.S.C. 552(a) and 1 by Inductively Coupled Plasma-Mass CFR part 51. Copies of this publication Spectrometry,’’ Rev. 4.4, April 1991, are available from NTIS, U.S. Depart- U.S. EPA, EMSL. The revision is con- ment of Commerce, 5285 Port Royal tained in the manual entitled ‘‘Meth- Rd., Springfield, VA 22161, or may be ods for the Determination of Metals in examined at the Food and Drug Admin- Environmental Samples,’’ Office of Re- istration’s Main Library, 10903 New search and Development, Washington, Hampshire Ave., Bldg. 2, Third Floor, DC 20460, (EPA/600/4–91/010), June 1991, Silver Spring, MD 20993, 301–796–2039, or which is incorporated by reference in at the National Archives and Records accordance with 5 U.S.C. 552(a) and 1 Administration (NARA). For informa- CFR part 51. The availability of this in- tion on the availability of this mate- corporation by reference is given in rial at NARA, call 202–741–6030, or go paragraph (b)(4)(iii)(E)(1)(ii) of this sec- to: http://www.archives.gov/ tion. federallregister/ (iii) Method 200.9—‘‘Determination of codeloflfederallregulations/ Trace Elements by Stabilized Tempera- ibrllocations.html. ture Graphite Furnace Atomic Absorp- (ii) Method 353.1—‘‘Colorimetric, tion Spectrometry,’’ Rev. 1.2, April automated, hydrazine reduction,’’ for 1991, U.S. EPA, EMSL. The revision is nitrate only, which is incorporated by contained in the manual entitled reference in accordance with 5 U.S.C. ‘‘Methods for the Determination of 552(a) and 1 CFR part 51, or Metals in Environmental Samples,’’ Of- (iii) Method 353.2—‘‘Colorimetric, fice of Research and Development, automated, cadmium reduction,’’ for Washington, DC 20460, (EPA/600/4–91/ both nitrate and nitrite, which is in- 010), June 1991, which is incorporated corporated by reference in accordance by reference in accordance with 5 with 5 U.S.C. 552(a) and 1 CFR part 51, U.S.C. 552(a) and 1 CFR part 51. The or availability of this incorporation by (iv) Method 353.3—‘‘Spectrophoto- reference is given in paragraph metric, cadmium reduction,’’ for both (b)(4)(iii)(E)(1)(ii) of this section. nitrate and nitrite, which is incor- (14) Arsenic shall be measured using porated by reference in accordance the following methods: with 5 U.S.C. 552(a) and 1 CFR part 51, (i) Method 200.8—‘‘Determination of or Trace Elements in Waters and Wastes

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by Inductively Coupled Plasma-Mass Supplement III,’’ EPA National Expo- Spectrometry,’’ Revision 5.4, which is sure Research Laboratory, Office of Re- incorporated by reference in accord- search and Development, EPA/600/R–95/ ance with 5 U.S.C. 552(a) and 1 CFR 131, August 1995, including Errata, No- part 51. Method 200.8 is contained in vember 27, 1995. The Director of the the manual entitled ‘‘Methods for the Federal Register approves this incorpo- Determination of Metals in Environ- ration by reference in accordance with mental Samples—Supplement 1,’’ EPA/ 5 U.S.C. 552(a) and 1 CFR part 51. Cop- 600/R–94/111, May 1994. Copies of this ies of these publications are available publication are available from the Na- from National Technical Information tional Technical Information Service Service, U.S. Department of Com- (NTIS), PB95–125472, U.S. Department merce, 5285 Port Royal Rd., Spring- of Commerce, 5825 Port Royal Rd., field, VA 22161. You may inspect a copy Springfield, VA 22161, or may be exam- at the Division of Dockets Manage- ined at the Food and Drug Administra- ment, 5630 Fishers Lane, rm. 1061, tion’s Main Library, 10903 New Hamp- Rockville, MD 20852, 301–827–6860 or at shire Ave., Bldg. 2, Third Floor, Silver the National Archives and Records Ad- Spring, MD 20993, 301–796–2039, or at the ministration (NARA). Hearing-im- National Archives and Records Admin- paired or speech-impaired individuals istration (NARA). For information on may access this number through TTY the availability of this material at by calling the toll-free Federal Relay NARA, call 202–741–6030, or go to: http:// Service at 800–877–8339. For information www.archives.gov/federallregister/ on the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federal-register/ cfr/ibr- (ii) Method 200.9—‘‘Determination of locations.html. Trace Elements by Stabilized Tempera- (1) Method 502.1—‘‘Volatile Halo- ture Graphite Furnace Atomic Absorp- genated Organic Compounds in Water tion,’’ Revision 2.2, which is incor- by Purge and Trap Gas Chroma- porated by reference in accordance tography,’’ Rev. 2.0, 1989, (applicable to with 5 U.S.C. 552(a) and 1 CFR part 51. VOC’s), which is incorporated by ref- Method 200.9 is contained in the man- erence in accordance with 5 U.S.C. ual entitled ‘‘Methods for the Deter- 552(a) and 1 CFR part 51, or mination of Metals in Environmental (2) Method 502.2—‘‘Volatile Organic Samples—Supplement 1,’’ EPA/600/R–94/ Compounds in Water by Purge and 111, May 1994. The availability of this Trap Capillary Column Gas Chroma- incorporation by reference is given in tography with Photoionization and paragraph (b)(4)(iii)(E)(14)(i) of this sec- Electrolytic Conductivity Detectors in tion. Series,’’ Rev. 2.0, 1989, (applicable to (F) Analyses to determine compli- VOC’s), which is incorporated by ref- ance with the requirements of para- erence in accordance with 5 U.S.C. graphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of 552(a) and 1 CFR part 51, or this section shall be conducted in ac- (3) Method 503.1—‘‘Volatile Aromatic cordance with an applicable method or and Unsaturated Organic Compounds applicable revisions to the methods in Water by Purge and Trap Gas Chro- listed in paragraphs (b)(4)(iii)(F)(1) matography,’’ Rev. 2.0, 1989, (applicable through (b)(4)(iii)(F)(22) of this section to VOC’s), which is incorporated by ref- and described, unless otherwise noted, erence in accordance with 5 U.S.C. in ‘‘Methods for the Determination of 552(a) and 1 CFR part 51, or Organic Compounds in Drinking (4) Method 524.1—‘‘Measurement of Water,’’ Office of Research and Devel- Purgeable Organic Compounds in opment, EMSL, EPA/600/4–88/039, De- Water by Packed Column Gas Chroma- cember 1988, or in ‘‘Methods for the De- tography/Mass Spectrometry,’’ Rev. termination of Organic Compounds in 3.0, 1989, (applicable to VOC’s), which is Drinking Water, Supplement 1,’’ Office incorporated by reference in accord- of Research and Development, EMSL, ance with 5 U.S.C. 552(a) and 1 CFR EPA/600/4–90/020, July 1990, or in part 51, or ‘‘Methods for the Determination of Or- (5) Method 524.2—‘‘Measurement of ganic Compounds in Drinking Water, Purgeable Organic Compounds in

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Water by Capillary Column Gas Chro- (11) Method 508A—‘‘Screening for matography/Mass Spectrometry,’’ Rev. Polychlorinated Biphenyls by Per- 3.0, 1989, (applicable to VOC’s), which is chlorination and Gas Chroma- incorporated by reference in accord- tography,’’ Rev. 1.0, 1989, (used to ance with 5 U.S.C. 552(a) and 1 CFR quantitate PCB’s as part 51, or decachlorobiphenyl if detected in (6) Method 504—‘‘1,2–Dibromoethane methods 505 or 508 in paragraph (EDB) and 1,2–Dibromo-3-Chloropro- (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this pane (DBCP) in Water by Microextrac- section, respectively, which is incor- tion and Gas Chromatography,’’ Rev. porated by reference in accordance 2.0, 1989, (applicable to dibromochloro- with 5 U.S.C. 552(a) and 1 CFR part 51, propane (DBCP) and ethylene or dibromide (EDB)), which is incor- (12) Method 515.1—‘‘Determination of porated by reference in accordance Chlorinated Acids in Water by Gas with 5 U.S.C. 552(a) and 1 CFR part 51, Chromatography with an Electron Cap- or ture Detector,’’ Rev. 5.0, 1991, (applica- (7) Method 505—‘‘Analysis of Organohalide Pesticides and Commer- ble to 2,4–D, 2,4,5–TP (Silvex), cial Polychlorinated Biphenyl (PCB) pentachlorophenol, dalapon, dinoseb, Products in Water by Microextraction and picloram), which is incorporated and Gas Chromatography,’’ Rev. 2.0, by reference in accordance with 5 1989, (applicable to alachlor, atrazine, U.S.C. 552(a) and 1 CFR part 51, or chlordane, heptachlor, heptachlor ep- (13) Method 525.1—‘‘Determination of oxide, lindane, methoxychlor, Organic Compounds in Drinking Water toxaphene, endrin, hexachlorobenzene, by Liquid-Solid Extraction and Cap- hexachlorocyclopentadiene, simazine, illary Column Gas Chromatography/ and as a screen for PCB’s), which is in- Mass Spectrometry,’’ Rev. 2.2, May corporated by reference in accordance 1991, (applicable to alachlor, atrazine, with 5 U.S.C. 552(a) and 1 CFR part 51, chlordane, heptachlor, heptachlor ep- or oxide, lindane, methoxychlor, (8) Method 506—‘‘Determination of pentachlorophenol, benzo(a)pyrene, Phthalate and Adipate Esters in Drink- di(2-ethylhexyl) adipate, endrin, ing Water by Liquid-Liquid Extraction hexachlorobenzene, hexachlorocyclo- or Liquid-Solid Extraction and Gas pentadiene, and simazine), which is in- Chromatography with Photoionization corporated by reference in accordance Detection,’’ applicable to di(2-ethyl- with 5 U.S.C. 552(a) and 1 CFR part 51, hexyl) adipate which is incorporated by or reference in accordance with 5 U.S.C. (14) Method 531.1—‘‘Measurement of 552(a) and 1 CFR part 51, or N-Methylcarbamoyloximes and N- (9) Method 507—‘‘Determination of Methylcarbamates in Water by Direct Nitrogen- and Phosphorus-Containing Aqueous Injection HPLC with Post Col- Pesticides in Water by Gas Chroma- umn Derivatization,’’ Rev. 3.0, 1989, tography with a Nitrogen-Phosphorus (applicable to carbofuran and oxamyl Detector,’’ Rev. 2.0, 1989, (applicable to alachlor, atrazine, and simazine), (vydate)), which is incorporated by ref- which is incorporated by reference in erence in accordance with 5 U.S.C. accordance with 5 U.S.C. 552(a) and 1 552(a) and 1 CFR part 51, or CFR part 51, or (15) Method 547—‘‘Determination of (10) Method 508—‘‘Determination of Glyphosate in Drinking Water by Di- Chlorinated Pesticides in Water by Gas rect-Aqueous-Injection HPLC, Post- Chromatography with an Electron Cap- Column Derivatization, and Fluores- ture Detector,’’ Rev. 3.0, 1989, (applica- cence Detection,’’ (applicable to ble to chlordane, heptachlor, hepta- glyphosate), which is incorporated by chlor epoxide, lindane, methoxychlor, reference in accordance with 5 U.S.C. toxaphene, endrin, hexachlorobenzene, 552(a) and 1 CFR part 51, or and as a screen for PCB’s), which is in- (16) Method 548—‘‘Determination of corporated by reference in accordance Endothall in Drinking Water by Aque- with 5 U.S.C. 552(a) and 1 CFR part 51, ous Derivatization, Liquid-Solid Ex- or traction, and Gas Chromatography

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with Electron-Capture Detection,’’ (ap- (21) Method 506, Rev. 1.1—‘‘Deter- plicable to endothall), which is incor- mination of phthalate and adipate porated by reference in accordance esters in drinking water by liquid/liq- with 5 U.S.C. 552(a) and 1 CFR part 51, uid extraction or liquid/solid extrac- or tion and gas chromatography with (17) Method 549—‘‘Determination of photoionization detection,’’ EPA/600/R– Diquat and Paraquat in Drinking 95/131, 1995, (applicable to di(2- Water by Liquid-Solid Extraction and ethylhexyl)phthalate), which is incor- HPLC with Ultraviolet Detection,’’ (ap- porated by reference in accordance plicable to diquat), which is incor- with 5 U.S.C. 552(a) and 1 CFR part 51, porated by reference in accordance or with 5 U.S.C. 552(a) and 1 CFR part 51, (22) Method 525.2, Rev. 2.0—‘‘Deter- or mination of organic compounds in (18) Method 550—‘‘Determination of drinking water by liquid-solid extrac- Polycyclic Aromatic Hydrocarbons in tion and capillary column gas chroma- Drinking Water by Liquid-Liquid Ex- tography/mass spectrometry,’’ EPA/600/ traction and HPLC with Coupled Ultra- R–95/131, 1995, (applicable to di(2- violet and Fluorescence Detection,’’ ethylhexyl)phthalate), which is incor- (applicable to benzo(a)pyrene and other porated by reference in accordance polynuclear aromatic hydrocarbons), with 5 U.S.C. 552(a) and 1 CFR part 51. which is incorporated by reference in (G) Analyses to determine compli- accordance with 5 U.S.C. 552(a) and 1 ance with the requirements of para- CFR part 51, or graph (b)(4)(iii)(D) of this section shall (19) Method 550.1—‘‘Determination of be conducted in accordance with an ap- Polycyclic Aromatic Hydrocarbons in plicable method and applicable revi- Drinking Water by Liquid-Solid Ex- sions to the methods listed in para- traction and HPLC with Coupled Ultra- graphs (b)(4)(iii)(G)(1) through violet and Fluorescence Detection,’’ (b)(4)(iii)(G)(3) of this section and de- (applicable to benzo(a)pyrene and other scribed, unless otherwise noted, in polynuclear aromatic hydrocarbons), ‘‘Methods of Chemical Analysis of which is incorporated by reference in Water and Wastes,’’ which is incor- accordance with 5 U.S.C. 552(a) and 1 porated by reference in accordance CFR part 51. The availability of these with 5 U.S.C. 552(a) and 1 CFR part 51. incorporation by reference is given in The availability of this incorporation paragraph (b)(4)(iii)(F) of this section. by reference is given in paragraph (20) Method 1613—‘‘Tetra- through (b)(4)(iii)(E) of this section. Octa- Chlorinated Dioxins and Furans (1) Aluminum shall be measured by Isotope Dilution HRGC/HRMS,’’ using the following methods: Rev. A, 1990, EPA, Office of Water Reg- (i) Method 202.1—‘‘Atomic Absorp- ulations and Standards, Industrial tion; direct aspiration technique,’’ Technology Division, (applicable to which is incorporated by reference in 2,3,7,8–TCDD (Dioxin)), which is incor- accordance with 5 U.S.C. 552(a) and 1 porated by reference in accordance CFR part 51, or with 5 U.S.C. 552(a) and 1 CFR part 51. (ii) Method 202.2—‘‘Atomic Absorp- Copies of this publication are available tion; furnace technique,’’ which is in- from USEPA-OST, Sample Control corporated by reference in accordance Center, P.O. Box 1407, Alexandria, VA with 5 U.S.C. 552(a) and 1 CFR part 51. 22313, or may be examined at the Food The availability of this incorporation and Drug Administration’s Main Li- by reference is given in paragraph brary, 10903 New Hampshire Ave., Bldg. (b)(4)(iii)(E). 2, Third Floor, Silver Spring, MD 20993, (iii) Method 200.7—‘‘Determination of 301–796–2039, or at the National Ar- Trace Elements in Water and Wastes chives and Records Administration by Inductively Coupled Plasma-Atomic (NARA). For information on the avail- Emission Spectrometry,’’ Rev. 3.3, ability of this material at NARA, call April 1991, U.S. EPA, EMSL. The revi- 202–741–6030, or go to: http:// sion is contained in the manual enti- www.archives.gov/federallregister/ tled ‘‘Methods for the Determination of codeloflfederallregulations/ Metals in Environmental Samples,’’ Of- ibrllocations.html. fice of Research and Development,

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Washington, DC 20460, (EPA/600/4–91/ tled ‘‘Methods for the Determination of 010), June 1991, which is incorporated Metals in Environmental Samples,’’ Of- by reference in accordance with 5 fice of Research and Development, U.S.C. 552(a) and 1 CFR part 51. The Washington, DC 20460, (EPA/600/4–91/ availability of this incorporation by 010), June 1991, which is incorporated reference is given in paragraph by reference in accordance with 5 (b)(4)(iii)(E)(1)(ii) of this section. U.S.C. 552(a) and 1 CFR part 51. The (iv) Method 200.8—‘‘Determination of availability of this incorporation by Trace Elements in Water and Wastes reference is given in paragraph by Inductively Coupled Plasma-Mass (b)(4)(iii)(E)(1)(ii) of this section. Spectrometry,’’ Rev. 4.4, April 1991, (iv) Method 200.8—‘‘Determination of U.S. EPA, EMSL. The revision is con- Trace Elements in Water and Wastes tained in the manual entitled ‘‘Meth- by Inductively Coupled Plasma-Mass ods for the Determination of Metals in Spectrometry,’’ Rev. 4.4, April 1991, Environmental Samples,’’ Office of Re- U.S. EPA, EMSL. The revision is con- search and Development, Washington, tained in the manual entitled ‘‘Meth- DC 20460, (EPA/600/4–91/010), June 1991, ods for the Determination of Metals in which is incorporated by reference in Environmental Samples,’’ Office of Re- accordance with 5 U.S.C. 552(a) and 1 search and Development, Washington, CFR part 51. The availability of this in- DC 20460, (EPA/600/4–91/010), June 1991, corporation by reference is given in which is incorporated by reference in paragraph (b)(4)(iii)(E)(1)(ii) of this sec- accordance with 5 U.S.C. 552(a) and 1 tion. CFR part 51. The availability of this in- (v) Method 200.9—‘‘Determination of corporation by reference is given in Trace Elements by Stabilized Tempera- paragraph (b)(4)(iii)(E)(1)(ii) of this sec- ture Graphite Furnace Atomic Absorp- tion. tion Spectrometry,’’ Rev. 1.2, April (v) Method 200.9—‘‘Determination of 1991, U.S. EPA, EMSL. The revision is Trace Elements by Stabilized Tempera- contained in the manual entitled ture Graphite Furnace Atomic Absorp- ‘‘Methods for the Determination of tion Spectrometry,’’ Rev. 1.2, April Metals in Environmental Samples,’’ Of- 1991, U.S. EPA, EMSL. The revision is fice of Research and Development, contained in the manual entitled Washington, DC 20460, (EPA/600/4–91/ ‘‘Methods for the Determination of 010), June 1991, which is incorporated Metals in Environmental Samples,’’ Of- by reference in accordance with 5 fice of Research and Development, U.S.C. 552(a) and 1 CFR part 51. The Washington, DC 20460, (EPA/600/4–91/ availability of this incorporation by 010), June 1991, which is incorporated reference is given in paragraph by reference in accordance with 5 (b)(4)(iii)(E)(1)(ii) of this section. U.S.C. 552(a) and 1 CFR part 51. The (2) Silver shall be measured using the availability of these incorporation by following methods: reference is given in paragraph (i) Method 272.1—‘‘Atomic Absorp- (b)(4)(iii)(E)(1)(ii) of this section. tion; direct aspiration technique,’’ (3) Sulfate shall be measured using which is incorporated by reference in the following methods: accordance with 5 U.S.C. 552(a) and 1 (i) Method 300.0—‘‘The Determination CFR part 51, or of Inorganic Anions in Water by Ion (ii) Method 272.2—‘‘Atomic Absorp- Chromatography—Method 300.0,’’ EPA, tion; furnace technique,’’ which is in- EMSL (EPA–600/4–84–017), March 1984, corporated by reference in accordance which is incorporated by reference in with 5 U.S.C. 552(a) and 1 CFR part 51. accordance with 5 U.S.C. 552(a) and 1 The availability of this incorporation CFR part 51. The availability of this in- by reference is given in paragraph corporation by reference is given in (b)(4)(iii)(E) of this section. paragraph (b)(4)(iii)(E)(11)(i) of this sec- (iii) Method 200.7—‘‘Determination of tion. Trace Elements in Water and Wastes (ii) Method 375.1—‘‘Colorimetric, by Inductively Coupled Plasma-Atomic Automated, Chloranilate,’’ which is in- Emission Spectrometry,’’ Rev. 3.3, corporated by reference in accordance April 1991, U.S. EPA, EMSL. The revi- with 5 U.S.C. 552(a) and 1 CFR part 51, sion is contained in the manual enti- or

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(iii) Method 375.3—‘‘Gravimetric,’’ (NTIS number PB94–121811), and EPA/ which is incorporated by reference in 600/R–98/118 (NTIS number PB98–169196). accordance with 5 U.S.C. 552(a) and 1 NTIS can be contacted at NTIS, U.S. CFR part 51, or Department of Commerce, 5285 Port (iv) Method 375.4—‘‘Turbidimetric,’’ Royal Rd., Springfield, VA 22161, 1–800– which is incorporated by reference in 553–6847 or 703–605–6000, www.ntis.gov. accordance with 5 U.S.C. 552(a) and 1 Copies of the publication EPA/600/R–98/ CFR part 51. The availability of these 118 are also available from the Chem- incorporation by reference is given in ical Exposure Research Branch, Micro- paragraph (b)(4)(iii)(E) of this section. biological and Chemical Exposure As- (H) The allowable levels for residual sessment Research Division, National disinfectants and disinfection byprod- Exposure Research Laboratory, U.S. ucts are as follows: EPA, Cincinnati, OH 45268, 513–569–7757,

Concentration in (FAX) 513–569–7757. Copies of ‘‘Standard Substance milligrams per liter Methods for the Examination of Water and Wastewater,’’ 19th Ed., are avail- Disinfection byproducts Bromate ...... 0.010 able from the American Public Health Chlorite ...... 1.0 Association, 1015 15th Street, NW., Haloacetic acids (five) (HAA5) ...... 0.060 Washington, DC 20005. All of the publi- Total Trihalomethanes (TTHM) ...... 0.080 Residual disinfectants cations cited in paragraph (b)(4)(iii)(I) Chloramine ...... 4.0 (as Cl2) of this section may be examined at the Chlorine ...... 4.0 (as Cl2) National Archives and Records Admin- Chlorine dioxide ...... 0.8 (as ClO2) istration (NARA), or at the Food and Drug Administration’s Main Library, (I) Analysis to determine compliance 10903 New Hampshire Ave., Bldg. 2, with the requirements of paragraph Third Floor, Silver Spring, MD 20993, (b)(4)(iii)(H) of this section shall be 301–796–2039. For information on the conducted in accordance with an appli- availability of this material at NARA, cable method listed in paragraphs call 202–741–6030, or go to: http:// (b)(4)(iii)(I)(1) through (b)(4)(iii)(I)(7) of this section and described in ‘‘Method www.archives.gov/federallregister/ 300.1, Determination of Inorganic codeloflfederallregulations/ Anions in Drinking Water by Ion Chro- ibrllocations.html. Copies of ‘‘Annual matography,’’ Rev. 1.0, U.S. EPA, 1997, Book of ASTM Standards,’’ 1996, vol. EPA/600/R–98/118; ‘‘Methods for the De- 11.01, are available from the American termination of Inorganic Substances in Society for Testing and Materials, 100 Environmental Samples,’’ U.S. EPA, Barr Harbor Dr., West Conshohoken, August 1993, EPA/600/R–93/100; ‘‘Meth- PA 19428, or may be examined at the ods for the Determination of Organic Office of the Federal Register. Copies Compounds in Drinking Water-Supple- of the methods incorporated by ref- ment II,’’ U.S. EPA, August 1992, EPA/ erence in paragraph (b)(4)(iii)(I) of this 600/R–92/129; ‘‘Methods for the Deter- section may also be examined at the mination of Organic Compounds in Food and Drug Administration’s Main Drinking Water-Supplement III,’’ U.S. Library, 10903 New Hampshire Ave., EPA, August 1995, EPA/600/R–95/131; Bldg. 2, Third Floor, Silver Spring, MD ‘‘Standard Methods for the Examina- 20993, 301–796–2039. tion of Water and Wastewater,’’ 19th (1) Bromate shall be measured using Ed., American Public Health Associa- the following method: Method 300.1— tion, 1995; and ‘‘Annual Book of ASTM ‘‘Determination of Inorganic Anions in Standards,’’ vol. 11.01, American Soci- Drinking Water by Ion Chroma- ety for Testing and Materials, 1996, tography,’’ Rev. 1.0, U.S. EPA, 1997, which are incorporated by reference in EPA/600/R–98/118, which is incorporated accordance with 5 U.S.C. 552(a) and 1 by reference in accordance with 5 CFR part 51. Copies of the following U.S.C. 552(a) and 1 CFR part 51. The publications are available from the Na- availability of this incorporation by tional Technical Information Service reference is given in paragraph (NTIS): EPA/600/R–95/131 (NTIS number (b)(4)(iii)(I) of this section. PB95–261616), EPA/600/R–92/129 (NTIS (2) Chlorite shall be measured using number PB92–207703), EPA/600/R–93/100 the following methods:

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(i) Method 300.0—‘‘Determination of in the book entitled ‘‘Standard Meth- Inorganic Anions by Ion Chroma- ods for the Examination of Water and tography,’’ Rev. 2.1. The revision is Wastewater,’’ 19th Ed., which is incor- contained in the manual entitled porated by reference in accordance ‘‘Methods for the Determination of In- with 5 U.S.C. 552(a) and 1 CFR part 51. organic Substances in Environmental The availability of this incorporation Samples,’’ U.S. EPA, August 1993, EPA/ by reference is given in paragraph 600/R–93/100, which is incorporated by (b)(4)(iii)(I) of this section. reference in accordance with 5 U.S.C. (4) TTHM shall be measured using 552(a) and 1 CFR part 51. The avail- the following methods: ability of this incorporation by ref- (i) Method 502.2—‘‘Volatile Organic erence is given in paragraph Compounds in Water by Purge and (b)(4)(iii)(I) of this section. Trap Capillary Column Gas Chroma- (ii) Method 300.1—‘‘Determination of tography with Photoionization and Inorganic Anions in Drinking Water by Ion Chromatography,’’ Rev. 1.0, U.S. Electrolytic Conductivity Detectors in EPA, 1997, EPA/600/R–98/118, which is Series,’’ Rev. 2.1. The revision is con- incorporated by reference in accord- tained in the manual entitled ‘‘Meth- ance with 5 U.S.C. 552(a) and 1 CFR ods for the Determination of Organic part 51. The availability of this incor- Compounds in Drinking Water-Supple- poration by reference is given in para- ment III,’’ U.S. EPA, August 1993, EPA/ graph (b)(4)(iii)(I) of this section. 600/R–95/131, which is incorporated by (3) HAA5 shall be measured using the reference in accordance with 5 U.S.C. following methods: 552(a) and 1 CFR part 51. The avail- (i) Method 552.1—‘‘Determination of ability of this incorporation by ref- Haloacetic Acids and Dalapon in erence is given in paragraph Drinking Water by Ion Exchange Liq- (b)(4)(iii)(I) of this section. uid-Solid Extraction and Gas Chroma- (ii) Method 524.2—‘‘Measurement of tography with Electron Capture Detec- Purgeable Organic Compounds in tion,’’ Rev. 1.0. The revision is con- Water by Capillary Column Gas Chro- tained in the manual entitled ‘‘Meth- matography/Mass Spectrometry,’’ Rev. ods for the Determination of Organic 1.0. The revision is contained in the Compounds in Drinking Water-Supple- manual entitled ‘‘Methods for the De- ment II,’’ U.S. EPA, August 1992, EPA/ termination of Organic Compounds in 600/R–92/129, which is incorporated by Drinking Water-Supplement III,’’ U.S. reference in accordance with 5 U.S.C. EPA, August 1993, EPA/600/R–95/131, 552(a) and 1 CFR part 51. The avail- which is incorporated by reference in ability of this incorporation by ref- accordance with 5 U.S.C. 552(a) and 1 erence is given in paragraph CFR part 51. The availability of this in- (b)(4)(iii)(I) of this section. corporation by reference is given in (ii) Method 552.2—‘‘Determination of paragraph (b)(4)(iii)(I) of this section. Haloacetic Acids and Dalapon in Drinking Water by Liquid-Liquid Ex- (iii) Method 551.1—‘‘Determination of traction, Derivatization and Gas Chro- Chlorination Disinfection Byproducts, matography with Electron Capture De- Chlorinated Solvents, and Halogenated tection,’’ Rev. 1.0. The revision is con- Pesticides/Herbicides in Drinking tained in the manual entitled ‘‘Meth- Water by Liquid-Liquid Extraction and ods for the Determination of Organic Gas Chromatography with Electron- Compounds in Drinking Water-Supple- Capture Detection,’’ Rev. 1.0. The revi- ment III,’’ U.S. EPA, August 1993, EPA/ sion is contained in the manual enti- 600/R–95/131, which is incorporated by tled ‘‘Methods for the Determination of reference in accordance with 5 U.S.C. Organic Compounds in Drinking Water- 552(a) and 1 CFR part 51. The avail- Supplement III,’’ U.S. EPA, August ability of this incorporation by ref- 1993, EPA/600/R–95/131, which is incor- erence is given in paragraph porated by reference in accordance (b)(4)(iii)(I) of this section. with 5 U.S.C. 552(a) and 1 CFR part 51. (iii) Method 6251 B—‘‘Disinfection By- The availability of this incorporation Products: Haloacetic Acids and by reference is given in paragraph Trichlorophenol,’’ which is contained (b)(4)(iii)(I) of this section.

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(5) Compliance with the chloramine and Wastewater,’’ 19th Ed., which is in- standard can be determined by meas- corporated by reference in accordance uring combined or total chlorine. The with 5 U.S.C. 552(a) and 1 CFR part 51. following methods shall be used to The availability of this incorporation measure chloramine: by reference is given in paragraph (i) ASTM Method D1253-86—‘‘ Stand- (b)(4)(iii)(I) of this section. ard Test Method for Residual Chlorine (6) Compliance with the chlorine in Water,’’ which is contained in the standard can be determined by meas- book entitled ‘‘Annual Book of ASTM uring free or total chlorine. The fol- Standards,’’ 1996, vol. 11.01, which is in- lowing methods shall be used to meas- corporated by reference in accordance ure chlorine: with 5 U.S.C. 552(a) and 1 CFR part 51. (i) ASTM Method D1253-86—‘‘Stand- The availability of this incorporation ard Test Method for Residual Chlorine by reference is given in paragraph in Water,’’ which is contained in the (b)(4)(iii)(I) of this section. book entitled ‘‘Annual Book of ASTM (ii) Method 4500-Cl D—‘‘Ampero- Standards,’’ 1996, vol. 11.01, which is in- metric Titration Method,’’ which is corporated by reference in accordance contained in the book entitled ‘‘Stand- with 5 U.S.C. 552(a) and 1 CFR part 51. ard Methods for the Examination of The availability of this incorporation Water and Wastewater,’’ 19th Ed., by reference is given in paragraph which is incorporated by reference in (b)(4)(iii)(I) of this section. accordance with 5 U.S.C. 552(a) and 1 (ii) Method 4500-Cl D—‘‘Ampero- CFR part 51. The availability of this in- metric Titration Method,’’ which is corporation by reference is given in contained in the book entitled ‘‘Stand- paragraph (b)(4)(iii)(I) of this section. ard Methods for the Examination of (iii) Method 4500-Cl F—‘‘DPD Ferrous Water and Wastewater,’’ 19th Ed., Titrimetric Method,’’ which is con- which is incorporated by reference in tained in the book entitled ‘‘Standard accordance with 5 U.S.C. 552(a) and 1 Methods for the Examination of Water CFR part 51. The availability of this in- and Wastewater,’’ 19th Ed., which is incorporated by reference in accordance corporation by reference is given in with 5 U.S.C. 552(a) and 1 CFR part 51. paragraph (b)(4)(iii)(I) of this section. The availability of this incorporation (iii) Method 4500-Cl F—‘‘DPD Ferrous by reference is given in paragraph Titrimetric Method,’’ which is con- (b)(4)(iii)(I) of this section. tained in the book entitled ‘‘Standard (iv) Method 4500-Cl G—‘‘DPD Colori- Methods for the Examination of Water metric Method,’’ which is contained in and Wastewater,’’ 19th Ed., which is in- the book entitled ‘‘Standard Methods corporated by reference in accordance for the Examination of Water and with 5 U.S.C. 552(a) and 1 CFR part 51. Wastewater,’’ 19th Ed., which is incor- The availability of this incorporation porated by reference in accordance by reference is given in paragraph with 5 U.S.C. 552(a) and 1 CFR part 51. (b)(4)(iii)(I) of this section. The availability of this incorporation (iv) Method 4500-Cl G—‘‘DPD Colori- by reference is given in paragraph metric Method,’’ which is contained in (b)(4)(iii)(I) of this section. the book entitled ‘‘Standard Methods (v) Method 4500-Cl E—‘‘Low-Level for the Examination of Water and Amperometric Titration Method,’’ Wastewater,’’ 19th Ed., which is incor- which is contained in the book entitled porated by reference in accordance ‘‘Standard Methods for the Examina- with 5 U.S.C. 552(a) and 1 CFR part 51. tion of Water and Wastewater,’’ 19th The availability of this incorporation Ed., which is incorporated by reference by reference is given in paragraph in accordance with 5 U.S.C. 552(a) and 1 (b)(4)(iii)(I) of this section. CFR part 51. The availability of this in- (v) Method 4500-Cl E—‘‘Low-Level corporation by reference is given in Amperometric Titration Method,’’ paragraph (b)(4)(iii)(I) of this section. which is contained in the book entitled (vi) Method 4500-Cl I—‘‘Iodometric ‘‘Standard Methods for the Examina- Electrode Technique,’’ which is con- tion of Water and Wastewater,’’ 19th tained in the book entitled ‘‘Standard Ed., which is incorporated by reference Methods for the Examination of Water in accordance with 5 U.S.C. 552(a) and 1

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CFR part 51. The availability of this in- radon and uranium) in excess of 15 corporation by reference is given in picocuries per liter of water. paragraph (b)(4)(iii)(I) of this section. (C) The bottled water shall not con- (vi) Method 4500-Cl I—‘‘Iodometric tain beta particle and photon radioac- Electrode Technique,’’ which is con- tivity from manmade radionuclides in tained in the book entitled ‘‘Standard excess of that which would produce an Methods for the Examination of Water annual dose equivalent to the total and Wastewater,’’ 19th Ed., which is in- body or any internal organ of 4 corporated by reference in accordance millirems per year calculated on the with 5 U.S.C. 552(a) and 1 CFR part 51. basis of an intake of 2 liters of the The availability of this incorporation water per day. If two or more beta or by reference is given in paragraph photon-emitting radionuclides are (b)(4)(iii)(I) of this section. present, the sum of their annual dose (vii) Method 4500-Cl H— equivalent to the total body or to any ‘‘Syringaldazine (FACTS) Method,’’ internal organ shall not exceed 4 which is contained in the book entitled millirems per year. ‘‘Standard Methods for the Examina- (D) The bottled water shall not con- tion of Water and Wastewater,’’ 19th tain uranium in excess of 30 Ed., which is incorporated by reference micrograms per liter of water. in accordance with 5 U.S.C. 552(a) and 1 (ii) Analyses conducted to determine CFR part 51. The availability of this in- compliance with the requirements of corporation by reference is given in paragraph (b)(5)(i) of this section shall paragraph (b)(4)(iii)(I) of this section. be made in accordance with the meth- (7) Chlorine dioxide shall be meas- ods described in the applicable sections ured using the following methods: of ‘‘Standard Methods for the Examina- (i) Method 4500-ClO D—‘‘DPD Meth- 2 tion of Water and Wastewater,’’ 20th od,’’ which is contained in the book en- Ed., which is incorporated by reference titled ‘‘Standard Methods for the Ex- in accordance with 5 U.S.C. 552(a) and 1 amination of Water and Wastewater,’’ CFR part 51. Copies of ‘‘Standard Meth- 19th Ed., which is incorporated by reference in accordance with 5 U.S.C. ods for the Examination of Water and 552(a) and 1 CFR part 51. The avail- Wastewater,’’ 20th Ed., may be ob- ability of this incorporation by ref- tained from the American Public erence is given in paragraph Health Association, 1015 15th St. NW., (b)(4)(iii)(I) of this section. Washington, DC 20005. Copies of the methods incorporated by reference in (ii) Method 4500-ClO2E—‘‘Ampero- metric Method II,’’ which is contained this paragraph (b)(5)(ii) may also be ex- in the book entitled ‘‘Standard Meth- amined at the National Archives and ods for the Examination of Water and Records Administration (NARA), or at Wastewater,’’ 19th Ed., which is incor- the Food and Drug Administration’s porated by reference in accordance Main Library, 10903 New Hampshire with 5 U.S.C. 552(a) and 1 CFR part 51. Ave., Bldg. 2, Third Floor, Silver The availability of this incorporation Spring, MD 20993, 301–796–2039. For in- by reference is given in paragraph formation on the availability of this (b)(4)(iii)(I) of this section. material at NARA, call 202–741–6030, or (5) Radiological quality. (i) Bottled go to: http://www.archives.gov/ water shall, when a composite of ana- federallregister/ lytical units of equal volume from a codeloflfederallregulations/ sample is examined by the methods de- ibrllocations.html. scribed in paragraph (b)(5)(ii) of this (A) Combined radium-226/-228 shall be section, meet standards of radiological measured using the following methods: quality as follows: (1) Method 7500–Ra B—‘‘Precipitation (A) The bottled water shall not con- Method,’’ which is contained in tain a combined radium-226 and ra- ‘‘Standard Methods for the Examina- dium-228 activity in excess of 5 tion of Water and Wastewater,’’ 20th picocuries per liter of water. Ed., which is incorporated by reference (B) The bottled water shall not con- in accordance with 5 U.S.C. 552(a) and 1 tain a gross alpha particle activity (in- CFR part 51. The availability of this including radium-226, but excluding corporation by reference is given in the

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introductory text of paragraph (b)(5)(ii) reference is given in the introductory of this section. text of paragraph (b)(5)(ii) of this sec- (2) Method 7500–Ra D—‘‘Sequential tion. Precipitation Method,’’ which is con- (D) Uranium shall be measured using tained in ‘‘Standard Methods for the the following methods: Examination of Water and Waste- (1) Method 7500–U B—‘‘Radiochemical water,’’ 20th Ed., which is incorporated Method’’ which is contained in by reference in accordance with 5 ‘‘Standard Methods for the Examina- U.S.C. 552(a) and 1 CFR part 51. The tion of Water and Wastewater,’’ 20th availability of this incorporation by Ed., which is incorporated by reference reference is given in the introductory in accordance with 5 U.S.C. 552(a) and 1 text of paragraph (b)(5)(ii) of this sec- CFR part 51. The availability of this in- tion. corporation by reference is given in the (B) Gross alpha particle radioactivity introductory text of paragraph (b)(5)(ii) shall be measured using the following of this section. method: Method 7110 C—‘‘Coprecipita- (2) Method 7500–U C—‘‘Isotopic Meth- tion Method for Gross Alpha Radioac- od’’ which is contained in ‘‘Standard tivity in Drinking Water,’’ which is Methods for the Examination of Water contained in ‘‘Standard Methods for and Wastewater,’’ 20th Ed., which is in- the Examination of Water and Waste- corporated by reference in accordance water,’’ 20th Ed., which is incorporated with 5 U.S.C. 552(a) and 1 CFR part 51. by reference in accordance with 5 The availability of this incorporation U.S.C. 552(a) and 1 CFR part 51. The by reference is given in the introduc- availability of this incorporation by tory text of paragraph (b)(5)(ii) of this reference is given in the introductory section. text of paragraph (b)(5)(ii) of this sec- (c) Label statements. When the micro- tion. biological, physical, chemical, or radio- (C) Beta particle and photon radioac- logical quality of bottled water is tivity shall be measured using the fol- below that prescribed by paragraphs lowing methods: (b)(2) through (b)(5), of this section, the (1) Method 7500–Sr B—‘‘Precipitation label shall bear the statement of sub- Method,’’ which is contained in standard quality specified in § 130.14(a) ‘‘Standard Methods for the Examina- of this chapter except that, as appro- tion of Water and Wastewater,’’ 20th priate, instead of or in addition to the Ed., which is incorporated by reference statement specified in § 130.14(a) the in accordance with 5 U.S.C. 552(a) and 1 following statement(s) shall be used: CFR part 51. The availability of this in- (1) ‘‘Contains Excessive Bacteria’’ if corporation by reference is given in the the bottled water fails to meet the re- introductory text of paragraph (b)(5)(ii) quirements of paragraph (b)(2)(i)(A) of of this section. this section. (2) Method 7500–3H B—‘‘Liquid Scin- (2) ‘‘Excessively Turbid’’, ‘‘Abnormal tillation Spectrometric Method,’’ Color’’, and/or ‘‘Abnormal Odor’’ if the which is contained in ‘‘Standard Meth- bottled water fails to meet the require- ods for the Examination of Water and ments of paragraph (b)(3) (i), (ii), or Wastewater,’’ 20th Ed., which is incor- (iii), respectively, of this section. porated by reference in accordance (3) ‘‘Contains Excessive lll,’’ with with 5 U.S.C. 552(a) and 1 CFR part 51. the blank filled in with the name of the The availability of this incorporation chemical for which a maximum con- by reference is given in the introduc- taminant level in paragraph (b)(4) of tory text of paragraph (b)(5)(ii) of this this section is exceeded (e.g., ‘‘Contains section. Excessive Arsenic,’’ ‘‘Contains Exces- (3) Method 7120 B—‘‘Gamma sive Trihalomethanes’’) except that Spectroscopic Method,’’ which is con- ‘‘Contains Excessive Chemical Sub- tained in ‘‘Standard Methods for the stances’’ may be used if the bottled Examination of Water and Waste- water is not mineral water. water,’’ 20th Ed., which is incorporated (4) ‘‘Excessively Radioactive’’ if the by reference in accordance with 5 bottled water fails to meet the require- U.S.C. 552(a) and 1 CFR part 51. The ments of paragraph (b)(5) of this sec- availability of this incorporation by tion.

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(d) Adulteration. Bottled water con- (a) Under section 403(g) of the Fed- taining a substance at a level consid- eral Food, Drug, and Cosmetic Act, any ered injurious to health under section article that is represented as or pur- 402(a)(1) of the Federal Food, Drug, and ports to be oleomargarine or margarine Cosmetic Act (the act), or that consists must conform to the definition and in whole or in part of any filthy, pu- standard of identity for oleomargarine trid, or decomposed substance, or that or margarine promulgated under sec- is otherwise unfit for food under section 401 of the act (Subpart B of this tion 402(a)(3) of the act is deemed to be part), and its label must bear the name adulterated, regardless of whether or ‘‘oleomargarine’’ or ‘‘margarine’’. not the water bears a label statement (b) The identity standard for oleo- of substandard quality prescribed by margarine or margarine applies to both paragraph (c) of this section. If E. coli the uncolored and the colored article. is present in bottled water, then the (c) In considering the requirement bottled water will be deemed adulter- that the word ‘‘oleomargarine’’ or ated under section 402(a)(3) of the act. ‘‘margarine’’ be in type or lettering at least as large as any other type or let- [60 FR 57124, Nov. 13, 1995; 60 FR 66495, Dec. 22, 1995, as amended at 61 FR 13264, Mar. 26, tering on the label, it must be borne in 1996; 61 FR 14480, Apr. 2, 1996; 63 FR 25769, mind that at least three factors are in- May 11, 1998; 66 FR 16865, Mar. 28, 2001; 66 FR volved—the height of each letter, the 17359, Mar. 30, 2001; 66 FR 35373, July 5, 2001; area occupied by each letter as meas- 66 FR 56035, Nov. 6, 2001; 58 FR 15355, Mar. 31, ured by a closely fitting rectangle 2003; 68 FR 9881, Mar. 3, 2003; 70 FR 33700, drawn around it, and the boldness of June 9, 2005; 74 FR 25665, May 29, 2009; 76 FR letters or breadth of the lines forming 64813, Oct. 19, 2011; 81 FR 5591, Feb. 3, 2016] the letters. The type or lettering used should meet the following tests: PART 166—MARGARINE (1) The height of each letter in the word ‘‘oleomargarine’’ or ‘‘margarine’’ Subpart A—General Provisions should equal or exceed the height of Sec. any other letter elsewhere on the label. 166.40 Labeling of margarine. (2) The area of the closely fitting rectangle with respect to any of the let- Subpart B—Requirements for Specific ters in the word ‘‘oleomargarine’’ or Standardized Margarine ‘‘margarine’’ should equal or exceed the area of such rectangle applied to 166.110 Margarine. the same or a corresponding letter else- AUTHORITY: 21 U.S.C. 321, 341, 343, 347, 348, where on the label. 371, 379e. (3) The letters in the word ‘‘oleomargarine’’ or ‘‘margarine’’ should be Subpart A—General Provisions equal to or exceed in prominence and boldness, such as breadth of lines form- § 166.40 Labeling of margarine. ing the letters, the same or cor- The Federal Food, Drug, and Cos- responding letters elsewhere on the metic Act was amended by Pub. L. 459, label. 81st Congress (64 Stat. 20) on colored (d) [Reserved] oleomargarine or margarine by adding (e) The word ‘‘oleomargarine’’ or thereto a new section numbered 407. ‘‘margarine’’ (and thus the other infor- Among other things, this section re- mation called for by the statute) quires that there appear on the label of should appear on each panel of the the package the word ‘‘oleomargarine’’ package label that might reasonably be or ‘‘margarine’’ in type or lettering at selected by the grocer for display pur- least as large as any other type or let- poses at the point of sale. tering on the label, and a full and accu- (f) The amendment covering colored rate statement of all the ingredients oleomargarine or colored margarine contained in such oleomargarine or states that, ‘‘for the purposes of * * * margarine. It provides that these re- section 407 of the Federal Food, Drug, quirements ‘‘shall be in addition to and and Cosmetic Act, as amended, the not in lieu of any of the other require- term ‘oleomargarine’ or ‘margarine’ in- ments of this Act’’. cludes: (1) All substances, mixtures,

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and compounds known as oleo- package under conditions of retail sale; margarine or margarine; (2) all sub- (2) the wrappers on the subdivisions are stances, mixtures, and compounds labeled with the statement ‘‘This Unit which have a consistency similar to Not Labeled For Retail Sale’’ in type that of butter and which contain any size not less than one-sixteenth inch in edible oils or fats other than milk fat if height. The word ‘‘Individual’’ may be made in imitation or semblance of but- used in lieu of or immediately pre- ter’’. Notwithstanding the difference ceding the word ‘‘Retail’’ in the state- between this definition and the defini- ment. tion and standard of identity for oleo- [42 FR 14477, Mar. 15, 1977, as amended at 46 margarine or margarine promulgated FR 31005, June 12, 1981; 47 FR 32421, July 27, under section 401 of the act, it was the 1982] clear intent of Congress that any article which is represented as or purports Subpart B—Requirements for to be oleomargarine or margarine is Specific Standardized Margarine misbranded if it fails to comply with the definition and standard of identity § 166.110 Margarine. for oleomargarine or margarine even (a) Description. Margarine (or oleo- though it may meet the statutory defi- margarine) is the food in plastic form nition. or liquid emulsion, containing not less (g) Section 407(a) states that ‘‘Col- than 80 percent fat determined by the ored oleomargarine or colored mar- method prescribed in ‘‘Official Methods garine which is sold in the same State of Analysis of the Association of Offi- or Territory in which it is produced cial Analytical Chemists,’’ 13th Ed. shall be subject in the same manner (1980), section 16.206, ‘‘Indirect Meth- and to the same extent to the provi- od,’’ under the heading ‘‘Fat (47)—Offi- sions of this act as if it had been intro- cial Final Action,’’ which is incor- duced in interstate commerce’’. porated by reference. Copies may be (h) Section 407(b)(4) requires that obtained from the AOAC INTER- each part of the contents of the pack- NATIONAL, 481 North Frederick Ave., age be ‘‘contained in a wrapper which suite 500, Gaithersburg, MD 20877, or bears the word ‘oleomargarine’ or may be examined at the National Ar- ‘margarine’ in type or lettering not chives and Records Administration smaller than 20-point type’’. The Food (NARA). For information on the avail- and Drug Administration interprets ability of this material at NARA, call this to mean that the height of the ac- 202–741–6030, or go to: http:// tual letters is no less than 20 points, or www.archives.gov/federallregister/ 20⁄72 of 1 inch. codeloflfederallregulations/ (i) The wrappers on the subdivisions ibrllocations.html. Margarine contains of oleomargarine or margarine con- only safe and suitable ingredients, as tained within the package sold at redefined in § 130.3(d) of this chapter. It is tail are labels within the meaning of produced from one or more of the op- section 201(k) and shall contain all of tional ingredients in paragraph (a)(1) of the label information required by sec- this section, and one or more of the options 403 and 407 of the Federal Food, tional ingredients in paragraph (a)(2) of Drug, and Cosmetic Act, just as in the this section, to which may be added case of 1-pound cartons, except that one or more of the optional ingredients wrappers on the subdivisions contained in paragraph (b) of this section. Mar- within the retail package shall be ex- garine contains vitamin A as provided empt from compliance with the re- for in paragraph (a)(3) of this section. quirements of section 403 (e)(1), (g)(2), (1) Edible fats and/or oils, or mix- (i)(2), and (k) of the act with respect to tures of these, whose origin is vege- the requirements for label declaration table or rendered animal carcass fats, of the name and place of business of or any form of oil from a marine spe- the manufacturer, packer, or dis- cies that has been affirmed as GRAS or tributor and label declaration of ingre- listed as a food additive for this use, dients when (1) the subdivisions are se- any or all of which may have been sub- curely enclosed within and are not in- jected to an accepted process of tended to be separated from the retail physico-chemical modification. They

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may contain small amounts of other combination, 0.02 percent; stearyl cit- lipids, such as phosphatides or unsa- rate, 0.15 percent; isopropyl citrate ponifiable constituents, and of free mixture, 0.02 percent. fatty acids naturally present in the fat (6) Color additives. For the purpose of or oil. this subparagraph, provitamin A (beta- (2) One or more of the following aque- carotene) shall be deemed to be a color ous phase ingredients: additive. (i) Water and/or milk and/or milk (7) Flavoring substances. If the fla- products. voring ingredients impart to the food a (ii) Suitable edible protein including, flavor other than in semblance of but- but not limited to, the liquid, con- ter, the characterizing flavor shall be densed, or dry form of whey, whey declared as part of the name of the food modified by the reduction of lactose in accordance with § 101.22 of this chap- and/or minerals, nonlactose containing ter. whey components, albumin, casein, ca- (8) Acidulants. seinate, vegetable proteins, or soy pro- (9) Alkalizers. tein isolate, in amounts not greater (c) Nomenclature. The name of the than reasonably required to accomplish food for which a definition and stand- the desired effect. ard of identity are prescribed in this (iii) Any mixture of two or more of section is ‘‘margarine’’ or ‘‘oleo- the articles named under paragraphs margarine’’. (a)(2) (i) and (ii) of this section. (d) Label declaration. Each of the in- (iv) The ingredients in paragraphs gredients used in the food shall be de- (a)(2) (i), (ii), and (iii) of this section clared on the label as required by the shall be pasteurized and then may be applicable sections of parts 101 and 130 subjected to the action of harmless of this chapter. For the purposes of bacterial starters. One or more of the this section the use of the term ‘‘milk’’ articles designated in paragraphs (a)(2) unqualified means milk from cows. If (i), (ii), and (iii) of this section is inti- any milk other than cow’s milk is used mately mixed with the edible fat and/or in whole or in part, the animal source ingredients to form a solidified or liq- shall be identified in conjunction with uid emulsion. the word milk in the ingredient state- (3) Vitamin A in such quantity that ment. Colored margarine shall be sub- the finished margarine contains not ject to the provisions of section 407 of less than 15,000 international units per the Federal Food, Drug, and Cosmetic pound. Act as amended. (b) Optional ingredients. (1) Vitamin D [42 FR 14478, Mar. 15, 1977, as amended at 47 in such quantity that the finished oleo- FR 11834, Mar. 19, 1982; 48 FR 13024, Mar. 29, margarine contains not less than 1,500 1983; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, international units of vitamin D per June 12, 1989; 58 FR 2886, Jan. 6, 1993; 58 FR pound. 21649, Apr. 23, 1993; 59 FR 26939, May 25, 1994; (2) Salt (sodium chloride); potassium 63 FR 14035, Mar. 24, 1998] chloride for dietary margarine or oleomargarine. PART 168—SWEETENERS AND TABLE (3) Nutritive carbohydrate sweet- SIRUPS eners. (4) Emulsifiers. Subpart A [Reserved] (5) Preservatives including but not limited to the following within these Subpart B—Requirements for Specific maximum amounts in percent by Standardized Sweeteners and Table Sirups weight of the finished food: Sorbic Sec. acid, benzoic acid and their sodium, po- 168.110 Dextrose anhydrous. tassium, and calcium salts, individ- 168.111 Dextrose monohydrate. ually, 0.1 percent, or in combination, 168.120 Glucose sirup. 0.2 percent, expressed as the acids; cal- 168.121 Dried glucose sirup. 168.122 Lactose. cium disodium EDTA, 0.0075 percent; 168.130 Cane sirup. propyl, octyl, and dodecyl gallates, 168.140 Maple sirup. BHT, BHA, ascorbyl palmitate, 168.160 Sorghum sirup. ascorbyl stearate, all individually or in 168.180 Table sirup.

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AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, Association of Official Analytical 379e. Chemists,’’ 13th Ed. (1980), which is in- SOURCE: 42 FR 14479, Mar. 15, 1977, unless corporated by reference. Copies may be otherwise noted. obtained from the AOAC INTER- NATIONAL, 481 North Frederick Ave., Subpart A [Reserved] suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar- Subpart B—Requirements for Spe- chives and Records Administration (NARA). For information on the avail- cific Standardized Sweeteners ability of this material at NARA, call and Table Sirups 202–741–6030, or go to: http:// § 168.110 Dextrose anhydrous. www.archives.gov/federallregister/ codeloflfederallregulations/ (a) Dextrose anhydrous is purified ibrllocations.html. and crystallized D-glucose without (1) Total solids content, 31.005. water of crystallization and conforms (2) Reducing sugar content, section to the specifications of § 168.111, except 31.220(a). that the total solids content is not less (3) Sulfated ash content, section than 98.0 percent m/m. 31.216. (b) The name of the food is ‘‘Dextrose (4) Sulfur dioxide content, sections anhydrous’’ or ‘‘Anhydrous dextrose’’ 20.106–20.111. or alternatively, ‘‘lll sugar anhydrous’’ or ‘‘Anhydrous sugar’’, with the [42 FR 14479, Mar. 15, 1977, as amended at 47 blank to be filled with the name of the FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, food source, for example, ‘‘Corn sugar Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] anhydrous’’. [42 FR 14479, Mar. 15, 1977, as amended at 58 § 168.120 Glucose sirup. FR 2886, Jan. 6, 1993] (a) Glucose sirup is the purified, concentrated, aqueous solution of nutri- § 168.111 Dextrose monohydrate. tive saccharides obtained from edible (a) Dextrose monohydrate is purified starch. and crystallized D-glucose containing (b) The food shall meet the following one molecule of water of crystalliza- specifications: tion with each molecule of D-glucose. (1) The total solids content is not less (b) The food shall meet the following than 70.0 percent mass/mass (m/m), and specifications: the reducing sugar content (dextrose (1) The total solids content is not less equivalent), expressed as D-glucose, is than 90.0 percent mass/mass (m/m), and not less than 20.0 percent m/m cal- the reducing sugar content (dextrose culated on a dry basis. equivalent), expressed as D-glucose, is (2) The sulfated ash content is not not less than 99.5 percent m/m cal- more than 1.0 percent m/m (calculated culated on a dry basis. on a dry basis), and the sulfur dioxide (2) The sulfated ash content is not content is not more than 40 mg/kg. more than 0.25 percent m/m (calculated (c) The name of the food is ‘‘Glucose on a dry basis), and the sulfur dioxide sirup’’. When the food is derived from a content is not more than 20 mg/kg. specific type of starch, the name may (c) The name of the food is ‘‘Dextrose alternatively be ‘‘lll sirup’’, the monohydrate’’ or ‘‘Dextrose’’ or alter- blank to be filled in with the name of natively, ‘‘lll sugar monohydrate’’ the starch. For example, ‘‘Corn sirup’’, or ‘‘lll sugar’’, with the blank to be ‘‘Wheat sirup’’, ‘‘Tapioca sirup’’. When filled with the name of the food source, the starch is derived from sorghum for example, ‘‘Corn sugar grain, the alternative name of the food monohydrate’’ or ‘‘Corn sugar’’. is ‘‘Sorghum grain sirup’’. The word (d) For purposes of this section, the ‘‘sirup’’ may also be spelled ‘‘syrup’’. methods of analysis to be used to de- (d) For purposes of this section, the termine if the food meets the specifica- methods of analysis to be used to de- tions of paragraph (b) (1) and (2) of this termine if the food meets the specifica- section are the following sections in tions of paragraph (b)(1) and (2) of this ‘‘Official Methods of Analysis of the section are the following sections in

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‘‘Official Methods of Analysis of the ‘‘Sorghum grain sirup solids’’. The Association of Official Analytical word ‘‘sirup’’ may also be spelled Chemists,’’ 13th Ed. (1980), which is in- ‘‘syrup’’. corporated by reference. Copies may be obtained from the AOAC INTER- § 168.122 Lactose. NATIONAL, 481 North Frederick Ave., (a) Lactose is the carbohydrate nor- suite 500, Gaithersburg, MD 20877, or mally obtained from whey. It may be may be examined at the National Ar- anhydrous or contain one molecule of chives and Records Administration water of crystallization or be a mixture (NARA). For information on the avail- of both forms. ability of this material at NARA, call (b) The food shall meet the following 202–741–6030, or go to: http:// specifications: www.archives.gov/federallregister/ (1) The lactose content is not less codeloflfederallregulations/ than 98.0 percent, mass over mass (m/ ibrllocations.html. m), calculated on a dry basis. (1) Total solids content, sections (2) The sulfated ash content is not 31.208–31.209. more than 0.3 percent, m/m, calculated (2) Reducing sugar content, section on a dry basis. 31.220(a). (3) The pH of a 10.0-percent m/m solu- (3) Sulfated ash content, section tion is not less than 4.5 nor more than 31.216. 7.5. (4) Sulfur dioxide content, sections (4) The loss on drying for 16 hours at 20.106–20.111. 120 °C is not more than 6.0 percent, m/ [42 FR 14479, Mar. 15, 1977, as amended at 47 m. FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, (c) The name of the food is ‘‘Lactose’’ 1984; 54 FR 24896, June 12, 1989; 63 FR 14035, or, alternatively, ‘‘Milk sugar’’. Mar. 24, 1998] (d) The methods of analysis in paragraphs (d)(1), (d)(2), (d)(3), (d)(4), and § 168.121 Dried glucose sirup. (d)(5) of this section are to be used to (a) Dried glucose sirup is glucose determine whether the food meets the sirup from which the water has been requirements of paragraphs (b)(1), partially removed and conforms to the (b)(2), (b)(3), and (b)(4) of this section. specifications of § 168.120, except that: The methods are contained in ‘‘Official (1) The total solids content is not less Methods of Analysis of the Association than 90.0 percent m/m when the reduc- of Official Analytical Chemists’’, 14th ing sugar content (dextrose equiva- Ed. (1984), including the 4th Supp. lent), expressed as D-glucose, is not (1988), which is incorporated by ref- less than 88.0 percent m/m, calculated erence in accordance with 5 U.S.C. on a dry basis; or 552(a). Copies of the material incor- (2) The total solids content is not less porated by reference may be obtained than 93.0 percent m/m when the reduc- from the AOAC INTERNATIONAL, 481 ing sugar content, (dextrose equiva- North Frederick Ave., suite 500, Gai- lent) expressed as D-glucose, is less thersburg, MD 20877, or may be exam- than 88.0 percent m/m, calculated on a ined at the National Archives and dry basis. Records Administration (NARA). For (b) The name of the food is ‘‘Dried information on the availability of this glucose sirup’’ or ‘‘Glucose sirup sol- material at NARA, call 202–741–6030, or ids’’. When the food is derived from a go to: http://www.archives.gov/ specific type of starch, the name may federallregister/ alternatively be ‘‘Dried lll sirup’’ or codeloflfederallregulations/ ‘‘lll sirup solids’’, the blank to be ibrllocations.html. filled in with the name of the starch; (1) Lactose content, sections 31.064 to for example, ‘‘Dried corn sirup’’, ‘‘Corn 31.071, ‘‘Purity of Lactose, Liquid sirup solids’’, ‘‘Dried wheat sirup’’, Chromatographic Method,’’ First Ac- ‘‘Wheat sirup solids’’, ‘‘Dried tapioca tion, 14th Ed. (1984), pp. 583 and 584. sirup’’, ‘‘Tapioca sirup solids’’. When (2) Lactose content, sections 31.064 to the starch is derived from sorghum 31.071, ‘‘Purity of Lactose, Liquid grain, the alternative name of the food Chromatographic Method,’’ ‘‘Changes is ‘‘Dried sorghum grain sirup’’ or in Official Methods of Analysis,’’ 14th

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Ed., 4th Supp. (1988), p. 212. This ref- It contains not less than 66 percent by erence recognizes the change in status weight of soluble solids derived solely of the method from first action to final from such sap. The concentration may action. be adjusted with or without added (3) Sulfated ash content, section water. It may contain one or more of 31.014, ‘‘Ash of Sugars and Sirups,’’ the optional ingredients provided for in Final Action, Sulfated Ash, 14th Ed. paragraph (b) of this section. All ingre- (1984), p. 575. dients from which the food is fab- (4) pH, section 14.022, ‘‘pH of Flour, ricated shall be safe and suitable. Potentiometric Method,’’ Final Action, (b) The optional ingredients that except that a 10-percent m/m solution may be used in maple sirup are: of lactose in water is used for the de- (1) Salt. termination, 14th Ed. (1984), p. 252. (2) Chemical preservatives. (5) Loss on drying at 120 °C, section (3) Defoaming agents. 31.070, 14th Ed. (1984), p. 584. (c) The name of the food is ‘‘Maple [42 FR 14479, Mar. 15, 1977, as amended at 47 sirup’’. Alternatively, the word ‘‘sirup’’ FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, may be spelled ‘‘syrup’’. 1984; 54 FR 24896, June 12, 1989; 55 FR 8459, (d) Label declaration. Each of the in- Mar. 8, 1990; 63 FR 14035, Mar. 24, 1998] gredients used in the food shall be declared on the label as required by the § 168.130 Cane sirup. applicable sections of parts 101 and 130 (a) Cane sirup is the liquid food de- of this chapter. rived by concentration and heat treatment of the juice of sugarcane [42 FR 14479, Mar. 15, 1977, as amended at 58 (Saccharum officinarum L.) or by solu- FR 2896, Jan. 6, 1993] tion in water of sugarcane concrete § 168.160 Sorghum sirup. made from such juice. It contains not less than 74 percent by weight of solu- (a) Sorghum sirup is the liquid food ble solids derived solely from such derived by concentration and heat juice. The concentration may be ad- treatment of the juice of sorghum cane justed with or without added water. It (sorgos) (Sorghum vulgare). It contains may contain one or more of the op- not less than 74 percent by weight of tional ingredients provided for in para- soluble solids derived solely from such graph (b) of this section. All ingredi- juice. The concentration may be ad- ents from which the food is fabricated justed with or without added water. It shall be safe and suitable. may contain one or more of the op- (b) The optional ingredients that tional ingredients provided for in para- may be used in cane sirup are: graph (b) of this section. All ingredi- (1) Salt. ents from which the food is fabricated (2) Preservatives. shall be safe and suitable. (3) Defoaming agents. (b) The optional ingredients that (c) The name of the food is ‘‘Cane may be used in sorghum sirup are: sirup’’ or ‘‘Sugar cane sirup’’. Alter- (1) Salt. natively, the word ‘‘sirup’’ may be (2) Chemical preservatives. spelled ‘‘syrup’’. (3) Defoaming agents. (d) Label declaration. Each of the in- (4) Enzymes. gredients used in the food shall be de- (5) Anticrystallizing agents. clared on the label as required by the (6) Antisolidifying agents. applicable sections of parts 101 and 130 (c) The name of the food is ‘‘Sorghum of this chapter. sirup’’ or ‘‘Sorghum’’. Alternatively, [42 FR 14479, Mar. 15, 1977, as amended at 58 the word ‘‘sirup’’ may be spelled FR 2886, Jan. 6, 1993] ‘‘syrup’’. (d) Label declaration. Each of the in- § 168.140 Maple sirup. gredients used in the food shall be de- (a) Maple sirup is the liquid food declared on the label as required by the rived by concentration and heat treat- applicable sections of parts 101 and 130 ment of the sap of the maple tree (Acer) of this chapter. or by solution in water of maple sugar [42 FR 14479, Mar. 15, 1977, as amended at 58 (mapel concrete) made from such sap. FR 2886, Jan. 6, 1993]

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§ 168.180 Table sirup. (c) Except as provided for in this paragraph and in paragraphs (d) (2) and (a) Table sirup is the liquid food con- (3) of this section, the name of the food sisting of one or more of the optional sweetening ingredients provided for in is ‘‘Table sirup’’, ‘‘Sirup’’, ‘‘Pancake paragraph (b)(1) of this section. The sirup’’, ‘‘Waffle sirup’’, ‘‘Pancake and food contains not less than 65 percent waffle sirup’’, or ‘‘lll sirup’’, the soluble sweetener solids by weight and blank being filled in with the word or is prepared with or without added words that designate the sweetening water. It may contain one or more of ingredient that characterizes the food, the optional ingredients prescribed in except ‘‘maple’’, ‘‘cane’’, or ‘‘sorghum’’ paragraphs (b)(2) through (12) of this alone, such sirups being required to section. All ingredients from which the comply in all respects with §§ 168.130, food is fabricated shall be safe and suit- 168.140, and 168.160, respectively, and in able. (Vitamins, minerals, and protein the case of more than one sweetening added for nutritional purposes and arti- ingredient, in descending order of pre- ficial sweeteners are not considered to dominance by weight in the food. The be suitable ingredients for this food.) type shall be of uniform style and size. (b) The optional ingredients that (1) When one of the sweeteners con- may be used in table sirup are: stitutes at least 80 percent of the total (1) One or more of the nutritive car- sweetener solids, the name of the food bohydrate sweeteners provided for in may be designated as the cor- this paragraph (b)(1). When a sweetener responding sirup, for example, ‘‘Corn provided for in paragraph (b)(1)(i) or sirup’’, provided that the name is im- (ii) of this section is used it shall con- mediately and conspicuously followed, stitute not less than 2 percent by without intervening written, printed, weight of the finished food. or graphic matter, by the statement (i) The sirups identified by §§ 168.130, ‘‘with lll’’ as part of the name, the 168.140, and 168.160, except that the use blank being filled in with the name or of any such ingredient is so limited names of each additional sweetening that the finished food does not meet ingredient present, stated in a clear the requirement prescribed for any legible manner in letters of uniform sirup by § 168.130, § 168.140, or § 168.160. style and size not less than one-half (ii) Honey. the height of, nor larger than, the let- (iii) Other nutritive carbohydrate ters used in the name of the principal sweeteners. sweetener. (2) Butter, in a quantity not less than (2) When butter is used, as provided 2 percent by weight of the finished for in paragraph (b)(2) of this section, food. the name of the food may be ‘‘Buttered (3) Edible fats and oils, except that, lll’’, the blank being filled in with in products designated as ‘‘buttered the name otherwise prescribed in this sirups’’, butter as provided for in para- paragraph. The percentage by weight of graph (b)(2) of this section is the only butter present shall be declared as part fat that may be used. of the name of the food as prescribed (4) Emulsifiers or stabilizers or both. by part 102 of this chapter. (5) Natural and artificial flavorings, (3) Alternatively, the word ‘‘sirup’’ either fruit or nonfruit, alone or in car- may be spelled ‘‘syrup’’. riers. (d)(1) Label declaration. Each of the (6) Color additives. ingredients used in the food shall be de- (7) Salt. clared on the label as required by the (8) Chemical preservatives. applicable sections of parts 101 and 130 (9) Viscosity adjusting agents. of this chapter. (10) Acidifying, alkalizing, or (2) A statement (other than in the in- buffering agents. gredient listing) or a vignette identi- (11) Defoaming agents. fying a flavor may be included on the (12) Any other ingredient (e.g., shred- label only if such flavor contributes ded coconut, ground orange peel) that the primary recognizable flavor that is not incompatible with other ingredi- characterizes the sirup. When maple, ents in the food. honey, or both maple and honey are

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represented as the characterizing fla- Vanilla planifolia Andrews and of Vanilla vors, the total quantity of maple sirup tahitensis Moore. or honey, singly, or of maple sirup and (b) The term unit weight of vanilla honey in combination, shall be not less beans means, in the case of vanilla than 10 percent by weight of the fin- beans containing not more than 25 per- ished food. The presence of any natural cent moisture, 13.35 ounces of such or artificial flavor in the food shall be beans; and, in the case of vanilla beans declared on the label as prescribed by containing more than 25 percent mois- the applicable sections of part 101 of ture, it means the weight of such beans this chapter. equivalent in content of moisture-free (3) The percentage of any optional in- vanilla-bean solids to 13.35 ounces of gredient used shall be declared as part vanilla beans containing 25 percent of the name of the food as prescribed by part 102 of this chapter when all of moisture. (For example, one unit the following conditions apply to the weight of vanilla beans containing 33.25 use of the ingredient: percent moisture amounts to 15 (i) It is one of the characterizing in- ounces.) The moisture content of va- gredients permitted by paragraphs nilla beans is determined by the meth- (b)(1) (i) and (ii) of this section. od prescribed in ‘‘Official Methods of (ii) The ingredient is either named on Analysis of the Association of Official the label other than in the list of ingre- Analytical Chemists,’’ 13th Ed. (1980), dients or is suggested by vignette or sections 7.004 and 7.005, which is incor- other labeling. porated by reference, except that the [42 FR 14479, Mar. 15, 1977, as amended at 58 toluene used is blended with 20 percent FR 2886, Jan. 6, 1993] by volume of benzene and the total distillation time is 4 hours. Copies of the PART 169—FOOD DRESSINGS AND material incorporated by reference FLAVORINGS may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Subpart A—General Provisions Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Sec. Archives and Records Administration 169.3 Definitions. (NARA). For information on the avail- Subpart B—Requirements for Specific ability of this material at NARA, call Standardized Food Dressings and 202–741–6030, or go to: http:// Flavorings www.archives.gov/federallregister/ codeloflfederallregulations/ 169.115 French dressing. ibrllocations.html. To prepare samples 169.140 Mayonnaise. for analysis, the pods are chopped into 169.150 Salad dressing. 1 169.175 Vanilla extract. pieces approximately ⁄4-inch in longest 169.176 Concentrated vanilla extract. dimension, using care to avoid mois- 169.177 Vanilla flavoring. ture change. 169.178 Concentrated vanilla flavoring. (c) The term unit of vanilla constituent 169.179 Vanilla powder. means the total sapid and odorous 169.180 Vanilla-vanillin extract. 169.181 Vanilla-vanillin flavoring. principles extractable from one unit 169.182 Vanilla-vanillin powder. weight of vanilla beans, as defined in paragraph (b) of this section, by an AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. aqueous alcohol solution in which the content of ethyl alcohol by volume SOURCE: 42 FR 14481, Mar. 15, 1977, unless amounts to not less than 35 percent. otherwise noted. [42 FR 14481, Mar. 15, 1977, as amended at 47 Subpart A—General Provisions FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 63 FR 14035, § 169.3 Definitions. Mar. 24, 1998] For the purposes of this part: (a) The term vanilla beans means the properly cured and dried fruit pods of

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Subpart B—Requirements for Spe- or diluted vinegar calculated as acetic cific Standardized Food acid. Dressings and Flavorings (10) Sequestrant(s), including but not limited to calcium disodium EDTA § 169.115 French dressing. (calcium disodium ethylenediamine- (a) Description. French dressing is the tetraacetate) and/or disodium EDTA separable liquid food or the emulsified (disodium ethylenediamine- viscous fluid food prepared from vege- tetraacetate), may be used to preserve table oil(s) and one or both of the color and/or flavor. acidifying ingredients specified in (11) Crystallization inhibitors, in- paragraph (b) of this section. One or cluding but not limited to oxystearin, more of the ingredients specified in lecithin, or polyglycerol esters of fatty paragraph (c) of this section may also acids. be used. The vegetable oil(s) used may (d) Nomenclature. The name of the contain an optional crystallization in- food is ‘‘French dressing’’. hibitor as specified in paragraph (c)(11) (e) Label declaration. Each of the in- of this section. All the ingredients gredients used in the food shall be de- from which the food is fabricated shall be safe and suitable. French dressing clared on the label as required by the contains not less than 35 percent by applicable sections of parts 101 and 130 weight of vegetable oil. French dress- of this chapter. ing may be mixed and packed in an at- [42 FR 14481 Mar. 15, 1977, as amended at 58 mosphere in which air is replaced in FR 2886, Jan. 6, 1993] whole or in part by carbon dioxide or nitrogen. § 169.140 Mayonnaise. (b) Acidifying ingredients. (1) Any vin- (a) Description. Mayonnaise is the egar or any vinegar diluted with water, or any such vinegar or diluted vinegar emulsified semisolid food prepared mixed with an optional acidifying in- from vegetable oil(s), one or both of the gredient as specified in paragraph (c)(9) acidifying ingredients specified in of this section. For the purpose of this paragraph (b) of this section, and one paragraph, any blend of two or more or more of the egg yolk-containing in- vinegars is considered to be a vinegar. gredients specified in paragraph (c) of (2) Lemon juice and/or lime juice in this section. One or more of the ingre- any appropriate form, which may be di- dients specified in paragraph (d) of this luted with water. section may also be used. The vege- (c) Other optional ingredients. The fol- table oil(s) used may contain an op- lowing optional ingredients may also tional crystallization inhibitor as spec- be used: ified in paragraph (d)(7) of this section. (1) Salt. All the ingredients from which the food (2) Nutritive carbohydrate sweet- is fabricated shall be safe and suitable. eners. Mayonnaise contains not less than 65 (3) Spices and/or natural flavorings. percent by weight of vegetable oil. (4) Monosodium glutamate. Mayonnaise may be mixed and packed (5) Tomato paste, tomato puree, cat- in an atmosphere in which air is re- sup, sherry wine. placed in whole or in part by carbon di- (6) Eggs and ingredients derived from eggs. oxide or nitrogen. (7) Color additives that will impart (b) Acidifying ingredients. (1) Any vin- the color traditionally expected. egar or any vinegar diluted with water (8) Stabilizers and thickeners to to an acidity, calculated as acetic acid, which calcium carbonate or sodium of not less than 21⁄2 percent by weight, hexametaphosphate may be added. or any such vinegar or diluted vinegar Dioctyl sodium sulfosuccinate may be mixed with an optional acidifying in- added in accordance with § 172.810 of gredient as specified in paragraph (d)(6) this chapter. of this section. For the purpose of this (9) Citric and/or malic acid, in an paragraph, any blend of two or more amount not greater than 25 percent of vinegars is considered to be a vinegar. the weight of the acids of the vinegar

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(2) Lemon juice and/or lime juice in as specified in paragraph (e) of this sec- any appropriate form, which may be dition. One or more of the ingredients in luted with water to an acidity, cal- paragraph (e) of this section may also culated as citric acid, of not less than be used. The vegetable oil(s) used may 21⁄2 percent by weight. contain an optional crystallization in- (c) Egg yolk-containing ingredients. hibitor as specified in paragraph (e)(8) Liquid egg yolks, frozen egg yolks, of this section. All the ingredients dried egg yolks, liquid whole eggs, fro- from which the food is fabricated shall zen whole eggs, dried whole eggs, or be safe and suitable. Salad dressing any one or more of the foregoing ingre- contains not less than 30 percent by dients listed in this paragraph with liq- weight of vegetable oil and not less egg uid egg white or frozen egg white. yolk-containing ingredient than is (d) Other optional ingredients. The fol- equivalent in egg yolk solids content lowing optional ingredients may also to 4 percent by weight of liquid egg be used: yolks. Salad dressing may be mixed (1) Salt. and packed in an atmosphere in which (2) Nutritive carbohydrate sweet- air is replaced in whole or in part by eners. carbon dioxide or nitrogen. (3) Any spice (except saffron or tur- (b) Acidifying ingredients. (1) Any vin- meric) or natural flavoring, provided it egar or any vinegar diluted with water, does not impart to the mayonnaise a or any such vinegar or diluted vinegar color simulating the color imparted by mixed with an optional acidifying in- egg yolk. gredient as specified in paragraph (e)(6) (4) Monosodium glutamate. of this section. For the purpose of this (5) Sequestrant(s), including but not paragraph, any blend of two or more limited to calcium disodium EDTA vinegars is considered to be a vinegar. (calcium disodium ethylenediamine- tetraacetate) and/or disodium EDTA (2) Lemon juice and/or lime juice in (disodium ethylenediaminetetra- any appropriate form, which may be di- acetate), may be used to preserve color luted with water. and/or flavor. (c) Egg yolk-containing ingredients. (6) Citric and/or malic acid in an Liquid egg yolks, frozen egg yolks, amount not greater than 25 percent of dried egg yolks, liquid whole eggs, fro- the weight of the acids of the vinegar zen whole eggs, dried whole eggs, or or diluted vinegar, calculated as acetic any one of more of the foregoing ingre- acid. dients listed in this paragraph with liq- (7) Crystallization inhibitors, includ- uid egg white or frozen egg white. ing but not limited to oxystearin, (d) Starchy paste. It may be prepared lecithin, or polyglycerol esters of fatty from a food starch, food starch-modi- acids. fied, tapioca flour, wheat flour, rye (e) Nomenclature. The name of the flour, or any two or more of these. food is ‘‘Mayonnaise’’. Water may be added in the preparation (f) Label declaration. Each of the in- of the paste. gredients used in the food shall be de- (e) Other optional ingredients. The fol- clared on the label as required by the lowing optional ingredients may also applicable sections of parts 101 and 130 be used: of this chapter. (1) Salt. [42 FR 14481, Mar. 15, 1977, as amended at 57 (2) Nutritive carbohydrate sweet- FR 34246, Aug. 4, 1992; 58 FR 2886, Jan. 6, 1993] eners. (3) Any spice (except saffron or tur- § 169.150 Salad dressing. meric) or natural flavoring, provided it (a) Description. Salad dressing is the does not impart to the salad dressing a emulsified semisolid food prepared color simulating the color imparted by from vegetable oil(s), one or both of the egg yolk. acidifying ingredients specified in (4) Monosodium glutamate. paragraph (b) of this section, one or (5) Stabilizers and thickeners. more of the egg yolk-containing ingre- Dioctyl sodium sulfosuccinate may be dients specified in paragraph (c) of this added in accordance with § 172.810 of section, and a starchy paste prepared this chapter.

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(6) Citric and/or malic acid may be ment ‘‘Made from lll’’ or ‘‘Made in used in an amount not greater than 25 part from lll’’, the blank being percent of the weight of the acids of filled in with the name or names ‘‘va- the vinegar or diluted vinegar cal- nilla oleoresin’’, ‘‘concentrated vanilla culated as acetic acid. extract’’, or ‘‘concentrated vanilla fla- (7) Sequestrant(s), including but not voring’’, as appropriate. If the article limited to calcium disodium EDTA contains two or more units of vanilla (calcium disodium ethylenediamine- constituent, the name of the food shall tetraacetate) and/or disodium EDTA include the designation ‘‘l–fold’’, the (disodium ethylenediamine- blank being filled in with the whole tetraactetate), may be used to preserve number (disregarding fractions) ex- color and/or flavor. pressing the number of units of vanilla (8) Crystallization inhibitors, includ- constituent per gallon of the article. ing but not limited to oxystearin, (3) Wherever the name of the food ap- lecithin, or polyglycerol esters of fatty pears on the label so conspicuously as acids. to be easily seen under customary con- (f) Nomenclature. The name of the ditions of purchase, the labeling re- food is ‘‘Salad dressing’’. quired by paragraph (b)(2) of this sec- (g) Label declaration. Each of the in- tion shall immediately and conspicu- gredients used in the food shall be de- ously precede or follow such name, clared on the label as required by the without intervening written, printed, applicable sections of parts 101 and 130 or graphic matter. of this chapter. (c) Label declaration. Each of the in- [42 FR 14481, Mar. 15, 1977, as amended at 42 gredients used in the food shall be de- FR 25325, May 17, 1977; 58 FR 2886, Jan. 6, clared on the label as required by the 1993] applicable sections of parts 101 and 130 of this chapter. § 169.175 Vanilla extract. [42 FR 14479, Mar. 15, 1977, as amended at 58 (a) Vanilla extract is the solution in FR 2886, Jan. 6, 1993] aqueous ethyl alcohol of the sapid and odorous principles extractable from va- § 169.176 Concentrated vanilla extract. nilla beans. In vanilla extract the con- (a) Concentrated vanilla extract content of ethyl alcohol is not less than 35 forms to the definition and standard of percent by volume and the content of identity and is subject to any require- vanilla constituent, as defined in ment for label statement of ingredients § 169.3(c), is not less than one unit per prescribed for vanilla extract by gallon. The vanilla constituent may be § 169.175, except that it is concentrated extracted directly from vanilla beans to remove part of the solvent, and each or it may be added in the form of con- gallon contains two or more units of centrated vanilla extract or con- vanilla constituent as defined in centrated vanilla flavoring or vanilla § 169.3(c). The content of ethyl alcohol flavoring concentrated to the semisolid is not less than 35 percent by volume. form called vanilla oleo-resin. Vanilla (b) The specified name of the food is extract may contain one or more of the ‘‘Concentrated vanilla extract l–fold’’ following optional ingredients: or ‘‘l–fold concentrated vanilla ex- (1) Glycerin. tract’’, the blank being filled in with (2) Propylene glycol. the whole number (disregarding frac- (3) Sugar (including invert sugar). tions) expressing the number of units (4) Dextrose. of vanilla constituent per gallon of the (5) Corn sirup (including dried corn article. (For example, ‘‘Concentrated sirup). vanilla extract 2–fold’’.) (b)(1) The specified name of the food is ‘‘Vanilla extract’’ or ‘‘Extract of va- [42 FR 14479, Mar. 15, 1977, as amended at 58 nilla’’. FR 2886, Jan. 6, 1993] (2) When the vanilla extract is made in whole or in part by dilution of va- § 169.177 Vanilla flavoring. nilla oleoresin, concentrated vanilla (a) Vanilla flavoring conforms to the extract, or concentrated vanilla fla- definition and standard of identity and voring, the label shall bear the state- is subject to any requirement for label

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statement of ingredients prescribed for (b) The anticaking ingredients re- vanilla extract by § 169.175, except that ferred to in paragraph (a) of this sec- its content of ethyl alcohol is less than tion are: 35 percent by volume. (1) Aluminum calcium silicate. (b) The specified name of the food is (2) Calcium silicate. ‘‘Vanilla flavoring’’. (3) Calcium stearate. [42 FR 14479, Mar. 15, 1977, as amended at 58 (4) Magnesium silicate. FR 2886, Jan. 6, 1993] (5) Tricalcium phosphate. (c)(1) The specified name of the food § 169.178 Concentrated vanilla fla- is ‘‘Vanilla powder l–fold’’ or ‘‘l–fold voring. vanilla powder’’, except that if sugar is (a) Concentrated vanilla flavoring the optional blending ingredient used, conforms to the definition and stand- the word ‘‘sugar’’ may replace the word ard of identity and is subject to any re- ‘‘powder’’. The blank in the name is quirement for label statement of ingre- filled in with the whole number (dis- dients prescribed for vanilla flavoring regarding fractions) expressing the by § 169.177, except that it is con- number of units of vanilla constituent centrated to remove part of the sol- per 8 pounds of the article. However, if vent, and each gallon contains two or the strength of the article is less than more units of vanilla constituent as de- 2–fold, the term ‘‘l–fold’’ is omitted fined in § 169.3(c). from the name. (b) The specified name of the food is (2) The label of vanilla powder shall ‘‘Concentrated vanilla flavoring l– bear the common names of any of the fold’’ or ‘‘l–fold concentrated vanilla optional ingredients specified in para- flavoring’’, the blank being filled in graphs (a) and (b) of this section that with the whole number (disregarding are used, except that where the alter- fractions) expressing the number of native name ‘‘Vanilla sugar’’ is used units of vanilla constituent per gallon for designating the food it is not re- of the article. (For example, ‘‘Con- quired that sugar be named as an op- centrated vanilla flavoring 3–fold’’.) tional ingredient. (3) Wherever the name of the food ap- [42 FR 14479, Mar. 15, 1977, as amended at 58 pears on the label so conspicuously as FR 2886, Jan. 6, 1993] to be easily seen under customary conditions of purchase, the labeling re- § 169.179 Vanilla powder. quired by paragraph (c)(2) of this sec- (a) Vanilla powder is a mixture of tion shall immediately and conspicu- ground vanilla beans or vanilla oleo- ously precede or follow such name, resin or both, with one or more of the without intervening written, printed, following optional blending ingredi- or graphic matter. ents: (d) Label declaration. Each of the in- (1) Sugar. gredients used in the food shall be de- (2) Dextrose. clared on the label as required by the (3) Lactose. applicable sections of parts 101 and 130 (4) Food starch (including food of this chapter. starch-modified as prescribed in [42 FR 14479, Mar. 15, 1977, as amended at 58 § 172.892 of this chapter). FR 2887, Jan. 6, 1993] (5) Dried corn sirup. (6) Gum acacia. § 169.180 Vanilla-vanillin extract. Vanilla powder may contain one or any (a) Vanilla-vanillin extract conforms mixture of two or more of the to the definition and standard of iden- anticaking ingredients specified in tity and is subject to any requirement paragraph (b) of this section, but the for label statement of ingredients pre- total weight of any such ingredient or scribed for vanilla extract by § 169.175, mixture is not more than 2 percent of except that for each unit of vanilla the weight of the finished vanilla pow- constituent, as defined in § 169.3(c), con- der. Vanilla powder contains in each 8 tained therein, the article also con- pounds not less than one unit of vanilla tains not more than 1 ounce of added constituent, as defined in § 169.3(c). vanillin.

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(b) The specified name of the food is However, if the strength of the article ‘‘Vanilla-vanillin extract l–fold’’ or is less than 2–fold, the term ‘‘l–fold’’ ‘‘l–fold vanilla-vanillin extract’’, fol- is omitted from the name. lowed immediately by the statement ‘‘contains vanillin, an artificial flavor [42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2887, Jan. 6, 1993] (or flavoring)’’. The blank in the name is filled in with the whole number (dis- § 169.182 Vanilla-vanillin powder. regarding fractions) expressing the sum of the number of units of vanilla con- (a) Vanilla-vanillin powder conforms stituent plus the number of ounces of to the definition and standard of iden- added vanillin per gallon of the article. tity and is subject to any requirement However, if the strength of the article for label statement of ingredients pre- is less than 2–fold, the term ‘‘l–fold’’ scribed for vanilla powder by § 169.179, is omitted from the name. except that for each unit of vanilla constituent as defined in § 169.3(c) con- [42 FR 14479, Mar. 15, 1977, as amended at 58 tained therein, the article also con- FR 2887, Jan. 6, 1993] tains not more than 1 ounce of added § 169.181 Vanilla-vanillin flavoring. vanillin. (b) The specified name of the food is (a) Vanilla-vanillin flavoring con- ‘‘Vanilla-vanillin powder l–fold’’ or forms to the definition and standard of ‘‘l–fold vanilla-vanillin powder’’, fol- identity and is subject to any require- lowed immediately by the statement ment for label statement of ingredients ‘‘contains vanillin, an artificial flavor prescribed for vanilla-vanillin extract (or flavoring)’’. If sugar is the optional by § 169.180, except that its content of ethyl alcohol is less than 35 percent by blending ingredient used, the word volume. ‘‘sugar’’ may replace the word ‘‘pow- (b) The specified name of the food is der’’ in the name. The blank in the ‘‘Vanilla-vanillin flavoring l–fold’’ or name is filled in with the whole num- ‘‘l–fold vanilla-vanillin flavoring’’, ber (disregarding fractions) expressing followed immediately by the statement the sum of the number of units of va- ‘‘contains vanillin, an artificial flavor nilla constituent plus the number of (or flavoring)’’. The blank in the name ounces of added vanillin per 8 pounds of is filled in with the whole number (dis- the article. However, if the strength of regarding fractions) expressing the sum the article is less than 2–fold the term of the number of units of vanilla con- ‘‘l–fold’’ is omitted from the name. stituent plus the number of ounces of [42 FR 14479, Mar. 15, 1977, as amended at 58 added vanillin per gallon of the article. FR 2887, Jan. 6, 1993]

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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually. Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

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Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) III Administrative Conference of the United States (Parts 300—399) IV Miscellaneous Agencies (Parts 400—500)

Title 2—Grants and Agreements

SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR GRANTS AND AGREEMENTS I Office of Management and Budget Governmentwide Guidance for Grants and Agreements (Parts 2—199) II Office of Management and Budget Guidance (Parts 200—299) SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND AGREEMENTS III Department of Health and Human Services (Parts 300—399) IV Department of Agriculture (Parts 400—499) VI Department of State (Parts 600—699) VII Agency for International Development (Parts 700—799) VIII Department of Veterans Affairs (Parts 800—899) IX Department of Energy (Parts 900—999) X Department of the Treasury (Parts 1000—1099) XI Department of Defense (Parts 1100—1199) XII Department of Transportation (Parts 1200—1299) XIII Department of Commerce (Parts 1300—1399) XIV Department of the Interior (Parts 1400—1499) XV Environmental Protection Agency (Parts 1500—1599) XVIII National Aeronautics and Space Administration (Parts 1800— 1899) XX United States Nuclear Regulatory Commission (Parts 2000—2099) XXII Corporation for National and Community Service (Parts 2200— 2299) XXIII Social Security Administration (Parts 2300—2399) XXIV Housing and Urban Development (Parts 2400—2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699) XXVII Small Business Administration (Parts 2700—2799)

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XXVIII Department of Justice (Parts 2800—2899) XXIX Department of Labor (Parts 2900—2999) XXX Department of Homeland Security (Parts 3000—3099) XXXI Institute of Museum and Library Services (Parts 3100—3199) XXXII National Endowment for the Arts (Parts 3200—3299) XXXIII National Endowment for the Humanities (Parts 3300—3399) XXXIV Department of Education (Parts 3400—3499) XXXV Export-Import Bank of the United States (Parts 3500—3599) XXXVI Office of National Drug Control Policy, Executive Office of the President (Parts 3600—3699) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899) LIX Gulf Coast Ecosystem Restoration Council (Parts 5900—5999)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—199)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) IV Office of Personnel Management and Office of the Director of National Intelligence (Parts 1400—1499) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Parts 2100—2199) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Parts 3200—3299) XXIII Department of Energy (Parts 3300—3399) XXIV Federal Energy Regulatory Commission (Parts 3400—3499) XXV Department of the Interior (Parts 3500—3599) XXVI Department of Defense (Parts 3600—3699) XXVIII Department of Justice (Parts 3800—3899)

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XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) XXXVI Department of Homeland Security (Parts 4600—4699) XXXVII Federal Election Commission (Parts 4700—4799) XL Interstate Commerce Commission (Parts 5000—5099) XLI Commodity Futures Trading Commission (Parts 5100—5199) XLII Department of Labor (Parts 5200—5299) XLIII National Science Foundation (Parts 5300—5399) XLV Department of Health and Human Services (Parts 5500—5599) XLVI Postal Rate Commission (Parts 5600—5699) XLVII Federal Trade Commission (Parts 5700—5799) XLVIII Nuclear Regulatory Commission (Parts 5800—5899) XLIX Federal Labor Relations Authority (Parts 5900—5999) L Department of Transportation (Parts 6000—6099) LII Export-Import Bank of the United States (Parts 6200—6299) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Parts 6400—6499) LV National Endowment for the Arts (Parts 6500—6599) LVI National Endowment for the Humanities (Parts 6600—6699) LVII General Services Administration (Parts 6700—6799) LVIII Board of Governors of the Federal Reserve System (Parts 6800— 6899) LIX National Aeronautics and Space Administration (Parts 6900— 6999) LX United States Postal Service (Parts 7000—7099) LXI National Labor Relations Board (Parts 7100—7199) LXII Equal Employment Opportunity Commission (Parts 7200—7299) LXIII Inter-American Foundation (Parts 7300—7399) LXIV Merit Systems Protection Board (Parts 7400—7499) LXV Department of Housing and Urban Development (Parts 7500— 7599) LXVI National Archives and Records Administration (Parts 7600—7699) LXVII Institute of Museum and Library Services (Parts 7700—7799) LXVIII Commission on Civil Rights (Parts 7800—7899) LXIX Tennessee Valley Authority (Parts 7900—7999) LXX Court Services and Offender Supervision Agency for the District of Columbia (Parts 8000—8099) LXXI Consumer Product Safety Commission (Parts 8100—8199) LXXIII Department of Agriculture (Parts 8300—8399) LXXIV Federal Mine Safety and Health Review Commission (Parts 8400—8499)

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LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699) LXXVII Office of Management and Budget (Parts 8700—8799) LXXX Federal Housing Finance Agency (Parts 9000—9099) LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts 9300—9399) LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499) LXXXVI National Credit Union Administration (Parts 9600—9699) XCVII Department of Homeland Security Human Resources Manage- ment System (Department of Homeland Security—Office of Personnel Management) (Parts 9700—9799) XCVIII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899) XCIX Military Compensation and Retirement Modernization Commis- sion (Parts 9900—9999) C National Council on Disability (Partys 10000—10049)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—199) X Privacy and Civil Liberties Oversight Board (Parts 1000—1099)

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199)

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XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299) XXV Office of Advocacy and Outreach, Department of Agriculture (Parts 2500—2599) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy Policy and New Uses, Department of Agri- culture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV National Institute of Food and Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299)

Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza- tion) (Parts 1—499)

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V Executive Office for Immigration Review, Department of Justice (Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

Title 10—Energy

I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XIII Nuclear Waste Technical Review Board (Parts 1300—1399) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) XVIII Northeast Interstate Low-Level Radioactive Waste Commission (Parts 1800—1899)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099) II Election Assistance Commission (Parts 9400—9499)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) X Bureau of Consumer Financial Protection (Parts 1000—1099) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XII Federal Housing Finance Agency (Parts 1200—1299) XIII Financial Stability Oversight Council (Parts 1300—1399) XIV Farm Credit System Insurance Corporation (Parts 1400—1499)

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XV Department of the Treasury (Parts 1500—1599) XVI Office of Financial Research (Parts 1600—1699) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Com- merce (Parts 300—399) IV Emergency Steel Guarantee Loan Board (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)

Title 14—Aeronautics and Space

I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—1199) V National Aeronautics and Space Administration (Parts 1200— 1299) VI Air Transportation System Stabilization (Parts 1300—1399)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Industry and Security, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399)

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XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399)

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

Title 17—Commodity and Securities Exchanges

I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury (Parts 0—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV U.S. Immigration and Customs Enforcement, Department of Homeland Security (Parts 400—599)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees’ Compensation Appeals Board, Department of Labor (Parts 500—599)

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V Employment and Training Administration, Department of Labor (Parts 600—699) VI Office of Workers’ Compensation Programs, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

Title 22—Foreign Relations

I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V Broadcasting Board of Governors (Parts 500—599) VII Overseas Private Investment Corporation (Parts 700—799) IX Foreign Service Grievance Board (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Millennium Challenge Corporation (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299)

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III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Housing and Office of Multifamily Housing Assistance Restructuring, Department of Housing and Urban Develop- ment (Parts 400—499) V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—1699) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XV Emergency Mortgage Insurance and Loan Programs, Depart- ment of Housing and Urban Development (Parts 2700—2799) [Reserved] XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXIV Board of Directors of the HOPE for Homeowners Program (Parts 4000—4099) [Reserved] XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

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I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Parts 1000—1199) VII Office of the Special Trustee for American Indians, Department of the Interior (Parts 1200—1299)

Title 26—Internal Revenue

I Internal Revenue Service, Department of the Treasury (Parts 1— End)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury (Parts 1—399) II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart- ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) VIII Court Services and Offender Supervision Agency for the District of Columbia (Parts 800—899) IX National Crime Prevention and Privacy Compact Council (Parts 900—999) XI Department of Justice and Department of State (Parts 1100— 1199)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199)

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II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Employee Benefits Security Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Bureau of Safety and Environmental Enforcement, Department of the Interior (Parts 200—299) IV Geological Survey, Department of the Interior (Parts 400—499) V Bureau of Ocean Energy Management, Department of the Inte- rior (Parts 500—599) VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999) XII Office of Natural Resources Revenue, Department of the Interior (Parts 1200—1299)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799)

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VIII Office of International Investment, Department of the Treasury (Parts 800—899) IX Federal Claims Collection Standards (Department of the Treas- ury—Department of Justice) (Parts 900—999) X Financial Crimes Enforcement Network, Department of the Treasury (Parts 1000—1099)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XVII Office of the Director of National Intelligence (Parts 1700—1799) XVIII National Counterintelligence Center (Parts 1800—1899) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399)

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IV Office of Career, Technical and Adult Education, Department of Education (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) [Reserved] VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvement, Department of Education (Parts 700—799) [Reserved] SUBTITLE C—REGULATIONS RELATING TO EDUCATION XI [Reserved] XII National Council on Disability (Parts 1200—1299)

Title 35 [Reserved]

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VI [Reserved] VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XV Oklahoma City National Memorial Trust (Parts 1500—1599) XVI Morris K. Udall Scholarship and Excellence in National Environ- mental Policy Foundation (Parts 1600—1699)

Title 37—Patents, Trademarks, and Copyrights

I United States Patent and Trademark Office, Department of Commerce (Parts 1—199) II U.S. Copyright Office, Library of Congress (Parts 200—299) III Copyright Royalty Board, Library of Congress (Parts 300—399) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—199) II Armed Forces Retirement Home (Parts 200—299)

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I United States Postal Service (Parts 1—999) III Postal Regulatory Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599) VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799) VIII Gulf Coast Ecosystem Restoration Council (Parts 1800—1899)

Title 41—Public Contracts and Property Management

SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM [NOTE] SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 61–1—61–999) 62—100 [Reserved] SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 102 Federal Management Regulation (Parts 102–1—102–299) 103—104 [Reserved] 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99) 128 Department of Justice (Parts 128–1—128–99) 129—200 [Reserved] SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED] SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM [RESERVED] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300–99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99)

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302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Part 303–1—303–99) 304 Payment of Travel Expenses from a Non-Federal Source (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—599) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 400— 999) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10099)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home- land Security (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599)

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VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) IX Denali Commission (Parts 900—999) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299) XIII Administration for Children and Families, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499) XXV Corporation for National and Community Service (Parts 2500— 2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Homeland Security (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399) IV National Telecommunications and Information Administration, Department of Commerce, and National Highway Traffic Safe- ty Administration, Department of Transportation (Parts 400— 499)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99)

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2 Defense Acquisition Regulations System, Department of Defense (Parts 200—299) 3 Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 30 Department of Homeland Security, Homeland Security Acquisi- tion Regulation (HSAR) (Parts 3000—3099) 34 Department of Education Acquisition Regulation (Parts 3400— 3499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300—5399) [Reserved] 54 Defense Logistics Agency, Department of Defense (Parts 5400— 5499) 57 African Development Foundation (Parts 5700—5799) 61 Civilian Board of Contract Appeals, General Services Adminis- tration (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399)

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99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Pipeline and Hazardous Materials Safety Administration, De- partment of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board (Parts 1000—1399) XI Research and Innovative Technology Administration, Depart- ment of Transportation (Parts 1400—1499) [Reserved] XII Transportation Security Administration, Department of Home- land Security (Parts 1500—1699)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

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CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Administrative Conference of the United States 1, III Advisory Council on Historic Preservation 36, VIII Advocacy and Outreach, Office of 7, XXV Afghanistan Reconstruction, Special Inspector General for 5, LXXXIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 2, VII; 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 2, IV; 5, LXXIII Advocacy and Outreach, Office of 7, XXV Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Economic Research Service 7, XXXVII Energy Policy and New Uses, Office of 2, IX; 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Institute of Food and Agriculture 7, XXXIV Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII

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VerDate Sep<11>2014 13:04 Jun 30, 2017 Jkt 241071 PO 00000 Frm 00776 Fmt 8092 Sfmt 8092 Q:\21\21V2.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB List of CFR Sections Affected All changes in this volume of the Code of Federal Regulations (CFR) that were made by documents published in the FEDERAL REGISTER since January 1, 2012 are enumerated in the following list. Entries indicate the nature of the changes effected. Page numbers refer to FEDERAL REGISTER pages. The user should consult the entries for chapters, parts and subparts as well as sections for revisions. For changes to this volume of the CFR prior to this listing, consult the annual edition of the monthly List of CFR Sections Affected (LSA). The LSA is available at www.fdsys.gov. For changes to this volume of the CFR prior to 2001, see the ‘‘List of CFR Sections Affected, 1949–1963, 1964–1972, 1973–1985, and 1986–2000’’ published in 11 separate volumes. The ‘‘List of CFR Sections Affected 1986–2000’’ is available at www.fdsys.gov.

2012 21 CFR—Continued 79 FR Page 21 CFR 77 FR Chapter I—Continued Page 106.30 (e)(2)(ii) revised...... 33071 Chapter I 106.35 (a)(4) and (b)(1) revised...... 33071 101 Policy statement...... 9842, 70885 106.50 (a)(2) revised ...... 33071 118 Policy statement ...... 50372 106.91 (b)(1), (2), (3), (4)(ii), (iii) and (iv) revised ...... 33071 2013 106.96 (c)(1), (2)(ii), (g)(1) and (2) revised; (g)(3) added ...... 33071 21 CFR 78 FR 106.100 (f)(4), (k)(5)(ii), (m) and (o) Page revised ...... 33072 Chapter I 106.120 (b)(7) added ...... 33072 101.91 Added ...... 47178 106.121 (d) and (i) revised; (j) 123 Policy statement ...... 69992 added...... 33072 107 Technical correction...... 41127 2014 107.1 Added ...... 8074 107.3 Amended...... 8074 21 CFR 79 FR Page 107.10 (a) introductory text, (2) introductory text and (b)(5) re- Chapter I vised ...... 8074 101 Policy statement ...... 23262 107.50 (e) revised...... 8074 Uniform compliance date ...... 73201 107.240 Revised ...... 8074 101.8 Added; eff. 12-1-16 ...... 71291 107.250 Introductory text re- 101.9 (j)(1)(i), (2) introductory vised ...... 8075 text and (3) introductory text revised; (j)(4) amended; eff. 12- 1-15 ...... 71253 2015 (j)(2)(ii), (4) and (13)(i) introduc- 21 CFR 80 FR tory text revised; eff. 12-1-16 ...... 71293 Page 101.10 Revised; eff. 12-1-15 ...... 71253 Chapter I 101.11 Added; eff. 12-1-15...... 71253 101 Policy statement ...... 13225 106 Revised ...... 8059 101.8 Regulation at 79 FR 71291 Policy statement ...... 33056 compliance date extended...... 39675 Technical correction ...... 41127 101.9 Regulation at 79 FR 71253 106.3 Amended ...... 33070 and 71291 compliance date ex- 106.20 (i) revised...... 33071 tended ...... 39675

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21 CFR—Continued 80 FR 21 CFR—Continued 80 FR Page Page Chapter I—Continued Chapter I—Continued 101.10 Regulation at 79 FR 71253 123 Compliance date clarifica- compliance date extended...... 39675 tion ...... 71934 101.11 Regulation at 79 FR 71253 123.3 Introductory text amend- compliance date extended...... 39675 ed ...... 56167 106 Compliance date clarifica- 123.5 (a) revised...... 56167 tion ...... 71934 123.11 (b) introductory text re- 106.100 (n) revised...... 56144 vised...... 56167 107.10 (a)(2) revised; eff. 6-22-16 ...... 35840 129 Compliance date clarifica- Regulation at 80 FR 35840 eff. tion ...... 71934 date confirmed...... 61293 129.1 Revised ...... 56167 107.100 (a) revised; eff. 6-22-16...... 35841 150.141 Removed ...... 72585 Regulation at 80 FR 35841 eff. 150.161 Removed ...... 72585 date confirmed...... 61293 161.170 (a)(5)(ii)(b) removed; 110 Removed; eff. 9-17-18...... 56144 (a)(5)(ii)(a) redesignated as Compliance date clarification...... 71934 (a)(5)(ii)...... 41436 111.5 Amended ...... 74352 112 Added ...... 74547 2016 Policy statement ...... 74670 21 CFR 81 FR 114 Compliance date clarifica- Page tion ...... 71934 100 Nomenclature change ...... 49895 114.5 Revised ...... 56144 100.155 (a) and (b) amended ...... 59131 117 Added ...... 56145 101 Policy statement...8833, 43061, 54499, Policy statement ...... 56358 54501, 66527, 85156 Compliance date clarification...... 71934 Nomenclature change ...... 49895 117.3 Eff. date pending in part...... 56145 101.2 (c) introductory text 117.5 Eff. date pending in part...... 56145 amended...... 59131 Regulation at 80 FR 56145 eff. in 101.4 (h) introductory text and (2) part 1-26-16 ...... 74354 amended ...... 5590 117.8 Eff. date pending in part...... 56145 101.7 Redesignated from 101.105; Regulation at 80 FR 56145 eff. in heading revised ...... 59131 part 1-26-16 ...... 74354 101.8 Regulation at 79 FR 71291 117.95 Added ...... 56337 compliance date extended in 117.405 Eff. date pending in part to 7-26-18...... 50303 part ...... 56145 101.9 (c)(1)(ii), (j)(5)(ii)(C), (D), (E) Regulation at 80 FR 56145 eff. in and (13)(ii)(C) removed; part 1-26-16 ...... 74354 (c)(1)(iii) and (j)(13)(ii)(D) re- 117.410 Eff. date pending in designated as new (c)(1)(ii) and part ...... 56145 new (j)(13)(ii)(C); (c)(1)(i)(A) Regulation at 80 FR 56145 eff. in through (E), new (ii), (2), (5), part 1-26-16 ...... 74354 (6)(i) through (4), (7), (8) intro- 117.430 Eff. date pending in ductory text, (i), (ii) introduc- part ...... 56145 tory text, (iii), (iv), (v), (9), Regulation at 80 FR 56145 eff. in (d)(1) introductory text, (iii), part 1-26-16 ...... 74354 (iv), (v), (2) through (5), (7) in- 117.435 Eff. date pending in troductory text, (i), (8), (9), part ...... 56145 (11)(ii), (iii), (12), (13)(ii), (e), (f) 117.475 Eff. date pending in introductory text, (2)(ii), (4), part ...... 56145 (5), (g) introductory text, (2), Regulation at 80 FR 56145 eff. (3)(ii), (4), (5), (6), (8), (h)(3)(iv), date confirmed in part...... 74354 (4) introductory text, (j)(5)(i), 120 Compliance date clarifica- (ii) introductory text, (A), (B), tion ...... 71934 (13)(i), (ii)(A)(1), (2), (B) and 120.3 Introductory text amend- (18)(iv) introductory text reed ...... 56167 vised; (c)(1)(i)(F), (8)(vii), 120.5 Revised ...... 56167 (g)(10), (11), (j)(5)(iii) and (l) 120.6 (b) amended ...... 56167 added...... 33979

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21 CFR—Continued 81 FR 21 CFR—Continued 81 FR Page Page (b)(2)(i)(D), (6), (8)(iii), (10)(ii) 112 Nomenclature change ...... 49896 and (h)(3)(ii) revised; Policy statement ...... 57784 (b)(2)(i)(E) removed; 112.3 (a), (b) and (c) introductory (b)(2)(i)(F) through (I) redesig- text removed; introductory nated as new (b)(2)(i)(E) text added; amended ...... 26467 through (H); (b)(12) added ...... 34040 112.55 (b) revised ...... 26468 (j)(1)(i), (2) introductory text and 114 Policy statement ...... 57784 (3) introductory text revised; 117 Nomenclature change ...... 49896 (j)(4) amended; eff. date note Policy statement ...... 57784, 75692 removed; CFR correction ...... 84465 117.1 (b) revised ...... 3715 Regulation at 79 FR 71253 compli- 117.3 Amended...... 3715 ance date extended to 5-5-17 ...... 96364 Regulation at 80 FR 56145 eff. 101.10 Revised; CFR correction .....84465 date confirmed in part...... 64060 Regulation at 79 FR 71253 compli- 117.5 (a) amended; (h)(3)(v) re- ance date extended to 5-5-17 ...... 96364 vised ...... 3716 101.11 Added; CFR correction ...... 84459 117.8 Correctly revised ...... 3956 Regulation at 79 FR 71253 compli- 117.136 (a)(2) introductory text, ance date extended to 5-5-17 ...... 96364 (5) and (b)(5) revised...... 3716 101.12 (f)(2) removed; (f)(3) redes- 117.145 (a) revised ...... 3716 ignated as new (f)(2); (b) tables 117.201 (b)(2)(i)(B) and (ii) re- 1 and 2, (c), (f)(1) and new (2) revised ...... 3716 vised...... 34041 117.257 (e) revised ...... 3716 101.13 (d)(2), (h)(4)(i) and (i)(2) 117.264 (a)(1) revised ...... 3716 amended...... 59131 117.405 (c) introductory text cor- 101.30 (e)(2) revised ...... 33994 rected ...... 3956 (g) amended ...... 59131 118 Nomenclature change ...... 49896 101.36 (b)(2)(i) introductory text, 118.8 (a) and (b) amended...... 5590 (B), (ii)(A), (B), (iii) introduc- 120 Policy statement ...... 57784 tory text, (D) through (G), 121 Added ...... 34219 (3)(ii)(A), (c)(4), (e) introduc- 123 Policy statement ...... 57784 tory text, (8), (11)(i) through 129 Policy statement ...... 57784 (viii), (12), (f) and (i)(1) revised; 130 Nomenclature change ...... 49896 (i) introductory text re- 161 Nomenclature change ...... 49896 moved ...... 33994 165.110 (a)(2)(iv), (vii), (b)(2)(ii), 101.75 (c)(1) and (2)(ii) revised; in- (3) introductory text, (4)(i)(C), terim...... 91722 (iii)(E) introductory text, 101.80 (c)(2)(iii)(C) amended...... 5590 (1)(ii), (iv), (7)(iv), (11)(i), (14)(i), 101.81 (c)(2)(ii)(A) introductory (F)(20), (I) and (5)(ii) introduc- text, (5), (B)(1) and (2) amend- tory text amended...... 5591 ed...... 5590 101.83 (c)(2)(ii)(A)(2) and (B)(2) 2017 amended ...... 5590 (Regulations published from January 1, 101.105 Redesignated as 101.7 ...... 59131 2017, through April 1, 2017) 102 Nomenclature change ...... 49895 104.5 (b) amended ...... 59131 21 CFR 82 FR 106 Policy statement ...... 22174, 57784 Page Nomenclature change ...... 49895 Chapter I 107 Nomenclature change ...... 49895 101.17 (h)(7)(ii) introductory text, 108 Nomenclature change ...... 49896 (B), (C) introductory text, (1), 108.25 (c)(1) and (2) revised ...... 46831 (4), (5), (6), (D), (E) and (F) re- 108.35 (c)(1), (2) introductory text, vised...... 14144 (ii) and (i) revised ...... 46831 112.209 Revised ...... 14145 109 Nomenclature change ...... 49896 115.50 (e)(2) introductory text, 110 Nomenclature change ...... 49896 (ii), (iii) introductory text, (A), Policy statement ...... 57784 (D), (E), (F), (iv), (v) and (vi) re- 111 Meeting...... 9761 vised...... 14145 Policy statement ...... 57784 117.274 Revised ...... 14146

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21 CFR—Continued 82 FR Page Chapter I—Continued 118.12 (a)(1)(i) introductory text, (2) introductory text, (ii), (iii) introductory text, (A), (D), (E), (F), (iv), (v) and (vi) revised ...... 14146 Æ

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