Incorporation by Reference of the Food Chemicals Codex, 7Th Edition

Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 71457

that there is specific, objective support small entities will have an estimated By the Commission. for the burden estimates associated with cost of $60 in Year 1 and no further Nathaniel J. Davis, Sr., the information requirements. ongoing costs. These figures are based Deputy Secretary. 62. Interested persons may obtain on information collection costs plus [FR Doc. 2013–28626 Filed 11–27–13; 8:45 am] information on the reporting additional costs for compliance. The BILLING CODE 6717–01–P requirements by contacting the Federal Commission does not consider this to be Energy Regulatory Commission, Office a significant economic impact for small of the Executive Director, 888 First entities because it should not represent DEPARTMENT OF HEALTH AND Street NE., Washington, DC 20426 a significant percentage of the small HUMAN SERVICES [Attention: Ellen Brown, email: Data entities’ operating budgets. The [email protected], phone: (202) 502– Food and Drug Administration 8663, fax: (202) 273–0873]. Commission solicited comments concerning is proposed Regulatory IV. Environmental Analysis Flexibility Act certification and did not 21 CFR Parts 172, 173, 178, and 180 63. The Commission is required to receive any comments. Accordingly, the [Docket No. FDA–2010–F–0320] prepare an Environmental Assessment Commission certifies that this Final or an Environmental Impact Statement Rule will not have a significant Food Additive Regulations; for any action that may have a economic impact on a substantial Incorporation by Reference of the significant adverse effect on the human number of small entities. Food Chemicals Codex, 7th Edition environment.54 The Commission has VI. Document Availability AGENCY: Food and Drug Administration, categorically excluded certain actions HHS. from this requirement as not having a 66. In addition to publishing the full ACTION: Final rule. significant effect on the human text of this document in the Federal environment. Included in the exclusion Register, the Commission provides all SUMMARY: The Food and Drug are rules that are clarifying, corrective, interested persons an opportunity to Administration (FDA or we) is or procedural or that do not view and/or print the contents of this amending select food additive substantially change the effect of the regulations that incorporate by reference 55 document via the Internet through the regulations being amended. The food-grade specifications from prior actions directed herein fall within this Commission’s Home Page (http:// www.ferc.gov) and in the Commission’s editions of the Food Chemicals Codex categorical exclusion in the (FCC) to incorporate by reference food- Commission’s regulations. Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. grade specifications from the FCC 7th V. Regulatory Flexibility Act Eastern time) at 888 First Street NE., Edition (FCC 7). We are taking this 64. The Regulatory Flexibility Act of Room 2A, Washington, DC 20426. action in response to a petition filed by 1980 (RFA) 56 generally requires a the United States Pharmacopeial 67. From the Commission’s Home Convention (U.S.P. or petitioner). description and analysis of proposed Page on the Internet, this information is rules that will have significant DATES: This rule is effective November available on eLibrary. The full text of 29, 2013. See the ‘‘Objections’’ heading economic impact on a substantial this document is available on eLibrary number of small entities. As discussed of the SUPPLEMENTARY INFORMATION in PDF and Microsoft Word format for above, regional Reliability Standard section for information on the filing of viewing, printing, and/or downloading. BAL–002–WECC–2 applies to 36 objections. Submit either electronic or registered balancing authorities and To access this document in eLibrary, written objections and requests for a reserve sharing groups in the NERC type the docket number excluding the hearing by December 30, 2013. The Compliance Registry. Comparison of the last three digits of this document in the Director of the Office of the Federal NERC Compliance Registry with data docket number field. Register approves the incorporation by submitted to the Energy Information 68. User assistance is available for reference of certain publications listed Administration on Form EIA–861 eLibrary and the Commission’s Web site in the rule as of November 29, 2013. indicates that, of the 36 registered during normal business hours from the ADDRESSES: You may submit either balancing authorities and reserve Commission’s Online Support at (202) electronic or written objections and sharing groups, two may qualify as 502–6652 (toll free at 1–866–208–3676) requests for a hearing, identified by small entities.57 or email at [email protected], Docket No. FDA–2010–F–0320, by any 65. The Commission estimates that, or the Public Reference Room at (202) of the following methods: on average, each of the two affected 502–8371, TTY (202) 502–8659. Email Electronic Submissions the Public Reference Room at 54 Regulations Implementing the National Submit electronic objections in the [email protected]. Environmental Policy Act of 1969, Order No. 486, following way: 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs., • Regulations Preambles 1986–1990 ¶ 30,783 (1987). VII. Effective Date and Congressional Federal eRulemaking Portal: http:// 55 18 CFR 380.4(a)(2)(ii). Notification www.regulations.gov. Follow the 56 5 U.S.C. 601–612. instructions for submitting comments. 57 69. These regulations are effective The RFA definition of ‘‘small entity’’ refers to Written Submissions the definition provided in the Small Business Act January 28, 2014. The Commission has (SBA), which defines a ‘‘small business concern’’ as determined, with the concurrence of the Submit written objections in the a business that is independently owned and Administrator of the Office of following ways: operated and that is not dominant in its field of • operation. See 15 U.S.C. 632. According to the Information and Regulatory Affairs of Mail/Hand delivery/Courier (for Small Business Administration, an electric utility is OMB, that this rule is not a ‘‘major rule’’ paper or CD–ROM submissions): defined as ‘‘small’’ if, including its affiliates, it is as defined in section 351 of the Small Division of Dockets Management (HFA– primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and Business Regulatory Enforcement 305), Food and Drug Administration, its total electric output for the preceding fiscal year Fairness Act of 1996. 5630 Fishers Lane, Rm. 1061, Rockville, did not exceed 4 million megawatt hours. MD 20852.

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Instructions: All submissions received public review and comment on U.S.P.’s III, IV, or V to industry or the public. must include the Agency name and Web site. U.S.P. scientists and its Food (Under 5 U.S.C. 552(a) and 1 CFR Docket No. FDA–2010–F–0320 for this Ingredients Expert Committee review 51.7(a)(4), a publication that is to be rulemaking. All objections received may these data and, if necessary, conduct incorporated by reference must be be posted without change to http:// laboratory tests. Once approved by the ‘‘reasonably available’’ to and capable of www.regulations.gov, including any Food Ingredients Expert Committee, being used by persons affected by the personal information provided. For new or updated monographs are publication.) Second, the petitioner detailed instructions on submitting published in the next edition or maintained that updating the references objections, see the ‘‘Objections’’ heading Supplement to the FCC. to older editions of the FCC to FCC 7 of the SUPPLEMENTARY INFORMATION The petitioner initially requested may avoid confusion, inconsistency, section of this document. amendments to 39 existing references to and lack of uniformity in the quality of Docket: For access to the docket to older editions of the FCC in parts 172, food additives and ingredients read background documents or 173, 178, and 180 to incorporate by manufactured and sold. Third, the objections received, go to http:// reference the specifications contained in petitioner noted that, in many cases, the www.regulations.gov and insert the FCC 7. The petitioner explained that of editions of the FCC prior to FCC 7 may docket number, found in brackets in the the regulations it has requested to be employ outdated analytical heading of this document, into the updated, 15 regulations refer to the third methodologies and equipment that do ‘‘Search’’ box and follow the prompts edition of the FCC (FCC III, published not reflect current scientific practices, and/or go to the Division of Dockets in 1981); 18 regulations refer to the and which may be difficult to obtain. Management, 5630 Fishers Lane, Rm. fourth edition of the FCC (FCC IV, We note that, subsequent to our 1061, Rockville, MD 20852. published in 1996); 4 regulations refer analysis of FCC 7, the U.S.P. published to the fifth edition of the FCC (FCC V, the eighth edition of the FCC (FCC 8) in FOR FURTHER INFORMATION CONTACT: published in 2004); and 2 regulations March 2012. Initiating a review of FCC Mical Honigfort, Center for Food Safety refer to the sixth edition of the FCC 8 at this time would delay issuance of and Applied Nutrition (HFS–265), Food (FCC 6, published in 2008). (The IOM this final rule. To avoid a delay in and Drug Administration, 5100 Paint used roman numerals when referring to updating the references to the FCC in Branch Pkwy., College Park, MD 20740– editions of the FCC, e.g., FCC III and our food additive regulations, we are 3835, 240–402–1278. FCC V. U.S.P. uses numbers rather than proceeding with issuing this final rule SUPPLEMENTARY INFORMATION: roman numerals to refer to the editions to incorporate by reference FCC 7. The I. Background of FCC that it has published, e.g., FCC specific food additive regulations 6 and FCC 7.) In most cases, the explain how to obtain copies of FCC 7. In a notice published in the Federal references to the FCC in the regulations As appropriate, we will provide further Register of August 10, 2010 (75 FR are to an entire FCC monograph. Some updates to our food additive regulations 48353), we announced that the U.S.P., references, however, only refer to part of to reflect more recent versions of the 12601 Twinbrook Pkwy., Rockville, MD an FCC monograph, i.e., a single FCC. 20852, had filed a food additive specification, or to an FCC analytical II. Evaluation of Amendments to Parts petition. The petition proposed that method. select food additive regulations in parts After discussions with us in July 172, 173, 178, and 180 172, 173, 178, and 180 (21 CFR parts 2011, the petitioner subsequently We compared the specifications and 172, 173, 178, and 180), which narrowed its petition to exclude six analytical methods in the versions of the incorporate by reference food-grade regulations ((§§ 172.172.723(b)(3), FCC currently referenced in the specifications from prior editions of the 172.833(b)(4), 172.846(b), 172.858(a), regulations to the specifications and FCC, be amended to incorporate by 180.25(b), and 180.30(a)). The current analytical methods in FCC 7 (Ref. 1). In reference food-grade specifications from regulation for epoxidized soybean oil addition, we note that some general FCC 7. (§ 172.723(b)(3)) includes a limit of 10 changes were made to FCC monographs The FCC is a compendium of milligrams per kilogram (mg/kg) for published in or after FCC IV that remain specification monographs for substances heavy metals (as lead (Pb)), as in FCC 7. One change is that the older used as food ingredients. The determined by Method II of the ‘‘Heavy FCC monographs discussed in this Committee on Food Chemicals Codex of Metals Test’’ in FCC IV. FCC 7, document that contain a specification the Food and Nutrition Board, Institute however, does not include a monograph limit for heavy metals (as Pb) were of Medicine (IOM) of the National for epoxidized soybean oil and does not updated in FCC V to remove this Academies published the first through include the ‘‘Heavy Metals Test’’ as a specification, and, when appropriate, to fifth editions of the FCC. In 2006, U.S.P. general test in the appendices of FCC 7. replace it with an individual acquired the rights to the FCC, and Accordingly, § 172.723(b)(3) has been specification limit for each relevant subsequently published the sixth, excluded from the petition. U.S.P. has heavy metal. Many FCC 7 monographs seventh, and eighth editions. excluded the remaining five regulations have also adopted lower lead limit Specifications and methods published (§§ 172.833(b)(4), 172.846(b), 172.858(a), specifications compared to earlier FCC in the FCC have been incorporated by 180.25(b), and 180.30(a)) based on its editions, to reduce lead in food. reference in various sections of 21 CFR need to further investigate the bases for Furthermore, if an earlier edition of the parts 73, 170, 172, 173, 178, 180, and such updates. FCC contained a specification limit for 184. The petitioner cited several reasons arsenic, that specification has been Since acquiring rights to the FCC, for updating the references to older removed unless the monograph met one U.S.P. has developed and continues to editions of the FCC to specifications and of the following criteria: (1) The develop standards for food ingredients analytical methodologies contained in ingredient or additive is a high-volume through public participation with a goal FCC 7. First, previous editions of the consumption item (greater than 25 of biennial publication of the FCC. Draft FCC are no longer readily available to million pounds per year), (2) the monographs and data are provided by industry or the public, since U.S.P. does ingredient or additive is derived from a food ingredient manufacturers, users, not maintain and therefore cannot natural (mineral) source where arsenic and suppliers and are published for provide copies of monographs from FCC may be an intrinsic contaminant, and/or

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(3) there is reason to believe that arsenic rather than as a required standard. Other analytical methodologies contained in constitutes a significant part of the total differences (e.g., solvent or instrument FCC 7. We are also amending § 178.1005 heavy metals content (Ref. 1). changes) between the specifications and to incorporate by reference the An FCC monograph typically consists analytical methods in the version of the specifications for ‘‘Acidity,’’ ‘‘Chloride’’ of a description of the substance, its FCC currently referenced in the and ‘‘Other requirements’’ for Hydrogen functional use, the recommended regulations and the specifications and Peroxide Concentrate in the United specifications for the substance, and analytical methods in FCC 7 are States Pharmacopeia, 36th Revision testing methodology. In many cases, discussed further in the FDA (2013). This updates the reference to the there are minor differences between the Memoranda from D. Folmer to M. United States Pharmacopeia XX (1980) description or functional use of a Honigfort (Refs. 1 through 3). already cited in § 178.1005. We substance provided in FCC 7 compared After review of each proposed to the description or functional use of a amendment, we are updating the compared the United States substance provided in earlier editions of regulations shown in table 1 to Pharmacopeia XX (1980) monograph for the FCC and the CFR. However, FCC 7 incorporate FCC 7 by reference. We note Hydrogen Peroxide Concentrate to the provides the description and functional that the safety of these additives has United States Pharmacopeia, 36th use of a substance specified in a been previously considered and there Revision (2013) monograph for monograph for informational purposes, are no safety concerns with the Hydrogen Peroxide Concentrate and e.g., to help industry understand the proposed changes to incorporate by determined that this update is safe and possible functions of the ingredients, reference the specifications and appropriate (Ref. 4).

TABLE 1—LIST OF REGULATIONS

21 CFR Section Name of Additive FCC 7 Reference

172.167(b) ...... Hydrogen peroxide ...... Meets FCC 7 specifications. 172.320(b)(1) ...... Amino acids ...... Meets FCC 7 specifications. 172.345(b) ...... Folic acid (folacin) ...... Meets FCC 7 specifications. 172.379(b) ...... Vitamin D2 ...... Meets FCC 7 specifications. 172.380(b) ...... Vitamin D3 ...... Meets FCC 7 specifications. 172.665(d)(2) ...... Gellan gum ...... Residual isopropyl alcohol limit not to exceed 0.075% by the procedure described in the Gellan Gum monograph in FCC 7. 172.712(b) ...... 1,3-Butylene glycol ...... Conforms to FCC 7 identity and specifications. 172.736(b)(2) ...... Glycerides and polyglycides of hydrogenated Acid value not greater than 2, and hydroxyl value, not greater than vegetable oils. 56 as determined by ‘‘Acid Value’’ and ‘‘Hydroxyl Value’’ methods. 172.780(b) ...... Acacia (gum arabic) ...... Meets FCC 7 specifications. 172.800(b)(2) ...... Acesulfame potassium ...... Fluoride content not more than 30 milligrams per kilogram (mg/kg) as determined by Method III of the Fluoride Limit Test (We have amended the specification for fluoride content in acesulfame potassium in § 172.800(b)(2) to replace ‘‘parts per million’’ with ‘‘mg/ kg’’ to be consistent with terminology used elsewhere in the regulations cited in this rule.). 172.804(b) ...... Aspartame ...... Meets FCC 7 specifications. 172.810 ...... Dioctyl sodium sulfosuccinate ...... Meets FCC 7 specifications. 172.812(a) ...... Glycine ...... Meets FCC 7 specifications. 172.831(b) ...... Sucralose ...... Meets FCC 7 specifications. 172.841(b) ...... Polydextrose ...... Meets FCC 7 specifications. 172.862(b)(1) ...... Oleic acid derived from tall oil fatty acids ...... Meets FCC 7 specifications except that titer (solidification point) shall not exceed 13.5 degrees Celsius and unsaponifiable matter shall not exceed 0.5%. 172.867(b) ...... Olestra ...... Meets FCC 7 specifications. 172.869(b)(6) ...... Sucrose oligoesters ...... Acid value not more than 4.0 as determined by the method ‘‘Acid Value,’’ Appendix VII, Method I (Commercial Fatty Acids). 172.869(b)(7) ...... Sucrose oligoesters ...... Residue on ignition not more than 0.7% as determined by ‘‘Residue on Ignition,’’ Appendix IIC, Method I (using a 1 gram sample). 172.869(b)(8) ...... Sucrose oligoesters ...... Residual methanol not more than 10 mg/kg as determined by the method listed in the monograph for ‘‘Sucrose Fatty Acid Esters’’. 172.869(b)(9) ...... Sucrose oligoesters ...... Residual dimethyl sulfoxide not more than 2.0 mg/kg as determined by the method listed in the monograph ‘‘Sucrose Fatty Acid Esters’’. 172.869(b)(10) ...... Sucrose oligoesters ...... Residual isobutyl alcohol not more than 10 mg/kg as determined by the method listed in the monograph ‘‘Sucrose Fatty Acid Esters’’. 172.869(b)(11) ...... Sucrose oligoesters ...... Lead not more than 1.0 mg/kg as determined by ‘‘Atomic Absorp- tion Spectrophotometric Graphite Furnace Method,’’ Method I. 173.160(d) ...... Candida gulliermondii ...... Citric acid produced must conform to FCC 7 specifications (under ‘‘Citric acid’’). 173.165(d) ...... Candida lipolytica ...... Citric acid produced must conform to FCC 7 specifications (under ‘‘Citric acid’’). 173.228(a) ...... Ethyl acetate ...... Meets FCC 7 specifications. 173.280(c) ...... Solvent extraction process for citric acid ...... Citric acid produced must conform to FCC 7 specifications (under ‘‘Citric acid’’).

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TABLE 1—LIST OF REGULATIONS—Continued

21 CFR Section Name of Additive FCC 7 Reference

173.310(c) ...... Boiler water additives; Sodium Contains not less than 95% sodium carboxymethylcellulose on a carboxymethylcellulose. dry-weight basis, with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2% by weight aqueous determined by the ‘‘Viscosity of Cellulose Gum’’ method cited in FCC 7. 173.310(c) ...... Boiler water additives; Sorbitol anhydride Polysorbate 20 present in sorbitol anhydride esters meets FCC 7 esters. specifications (We have amended the limitation for sorbitol anhydride esters in § 173.310(c) to replace ‘‘parts per million’’ with ‘‘mg/kg’’ to be consistent with terminology used elsewhere in the regulations cited in this rule.). 173.368(c) ...... Ozone ...... Meets FCC 7 specifications. 178.1005(c) ...... Hydrogen peroxide solution ...... Meets FCC 7 specifications (We are also amending the regulation to incorporate by reference the United States Pharmacopeia, 36th Revision.). 180.37(b) ...... Saccharin, ammonium saccharin, calcium Meets FCC 7 specifications. saccharin, and sodium saccharin.

The petitioner also requested IV. Public Availability of Documents we would review the potential amending § 173.115(b)(3) (Alpha- In accordance with § 171.1(h) (21 CFR environmental impact of the petition. acetolactate decarboxylase (a-ALDC) 171.1(h)), the petition and the We placed the petitioner’s enzyme preparation derived from a documents that we considered and environmental assessment on display in recombinant Bacillus subtilis). The relied upon in reaching our decision to the Division of Dockets Management for current regulation requires that the approve the petition will be made public review and comment. enzyme preparation should meet the available for public disclosure (see FOR We have carefully reviewed the general and additional requirements for FURTHER INFORMATION CONTACT). As environmental assessment and enzyme preparations found in FCC IV. provided in § 171.1(h), we will delete considered the potential environmental FCC 7 specifically includes a-ALDC in from the documents any materials that effects of this action. We have the list of enzyme preparations, but does are not available for public disclosure. concluded that the action will not have not contain an assay method specific to a significant impact on the human a-ALDC. We are not amending V. Environmental Impact environment, and that an environmental § 173.115(b)(3) at this time to Under part H in § 171.1(c), either an impact statement is not required. Our incorporate by reference the environmental assessment under 21 finding of no significant impact and the specifications in FCC 7 because the CFR 25.40 or a claim of categorical evidence supporting that finding, assay method for a-ALDC has been exclusion under § 25.30 (21 CFR 25.30) contained in the environmental omitted from FCC 7. or § 25.32 (21 CFR 25.32) is required to assessment, may be seen in the Division be submitted with a food additive of Dockets Management (see ADDRESSES) Additionally, on our own initiative, petition. As initially filed by U.S.P., the between 9 a.m. and 4 p.m., Monday we are amending certain provisions in petition contained a claim of categorical through Friday. parts 172, 173, 178, and 180 to update exclusion under § 25.30(i), which the address at which copies of FCC 7 applies to corrections and technical VI. Paperwork Reduction Act of 1995 can be examined. In most cases, the changes in regulations. We reviewed the This final rule contains no collection existing regulations refer to an FDA petitioner’s claim of categorical of information. Therefore, clearance by address at ‘‘5100 Paint Branch Pkwy., exclusion and stated in our original the Office of Management and Budget College Park, MD 20740.’’ However, in filing notice of August 10, 2010, that we under the Paperwork Reduction Act of 2013, we consolidated our library agreed that, under § 25.30(i), the 1995 is not required. holdings at our main library at 10903 proposed action was of a type that VII. Objections New Hampshire Ave., Silver Spring, MD would not individually or cumulatively 20993. Therefore, we are amending have a significant effect on the human If you will be adversely affected by various provisions to reflect the current environment and therefore that neither one or more provisions of this FDA address at which copies of FCC 7 an environmental assessment nor an regulation, you may file with the can be examined. environmental impact statement would Division of Dockets Management (see III. Conclusion be required. ADDRESSES) either electronic or written However, upon further review, we objections. You must separately number We reviewed data in the petition and decided that as a group, the actions each objection, and within each other relevant material and conclude being requested are neither corrections numbered objection you must specify that the proposed amendments to the nor technical changes and therefore the with particularity the provision(s) to regulations listed in table 1 to categorical exclusion in § 25.30(i) would which you object and the grounds for incorporate by reference food-grade not be applicable. Accordingly we your objection. Within each numbered specifications and analytical announced, in an amended filing notice objection, you must specifically state methodologies from FCC 7, as discussed published in the Federal Register of whether you are requesting a hearing on in Section II of this document, are safe January 18, 2012 (77 FR 2492), that the particular provision that you specify and appropriate. Therefore, we are U.S.P. had submitted an environmental in that numbered objection. If you do amending parts 172, 173, 178, and 180 assessment for the petition in lieu of a not request a hearing for any particular as set forth in this document. claim of categorical exclusion and that objection, you waive the right to a

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hearing on that objection. If you request and may be seen by interested persons and Drug Administration’s Main a hearing, your objection must include between 9 a.m. and 4 p.m., Monday Library, 10903 New Hampshire Ave., a detailed description and analysis of through Friday, and are available Bldg. 2, Third Floor, Silver Spring, MD the specific factual information you electronically at http:// 20993, 301–796–2039, or at the National intend to present in support of the www.regulations.gov. Archives and Records Administration objection in the event that a hearing is 1. FDA Memorandum from D. Folmer to M. (NARA). For information on the held. If you do not include such a Honigfort, October 24, 2011. availability of this material at NARA, description and analysis for any 2. FDA Memorandum from D. Folmer to M. call 202–741–6030 or go to: http:// particular objection, you waive the right Honigfort, February 8, 2013. www.archives.gov/federal-register/cfr/ to a hearing on the objection. It is only 3. FDA Memorandum from D. Folmer to M. ibr-locations.html. necessary to send one set of documents. Honigfort, February 27, 2013. * * * * * Identify documents with the docket 4. FDA Memorandum from D. Folmer to M. ■ 3. Revise § 172.320 to read as follows: number found in brackets in the Honigfort, October 31, 2013. heading of this document. Any § 172.320 Amino acids. List of Subjects objections received in response to the The food additive amino acids may be regulation may be seen in the Division 21 CFR Part 172 safely used as nutrients added to foods of Dockets Management between 9 a.m. Food additives, Incorporation by in accordance with the following and 4 p.m., Monday through Friday, and conditions: will be posted to the docket at http:// reference, Reporting and recordkeeping requirements. (a) The food additive consists of one www.regulations.gov. or more of the following individual VIII. Section 301(ll) of the Federal 21 CFR Part 173 amino acids in the free, hydrated, or Food, Drug, and Cosmetic Act Food additives, Incorporation by anhydrous form, or as the Our review of this petition was reference. hydrochloride, sodium, or potassium salts: limited to section 409 of the Federal 21 CFR Part 178 Food, Drug, and Cosmetic Act (the (1) L-Alanine FD&C Act) (21 U.S.C. 348). This final Food additives, Food packaging, (2) L-Arginine rule is not a statement regarding Incorporation by reference. (3) L-Asparagine (4) L-Aspartic acid compliance with other sections of the 21 CFR Part 180 FD&C Act. For example, the Food and (5) L-Cysteine Drug Administration Amendments Act Food additives, Incorporation by (6) L-Cystine of 2007, which was signed into law on reference. (7) L-Glutamic acid September 27, 2007, amended the FD&C Therefore, under the Federal Food, (8) L-Glutamine Act to, among other things, add section Drug, and Cosmetic Act and under (9) Aminoacetic acid (glycine) 301(ll) of the FD&C Act (21 U.S.C. authority delegated to the Commissioner (10) L-Histidine 331(ll)). Section 301(ll) of the FD&C Act of Food and Drugs and redelegated to (11) L-Isoleucine prohibits the introduction or delivery the Director, Center for Food Safety and (12) L-Leucine for introduction into interstate Applied Nutrition, 21 CFR parts 172, (13) L-Lysine commerce of any food that contains a 173, 178, and 180 are amended as (14) DL-Methionine (not for infant drug approved under section 505 of the follows: foods) FD&C Act (21 U.S.C. 355), a biological (15) L-Methionine PART 172—FOOD ADDITIVES (16) L-Phenylalanine product licensed under section 351 of PERMITTED FOR DIRECT ADDITION the Public Health Service Act (42 U.S.C. (17) L-Proline TO FOOD FOR HUMAN 262), or a drug or biological product for (18) L-Serine CONSUMPTION which substantial clinical investigations (19) L-Threonine (20) L-Tryptophan have been instituted and their existence ■ 1. The authority citation for 21 CFR (21) L-Tyrosine has been made public, unless one of the part 172 continues to read as follows: exceptions in section 301(ll)(1) to (ll)(4) (22) L-Valine of the FD&C Act applies. In our review Authority: 21 U.S.C. 321, 341, 342, 348, (b) The food additive meets the 371, 379e. of this petition, we did not consider following specifications: whether section 301(ll) of the FD&C Act ■ 2. Amend § 172.167 by revising (1) As found in Food Chemicals or any of its exemptions apply to food paragraph (b) to read as follows: Codex: containing these additives. Accordingly, (i) L-Alanine, pages 28 and 29. this final rule should not be construed § 172.167 Silver nitrate and hydrogen (ii) L-Arginine, pages 69 and 70. to be a statement that a food containing peroxide solution. (iii) L-Arginine Monohydrochloride, these additives, if introduced or * * * * * pages 70 and 71. delivered for introduction into interstate (b) Hydrogen peroxide meets the (iv) L-Cysteine Monohydrochloride, commerce, would not violate section specifications of the Food Chemicals pages 269 and 270. 301(ll) of the FD&C Act. Furthermore, Codex, 7th ed. (2010), pp. 496–497, (v) L-Cystine, pages 270 and 271. this language is included in all food which is incorporated by reference. The (vi) Aminoacetic acid (glycine), pages additive final rules and therefore should Director of the Office of the Federal 457 and 458. not be construed to be a statement of the Register approves this incorporation by (vii) L-Leucine, pages 577 and 578. likelihood that section 301(ll) of the reference in accordance with 5 U.S.C. (viii) DL-Methionine, pages 641 and FD&C Act applies. 552(a) and 1 CFR part 51. You may 642. obtain copies from the United States (ix) L-Methionine, pages 642 and 643. IX. References Pharmacopeial Convention, 12601 (x) L-Tryptophan, pages 1060 and 1061. The following references have been Twinbrook Pkwy., Rockville, MD 20852 (xi) L-Phenylalanine, pages 794 and 795. placed on display in the Division of (Internet address http://www.usp.org). (xii) L-Proline, pages 864 and 865. Dockets Management (see ADDRESSES) Copies may be examined at the Food (xiii) L-Serine, pages 915 and 916.

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(xiv) L-Threonine, pages 1031 and 1032. a food containing naturally occurring achieve a statistically significant (xv) L-Glutamic Acid Hydrochloride, primarily intact protein that is increase) added results in a statistically page 440. considered a significant dietary protein significant increase in the PER as (xvi) L-Isoleucine, pages 544 and 545. source, provided that: determined by the method described in (xvii) L-Lysine Monohydrochloride, (1) A reasonable daily adult intake of paragraph (d) of this section. The pages 598 and 599. the finished food furnishes at least 6.5 minimum amount of the amino acid(s) (xviii) Monopotassium L-glutamate, grams of naturally occurring primarily to achieve the desired effect must be pages 697 and 698. intact protein (based upon 10 percent of used and the increase in PER over the (xix) L-Tyrosine, page 1061. the daily allowance for the ‘‘reference’’ primarily intact naturally occurring (xx) L-Valine, pages 1072. adult male recommended by the protein in the food must be (2) As found in ‘‘Specifications and National Academy of Sciences in substantiated as a statistically Criteria for Biochemical Compounds,’’ ‘‘Recommended Dietary Allowances,’’ significant difference with at least a NAS/NRC Publication, for the NAS Publication No. 1694. probability (P) value of less than 0.05. following: (2) The additive(s) results in a protein (i) L-Asparagine efficiency ratio (PER) of protein in the (4) The amount of the additive added (ii) L-Aspartic acid finished ready-to-eat food equivalent to for nutritive purposes plus the amount (iii) L-Glutamine casein as determined by the method naturally present in free and combined (iv) L-Histidine specified in paragraph (d) of this (as protein) form does not exceed the (c) The additive(s) is used or intended section. following levels of amino acids for use to significantly improve the (3) Each amino acid (or combination expressed as percent by weight of the biological quality of the total protein in of the minimum number necessary to total protein of the finished food:

Percent by weight of total protein (expressed as free amino acid)

L-Alanine ...... 6.1 L-Arginine ...... 6.6 L-Aspartic acid (including L-asparagine) ...... 7.0 L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 Aminoacetic acid (glycine) ...... 3.5 L-Histidine ...... 2.4 L-Isoleucine ...... 6.6 L-Leucine ...... 8.8 L-Lysine ...... 6.4 L- and DL-Methionine ...... 3.1 L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 L-Serine ...... 8.4 L-Threonine ...... 5.0 L-Tryptophan ...... 1.6 L-Tyrosine ...... 4.3 L-Valine ...... 7.4

(d) Compliance with the limitations materials on hand as he deems paragraphs (c) and (d) of this section concerning PER under paragraph (c) of necessary and otherwise to check the and may be used in such foods at levels this section shall be determined by the correctness of such records. not to exceed good manufacturing method described in sections 43.212– (e) To assure safe use of the additive, practices. 43.216, ‘‘Official Methods of Analysis of the label and labeling of the additive (g) The standards required in this the Association of Official Analytical and any premix thereof shall bear, in section are incorporated by reference Chemists.’’ Each manufacturer or person addition to the other information into this section with the approval of employing the additive(s) under the required by the Act, the following: the Director of the Federal Register provisions of this section shall keep and (1) The name of the amino acid(s) under 5 U.S.C. 552(a) and 1 CFR part 51. maintain throughout the period of his contained therein including the specific Copies may be examined at the Food and Drug Administration’s Main use of the additive(s) and for a optical and chemical form. (2) The amounts of each amino acid Library, 10903 New Hampshire Ave., minimum of 3 years thereafter, records contained in any mixture. Bldg. 2, Third Floor, Silver Spring, MD of the tests required by this paragraph (3) Adequate directions for use to 20993, 301–796–2039, or at the National and other records required to assure provide a finished food meeting the Archives and Records Administration effectiveness and compliance with this limitations prescribed by paragraph (c) (NARA). For information on the regulation and shall make such records of this section. availability of this material at NARA, available upon request at all reasonable (f) The food additive amino acids call 202–741–6030 or go to: http:// hours by any officer or employee of the added as nutrients to special dietary www.archives.gov/federal-register/cfr/ Food and Drug Administration, or any foods that are intended for use solely ibr-locations.html. other officer or employee acting on under medical supervision to meet (1) AOAC INTERNATIONAL, 481 behalf of the Secretary of Health and nutritional requirements in specific North Frederick Ave., suite 500, Human Services and shall permit such medical conditions and comply with the Gaithersburg, MD 20877: officer or employee to conduct such requirements of part 105 of this chapter (i) Sections 43.212–43.216, ‘‘Official inventories of raw and finished are exempt from the limitations in Methods of Analysis of the Association

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of Official Analytical Chemists,’’ 13th (Internet address http://www.usp.org). and Records Administration (NARA). Ed. (1980). Copies may be examined at the Food For information on the availability of (ii) [Reserved]. and Drug Administration’s Main this material at NARA, call 202–741– (2) National Academy of Sciences, Library, 10903 New Hampshire Ave., 6030 or go to: http://www.archives.gov/ available from the FDA Main Library, Bldg. 2, Third Floor, Silver Spring, MD federal-register/cfr/ibr-locations.html. 10903 New Hampshire Ave., Silver 20993, 301–796–2039, or at the National * * * * * Spring, MD 20993: Archives and Records Administration ■ (i) ‘‘Recommended Dietary (NARA). For information on the 8. Amend § 172.712 by revising Allowances,’’ NAS Publication No. availability of this material at NARA, paragraph (b) to read as follows: 1694, 7th Ed. (1968). call 202–741–6030 or go to: http:// § 172.712 1,3-Butylene glycol. (ii) ‘‘Specifications and Criteria for www.archives.gov/federal-register/cfr/ Biochemical Compounds,’’ NAS/NRC ibr-locations.html. * * * * * Publication, 3rd Ed. (1972). * * * * * (b) The food additive shall conform to the identity and specifications of the (3) United States Pharmacopeial ■ 6. Amend § 172.380 by revising Food Chemicals Codex, 7th ed. (2010), Convention, 12601 Twinbrook Pkwy., paragraph (b) to read as follows: Rockville, MD 20852 (Internet address p. 126, which is incorporated by http://www.usp.org): § 172.380 Vitamin D3. reference. The Director of the Office of (i) Food Chemicals Codex, 7th ed. * * * * * the Federal Register approves this (2010), pages 28, 29, 69, 70, 71, 269, (b) Vitamin D3 meets the incorporation by reference in 270, 271, 440, 457, 458, 544, 545, 577, specifications of the Food Chemicals accordance with 5 U.S.C. 552(a) and 1 578, 598, 599, 641, 642, 643, 697, 698, Codex, 7th ed. (2010), pp. 1081–1082, CFR part 51. You may obtain copies 794, 795, 864, 865, 915, 916, 1031, 1032, which is incorporated by reference. The from the United States Pharmacopeial 1060, 1061, and 1072. Director of the Office of the Federal Convention, 12601 Twinbrook Pkwy., (ii) [Reserved]. Register approves this incorporation by Rockville, MD 20852 (Internet address ■ 4. Amend § 172.345 by revising reference in accordance with 5 U.S.C. http://www.usp.org). Copies may be paragraph (b) to read as follows: 552(a) and 1 CFR part 51. You may examined at the Food and Drug obtain copies from the United States Administration’s Main Library, 10903 § 172.345 Folic acid (folacin). Pharmacopeial Convention, 12601 New Hampshire Ave., Bldg. 2, Third * * * * * Twinbrook Pkwy., Rockville, MD 20852 Floor, Silver Spring, MD 20993, 301– (b) Folic acid meets the specifications (Internet address http://www.usp.org). 796–2039, or at the National Archives of the Food Chemicals Codex, 7th ed. Copies may be examined at the Food and Records Administration (NARA). (2010), pp. 406–407, which is and Drug Administration’s Main For information on the availability of incorporated by reference. The Director Library, 10903 New Hampshire Ave., this material at NARA, call 202–741– of the Office of the Federal Register Bldg. 2, Third Floor, Silver Spring, MD 6030 or go to: http://www.archives.gov/ approves this incorporation by reference 20993, 301–796–2039, or at the National federal-register/cfr/ibr-locations.html. in accordance with 5 U.S.C. 552(a) and Archives and Records Administration * * * * * 1 CFR part 51. You may obtain copies (NARA). For information on the ■ from the United States Pharmacopeial availability of this material at NARA, 9. Amend § 172.736 by revising Convention, 12601 Twinbrook Pkwy., call 202–741–6030 or go to: http:// paragraph (b)(2) to read as follows: Rockville, MD 20852 (Internet address www.archives.gov/federal-register/cfr/ § 172.736 Glycerides and polyglycides of http://www.usp.org). Copies may be ibr-locations.html. hydrogenated vegetable oils. examined at the Food and Drug * * * * * Administration’s Main Library, 10903 * * * * * ■ 7. Amend § 172.665 by revising New Hampshire Ave., Bldg. 2, Third (b) * * * paragraph (d)(2) to read as follows: Floor, Silver Spring, MD 20993, 301– (2) Acid value, not greater than 2, and 796–2039, or at the National Archives § 172.665 Gellan gum. hydroxyl value, not greater than 56, as and Records Administration (NARA). * * * * * determined by the methods entitled For information on the availability of (d) * * * ‘‘Acid Value,’’ p. 1220 and ‘‘Hydroxyl this material at NARA, call 202–741– (2) Residual isopropyl alcohol (IPA) Value,’’ p. 1223, respectively, in the 6030 or go to: http://www.archives.gov/ not to exceed 0.075 percent as Food Chemicals Codex, 7th ed. (2010), federal-register/cfr/ibr-locations.html. determined by the procedure described which is incorporated by reference. The * * * * * in the ‘‘Gellan gum’’ monograph in the Director of the Office of the Federal ■ 5. Amend § 172.379 by revising Food Chemicals Codex, 7th ed. (2010), Register approves this incorporation by paragraph (b) to read as follows: pp. 425–426, which is incorporated by reference in accordance with 5 U.S.C. reference. The Director of the Office of 552(a) and 1 CFR part 51. You may § 172.379 Vitamin D2. the Federal Register approves this obtain copies from the United States * * * * * incorporation by reference in Pharmacopeial Convention, 12601 (b) Vitamin D2 meets the accordance with 5 U.S.C. 552(a) and 1 Twinbrook Pkwy., Rockville, MD 20852 specifications of the Food Chemicals CFR part 51. You may obtain copies (Internet address http://www.usp.org). Codex, 7th ed. (2010), pp. 1080–1081, from the United States Pharmacopeial Copies may be examined at the Food which is incorporated by reference. The Convention, 12601 Twinbrook Pkwy., and Drug Administration’s Main Director of the Office of the Federal Rockville, MD 20852 (Internet address Library, 10903 New Hampshire Ave., Register approves this incorporation by http://www.usp.org). Copies may be Bldg. 2, Third Floor, Silver Spring, MD reference in accordance with 5 U.S.C. examined at the Food and Drug 20993, 301–796–2039, or at the National 552(a) and 1 CFR part 51. You may Administration’s Main Library, 10903 Archives and Records Administration obtain copies from the United States New Hampshire Ave., Bldg. 2, Third (NARA). For information on the Pharmacopeial Convention, 12601 Floor, Silver Spring, MD 20993, 301– availability of this material at NARA, Twinbrook Pkwy., Rockville, MD 20852 796–2039, or at the National Archives call 202–741–6030 or go to: http://

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www.archives.gov/federal-register/cfr/ (b) The additive meets the 552(a) and 1 CFR part 51. You may ibr-locations.html. specifications of the Food Chemicals obtain copies from the United States * * * * * Codex, 7th ed. (2010), pp. 73–74, which Pharmacopeial Convention, 12601 ■ 10. Amend § 172.780 by revising is incorporated by reference. The Twinbrook Pkwy., Rockville, MD 20852 paragraph (b) to read as follows: Director of the Office of the Federal (Internet address http://www.usp.org). Register approves this incorporation by Copies may be examined at the Food § 172.780 Acacia (gum arabic). reference in accordance with 5 U.S.C. and Drug Administration’s Main * * * * * 552(a) and 1 CFR part 51. You may Library, 10903 New Hampshire Ave., (b) The ingredient meets the obtain copies from the United States Bldg. 2, Third Floor, Silver Spring, MD specifications of the Food Chemicals Pharmacopeial Convention, 12601 20993, 301–796–2039, or at the National Codex, 7th ed. (2010), p. 460, which is Twinbrook Pkwy., Rockville, MD 20852 Archives and Records Administration incorporated by reference. The Director (Internet address http://www.usp.org). (NARA). For information on the of the Office of the Federal Register Copies may be examined at the Food availability of this material at NARA, approves this incorporation by reference and Drug Administration’s Main call 202–741–6030 or go to: http:// in accordance with 5 U.S.C. 552(a) and Library, 10903 New Hampshire Ave., www.archives.gov/federal-register/cfr/ 1 CFR part 51. You may obtain copies Bldg. 2, Third Floor, Silver Spring, MD ibr-locations.html. from the United States Pharmacopeial 20993, 301–796–2039, or at the National * * * * * Convention, 12601 Twinbrook Pkwy., Archives and Records Administration ■ 15. Amend § 172.831 by revising Rockville, MD 20852 (Internet address (NARA). For information on the paragraph (b) to read as follows: http://www.usp.org). Copies may be availability of this material at NARA, examined at the Food and Drug call 202–741–6030 or go to: http:// § 172.831 Sucralose. Administration’s Main Library, 10903 www.archives.gov/federal-register/cfr/ * * * * * New Hampshire Ave., Bldg. 2, Third ibr-locations.html. (b) The additive meets the Floor, Silver Spring, MD 20993, 301– * * * * * specifications of the Food Chemicals 796–2039, or at the National Archives ■ 13. Revise the introductory text of Codex, 7th ed. (2010), pp. 993–995, and Records Administration (NARA). § 172.810 to read as follows: which is incorporated by reference. The For information on the availability of Director of the Office of the Federal this material at NARA, call 202–741– § 172.810 Dioctyl sodium sulfosuccinate. Register approves this incorporation by 6030 or go to: http://www.archives.gov/ The food additive, dioctyl sodium reference in accordance with 5 U.S.C. federal-register/cfr/ibr-locations.html. sulfosuccinate, meets the specifications 552(a) and 1 CFR part 51. You may * * * * * of the Food Chemicals Codex, 7th ed. obtain copies from the United States ■ 11. Amend § 172.800 by revising (2010), pp. 313–314, which is Pharmacopeial Convention, 12601 paragraph (b)(2) to read as follows: incorporated by reference. The Director Twinbrook Pkwy., Rockville, MD 20852 of the Office of the Federal Register (Internet address http://www.usp.org). § 172.800 Acesulfame potassium. approves this incorporation by reference Copies may be examined at the Food * * * * * in accordance with 5 U.S.C. 552(a) and and Drug Administration’s Main (b) * * * 1 CFR part 51. You may obtain copies Library, 10903 New Hampshire Ave., (2) Fluoride content is not more than from the United States Pharmacopeial Bldg. 2, Third Floor, Silver Spring, MD 30 milligrams per kilogram, as Convention, 12601 Twinbrook Pkwy., 20993, 301–796–2039, or at the National determined by method III of the Rockville, MD 20852 (Internet address Archives and Records Administration Fluoride Limit Test of the Food http://www.usp.org). Copies may be (NARA). For information on the Chemicals Codex, 7th ed. (2010), p. examined at the Food and Drug availability of this material at NARA, 1151, which is incorporated by Administration’s Main Library, 10903 call 202–741–6030 or go to: http:// reference. The Director of the Office of New Hampshire Ave., Bldg. 2, Third www.archives.gov/federal-register/cfr/ the Federal Register approves this Floor, Silver Spring, MD 20993, 301– ibr-locations.html. incorporation by reference in 796–2039, or at the National Archives * * * * * accordance with 5 U.S.C. 552(a) and 1 and Records Administration (NARA). ■ 16. Amend § 172.841 by revising CFR part 51. You may obtain copies For information on the availability of paragraph (b) to read as follows: from the United States Pharmacopeial this material at NARA, call 202–741– Convention, 12601 Twinbrook Pkwy., 6030 or go to: http://www.archives.gov/ § 172.841 Polydextrose. Rockville, MD 20852 (Internet address federal-register/cfr/ibr-locations.html). * * * * * http://www.usp.org). Copies may be The food additive, dioctyl sodium (b) The additive meets the examined at the Food and Drug sulfosuccinate, may be safely used in specifications of the Food Chemicals Administration’s Main Library, 10903 food in accordance with the following Codex, 7th ed. (2010), pp. 811–814, New Hampshire Ave., Bldg. 2, Third prescribed conditions: which is incorporated by reference. The Floor, Silver Spring, MD 20993, 301– * * * * * Director of the Office of the Federal 796–2039, or at the National Archives ■ 14. Amend § 172.812 by revising Register approves this incorporation by and Records Administration (NARA). paragraph (a) to read as follows: reference in accordance with 5 U.S.C. For information on the availability of 552(a) and 1 CFR part 51. You may this material at NARA, call 202–741– § 172.812 Glycine. obtain copies from the United States 6030 or go to: http://www.archives.gov/ * * * * * Pharmacopeial Convention, 12601 federal-register/cfr/ibr-locations.html. (a) The additive meets the Twinbrook Pkwy., Rockville, MD 20852 * * * * * specifications of the Food Chemicals (Internet address http://www.usp.org). ■ 12. Amend § 172.804 by revising Codex, 7th ed. (2010), pp. 457–458, Copies may be examined at the Food paragraph (b) to read as follows: which is incorporated by reference. The and Drug Administration’s Main Director of the Office of the Federal Library, 10903 New Hampshire Ave., § 172.804 Aspartame. Register approves this incorporation by Bldg. 2, Third Floor, Silver Spring, MD * * * * * reference in accordance with 5 U.S.C. 20993, 301–796–2039, or at the National

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Archives and Records Administration Floor, Silver Spring, MD 20993, 301– 6030 or go to: http://www.archives.gov/ (NARA). For information on the 796–2039, or at the National Archives federal-register/cfr/ibr-locations.html. availability of this material at NARA, and Records Administration (NARA). * * * * * call 202–741–6030 or go to: http:// For information on the availability of ■ 19. Amend § 172.869 by revising www.archives.gov/federal-register/cfr/ this material at NARA, call 202–741– paragraph (b) introductory text and ibr-locations.html. 6030 or go to: http://www.archives.gov/ paragraphs (b)(6) through (b)(11) to read * * * * * federal-register/cfr/ibr-locations.html. as follows: ■ 17. Amend § 172.862 by revising * * * * * § 172.869 Sucrose oligoesters. paragraph (b)(1) to read as follows: ■ 18. Amend § 172.867 by revising paragraph (b) to read as follows: * * * * * § 172.862 Oleic acid derived from tall oil (b) Sucrose oligoesters meet the fatty acids. § 172.867 Olestra. specifications in the methods listed in * * * * * * * * * * the table in this paragraph. The methods (b) * * * (b) Olestra meets the specifications of for determining compliance with each (1) Specifications for oleic acid the Food Chemicals Codex, 7th ed. specification are incorporated by prescribed in the Food Chemicals (2010), pp. 744–746, which is reference. The Director of the Office of Codex, 7th ed. (2010), pp. 743–744, incorporated by reference. The Director the Federal Register approves this which is incorporated by reference, of the Office of the Federal Register incorporation by reference in except that titer (solidification point) approves this incorporation by reference accordance with 5 U.S.C. 552(a) and 1 shall not exceed 13.5 °C and in accordance with 5 U.S.C. 552(a) and CFR part 51. Copies may be examined unsaponifiable matter shall not exceed 1 CFR part 51. You may obtain copies at the Food and Drug Administration’s 0.5 percent. The Director of the Office from the United States Pharmacopeial Main Library, 10903 New Hampshire of the Federal Register approves this Convention, 12601 Twinbrook Pkwy., Ave., Bldg. 2, Third Floor, Silver Spring, incorporation by reference in Rockville, MD 20852 (Internet address MD 20993, 301–796–2039, or at the accordance with 5 U.S.C. 552(a) and 1 http://www.usp.org). Copies may be National Archives and Records CFR part 51. You may obtain copies examined at the Food and Drug Administration (NARA). For from the United States Pharmacopeial Administration’s Main Library, 10903 information on the availability of this Convention, 12601 Twinbrook Pkwy., New Hampshire Ave., Bldg. 2, Third material at NARA, call 202–741–6030 or Rockville, MD 20852 (Internet address Floor, Silver Spring, MD 20993, 301– go to: http://www.archives.gov/federal- http://www.usp.org). Copies may be 796–2039, or at the National Archives register/cfr/ibr-locations.html. Copies of examined at the Food and Drug and Records Administration (NARA). the methods are available from the Administration’s Main Library, 10903 For information on the availability of sources listed in the table in this New Hampshire Ave., Bldg. 2, Third this material at NARA, call 202–741– paragraph:

Specification Limit Method cited Source for obtaining method

******* (6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, United States Pharmacopeial Con- Method I (Commercial Fatty vention, 12601 Twinbrook Pkwy., Acids), in the Food Chemi- Rockville, MD 20852 (Internet ad- cals Codex, 7th ed. (2010), dress http://www.usp.org) p. 1220.. (7) Residue on Ignition Not more than 0.7% .. ‘‘Residue on Ignition,’’ Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 7th ed. (2010), pp. 1141–1142 (using a 1-gram sample).. (8) Residual Methanol Not more than 10 mil- Method listed in the mono- Do ligrams/kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the Food Chemicals Codex, 7th ed. (2010), pp. 998–1000.. (9) Residual Dimethyl Not more than 2.0 mil- ...... do ...... Do. Sulfoxide. ligrams/kilogram. (10) Residual Isobutyl Not more than 10 mil- ...... do ...... Do. Alcohol. ligrams/kilogram. (11) Lead ...... Not more than 1.0 mil- ‘‘Atomic Absorption Do. ligram/kilogram. Spectrophometric Graphite Furnace Method,’’ Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154–1155.

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* * * * * Codex, 7th ed. (2010), pp. 226–227, call 202–741–6030 or go to: http:// which is incorporated by reference. The www.archives.gov/federal-register/cfr/ PART 173—SECONDARY DIRECT Director of the Office of the Federal ibr-locations.html. FOOD ADDITIVES PERMITTED IN Register approves this incorporation by * * * * * FOOD FOR HUMAN CONSUMPTION reference in accordance with 5 U.S.C. ■ 24. Amend § 173.280 by revising ■ 552(a) and 1 CFR part 51. You may 20. The authority citation for 21 CFR obtain copies from the United States paragraph (c) to read as follows: part 173 continues to read as follows: Pharmacopeial Convention, 12601 § 173.280 Solvent extraction process for Authority: 21 U.S.C. 321, 342, 348. Twinbrook Pkwy., Rockville, MD 20852 citric acid. ■ 21. Amend § 173.160 by revising (Internet address http://www.usp.org). * * * * * paragraph (d) to read as follows: Copies may be examined at the Food (c) The citric acid so produced meets and Drug Administration’s Main the polynuclear aromatic hydrocarbon § 173.160 Candida guilliermondii. Library, 10903 New Hampshire Ave., specifications of § 173.165 and the * * * * * Bldg. 2, Third Floor, Silver Spring, MD specifications of the Food Chemicals (d) The additive is so used that the 20993, 301–796–2039, or at the National Codex, 7th ed. (2010), pp. 226–227, citric acid produced conforms to the Archives and Records Administration which is incorporated by reference. The specifications of the Food Chemicals (NARA). For information on the Director of the Office of the Federal Codex, 7th ed. (2010), pp. 226–227, availability of this material at NARA, Register approves this incorporation by which is incorporated by reference. The call 202–741–6030 or go to: http:// reference in accordance with 5 U.S.C. Director of the Office of the Federal www.archives.gov/federal-register/cfr/ 552(a) and 1 CFR part 51. You may Register approves this incorporation by ibr-locations.html. *** reference in accordance with 5 U.S.C. obtain copies from the United States * * * * * 552(a) and 1 CFR part 51. You may Pharmacopeial Convention, 12601 ■ obtain copies from the United States 23. Amend § 173.228 by revising Twinbrook Pkwy., Rockville, MD 20852 Pharmacopeial Convention, 12601 paragraph (a) and removing footnote 1 (Internet address http://www.usp.org). Twinbrook Pkwy., Rockville, MD 20852 to read as follows: Copies may be examined at the Food (Internet address http://www.usp.org). § 173.228 Ethyl acetate. and Drug Administration’s Main Copies may be examined at the Food Library, 10903 New Hampshire Ave., * * * * * Bldg. 2, Third Floor, Silver Spring, MD and Drug Administration’s Main (a) The additive meets the 20993, 301–796–2039, or at the National Library, 10903 New Hampshire Ave., specifications of the Food Chemicals Archives and Records Administration Bldg. 2, Third Floor, Silver Spring, MD Codex, 7th ed. (2010), pp. 343–344, (NARA). For information on the 20993, 301–796–2039, or at the National which is incorporated by reference. The availability of this material at NARA, Archives and Records Administration Director of the Office of the Federal call 202–741–6030 or go to: http:// (NARA). For information on the Register approves this incorporation by www.archives.gov/federal-register/cfr/ availability of this material at NARA, reference in accordance with 5 U.S.C. ibr-locations.html. call 202–741–6030 or go to: http:// 552(a) and 1 CFR part 51. You may www.archives.gov/federal-register/cfr/ obtain copies from the United States * * * * * ibr-locations.html. Pharmacopeial Convention, 12601 ■ 25. Amend § 173.310 in the table in ■ 22. Amend § 173.165 by removing the Twinbrook Pkwy., Rockville, MD 20852 paragraph (c) by revising the entries for first three sentences in paragraph (d) (Internet address http://www.usp.org). ‘‘Acrylic acid/2-acrylamido-2-methyl and adding five sentences in their place Copies may be examined at the Food propane sulfonic acid copolymer’’, to read as follows: and Drug Administration’s Main ‘‘Sodium carboxymethylcellulose’’, and Library, 10903 New Hampshire Ave., ‘‘Sorbitol anhydride esters’’ and add § 173.165 Candida lipolytica. Bldg. 2, Third Floor, Silver Spring, MD paragraph (f) to read as follows: * * * * * 20993, 301–796–2039, or at the National (d) The additive is so used that the Archives and Records Administration § 173.310 Boiler water additives. citric acid produced conforms to the (NARA). For information on the * * * * * specifications of the Food Chemicals availability of this material at NARA, (c) List of substances:

Substances Limitations

******* Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copolymer Total not to exceed 20 parts per million (active) in boiler feedwater. having a minimum weight average molecular weight of 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled ‘‘Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS’’.

******* Sodium carboxymethylcellulose ...... Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 °C; by the ‘‘Viscosity of Cellulose Gum’’ method prescribed in the Food Chemicals Codex, pp. 1128–1129.

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Substances Limitations

******* Sorbitol anhydride esters: A mixture consisting of sorbitan monostea- The mixture is used as an anticorrosive agent in steam boiler distribu- rate as defined in § 172. 842 of this chapter; polysorbate 60 tion systems, with each component not to exceed 15 milligrams per ((polyoxyethylene (20) sorbitan monostearate)) as defined in kilogram in the steam. § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, pp. 825–827..

*******

* * * * * and Records Administration (NARA). PART 180—FOOD ADDITIVES (f) The standards required in this For information on the availability of PERMITTED IN FOOD OR IN CONTACT section are incorporated by reference this material at NARA, call 202–741– WITH FOOD ON AN INTERIM BASIS into this section with the approval of 6030 or go to: http://www.archives.gov/ PENDING ADDITIONAL STUDY the Director of the Federal Register federal-register/cfr/ibr-locations.html. under 5 U.S.C. 552(a) and 1 CFR part 51. ■ 29. The authority citation for 21 CFR Copies may be examined at the Food * * * * * part 180 continues to read as follows: and Drug Administration’s Main PART 178—INDIRECT FOOD Library, 10903 New Hampshire Ave., Authority: 21 U.S.C. 321, 342, 343, 348, ADDITIVES: ADJUVANTS, Bldg. 2, Third Floor, Silver Spring, MD 371; 42 U.S.C. 241. PRODUCTION AIDS, AND SANITIZERS 20993, 301–796–2039, or at the National ■ 30. Amend § 180.37 by revising Archives and Records Administration ■ paragraph (b) to read as follows: (NARA). For information on the 27. The authority citation for 21 CFR availability of this material at NARA, part 178 continues to read as follows: § 180.37 Saccharin, ammonium saccharin, call 202–741–6030 or go to: http:// Authority: 21 U.S.C. 321, 342, 348, 379e. calcium saccharin, and sodium saccharin. www.archives.gov/federal-register/cfr/ ■ * * * * * ibr-locations.html. 28. Amend § 178.1005 by revising (1) FDA Main Library, 10903 New paragraph (c) to read as follows: (b) The food additives meet the specifications of the Food Chemicals Hampshire Ave., Silver Spring, MD § 178.1005 Hydrogen peroxide solution. 20993: Codex, 7th ed. (2010), pp. 52–54, 153– (i) ‘‘Determination of Weight Average * * * * * 154, 898–899, 961–962, which is and Number Average Molecular Weight (c) Specifications. Hydrogen peroxide incorporated by reference. The Director of 60/40 AA/AMPS’’ (October 23, 1987). solution shall meet the specifications of of the Office of the Federal Register (ii) [Reserved]. the Food Chemicals Codex, 7th ed. approves this incorporation by reference (2) United States Pharmacopeial (2010), pp. 496–497, which is in accordance with 5 U.S.C. 552(a) and Convention, 12601 Twinbrook Pkwy., incorporated by reference. Hydrogen 1 CFR part 51. You may obtain copies Rockville, MD 20852 (Internet address peroxide solution shall also meet the from the United States Pharmacopeial http://www.usp.org): Convention, 12601 Twinbrook Pkwy., (i) Food Chemicals Codex, 7th ed. specifications for ‘‘Acidity,’’ ‘‘Chloride,’’ Rockville, MD 20852 (Internet address (2010), pp. 1128–1129. and ‘‘Other requirements’’ for Hydrogen (ii) Food Chemicals Codex, 7th ed. Peroxide Concentrate in the United http://www.usp.org). Copies may be (2010), pp. 825–827. States Pharmacopeia 36th Revision examined at the Food and Drug ■ 26. Amend § 173.368 by revising (2013), pp. 3848–3849, which is Administration’s Main Library, 10903 paragraph (c) to read as follows: incorporated by reference. The Director New Hampshire Ave., Bldg. 2, Third of the Office of the Federal Register Floor, Silver Spring, MD 20993, 301– § 173.368 Ozone. approves this incorporation by reference 796–2039, or at the National Archives * * * * * in accordance with 5 U.S.C. 552(a) and and Records Administration (NARA). (c) The additive meets the 1 CFR part 51. You may obtain copies For information on the availability of specifications for ozone in the Food from the United States Pharmacopeial this material at NARA, call 202–741– Chemicals Codex, 7th ed. (2010), pp. Convention, 12601 Twinbrook Pkwy., 6030 or go to: http://www.archives.gov/ 754–755, which is incorporated by Rockville, MD 20852 (Internet address federal-register/cfr/ibr-locations.html. reference. The Director of the Office of the Federal Register approves this http://www.usp.org). Copies may be * * * * * examined at the Food and Drug incorporation by reference in Dated: November 21, 2013. Administration’s Main Library, 10903 accordance with 5 U.S.C. 552(a) and 1 Susan M. Bernard, CFR part 51. You may obtain copies New Hampshire Ave., Bldg. 2, Third Director, Office of Regulations, Policy and from the United States Pharmacopeial Floor, Silver Spring, MD 20993, 301– 796–2039, or at the National Archives Social Sciences, Center for Food Safety and Convention, 12601 Twinbrook Pkwy., Applied Nutrition. Rockville, MD 20852 (Internet address and Records Administration (NARA). [FR Doc. 2013–28439 Filed 11–27–13; 8:45 am] http://www.usp.org). Copies may be For information on the availability of examined at the Food and Drug this material at NARA, call 202–741– BILLING CODE 4160–01–P Administration’s Main Library, 10903 6030 or go to: http://www.archives.gov/ New Hampshire Ave., Bldg. 2, Third federal-register/cfr/ibr-locations.html. Floor, Silver Spring, MD 20993, 301– * * * * * 796–2039, or at the National Archives

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