SUBCHAPTER A—MANDATORY MEAT INSPECTION
PART 301—DEFINITIONS make such article unfit for human food; Sec. (ii) If it is, in whole or in part, a raw 301.1 Meaning of terms. agricultural commodity and such com- 301.2 Definitions. modity bears or contains a pesticide AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. chemical which is unsafe within the 601–695; 7 CFR 2.17, 2.55. meaning of section 408 of the Federal Food, Drug, and Cosmetic Act; § 301.1 Meaning of terms. (iii) If it bears or contains any food As used in this subchapter, unless additive which is unsafe within the otherwise required by the context, the meaning of section 409 of the Federal singular form shall also import the plu- Food, Drug, and Cosmetic Act; ral and the masculine form shall also (iv) If it bears or contains any color import the feminine, and vice versa. additive which is unsafe within the meaning of section 706 of the Federal [35 FR 15554, Oct. 3, 1970] Food, Drug, and Cosmetic Act: Pro- vided, That an article which is not § 301.2 Definitions. deemed adulterated under paragraphs As used in this subchapter, unless (aa)(2) (ii), (iii), or (iv) of this section otherwise required by the context, the shall nevertheless be deemed adulter- following terms shall be construed, re- ated if use of the pesticide chemical spectively, to mean: food additive, or color additive in or on (a) The Act. The Federal Meat Inspec- such article is prohibited by the regu- tion Act, as amended, (34 Stat. 1260, as lations in this subchapter in official es- amended, 81 Stat. 584, 84 Stat. 438, 92 tablishments; Stat. 1069, 21 U.S.C., sec. 601 et seq.). (3) If it consists in whole or in part of (b) Administrator. The Administrator any filthy, putrid, or decomposed sub- of the Food Safety and Inspection stance or is for any other reason un- Service or any officer or employee of sound, unhealthful, unwholesome, or the Department to whom authority has otherwise unfit for human food; heretofore been delegated or may here- (4) If it has been prepared, packed, or after be delegated to act in his/her held under unsanitary conditions stead. whereby it may have become contami- (c) Adulterated. This term applies to nated with filth, or whereby it may any carcass, part thereof, meat or meat have been rendered injurious to health; food product under one or more of the (5) If it is, in whole or in part, the following circumstances: product of an animal which has died (1) If it bears or contains any such otherwise than by slaughter; poisonous or deleterious substance (6) If its container is composed, in which may render it injurious to whole or in part, of any poisonous or health; but in case the substance is not deleterious substance which may an added substance, such article shall render the contents injurious to not be considered adulterated under health; this clause if the quantity of such sub- (7) If it has been intentionally sub- stance in or on such article does not jected to radiation, unless the use of ordinarily render it injurious to health; the radiation was in conformity with a (2)(i) If it bears or contains (by rea- regulation or exemption in effect pur- son of administration of any substance suant to section 409 of the Federal to the live animal or otherwise) any Food, Drug, and Cosmetic Act; added poisonous or added deleterious (8) If any valuable constituent has substance (other than one which is: been in whole or in part omitted or ab- (A) A pesticide chemical in or on a stracted therefrom; or if any substance raw agricultural commodity; has been substituted, wholly or in part (B) A food additive; or therefor; or if damage or inferiority (C) A color additive which may, in has been concealed in any manner; or if the judgment of the Administrator, any substance has been added thereto
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or mixed or packed therewith so as to (l) Capable of use as human food. This increase its bulk or weight, or reduce term applies to any carcass, or part or its quality or strength, or make it ap- product of a carcass, of any livestock, pear better or of greater value than it unless it is denatured or otherwise is; or, identified as required by the applicable (9) If it is margarine containing ani- provisions of §§ 314.3, 314.10, 325.11, and mal fat and any of the raw material 325.13 of this subchapter to deter its use used therein consisted in whole or in as a human food, or it is naturally in- part of any filthy, putrid, or decom- edible by humans; e.g., hoofs or horns posed substance, or is otherwise adul- in their natural state. terated. (m) Captive bolt. A stunning instru- (d) Anesthesia. Loss of sensation or ment which when activated drives a feeling. bolt out of a barrel for a limited dis- (e) Animal food. Any article intended tance. for use as food for dogs, cats, or other (n) Carbon dioxide. A gaseous form of animals derived wholly, or in part, the chemical formula CO2. from the carcass or parts or products of (o) Carbon dioxide concentration. Ratio the carcass of any livestock, except of carbon dioxide gas and atmospheric that the term animal food as used here- air. in does not include: (p) Carcass. All parts, including (1) Processed dry animal food or viscera, of any slaughtered livestock. (2) Livestock or poultry feeds manu- (q) Chemical preservative. Any chemi- factured from processed livestock by- cal that, when added to a meat or meat products (such as meatmeal tankage, food product, tends to prevent or re- meat and bonemeal, bloodmeal, and tard deterioration thereof, but does not feed grade animal fat). include common salt, sugars, vinegars, (f) Animal food manufacturer. Any per- spices, or oils extracted from spices or son engaged in the business of manu- substances added to meat and meat facturing or processing animal food. food products by exposure to wood (g) Area. One or more circuits under smoke. the supervision of an area supervisor. Other definitions, if any, that are ap- (h) Area Supervisor. The official in plicable only for purposes of a specific charge of an area. part of the regulations in this sub- (i) Artificial coloring. A coloring con- chapter, are set forth in such part. taining any dye or pigment, which dye (r) Circuit. One or more official estab- or pigment was manufactured by a lishments included under the super- process of synthesis or other similar vision of a circuit supervisor. artifice, or a coloring which was manu- (s) Circuit supervisor. The supervisor factured by extracting a natural dye or of a circuit. natural pigment from a plant or other (t) Commerce. Commerce between any material in which such dye or pigment State, any Territory, or the District of was naturally produced. Columbia, and any place outside there- (j) Artificial flavoring. A flavoring of; or within any Territory not orga- containing any sapid or aromatic con- nized with a legislative body, or the stituent, which constituent was manu- District of Columbia. factured by a process of synthesis or (u) Consciousness. Responsiveness of other similar artifice. the brain to the impressions made by (k) Biological residue. Any substance, the senses. including metabolites, remaining in (v) Cutting up. Any division of any livestock at time of slaughter or in any carcass or part thereof, except that the of its tissues after slaughter as the re- trimming of carcasses or parts thereof sult of treatment or exposure of the to remove surface contaminants is not livestock to a pesticide, organic or in- considered as cutting up. organic compound, hormone, hormone- (w) Dead livestock. The body (cadaver) like substance, growth promoter, anti- of livestock which has died otherwise biotic, anthelmintic, tranquilizer, or than by slaughter. other therapeutic or prophylactic (x) The Department. The United agent. States Department of Agriculture.
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(y) Dying, diseased, or disabled live- York City), Connecticut, Rhode Island, Ver- stock. Livestock which has or displays mont, New Hampshire and Maine. symptoms of having any of the follow- IFO #2. New York, NY—Covering the areas of New York City and northern New Jersey. ing: IFO #3. Philadelphia, PA—Covering the (1) Central nervous system disorder; State of Pennsylvania and the area of south- (2) Abnormal temperature (high or ern New Jersey. low); IFO #4. Baltimore, MD—Covering the (3) Difficult breathing; States of Maryland, Delaware, West Vir- (4) Abnormal swellings; ginia, Virginia and Kentucky. IFO #5. Charleston, SC—Covering the (5) Lack of muscular coordination; States of Tennessee, North Carolina, South (6) Inability to walk normally or Carolina, Georgia and Florida (excluding stand; south Florida). (7) Any of the conditions for which 1IFO #6. Miami, FL—Covering the areas of livestock is required to be condemned southern Florida, Puerto Rico and the Virgin on ante-mortem inspection in accord- Islands. 1IFO #7. New Orleans, LA—Covering the ance with the regulations in part 309 of States of Louisiana, Mississippi, Alabama, this subchapter. Arkansas, Texas, Oklahoma, Kansas, New (z) Edible. Intended for use as human Mexico and Colorado. food. 1IFO #8. San Pedro, CA—Covering the (aa) Experimental animal. Any animal States of Hawaii, Arizona, Utah, Nevada, the used in any research investigation in- area of southern California, American Samoa, Guam, and the Northern Marianas. volving the feeding or other adminis- 1IFO #9. Tacoma, WA—Covering the States tration of, or subjection to, an experi- of Washington, Oregon, Idaho, Montana, Wy- mental biological product, drug, or oming, North Dakota, South Dakota, Alas- chemical or any nonexperimental bio- ka, and Nebraska, and the area of northern logical product, drug, or chemical used California. in a manner for which it was not in- 1IFO #10. Detroit, MI—Covering the States tended. of Michigan, Wisconsin, Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio. (bb) Exposure time. The period of time an animal is exposed to an anesthesia- (ii) Import Supervisor. The official in producing carbon dioxide concentra- charge of import inspection activities tion. within each of the import field offices. (cc) Federal Food, Drug, and Cosmetic (jj) Inedible. Adulterated, Act. The Act so entitled, approved June uninspected, or not intended for use as 25, 1938 (52 Stat. 1040), and Acts amend- human food. atory thereof or supplementary there- (kk) Inhumane slaughter or handling to. in connection with slaughter. Slaughter (dd) Firm. Any partnership, associa- or handling in connection with slaugh- tion, or other unincorporated business ter not in accordance with the Act of organization. August 27, 1958 (72 Stat. 862; 7 U.S.C. (ee) Food Safety and Inspection Service. 1901 through 1906, as amended by the The Food Safety and Inspection Serv- Humane Methods of Slaughter Act of ice of the Department. 1978, 92 Stat. 1069) and part 313 of this subchapter. (ff) Further processing. Smoking, (ll) ‘‘Inspected and passed’’ or ‘‘U.S. cooking, canning, curing, refining, or Inspected and Passed’’ or ‘‘U.S. Inspected rendering in an official establishment and Passed by Department of Agri- of product previously prepared in offi- culture’’ (or any authorized abbreviation cial establishments. thereof). This term means that the (gg) Immediate container. The recep- product so identified has been in- tacle or other covering in which any spected and passed under the regula- product is directly contained or wholly tions in this subchapter, and at the or partially enclosed. time it was inspected, passed, and iden- (hh) Import Field Office (IFO). The of- tified, it was found to be not adulter- fice of the supervisor of import inspec- ated. tion activities for a particular import- (mm) Inspector. An inspector of the ing field area. The areas are as follows: Program. IFO #1. Boston, MA—Covering the States (nn) Inspector in charge. A designated of Massachusetts, New York (excluding New program employee who is in charge of
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one or more official establishments (tt) Meat byproduct. Any part capable within a circuit and is responsible to of use as human food, other than meat, the circuit supervisor or his/her des- which has been derived from one or ignee. more cattle, sheep, swine, or goats. (oo) Label. A display of written, This term, as applied to products of printed, or graphic matter upon the equines, shall have a meaning com- immediate container (not including parable to that provided in this para- package liners) of any article. graph with respect to cattle, sheep, (pp) Labeling. All labels and other swine, and goats. written, printed, or graphic matter: (uu) Meat food product. Any article (1) Upon any article or any of its con- capable of use as human food which is tainers or wrappers, or made wholly or in part from any meat (2) Accompanying such article. or other portion of the carcass of any (qq) Livestock. Cattle, sheep, swine, cattle, sheep, swine, or goats, except goat, horse, mule, or other equine. those exempted from definition as a (rr) Meat. (1) The part of the muscle meat food product by the Adminis- of any cattle, sheep, swine, or goats, trator in specific cases or by the regu- which is skeletal or which is found in lations in part 317 of this subchapter, the tongue, in the diaphragm, in the upon a determination that they con- heart, or in the esophagus, with or tain meat or other portions of such without the accompanying and over- carcasses only in a relatively small lying fat, and the portions of bone, proportion or historically have not skin, sinew, nerve, and blood vessels been considered by consumers as prod- which normally accompany the muscle ucts of the meat food industry, and tissue and which are not separated provided that they comply with any re- from it in the process of dressing. It quirements that are imposed in such does not include the muscle found in cases or regulations as conditions of the lips, snout, or ears. This term, as such exemptions to assure that the applied to products of equines, shall meat or other portions of such car- have a meaning comparable to that casses contained in such articles are provided in this paragraph with respect not adulterated and that such articles to cattle, sheep, swine, and goats. are not represented as meat food prod- (2) The product derived from the me- ucts. This term, as applied to food chanical separation of the skeletal products of equines, shall have a mean- muscle tissue from the bones of live- ing comparable to that provided in this stock using the advances in mechanical paragraph with respect to cattle, meat/bone separation machinery and sheep, swine, and goats. meat recovery systems that do not (vv) Misbranded. This term applies to crush, grind, or pulverize bones, and any carcass, part thereof, meat or meat from which the bones emerge com- food product under one or more of the parable to those resulting from hand- following circumstances: deboning (i.e., essentially intact and in (1) If its labeling is false or mislead- natural physical conformation such ing in any particular; that they are recognizable, such as loin (2) If it is offered for sale under the bones and rib bones, when they emerge name of another food; from the machinery) which meets the (3) If it is an imitation of another criteria of no more than 0.15 percent or food, unless its label bears, in type of 150 mg/100 gm of product for calcium uniform size and prominence, the word (as a measure of bone solids content) ‘‘imitation’’ and immediately there- within a tolerance of 0.03 percent or 30 after, the name of the food imitated; mg. (4) If its container is so made, (ss) Meat broker. Any person engaged formed, or filled as to be misleading; in the business of buying or selling car- (5) If in a package or other container casses, parts of carcasses, meat or unless it bears a label showing: meat food products of livestock on (i) The name and place of business of commission, or otherwise negotiating the manufacturer, packer, or distribu- purchases or sales of such articles tor; and other than for his/her own account or (ii) An accurate statement of the as an employee of another person. quantity of the contents in terms of
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weight, measure, or numerical count; (11) If it bears or contains any artifi- except as otherwise provided in part 317 cial flavoring, artificial coloring, or of this subchapter with respect to the chemical preservative, unless it bears a quantity of contents; label stating that fact; except as other- (6) If any word, statement, or other wise provided by the regulations in information required by or under au- part 317 of this subchapter; or thority of the Act to appear on the (12) If it fails to bear, directly there- label or other labeling is not promi- on or on its containers, when required nently placed thereon with such con- by the regulations in part 316 or 317 of spicuousness (as compared with other this subchapter, the inspection legend words, statements, designs, or devices, and, unrestricted by any of the fore- in the labeling) and in such terms as to going, such other information as the render it likely to be read and under- Administrator may require in such reg- stood by the ordinary individual under ulations to assure that it will not have customary conditions of purchase and false or misleading labeling and that use; the public will be informed of the man- (7) If it purports to be or is rep- ner of handling required to maintain resented as a food for which a defini- the article in a wholesome condition. tion and standard of identity or com- (ww) Nonfood compound. Any sub- position has been prescribed by the reg- stance proposed for use in official es- ulations in part 319 of this subchapter tablishments, the intended use of unless: which will not result, directly or indi- (i) It conforms to such definition and rectly, in the substance becoming a standard, and component or otherwise affecting the (ii) Its label bears the name of the characteristics of meat food and meat food specified in the definition and products, excluding labeling and pack- standard and, insofar as may be re- aging materials as covered in part 317 quired by such regulations, the com- of the subchapter. mon names of optional ingredients (xx) Official certificate. Any certifi- (other than spices, flavoring, and color- cate prescribed by the regulations in ing) present in such food; this subchapter for issuance by an in- (8) If it purports to be or is rep- spector or other person performing offi- resented as a food for which a standard cial functions under the Act. or standards of fill of container have (yy) Official device. Any device pre- been prescribed by the regulations in scribed by the regulations in part 312 of part 319 of this subchapter, and it falls this subchapter for use in applying any below the standard of fill of container official mark. applicable thereto, unless its label (zz) Official establishment. Any slaugh- bears, in such manner and form as such tering, cutting, boning, meat canning, regulations specify, a statement that it curing, smoking, salting, packing, ren- falls below such standard; dering, or similar establishment at (9) If it is not subject to the provi- which inspection is maintained under sions of paragraph (vv)(7)(ii) of this the regulations in this subchapter. section unless its label bears: (aaa) Official import inspection estab- (i) The common or usual name of the lishment. This term means any estab- food, if any there be, and lishment, other than an official estab- (ii) In case it is fabricated from two lishment as defined in paragraph (zz) of or more ingredients, the common or this section, where inspections are au- usual name of each such ingredient, ex- thorized to be conducted as prescribed cept as otherwise provided in part 317 in § 327.6 of this subchapter. of this subchapter; (bbb) Official inspection legend. Any (10) If it purports to be or is rep- symbol prescribed by the regulations in resented for special dietary uses, unless this subchapter showing that an article its label bears such information con- was inspected and passed in accordance cerning its vitamin, mineral, and other with the Act. dietary properties as is required by the (ccc) Official mark. The official in- regulations in part 317 of this sub- spection legend or any other symbol chapter. prescribed by the regulations in this
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subchapter to identify the status of Southwestern Region— Arkansas, Kansas, any article or animal under the Act. Louisiana, Missouri, Nebraska, New Mexico, (ddd) Packaging material. Any cloth, Oklahoma, and Texas. paper, plastic, metal, or other material Western Region— Alaska, Arizona, Califor- used to form a container, wrapper, nia, Colorado, Hawaii, Idaho, Montana, Ne- label, or cover for meat products. vada, North Dakota, Oregon, South Dakota, (eee) Person. Any individual, firm, or Utah, Washington, and Wyoming, American corporation. Samoa, Guam, and the Northern Mariana Is- (fff) Pesticide chemical, food additive, lands. color additive, raw agricultural commod- (lll) Renderer. Any person engaged in ity. These terms shall have the same the business of rendering carcasses or meanings for purposes of the Act and parts or products of the carcasses of the regulations in this subchapter as any livestock except rendering con- under the Federal Food, Drug, and Cos- ducted under inspection or exemption metic Act. under Title I of the Act. (ggg) Prepared. Slaughtered, canned, (mmm) Secretary. The Secretary of salted, rendered, boned, cut up, or oth- Agriculture of the United States or his/ erwise manufactured or processed. (hhh) Product. Any carcass, meat, her delegate. meat byproduct, or meat food product, (nnn) Shipping container. The outside capable of use as human food. container (box, bag, barrel, crate, or (iii) Program. The organizational unit other receptacle or covering) contain- within the Department having the re- ing or wholly or partly enclosing any sponsibility for carrying out the provi- product packed in one or more imme- sions of the Act. diate containers. (jjj) Program employee. Any inspector (ooo) State. Any State of the United or other individual employed by the States or the Commonwealth of Puerto Department or any cooperating agency Rico. who is authorized by the Secretary to (ppp) Supervision. The controls, as do any work or perform any duty in prescribed in instructions to Program connection with the Program. employees, to be exercised by them 1 (kkk) Regional Director. The official over particular operations to insure in charge of the program within each of that such operations are conducted in the following regions: compliance with the Act and the regu- Northeastern Region—Connecticut, Dela- lations in this subchapter. ware, District of Columbia, Maine, Mary- (qqq) Surgical anesthesia. A state of land, Massachusetts, New Hampshire, New unconsciousness measured in conform- Jersey, New York, Pennsylvania, Rhode Is- land, Vermont, and Virginia (except for ity with accepted surgical practices. Northwestern part). (rrr) Territory. Guam, the Virgin Is- Southeastern Region— Alabama, Florida, lands of the United States, American Georgia, Kentucky, Mississippi, North Caro- Samoa, and any other territory or pos- lina, South Carolina, Tennessee, Virginia session of the United States, excluding (Northwestern), West Virginia, Puerto Rico, and the Virgin Islands. the Canal Zone. North Central Region— Illinois, Indiana, (sss) U.S. Condemned. This term Iowa, Michigan, Minnesota, Ohio, and Wis- means that the livestock so identified consin. has been inspected and found to be in a dying condition, or to be affected with 1 The addresses of the Regional Directors any other condition or disease that are as follows: would require condemnation of its car- Northeastern Region—Seventh Floor, 1421 cass. Cherry Street, Philadelphia, PA 19102. Southeastern Region—Room 299 South, (ttt) U.S. Inspected and Condemned (or 1718 Peachtree Street, NW., Atlanta, GA any authorized abbreviation thereof). 30309. This term means that the carcass, North Central Region—607 East Second viscera, other part of carcass, or other Street, Des Moines, IA 50309. product so identified has been in- Southwestern Region—Room 5–F41, 1100 Commerce Street, Dallas, TX 75201. spected, found to be adulterated, and Western Region—Room 620 Central Ave- condemned under the regulations in nue, Building 2C, Alameda, CA 94501. this subchapter.
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(uuu) U.S. Passed for Cooking. This are slaughtered for transportation or term means that the meat or meat by- sale as articles of commerce, or in product so identified has been in- which any products of, or derived from, spected and passed on condition that it carcasses of livestock are, wholly or in be cooked or rendered as prescribed by part, prepared for transportation or the regulations in part 315 of this chap- sale as articles of commerce, which are ter. intended for use as human food; (vvv) U.S. Passed for Refrigeration. (2) Every establishment, except as This term means that the meat or provided in § 303.1 (a) and (b), or (d) of meat byproduct so identified has been this subchapter, within any State or inspected and passed on condition that organized Territory which is des- it be refrigerated or otherwise handled ignated pursuant to paragraph 301(c) of as prescribed by the regulations in part the Act, at which any livestock are 311 of this subchapter. slaughtered or any products of any (www) U.S. Retained. This term livestock are prepared, for use as means that the carcass, viscera, other human food solely for distribution part of carcass, or other product, or ar- within such jurisdiction; and ticle so identified is held for further ex- amination by an inspector to deter- (3) Every establishment, except as mine its disposal. provided in § 303.1 (a) and (b) of this (xxx) U.S. Suspect. This term means subchapter, that is designated by the that the livestock so identified is sus- Administrator pursuant to paragraph pected of being affected with a disease 301(c) of the Act as one producing adul- or condition which may require its con- terated products which would clearly demnation, in whole or in part, when endanger the public health. slaughtered, and is subject to further [35 FR 15556, Oct. 3, 1970, as amended at 36 FR examination by an inspector to deter- 12002, June 24, 1971] mine its disposal. (yyy) United States. The States, the § 302.2 Application of requirements in District of Columbia, and the Terri- designated States or Territories; tories of the United States. and to designated plants endanger- ing public health. [35 FR 15554, Oct. 3, 1970] Special provisions with respect to es- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 301.2, see the List of CFR tablishments and their operations and Sections Affected in the Finding Aids sec- transactions by any persons in des- tion of this volume. ignated States and Territories and with respect to establishments des- PART 302—APPLICATION OF IN- ignated as producing adulterated prod- SPECTION AND OTHER REQUIRE- ucts which clearly endanger public MENTS health, and the operators thereof, in any State or Territory appear in part 331 of this subchapter, and apply to Sec. 302.1 Establishments requiring inspection. such establishments, operations and 302.2 Application of requirements in des- transactions in lieu of the regulations ignated States or Territories; and to des- elsewhere in this subchapter except in- ignated plants endangering public sofar as such regulations are made ap- health. plicable by the provisions in part 331 of 302.3 Livestock and products entering offi- this subchapter. cial establishments.
AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, [35 FR 15556, Oct. 3, 1970, as amended at 51 FR 2.55. 29909, Aug. 21, 1986]
§ 302.1 Establishments requiring in- § 302.3 Livestock and products enter- spection. ing official establishments. (a) Inspection under the regulations All livestock and all products enter- in this subchapter is required at: ing any official establishment and all (1) Every establishment, except as products prepared, in whole or in part, provided in § 303.1 (a) and (b), or (c) of therein, shall be inspected, handled, this subchapter, in which any livestock stored, prepared, packaged, marked,
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and labeled as required by the regula- Provided, That the provisions of said tions in this subchapter. sections relating to inspection or su- pervision of specified activities or [35 FR 15556, Oct. 3, 1970] other action by a Program employee shall not apply to the preparation and PART 303—EXEMPTIONS handling of such exempted products: Provided, further, That the requirement Sec. of § 308.4 for separate facilities for men 303.1 Exemptions. 303.2 Experimentation: Intensity of inspec- and women workers shall not apply to tion coverage. such establishments when the majority of the workers in the establishment are AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. related by blood or marriage and this arrangement will not conflict with mu- § 303.1 Exemptions. nicipal or State requirements, and the requirement of § 308.4 for separation of (a) The requirements of the Act and toilet soil lines from house drainage the regulations in this subchapter for inspection of the preparation of prod- lines to a point outside the buildings ucts do not apply to: will not apply to such establishments (1) The slaughtering by any individ- when positive acting backflow devices ual of livestock of his own raising, and are installed: And provided, further, the preparation by him and transpor- That the requirements of § 308.13 for tation in commerce of the carcasses, paved driveways, approaches, yards, parts thereof, meat and meat food pens, and alleys shall not apply to such products of such livestock exclusively establishments. However, if custom op- for use by him and members of his erations are conducted in an official es- household and his nonpaying guests tablishment, all of the provisions of and employees; part 308 shall apply to such establish- (2) The custom slaughter by any per- ment. son of cattle, sheep, swine, or goats de- (ii) If the custom operator prepares livered by the owner thereof for such or handles any products for sale, they slaughter, and the preparation by such are kept separate and apart from the slaughterer and transportation in com- custom prepared products at all times merce of the carcasses, parts thereof, while the latter are in his custody; meat and meat food products of such (iii) The custom prepared products livestock, exclusively for use, in the are plainly marked ‘‘Not for Sale’’ as household of such owner, by him and provided in § 316.16 of this subchapter, members of his household and his non- immediately after being prepared and paying guests and employees; nor to are kept so identified until delivered to the custom preparation by any person the owner; and of carcasses, parts thereof, meat or (iv) If exempted custom slaughtering meat food products derived from the or other preparation of products is con- slaughter by any individual of cattle, ducted in an official establishment, all sheep, swine, or goats of his own rais- facilities and equipment in the official ing or from game animals, delivered by establishment used for such custom op- the owner thereof for such custom erations shall be thoroughly cleaned preparation, and transportation in and sanitized before they are used for commerce of such custom prepared ar- preparing any products for sale. ticles, exclusively for use in the house- (b)(1) The exempted custom prepared hold of such owner, by him and mem- products shall be prepared and handled bers of his household and his nonpay- in accordance with the provisions of ing guests and employees: Provided, §§ 318.5, 318.6, 318.7, 318.10, and 318.300 That the following requirements are through 318.311 of this subchapter and met by such custom operator; shall not be adulterated as defined in (i) The establishment in which the paragraph 1(m) of the Act: Provided, custom operations are conducted is That the provisions of §§ 318.5, 318.6, maintained and operated in accordance 318.10, and 318.300 through 318.311 relat- with the provisions of §§ 308.4 through ing to inspection or supervision of 308.11, 308.13, 308.14, and 308.3 (except specified activities or other action by a § 308.3(d) (2) and (3), of this subchapter: Program inspector, and the provisions
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of § 318.6(b)(9) and (10), shall not apply products do not apply to operations of to the preparation and handling of such types traditionally and usually con- exempted products. ducted at retail stores and restaurants, (2) The exempted custom prepared when conducted at any retail store or products shall comply with the require- restaurant or similar retail-type estab- ments of §§ 316.16 and 317.16 of this sub- lishment for sale in normal retail chapter. quantities or service of such articles to (3) The custom operators claiming consumers at such establishments. exemption under paragraph (a)(2) of (2) For purposes of paragraph (d)(1) of this section shall keep records, in addi- this section: tion to records otherwise required by (i) Operations of types traditionally part 320 of this subchapter, showing the and usually conducted at retail stores numbers and kinds of livestock slaugh- and restaurants are the following: tered on a custom basis, the quantities (a) Cutting up, slicing, and trimming and types of products prepared on a carcasses, halves, quarters, or whole- custom basis, and the names and ad- sale cuts into retail cuts such as dresses of the owners of the livestock steaks, chops, and roasts, and freezing and products. such cuts; (4) Articles capable of use as human (b) Grinding and freezing products food, resulting from the exempted cus- made from meat; tom slaughter or other preparation of (c) Curing, cooking, smoking, render- products shall be promptly denatured ing or refining of livestock fat, or other or otherwise identified in accordance preparation of products, except slaugh- with § 325.13 of this subchapter and not tering or the retort processing of removed from the establishment where canned products; the custom operations are conducted (d) Breaking bulk shipments of prod- until so identified, unless they are de- ucts; livered to the owner of the articles for (e) Wrapping or rewrapping products. use in accordance with paragraph (a)(2) (ii) Any quantity or product pur- of this section. chased by a consumer from a particular (c) It has been determined that it is retail supplier shall be deemed to be a impracticable to provide inspection of normal retail quantity if the quantity the preparation of products at estab- so purchased does not in the aggregate lishments in any unorganized Territory exceed one-half carcass. The following at which livestock are slaughtered or amounts of product will be accepted as their products are prepared for dis- representing one-half carcass of the tribution solely within such jurisdic- species identified: tion and that exempting such estab- One-half lishments from requirements of the carcass Act for such inspections under the con- pounds ditions stated in this section will oth- Cattle ...... 300 erwise facilitate enforcement of the Calves ...... 37.5 Act. Therefore, such inspection re- Sheep ...... 27.5 Swine ...... 100 quirements of the Act and of the regu- Goats ...... 25 lations in this subchapter shall not apply at such establishments if they (iii) A retail store is any place of are operated in accordance with the business where: regulations in part 308 of this sub- (a) The sales of product are made to chapter, except §§ 308.1, 308.2, and 308.15. consumers only; However, the Administrator may (b) At least 75 percent, in terms of refuse, withdraw, or modify any exemp- dollar value, of total sales of product tion under this paragraph when he de- represents sales to household consum- termines in any specific case in accord- ers and the total dollar value of sales ance with the applicable rules of prac- of product to consumers other than tice that such action is necessary to ef- household consumers does not exceed fectuate the purposes of this Act. the dollar limitation per calendar year (d)(1) The requirements of the Act set by the Administrator. This dollar and the regulations in this subchapter limitation is a figure which will auto- for inspection of the preparation of matically be adjusted during the first
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quarter of each calendar year, upward (4) The preparation of product is lim- or downward, whenever the Consumer ited to traditional and usual operations Price Index, published by the Bureau of as defined in paragraph (d)(2)(i) of this Labor Statistics, Department of Labor, section. indicates a change in the price of this (b) The definition of a restaurant in- same volume of product which exceeds cludes a caterer which delivers or $500. Notice of the adjusted dollar limi- serves product in meals, or as entrees, tation will be published in the FEDERAL only to individual consumers and oth- 1 REGISTER. erwise meets the requirements of this (c) Only federally or State inspected paragraph. and passed product is handled or used (c) For purposes of this paragraph, in the preparation of any product, ex- operations conducted at a restaurant cept that product resulting from the custom slaughter or custom prepara- central kitchen facility shall be consid- tion of product may be handled or used ered as being conducted at a restaurant in accordance with paragraph (a)(2) and if the restaurant central kitchen pre- (b) of this section but not for sale; pares meat or meat food products that (d) No sale of product is made in ex- are ready to eat when they leave such cess of a normal retail quantity as de- facility (i.e., no further cooking or fined in paragraph (d)(2)(ii) of this sec- other preparation is needed, except tion; that they may be reheated prior to (e) The preparation of products for serving if chilled during transpor- sale to household consumers is limited tation), transported directly to a re- to traditional and usual operations as ceiving restaurant by its own employ- defined in paragraph (d)(2)(i) of this ees, without intervening transfer or section; and storage, maintained in a safe, unadul- (f) The preparation of products for terated condition during transpor- sale to other than household consum- tation, and served in meals or as ers is limited to traditional and usual entrees only to customers at res- operations as defined in paragraph taurants, or through vending ma- (d)(2)(i) (a), (b), (d), and (e) of this sec- chines, owned or operated by the same tion. (A retail store at which custom person that owns or operates such fa- slaughtering or preparation of products cility, and which otherwise meets the is conducted is not thereby disqualified requirements of this paragraph: Pro- from exemption as a retail store under vided, That the requirements of §§ 320.1 this paragraph (d).) through 320.4 of this subchapter apply (iv) Restaurants. (a) A restaurant is to such facility. Provided further, That any establishment where: the exempted facility may be subject (1) Product is prepared only for sale to inspection requirements under the or service in meals or as entrees di- Act for as long as the Administrator rectly to individual consumers at such deems necessary, if the Administrator establishments; determines that the sanitary condi- (2) Only federally or State inspected tions or practices of the facility or the and passed product or such product processing procedures or methods at prepared at a retail store exempted the facility are such that any of its under paragraph (d)(2)(iii) of this sec- meat or meat food products are ren- tion is handled or used in the prepara- dered adulterated. When the Adminis- tion of any product; trator has made such determination (3) No sale of product is made in ex- and subjected a restaurant central cess of a normal retail quantity as de- kitchen facility to such inspection re- fined in paragraph (d)(2)(ii) of this sec- quirements, the operator of such facil- tion; and ity shall be afforded an opportunity to dispute the Administrator’s determina- 1 The dollar limitation currently in effect tion in a hearing pursuant to rules of may be obtained by contacting Director, practice which will be adopted for this Slaughter Inspection Standards and Proce- proceeding. dures Division, Technical Services, Food and Safety Inspection Service, U.S. Department (v) Similar retail-type establishment: of Agriculture, Washington, DC 20250 (202) Any establishment which is a combina- 447–3219. tion retail store and restaurant; any
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delicatessen which meets the require- and passed in a cured or cooked form as ments for a retail store or restaurant ready-to-eat (i.e., no further cooking or as prescribed in paragraphs (d)(2) (iii) other preparation is needed) in compli- or (iv) of this section; or other estab- ance with the requirements of the Act lishment as determined by the Admin- and these regulations; and the meat istrator in specific cases. pizzas are to be served in public or pri- (vi) Consumer: Any household con- vate nonprofit institutions, provided sumer, hotel, restaurant, or similar in- that the meat pizzas are ready-to-eat stitution as determined by the Admin- (i.e., no further cooking or other prepa- istrator in specific cases. ration is needed, except that they may (3) Whenever any complaint is re- be reheated prior to serving if chilled ceived by the Administrator from any during transportation), transported di- person alleging that any retail store rectly to the receiving institution by claiming exemption under this para- employees of the preparing firm, re- graph (d), in any designated State or ceiving institution, or a food service organized Territory that is identified management company contracted to under section 205 of the Act (as one conduct food service at the public or that does not have or is not exercising private nonprofit institution, without adequate authority with respect to rec- intervening transfer or storage. ordkeeping requirements) has been op- (2) The definitions at Chapter 1, 1–102, erated in violation of the conditions except 1–102(z) and the provisions of prescribed in this section for exemp- Chapters 2 through 8, except sections 2– tion, and the Administrator, upon in- 102(a) and (b), 2–302(d), 2–403(a), 2–403(c), vestigation of the complaint, has rea- 2–404, 2–405, 2–407, 2–502 through 2–506, son to believe that any such violation 2–508, 2–509, 4–105, 4–201(c), 4–208, 5– has occurred, he shall so notify the op- 101(a), 5–103, 5–104, 5–202(c), 5–203, and 6– erator of the retail store and afford 105, part IV, of the Food and Drug Ad- him reasonable opportunity to present ministration’s Food Service Sanitation his views informally with respect to Manual (1976 Recommendations), the matter. Thereafter, if the Adminis- DHEW Publication No. (FDA) 78–2081, trator still has reason to believe that which is incorporated by reference, such a violation has occurred, and that shall apply to the facilities and oper- a requirement that the operator keep ations of businesses claiming this ex- records concerning the operations of emption. (These materials are incor- the retail store would effectuate the porated as they exist on the date of ap- purposes of the Act, the Administrator proval. This incorporation by reference shall order the operator to maintain was approved by the Director of the complete, accurate, and legible records Federal Register in accordance with 5 of total monthly purchases and of total U.S.C. 552(a) and 1 CFR part 51. Copies monthly sales of meat, meat byprod- may be purchased from the Super- ucts, and meat food products, in terms intendent of Documents, U.S. Govern- of dollar values of the products in- ment Printing Office, Washington, DC volved. Such records shall separately 20402. It is also available for inspection show total sales to household consum- at the Office of the Federal Register In- ers and total sales to other consumers formation Center, suite 700, 800 North and shall be maintained for the period Capitol Street, NW., Washington, DC, prescribed in § 320.3 of this subchapter. or the FSIS Hearing Clerk, room 3171, If the operator maintains copies of South Building, Food Safety and In- bills of lading, receiving and shipping spection Service, U.S. Department of invoices, warehouse receipts, or similar Agriculture, Washington, DC 20250.) documents which give the information (3) Facilities and operations of busi- required herein, additional records are nesses claiming this exemption shall not required by this subparagraph. also conform to the following require- (e)(1) The requirements of the Act ments: and the regulations in this subchapter (i) Manual cleaning and sanitizing. (A) for inspection of the preparation of For manual washing, rinsing and sani- products do not apply to meat pizzas tizing of utensils and equipment, a sink containing meat food product ingredi- with not fewer than three compart- ents which were prepared, inspected, ments shall be provided and used. Sink
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compartments shall be large enough to (4) Immersion in a clean solution permit the accommodation of the containing any other chemical sanitiz- equipment and utensils, and each com- ing agent allowed under 21 CFR 178.1010 partment of the sink shall be supplied that will provide the equivalent bac- with hot and cold potable running tericidal effect of a solution containing water. Fixed equipment and utensils at least 50 parts per million of avail- and equipment too large to be cleaned able chlorine as a hypochlorite at a in sink compartments shall be washed temperature of at least 75 °F for 1 manually or cleaned through pressure minute; or spray methods. (5) Treatment with steam free from (B) Drain boards or easily movable materials or additives other than those dish tables of adequate size shall be specified in 21 CFR 173.310 in the case provided for proper handling of soiled of equipment too large to sanitize by utensils prior to washing and for immersion, but in which steam can be cleaned utensils following sanitizing confined; or and shall be located so as not to inter- (6) Rinsing, spraying, or swabbing fere with the proper use of the dish- with a chemical sanitizing solution of washing facilities. at least twice the strength required for (C) Equipment and utensils shall be that particular sanitizing solution preflushed or prescraped and, when under paragraph (e)(3)(i)(E)(4) of this necessary, presoaked to remove gross section in the case of equipment too food particles and soil. large to sanitize by immersion. (D) Except for fixed equipment and (F) When hot water is used for sani- utensils too large to be cleaned in sink tizing, the following facilities shall be compartments, manual washing, rins- provided and used: ing and sanitizing shall be conducted in (1) An integral heating device or fix- the following sequence: ture installed in, on, or under the sani- (1) Sinks shall be cleaned prior to tizing compartment of the sink capable use. of maintaining the water at a tempera- (2) Equipment and utensils shall be ture of at least 170 °F; and thoroughly washed in the first com- (2) A numerically scaled indicating partment with a hot detergent solution thermometer, accurate to ±3 °F, con- that is kept clean. venient to the sink for frequent checks (3) Equipment and utensils shall be of water temperature; and rinsed free of detergent and abrasives (3) Dish baskets of such size and de- with clean water in the second com- sign to permit complete immersion of partment. the tableware, kitchenware, and equip- (4) Equipment and utensils shall be ment in the hot water. sanitized in the third compartment ac- (G) When chemicals are used for sani- cording to one of the methods pre- tization, they shall not have con- scribed in paragraph (e)(3)(i)(E) (1) centrations higher than the maximum through (4) of this section. permitted under 21 CFR 178.1010 and a (E) The food-contact surfaces of all test kit or other device that accurately equipment and utensils shall be sani- measures the parts per million con- tized by: centration of the solution shall be pro- (1) Immersion for at least 1⁄2 minute vided and used. in clean, hot water at a temperature of (ii) Mechanical cleaning and sanitizing. at least 170 °F; or (A) Cleaning and sanitizing may be (2) Immersion for at least 1 minute in done by spray-type or immersion dish- a clean solution containing at least 50 washing machines or by any other type parts per million of available chlorine of machine or device if it is dem- as a hypochlorite and at a temperature onstrated that it thoroughly cleans of at least 75 °F; or and sanitizes equipment and utensils. (3) Immersion for at least 1 minute in These machines and devices shall be a clean solution containing at least 12.5 properly installed and maintained in parts per million of available iodine good repair. and having a pH not higher than 5.0 Machines and devices shall be oper- and at a temperature of at least 75 °F; ated in accordance with manufactur- or ers’ instructions, and utensils and
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equipment placed in the machine shall tergent wash and clean rinse waters be exposed to all dishwashing cycles. and that permits free draining. Automatic detergent dispensers, wet- (G) Machines (single-tank, station- ting agent dispensers, and liquid sani- ary-rack, door-type machines and tizer injectors, if any, shall be properly spray-type glass washers) using chemi- installed and maintained. cals for sanitization may be used: Pro- (B) The pressure of final rinse water vided, That, supplied to spray-type dishwashing ma- (1) The temperature of the wash chines shall not be less than 15 nor water shall not be less than 120 °F. more than 25 pounds per square inch (2) The wash water shall be kept measured in the water line imme- clean. diately adjacent to the final rinse con- (3) Chemicals added for sanitization purposes shall be automatically dis- trol valve. A 1⁄4–inch IPS valve shall be provided immediately up stream from pensed. the final rinse control valve to permit (4) Utensils and equipment shall be checking the flow pressure of the final exposed to the final chemical sanitiz- rinse water. ing rinse in accordance with manufac- turers’ specifications for time and con- (C) Machine or water line mounted centration. numerically scaled indicating ther- (5) The chemical sanitizing rinse mometers, accurate to 3 °F, shall be ≤ water temperature shall be not less provided to indicate the temperature of than 75 °F nor less than the tempera- the water in each tank of the machine ture specified by the machine’s manu- and the temperature of the final rinse facturer. water as it enters the manifold. (6) Chemical sanitizers used shall (D) Rinse water tanks shall be pro- meet the requirements of 21 CFR tected by baffles, curtains, or other ef- 178.1010. fective means to minimize the entry of (7) A test kit or other device that ac- wash water into the rinse water. Con- curately measures the parts per mil- veyors in dishwashing machines shall lion concentration of the solution shall be accurately timed to assure proper be available and used. exposure times in wash and rinse cy- (H) Machines using hot water for cles in accordance with manufacturers’ sanitizing may be used provided that specifications attached to the ma- wash water and pumped rinse water chines. shall be kept clean and water shall be (E) Drain boards shall be provided maintained at not less than the follow- and be of adequate size for the proper ing temperatures: handling of soiled utensils prior to (1) Single-tank, stationary-rack, washing and of cleaned utensils follow- dual-temperature machine: ing sanitization and shall be so located and constructed as not to interfere Wash temperature ...... 150 °F with the proper use of the dishwashing Final rinse temperature ...... 180 °F facilities. This does not preclude the (2) Single-tank, stationary-rack, sin- use of easily movable dish tables for gle-temperature machine: the storage of soiled utensils or the use ° of easily movable dishtables for the Wash temperature ...... 165 F Final rinse temperature ...... 165 °F storage of clean utensils following sanitization. (3) Single-tank, conveyor machine: (F) Equipment and utensils shall be Wash temperature ...... 160 °F flushed or scraped and, when necessary, Final rinse temperature ...... 180 °F soaked to remove gross food particles (4) Multitank, conveyor machine: and soil prior to being washed in a dishwashing machine unless a Wash temperature ...... 150 °F prewashcycle is a part of the dishwash- Pumped rinse temperature ...... 160 °F ° ing machine operation. Equipment and Final rinse temperature ...... 180 F utensils shall be placed in racks, trays, (5) Single-tank, pot, pan, and utensil or baskets, or on conveyors, in a way washer (either stationary or moving- that food-contact surfaces are exposed rack): to the unobstructed application of de- Wash temperature ...... 140 °F
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Final rinse temperature ...... 180 °F with respect to the disputed fact, in ac- (I) All dishwashing machines shall be cordance with rules of practice which thoroughly cleaned at least once a day shall be adopted for the proceeding. or more often when necessary to main- However, such withdrawal or modifica- tain them in a satisfactory operating tion shall become effective pending condition. final determination in the proceeding (iii) Steam. Steam used in contact when the Administrator determines with food or food-contact surfaces shall that an imminent threat to food safety be free from any materials or additives or public health exists, and that such other than those specified in 21 CFR action is, therefore, necessary to pro- 173.310. tect the public health, interest or safe- (4) For purposes of this paragraph, ty. Such withdrawal or modification the term ‘‘private nonprofit institu- shall be effective upon oral or written tion’’ means ‘‘a corporation, and any notification, whichever is earlier, to community chest, fund, or foundation, the owner or operator of the particular organized and operated exclusively for establishment as promptly as cir- religious, charitable, scientific, testing cumstances permit. In the event of oral for public safety, literary, or edu- notification, written confirmation cational purposes, or to foster national shall be given to the owner or operator or international amateur sports com- of the establishment as promptly as petition (but only if no part of its ac- circumstances permit. This withdrawal tivities involve the provision of ath- or modification shall continue in effect letic facilities or equipment), or for the ending the completion of the proceed- prevention of cruelty to children or ing and any judicial review thereof, un- animals, no part of the net earnings of less otherwise ordered by the Adminis- which inures to the benefit of any pri- trator. vate shareholder or individual, no sub- (f) The adulteration and misbranding stantial part of the activities of which provisions of the Act and the regula- is carrying on propaganda, or other- tions in this subchapter, other than the wise attempting, to influence legisla- requirement of the official inspection tion, and which does not participate in, legend, apply to articles which are ex- or intervene in (including the publish- empted from inspection or not required ing or distribution of statements), any to be inspected under this section. This political campaign on behalf of (or in includes the requirement that any pork opposition to) any candidate for public and any product containing pork be office.’’ prepared only in compliance with any (5) The Administrator may withdraw applicable requirement for the destruc- or modify the exemption set forth in tion of trichina as provided in § 318.10 of § 303.1(e)(1) for a particular establish- this subchapter. ment when he or she determines that (g) The Administrator may extend such action is necessary to ensure food the requirements of titles I and IV of safety and public health. Before such the Act to any establishment in any action is taken, the owner or operator State or organized Territory at which of the particular establishment shall be products are prepared for distribution notified, in writing, of the reasons for solely within such jurisdiction, if he the proposed action and shall be given determines in accordance with the pro- an opportunity to respond, in writing, visions of paragraph 301(c)(1) of the Act to the Administrator within 20 days that it is producing adulterated prod- after notification of the proposed ac- ucts which would clearly endanger the tion. The written notification shall be public health. served on the owner or operator of the (h) The Administrator may in spe- establishment in the manner pre- cific classes of cases waive for limited scribed in section 1.147(b) of the De- periods any provisions of the regula- partment’s Uniform Rules of Practice tions in this subchapter in order to per- (7 CFR 1.147(b)). In those instances mit appropriate and necessary action where there is conflict of any material in the event of a public health emer- fact, the owner or operator of the es- gency or to permit experimentation so tablishment, upon request, shall be af- that new procedures, equipment, and/or forded an opportunity for a hearing processing techniques may be tested to
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facilitate definite improvements: Pro- characteristics and such establish- vided, That such waivers of the provi- ments. sions of such regulations are not in (1) In assessing the performance of an conflict with the purposes or provisions establishment, the following factors of the Act. are appropriate for consideration: (Approved by the Office of Management and (i) The history of compliance with Budget under control number 0583–0015) applicable regulatory requirements by the person conducting operations at [35 FR 15558, Oct. 3, 1970, as amended at 36 FR such establishment or by anyone re- 12002, 12004, June 24, 1971; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 746, sponsibly connected with the business Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR conducting operations at such estab- 10032, Mar. 30, 1987; 52 FR 48091, Dec. 18, 1987; lishment, as ‘‘responsibly connected’’ 53 FR 24679, June 30, 1988; 57 FR 34182, Aug. is defined in section 401(g) of the Act, 3, 1992] (ii) The competence of the person § 303.2 Experimentation: Intensity of conducting operations at such estab- inspection coverage. lishment, as indicated by: (a) Pursuant to the Processed Prod- (A) Knowledge of appropriate manu- ucts Inspection Improvement Act of facturing practices and applicable reg- 1986, Title IV of the Futures Trading ulatory requirements, Act of 1986 (Pub. L. 99–641), in estab- (B) Demonstrated ability to apply lishments preparing products at which such knowlege in a timely and consist- inspection under the Act and regula- ent manner, and tions is required, the frequency with (C) Commitment to correcting defi- which and the manner in which meat ciencies noted by Program employees food products made from livestock pre- and otherwise assuring compliance viously slaughtered in official estab- with applicable regulatory require- lishments are examined and inspected ments, and by Program employees is to be based (iii) The procedures used in such es- on considerations relevant to effective tablishment to control the production regulation of meat food products and process, environment, and resulting protection of the health and welfare of consumers. In order to test procedures product in order to assure and monitor for use in making such determinations compliance with the requirements of and, in particular, for determining the Act and the rules and regulations whether and, is so, to what extent the promulgated thereunder. intensity of inspection coverage ex- (2) In assessing the characteristics of ceeds that which should be considered an establishment, the following factors necessary pursuant to section 6 of the are appropriate for consideration: Act, as amended by section 403(a) of (i) The complexity of the processing the Futures Trading Act of 1986, the operation(s) conducted at such estab- Administrator is initiating experimen- lishment, tation of a new system of inspection (ii) The frequency with which each for reviewing the performance of estab- such operation is conducted at such es- lishments and for designing the super- tablishment, vision and other conditions and meth- (iii) The volume of product resulting ods of inspection coverage. For the pe- from each such operation at such es- riod of such experimentation, the Ad- tablishment, ministrator shall identify establish- (iv) Whether and to what extent ments for review, and the frequency slaughter operations also are con- and the manner of inspection by Pro- gram employees shall be determined on ducted at such establishment, the basis of the results of those reviews (v) What, if any, food products not and be otherwise in accordance with regulated under this Act or the Poultry this section. Products Inspection Act also are pre- (b) The determinations referred to in pared at such establishment, and paragraph (a) of this section shall be (vi) The size of such establishment. made by the program and shall reflect (c)(1) For the period of experimen- evaluations of the performance and the tation described in paragraph (a) of
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this section, the frequency of inspec- PART 304—APPLICATION FOR IN- tion by Program employees of oper- SPECTION; GRANT OR REFUSAL ations other than slaughter may be re- OF INSPECTION duced in an establishment in which the procedures referred to therein are Sec. being tested if and only if the evalua- 304.1 Application for inspection. tion of the performance of such estab- 304.2 Information to be furnished; grant or lishment described in paragraph (b)(1) refusal of inspection. indicates that there are: 304.3 Conditions for receiving inspection. (i) No instances, documented in AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, records compiled no earlier than 10 2.53. years before, of substantial and recent § 304.1 Application for inspection. noncompliance with applicable regu- (a) Before the inspection is granted, latory requirements (taking into ac- each person conducting operations at count both the nature and frequency of an establishment subject to the Act, any such noncompliance), and whether tenant, subsidiary, or land- (ii) The competence and control pro- lord, shall make application therefor cedures needed to assure and monitor to the Administrator as provided for in compliance with applicable regulatory this part. requirements. (b) Every application under this sec- (2)(i) The frequency of Federal in- tion shall be made on an official form spection and other conditions and furnished by the Program, available methods of inspection coverage in any from any Regional Director identified establishment in which the frequency in § 301.2(kkk) of this subchapter, and of Federal inspection is reduced shall shall be completed to include all infor- be based on: mation requested. Trade names of the (A) The evaluation of the character- applicant for labeling purposes, shall istics of such establishment described be inserted in the appropriate blank in the application. Each applicant for in- in paragraph (b)(2) of this section,1 spection will be held responsible for (B) The significance of potential pub- compliance with the Act and the regu- lic health consequences of noncompli- lations in this subchapter if inspection ance, and is granted. Preparation of product and (C) The availability of Program em- other operations at the establishment ployees. for which inspection is granted may be (ii) To the extent that such frequency conducted only by the applicant named of inspection or other conditions and in the application. methods of inspection coverage are (c) In cases of change of ownership or identified as conflicting with provi- location, a new application shall be sions of the regulations in this sub- made. chapter, the Administrator will waive [40 FR 2575, Jan. 14, 1975, as amended at 53 such provisions for the period of experi- FR 49848, Dec. 12, 1988] mentation, in accordance with § 303.1(g) of this subchapter. § 304.2 Information to be furnished; grant or refusal of inspection. [52 FR 10032, Mar. 30, 1987 and 52 FR 48091, (a) FSIS shall give notice in writing Dec. 18, 1987] to each applicant granted inspection and shall specify in the notice the es- tablishment, including the limits of 1 These evaluations will be based upon the establishment’s premises, to which guidelines developed by FSIS and the com- the grant pertains. plexity categorization in FSIS Directive 1030.2 (Documentation of Processing and (b) The Administrator is authorized Combination Assignments, 4/22/85). The to grant inspection upon his deter- guidelines and Directive will be available for mination that the applicant and the es- public inspection and copying in the Policy tablishment are eligible therefor and Office, Room 3168, South Agriculture Build- to refuse to grant inspection at any es- ing, 14th Street and Independence Avenue, tablishment if he determines that it SW., Washington, DC. does not meet the requirements of this
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part or the regulations in parts 305, 307, prior thereto such certification has and 308 of this subchapter or that the been obtained and the other require- applicant has not received approval of ments of subsection 21(b) are met. labeling and containers to be used at (e) Inspection may be refused in ac- the establishment as required by the cordance with humane slaughter and regulations in parts 316 and 317 of this handling provisions of the Act (21 subchapter. When inspection is refused U.S.C. 603(b)) and the applicable rules for any reason, the applicant shall be of practice. informed of the action and the reasons [35 FR 15558, Oct. 3, 1970, as amended at 41 FR therefor and afforded an opportunity to 4889, Feb. 3, 1976; 44 FR 68813, Nov. 30, 1979; 62 present his views. FR 45024, Aug. 25, 1997] (c) Inspection may also be refused in accordance with section 401 of the Act § 304.3 Conditions for receiving in- and the applicable rules of practice. spection. (d)(1) Any applicant for inspection at (a) Before being granted Federal in- an establishment where the operations spection, an establishment shall have thereof may result in any discharge developed written sanitation Standard into the navigable waters in the United Operating Procedures, as required by States is required by subsection 21(b) of part 416 of this chapter. the Federal Water Pollution Control (b) Before being granted Federal in- Act, as amended (84 Stat. 91), to pro- spection, an establishment shall have vide the Administrator with a certifi- conducted a hazard analysis and devel- cation as prescribed in said subsection oped and validated a HACCP plan, as that there is reasonable assurance that required by §§ 417.2 and 417.4 of this such activity will be conducted in a chapter. A conditional grant of inspec- manner which will not violate the ap- tion shall be issued for a period not to plicable water quality standards. No exceed 90 days, during which period the grant of inspection can be issued after establishment must validate its April 3, 1970 (the date of enactment of HACCP plan. the Water Quality Improvement Act), (c) Before producing new product for unless such certification has been ob- distribution in commerce, an establish- tained, or is waived because of failure ment shall have conducted a hazard or refusal of the State, interstate agen- analysis and developed a HACCP plan cy or the Secretary of the Interior to applicable to that product in accord- act on a request for certification with- ance with § 417.2 of this chapter. During in a reasonable period (which shall not a period not to exceed 90 days after the exceed 1 year after receipt of such re- date the new product is produced for quest). distribution in commerce, the estab- (2) However, certification is not ini- lishment shall validate its HACCP tially required in connection with an plan, in accordance with § 417.4 of this application for inspection granted after chapter. April 3, 1970, for facilities existing or [61 FR 38864, July 25, 1996] under construction on April 3, 1970, al- though certification for such facilities is required to be obtained within the 3- PART 305—OFFICIAL NUMBERS; IN- year period immediately following AUGURATION OF INSPECTION; April 3, 1970. Failure to obtain such WITHDRAWAL OF INSPECTION; certification and meet the other re- REPORTS OF VIOLATION quirements of subsection 21(b) prior to April 3, 1973, will result in the termi- Sec. nation of inspection at such facilities 305.1 Official numbers; subsidiaries and ten- on that date. ants. 305.2 Separation of official establishments. Further, any application for inspection 305.3 Sanitation and adequate facilities. pending on April 3, 1970, and granted 305.4 Inauguration of inspection. within 1 year thereafter shall not re- 305.5 Withdrawal of inspection; statement quire certification for 1 year following of policy. the grant of inspection but such grant 305.6 Reports of violations. of inspection shall terminate at the AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, end of 1 year after its issuance unless 2.55.
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SOURCE: 35 FR 15559, Oct. 3, 1970, unless quested is separated from such quar- otherwise noted. ters by floors, walls, and ceilings of solid concrete, brick, wood, or similar § 305.1 Official numbers; subsidiaries material, and the floors, walls, and and tenants. ceilings are without openings that di- (a) An official number shall be as- rectly or indirectly communicate with signed to each establishment granted any part of the building used as living inspection. Such number shall be used quarters. to identify all inspected and passed products prepared in the establish- § 305.3 Sanitation and adequate facili- ment. More than one number shall not ties. be assigned to an establishment. Inspection shall not be inaugurated if (b) Two or more official establish- an establishment is not in a sanitary ments under the same ownership or condition nor unless the establishment control may be granted the same offi- agrees to maintain a sanitary condi- cial number, provided a serial letter is tion and provides adequate facilities added in each case to identify each es- for conducting such inspection. tablishment and the products thereof. (c) When inspection has been granted § 305.4 Inauguration of inspection. to any applicant at an establishment, When inspection is granted, the cir- it shall not be granted to any other cuit supervisor shall, at or prior to the person at the same establishment. inauguration of inspection, inform the However, persons operating as separate operator of the establishment of the re- entities in the same building or struc- quirements of the regulations in this ture may operate separate establish- subchapter. If the establishment, at ments therein only under their own the time inspection is inaugurated, grant of inspection. All such persons contains any product which has not operating separate establishments in theretofore been inspected, passed, and the same building or structure shall be marked in compliance with the regula- responsible for compliance with the tions in this subchapter, the identity of Act and regulations in their own estab- the same shall be maintained, and it lishments, which shall include common shall not be distributed in commerce, areas, e.g., hallways, stairways, and or otherwise subject to the require- elevators. ments of such regulations, or dealt [35 FR 15559, Oct. 3, 1970, as amended at 40 FR with as inspected and passed under the 2576, Jan. 14, 1975] regulations. The establishment shall adopt and enforce all necessary meas- § 305.2 Separation of official establish- ures and shall comply with all such di- ments. rections as the circuit supervisor may (a) Each official establishment shall prescribe, for carrying out the purposes be separate and distinct from any unof- of this section. ficial establishment except a poultry products processing establishment op- § 305.5 Withdrawal of inspection; state- erated under Federal inspection under ment of policy. the Poultry Products Inspection Act or (a) The Administrator is authorized under State inspection. to withdraw inspection from an official (b) The slaughter or other prepara- establishment where the sanitary con- tion of products of horses, mules, or ditions are such that its products are other equines required to be conducted rendered adulterated, or for failure of under inspection pursuant to the regu- the operator to destroy condemned lations in this subchapter shall be done products as required by the Act and the in establishments separate from any regulations in this subchapter. Inspec- establishment in which cattle, sheep, tion may be withdrawn in accordance swine, or goats are slaughtered or their with section 401 of the Act and the ap- products are prepared. plicable rules of practice. (c) Inspection shall not be inaugu- (b) The assignment of inspectors may rated in any building, any part of be temporarily suspended, in whole or which is used as living quarters, unless in part, by the Administrator to the the part for which inspection is re- extent it is determined necessary to
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avoid impairment of the effective con- PART 306—ASSIGNMENT AND AU- duct of the program when the operator THORITIES OF PROGRAM EM- of any official establishment or any subsidiary therein, or any officer, em- PLOYEES ployee, or agent of any such operator or any subsidiary therein, acting with- Sec. in the scope of his office, employment, 306.1 Designation of circuit supervisor and or agency, threatens to forcibly assault assistants. or forcibly assaults, intimidates, or 306.2 Program employees to have access to establishments. interferes with any program employee 306.3 Badge as identification of inspectors. in or on account of the performance of 306.4 Assignment of Program employees his official duties under the act, unless where members of family employed; so- promptly upon the incident being liciting employment; procuring product brought by an authorized supervisor of from official establishments. the program employee to the attention 306.5 Appeals. of the operator of the establishment the operator (1) satisfactorily justifies AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. the incident, (2) takes effective steps to prevent a recurrence, or (3) provides ac- SOURCE: 35 FR 15559, Oct. 3, 1970, unless ceptable assurance that there will not otherwise noted. be any recurrences. Such suspension shall remain in effect until one of such § 306.1 Designation of circuit super- actions is taken by the operator: Pro- visor and assistants. vided, That upon request of the opera- The Administrator shall designate a tor he shall be afforded an opportunity circuit supervisor of the inspection in for an expedited hearing to show cause each circuit, and assign to said inspec- why the suspension should be termi- tor such assistants as may be nec- nated. essary. (c) Inspection service may be tempo- rarily suspended, in whole or in part, § 306.2 Program employees to have ac- at an official establishment, by the Ad- cess to establishments. ministrator, to the extent that it is de- For the purpose of any examination termined necessary to prevent in-hu- mane slaughtering or handling in con- or inspection necessary to prevent the nection with slaughter of livestock as use in commerce of any adulterated defined in § 301.2(kk) (9 CFR 301.2(kk)). product, Program employees shall have The Administrator shall notify the op- access at all times, by day or night, erator of an establishment orally or in whether the establishment is operated writing, as promptly as circumstances or not, to every part of any official es- permit, of such suspension and the rea- tablishment to which they are as- sons therefor. Such suspension shall re- signed. Access to establishments is also main in effect until the operator of the authorized in accordance with section establishment takes effective steps to 202 of the Act and the regulations in prevent a recurrence, or provides other part 320 of this subchapter. satisfactory assurances that there will not be any recurrences. Upon request, § 306.3 Badge as identification of in- the operator shall be afforded an oppor- spectors. tunity for a hearing to show cause why Each inspector will be furnished with the suspension should be terminated. a numbered official badge, which he [38 FR 9794, Apr. 20, 1973, as amended at 44 shall not allow to leave his possession, FR 68813, Nov. 30, 1979; 53 FR 49848, Dec. 12, and which he shall wear in such man- 1988] ner and at such times as the Adminis- trator may prescribe. This badge shall § 305.6 Reports of violations. be sufficient identification to entitle Program employees shall report, in a him to admittance at all regular en- manner prescribed by the Adminis- trances and to all parts of the estab- trator, all violations of the Act or reg- lishment and premises to which he is ulations in this subchapter of which assigned. they have information.
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§ 306.4 Assignment of Program em- 307.2 Other facilities and conditions to be ployees where members of family provided by establishment. employed; soliciting employment; 307.3 Inspectors to furnish implements and procuring product from official es- maintain hands and implements in sani- tablishments. tary condition. 307.4 Schedule of operations. (a) Except as specifically authorized 307.5 Overtime and holiday inspection serv- by the Administrator, no Program em- ice. ployee shall be detailed for duty at an 307.6 Basis of billing for overtime and holi- establishment where any member of day services. his family is employed by the operator 307.7 Safety requirements for electrical of the establishment, or any tenant or stimulating (EST) equipment. subsidiary of such operator nor shall AUTHORITY: 7 U.S.C. 394, 21 U.S.C. 601–695; 7 any circuit supervisor or other em- CFR 2.17, 2.55. ployee acting in a supervisory capacity SOURCE: 35 FR 15560, Oct. 3, 1970, unless be continued on duty at a circuit where otherwise noted. any member of his family is so em- ployed at any establishment under his § 307.1 Facilities for Program employ- jurisdiction. Program employees are ees. forbidden to solicit, for any person, em- Office space, including necessary fur- ployment at any official establish- nishings, light, heat, and janitor serv- ment, or by any officer, manager, or ice, shall be provided by official estab- employee thereof. lishments, rent free, for the exclusive (b) Program employees shall not pro- use for official purposes of the inspec- cure product from any official estab- tor and other Program employees as- lishment or any other establishment if signed thereto. The space set aside for its operations or products are inspected this purpose shall meet with approval or regulated under the Poultry Prod- of the circuit supervisor and shall be ucts Inspection Act or the Agricultural conveniently located, properly venti- Marketing Act of 1946, as amended, or lated and provided with lockers suit- any other law administered by the De- able for the protection and storage of partment unless the store or outlet Program supplies and with facilities from which the purchase is made is suitable for Program employees to open to the general public and the change clothing if such clothes chang- price paid by such employee is the ing facilities are deemed necessary by same as the price paid by the general the circuit supervisor. At the discre- public. Program employees must pay, tion of the Administrator, small plants and obtain receipts for money paid to requiring the services of less than one such establishments for all such prod- full time inspector need not furnish fa- uct and keep such receipts subject to cilities for Program employees as pre- inspection by supervisory employees or scribed in this section, where adequate other authorized Department employ- facilities exist in a nearby convenient ees. location. Laundry service for inspec- § 306.5 Appeals. tors’ outer work clothing shall be pro- vided by each establishment. Any appeal from a decision of any Program employee shall be made to § 307.2 Other facilities and conditions his/her immediate supervisor having to be provided by establishment. jurisdiction over the subject matter of When required by the circuit super- the appeal, except as otherwise pro- visor, the following facilities and con- vided in the applicable rules of prac- ditions, and such others as may be tice. found to be essential to efficient con- [48 FR 11418, Mar. 18, 1983, as amended at 60 duct of inspection and maintenance of FR 67454, Dec. 29, 1995] sanitary conditions, shall be provided by each official establishment: PART 307—FACILITIES FOR (a) Satisfactory pens, equipment, and INSPECTION assistants for conducting ante-mortem inspection and for separating, marking Sec. and holding apart from passed live- 307.1 Facilities for Program employees. stock those marked ‘‘U.S. suspect’’ and
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those marked ‘‘U.S. condemned’’ (pens, other equipment shall be sufficient to alleys, and runways shall be paved, prevent carcasses and parts passed for drained, and supplied with adequate food or cooking, from being contami- hose connections for cleanup purposes); nated by contact with condemned car- (b) Sufficient light to be adequate for casses or parts; they shall be equipped proper conduct of inspection; with hot water, lavatory, sterilizer, ta- (c) Racks, receptacles, or other suit- bles, and other equipment required for able devices for retaining such parts as ready, efficient, and sanitary conduct the head, tongue, tail, thymus gland, of the inspection; the floors shall be of and viscera, and all parts and blood to such construction as to facilitate the be used in the preparation of meat food maintenance of sanitary conditions products or medical products, until and shall have proper drainage connec- after the post-mortem examination is tions, and when the final inspection completed, in order that they may be place is part of a larger floor, it shall identified in case of condemnation of be separated from the rest of the floor the carcass; equipment, trucks, and re- by a curb, railing, or otherwise); ceptacles for the handling of viscera of (h) Retention rooms, cages, or other slaughtered animals so as to prevent compartments, and receptacles in contact with the floor; and trucks, which carcasses and product may be racks, marked receptacles, tables, and held for further inspection (these shall other necessary equipment for the sep- be in such number and in such loca- arate and sanitary handling of car- tions as the needs of the inspection in casses or parts passed for cooking; the establishment may require; they (d) Tables, benches, and other equip- shall be equipped for secure locking or ment on which inspection is to be per- sealing and shall be held under locks or formed, of such design, material, and official seals furnished by the Depart- construction as to enable Program em- ment; the keys of such locks shall not ployees to conduct their inspection in a leave the custody of Program employ- ready, efficient and clean manner; ees. Every such room, compartment, or (e) Watertight metal trucks or recep- receptacle shall be marked conspicu- tacles for holding and handling dis- ously with the phrase ‘‘U.S. retained’’ eased carcasses and parts, so con- in letters not less than 2 inches high; structed as to be readily cleaned; such rooms or compartments for these pur- trucks or receptacles to be marked in a poses shall be secure and susceptible of conspicuous manner with the phrase being kept clean, including a sanitary ‘‘U.S. condemned’’ in letters not less disposal of the floor liquids; establish- than 2 inches high, and, when required ment employees shall not enter any re- by the circuit supervisor, to be tention rooms or compartments or equipped with facilities for locking or open any retention receptacles unless sealing; authorized by Program employees); (f) Adequate arrangements, including (i) Adequate facilities, including de- liquid soap and cleansers, for cleansing naturing materials, for the proper dis- and disinfecting hands, for sterilizing posal of condemned articles in accord- all implements used in dressing dis- ance with the regulations in this sub- eased carcasses, floors, and such other chapter (tanks or other rendering articles and places as may be contami- equipment which, under the regula- nated by diseased carcasses or other- tions in this subchapter, must be wise; sealed, shall be properly equipped for (g) In establishments in which sealing as specified by the regulations slaughtering is done, rooms, compart- in part 314 of this subchapter or by the ments, or specially prepared open circuit supervisor in specific cases); places, to be known as ‘‘final inspec- (j) Docks and receiving rooms, to be tion places,’’ at which the final inspec- designated by the operator of the offi- tion of retained carcasses may be con- cial establishment, with the circuit su- ducted (competent assistants for han- pervisor, for the receipt and inspection dling retained carcasses and parts shall of all products as provided in § 318.3 of be provided by the establishment; final this subchapter. inspection places shall be adequate in (k) Suitable lockers in which brands size and their rail arrangement and bearing the official inspection legend
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and other official devices (excluding la- spection station can readily view the bels) and official certificates shall be back of the carcass. kept when not in use (all such lockers [35 FR 15560, Oct. 3, 1970, as amended at 47 FR shall be equipped for sealing or locking 33676, Aug. 4, 1982; 50 FR 19902, May 13, 1985] with locks or seals to be supplied by the Department; the keys of such locks § 307.3 Inspectors to furnish imple- shall not leave the custody of Program ments and maintain hands and im- plements in sanitary condition. employees); (l) Sanitary facilities and accom- Inspectors shall furnish their own modations as prescribed by § 308.4 of work clothing and implements, such as this subchapter. flashlights and triers, for conducting inspection and shall cleanse their (m) In addition to any facilities re- hands and implements as prescribed by quired to accomplish sanitary dressing § 308.8 of this subchapter. procedures, the following inspection station facilities for cattle and swine § 307.4 Schedule of operations. slaughter lines described in § 310.1(b) of (a) No operations requiring inspec- this subchapter are required: tion shall be conducted except under (1) An inspection station consisting the supervision of a Program employee. of 5 feet of unobstructed line space for All slaughtering of animals and prepa- each head or carcass inspector and, for ration of products shall be done with viscera table kills, 8 feet for each reasonable speed, considering the offi- viscera inspector on the inspector’s cial establishment’s facilities. side of the table. (b) A shift is a regularly scheduled (2) A minimum of 50 foot candles of operating period, exclusive of meal- shadow-free lighting at the inspection time. One lunch period is the only offi- surfaces of the head, viscera, and car- cial authorized interruption in the in- cass. spector’s tour of duty once it begins. (3) A handwash lavatory (other than Lunch periods may be 30 minutes, 45 one which is hand operated), furnished minutes, or in any case may not exceed one hour in duration. Once established, with soap, towels, and hot and cold the lunch period must remain rel- water, and located adjacent to the in- atively constant as to time and dura- spector’s work area. In addition, for tion. Lunch periods for inspectors shall each head and viscera inspector on cat- not, except as provided herein, occur tle slaughter lines, and each head in- prior to 4 hours after the beginning of spector on swine slaughter lines, a scheduled operations nor later than 5 sterilizer located adjacent to the in- hours after operations begin. In plants spector’s work area. where a company rest break of not less (4) For mechanized operations, a line than 30 minutes is regularly observed, control switch located adjacent to each approximately midpoint between start inspection station. of work and the lunch period, and the (5) Facilities to position tally sheets inspector is allowed this time to meet or other recording devices, such as dig- his personal needs, the lunch period ital counters, and facilities to contain may be scheduled as long as 51⁄2 hours condemned brands. after the beginning of scheduled oper- (6) For swine slaughter lines requir- ations. ing three or more inspectors, and for (c) Official establishments, import- those one- and two-inspector configura- ers, and exporters shall be provided in- spection service, without charge, up to tions where the establishment installs 8 consecutive hours per shift during the a mirror: At the carcass inspection sta- basic workweek subject to the provi- tion one glass or plastic, distortion- sions of § 307.5: That any addi- × Provided, free mirror, at least 5 feet 5 feet, tional shifts meet requirements as de- mounted far enough away from the ver- termined by the Administrator or his tical axis of the moving line to allow designee. The basic workweek shall the carcass to be turned, but not over consist of 5 consecutive 8-hour days 3 feet away, and so mounted that any within the administrative workweek inspector standing at the carcass in- Sunday through Saturday, excluding
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the lunch period; except that, when § 307.5 Overtime and holiday inspec- possible, the Department shall sched- tion service. ule the basic workweek so as to consist (a) The management of an official es- of 5 consecutive 8-hour days Monday tablishment, an importer, or an ex- through Friday, excluding lunch pe- porter shall reimburse the Program, at riod. The Department may depart from the rate specified in § 391.3, for the cost the basic workweek in those cases of the inspection service furnished on where maintaining such a schedule any holiday as specified in paragraph would seriously handicap the Depart- (b) of this section; or for more than 8 ment in carrying out its function. hours on any day, or more than 40 These provisions are applicable to all hours in any administrative workweek official establishments except in cer- Sunday through Saturday. tain cases as provided in § 318.4(h) of (b) Holidays for Federal employees this subchapter. shall be New Year’s Day, January 1; Birthday of Martin Luther King, Jr., (d)(1) Each official establishment the third Monday in January; Washing- shall submit a work schedule to the ton’s Birthday, the third Monday in area supervisor for approval. In consid- February; Memorial Day, the last Mon- eration of whether the approval of an day in May; Independence Day, July 4; establishment work schedule shall be Labor Day, the first Monday in Sep- given, the area supervisor shall take tember; Columbus Day, the second into account the efficient and effective Monday in October; Veterans’ Day, No- use of inspection personnel. The work vember 11; Thanksgiving Day, the schedule must specify daily clock fourth Thursday in November; Christ- hours of operation and lunch periods mas Day, December 25. When any of for all departments of the establish- the above-listed holidays falls outside ment requiring inspection. the basic workweek, the nearest work- (2) Establishments shall maintain day within that week shall become a consistent work schedules. Any request holiday. by an establishment for a change in its [40 FR 45800, Oct. 3, 1975, as amended at 43 FR work schedule involving an addition or 51754, Nov. 7, 1978; 50 FR 724, Jan. 7, 1985; 50 elimination of shifts shall be submitted FR 51513, Dec. 18, 1985; 52 FR 4, Jan. 2, 1987; to the area supervisor at least 2 weeks 53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, 1989] in advance of the proposed change. Fre- quent requests for change shall not be § 307.6 Basis of billing for overtime approved: Provided, however, minor de- and holiday services. viations from a daily operating sched- (a) Each recipient of overtime or hol- ule may be approved by the inspector iday inspection service, or both, shall in charge, if such request is received on be billed as provided for in § 307.5(a) and the day preceding the day of change. at the rates specified in § 391.3, in incre- (3) Request for inspection service ments of quarter hours. For billing outside an approved work schedule purposes, 8 or more minutes shall be shall be made as early in the day as considered a full quarter hour. Billing possible for overtime work to be per- will be for each quarter hour of service formed within that same workday; or rendered by each Program employee. made prior to the end of the day’s oper- (b) Official establishments, import- ation when such a request will result in ers, or exporters requesting and receiv- overtime service at the start of the fol- ing the services of a Program employee after he has completed his day’s assign- lowing day: Provided, That an inspector ment and left the premises, or called may be recalled to his assignment after back to duty during any overtime or completion of his daily tour of duty holiday period, shall be billed for a under the provisions of § 307.6(b). minimum of 2 hours overtime or holi- [40 FR 45799, Oct. 3, 1975, as amended at 40 FR day inspection service at the estab- 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; lished rate. 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, (c) Bills are payable upon receipt and 1986] become delinquent 30 days from the
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date of the bill. Overtime or holiday in- conduct electricity. The interior of the spection will not be performed for any- stimulating area shall be visible from one having a delinquent account. the start switch so the operator can be [40 FR 45800, Oct. 3, 1975, as amended at 54 FR assured that there is no person, equip- 6389, Feb. 10, 1989] ment or material present that should not be there prior to starting the stim- § 307.7 Safety requirements for elec- ulating sequence. If light or sound trical stimulating (EST) equipment. beam sensors form the enclosure, the (a) General. Electrical stimulating stimulating equipment shall be auto- (EST) equipment is equipment that matically shut off when the sensor sig- provides electric shock treatment to nals are broken. carcasses for the purpose of accelerat- (3) Mandatory Warning Devices and ing rigor mortis of facilitating blood Signals. The following warning devices removal. These provisions do not apply or signals shall be installed at each to electrical equipment used to stun opening to the stimulating area and/or slaughter animals or to facili- tate hide removal. Electrical stimulat- through which a person would nor- ing equipment consists of two separate mally enter: pieces—the control system and the ap- (i) A red light that flashes distinctly plicator. The EST control system con- during the operating cycle of the stim- tains the circuitry to generate pulsed ulating equipment. DC or AC voltage for stimulation and (ii) An ANSI Z53.1-Color Code sign is separate from the equipment used to reading (a) ‘‘Danger Electrical Hazard’’ apply the voltage to the carcass. The for stimulating voltage below 50 or (b) voltage is applied by inserting a probe ‘‘Danger High Voltage’’ for stimulating that penetrates the carcass or is in- voltage above 50. serted in the rectum, placing a clamp (iii) An emergency stop button. in the nose, a carcass rub-bar, a con- (4) Optional Warning Device—Horn or veyor with energized surfaces traveling Bell. If a warning horn or bell is in- with the carcass, or any other method stalled, the signal shall be audible found to be acceptable by the Adminis- above background noises in the vicin- trator. The Administrator will evalu- ity, and it shall sound for at least 1 ate EST equipment to determine its ac- second before each manual stimulation ceptability for its proposed use before it is installed in an official establish- or before the carcass chain is started in ment as set forth in § 308.5 of this sub- an automatic system. chapter. (c) Operation— (b) Safety requirements—(1) Circuits, (1) Training. Only persons who have grounding. Either a bonded grounding received safety instruction by the conductor shall lead from each section equipment manufacturer or designee of the carcass rail within the stimulat- may operate electrical stimulating ing enclosure to the service ground, or equipment. the secondary voltage (stimulating cir- (2) Cleaning and Maintenance. To pre- cuit) shall be insulated from the serv- vent an electrical shock to personnel, ice ground. If the stimulating section the electricity supplied to the stimu- of the carcass rail and carcass drive lating surfaces shall be locked-off when mechanisms are insulated from the cleaning, mechanical inspection, main- service ground then the stimulating tenance or testing are performed. rail or the return path shall be elec- (3) Water. To prevent an electrical trically bonded to the transformer sec- shock, personnel shall not spray ondary to isolate the stimulation volt- streams of water on energized car- age. (2) Enclosure. Electrical stimulation casses or on energized stimulating sur- shall occur in an area that will prevent faces. persons from contacting an energized (d) Special provisions for manually surface. If the area is surrounded by operated equipment. physical barriers, the enclosure shall (1) Stimulating probes or clamps be either electrically grounded or it shall be stored in a sanitary container shall be made of materials that do not
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which is insulated with a material ap- ment and premises shall be made by a proved by the Administrator.1 Program employee and the require- (2) The electric wires attached to a ments for sanitation and the necessary clamp or probe shall not allow for con- facilities for inspection shall be speci- tact between the probe or clamp and an fied by him in accordance with the reg- electrical ground and shall not extend ulations in this part and part 307 of outside the enclosure. this subchapter. [53 FR 46432, Nov. 17, 1988] § 308.2 [Reserved]
PART 308—SANITATION § 308.3 Establishments; sanitary condi- tion; requirements. Sec. 308.1 Examination and specifications for (a) Official establishments shall be equipment and sanitation prior to grant- maintained in sanitary condition, and ing inspection. to this end the requirements of this 308.2 [Reserved] section shall be complied with. The 308.3 Establishments; sanitary condition; provisions of part 416 of this chapter requirements. apply to all establishments, except es- 308.4 Sanitary facilities and accommoda- tablishments that are exempt in ac- tions; specific requirements. 308.5 Equipment and utensils to be easily cordance with § 303.1 of this chapter. cleaned; those for inedible products to be (b) There shall be abundant light, of so marked; PCB-containing equipment. good quality and well distributed, and 308.6 Scabbards for knives. sufficient ventilation for all rooms and 308.7 Rooms, compartments, etc., to be compartments to insure sanitary con- clean and sanitary. dition. 308.8 Operations, procedures, rooms, cloth- ing, utensils, etc., to be clean and sani- (c) There shall be an efficient drain- tary. age and plumbing system for the estab- 308.9 Protective handling of products. lishment and premises, and all drains 308.10 Slack barrels and similar containers and gutters shall be properly installed and means of conveyance used for prod- with traps and vents approved by the uct; paper in contact with product. circuit supervisor. 308.11 Burlap wrapping for meat. 308.12 Second-hand tubs, barrels, and other (d)(1) The water supply shall be containers. ample, clean, and potable, with ade- 308.13 Inedible operating and storage rooms; quate facilities for its distribution in outer premises, docks, driveways, ap- the plant and its protection against proaches, pens, alleys, etc.; flybreeding contamination and pollution. Every es- material; other conditions. tablishment shall make known and, 308.14 Employment of diseased persons. whenever required by the circuit super- 308.15 Tagging insanitary equipment, uten- visor, shall afford opportunity for in- sils, rooms or compartments. 308.16 Sanitation requirements for elec- spection of the source of its water sup- trical stimulating (EST) equipment. ply, the storage facilities, and the dis- tribution system. Equipment using po- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. table water shall be so installed as to prevent back-siphonage into the pot- SOURCE: 35 FR 15561, Oct. 3, 1970, unless able water system. Nonpotable water is otherwise noted. permitted only in those parts of offi- § 308.1 Examination and specifications cial establishments where no edible for equipment and sanitation prior product is handled or prepared, and to granting inspection. then only for limited purposes such as Prior to the inauguration of inspec- on ammonia condensers not connected tion, an examination of the establish- with the potable water supply, in vapor lines serving inedible product render- ing tanks, in connection with equip- 1 A list of approved insulation materials is ment used for hashing and washing in- available upon request from the Facilities, Equipment and Sanitation Division, Tech- edible products preparatory to tanking, nical Services, Food Safety and Inspection and in sewer lines for moving heavy Service, U.S. Department of Agriculture, solids in the sewage. Nonpotable water Washington, DC 20250. is not permitted for washing floors,
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areas, or equipment involved in truck- such temperature as to accomplish a ing materials to and from edible prod- thorough cleanup. uct departments nor is it permitted in (e) The floors, walls, ceilings, parti- hog scalding vats, dehairing machines, tions, posts, doors, and other parts of or vapor lines serving edible product all structures shall be of such mate- rendering equipment, or for cleanup of rials, construction, and finish as will shackling pens, bleeding areas, or run- make them susceptible of being readily ways within the slaughtering depart- and thoroughly cleaned. The floors ment. In all cases, nonpotable shall be kept watertight. The rooms waterlines shall be clearly identified and compartments used for edible prod- and shall not be cross-connected with uct shall be separate and distinct from the potable water supply unless this is those used for inedible product. necessary for fire protection and such (f) Rails should be located and pas- connection is of a type with an ade- sageway space provided so that exposed quate break to assure against acciden- product does not come in contact with tal contamination, and is approved by posts, walls, and other fixed parts of local authorities and by the circuit su- the building, or with barrels, boxes, pervisor. and other containers trafficked (2) The circuit supervisor may permit through holding and operating areas. the reuse of water in vapor lines lead- Exposed product shall not be placed or ing from deodorizers used in the prepa- stored beneath carcasses in coolers or ration of lard and similar edible prod- holding areas. uct and in equipment where such water (g) The rooms and compartments in is used to thermally process canned which any product is prepared or han- product packed in hermetically sealed dled shall be free from dust and from containers, provided: odors from dressing and toilet rooms, (i) The reuse is for the identical catch basins, hide cellars, casing original purpose. rooms, inedible tank and fertilizer rooms, and livestock pens. (ii) All pipelines, reservoirs, tanks, (h) Every practicable precaution cooling towers, and like equipment em- shall be taken to exclude flies, rats, ployed in handling the reused water are mice, and other vermin from official so constructed and installed so they establishments. The use of poisons for can be cleaned and drained, and are any purpose in rooms or compartments kept clean. where any unpacked product is stored (3) Approval for the reuse of water or handled is forbidden, except under other than as specified in paragraph such restrictions and precautions as (d)(2) of this section or in § 318.305(h) are prescribed by the regulations in shall be obtained from the Adminis- this part or by the circuit supervisor in trator in specific cases. specific cases. The use of insecticides, (4) An ample supply of water at not rodenticides, and similar pest control less than 180 °F. shall be furnished and substances in hide cellars, inedible used for the cleaning of inspection product departments, outbuildings, or equipment and other equipment, floors, similar places, or in storerooms con- and walls which are subject to con- taining canned or tierced products is tamination by the dressing or handling not forbidden but only those approved of diseased carcasses, their viscera, and by the Administrator may be used. 1 other parts. Whenever necessary to de- So-called rat viruses shall not be used termine compliance with this require- in any part of an establishment or the ment, conveniently located thermom- premises thereof. eters shall be installed by the operator (i) Dogs and cats shall be excluded of the official establishment to show from the interior of official establish- the temperature of the water at the ments; however, dogs may be permitted point of use. (5) Hot water for cleaning rooms and 1 A list of approved pest control substances equipment other than those mentioned is available upon request to the Scientific in paragraph (d)(4) of this section shall Services, Meat and Poultry Inspection, Food be delivered under pressure to suffi- Safety and Inspection Service, U.S. Depart- cient convenient outlets and shall be of ment of Agriculture, Washington, DC 20250.
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on the outer premises for guard pur- to these requirements, equipment and poses. utensils shall not in any way interfere [35 FR 15561, Oct. 3, 1970, as amended at 51 FR with or impede inspection procedures. 45619, Dec. 19, 1986; 61 FR 38864, July 25, 1996; Receptacles used for handling inedible 62 FR 26217, May 13, 1997] material shall be of such material and construction that their use will not re- § 308.4 Sanitary facilities and accom- sult in adulteration of any edible prod- modations; specific requirements. uct or in insanitary conditions at the Adequate sanitary facilities and ac- establishment, and they shall bear con- commodations shall be furnished by spicuous and distinctive marking to every official establishment. Of these, identify them as only for such use and the following are specifically required: shall not be used for handling any edi- (a) Dressing rooms, toilet rooms, and ble product. urinals shall be sufficient in number, (b) New or replacement equipment or ample in size, and conveniently lo- machinery (including any replacement cated. The rooms shall be provided parts) brought onto the premises of with facilities to provide abundant light of good quality and well distrib- any official establishment shall not uted. They shall be properly ventilated, contain liquid polychlorinated and meet all requirements of the regu- biphenyls (PCBs) in concentrations lations in this part as to sanitary con- above 50 parts per million by weight of struction and equipment. They shall be the liquid medium. This provision ap- separate from the rooms and compart- plies to both food processing and ments in which products are prepared, nonfood processing equipment and ma- stored, or handled. Where both sexes chinery, and any replacement parts for are employed, separate facilities shall such equipment and machinery. To- be provided. tally enclosed capacitors containing (b) Acceptable lavatories, including less than 3 pounds of PCBs are exempt- running hot and cold water, soap, and ed from this prohibition. towels, shall be placed in or near toilet and urinal rooms and also at such [40 FR 25439, June 16, 1975, as amended at 40 other places in the establishment as FR 60053, Dec. 31, 1975; 45 FR 68918, Oct. 17, 1980; 62 FR 45024, Aug. 25, 1997] may be essential to assure cleanliness of all persons handling any product. § 308.6 Scabbards for knives. (c) Toilet soil lines shall be separate from house drainage lines to a point Scabbards and similar devices for the outside the building and drainage from temporary retention of knives, steels, toilet bowls and urinals shall not be triers, etc., by workers and others at discharged into a grease catch basin. official establishments shall be con- (d) Properly located facilities shall structed of rust-resisting metal or be provided for cleansing and disinfect- other impervious material, shall be of ing utensils and hands of all persons a type that may be readily cleaned, and handling any product. shall be kept clean.
§ 308.5 Equipment and utensils to be § 308.7 Rooms, compartments, etc., to easily cleaned; those for inedible be clean and sanitary. products to be so marked; PCB-con- taining equipment. Rooms, compartments, places, equip- (a) Equipment and utensils used for ment, and utensils used for preparing, preparing or otherwise handling any storing, or otherwise handling any edible product or ingredient thereof in product, and all other parts of the es- any official establishment shall be of tablishment, shall be kept clean and in such material and construction as will sanitary condition. There shall be no facilitate their thorough cleaning and handling or storing of materials which insure cleanliness in the preparation create an objectionable condition in and handling of all edible products and rooms, compartments, or places where otherwise avoid adulteration and mis- any product is prepared, stored, or oth- branding of such products. In addition erwise handled.
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§ 308.8 Operations, procedures, rooms, from the mouth such receptacles as clothing, utensils, etc., to be clean tierces, kegs, or casks, containing or and sanitary. intended as containers of any product, (a) Operations and procedures involv- are prohibited. Only mechanical means ing the preparation, storing, or han- may be used for such testing. Care dling of any product shall be strictly in shall be taken to prevent the contami- accord with clean and sanitary meth- nation of product with perspiration, ods. hair, cosmetics, medications, and simi- (b) Rooms and compartments in lar substances. which inspections are made and those (f) Equipment or substances which in which livestock are slaughtered or generate gases or odors shall not be any product is prepared shall be kept used in official establishments except sufficiently free of steam and vapors to as permitted by the regulations in this enable Program employees to make in- part or by the circuit supervisor in spe- spections and to insure clean oper- cific cases in which he determines that ations. The walls, ceilings, and over- such use will not result in adulteration head structure of rooms and compart- of any product. ments in which product is prepared, handled, or stored shall be kept reason- § 308.9 Protective handling of prod- ably free from moisture to prevent ucts. dripping and contamination of product. Products shall be protected from con- (c) Butchers and others who dress or tamination from any source such as handle diseased carcasses or parts dust, dirt, or insects during storage, shall, before handling or dressing other loading, or unloading at and transpor- carcasses or parts, cleanse their hands tation from official establishments. with liquid soap and hot water, and rinse them in clean water. Implements § 308.10 Slack barrels and similar con- used in dressing diseased carcasses tainers and means of conveyance shall be thoroughly cleansed with hot used for product; paper in contact water having a minimum temperature with product. of 180 °F. or in a disinfectant 2 approved (a) When necessary to avoid contami- by the Administrator, followed by rins- nation of product with wood splinters ing in clean water. The employees of or similar contaminants, slack barrels the establishment who handle any and similar containers and the cargo product shall keep their hands clean, space of trucks, railroad cars, or other and in all cases after visiting the toilet means of conveyance shall be lined rooms or urinals shall wash their hands with suitable material of good quality before handling any product or imple- before packing. ments used in the preparation of prod- (b) Slack barrels and similar contain- uct. ers and trucks, railroad cars, and other (d) Aprons, frocks, and other outer means of conveyance in which any clothing worn by persons who handle product is transported shall be kept in any product shall be of material that is a clean and sanitary condition. readily cleansed. Clean garments shall (c) Paper used for covering or lining be worn at the start of each working slack barrels and similar containers day and the garments shall be changed and the cargo space of trucks, railroad during the day when required by the cars, or other means of conveyance inspector in charge. shall be of a kind which does not tear (e) Such practices as spitting on during use but remains intact when whetstones; spitting on the floor; plac- moistened by the product and does not ing skewers, tags, or knives in the disintegrate. mouth; inflating lungs or casings with air from the mouth; or testing with air § 308.11 Burlap wrapping for meat. Since burlap used without any other 2 A list of approved disinfectants is avail- able upon request to the Scientific Services, material as a wrapping for meat depos- Meat and Poultry Inspection, Food Safety its lint on the meat and does not suffi- and Inspection Service, U.S. Department of ciently protect it from outside con- Agriculture, Washington, DC 20250. tamination, the use of burlap as a
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wrapping for meat will not be per- § 308.14 Employment of diseased per- mitted unless the meat is first wrapped sons. with a good grade of paper or cloth of No operator of an official establish- a kind which will prevent contamina- ment or other person preparing product tion with lint or other foreign matter. in an official establishment shall em- § 308.12 Second-hand tubs, barrels, ploy, in any department where any and other containers. product is handled or prepared, any person showing evidence of a commu- Second-hand tubs, barrels, and boxes nicable disease in a transmissible intended for use as containers of any stage, or known to be a carrier of such product shall be inspected when re- ceived at the official establishment and a disease, or while affected with boils, before they are cleaned. Those showing sores, infected wounds, or other abnor- evidence of misuse rendering them mal sources of microbiological con- unfit to serve as containers for food taminants. products shall be rejected. The use of § 308.15 Tagging insanitary equipment, those showing no evidence of previous utensils, rooms or compartments. misuse may be allowed after they have been thoroughly and properly cleaned. When, in the opinion of a Program Steaming, after thorough scrubbing employee, any equipment, utensil, and rinsing, is essential to cleaning room, or compartment at an official es- tubs and barrels. tablishment is unclean or its use would be in violation of any of the regula- [35 FR 15561, Oct. 3, 1970, as amended at 38 FR tions in this subchapter, he will attach 29214, Oct. 23, 1973; 41 FR 23700, June 11, 1976] a ‘‘U.S. Rejected’’ tag thereto. No § 308.13 Inedible operating and stor- equipment, utensil, room, or compart- age rooms; outer premises, docks, ment so tagged shall again be used driveways, approaches, pens, alleys, until made acceptable. Such tag so at- etc.; flybreeding material; other tached shall not be removed by anyone conditions. other than a Program employee. All operating and storage rooms and departments of official establishments § 308.16 Sanitation requirements for used for inedible materials shall be electrical stimulating (EST) equip- maintained in acceptably clean condi- ment. tion. The outer premises of every offi- (a) Hide-on stimulation. Automatic cial establishment, including docks and manually operated equipment may and areas where cars and vehicles are be used to apply electrical stimualtion loaded, and the driveways, approaches, to the hide-on surface of slaughtered yards, pens, and alleys, shall be prop- carcasses provided no opening cuts erly paved and drained and kept in other than the stick wound or foot re- clean and orderly condition. All catch moval have been made in the carcass. basins on the premises shall be of such If the hide is penetrated by electrodes, construction and location and shall be the penetrated tissue shall be trimmed. given such attention as will insure Disinfection of electrodes between each their being kept in acceptable condi- hide-on carcass stimulation is not nec- tion as regards odors and cleanliness. essary. Catch basins shall not be located in de- (b) Hide-off stimulation. (1) Automatic partments where any product is pre- or manually operated equipment may pared, handled, or stored. The accumu- lation on the premises of official estab- be used to apply electrical stimulation lishments of any material in which to carcasses after complete hide re- flies may breed, such as hog hair, moval. Partially skinned carcasses bones, paunch contents, or manure, is shall not be stimulated. forbidden. No other conditions that (2) If stimulation is applied before may result in adulteration of product the carcass has been inspected, the car- or interfere with inspection shall be al- cass contact surfaces of the equipment lowed in any official establishment or shall be disinfected with a disinfectant on its premises.
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approved by the Administrator 1 before 309.2 Livestock suspected of being diseased stimulation of the next carcass. In the or affected with certain conditions; iden- event that carcass contact surfaces of tifying suspects; disposition on post- mortem inspection or otherwise. the equipment cannot be cleaned and 309.3 Dead, dying, disabled, or diseased and disinfected between carcass stimula- similar livestock. tions, those surfaces shall be imme- 309.4 Livestock showing symptoms of cer- diately removed from contact with the tain metabolic, toxic, nervous, or cir- exposed carcass and cleaned and dis- culatory disturbances, nutritional imbal- infected before carcass contact is re- ances, or infectious or parasitic diseases. sumed. 309.5 Swine; disposal because of hog cholera. 309.6 Epithelioma of the eye. (3) If stimulation is applied after the 309.7 Livestock affected with anthrax; carcass has been inspected, carcass cleaning and disinfection of infected live- contact surfaces of the equipment need stock pens and driveways. not be disinfected with a disinfectant 309.8 Cattle affected with anasarca and gen- approved by the Administrator before eralized edema. 309.9 Swine erysipelas. stimulation of the next carcass. Car- 309.10 Onset of parturition. cass contact surfaces shall be main- 309.11 Vaccine livestock. tained in a clean and sanitary condi- 309.12 Emergency slaughter; inspection tion. prior to. (c) Preventing product contamination. 309.13 Disposition of condemned livestock. Carcass contamination of edible tissue 309.14 Brucellosis-reactor goats. 309.15 Vesicular diseases. by stomach contents, feces and/or urine 309.16 Livestock suspected of having bio- is unacceptable. To prevent such occur- logical residues. rences, any of the following optional 309.17 Livestock used for research. procedures may be used before stimula- 309.18 Official marks and devices for pur- tion to prevent this contamination: poses of ante-mortem inspection. (1) Leave the sphincter muscles in- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, tact; 2.55. (2) Cut the rectum and the urethra SOURCE: 35 FR 15563, Oct. 3, 1970, unless free from surrounding tissue and se- otherwise noted. curely tie each off; (3) Partially open the mid-line and/or § 309.1 Ante-mortem inspection in pens saw the brisket to reduce pressure on of official establishments. the visceral organs; or (a) All livestock offered for slaughter (4) Any other pressure-relieving or in an official establishment shall be ex- discharge-restricting alternative ac- amined and inspected on the day of and ceptable to the Administrator. Alter- before slaughter unless, because of un- natives should be presented in writing, usual circumstances, prior arrange- through the inspector-in-charge, to the ments acceptable to the Administrator Program for approval. have been made in specific cases by the (d) Cleaning. All equipment must be circuit supervisor for such examination thoroughly cleaned at least daily. and inspection to be made on a dif- ferent day before slaughter. [53 FR 46433, Nov. 17, 1988] (b) Such ante-mortem inspection shall be made in pens on the premises PART 309—ANTE–MORTEM of the establishment at which the live- INSPECTION stock are offered for slaughter before the livestock shall be allowed to enter Sec. into any department of the establish- 309.1 Ante-mortem inspection in pens of of- ment where they are to be slaughtered ficial establishments. or dressed or in which edible products are handled. When the holding pens of an official establishment are located in 1 A list of approved disinfectants is avail- a public stockyard and are reserved for able upon request from the Facilities, Equip- ment and Sanitation Division, Technical the exclusive use of the establishment, Services, Food Safety and Inspection Serv- such pens shall be regarded as part of ice, U.S. Department of Agriculture, Wash- the premises of that establishment and ington, DC 20250. the operator of the establishment shall
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be responsible for compliance with all pects and disposed of as provided in requirements of the regulations in this § 311.8 of this subchapter or paragraph subchapter with respect to such pens. (g) of this section. (g) Any livestock suspected of being § 309.2 Livestock suspected of being affected with anasarca may be set diseased or affected with certain apart and held for treatment under conditions; identifying suspects; disposition on post-mortem inspec- Program or other responsible official tion or otherwise. supervision approved by the area super- visor. If at the expiration of the treat- (a) Any livestock which, on ante- ment period the livestock upon exam- mortem inspection, do not clearly ination is found to be free from disease, show, but are suspected of being af- it may be released for any purpose. fected with any disease or condition Otherwise, it shall be identified as U.S. that, under part 311 of this subchapter, Suspect and disposed of as provided in may cause condemnation of the carcass § 311.8 of this subchapter or condemned on post-mortem inspection, and any and disposed of as provided in § 309.8, livestock which show, on ante-mortem whichever is appropriate. inspection, any disease or condition (h) All hogs suspected on ante- that, under part 311 of this subchapter would cause condemnation of only part mortem inspection of being affected of the carcass on post-mortem inspec- with swine erysipelas shall be identi- tion, shall be so handled as to retain fied as U.S. Suspects and disposed of as its identity as a suspect until it is provided in § 311.5 of this subchapter or given final post-mortem inspection, paragraph (i) of this section. when the carcass shall be marked and (i) A hog suspected of being affected disposed of as provided in parts 310 and with swine erysipelas may be set apart 311 of this subchapter, or until it is dis- and held for treatment under Program posed of as otherwise provided in this or other responsible official super- part. vision approved by the area supervisor. (b) All seriously crippled animals and If at the expiration of the treatment animals commonly termed ‘‘downers,’’ period the animal upon examination is shall be identified as U.S. Suspects and found to be free from disease, it may be disposed of as provided in § 311.1 of this released for any purpose. Otherwise, it subchapter unless they are required to shall be identified as U.S. Suspect and be classed as condemned under § 309.3. disposed of as provided in § 311.5 of this (c) Livestock which have reacted to a subchapter, or condemned and disposed test for leptospirosis, or anaplasmosis, of as provided in § 309.13, whichever is but which show no symptoms of the appropriate. disease, shall be identified as U.S. Sus- (j) Any livestock which is affected pects and disposed of as provided in with vesicular exanthema or vesicular § 311.10 of this subchapter. stomatitis, but which has recovered to (d) Livestock which are known to the extent that the lesions are in proc- have reacted to the tuberculin test ess of healing, the temperature is with- shall be identified as U.S. Suspects and in normal range, and the livestock disposed of as provided in § 311.2 of this shows a return to normal appetite and subchapter, except that livestock bear- activity, shall be identified as U.S. ing an official ‘‘USDA Reactor’’ or Suspect and disposed of as provided in similar State reactor tag shall not be § 311.32 of this subchapter, except that tagged as U.S. Suspects. if desired, such livestock may be set (e) Any cattle found on ante-mortem apart and held under supervision of a inspection to be affected with Program employee or other official epithelioma of the eye or of the orbital designated by the area supervisor for region to a lesser extent than as de- treatment. If the livestock is set aside scribed in § 309.6 shall be identified as a for treatment, the U.S. Suspect identi- U.S. Suspect and disposed of as pro- fication device will be removed by a vided in § 311.12 of this subchapter. Program employee, following such (f) Cattle found on ante-mortem in- treatment, if the livestock is found to spection to be affected with anasarca be free from any such disease. Such to a lesser extent than as described in livestock found to be free from any § 309.8 shall be identified as U.S. Sus- such disease may be released for
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slaughter or for purposes other than animal was classed as a suspect, in- slaughter, provided that in the latter cluding its temperature when the tem- instance, the operator of the official perature of such animal might have a establishment or the owner of the ani- bearing on the disposition of the car- mal shall first obtain permission from cass on post-mortem inspection. the local, State, or Federal livestock (p) When any animal identified as a sanitary official having jurisdiction U.S. Suspect is released for any pur- over the movement of such livestock. pose or reason, as provided in this part, (k) Livestock which are offered for the official identification device shall ante-mortem inspection under this be removed only by a Program em- part, and which are regarded by the in- ployee and he shall report his action to spector as immature, shall be identi- the area supervisor. When a suspect is fied as U.S. Suspects and, if slaugh- to be released under the provisions of tered, the disposition of their carcasses this part for a purpose other than shall be determined by the post- slaughter, the operator of the official mortem findings in connection with establishment or the owner of the ani- the ante-mortem conditions. If not mal shall first obtain permission for slaughtered as suspects, such livestock the removal of such animal from the shall be held under supervision of a local, State or Federal livestock sani- Program employee or other official tary official having jurisdiction. designated by the area supervisor, and [35 FR 15563, Oct. 3, 1970, as amended at 38 FR after sufficient development may be re- 29214, Oct. 23, 1973; 39 FR 36000, Oct. 17, 1974] leased for slaughter or may be released for any other purpose, provided they § 309.3 Dead, dying, disabled, or dis- have not been exposed to any infec- eased and similar livestock. tious or contagious disease. If such ex- (a) Livestock found to be dead or in a posure occurs, permission should be ob- dying condition on the premises of an tained from the nearest Veterinary official establishment shall be identi- Services unit of the Animal and Plant fied as U.S. Condemned and disposed of Health Inspection Service prior to re- in accordance with § 309.13. lease of such livestock. (b) Livestock plainly showing on (l) Livestock previously condemned ante-mortem inspection any disease or for listeriosis, if released for slaughter condition that, under part 311 of this under § 309.13(b) shall be identified as a subchapter, would cause condemnation U.S. Suspect in accordance with of their carcasses on post-mortem in- § 309.13(c). spection shall be identified as U.S. Con- (m) Each animal required by this demned and disposed of in accordance part to be treated as a U.S. Suspect with § 309.13. shall be identified as such by or under (c) Any swine having a temperature the supervision of a Program employee of 106 °F. or higher and any cattle, with an official device in accordance sheep, goats, horses, mules, or other with § 309.18. No such device shall be re- equines having a temperature of 105 °F. moved except by a Program employee. or higher shall be identified as U.S. (n) Each animal identified as a U.S. Condemned. In case of doubt as to the Suspect on ante-mortem inspection cause of the high temperature, or when shall be set apart and shall be slaugh- for other reasons a Program employee tered separately from other livestock deems such action warranted, any such at that establishment unless disposed livestock may be held for a reasonable of as otherwise provided in this part. time under the supervision of a Pro- (o) Each animal identified as a U.S. gram employee for further observation Suspect on ante-mortem inspection, and taking of temperature before final when presented for slaughter shall be disposition of such livestock is deter- accompanied with a form MP 402–2 on mined. Any livestock so held shall be which the inspector at the establish- reinspected on the day it is slaugh- ment shall record the U.S. Suspect tered. If, upon such reinspection, or identification number and any other when not held for further observation identifying tag numbers present and a and taking of temperature, then on the brief description of the animal and of original inspection, the animal has a the disease or condition for which the temperature of 106 °F. or higher in the
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case of swine, or 105 °F. or higher in the § 309.5 Swine; disposal because of hog case of other livestock, it shall be con- cholera. demned and disposed of in accordance (a) All swine found by an inspector to with § 309.13. be affected with hog cholera shall be (d) Any livestock found in a coma- identified as U.S. Condemned and dis- tose or semicomatose condition or af- posed of in accordance with § 309.13. Im- fected with any condition not other- mediate notification shall be given by wise covered in this part, which would the inspector to the official in the Vet- preclude release of the animal for erinary Services unit of the Animal slaughter for human food, shall be and Plant Health Inspection Service identified ‘‘U.S. Condemned’’ and dis- who has responsibility for the control posed of in accordance with § 309.13, ex- of swine diseases in the State where cept that such animal may be set apart the swine are located. and held for further observation or (b) All swine, even though not them- treatment under supervision of a Pro- selves identified as U.S. Suspects, gram employee or other official des- which are of lots in which one or more ignated by the area supervisor and for animals have been condemned or iden- final disposition in accordance with tified as U.S. Suspect for hog cholera, this part. shall, as far as possible, be slaughtered separately and apart from all other § 309.4 Livestock showing symptoms of livestock passed on ante-mortem in- certain metabolic, toxic, nervous, or spection. circulatory disturbances, nutri- tional imbalances, or infectious or [40 FR 27225, June 27, 1975] parasitic diseases. § 309.6 Epithelioma of the eye. (a) All livestock showing, on ante- Any animal found on ante-mortem mortem inspection, symptoms of inspection to be affected with anaplasmosis, ketosis, leptospirosis, epithelioma of the eye and the orbital listeriosis, parturient paresis, region in which the eye has been de- pseudorabies, rabies, scrapie, tetanus, stroyed or obscured by neoplastic tis- grass tetany, transport tetany, stran- sue and which shows extensive infec- gles, purpura hemorrhagica, azoturia, tion, suppuration, and necrosis, usually infectious equine encephalomyelitis, accompanied with foul odor, or any toxic encephalomyelitis (forage poison- animal affected with epithelioma of ing), dourine, acute influenza, general- the eye or of the orbital region which, ized osteoporosis, glanders (farcy), regardless of extent, is accompanied acute inflammatory lameness or exten- with cachexia shall be identified as sive fistula shall be identified as U.S. U.S. Condemned and disposed of in ac- Condemned and disposed of in accord- cordance with § 309.13. ance with § 309.13. (b) If any equine is suspected on ante- § 309.7 Livestock affected with an- mortem inspection of being infected thrax; cleaning and disinfection of infected livestock pens and drive- with glanders or dourine, the nearest ways. Veterinary Services unit of the Animal and Plant Health Inspection Service (a) Any livestock found on ante- shall be so informed by a Program em- mortem inspection to be affected with ployee. Tests shall be performed by anthrax shall be identified as U.S. Con- said unit to determine whether the ani- demned and disposed of in accordance mal is, in fact, infected with such dis- with § 309.13. (b) No other livestock of a lot in ease. If it is found on such tests to be which anthrax is found on ante- infected, the animal shall be disposed mortem inspection shall be slaughtered of in accordance with paragraph (a) of and presented for post-mortem inspec- this section. Otherwise, the animal tion until it has been determined by a shall be identified as a U.S. Suspect careful ante-mortem inspection that no and disposed of as provided in § 311.10 of anthrax infected livestock remains in this subchapter. the lot. [35 FR 15563, Oct. 3, 1970 as amended at 38 FR (c) Apparently healthy livestock 29214, Oct. 23, 1973] (other than hogs) from a lot in which
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anthrax is detected, and any appar- and disposed of in accordance with ently healthy livestock which have § 309.13. been treated with anthrax biologicals which do not contain living anthrax or- § 309.9 Swine erysipelas. ganisms, may be slaughtered and pre- All hogs plainly showing on ante- sented for post-mortem inspection if mortem inspection that they are af- they have been held not less than 21 fected with acute swine erysipelas shall days following the last treatment or be identified as U.S. Condemned and the last death of any livestock in the disposed of in accordance with § 309.13. lot. Alternatively, if desired, all appar- ently healthy livestock of the lot may § 309.10 Onset of parturition. be segregated and held for treatment Any livestock showing signs of the by a State licensed veterinarian under onset of parturition shall be withheld supervision of a Program employee or from slaughter until after parturition other official designated by the area and passage of the placenta. Slaughter supervisor. No anthrax vaccine (live or- or other disposition may then be per- ganisms) shall be used on the premises mitted if the animal is otherwise ac- of an official establishment. ceptable. (d) Livestock which have been in- § 309.11 Vaccine livestock. jected with anthrax vaccines (live or- ganisms) within 6 weeks, and those Vaccine livestock with unhealed le- bearing evidence of reaction to such sions of vaccinia, accompanied with treatment, such as inflammation, tu- fever, which have not been exposed to mefaction, or edema at the site of the any other infectious or contagious dis- injection, shall be condemned on ante- ease, are not required to be slaughtered mortem inspection, or such animals and may be released for removal from may be held under supervision of a Pro- the premises. gram employee or other official des- § 309.12 Emergency slaughter; inspec- ignated by the area supervisor until tion prior to. the expiration of the 6-week period and the disappearance of any evidence of In all cases of emergency slaughter, reaction to the treatment. except as provided in § 311.27 of this subchapter, the animals shall be in- (e) When livestock are found on ante- spected immediately before slaughter, mortem inspection to be affected with whether theretofore inspected or not. anthrax, all exposed livestock pens and When the necessity for emergency driveways of the official establishment slaughter exists, the establishment shall be cleaned and disinfected by shall notify the inspector in charge so promptly and thoroughly removing and that such inspection may be made. burning all straw, litter, and manure. This shall be followed immediately by § 309.13 Disposition of condemned live- a thorough disinfection of the exposed stock. premises by soaking the ground, (a) Except as otherwise provided in fences, gates, and all exposed material this part, livestock identified as U.S. with a 5 percent solution of sodium hy- Condemned shall be killed by the offi- droxide or commercial lye prepared as cial establishment, if not already dead. outlined in § 310.9(e)(1) of this sub- Such animals shall not be taken into chapter, or other disinfectant that may the official establishment to be slaugh- be approved in specific cases by the Ad- tered or dressed; nor shall they be con- ministrator specifically for this pur- veyed into any department of the es- pose. tablishment used for edible products; but they shall be disposed of in the § 309.8 Cattle affected with anasarca manner provided for condemned car- and generalized edema. casses in part 314 of this subchapter. All cattle found on ante-mortem in- The official U.S. Condemned tag shall spection to be affected with anasarca not be removed from, but shall remain in advanced stages and characterized on the carcass until it goes into the by an extensive and generalized edema tank, or is otherwise disposed of as pre- shall be identified as U.S. Condemned scribed in part 314 of this subchapter,
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at which time such tag may be re- the acute stages, as evidenced by acute moved by a Program employee only. and active lesions or an elevated tem- The number of such tag shall be re- perature, shall be identified as U.S. ported to the veterinary medical offi- Condemned and disposed of in accord- cer by the inspector who affixed it, and ance with § 309.13. also by the inspector who supervised the tanking of the carcass. § 309.16 Livestock suspected of having (b) Any livestock condemned on ac- biological residues. count of ketosis, swine erysipelas, ve- (a) Except as provided by paragraph sicular diseases, grass tetany, trans- (d) of this section, livestock suspected port tetany, parturient paresis, of having been treated with or exposed anasarca, anaplasmosis, leptospirosis, to any substance that may impart a bi- listeriosis, or inflammatory condition ological residue which would make the including pneumonia, enteritis, and edible tissues unfit for human food or peritonitis may be set apart and held otherwise adulterated shall be handled for treatment under supervision of a in compliance with the provisions of Program employee or official des- this paragraph. They shall be identified ignated by the area supervisor. The at official establishments as ‘‘U.S. Con- U.S. Condemned identification tag will demned.’’ These livestock may be held be removed by a Program employee fol- under the custody of a Program em- lowing treatment under such super- ployee, or other official designated by vision if the animal is found to be free the Administrator, until metabolic from any such disease. processes have reduced the residue suf- (c) Livestock previously affected ficiently to make the tissues fit for with listeriosis, including those re- human food and otherwise not adulter- leased for slaughter after treatment ated. When the required time has under paragraph (b) of this section, elapsed, the livestock, if returned for shall be identified as U.S. Suspect. slaughter, must be re-examined on (d) When livestock under the provi- ante-mortem inspection. To aid in de- sions of this section is to be released termining the amount of residue for a purpose other than slaughter, the present in the tissues, officials of the operator of the official establishment Program may permit the slaughter of or the owner of the livestock shall first any such livestock for the purpose of obtain permission for the movement of collecting tissues for analysis for the such livestock from the local, State, or residue. Such analysis may include the Federal livestock sanitary official hav- use of inplant screening procedures de- ing jurisdiction. signed to detect the presence of anti- microbial residues in any species of § 309.14 Brucellosis-reactor goats. livestock. Goats which have reacted to a test (b) All carcasses and edible organs for brucellosis shall not be slaughtered and other parts thereof, in which are in an official establishment. found any biological residues which render such articles adulterated, shall § 309.15 Vesicular diseases. be marked as ‘‘U.S. Condemned’’ and (a) Immediate notification shall be disposed of in accordance with § 314.1 or given by the inspector to the local, § 314.3 of this chapter. State, and Federal livestock sanitary (c) [Reserved] officials having jurisdiction when any (d) Calves shall not be presented for livestock is found to be affected with a ante-mortem inspection in an official vesicular disease. establishment except under the provi- (b) No livestock under quarantine by sions of this paragraph. State or Federal livestock sanitary of- (1) Definitions. For purposes of this ficials on account of a vesicular disease paragraph, the following definitions will be given ante-mortem inspection. shall apply: If no quarantine is invoked, or if quar- (i) Calf. A calf up to 3 weeks of age or antine is invoked and later removed, up to 150 pounds. upon ante-mortem inspection, any ani- (ii) Certified calf. A calf that the pro- mal found to be affected with vesicular ducer and all other subsequent exanthema or vesicular stomatitis in custodians of the calf certify in writing
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has not been treated with any animal ance with FDA approved label directions and drug while in his or her custody or has have been withheld from slaughter for the been treated with one or more drugs in period(s) of time specified by those label di- accordance with FDA approved label rections. I certify that, to the best of my knowledge and belief, all information con- directions while in his or her custody tained herein is true, that the information and has been withheld from slaughter may be relied upon at the official establish- for the period(s) of time specified by ment, and that I understand that any willful those label directions. falsification of this certification is a felony (iii) Healthy calf. A calf that an in- and may result in a fine of up to $250,000 for spector determines shows no visual an individual or up to $500,000 for an organi- signs of disease or treatment of disease zation, or imprisonment for not more than 5 at ante-mortem inspection. years, or both (21 U.S.C. 677, 18 U.S.C. 1001 and 3571). (iv) Producer. The owner of the calf at the time of its birth. Executed on ————————————————— (v) Sick calf. A calf that an inspector (date of certification) on ante-mortem inspection determines ———————————————————————— has either signs of treatment or signs (signature of certifier) of disease. ———————————————————————— (vi) Veterinary medical officer. An in- (typed or printed name and address of cer- spector of the Program that has ob- tifier) tained a Doctor of Veterinary Medicine ———————————————————————— degree which is recognized by the Pro- (business of certifier) gram. (ii) Each calf must be identified by (2) General requirements. (i) The iden- use of backtag, eartag, or other type of tity of the producer of each calf pre- secure identification which displays a sented for ante-mortem inspection number which shall be recorded on all shall be made available by the official written certifications. establishment to the inspection prior (iii) The inspector shall have seg- to the animal being presented for ante- regated for veterinary medical officer mortem inspection. examination any certified calf which (ii) The inspector shall segregate the he or she determines to show any sign calves presented for ante-mortem in- of disease or which is not identified in- spection at the establishment and iden- dividually. Such animal will be tagged tify each calf as one of the following: as ‘‘U.S. Suspect’’ and its carcass will (a) Certified, (B) noncertified, or (C) be retained on post-mortem inspection previous residue condemnation. and handled in accordance with § 310.21 (3) Certified group. (i) For a calf to be (c) and (d). considered certified, the producer and (iv) The inspector shall handle the re- all other subsequent custodians of the maining carcasses of healthy animals calf must certify in writing that while in accordance with § 310.21(c) and (d). the calf was in his or her custody, the (4) Noncertified group. On ante- calf was not treated with animal drugs mortem inspection, the inspector shall or was treated with one or more drugs have segregated for veterinary medical in accordance with FDA approved label officer examination any calf which he directions and was withheld from or she determines to show any sign of slaughter for the period(s) of time spec- disease. Such animal will be tagged as ified by those label directions. All prior ‘‘U.S. Suspect’’ and its carcass will be certifications must be presented with retained on post-mortem inspection the animal at the time of slaughter. and handled in accordance with The certifications shall contain a list § 310.21(c). The inspector shall handle of the calves with accompanying iden- the remaining carcasses of healthy ani- tification numbers, as required by mals in accordance with § 310.21(c). paragraph (d)(3)(ii) of this section, fol- (5) Calves from producers with previous lowed by the following language: residue condemnation. On ante-mortem inspection, the inspector shall have I hereby certify that, while in my custody, from llll to llll (time period of cus- segregated for veterinary medical offi- tody), the above-listed calf or calves have cer examination any calf which he or not been treated with drugs, or have been she determines to show any sign of dis- treated with one or more drugs in accord- ease. Such animal will be tagged as
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‘‘U.S. Suspect’’ and its carcass will be (3) In the case of an animal adminis- retained on post-mortem inspection tered any unlicensed, experimental and handled in accordance with veterinary biologic product regulated § 310.21(e). The inspector shall handle under the Virus-Serum Toxin Act (21 the remaining carcasses of healthy ani- U.S.C. 151 et seq.), the product was pre- mals in accordance with § 310.21(e). pared and distributed in compliance (e) The name of each and all person(s) with Part 103 of the regulations issued who sold or consigned each swine to under said Act (part 103 of this title), the establishment shall be made avail- and used in accordance with the label- able by the establishment to any Pro- ing approved under said regulations; gram employee or other authorized em- (4) In the case of an animal adminis- ployee of the United States Depart- tered any investigational drug regu- ment of Agriculture upon that employ- lated under the Federal Food, Drug, ee’s request and presentation of his or and Cosmetic Act, as amended (21 her official credentials. Swine identi- U.S.C. 301 et seq.), the drug was pre- fication, by means approved by the pared and distributed in compliance Animal and Plant Health Inspection with the applicable provisions of part Service, USDA, under part 71 of this 135 of the regulations issued under said title, must be maintained throughout Act (21 CFR part 135), and used in ac- post-mortem inspection, in accordance cordance with the labeling approved with § 310.23(a) of this subchapter. under said regulations; (Recordkeeping requirements approved by (5) In the case of an animal subjected the Office of Management and Budget under to any experimental economic poison control number 0583–0053) under section 2(a) of the Federal Insec- ticide, Fungicide, and Rodenticide Act, [36 FR 24928, Dec. 24, 1971, as amended at 44 FR 45606, Aug. 3, 1979; 44 FR 59499, Oct. 16, as amended (7 U.S.C. 135 et seq.), the 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. product was prepared and distributed 20, 1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, in accordance with § 362.17 of the regu- Dec. 30, 1985; 52 FR 2104, Jan. 20, 1987; 53 FR lations issued under said Act (7 CFR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990] 362.17), and used in accordance with the labeling approved under said regula- § 309.17 Livestock used for research. tions. (a) No livestock used in any research (6) In the case of an animal adminis- investigation involving an experi- tered or subjected to any substance mental biological product, drug, or that is a food additive or pesticide chemical shall be eligible for slaughter chemical under the Federal Food, at an official establishment unless: Drug, and Cosmetic Act, supra, there (1) The operator of such establish- has been compliance with all tolerance ment, the sponsor of the investigation, limitations established by said Act and or the investigator has submitted to the regulations promulgated there- the Program, or the Veterinary Serv- under (21 CFR 1.1 et seq.), and all other ices unit of the Animal and Plant restrictions and requirements imposed Health Inspection Service of the De- by said Act and said regulations will be partment of Agriculture or to the Envi- complied with at the time of slaughter. ronmental Protection Agency or to the (b) The inspector in charge may deny Food and Drug Administration of the or withdraw the approval for slaughter Department of Health, Education, and of any livestock subject to the provi- Welfare, data or a summary evaluation sion of this section when he deems it of the data which demonstrates that necessary to assure that all products the use of such biological product, prepared at the official establishment drug, or chemical will not result in the are free from adulteration. products of such livestock being adul- terated, and a Program employee has § 309.18 Official marks and devices for approved such slaughter; purposes of ante-mortem inspec- (2) Written approval by the Deputy tion. Administrator, Meat and Poultry In- (a) All livestock required by this part spection Field Operations is furnished to be identified as U.S. Suspects shall the area supervisor prior to the time of be tagged with a serially numbered slaughter; metal ear tag bearing the term ‘‘U.S.
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Suspect,’’ except as provided in 310.11 Cleaning of hog carcasses before in- § 309.2(d) and except that cattle affected cising. with epithelioma of the eye, 310.12 Sternum to be split; abdominal and antinomycosis, or actinobacillosis to thoracic viscera to be removed. such an extent that the lesions would 310.13 Inflating carcasses or parts thereof; transferring caul or other fat. be readily detected on post-mortem in- 310.14 Handling of bruised parts. spection, need not be individually 310.15 Disposition of thyroid glands and la- tagged on ante-mortem inspection with ryngeal muscle tissue. the U.S. Suspect tag, provided that 310.16 Disposition of lungs. such cattle are segregated and other- 310.17 Inspection of mammary glands. wise handled as U.S. Suspects. 310.18 Contamination of carcasses, organs, (b) In addition, identification of U.S. or other parts. Suspect swine must include the use of 310.19 Inspection of kidneys. tattoos specified by the inspector to 310.20 Saving of blood from livestock as an edible product. maintain the identity of the animals 310.21 Carcasses suspected of containing through the dehairing equipment when sulfa and antibiotic residues; sampling such equipment is used. frequency; disposition of affected car- (c) All livestock required by this part casses and parts. to be identified as U.S. Condemned 310.22 [Reserved] shall be tagged with a serially num- 310.23 Identification of carcasses and parts bered metal ear tag bearing the term of swine. ‘‘U.S. Condemned.’’ 310.24 [Reserved] (d) The devices described in para- 310.25 Contamination with microorganisms; pathogen reduction performance stand- graphs (a), (b), and (c) of this section ards for Salmonella. shall be the official devices for identi- fication of livestock required to be AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, identified as U.S. Suspect or U.S. Con- 2.53. demned as provided in this part. SOURCE: 35 FR 15567, Oct. 3, 1970, unless otherwise noted.
PART 310—POST–MORTEM § 310.1 Extent and time of post-mortem INSPECTION inspection; post-mortem inspection staffing standards. Sec. (a) A careful post-mortem examina- 310.1 Extent and time of post-mortem in- tion and inspection shall be made of spection; post-mortem inspection staff- ing standards. the carcasses and parts thereof of all 310.2 Identification of carcass with certain livestock slaughtered at official estab- severed parts thereof and with animal lishments. Such inspection and exam- from which derived. ination shall be made at the time of 310.3 Carcasses and parts in certain in- slaughter unless, because of unusual stances to be retained. circumstances, prior arrangements ac- 310.4 Identification of carcasses and parts; ceptable to the Administrator have tagging. been made in specific cases by the cir- 310.5 Condemned carcasses and parts to be cuit supervisor for making such inspec- so marked; tanking; separation. tion and examination at a later time. 310.6 Carcasses and parts passed for cook- ing; marking. (b)(1) The staffing standards on the 310.7 Removal of spermatic cords, pizzles basis of the number of carcasses to be and preputial diverticuli. inspected per hour are outlined in the 310.8 Passing and marking of carcasses and following tables. Standards for mul- parts. tiple inspector lines are based on in- 310.9 Anthrax; carcasses not to be evis- spectors rotating through the different cerated; disposition of affected carcasses; types of inspection stations during hides, hoofs, horns, hair, viscera and con- each shift to equalize the workload. tents, and fat; handling of blood and The inspector in charge shall have the scalding vat water; general cleanup and disinfection. authority to require the establishment 310.10 Carcasses with skin or hide on; clean- to reduce slaughter line speeds where, ing before evisceration; removal of lar- in his judgment, the inspection proce- vae of Hypodermae, external parasites dure cannot be adequately performed and other pathological skin conditions. at the current line speed because of
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particular deficiencies in carcass prep- STEERS AND HEIFERSÐContinued aration and presentation by the plant at the higher speed, or because the Number of inspectors by stations health condition of the particular ani- Maximum slaughter rates (head per hour) mals indicates a need for more exten- Car- Head Viscera cass sive inspection. (2) Cattle inspection. For all cattle 87 to 143 ...... 2 2 1 staffing standards, an ‘‘a’’ in the ‘‘Number of Inspectors by Stations’’ COWS AND BULLS column means that one inspector per- forms the entire inspection procedure Number of inspectors by stations and a ‘‘b’’ means that one inspector Maximum slaughter rates (head per hour) performs the head and lower carcass in- Head Viscera Car- spection and a second inspector per- cass forms the viscera and upper carcass in- 1 to 27 ...... a a a spection.1 28 to 55 ...... b b b (i) Inspection Using the Viscera 56 to 77 ...... 1 1 1 Truck. 78 to 81 ...... 1 2 1 82 to 134 ...... 2 2 1 STEERS AND HEIFERS (A) Rules for determining adjusted Number of inspectors maximum slaughter rates for single-in- by stations Maximum slaughter rates (head per spector kills considering walking dis- hour) Car- tance according to the table in this Head Viscera cass subdivision: Determine the distances 1 to 27 ...... a a a the inspector actually walks between 28 to 56 ...... b b b the points shown in columns 2 through 57 to 84 ...... 1 1 1 85 to 86 ...... 1 2 1 14 of the following table. For each col- umn, determine the deduction figure 1 The ‘‘Maximum Slaughter Rates’’ figures opposite the appropriate number of feet listed in paragraph (b)(2)(i) of this section for in column 1. Compute the total of the one (a) and two (b) inspector kills are over- deduction figures for columns 2 stated because the time required to walk through 14. The adjusted maximum from one inspection station to another is not rate is the maximum rate in paragraph included. To determine the proper adjusted (b)(2)(i) of this section minus total of maximum slaughter line speed, paragraph the deduction figures. If the resultant (b)(2)(i)(A) of this section for one inspector kills or paragraph (b)(2)(i)(B) of this section number is not a whole number, it must for two inspector kills must be used along be rounded off to the next lowest whole with their accompanying rules. number.
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(B) Rules for determining adjusted termine the deduction figure opposite maximum slaughter rates for two-in- the appropriate number of feet in col- spector kills considering walking dis- umn 1. Compute the total of the deduc- tance according to the table in this tion figures for columns 2 through 9. subdivision: Determine the distances Divide this total by 2. The adjusted the inspectors actually walk between maximum rate is the maximum rate in the points shown in columns 2 through paragraph (b)(2)(i) of this section 9 of the following table. Column 9 is minus the number calculated above. If used only if the condemned brands and the resultant number is not a whole tags the viscera inspector uses are kept number, it must be rounded off to the at a location other than at the wash- next whole number. basin-sterilizer. For each column, de- lowest
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(ii) Inspection Using Viscera Table, COWS AND BULLS Tongue-In Presentation of Heads. Number of inspectors by stations STEERS AND HEIFERS Maximum slaughter rates (head per hour) Car- Head Viscera cass Number of inspectors by stations Maximum slaughter rates (head per 1 to 29 ...... a a a hour) Car- 30 to 56 ...... b b b Head Viscera cass 57 to 79 ...... 1 1 1 80 to 98 ...... 1 2 1 1 to 32 ...... a a a 99 to 147 ...... 2 2 1 33 to 58 ...... b b b 148 to 174 ...... 2 3 1 175 to 205 ...... 3 3 1 59 to 84 ...... 1 1 1 206 to 233 ...... 3 4 1 85 to 86 ...... 1 2 1 234 to 256 ...... 3 4 2 87 to 143 ...... 2 2 1 257 to 288 ...... 4 4 2 144 to 171 ...... 3 2 1 289 to 316 ...... 5 4 2 172 to 198 ...... 3 3 1 317 to 343 ...... 5 5 2 199 to 226 ...... 3 3 2 227 to 253 ...... 4 3 2 (3) Swine Inspection. The following in- 254 to 280 ...... 4 4 2 spection staffing standards are applica- 281 to 306 ...... 5 4 2 ble to swine slaughter configurations. 307 to 333 ...... 5 5 2 The inspection standards for all slaughter lines are based upon the ob- COWS AND BULLS servation rather than palpation, at the viscera inspection station, of the Number of inspectors spleen, liver, heart, lungs, and medi- Maximum slaughter rates (head per by stations astinal lymph nodes. In addition, for hour) Car- Head Viscera cass one- and two-inspector lines, the stand- ards are based upon the distance 1 to 29 ...... a a a walked (in feet) by the inspector be- 30 to 56 ...... b b b tween work stations; and for three or 57 to 77 ...... 1 1 1 78 to 81 ...... 1 2 1 more inspector slaughter lines, upon 82 to 134 ...... 2 2 1 the use of a mirror, as described in 135 to 159 ...... 2 3 1 § 307.2(m)(6), at the carcass inspection 160 to 187 ...... 3 3 1 station. Although not required in a 188 to 213 ...... 3 4 1 one- or two-inspector slaughter con- 214 to 234 ...... 3 4 2 figuration, except in certain cases as 235 to 264 ...... 4 4 2 265 to 289 ...... 5 4 2 determined by the inspection service, if 290 to 314 ...... 5 5 2 a mirror is used, it must comply with the requirements of § 307.2(m)(6). (iii) Inspection Using Viscera Table, Tongue-Out Presentation of Heads. TABLE 1.ÐONE INSPECTORÐSTAFFING STANDARDS FOR SWINE
STEERS AND HEIFERS Maximum inspection rates (head per hour) Number of inspectors by stations Market hogs Sows and boars Maximum slaughter rates (head per Distance walked 1 in (heads attached (heads de- hour) Car- feet isÐ or detached) tached) Head Viscera cass With- With With- With 1 to 32 ...... a a a out out mirror mirror mirror mirror 33 to 58 ...... b b b 59 to 86 ...... 1 1 1 0 to 5 ...... 140 150 131 143 87 to 103 ...... 1 2 1 6 to 10 ...... 134 144 126 137 104 to 156 ...... 2 2 1 11 to 15 ...... 129 137 122 132 157 to 186 ...... 2 3 1 16 to 20 ...... 124 132 117 127 187 to 216 ...... 3 3 1 21 to 35 ...... 120 127 113 122 26 to 30 ...... 116 122 110 118 217 to 246 ...... 3 3 2 31 to 35 ...... 112 118 106 114 247 to 275 ...... 3 4 2 36 to 40 ...... 108 114 103 110 276 to 304 ...... 4 4 2 41 to 45 ...... 105 110 100 106 305 to 333 ...... 4 5 2 46 to 50 ...... 101 107 97 103 334 to 362 ...... 5 5 2 51 to 55 ...... 98 103 94 100 363 to 390 ...... 5 6 2 56 to 60 ...... 96 100 91 97 61 to 65 ...... 93 97 89 94
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TABLE 1.ÐONE INSPECTORÐSTAFFING TABLE 3.ÐTWO INSPECTORSÐSTAFFING STANDARDS FOR SWINEÐContinued STANDARDS FOR SOWS AND BOARS
Maximum inspection rates (head Maximum inspection rates (head per per hour) hour) Market hogs Sows and boars Line Configuration Distance walked 1 in (heads attached (heads de- Distance 1 2 2 feet isÐ or detached) tached) walked in feet Car- Viscera, Head, 2 2 Head, by inspector B cass, head viscera viscera With- With- isÐ head car- car- car- With With viscera,3 cass,3 cass,3 out mirror out mirror cass,3 mirror mirror heads heads heads heads de- de- de- attached 66 to 70 ...... 90 95 87 92 tached tached tached 71 to 75 ...... 88 92 85 89 Without Mirror 76 to 80 ...... 86 89 82 87 81 to 85 ...... 84 87 80 85 86 to 90 ...... 82 85 79 83 0 to 5 ...... 144±248 144±254 144±267 144±267 91 to 95 ...... 80 83 77 81 6 to 10 ...... 144±235 144±240 144±253 144±253 96 to 100 ...... 78 81 75 79 11 to 15 ...... 144±222 144±227 144±239 144±239 16 to 20 ...... 144±211 144±215 144±226 144±226 1 Distance walked is the total distance that the inspector will 21 to 25 ...... 144±201 144±205 144±214 144±214 have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, head, and wash-basin). With Mirror
TABLE 2.ÐTWO INSPECTORSÐSTAFFING 0 to 5 ...... 144±248 144±292 144±305 144±292 STANDARDS FOR MARKET HOGS 6 to 10 ...... 144±235 144±273 144±291 144±280 11 to 15 ...... 144±222 144±256 144±272 144±268 Maximum inspection rates (head 16 to 20 ...... 144±211 144±241 144±255 144±255 per hour with heads attached or 21 to 25 ...... 144±201 144±228 144±240 144±240 detached) 1 Distance walked is the total distance that Inspector B will 1 Distance walked in feet Line configuration have to walk between work stations during one inspection by inspector B isÐ cycle (e.g., between viscera, carcass, and washbasin). Carcass,2 Viscera,2 Head,2 2 Inspector A. head head car- viscera 3 Inspector B. viscera 3 cass 3 carcass 3 NOTE: In multiple-inspector plants, the in- Without Mirror spectors must rotate between all inspection positions during each shift to equalize the 0 to 5 ...... 151±253 151±271 151±296 workload. 6 to 10 ...... 151±239 151±255 151±277 11 to 15 ...... 151±226 151±240 151±260 TABLE 4.ÐTHREE INSPECTORS OR MOREÐ 16 to 20 ...... 151±214 151±227 151±244 STAFFING STANDARDS FOR SWINE 21 to 25 ...... 151±204 151±215 151±231
Maximum inspection Number of inspectors by station With Mirror rates (head per hour Car- with heads attached) Head Viscera cass Total 0 to 5 ...... 151±253 151±303 151±318 6 to 10 ...... 151±239 151±283 151±304 Market hogs: 11 to 15 ...... 151±226 151±265 151±289 319 to 506 ...... 1 1 1 3 16 to 20 ...... 151±214 151±249 151±270 507 to 540 ...... 1 2 1 4 21 to 25 ...... 151±204 151±235 151±254 541 to 859 ...... 2 2 1 5 860 to 1,022 ...... 2 3 1 6 1 Distance walked is the total distance that Inspector B will 1,023 to 1,106 ...... 3 3 1 7 have to walk between work stations during one inspection Sows and boars: cycle (e.g., between viscera, carcass, and washbasin). 306 to 439 ...... 1 1 1 3 2 Inspector A. 306 to 462 1 ...... 1 1 1 3 3 Inspector B. 440 to 475 ...... 2 1 1 4 476 to 752 ...... 2 2 1 5 NOTE: In multiple-inspector plants, the in- 753 to 895 ...... 3 2 1 6 spectors must rotate between all inspection 896 to 964 ...... 3 3 1 7 positions during each shift to equalize the 1 This rate applies if the heads of sows and boars are de- workload. tached from the carcasses at the time of inspection.
NOTE: In multiple-inspector plants, the in- spectors must rotate between all inspection positions during each shift to equalize the workload. [35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19903, May 13, 1985]
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§ 310.2 Identification of carcass with this section if such alternate method certain severed parts thereof and would provide a ready means of identi- with animal from which derived. fying a specific carcass with the cor- (a) The head, tail, tongue, thymus responding devices by a Program in- gland, and all viscera of each slaugh- spector during the post-mortem inspec- tered animal, and all blood and other tion. parts of such animal to be used in the (5) Disposition and use of identifying preparation of meat food products or devices. medical products, shall be handled in (i) The official State-Federal Depart- such a manner as to identify them with ment backtags will be collected by a the rest of the carcass and as being de- Program inspector and used to obtain rived from the particular animal in- traceback information necessary for volved, until the post-mortem exam- proper disposition of the animal or car- ination of the carcass and parts thereof cass and otherwise handled according has been completed. Such handling to instructions issued to the inspec- shall include the retention of ear tags, tors. backtags, implants, and other identify- (ii) The devices described in para- ing devices affixed to the animal, in graph (b)(2) of this section shall be col- such a way to relate them to the car- lected by the Program inspector when cass until the post-mortem examina- required to obtain traceback informa- tion has been completed. tion necessary for proper disposition of (b) The official State-Federal Depart- the animal or carcass and for control- ment backtag on any carcass shall: ling the slaughter of reactor animals. (1)(i) Be removed from the hide of the Devices not collected for these pur- animal by an establishment employee poses shall be discarded after the post- and placed in a clear plastic bag. The mortem examination is complete. bag containing the tag shall be affixed (6) Plastic bags used by the establish- to the corresponding carcass. ment for collecting identifying devices (ii) The bag containing the tag shall will be furnished by the Department. be removed from the carcass by an es- tablishment employee and presented [35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, with the viscera to the Program in- 1971] spector at the point where such inspec- § 310.3 Carcasses and parts in certain tor conducts the viscera inspection. instances to be retained. (2)(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales Each carcass, including all detached tags, ear bangles, and similar identi- organs and other parts, in which any fication devices shall be removed from lesion or other condition is found that the animal’s hide or ear by an estab- might render the meat or any part lishment employee and shall be placed unfit for food purposes, or otherwise in a clear plastic bag and affixed to the adulterated, and which for that reason corresponding carcass. would require a subsequent inspection, (ii) The bag containing the tag shall shall be retained by the Program em- be removed from the carcass by an es- ployee at the time of inspection. The tablishment employee and presented identity of every such retained carcass, with the viscera to the Program in- detached organ, or other part shall be spector at the point where such inspec- maintained until the final inspection tor conducts the viscera inspection. has been completed. Retained carcasses (3) In cases where both types of de- shall not be washed or trimmed unless vices described in paragraphs (b)(1) and authorized by the Program employee. (2) of this section are present on the same animal, both types may be placed § 310.4 Identification of carcasses and in the same plastic bag or in two sepa- parts; tagging. rate bags. Such devices and methods as may be (4) The circuit supervisor may allow approved by the Administrator may be the use of any alternate method pro- used for the temporary identification posed by the operator of an official es- of retained carcasses, organs, and other tablishment for handling the type of parts. In all cases, the identification devices described in paragraph (b)(2) of shall be further established by affixing
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‘‘U.S. Retained’’ tags as soon as prac- ‘‘U.S. Retained’’ tags are attached to ticable and before final inspection. the carcasses, the affected tissues shall These tags shall not be removed except be removed and condemned before the by a Program employee. tags are removed. ‘‘U.S. Retained’’ tags shall be removed only by a Program § 310.5 Condemned carcasses and parts to be so marked; tanking; sep- employee. aration. § 310.9 Anthrax; carcasses not to be Each carcass or part which is found eviscerated; disposition of affected on final inspection to be unsound, carcasses; hides, hoofs, horns, hair, unhealthful, unwholesome, or other- viscera and contents, and fat; han- wise adulterated shall be conspicuously dling of blood and scalding vat marked, on the surface tissues thereof, water; general cleanup and dis- by a Program employee at the time of infection. inspection, as ‘‘U.S. Inspected and Con- (a) Carcasses found before eviscera- demned.’’ Condemned detached organs tion to be affected with anthrax shall and other parts of such character that not be eviscerated but shall be re- they cannot be so marked shall be placed immediately in trucks or recep- tained, condemned, and immediately tacles which shall be kept plainly tanked or otherwise disposed of as pro- marked ‘‘U.S. Condemned,’’ in letters vided in part 314 of this subchapter. not less than 2 inches high. All con- (b) All carcasses and all parts, includ- demned carcasses and parts shall re- ing hides, hoofs, horns, hair, viscera main in the custody of a Program em- and contents, blood, and fat of any ployee and shall be disposed of as re- livestock found to be affected with an- quired in the regulations in part 314 of thrax shall be condemned and imme- this subchapter at or before the close diately disposed of as provided in part of the day on which they are con- 314 of this subchapter, except that the demned. blood may be handled through the usual blood cooking and drying equip- § 310.6 Carcasses and parts passed for cooking; marking. ment. (c) Any part of any carcass that is Carcasses and parts passed for cook- contaminated with anthrax-infected ing shall be marked conspicuously on material through contact with soiled the surface tissues thereof by a Pro- gram employee at the time of inspec- instruments or otherwise shall be im- tion, ‘‘U.S. Passed for Cooking.’’ All mediately condemned and disposed of such carcasses and parts shall be as provided in part 314 of this sub- cooked in accordance with part 315 of chapter. this subchapter, and until so cooked (d) The scalding vat water through shall remain in the custody of a Pro- which hog carcasses affected with an- gram employee. thrax have passed shall be immediately drained into the sewer and all parts of § 310.7 Removal of spermatic cords, the scalding vat shall be cleaned and pizzles and preputial diverticuli. disinfected as provided in paragraph (e) Spermatic cords and pizzles shall be of this section. removed from all carcasses. Preputial (e)(1) That portion of the slaughter- diverticuli shall be removed from hog ing department, including the bleeding carcasses. area, scalding vat, gambrelling bench, § 310.8 Passing and marking of car- floors, walls, posts, platforms, saws, casses and parts. cleavers, knives, and hooks, as well as Carcasses and parts found to be employees’ boots and aprons, contami- sound, healthful, wholesome, and oth- nated through contact with anthrax-in- erwise not adulterated shall be passed fected material, shall, except as pro- and marked as provided in part 316 of vided in paragraph (e)(2) of this section this subchapter. In all cases where car- be cleaned immediately and disinfected casses showing localized lesions are with one of the following disinfectants passed for food or for cooking and
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or other disinfectant 1approved specifi- (3) The first and indispensable pre- cally for this purpose by the Adminis- cautionary step for persons who have trator: handled anthrax material is thorough (i) A 5 percent solution of sodium hy- cleansing of the hands and arms with droxide or commercial lye containing liquid soap and running hot water. It is at least 94 percent of sodium hydrox- important that this step be taken im- ide. The solution shall be freshly pre- mediately after exposure, before vege- pared immediately before use by dis- tative anthrax organisms have had solving 21⁄2 pounds of sodium hydroxide time to form spores. In the cleansing, a or lye in 51⁄2 gallons of hot water and brush or other appropriate appliance shall be applied as near scalding hot as shall be used to insure the removal of possible to be most effective. (Owing to all contaminating material from under the extremely caustic nature of sodium and about the fingernails. This process hydroxide solution, precautionary of cleansing is most effective when per- measures such as the wearing of rubber formed in repeated cycles of lathering gloves and boots to protect the hands and rinsing rather than in spending the and feet, and goggles to protect the same amount of time in scrubbing with eyes, should be taken by those engaged a single lathering. After the hands in the disinfection process. It is also have been cleansed thoroughly and advisable to have an acid solution, rinsed free of soap, they may, if de- such as vinegar, in readiness in case sired, be immersed for about 1 minute any of the sodium hydroxide solution in a 1:1,000 solution of bichloride of should come in contact with any part mercury, followed by thorough rinsing of the body.) in clean running water. Supplies of bi- (ii) A solution of sodium hypochlorite chloride of mercury for the purpose containing approximately one-half of 1 must be held in the custody of the vet- percent (5,000 parts per million) of erinary medical officer. (As a pre- available chlorine. The solution shall cautionary measure, all persons ex- be freshly prepared. posed to anthrax infection should re- (iii) When a disinfectant solution has port promptly any suspicious condition been applied to equipment which will (sore or carbuncle) or symptom to a afterwards contact product, the equip- physician, in order that anti-anthrax ment shall be rinsed with clean water serum or other treatment may be ad- before such contact. ministered as indicated.) (2) In case anthrax infection is found in the hog slaughtering department, an [35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, immediate preliminary disinfection 1971] shall be made from the head-dropper’s station to the point where the disease § 310.10 Carcasses with skin or hide on; cleaning before evisceration; re- is detected and the affected carcasses moval of larvae of Hypodermae, ex- shall be cut down from the rail and re- ternal parasites and other patholog- moved from the room. Upon comple- ical skin conditions. tion of the slaughtering of the lot of When a carcass is to be dressed with hogs of which the anthrax-infected ani- the skin or hide left on, the skin or mals were a part, slaughtering oper- hide shall be thoroughly washed and ations shall cease, and a thorough cleanup and disinfection shall be made, cleaned before any incision is made for as provided in paragraph (e)(1) of this the purpose of removing any part section. If the slaughter of the lot has thereof or evisceration, except that not been completed by the close of the where calves are slaughtered by the ko- day on which anthrax was detected, the sher method, the heads shall be re- cleanup and disinfection shall not be moved from the carcasses, before wash- deferred beyond the close of that day. ing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass in- 1 A list of disinfectants approved for this fested with the larvae of the purpose is available upon request to the Sci- entific Services, Meat and Poultry Inspec- ‘‘oxwarble’’ fly (Hypoderma lineata and tion, Food Safety and Inspection Service, Hypoderma bovis), or external para- U.S. Department of Agriculture, Washing- sites, or affected with other patholog- ton, DC 20250. ical skin conditions.
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§ 310.11 Cleaning of hog carcasses be- facts, a hearing, under applicable rules fore incising. of practice, will be held to resolve the All hair, scurf, dirt, hoofs and claws conflict. shall be removed from hog carcasses, (iii) Final approval of an acceptable and the carcasses shall be thoroughly new proposed method shall be effec- washed and cleaned before any incision tuated by modifying, through rule- is made for inspection or evisceration. making procedures, the Federal regula- tions to include the new method. § 310.12 Sternum to be split; abdomi- (iv) Uses for which approval is grant- nal and thoracic viscera to be re- ed are: moved. (A) Compressed air injection of cattle The sternum of each carcass shall be feet to facilitate removal of hair from split and the abdominal and thoracic feet intended for human consumption; viscera shall be removed at the time of (B) Compressed air injection under slaughter in order to allow proper in- the skin of cattle heads to facilitate spection. head skinning; (C) Compressed air injection into the § 310.13 Inflating carcasses or parts skull in conjunction with a captive thereof; transferring caul or other bolt stunner to hold the animal still fat. for dressing operations; or (a)(1) Establishments shall not in- (D) Compressed air injected into the flate carcasses or parts of carcasses abdominal cavity of swine to facilitate with air, except as set forth in para- the skinning operation and to mini- graph (a)(2) of this section. mize the loss of body fat. (2)(i) Any establishment slaughtering The method of compressed air injection livestock that wishes to inflate car- shall be a sanitary procedure that in- casses or parts thereof with air, using cludes air filtration and injection nee- procedures other than the approved dle disinfection. Air filtration shall methods listed below, shall submit a consist of not less than two stages. An request for approval for experimental initial stage of filtration shall occur at testing to the Administrator. Such a or near the use point and shall consist request shall include the purpose of the of an aerosol or coalescing filter, capa- use of air, a detailed description of the ble of filtration to not more than 0.75 procedure for injecting the air and evi- micron, for the removal of oil and dence that the procedure can be per- water. A subsequent stage of filtration formed in a sanitary manner. shall occur at or near the point of nee- (ii) The Administrator shall evaluate dle hose attachment to the air line and newly submitted procedures for the use shall be a particulate filter, capable of of air. If the Administrator determines filtration to not more than 0.3 micron. that any such procedure will likely re- The filters shall be maintained by in- sult in wholesome, unadulterated meat specting regularly to assure they are product, then the Administrator shall working properly, and cleaned or re- approve experimental testing of the placed when necessary. The injection new procedure. In any situation where needle shall be disinfected by place- the Administrator finds a submitted ment in water that is not less than 180 procedure to be unlikely to result in °F. for at least 10 seconds immediately wholesome, unadulterated meat prod- prior to each injection. uct, the Administrator shall send writ- (b) Transferring the caul or other fat ten notification to the establishment from a fat to a lean carcass is prohib- of the denial of such approval. The es- ited. tablishment may re-submit for evalua- (Approved by the Office of Management and tion a testing procedure that has been Budget under control number 0583–0015) denied, provided that modifications have been made to address the original [54 FR 36756, Sept. 5, 1989, as amended at 55 reason for denial. The establishment FR 29565, July 20, 1990] also shall be afforded an opportunity to submit a written statement in response § 310.14 Handling of bruised parts. to the notification of denial. In those When only a portion of a carcass is to instances where there is a conflict of be condemned on account of slight
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bruises, either the bruised portion shall Only.’’ Otherwise, they shall be dis- be removed immediately and disposed posed of at the official establishment, of in accordance with part 314 of this in accordance with §§ 314.1 and 314.3 of subchapter, or the carcass shall be this subchapter. promptly placed in a retaining room [36 FR 11639, June 17, 1971] and kept until chilled and the bruised portion shall then be removed and dis- § 310.17 Inspection of mammary posed of as provided in part 314 of this glands. subchapter. (a) Lactating mammary glands and § 310.15 Disposition of thyroid glands diseased mammary glands of cattle, and laryngeal muscle tissue. sheep, swine, and goats shall be re- moved without opening the milk ducts (a) Livestock thyroid glands and la- or sinuses. If pus or other objectionable ryngeal muscle tissue shall not be used material is permitted to come in con- for human food. tact with the carcass, the parts of the (b) Livestock thyroid glands and la- carcass thus contaminated shall be re- ryngeal muscle tissue may be distrib- moved and condemned. uted to pharmaceutical manufacturers (b) Nonlactating cow udders may be for pharmaceutical use in accordance saved for food purposes provided suit- with § 314.9 or § 325.19(c) of this sub- able facilities for handling and inspect- chapter, if they are labeled in accord- ing them are provided. Examination of ance with § 316.13(f) of this subchapter. udders by palpation shall be done by a Otherwise, they shall be disposed of at Program employee. When necessary, in the official establishment in accord- the judgment of the Program employee ance with § 314.1 or § 314.3 of this sub- for adequate inspection, the official es- chapter. tablishment employees shall incise [53 FR 45890, Nov. 15, 1988] udders in sections no greater than 2 inches in thickness. All udders showing § 310.16 Disposition of lungs. disease lesions shall be condemned by a (a) Livestock lungs shall not be saved Program employee. Each udder shall be for use as human food. properly identified with its respective (b) Lungs found to be affected with carcass and kept separate and apart disease or pathology and lungs found to from other udders until its disposal has be adulterated with chemical or bio- been accomplished in accordance with logical residue shall be condemned and the provisions of part 311 of this sub- identified as ‘‘U.S. Inspected and Con- chapter. demned.’’ Condemned lungs may not be (c) Lactating mammary glands of saved for pet food or other nonhuman cattle, sheep, swine, and goats shall food purposes. They shall be main- not be saved for edible purposes. tained under inspectional control and (d) The udders from cows officially disposed of in accordance with §§ 314.1 designated as ‘‘Brucellosis reactors’’ or and 314.3 of this subchapter. as ‘‘Mastitis elimination cows’’ shall be (c) Lungs not condemned under para- condemned. graph (b) of this section may be used in the preparation of pet food or for other § 310.18 Contamination of carcasses, nonhuman food purposes at the official organs, or other parts. establishment, provided they are han- (a) Carcasses, organs, and other parts dled in the manner prescribed in § 318.12 shall be handled in a sanitary manner of this subchapter, or they may be dis- to prevent contamination with fecal tributed from the establishment in material, urine, bile, hair, dirt, or for- commerce, or otherwise, in accordance eign matter; however, if contamination with the conditions prescribed in § 325.8 occurs, it shall be promptly removed in of this subchapter for nonhuman food a manner satisfactory to the inspector. purposes or they may be so distributed (b) Brains, cheek meat, and head to pharmaceutical manufacturers for trimmings from animals stunned by pharmaceutical use in accordance with lead, sponge iron, or frangible bullets §§ 314.9 and 325.19(b) of this subchapter, shall not be saved for use as human if they are labeled as ‘‘Inedible [SPE- food but shall be handled as described CIES] Lungs—for Pharmaceutical Use in § 314.1 or § 314.3 of this subchapter.
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§ 310.19 Inspection of kidneys. disease treatment or lesions of disease An employee of the establishment or was from an animal identified as shall open the kidney capsule and ex- sick on ante-mortem. pose the kidneys of all livestock at the (6) Sign of treatment. Sign of treat- time of slaughter for the purpose of ex- ment of a disease is indicated by leak- amination by a Program employee. age around jugular veins, subcutane- ous, intramuscular or intraperitoneal § 310.20 Saving of blood from livestock injection lesions, or discoloration from as an edible product. particles or oral treatment in any part Blood may be saved for edible pur- of the digestive tract. poses at official establishments pro- (7) Veterinary medical officer. An in- vided it is derived from livestock, the spector of the Program that has ob- carcasses of which are inspected and tained a Doctor of Veterinary Medicine passed, and the blood is collected, degree which is recognized by the Pro- defibrinated, and handled in a manner gram. so as not to render it adulterated under (c) Selection of carcasses for testing. the Federal Meat Inspection Act and The inspector shall perform a swab bio- regulations issued pursuant thereto. assay test 1 on: The defibrination of blood intended for (1) Any carcass from a calf tagged as human food purposes shall not be done ‘‘U.S. Suspect’’ at the time of ante- with the hands. Anticoagulants speci- mortem inspection, except that calves fied in § 318.7(c)(4) of this subchapter whose carcasses are condemned for pa- may be used in lieu of defibrination. thology shall not be tested for drug residues. [39 FR 1973, Jan. 16, 1974] (2) Any carcass which he/she finds § 310.21 Carcasses suspected of con- has either lesions of disease which is taining sulfa and antibiotic resi- not condemned because of these lesions dues; sampling frequency; disposi- or a sign of treatment of disease at the tion of affected carcasses and parts. time of post-mortem inspection, (a) Calf carcasses from animals sus- (3) Any carcass of a calf from a pro- pected of containing biological residues ducer whose calf or calves have pre- under § 309.16(d) of this subchapter viously been condemned for residues as shall, on post-mortem inspection, be prescribed in paragraph (e) of this sec- handled in accordance with the provi- tion, and sions of this section. (4) Carcasses from healthy-appearing (b) For purposes of this section, the certified and noncertified calves, as de- following definitions shall apply: termined by the veterinary medical of- (1) Calf. A calf up to 3 weeks of age or ficer during ante-mortem inspection, up to 150 pounds. will be selected for testing as set forth (2) Certified calf. A calf that the pro- below: ducer and all other subsequent Sampling Rate (percent custodians of the calf certify in writing of estimated day's has not been treated with any animal Testing level slaughter) drug while in his or her custody or has Noncer- been treated with one or more drugs in Certified tified accordance with FDA approved label A ...... 100 100 directions while in his or her custody B ...... 50 50 and has been withheld from slaughter C ...... 20 30 for the period(s) of time specified by (Start) D ...... 5 10 those label directions. E ...... 2 5 (3) Healthy carcass. A carcass that an inspector determines shows no lesions 1 The procedures for performing the swab of disease or signs of disease treatment bioassay test are set forth in one of two self– at post-mortem inspection instructional guides: ‘‘Performing the (4) Producer. The owner of the calf at CAST’’ or ‘‘Fast Antimicrobial Screen Test.’’ These guides are available for review in the the time of its birth. office of the FSIS Docket Clerk, Room 4352 (5) Sick calf carcass. A calf carcass South, Food Safety and Inspection Service, that an inspector on post-mortem in- U.S. Department of Agriculture, Washing- spection determines has either signs of ton, DC 20250.
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Sampling Rate (percent (8) The veterinary medical officer of estimated day's slaughter) may reduce inspection line rates when, Testing level in his/her judgment, the prescribed Noncer- Certified tified testing cannot be adequately per- formed within the time available be- F ...... 1 2 cause the establishment’s compliance history dictates a need for extensive (d) Testing of carcasses: testing. (1) The inspector shall test all car- (e) Calves from producers with a pre- casses as prescribed in paragraph (c) of vious residue condemnation. The inspec- this section. tor shall perform a swab bioassay test (2) Upon initiation of this program at on all carcasses of all calves in the an establishment, the inspector shall group. The veterinary medical officer begin the testing rate for carcasses shall determine the test results and from healthy-appearing certified and noncertified calves at Level D as pre- shall condemn any carcass and parts scribed in paragraph (c)(4) of this sec- thereof for which there is a positive tion. The inspector shall increase the test result and pass for human con- testing rate to the next higher level sumption any such carcass and parts the following business day when three thereof for which there is a negative carcasses in 100 or less consecutively test result. All subsequent calves from tested show a positive test result for a the same producer which has pre- drug residue. The inspector shall de- viously sold or delivered to official es- crease it to the next lower level when tablishments any carcass that was con- no more than two calves show a posi- demned because of drug residues must tive test result for a drug residue in ei- be tested according to this paragraph ther 500 calves consecutively tested or until five consecutive animals test all calves tested over a 60 working day completely free of animal drug resi- period. dues. (3) Test results shall be determined (f) If the owner or operator of an offi- by the veterinary medical officer. cial establishment disagrees with the (4) The establishment may designate veterinary medical officer’s disposition one or more of its employees to aid the of carcasses and parts thereof, the inspector in performing the swab bio- owner or operator may appeal as pro- assay test under the supervision of the vided in section 306.5 of this chapter. veterinary medical officer who shall in- terpret the results, maintain animal [50 FR 32164, Aug. 9, 1985, as amended at 52 FR 2104, Jan. 20, 1987; 55 FR 7475, Mar. 2, 1990; identification with the test unit, and 60 FR 66483, Dec. 22, 1995] ensure integrity of the testing pro- gram. § 310.22 [Reserved] (5) All carcasses and parts thereof from calves selected for testing shall § 310.23 Identification of carcasses and be retained until all test results are parts of swine. complete. (a) The identification of the car- (6) The veterinary medical officer casses and parts of swine identified in shall condemn all carcasses and parts accordance with part 71 of this title thereof for which there are positive shall be made available to the inspec- test results and release for human con- tor upon the inspector’s request sumption all carcasses and parts there- throughout post-mortem inspection. of for which there are negative test re- (b) If the establishment fails to pro- sults. vide required swine identification, the (7) If there is a positive test result, inspector shall order the retention of subsequent calves from the producer of swine caracasses at the establishment the calf shall be tested in accordance until the completion of tests to con- with paragraph (e) of this section. firm that the carcasses are not adulter- These test results will not be included ated. in computations to determine an estab- lishment’s compliance record. [53 FR 40387, Oct. 14, 1988]
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§ 310.24 [Reserved] (iii) Sampling frequency. Slaughter es- tablishments, except very low volume § 310.25 Contamination with micro- establishments as defined in paragraph organisms; pathogen reduction per- (a)(2)(v) of this section, shall take sam- formance standards for Salmonella. ples at a frequency proportional to the (a) Criteria for verifying process con- volume of production at the following trol; E. coli testing. rates: (1) Each official establishment that Cattle: 1 test per 300 carcasses, but at slaughters cattle and/or swine shall a minimum one sample each week of test for Escherichia coli Biotype 1 (E. operation. coli). Establishments that slaughter Swine: 1 test per 1000 carcasses, but at more than one type of livestock or a minimum one sample each week of both livestock and poultry, shall test operation. the type of livestock or poultry slaugh- (iii) Sampling frequency. Samples tered in the greatest number. The es- shall be taken at a frequency propor- tablishment shall: tional to a slaughter establishment’s (i) Collect samples in accordance volume of production, at the following with the sampling techniques, meth- rates: odology, and frequency requirements in Bovines: 1 test per 300 carcasses paragraph (a)(2) of this section; Swine: 1 test per 1,000 carcasses (ii) Obtain analytic results in accord- (iv) Sampling frequency alternatives. ance with paragraph (a)(3) of this sec- An establishment operating under a tion; and validated HACCP plan in accordance (iii) Maintain records of such ana- with § 417.2(b) of this chapter may sub- lytic results in accordance with para- stitute an alternative frequency for the graph (a)(4) of this section. frequency of sampling required under (2) Sampling requirements. paragraph (a)(2)(iii) of this section if, (i) Written procedures. Each establish- (A) The alternative is an integral ment shall prepare written specimen part of the establishment’s verification collection procedures which shall iden- procedures for its HACCP plan and, tify employees designated to collect (B) FSIS does not determine, and no- samples, and shall address location(s) tify the establishment in writing, that of sampling, how sampling randomness the alternative frequency is inadequate is achieved, and handling of the sample to verify the effectiveness of the estab- to ensure sample integrity. The writ- lishment’s processing controls. ten procedure shall be made available (v) Sampling in very low volume estab- to FSIS upon request. lishments. (ii) Sample collection. The establish- (A) Very low volume establishments ment shall collect samples from all annually slaughter no more than 6,000 chilled swine or cattle carcasses, except cattle, 20,000 swine, or a combination of those boned before chilling (hot-boned), cattle and swine not exceeding 6,000 which must be sampled after the final cattle and 20,000 total of both types. wash. Samples shall be collected by ei- Very low volume establishments that ther sponging or excising tissue from collect samples by sponging shall col- three sites on the selected carcass. On lect at least one sample per week, cattle carcasses, establishments shall starting the first full week of operation sponge or excise tissue from the flank, after June 1 of each year, and continue brisket and rump, except for hide-on sampling at a minimum of once each calves, in which case establishments week the establishment operates until shall take samples by sponging from June 1 of the following year or until 13 inside the flank, inside the brisket, and samples have been collected, whichever inside the rump; on swine carcasses, es- comes first. Very low volume establish- tablishments shall sponge or excise tis- ments collecting samples by excising sue from the ham, belly and jowl tissue from carcasses shall collect one areas. 1 sample per week, starting the first full week of operation after June 1 of each 1 A copy of FSIS’s ‘‘Guidelines for E. coli Testing for Process Control verification in is available for inspection in the FSIS Dock- Cattle and Swine Slaughter Establishments’’ et Room.
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year, and continue sampling at a mini- ognized protocol on collaborative trials mum of once each week the establish- and compared against the three tube ment operates until one series of 13 Most Probable Number (MPN) method tests meets the criteria set forth in and agreeing with the 95 percent upper paragraph (a)(5)(i) of this section. and lower confidence limit of the ap- (B) Upon the establishment’s meeting propriate MPN index. requirements of paragraph (a)(2)(v)(A) (4) Recording of test results. The estab- of this section, weekly sampling and lishment shall maintain accurate testing is optional, unless changes are records of all test results, in terms of made in establishment facilities, equip- CFU/cm2 of surface area sponged or ment, personnel or procedures that excised. Results shall be recorded onto may affect the adequacy of existing a process control chart or table show- process control measures, as deter- ing at least the most recent 13 test re- mined by the establishment or FSIS. sults, by type of livestock slaughtered. FSIS determinations that changes Records shall be retained at the estab- have been made requiring resumption lishment for a period of 12 months and of weekly testing shall be provided to shall be made available to FSIS upon the establishment in writing. request. (3) Analysis of samples. Laboratories (5) Criteria for evaluation of test results. may use any quantitative method for (i) An establishment excising sam- analysis of E. coli that is approved as ples from carcasses is operating within an AOAC Official Method of the AOAC the criteria when the most recent E. International (formerly the Associa- coli test result does not exceed the tion of Official Analytical Chemists) 2 upper limit (M), and the number of or approved and published by a sci- samples, if any, testing positive at lev- entific body and based on the results of els above (m) is three or fewer out of a collaborative trial conducted in ac- the most recent 13 samples (n) taken, cordance with an internationally rec- as follows:
TABLE 1.ÐEVALUATION OF E. COLI TEST RESULTS
Maximum Number of number per- Type of livestock Lower limit of marginal range Upper limit of marginal range sample test- mitted in ed marginal range
(m) (M) (n) (c)
Cattle ...... Negative a ...... 100 CFU/cm 2 ...... 13 3 Swine ...... 10 CFU/cm 2 ...... 10,000 CFU/cm 2 ...... 13 3 a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of at least 5 cfu/cm2 carcass surface area.
(ii) Establishments sponging car- applicable provisions of the law are casses shall evaluate E. coli test results being met. using statistical process control tech- (7) Failure to test and record. Inspec- niques. tion shall be suspended in accordance (6) Failure to meet criteria. Test results with rules of practice that will be that do not meet the criteria described adopted for such proceedings upon a in paragraph (a)(5) of this section are finding by FSIS that one or more pro- an indication that the establishment visions of paragraphs (a) (1)–(4) of this section have not been complied with may not be maintaining process con- and written notice of same has been trols sufficient to prevent fecal con- provided to the establishment. tamination. FSIS shall take further ac- (b) Pathogen reduction performance tion as appropriate to ensure that all standard; Salmonella.
2 A copy of the current edition/revision of eral Register, and may be purchased from the ‘‘Official Methods of AOAC Inter- the Association of Official Analytical Chem- national,’’ 16th edition, 3rd revision, 1997, is ists International, Inc., 481 North Frederick on file with the Director, Office of the Fed- Ave., Suite 500, Gaithersburg, MD 20877–2417.
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(1) Raw meat product performance test positive for Salmonella at a rate ex- standards for Salmonella. An establish- ceeding the applicable national patho- ment’s raw meat products, when sam- gen reduction performance standard, as pled and tested by FSIS for Salmonella, provided in Table 2: as set forth in this section, may not
TABLE 2.ÐSALMONELLA PERFORMANCE STANDARDS
Perform- Maximum ance Stand- Number of number of ard (percent samples positives to Class of product positive for tested achieve Sal- (n) Standard monella)a (c)
Steers/heifers ...... 1.0 82 1 Cows/bulls ...... 2.7 58 2 Ground beef ...... 7.5 53 5 Hogs ...... 8.7 55 6 Fresh pork sausages ...... 30 53 18 a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw product based on data developed by FSIS in its nationwide microbiological data collection programs and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.)
(2) Enforcement. FSIS will sample and meet the standard on the third con- test raw meat products in an individual secutive series of FSIS-conducted tests establishment on an unannounced basis for that product, constitutes failure to to determine prevalence of Salmonella maintain sanitary conditions and fail- in such products to determine compli- ure to maintain an adequate HACCP ance with the standard. The frequency plan, in accordance with part 417 of and timing of such testing will be this chapter, for that product, and will based on the establishment’s previous cause FSIS to suspend inspection serv- test results and other information con- ices. Such suspension will remain in ef- cerning the establishment’s perform- fect until the establishment submits to ance. In an establishment producing the FSIS Administrator or his/her des- more than one class of product subject ignee satisfactory written assurances to the pathogen reduction standard, detailing the action taken to correct FSIS may sample any or all such class- the HACCP system and, as appropriate, es of products.3 other measures taken by the establish- (3) Noncompliance and establishment ment to reduce the prevalence of response. When FSIS determines that pathogens. an establishment has not met the per- [61 FR 38864, July 25, 1996, as amended at 62 formance standard: FR 26217, May 13, 1997; 62 FR 6100, Nov. 14, (i) The establishment shall take im- 1997] mediate action to meet the standard. EFFECTIVE DATE NOTE: At 62 FR 61008, (ii) If the establishment fails to meet Nov. 14, 1997, § 310.25 was amended by revising the standard on the next series of com- the table in paragraph (b)(1), effective Jan. pliance tests for that product, the es- 13, 1998. For the convenience of the user, the tablishment shall reassess its HACCP superseded text is set forth as follows: plan for that product and take appro- § 310.25 Contamination with microorga- priate corrective actions. nisms; pathogen reduction performance (iii) Failure by the establishment to standards for Salmonella. act in accordance with paragraph (b)(3)(ii) of this section, or failure to * * * * *
3 A copy of FSIS’s ‘‘Sample Collection Identification of Salmonella from Meat and Guidelines and Procedure for Isolation and Poultry Products’’ is available for inspection in the FSIS Docket Room. 128
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TABLE 2.ÐSALMONELLA PERFORMANCE STANDARDS
Perform- Maximum ance Stand- Number of number of ard (percent samples positives to Class of product positive for tested achieve Sal- (n) Standard monella)a (c)
Steers/heifers ...... 1.0% 82 1 Cows/bulls ...... 2.7% 58 2 Ground beef ...... 7.5% 53 5 Hogs ...... 8.7% 55 6 Fresh pork sausages ...... b N.A. N.A. N.A. a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw product based on data developed by FSIS in its nationwide microbiological data collection programs and surveys. Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room. b Not available; values for fresh pork sausage will be added upon completion data collection programs for those products.
* * * * * 311.22 Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or er- ythema. PART 311—DISPOSAL OF DISEASED 311.23 Tapeworm cysts (cysticercus bovis) in OR OTHERWISE ADULTERATED cattle. CARCASSES AND PARTS 311.24 Hogs affected with tapeworm cysts. 311.25 Parasites not transmissible to man; Sec. tapeworm cysts in sheep; hydatid cysts; 311.1 Disposal of diseased or otherwise adul- flukes; gid bladder-worms. terated carcasses and parts; general. 311.26 Emaciation. 311.2 Tuberculosis. 311.27 Injured animals slaughtered at un- 311.3 Hog cholera. usual hours. 311.5 Swine erysipelas. 311.28 Carcasses of young calves, pigs, kids, 311.6 Diamond-skin disease. lambs, and foals. 311.7 Arthritis. 311.29 Unborn and stillborn animals. 311.8 Cattle carcasses affected with 311.30 Livestock suffocated and hogs scalded anasarca or generalized edema. alive. 311.9 Actinomycosis and actinobacillosis. 311.31 Livers affected with carotenosis; liv- 311.10 Anaplasmosis, anthrax, babesiosis, ers designated as ‘‘telangiectatic,’’ ‘‘saw- bacillary hemoglobinuria in cattle, dust,’’ or ‘‘spotted.’’ blackleg, bluetongue, hemorrhagic septi- 311.32 Vesicular diseases. cemia, icterohematuria in sheep, infec- 311.33 Listeriosis. tious bovine rhinotracheitis, leptospiro- 311.34 Anemia. sis, malignant epizootic catarrh, stran- 311.35 Muscular inflammation, degenera- gles, purpura hemorrhagica, azoturia, in- tion, or infiltration. fectious equine encephalomyelitis, toxic 311.36 Coccidioidal granuloma. encephalomyelitis (forage poisoning), in- 311.37 Odors, foreign and urine. fectious anemia (swamp fever), dourine, 311.38 Meat and meat byproducts from live- acute influenza, generalized osteoporosis, stock which have been exposed to radi- glanders (farcy), acute inflammatory ation. lameness, extensive fistula, and unhealed 311.39 Biological residues. vaccine lesions. AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 311.11 Neoplasms. 2.55. 311.12 Epithelioma of the eye. 311.13 Pigmentary conditions; melanosis, SOURCE: 35 FR 15569, Oct. 3, 1970, unless xanthosis, ochronosis, etc. otherwise noted. 311.14 Abrasions, bruises, abscesses, pus, etc. § 311.1 Disposal of diseased or other- 311.15 Brucellosis. wise adulterated carcasses and 311.16 Carcasses so infected that consump- parts; general. tion of the meat may cause food poison- (a) The carcasses or parts of car- ing. casses of all animals slaughtered at an 311.17 Necrobacillosis, pyemia, and septice- official establishment and found at the mia. 311.18 Caseous lymphadenitis. time of slaughter or at any subsequent 311.19 Icterus. inspection to be affected with any of 311.20 Sexual odor of swine. the diseases or conditions named in 311.21 Mange or scab. this part shall be disposed of according
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to the section pertaining to the disease sible only by entry of the bacilli into or condition: Provided, That no product the systemic circulation); shall be passed for human food under (2) When on ante mortem inspection any such section unless it is found to the animal is observed to have a fever be otherwise not adulterated. Products found to be associated with an active passed for cooking or refrigeration tuberculosis lesion on post mortem in- under this part must be so handled at spection; the official establishment where they (3) When there is an associated are initially prepared unless they are cachexia; moved to another official establish- (4) When a tuberculosis lesion is ment for such handling or in the case found in any muscle or intermuscular of products passed for refrigeration are tissue, or bone, or joint, or abdominal moved for such refrigeration to a freez- organ (excluding the gastrointestinal ing facility approved by the Adminis- tract) or in any lymph node as a result trator in specific cases: Provided, That of draining a muscle, bone, joint, or ab- when so moved the products are dominal organ (excluding the gastro- shipped in containers sealed in accord- intestinal tract); ance with § 318.10(c) of this subchapter (5) When the lesions are extensive in or in a sealed means of conveyance as tissues of either the thoracic or the ab- provided in § 325.7 of this subchapter. dominal cavity; Owning to the fact that it is imprac- (6) When the lesions are multiple, ticable to formulate rules covering acute, and actively progressive; or every case and to designate at just (7) When the character or extent of what stage a disease process or a condi- the lesions otherwise is not indicative tion results in adulteration of a prod- of a localized condition. uct, the decision as to the disposal of (b) Organs or other parts condemned. all carcasses, organs, or other parts not An organ or other part of a swine, cat- specifically covered in this part shall tle, sheep, goat, or equine carcass af- be left to the veterinary medical offi- fected by localized tuberculosis shall cer. The veterinary medical officer be condemned when it contains lesions shall exercise his judgment regarding of tuberculosis or when the correspond- the disposition of all carcasses or parts ing lymph node contains lesions of tu- of carcasses under this part in a man- berculosis. ner which will insure that only whole- (c) Carcasses of cattle passed without some, unadulterated product is passed restriction for human food. Carcasses of for human food. cattle may be passed without restric- (b) In cases of doubt as to a condi- tion for human food only when the car- tion, a disease, or the cause of a condi- cass of an animal not identified as a re- tion, or to confirm a diagnosis, rep- actor to a tuberculin test administered resentative specimens of the affected by an Animal and Plant Health Inspec- tissues, properly prepared and pack- tion Service, State, or accredited vet- aged, shall be sent for examination to erinarian 1 is found free of tuberculosis one of the laboratories of the Biologi- lesions during postmortem inspection. cal Control Section of the Program. (d) Portions of carcasses and carcasses of cattle passed for cooking. (1) When a § 311.2 Tuberculosis. cattle carcass reveals a tuberculosis le- The following principles shall apply sion or lesions not so severe or so nu- to the disposition of carcasses of live- merous as the lesions described in stock based on the difference in the paragraph (a) of this section, the unaf- pathogenesis of tuberculosis in swine, fected portion of the carcass may be cattle, sheep, goats, and equines. passed for cooking in accordance with (a) Carcasses condemned. The entire part 315 of this chapter; if the char- carcass of swine, cattle, sheep, goats, acter and extent of the lesions indicate and equines shall be condemned if any a localized condition, and if the lesions of the following conditions occur: (1) When the lesions of tuberculosis 1 Such testing is conducted in the tuber- are generalized (tuberculosis is consid- culosis eradication program of the Animal ered to be generalized when the lesions and Plant Health Inspection Service, U.S. are distributed in a manner made pos- Department of Agriculture.
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are calcified or encapsulated, and pro- condition, and if the lesions are calci- vided the affected organ or other part fied or encapsulated, and provided the is condemned. affected organ or other part is con- (2) When the carcass of a cattle iden- demned. tified as a reactor to a tuberculin test [37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, administered by an Animal and Plant 1973] Health Inspection Service, State or ac- credited veterinarian is found free of § 311.3 Hog cholera. lesions of tuberculosis, the carcass may (a) The carcasses of all hogs affected be passed for cooking in accordance with hog cholera shall be condemned. with part 315 of this chapter. (b) Inconclusive but suspicious symp- (e) Portions of carcasses and carcasses toms of hog cholera observed during of swine passed without restriction for the ante-mortem inspection of a U.S. human food. Swine carcasses found free suspect shall be duly considered in con- of tuberculosis lesions during post nection with post-mortem findings and mortem inspection may be passed for when the carcass of such a suspect human food without restriction. When shows lesions in the kidneys and the tuberculosis lesions in any swine car- lymph nodes which resemble lesions of cass are localized and confined to one hog cholera, they shall be regarded as primary seat of infection, such as the those of hog cholera and the carcass cervical lymph nodes, the mesenteric shall be condemned. lymph nodes, or the mediastinal lymph (c) When lesions resembling those of nodes, the unaffected portion of the hog cholera occur in kidneys and carcass may be passed for human food lymph nodes of carcasses of hogs which without restriction after the affected appeared normal on ante-mortem in- organ or other part is condemned. spection, further inspection of such (f) Portions of carcasses of swine passed carcasses shall be made for corrobora- for cooking. When the carcass of any tive lesions. If on such further inspec- swine reveals lesions more severe or tion, characteristic lesions of hog chol- more numerous than those described in era are found in some organ or tissue paragraph (e) of this section, but not so in addition to those in the kidneys or severe or so numerous as the lesions in the lymph nodes or in both, then all described in paragraph (a) of this sec- lesions shall be regarded as those of tion, the unaffected portions of such hog cholera and the carcass shall be carcass may be passed for cooking in condemned. Immediate notification accordance with part 315 of this chap- shall be given by the inspector to the ter; if the character and extent of the official in the Veterinary Services unit lesions indicate a localized condition, of the Animal and Plant Health Inspec- and if the lesions are calcified or en- tion Service who has responsibility for capsulated, and provided the affected control of swine diseases in the State organ or other part is condemned. where the swine are located. (g) Carcasses of sheep, goats, and equines passed without restriction for [35 FR 15569, Oct. 3, 1970, as amended at 40 FR human food. Carcasses of sheep, goats, 27225, June 27, 1975] and equines may be passed without re- striction for human food only if found § 311.5 Swine erysipelas. free of tuberculosis lesions during post Carcasses affected with swine ery- mortem inspection. sipelas which is acute or generalized, (h) Portions of carcasses of sheep, goats, or which show systemic change, shall and equines passed for cooking. If a car- be condemned. cass of any sheep, goat, or equine re- veals a tuberculosis lesion or lesions § 311.6 Diamond-skin disease. that are not so severe or so numerous Carcasses of hogs affected with dia- as the lesions described in paragraph mond-skin disease when localized and (a) of this section, the unaffected por- not associated with systemic change tion of the carcass may be passed for may be passed for human food after re- cooking in accordance with part 315 of moval and condemnation of the af- this chapter; if the character and ex- fected parts, provided such carcasses tent of the lesions indicate a localized are otherwise healthy.
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§ 311.7 Arthritis. the disease is slight and confined to the (a) Carcasses affected with arthritis lymph nodes, the head including the which is localized and not associated tongue, may be passed for human food with systemic change may be passed after the affected nodes have been re- for human food after removal and con- moved and condemned. demnation of all affected parts. Af- (d) When the disease is slight and fected joints with corresponding lymph confined to the tongue, with or without nodes shall be removed and condemned. involvement of the corresponding In order to avoid contamination of the lymph nodes, the head may be passed meat which is passed, a joint capsule for human food after removal and con- shall not be opened until after the af- demnation of the tongue and cor- fected joint is removed. responding lymph nodes. (b) Carcasses affected with arthritis § 311.10 Anaplasmosis, anthrax, babes- shall be condemned when there is evi- iosis, bacillary hemoglobinuria in dence of systemic involvement. cattle, blackleg, bluetongue, hemor- rhagic septicemia, icterohematuria § 311.8 Cattle carcasses affected with in sheep, infectious bovine rhino- anasarca or generalized edema. tracheitis, leptospirosis, malignant (a) Carcasses of cattle found on post- epizootic catarrh, strangles, pur- mortem inspection to be affected with pura hemorrhagica, azoturia, infec- anasarca in advanced stages and char- tious equine encephalomyelitis, acterized by an extensive or well- toxic encephalomyelitis (forage poi- soning), infectious anemia (swamp marked generalized edema shall be fever), dourine, acute influenza, condemned. generalized osteoporosis, glanders (b) Carcasses of cattle, including (farcy), acute inflammatory lame- their detached organs and other parts, ness, extensive fistula, and found on post-mortem inspection to be unhealed vaccine lesions. affected with anasarca to a lesser ex- (a) Carcasses of livestock affected tent than as described in paragraph (a) with or showing lesions of any of the of this section may be passed for following named diseases or conditions human food after removal and con- shall be condemned: demnation of the affected tissues, pro- (1) Anthrax. vided the lesion is localized. (2) Blackleg. (3) Unhealed vaccine lesions § 311.9 Actinomycosis and actinobacil- (vaccinia). losis. (4) Strangles. (a) The definition of generalization (5) Purpura hemorrhagica. as outlined for tuberculosis in § 311.2(a) (6) Azoturia. shall apply for actinomycosis and acti- (7) Infectious equine encephalomye- nobacillosis, and carcasses of livestock litis. with generalized lesions of either such (8) Toxic encephalomyelitis (forage disease shall be condemned. poisoning). (b) Carcasses of livestock in a well- (9) Infectious anemia (swamp fever). nourished condition showing uncompli- (10) Dourine. cated localized lesions of actinomy- (11) Acute influenza. cosis or actinobacillosis may be passed (12) Generalized osteoporosis. for human food after the infected or- (13) Glanders (farcy). gans or other infected parts have been (14) Acute inflammatory lameness. removed and condemned, except as pro- (15) Extensive fistula. vided in paragraphs (c) and (d) of this (b) Carcasses of livestock affected section. with or showing lesions of any of the (c) Heads affected with actinomy- following named diseases or conditions cosis or actinobacillosis, including the shall be condemned, except when re- tongue, shall be condemned, except covery has occurred to the extent that that when the disease of the jaw is only localized lesions persist, in which slight, strictly localized, and without case the carcass may be passed for suppuration, fistulous tracts, or lymph human food after removal and con- node involvement, the tongue, if free demnation of the affected organs or from disease, may be passed, or, when other parts:
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(1) Anaplasmosis. pigmentary deposits shall be con- (2) Bacillary hemoglobinuria in cat- demned. tle. (b) The affected parts of carcasses (3) Babesiosis (piroplasmosis). showing localized pigmentary deposits (4) Bluetongue. of such character as to be unwholesome (5) Hemorrhagic septicemia. or otherwise adulterated shall be re- (6) Icterohematuria in sheep. moved and condemned. (7) Infectious bovine rhinotracheitis. (8) Leptospirosis. § 311.14 Abrasions, bruises, abscesses, pus, etc. (9) Malignant epizootic catarrh. All slight, well-limited abrasions on [35 FR 15569, Oct. 3, 1970, as amended at 36 FR the tongue and inner surface of the lips 12004, June 24, 1971] and mouth, when without lymph node § 311.11 Neoplasms. involvement, shall be carefully excised, leaving only sound, normal tissue, (a) An individual organ or other part which may be passed for human food. of a carcass affected with a neoplasm Any organ or other part of a carcass shall be condemned. If there is evi- which is badly bruised or which is af- dence of metastasis or that the general fected by an abscess, or a suppurating condition of the animal has been ad- sore shall be condemned; and when the versely affected by the size, position, lesions are of such character or extent or nature of the neoplasm, the entire as to affect the whole carcass, the carcass shall be condemned. whole carcass shall be condemned. Por- (b) Carcasses affected with malignant tions of carcasses which are contami- lymphoma shall be condemned. nated by pus or other diseased material shall be condemned. § 311.12 Epithelioma of the eye. (a) Carcasses of animals affected with § 311.15 Brucellosis. epithelioma of the eye, or the orbital Carcasses affected with localized le- region shall be condemned in their en- sions of brucellosis may be passed for tirety if one of the following three con- human food after the affected parts are ditions exists: removed and condemned. (1) The affection has involved the os- seous structures of the head with ex- § 311.16 Carcasses so infected that con- tensive infection, suppuration, and ne- sumption of the meat may cause crosis; food poisoning. (2) There is metastasis from the eye, (a) All carcasses of animals so in- or the orbital region, to any lymph fected that consumption of the prod- node including the parotid lymph node, ucts thereof may give rise to food poi- internal organs, muscles, skeleton, or soning shall be condemned. This in- other structures, regardless of the ex- cludes all carcasses showing signs of: tent of the primary tumor; or (1) Acute inflammation of the lungs, (3) The affection, regardless of ex- pleura, pericardium, peritoneum, or tent, is associated with cachexia or evi- meninges. dence of absorption or secondary (2) Septicemia or pyemia, whether changes. puerperal, traumatic, or without any (b) Carcasses of animals affected with evident cause. epithelioma of the eye, or the orbital (3) Gangrenous or severe hemorrhagic region, to a lesser extent than as de- enteritis or gastritis. scribed in paragraph (a) of this section (4) Acute diffuse metritis or mam- may be passed for human food after re- mitis. moval and condemnation of the head, (5) Phlebitis of the umbilical veins. including the tongue, provided the car- (6) Septic or purulent traumatic peri- cass is otherwise normal. carditis. (7) Any acute inflammation, abscess, § 311.13 Pigmentary conditions; mela- or suppurating sore, if associated with nosis, xanthosis, ochronosis, etc. acute nephritis, fatty and degenerated (a) Except as provided in § 311.19, car- liver, swollen soft spleen, marked pul- casses of livestock showing generalized monary hyperemia, general swelling of
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lymph nodes, diffuse redness of the (c) A thin carcass showing only slight skin, cachexia, icteric discoloration of lesions in the skeletal lymph nodes and the carcass or similar condition, either in the viscera may be passed for human singly or in combination. food without restriction. (8) Salmonellosis. (d) A well-nourished carcass showing (b) Implements contaminated by con- well-marked lesions in the viscera and tact with carcasses affected with any with only slight lesions elsewhere or of the disease conditions mentioned in showing well-marked lesions confined this section shall be thoroughly to the skeletal lymph nodes with only cleaned and sanitized as prescribed in slight lesions elsewhere may be passed part 308 of this subchapter. The equip- for human food without restriction. ment used in the dressing of such car- (e) A well-nourished carcass showing casses, such as viscera trucks or in- well-marked lesions in the viscera and spection tables, shall be sanitized with the skeletal lymph nodes may be hot water having a minimum tempera- passed for cooking; but where the le- ture of 180 °F. Carcasses or parts of car- sions in a well-nourished carcass are casses contaminated by contact with both numerous and extensive, it shall such diseased carcasses shall be con- be condemned. demned unless all contaminated tissues (f) All affected organs and nodes of are removed within 2 hours. carcasses passed for human food with- out restriction or passed for cooking § 311.17 Necrobacillosis, pyemia, and shall be removed and condemned. septicemia. (g) As used in this section, the term From the standpoint of meat inspec- ‘‘thin’’ does not apply to a carcass tion, necrobacillosis may be regarded which is anemic or emaciated; and the as a local infection at the beginning, term ‘‘lesions’’ refers to lesions of case- and carcasses in which the lesions are ous lymphadenitis. localized may be passed for human food § 311.19 Icterus. if in a good state of nutrition, after those portions affected with necrotic Carcasses showing any degree of ic- lesions are removed and condemned. terus shall be condemned. Yellow fat However, when emaciation, cloudy conditions caused by nutritional fac- swelling of the parenchymatous tissue tors or characteristic of certain breeds of organs or enlargement of the lymph of livestock and yellow fat sometimes nodes is associated with the infection, seen in sheep shall not be confused it is evident that the disease has pro- with icterus. Such carcasses should be gressed beyond the condition of local- passed for human food, if otherwise ization to a state of toxemia, and the normal. entire carcass shall therefore be con- demned as both unwholesome and nox- § 311.20 Sexual odor of swine. ious. Pyemia or septicemia may inter- (a) Carcasses of swine which give off vene as a complication of the local ne- a pronounced sexual odor shall be con- crosis, and when present the carcass demned. shall be condemned in accordance with (b) The meat of swine carcasses § 311.16. which give off a sexual odor less than pronounced may be passed for use in § 311.18 Caseous lymphadenitis. comminuted cooked meat food product (a) A thin carcass showing well- or for rendering. Otherwise it shall be marked lesions in the viscera and the condemned. skeletal lymph nodes, or a thin carcass showing extensive lesions in any part § 311.21 Mange or scab. shall be condemned. Carcasses of livestock affected with (b) A thin carcass showing well- mange or scab in advanced stages, marked lesions in the viscera with only showing cachexia or extensive inflam- slight lesions elsewhere or showing mation of the flesh, shall be con- well-marked lesions in the skeletal demned. When the disease is slight, the lymph nodes with only slight lesions carcass may be passed after removal of elsewhere may be passed for cooking. the affected portion.
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§ 311.22 Hogs affected with urticaria, is held under positive control of a Pro- tinea tonsurans, demodex follicur- gram Inspector at a temperature of not lorum, or erythema. higher than 15 °F. continuously for a Carcasses of hogs affected with urti- period of not less than 20 days. As an caria (nettle rash), tinea tonsurans, alternative to retention in cold storage demodex folliculorum, or erythema as provided in this subparagraph, such may be passed for human food after de- carcasses and meat may be heated taching and condemning the affected throughout to a temperature of at skin, if the carcass is otherwise not least 140 °F. under positive control of a adulterated. Program Inspector. (b) Edible viscera and offal shall be § 311.23 Tapeworm cysts (cysticercus disposed of in the same manner as the bovis) in cattle. rest of the carcass from which they (a) Except as provided in paragraph were derived unless any lesion of (b) of this section, carcasses of cattle cysticercus bovis is found in these by- affected with lesions of cysticercus products, in which case they shall be bovis shall be disposed of as follows: condemned. (1) Carcasses of cattle displaying le- [36 FR 4591, Mar. 10, 1971] sions of cysticercus bovis shall be con- demned if the infestation is extensive § 311.24 Hogs affected with tapeworm or if the musculature is edematous or cysts. discolored. Carcasses shall be consid- Carcasses of hogs affected with tape- ered extensively infested if in addition worm cysts (Cysticercus cellulosae) to finding lesions in at least two of the may be passed for cooking, unless the usual inspection sites, namely the infestation is excessive, in which case heart, diaphragm and its pillars, mus- the carcass shall be condemned. cles of mastication, esophagus, tongue, and musculature exposed during nor- § 311.25 Parasites not transmissible to mal dressing operations, they are found man; tapeworm cysts in sheep; in at least two of the sites exposed by hydatid cysts; flukes; gid bladder- (i) an incision made into each round ex- worms. posing the musculature in cross sec- (a) In the disposal of carcasses, edible tion, and (ii) a transverse incision into organs, and other parts of carcasses each forelimb commencing 2 or 3 showing evidence of infestation with inches above the point of the olecranon parasites not transmissible to man, the and extending to the humerus. following general rules shall govern ex- (2) Carcasses of cattle showing one or cept as otherwise provided in this sec- more tapeworm lesions of cysticercus tion: If the lesions are localized in such bovis but not so extensive as indicated manner and are of such character that in paragraph (a)(1) of this section, as the parasites and the lesions caused by determined by a careful examination, them can be completely removed, the including examination of, but not lim- nonaffected portion of the carcass, ited to, the heart, diaphragm and its organ, or other part of the carcass may pillars, muscles of mastication, esopha- be passed for human food after the re- gus, tongue, and musculature exposed moval and condemnation of the af- during normal dressing operations, fected portions. If an organ or other may be passed for human food after re- part of a carcass shows numerous le- moval and condemnation of the lesions sions caused by parasites, or if the with surrounding tissues: Provided, character of the infestation is such That the carcasses, appropriately iden- that complete extirpation of the para- tified by retained tags, are held in cold sitic infestation or invasion renders storage under positive control of a the part in any way unfit for human USDA Food Inspector at a temperature food, the affected part shall be con- not higher than 15 °F. continuously for demned. If parasites are found to be a period of not less than 10 days, or in distributed in a carcass in such a man- the case of boned meat derived from ner or to be of such character that such carcasses, the meat, when in their removal and the removal of the boxes, tierces, or other containers, ap- lesions caused by them is impractica- propriately identified by retained tags, ble, no part of the carcass shall be
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passed for human food. If the infesta- viscera except the stomach, bladder, tion is excessive, the carcass shall be and intestines held by the natural at- condemned. If the infestation is mod- tachments. If all parts are not so kept erate, the carcass may be passed for for inspection, the carcass shall be con- cooking, but in case such carcass is not demned. If, on inspection of a carcass cooked as required by part 315 of this slaughtered in the absence of an in- subchapter, it shall be condemned. spector, any lesion or other evidence is (b) In the case of sheep carcasses af- found indicating that the animal was fected with tapeworm cysts (Cysticer- sick or diseased, or affected with any cus ovis, so-called sheep measles, not other condition requiring condemna- transmissible to man), such carcasses tion of the animal on ante-mortem in- may be passed for human food after the spection, or if there is lacking evidence removal and condemnation of the af- fected portions: Provided, however, That of the condition which rendered emer- if, upon the final inspection of sheep gency slaughter necessary, the carcass carcasses retained on account of mea- shall be condemned. sles, the total number of cysts found embedded in muscular tissue, or in im- § 311.28 Carcasses of young calves, pigs, kids, lambs, and foals. mediate relation with muscular tissue, excluding the heart, exceeds five, the Carcasses of young calves, pigs, kids, entire carcass shall be condemned, or lambs, and foals are unwholesome and such carcass shall be heated through- shall be condemned if (a) the meat has out to a temperature of at least 140 °F. the appearance of being water-soaked, After removal and condemnation of all is loose, flabby, tears easily, and can be affected portions. perforated with the fingers; or (b) its (c) Carcasses found infested with gid color is grayish-red; or (c) good mus- bladder-worms (Coenurus cerebralis, cular development as a whole is lack- Multiceps multiceps) may be passed for ing, especially noticeable on the upper human food after condemnation of the shank of the leg, where small amounts affected organ (brain or spinal cord). of serous infiltrates or small edema- (d) Organs or other parts of carcasses tous patches are sometimes present be- infested with hydatid cysts tween the muscles; or (d) the tissue (echinococus) shall be condemned. which later develops as the fat capsule (e) Livers infested with flukes or of the kidneys is edematous, dirty yel- fringed tapeworms shall be condemned. low, or grayish-red, tough, and § 311.26 Emaciation. intermixed with islands of fat. Carcasses of livestock too emaciated § 311.29 Unborn and stillborn animals. to produce wholesome meat, and car- casses which show a serous infiltration All unborn and stillborn animals of muscle tissues, or a serous or mu- shall be condemned and no hide or skin coid degeneration of the fatty tissue, thereof shall be removed from the car- shall be condemned. A gelatinous cass within a room in which edible change of the fat of the heart and kid- products are handled. neys of well-nourished carcasses and mere leanness shall not be classed as § 311.30 Livestock suffocated and hogs emaciation. scalded alive. [35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, All livestock which have been suffo- 1971] cated in any way and hogs which have entered the scalding vat alive shall be § 311.27 Injured animals slaughtered condemned. at unusual hours. When it is necessary for humane rea- § 311.31 Livers affected with caroten- sons to slaughter an injured animal at osis; livers designated as night or on Sunday or a holiday when ‘‘telangiectatic,’’ ‘‘sawdust,’’ or the inspector cannot be obtained, the ‘‘spotted.’’ carcass and all parts shall be kept for (a) Livers affected with carotenosis inspection, with the head and all shall be condemned.
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(b) Cattle livers and calf livers show- § 311.34 Anemia. ing the conditions sometimes des- Carcasses of livestock too anemic to ignated as ‘‘telangiectatic,’’ ‘‘saw- produce wholesome meat shall be con- dust,’’ or ‘‘spotted’’ shall be disposed of demned. as follows: (1) When any or all of the conditions § 311.35 Muscular inflammation, de- are slight in the organ, the whole generation, or infiltration. organ shall be passed for human food (a) If muscular lesions are found to without restriction. be distributed in such a manner or to (2) When any or all of the conditions be of such character that removal is are more severe than slight and involve impractical, the carcass shall be con- less than one-half of the organ, while demned. in the remainder of the organ the con- (b) If muscular lesions are found to ditions are slight or nonexistent, the be distributed in such a manner or to remainder shall be passed for human be of such character that removal is food without restriction and the other practical, the following rules shall gov- portion shall be condemned. ern the disposal of the carcasses, edible (3) When any or all of the conditions organs, and other parts of carcasses are more severe than slight and involve showing such muscular lesions. If the one-half or more of the organ, the lesions are localized in such a manner whole organ shall be condemned. and are of such a character that the af- (4) The divisions of an organ into two fected tissues can be removed, the non- parts as contemplated in this para- affected parts of the carcass may be graph for disposition, shall be accom- passed for human food after the re- plished by one cut through the organ. moval and condemnation of the af- This, of course, does not prohibit inci- fected portion. If a part of the carcass sions which are necessary for inspec- shows numerous lesions, or if the char- tion. acter of the lesion is such that com- (c) ‘‘Telangiectatic,’’ ‘‘sawdust,’’ or plete extirpation is difficult and uncer- ‘‘spotted’’ livers and parts of livers tainly accomplished, or if the lesion which are condemned for human food renders the part in any way unfit for may be shipped from an official estab- human food, the part shall be con- lishment for purposes other than demned. human food in accordance with § 314.10 (c) If the lesions are slight or of such of this subchapter. character as to be insignificant from a standpoint of wholesomeness, the car- § 311.32 Vesicular diseases. cass or parts may be passed for use in (a) Any carcass affected with vesicu- the manufacture of comminuted lar disease shall be condemned if the cooked product, after removal and con- condition is acute and if the extent of demnation of the visibly affected por- the condition is such that it affects the tions. entire carcass or there is evidence of absorption or secondary change. § 311.36 Coccidioidal granuloma. (b) Any carcass affected with vesicu- (a) Carcasses which are affected with lar disease to a lesser extent than as generalized coccidioidal granuloma or described in paragraph (a) of this sec- which show systemic changes because tion may be passed for human food of such disease shall be condemned. after removal and condemnation of the (b) Carcasses affected with localized affected parts, if the carcass is other- lesions of this disease may be passed wise healthy. for human food after the affected parts are removed and condemned. § 311.33 Listeriosis. Carcasses of livestock identified as § 311.37 Odors, foreign and urine. U.S. Suspects because of a history of (a) Carcasses which give off a pro- listeriosis shall be passed for human nounced odor of medicinal, chemical, food after condemnation of the head if or other foreign substance shall be con- the carcass is otherwise normal. demned.
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(b) Carcasses which give off a pro- § 312.1 General. nounced urine odor shall be con- The marks, devices, and certificates demned. prescribed or referenced in this part (c) Carcasses, organs, or parts af- fected by odor to a lesser degree than shall be official marks, devices, and as described in paragraphs (a) and (b) of certificates for purposes of the Act, and this section and in which the odor can shall be used in accordance with the be removed by trimming or chilling provisions of this part and the regula- may be passed for human food, after re- tions cited therein. moval of affected parts or dissipation of the condition. § 312.2 Official marks and devices to identify inspected and passed prod- § 311.38 Meat and meat byproducts ucts of cattle, sheep, swine, or from livestock which have been ex- goats. posed to radiation. (a) The official inspection legend re- Meat and meat byproducts from live- quired by part 316 of this subchapter to stock which have been administered ra- be applied to inspected and passed car- dioactive material shall be condemned casses and parts of carcasses of cattle, unless the use of the radiation was in sheep, swine and goats, meat food prod- conformity with a regulation or exemp- ucts in animal casings, and other prod- tion in effect pursuant to section 409 of ucts as approved by the Administrator, the Federal Food, Drug, and Cosmetic shall be in the appropriate form as Act. hereinafter specified: 1 § 311.39 Biological residues. Carcasses, organs, or other parts of carcasses of livestock shall be con- demned if it is determined that they are adulterated because of the presence of any biological residues.
PART 312—OFFICIAL MARKS, For application to sheep carcasses, the loins and ribs of pork, beef tails, DEVICES AND CERTIFICATES and the smaller varieties of sausage and meat food products in animal cas- Sec. 312.1 General. ings. 312.2 Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats. 312.3 Official marks and devices to identify inspected and passed equine products. 312.4 Official ante-mortem inspection marks and devices. 312.5 Official seals for transportation of products. 312.6 Official marks and devices in connec- tion with post-mortem inspection and identification of adulterated products and insanitary equipment and facilities. For application to calf and goat car- 312.7 [Reserved] 312.8 Official export inspection marks, de- casses and on the larger varieties of vices, and certificates. sausage and meat food products in ani- 312.9 Official detention marks and devices. mal casings. 312.10 Official mark for maintaining the identity and integrity of samples.
AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 1 The number ‘‘38’’ is given as an example 2.55. only. The establishment number of the offi- SOURCE: 35 FR 15573, Oct. 3, 1970, unless cial establishment where the product is pre- otherwise noted. pared shall be used in lieu thereof.
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be conspicuously displayed and readily legible and the same proportions of let- ter size and boldness are maintained as illustrated:
For application to beef and hog car- casses primal parts and cuts therefrom, beef livers, beef tongues, beef hearts, and smoked meats not in casings. (2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp. (3) The official inspection legend de- scribed in paragraph (b)(1) of this sec- tion may also be used for purposes of part 316 of this subchapter on shipping containers, band labels, artificial cas- ings, and other articles with the ap- proval of the Administrator. (c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark pre- scribed in paragraphs (a) or (b) of this section shall be an official device for purposes of the Act. [35 FR 15573, Oct. 3, 1970; 36 FR 12002, June 24, 1971] For application to burlap, muslin, cheesecloth, heavy paper, or other ac- § 312.3 Official marks and devices to ceptable material that encloses car- identify inspected and passed casses or parts of carcasses. equine products. (b)(1) The official inspection legend (a) The official inspection legend re- required by part 317 of this subchapter quired by § 316.12 or § 317.2 of this sub- to be shown on all labels for inspected chapter to identify inspected and and passed products of cattle, sheep, passed horse carcasses and parts of car- swine, and goats shall be in the follow- casses, or horse meat food products ing form 1 except that it need not be of shall be in the appropriate form as the size illustrated, provided that it is hereinafter specified: 1 a sufficient size and of such color as to
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(c) Any brand, stamp, label, or other (b) The official inspection legend re- device approved by the Administrator quired by § 316.12 or § 317.2 of this sub- and bearing any official mark pre- chapter to identify inspected and scribed in paragraphs (a) or (b) of this passed mule and other (nonhorse) section shall be an official device for equine carcasses and parts of carcasses, purposes of the Act. or equine meat food products shall be in whichever of the following form, is § 312.4 Official ante-mortem inspection marks and devices. appropriate:1 The official marks and devices used in connection with ante-mortem in- spection are those prescribed in § 309.18 of this subchapter.
§ 312.5 Official seals for transportation of products. The official mark for use in sealing railroad cars or other means of convey- ance as prescribed in part 325 of this subchapter shall be the inscription and a serial number as hereinafter shown 2 1 The number ‘‘38’’ is given as an example only. The establishment number of the offi- 2 The number ‘‘2135202’’ is given as an ex- cial establishment where the product is pre- ample only. The serial number of the specific pared shall be used in lieu thereof. seal will be shown in lieu thereof.
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and any seal approved by the Adminis- means of conveyance only by a Pro- trator for applying such mark shall be gram employee and he shall also affix an official device for purposes of the thereto a ‘‘Warning Tag’’ (Form MP– Act. This seal shall be attached to the 408–3).
[35 FR 15573, Oct. 3, 1970, as amended at 39 FR 36000, Oct. 7, 1974; 51 FR 37707, Oct. 24, 1986]
§ 312.6 Official marks and devices in connection with post-mortem in- spection and identification of adul- terated products and insanitary equipment and facilities. (a) The official marks required by parts 308 and 310 of this subchapter for (5) The ‘‘U.S. Inspected and Con- use in post-mortem inspection and demned’’ mark shall be applied to prod- identification of adulterated products ucts condemned as prescribed in part and insanitary equipment and facilities 310 by means of a brand and is in the are: following form: (1) The tag (Form MP–427) which is used to retain carcasses and parts of carcasses in the slaughter department; it is black and white, and bears the leg- end ‘‘U.S. Retained.’’ (2) The ‘‘U.S. Retained’’ mark which is applied to products and articles as prescribed in part 310 of this sub- chapter by means of a paper tag (Form (b) The U.S. Retained and U.S. Re- MP–35) bearing the legend ‘‘U.S. Re- jected tags, and all other brands, tained.’’ stamps, labels, and other devices ap- proved by the Administrator and bear- (3) The ‘‘U.S. Rejected’’ mark which ing any official mark prescribed in is used to identify insanitary buildings, paragraph (a) of this section, shall be rooms, or equipment as prescribed in official devices for purposes of the Act. part 308 of this subchapter and is ap- plied by means of a paper tag (Form [35 FR 15573, Oct. 3, 1970, as amended at 38 FR MP–35) bearing the legend ‘‘U.S. Re- 29214, Oct. 23, 1973; 39 FR 36000; Oct. 7, 1974; 43 jected.’’ FR 29268, July 7, 1978] (4) The ‘‘U.S. Passed for Cooking’’ mark is applied on products passed for § 312.7 [Reserved] cooking as prescribed in part 310 of this § 312.8 Official export inspection subchapter by means of a brand and is marks, devices, and certificates. in the following form: (a) The official export meat inspec- tion mark required by part 322 of this
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subchapter shall be in the following § 312.10 Official mark for maintaining form as hereinafter specified: 1 the identity and integrity of sam- ples. The official mark for use in sealing containers of samples submitted under any requirements in this subchapter and section 202 of the Federal Meat In- spection Act shall bear the designation ‘‘Sample Seal’’ accompanied by the of- ficial USDA logo as shown below. Any seal approved by the Administrator for applying such mark shall be deemed an official device for purposes of the Act. Any rubber stamp approved by the Ad- Such device shall be supplied to inspec- ministrator, in the manner provided tors, compliance officers, and other for in part 317 of this subchapter, and designated Agency officials by the bearing the official mark prescribed in United States Department of Agri- this paragraph shall be an official de- culture. vice for the purposes of the Act. (b) The official export certificate re- quired by part 322 of this subchapter is a paper certificate form for signature by a Program employee, bearing a let- terhead and the seal of the United States Department of Agriculture, with a certification that meat or meat food products described on the form is from animals that received ante- mortem and post-mortem inspection and were found sound and healthy and that it has been inspected and passed as provided by law and the regulations of the Department of Agriculture and [52 FR 41958, Nov. 2, 1987] is sound and wholesome. The certifi- cate also bears a serial number such as PART 313—HUMANE SLAUGHTER ‘‘No. 184432.’’ OF LIVESTOCK [35 FR 15573, Oct. 3, 1970, as amended at 42 FR 11825, Mar. 1, 1977; 47 FR 29823, July 9, 1982] Sec. 313.1 Livestock pens, driveways and ramps. § 312.9 Official detention marks and 313.2 Handling of livestock. devices. 313.5 Chemical; carbon dioxide The official mark for articles and 313.15 Mechanical; captive bolt. livestock detained under part 329 of 313.16 Mechanical; gunshot. this subchapter shall be the designa- 313.30 Electrical; stunning or slaughtering with electric current. tion ‘‘U.S. Detained’’ and the official 313.50 Tagging of equipment, alleyways, device for applying such mark shall be pens or compartments to prevent inhu- the official ‘‘U.S. Detained’’ tag (FSIS mane slaughter or handling in connec- Form 8400–2) as prescribed in § 329.2 of tion with slaughter. this subchapter. 313.90 [Reserved] [55 FR 47842, Nov. 16, 1990] AUTHORITY: 7 U.S.C. 1901–1906; 21 U.S.C. 601– 695; 7 CFR 2.17, 2.55.
1 The number ‘‘529893’’ is given as an exam- SOURCE: 44 FR 68813, Nov. 30, 1979, unless ple only. The number of the offical export otherwise noted. certificate will be shown in lieu thereof.
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§ 313.1 Livestock pens, driveways and of the inspector, would cause injury or ramps. unnecessary pain to the animal shall (a) Livestock pens, driveways and not be used to drive livestock. ramps shall be maintained in good re- (d) Disabled livestock and other ani- pair. They shall be free from sharp or mals unable to move. protruding objects which may, in the (1) Disabled animals and other ani- opinion of the inspector, cause injury mals unable to move shall be separated or pain to the animals. Loose boards, from normal ambulatory animals and splintered or broken planking, and un- placed in the covered pen provided for necessary openings where the head, in § 313.1(c). feet, or legs of an animal may be in- (2) The dragging of disabled animals jured shall be repaired. and other animals unable to move, (b) Floors of livestock pens, ramps, while conscious, is prohibited. Stunned and driveways shall be constructed and animals may, however, be dragged. (3) Disabled animals and other ani- maintained so as to provide good foot- mals unable to move may be moved, ing for livestock. Slip resistant or waf- while conscious, on equipment suitable fled floor surfaces, cleated ramps and for such purposes; e.g., stone boats. the use of sand, as appropriate, during (e) Animals shall have access to winter months are examples of accept- water in all holding pens and, if held able conctruction and maintenance. longer than 24 hours, access to feed. (c) U.S. Suspects (as defined in There shall be sufficient room in the § 301.2(xxx)) and dying, diseased, and holding pen for animals held overnight disabled livestock (as defined in to lie down. § 301.2(y)) shall be provided with a cov- (f) Stunning methods approved in ered pen sufficient, in the opinion of § 313.30 shall be effectively applied to the inspector, to protect them from the animals prior to their being shackled, adverse climatic conditions of the lo- hoisted, thrown, cast, or cut. cale while awaiting disposition by the inspector. § 313.5 Chemical; carbon dioxide. (d) Livestock pens and driveways shall be so arranged that sharp corners The slaughtering of sheep, calves and and direction reversal of driven ani- swine with the use of carbon dioxide mals are minimized. gas and the handling in connection therewith, in compliance with the pro- [44 FR 68813, Nov. 30, 1979, as amended at 53 visions contained in this section, are FR 49848, Dec. 12, 1988] hereby designated and approved as hu- mane methods of slaughtering and han- § 313.2 Handling of livestock. dling of such animals under the Act. (a) Driving of livestock from the un- (a) Administration of gas, required ef- loading ramps to the holding pens and fect; handling. (1) The carbon dioxide from the holding pens to the stunning gas shall be administered in a chamber area shall be done with a minimum of in accordance with this section so as to excitement and discomfort to the ani- produce surgical anesthesia in the ani- mals. Livestock shall not be forced to mals before they are shackled, hoisted, move faster than a normal walking thrown, cast, or cut. The animals shall speed. be exposed to the carbon dioxide gas in (b) Electric prods, canvas slappers, or a way that will accomplish the anes- other implements employed to drive thesia quickly and calmly, with a min- animals shall be used as little as pos- imum of excitement and discomfort to sible in order to minimize excitement the animals. In swine, carbon dioxide and injury. Any use of such imple- may be administered to induce death in ments which, in the opinion of the in- the animals before they are shackled, spector, is excessive, is prohibited. hoisted, thrown, cast, or cut. Electrical prods attached to AC house (2) The driving or conveying of the current shall be reduced by a trans- animals to the carbon dioxide chamber former to the lowest effective voltage shall be done with a minimum of ex- not to exceed 50 volts AC. citement and discomfort to the ani- (c) Pipes, sharp or pointed objects, mals. Delivery of calm animals to the and other items which, in the opinion anesthesia chamber is essential since
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the induction, or early phase, of anes- (ii) Flow of animals into and through thesia is less violent with docile ani- the carbon dioxide chamber is depend- mals. Among other things this requires ent on one operator. The operation or that, in driving animals to the anesthe- stoppage of the conveyor is entirely de- sia chamber, electrical equipment be pendent upon this operator. It is nec- used as little as possible and with the essary that he be skilled, attentive, lowest effective voltage. and aware of his responsibility. Over- (3) On emerging from the carbon di- dosages and death of animals can be oxide tunnel, the animals shall be in a brought about by carelessness of this state of surgical anaesthesia and shall individual. remain in this condition throughout (2) Special requirements for gas chamber shackling, sticking, and bleeding, ex- and auxiliary equipment. The ability of cept for swine in which death has been anesthetizing equipment to perform induced by the administration of car- with maximum efficiency is dependent bon dioxide. Asphyxia or death from on its proper design and efficient me- any cause shall not be produced in ani- chanical operation. Pathways, com- mals before bleeding, except for swine partments, gas chambers, and all other in which death has been induced by the equipment used must be designed to ac- administration of carbon dioxide. commodate properly the species of ani- (b) Facilities and procedures—(1) Gen- mals being anesthetized. They shall be eral requirements for gas chambers and free from pain-producing restraining auxiliary equipment; operator. (i) The devices. Injury of animals must be pre- carbon dioxide gas shall be adminis- vented by the elimination of sharp pro- tered in a tunnel which is designed to jections or exposed wheels or gears. permit the effective exposure of the There shall be no unnecessary holes, animal. Two types of tunnels, based on spaces or openings where feet or legs of the same principle, are in common use animals may be injured. Impellers or for carbon dioxide anesthesia. They are other devices designed to mechanically the ‘‘U’’ type tunnel and the ‘‘Straight move or drive animals or otherwise Line’’ type tunnel, and are based on keep them in motion or compartmen- the principle that carbon dioxide gas talized shall be constructed of flexible has a higher specific gravity than air. or well padded rigid material. Power The tunnels are open at both ends for activated gates designed for constant entry and exit of animals and have a flow of animals to anesthetizing equip- depressed central section. Anesthetiz- ment shall be so fabricated that they ing, or, in the case of swine, death-in- will not cause injury. All equipment in- ducing, carbon dioxide concentrations volved in anesthetizing animals shall are maintained in the central sections be maintained in good repair. of the tunnels. Effective anaestheti- (3) Gas. Maintenance of a uniform zation is produced in these central sec- carbon dioxide concentration and dis- tions. Animals are driven from holding tribution in the anesthesia chamber is pens through pathways constructed of a vital aspect of producing surgical an- large-diameter pipe or smooth metal esthesia. This may be assured by rea- and onto continuous conveyor devices sonably accurate instruments which that move the animals through the sample and analyze carbon dioxide gas tunnels. The animals are either com- concentration within the chamber partmentalized on the conveyors by throughout anesthetizing operations. mechanical impellers synchronized Gas concentration shall be maintained with the conveyor or they are other- uniform so that the degree of anesthe- wise prevented from crowding. While sia in exposed animals will be constant. impellers are used to compartmen- Carbon dioxide gas supplied to anesthe- talize the animals, mechanically or sia chambers may be from controlled manually operated gates are used to reduction of solid carbon dioxide or move the animals onto the conveyors. from a controlled liquid source. In ei- Surgically anaesthetized animals, or ther case the carbon dioxide shall be killed swine, are moved out of the tun- supplied at a rate sufficient to anes- nels by the same continuous conveyors thetize adequately and uniformly the that moved them into and through the number of animals passing through the carbon dioxide gas. chamber. Sampling of gas for analysis
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shall be made from a representative stunning areas, electrical equipment be place or places within the chamber and used as little as possible and with the on a continuing basis. Gas concentra- lowest effective voltage. tions and exposure time shall be (3) Immediately after the stunning graphically recorded throughout each blow is delivered the animals shall be day’s operation. Neither carbon dioxide in a state of complete unconsciousness nor atmospheric air used in the anes- and remain in this condition through- thesia chambers shall contain noxious out shackling, sticking and bleeding. or irritating gases. Each day before (b) Facilities and procedures—(1) Gen- equipment is used for anesthetizing eral requirements for stunning facilities; animals, proper care shall be taken to operator. (i) Acceptable captive bolt mix adequately the gas and air within stunning instruments may be either the chamber. All gas producing and skull penetrating or nonpenetrating. control equipment shall be maintained in good repair and all indicators, in- The latter type is also described as a struments, and measuring devices must concussion or mushroom type stunner. be available for inspection by Program Penetrating instruments on detonation inspectors during anesthetizing oper- deliver bolts of varying diameters and ations and at other times. An exhaust lengths through the skull and into the system must be provided so that, in brain. Unconsciousness is produced im- case of equipment failure, non-uniform mediately by physical brain destruc- carbon dioxide concentrations in the tion and a combination of changes in gas tunnel or contamination of the am- intracranial pressure and acceleration bient air of the establishment will be concussion. Nonpenetrating or mush- prevented. room stunners on detonation deliver a bolt with a flattened circular head [44 FR 68813, Nov. 30, 1979, as amended at 59 against the external surface of the ani- FR 21640, Apr. 26, 1994] mal’s head over the brain. Diameter of § 313.15 Mechanical; captive bolt. the striking surface of the stunner may vary as conditions require. Uncon- The slaughtering of sheep, swine, sciousness is produced immediately by goats, calves, cattle, horses, mules, and a combination of acceleration concus- other equines by using captive bolt stunners and the handling in connec- sion and changes in intracranial pres- tion therewith, in compliance with the sures. A combination instrument uti- provisions contained in this section, lizing both penetrating and nonpene- are hereby designated and approved as trating principles is acceptable. Ener- humane methods of slaughtering and gizing of instruments may be accom- handling of such animals under the plished by detonation of measured Act. charges of gunpowder or accurately (a) Application of stunners, required ef- controlled compressed air. Captive fect; handling. (1) The captive bolt stun- bolts shall be of such size and design ners shall be applied to the livestock in that, when properly positioned and ac- accordance with this section so as to tivated, immediate unconsciousness is produce immediate unconsciousness in produced. the animals before they are shackled, (ii) To assure uniform unconscious- hoisted, thrown, cast, or cut. The ani- ness with every blow, compressed air mals shall be stunned in such a manner devices must be equipped to deliver the that they will be rendered unconscious necessary constant air pressure and with a minimum of excitement and dis- must have accurate, constantly operat- comfort. ing air pressure gauges. Gauges must (2) The driving of the animals to the be easily read and conveniently located stunning area shall be done with a min- for use by the stunning operator and imum of excitement and discomfort to the inspector. For purposes of protect- the animals. Delivery of calm animals ing employees, inspectors, and others, to the stunning areas is essential since it is desirable that any stunning device accurate placement of stunning equip- be equipped with safety features to pre- ment is difficult on nervous or injured vent injuries from accidental dis- animals. Among other things, this re- charge. Stunning instruments must be quires that, in driving animals to the maintained in good repair.
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(iii) The stunning area shall be so de- mane methods of slaughtering and han- signed and constructed as to limit the dling of such animals under the Act. free movements of animals sufficiently (a) Utilization of firearms, required ef- to allow the operator to locate the fect; handling. (1) The firearms shall be stunning blow with a high degree of ac- employed in the delivery of a bullet or curacy. All chutes, alleys, gates and re- projectile into the animal in accord- straining mechanisms between and in- ance with this section so as to produce cluding holding pens and stunning immediate unconsciousness in the ani- areas shall be free from pain-producing mal by a single shot before it is shack- features such as exposed bolt ends, led, hoisted, thrown, cast, or cut. The loose boards, splintered or broken animal shall be shot in such a manner planking, and protruding sharp metal that they will be rendered unconscious of any kind. There shall be no unneces- with a minimum of excitement and dis- sary holes or other openings where feet comfort. or legs of animals may be injured. (2) The driving of the animals to the Overhead drop gates shall be suitably shooting areas shall be done with a covered on the bottom edge to prevent minimum of excitement and discom- injury on contact with animals. Rough- fort to the animals. Delivery of calm ened or cleated cement shall be used as animals to the shooting area is essen- flooring in chutes leading to stunning tial since accurate placement of the areas to reduce falls of animals. bullet is difficult in case of nervous or Chutes, alleys, and stunning areas injured animals. Among other things, shall be so designed that they will com- this requires that, in driving animals fortably accommodate the kinds of ani- to the shooting areas, electrical equip- mals to be stunned. ment be used as little as possible and (iv) The stunning operation is an ex- with the lowest effective voltage. acting procedure and requires a well- (3) Immediately after the firearm is trained and experienced operator. He discharged and the projectile is deliv- must be able to accurately place the ered, the animal shall be in a state of stunning instrument to produce imme- complete unconsciousness and remain diate unconsciousness. He must use the in this condition throughout shackling, correct detonating charge with regard sticking and bleeding. to kind, breed, size, age, and sex of the (b) Facilities and procedure—(1) Gen- animal to produce the desired results. eral requirements for shooting facilities; operator. (i) On discharge, acceptable (2) Special requirements. Choice of in- firearms dispatch free projectiles or strument and force required to produce bullets of varying sizes and diameters immediate unconsciousness varies, de- through the skull and into the brain. pending on kind, breed, size, age, and Unconsciousness is produced imme- sex of the animal. Young swine, lambs, diately by a combination of physical and calves usually require less stun- brain destruction and changes in ning force than mature animals of the intracranial pressure. Caliber of fire- same kind. Bulls, rams, and boars usu- arms shall be such that when properly ally require skull penetration to aimed and discharged, the projectile produce immediate unconsciousness. produces immediate unconsciousness. Charges suitable for smaller kinds of (ii) To assure uniform unconscious- livestock such as swine or for young ness of the animal with every discharge animals are not acceptably inter- where small-bore firearms are em- changed for use on larger kinds or ployed, it is necessary to use one of the older livestock, respectively. following type projectiles: Hollow pointed bullets; frangible iron plastic § 313.16 Mechanical; gunshot. composition bullets; or powdered iron The slaughtering of cattle, calves, missiles. When powdered iron missiles sheep, swine, goats, horses, mules, and are used, the firearms shall be in close other equines by shooting with fire- proximity with the skull of the animal arms and the handling in connection when fired. Firearms must be main- therewith, in compliance with the pro- tained in good repair. For purposes of visions contained in this section, are protecting employees, inspectors and hereby designated and approved as hu- others, it is desirable that all firearms
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be equipped with safety devices to pre- electric current shall be done with a vent injuries from accidental dis- minimum of excitement and discom- charge. Aiming and discharging of fire- fort to the animals. Delivery of calm arms should be directed away from op- animals to the place of application is erating areas. essential to ensure rapid and effective (iii) The provisions contained in insensibility. Among other things, this § 313.15(b)(1)(iii) with respect to the requires that, in driving animals to the stunning area also apply to the shoot- place of application, electrical equip- ing area. ment be used as little as possible and (iv) The shooting operation is an ex- with the lowest effective voltage. acting procedure and requires a well- (3) The quality and location of the trained and experienced operator. He electrical shock shall be such as to must be able to accurately direct the produce immediate insensibility to projectile to produce immediate uncon- pain in the exposed animal. sciousness. He must use the correct (4) The stunned animal shall remain caliber firearm, powder charge and in a state of surgical anesthesia type of ammunition to produce the de- through shackling, sticking, and bleed- sired results. ing. (2) Special requirements. Choice of fire- (b) Facilities and procedures; operator— arms and ammunition with respect to (1) General requirements for operator. It caliber and choice of powder charge re- is necessary that the operator of elec- quired to produce immediate uncon- tric current application equipment be sciousness of the animal may vary de- skilled, attentive, and aware of his or pending on age and sex of the animal. her responsibility. In the case of bulls, rams, and boars, (2) Special requirements for electric cur- small bore firearms may be used pro- rent application equipment. The ability vided they are able to produce imme- of electric current equipment to per- diate unconsciousness of the animals. form with maximum efficiency is de- Small bore firearms are usually effec- pendent on its proper design and effi- tive for stunning other cattle, sheep, cient mechanical operation. Pathways, swine, and goats, and calves, horses, compartments, current applicators, and mules. and all other equipment used must be designed to properly accommodate the § 313.30 Electrical; stunning or slaugh- species of animals being anesthetized. tering with electric current. Animals shall be free from pain-pro- The slaughtering of swine, sheep, ducing restraining devices. Injury of calves, cattle, and goats with the use of animals must be prevented by the electric current and the handling in elimination of sharp projections or ex- connection therewith, in compliance posed wheels or gears. There shall be with the provisions contained in this no unnecessary holes, spaces or open- section, are hereby designated and ap- ings where feet or legs of animals may proved as humane methods of slaugh- be injured. Impellers or other devices tering and handling of such animals designed to mechanically move or under the Act. drive animals or otherwise keep them (a) Administration of electric current, in motion or compartmentalized shall required effect; handling. (1) The electric be constructed of flexible or padded current shall be administered so as to material. Power activated gates de- produce, at a minimum, surgical anes- signed for constant flow of animals thesia, i.e., a state where the animal shall be so fabricated that they will feels no painful sensation. The animals not cause injury. All equipment used to shall be either stunned or killed before apply and control the electrical cur- they are shackled, hoisted, thrown, rent shall be maintained in good re- cast, or cut. They shall be exposed to pair, and all indicators, instruments, the electric current in a way that will and measuring devices shall be avail- accomplish the desired result quickly able for inspection by Program inspec- and effectively, with a minimum of ex- tors during the operation and at other citement and discomfort. times. (2) The driving or conveying of the (3) Electric current. Each animal shall animals to the place of application of be given a sufficient application of
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electric current to ensure surgical an- inspector. All livestock slaughtered esthesia throughout the bleeding oper- prior to the tagging may be dressed, ation. Suitable timing, voltage and processed, or prepared under inspec- current control devices shall be used to tion. ensure that each animal receives the (c) If the cause of inhumane treat- necessary electrical charge to produce ment is the result of improper stun- immediate unconsciousness. The cur- ning, the inspector shall attach a ‘‘U.S. rent shall be applied so as to avoid the Rejected’’ tag to the stunning area. production of hemorrhages or other tis- Stunning procedures shall not be re- sue changes which could interfere with sumed until the inspector receives sat- inspection procedures. isfactory assurances from the estab- [44 FR 68813, Nov. 30, 1979, as amended at 50 lishment operator that there will not FR 25202, June 18, 1985] be a recurrence. The tag shall not be removed by anyone other than an in- § 313.50 Tagging of equipment, alley- ways, pens, or compartments to pre- spector. All livestock slaughtered prior vent inhumane slaughter or han- to such tagging may be dressed, proc- dling in connection with slaughter. essed, or prepared under inspection. When an inspector observes an inci- dent of inhumane slaughter or han- § 313.90 [Reserved] dling in connection with slaughter, he/ she shall inform the establishment op- PART 314—HANDLING AND DIS- erator of the incident and request that POSAL OF CONDEMNED OR the operator take the necessary steps OTHER INEDIBLE PRODUCTS AT to prevent a recurrence. If the estab- OFFICIAL ESTABLISHMENTS lishment operator fails to take such ac- tion or fails to promptly provide the Sec. inspector with satisfactory assurances 314.1 Disposition of condemned products at that such action will be taken, the in- official establishments having tanking spector shall follow the procedures facilities; sealing of tanks. specified in paragraph (a), (b), or (c) of 314.2 Tanking and other facilities for ined- this section, as appropriate. ible products to be separate from edible (a) If the cause of inhumane treat- product facilities. ment is the result of facility defi- 314.3 Disposition of condemned products at ciencies, disrepair, or equipment official establishments having no breakdown, the inspector shall attach tanking facilities. a ‘‘U.S. Rejected’’ tag thereto. No 314.4 Suppression of odors in preparing ined- equipment, alleyway, pen or compart- ible products. ment so tagged shall be used until 314.5 Inedible rendered fats prepared at offi- cial establishments. made acceptable to the inspector. The 314.6 Inedible fats from outside official es- tag shall not be removed by anyone tablishments. other than an inspector. All livestock 314.7 Carcasses of livestock condemned on slaughtered prior to such tagging may ante-mortem inspection not to pass be dressed, processed, or prepared through edible product areas. under inspection. 314.8 Dead animal carcasses. (b) If the cause of inhumane treat- 314.9 Specimens for educational, research, ment is the result of establishment em- and other nonfood purposes; permits for, ployee actions in the handling or mov- required. ing of livestock, the inspector shall at- 314.10 Livers condemned because of para- tach a ‘‘U.S. Rejected’’ tag to the al- sitic infestation and for other causes; leyways leading to the stunning area. conditions for disposal for purposes other than human food. After the tagging of the alleyway, no 314.11 Handling of certain condemned prod- more livestock shall be moved to the ucts for purposes other than human food. stunning area until the inspector re- ceives satisfactory assurances from the AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, establishment operator that there will 2.55. not be a recurrence. The tag shall not SOURCE: 35 FR 15575, Oct. 3, 1970, unless be removed by anyone other than an otherwise noted.
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§ 314.1 Disposition of condemned prod- (c) Carcasses of animals condemned ucts at official establishments hav- under § 309.3 of this subchapter may be ing tanking facilities; sealing of disposed of as provided in § 314.3, in lieu tanks. of tanking, with the approval of the in- (a) Carcasses, parts of carcasses, and spector. other products condemned at official establishments having facilities for § 314.2 Tanking and other facilities for tanking shall, except as provided in inedible products to be separate paragraph (c) of this section or else- from edible product facilities. where in this part, be disposed of by All tanks and equipment used for tanking as follows: rendering, otherwise preparing, or stor- (1) The lower opening of the tank ing inedible products shall be in rooms shall first be sealed securely by a Pro- or compartments separate from those gram employee, except when perma- used for preparing or storing edible nently connected with a blow line; then products. There shall be no connection the condemned products shall be placed between rooms or compartments con- in the tank in his presence, after which the upper opening shall also be sealed taining inedible products and those securely by such employee, who shall containing edible products, except that then see that the contents of the tank there may be one connecting doorway are subjected to sufficient heating for between the slaughtering or viscera sufficient time to effectively destroy separating department and the tank the contents for human food purposes. charging room of the inedible products (2) The use of equipment such as rendering department. Pipes and crushers or hashers for pretanking chutes installed in accordance with preparation of condemned products in such arrangements as are permitted by the inedible products department has part 308 of this subchapter, or as may been found to give inedible character be approved by the Administrator in and appearance to the material. Ac- specific cases, may be used to convey cordingly, if condemned products are inedible and condemned material from so crushed or hashed, conveying sys- edible product departments to inedible tems, rendering tanks, and other equip- product departments. ment used in the further handling of crushed or hashed material need not be § 314.3 Disposition of condemned prod- locked or sealed during the tanking op- ucts at official establishments hav- erations. If the rendering tanks or ing no tanking facilities. other equipment contain condemned (a) Carcasses, parts of carcasses, and material not so crushed or hashed, the other products condemned at an offi- equipment shall be sealed as prescribed cial establishment which has no facili- in paragraph (a)(1) of this section. If ties for tanking shall, except as pro- the crushed or hashed material is not vided in paragraph (b) of this section or rendered in the establishment where elsewhere in this part, be destroyed in produced, it shall be denatured as pro- the presence of an inspector by inciner- vided for in § 314.3 before leaving such ation, or denatured with crude carbolic establishment. (b) The seals of tanks shall be broken acid, or cresylic disinfectant, or a for- only by a Program employee and only mula consisting of one part FD&C No. after the contents of the tanks have 3 green coloring, 40 parts water, 40 been treated as provided in paragraph parts liquid detergent, and 40 parts oil (a) of this section. The rendered fat de- of citronella or any other proprietary rived from condemned material shall material approved by the Adminis- be held until a Program employee shall trator in specific cases. When such have had an opportunity to determine product is to be denatured, it shall be whether it conforms with the require- freely slashed before the denaturing ments of this section. Samples shall be agent is applied, except that, in the taken by Program employees as often case of dead animals that have not as is necessary to determine whether been dressed, the denaturant may be the rendered fat is effectually dena- applied by injection. The denaturant tured. must be deposited in all portions of the
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carcass or product to the extent nec- the premises; nor shall such fats be re- essary to preclude its use for food pur- ceived in such volume as interferes poses. with prompt disposal of condemned or (b) All carcasses and parts con- other inedible material produced at the demned on account of anthrax, as iden- establishment. When received, they tified in § 310.9(b) of this subchapter, at shall not enter any room or compart- official establishments which are not ment used for edible products. equipped with tanking facilities shall be disposed of by (1) complete inciner- [35 FR 15575, Oct. 3, 1970, as amended at 53 FR ation, or (2) by thorough denaturing 24679, June 30, 1988] with crude carbolic acid, or cresylic disinfectant, and then disposed of in § 314.7 Carcasses of livestock con- accordance with the requirements of demned on ante-mortem inspection the particular State or municipal au- not to pass through edible product areas. thorities, who shall be notified imme- diately by the area supervisor. Carcasses of livestock which have been condemned on ante-mortem in- § 314.4 Suppression of odors in prepar- spection shall not be taken through ing inedible products. rooms or compartments in which an Tanks, fertilizer driers, and other edible product is prepared, handled, or equipment used in the preparation of stored. inedible product shall be properly equipped with condensers and other ap- § 314.8 Dead animal carcasses. pliances which will acceptably suppress (a) With the exception of dead live- odors incident to such preparation. stock which have died en route and are § 314.5 Inedible rendered fats pre- received with livestock for slaughter at pared at official establishments. an official establishment, no dead ani- mal or part of the carcass of any live- Except as provided in § 325.11(b) of stock that died otherwise than by this subchapter, rendered animal fat derived from condemned or other ined- slaughter may be brought on the prem- ible materials at official establish- ises of an official establishment unless ments shall be denatured to effectually advance permission therefore is ob- distinguish it from an edible product, tained from the circuit supervisor. either with low grade offal during the (b) Under no circumstances shall the rendering or by adding to, and mixing carcasses of any animal which has died thoroughly with, such fat, denaturing otherwise than by slaughter, or any oil, No. 2 fuel oil, or brucine dissolved part thereof, be brought into any room in a mixture of alcohol and pine oil or or compartment in which any edible oil of rosemary, and may be shipped in product is prepared, handled, or stored. commerce in accordance with § 325.11(c) of this subchapter. § 314.9 Specimens for educational, re- search, and other nonfood pur- [35 FR 15575, Oct. 3, 1970, as amended at 53 FR poses; permits for, required. 24679, June 30, 1988] (a) Specimens of condemned or other § 314.6 Inedible fats from outside offi- inedible materials, including embryos cial establishments. and specimens of animal parasites, Except as provided in § 325.11(b) of may be released for educational, re- this subchapter, inedible fats from out- search, or other nonfood purposes side the premises of any official estab- under permit issued by the inspector in lishment shall not be received into an charge: Provided, That the person desir- official establishment except into the ing such specimens makes a written tank room provided for inedible prod- application to the inspector in charge ucts, and then only when they have for such permit on Form MP–403–10 and been denatured in accordance with arranges with and receives permission § 314.5 and are marked in accordance from the official establishment to ob- with § 316.15 of this subchapter, and tain the specimens. Permits shall be when their receipt into the tank room issued for a period not longer than 1 produces no insanitary condition on year. The permit may be revoked by
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the inspector in charge if the speci- this section shall be in containers mens are not used as stated in the ap- plainly marked ‘‘inedible’’. plication, or if the collection or han- [41 FR 23701, June 11, 1976] dling of the specimens interferes with inspection or the maintenance of sani- § 314.11 Handling of certain con- tary conditions in the establishment. demned products for purposes (b) The specimens referred to in para- other than human food. graph (a) of this section shall be col- Condemned carcasses of animals af- lected and handled only at such time fected with one or more of the follow- and place and in such manner as not to ing conditions may be shipped from an interfere with the inspection or to official establishment only for pur- cause any objectionable condition and poses other than human food and only shall be identified as inedible when if permission therefor is obtained from they leave the establishment. the circuit supervisor: Anasarca, Ocu- lar Squamous Cell Carcinoma (after re- [35 FR 15575, Oct. 3, 1970, as amended at 38 FR moval of neoplastic tissue), emacia- 18665, July 13, 1973; 39 FR 36000, Oct. 7, 1974] tion, eosinophilic myositis, immatu- rity, nonseptic bruises and injuries, § 314.10 Livers condemned because of and sarcosporidiosis. This provision parasitic infestation and for other also applies to unborn calves and to causes; conditions for disposal for products such as paunches and udders purposes other than human food. when they have not been handled as re- (a) Livers condemned on account of quired under this subchapter for prod- hydatid cysts shall be disposed of by ucts for human food purposes; pro- tanking pursuant to the provisions of vided, such articles have not been con- § 314.1 of this subchapter if condemned demned for other pathological reasons. at official establishments having facili- Such permission will be granted only if ties for tanking; otherwise they shall all parts to be so used will be promptly be destroyed pursuant to the provisions handled, freely slashed and adequately of § 314.3 of this subchapter. identified as required by § 325.13(a)(2) of (b) Livers condemned because of this subchapter. The slashing, identi- parasites other than hydatid cysts; and fication and packing of the product livers condemned because of shall be accomplished in an inedible product area under the supervision of telangiectasis, angioma, ‘‘sawdust’’ an inspector. Facilities must be ade- condition, cirrhosis, carotenosis, or quate so that the carcasses or parts other nonmalignant change, benign ab- saved under these provisions are not scesses, or contamination, when these contaminated with pus, manure, septic, conditions are not associated with in- or toxic materials, or similar sub- fectious diseases in the carcasses, may stances. The operation must not result be shipped from an official establish- in insanitary conditions within the es- ment only for purposes other than tablishment. human food, and only if all tissue af- fected with abscesses is removed and [35 FR 15575, Oct. 3, 1970, as amended at 36 FR destroyed within the establishment, 11639, June 17, 1971; 36 FR 11903, June 23, 1971] and all livers are processed and dena- tured, with any agent prescribed in PART 315—RENDERING OR OTHER § 325.13(a)(1) or (2) or (5), and in accord- DISPOSAL OF CARCASSES AND ance with § 325.13(a)(6) of this sub- PARTS PASSED FOR COOKING chapter. This provision for movement from an official establishment is made Sec. solely under the Federal Meat Inspec- 315.1 Carcasses and parts passed for cook- tion Act and is not intended to relieve ing; rendering into lard or tallow. 315.2 Carcasses and parts passed for cook- or modify any other applicable require- ing; utilization for food purposes after ments under any other law regarding cooking. the movement of such articles, for pur- 315.3 Disposal of products passed for cook- poses other than use as human food. ing if not handled according to this part. (c) Livers condemned because of con- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, ditions described in paragraph (b) of 2.55.
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§ 315.1 Carcasses and parts passed for § 315.3 Disposal of products passed for cooking; rendering into lard or tal- cooking if not handled according to low. this part. Carcasses and parts passed for cook- Products passed for cooking if not ing may be rendered into lard in ac- handled and processed in accordance cordance with § 319.702 of this sub- with the provisions of this part, shall chapter or rendered into tallow, pro- be disposed of in accordance with § 314.1 vided such rendering is done in the fol- or § 314.3 of this subchapter. lowing manner: [35 FR 15577, Oct. 3, 1970. Redesignated at 37 (a) When closed rendering equipment FR 2661, Feb. 4, 1972] is used, the lower opening, except when permanently connected with a PART 316—MARKING PRODUCTS blowline, shall first be sealed securely AND THEIR CONTAINERS by a Program employee; then the car- casses or parts shall be placed in such Sec. equipment in his presence, after which 316.1 Authorization required to make de- the upper opening shall be securely vices bearing official marks. sealed by such employee. When the 316.2 Approval required for official marks. product passed for cooking in the tank 316.3 Use of official marks prohibited except does not consist of a carcass or whole under supervision of Program employee; removal of official marks, when required. primal part, the requirements for seal- 316.4 Marking devices; to be furnished by of- ing shall be at the discretion of the cir- ficial establishments; control of. cuit supervisor. Such carcasses and 316.5 Branding ink; to be furnished by offi- parts shall be cooked for a time suffi- cial establishments; approval by Pro- cient to render them effectually into gram; color. lard or tallow, provided all parts of the 316.6 Products not to be removed from offi- products are heated to a temperature cial establishments unless marked in ac- ° cordance with the regulations. not lower than 170 F. for a period of 316.7 Marking devices not to be false or mis- not less than 30 minutes. leading; style and size of lettering; ap- (b) At establishments not equipped proval required. with closed rendering equipment for 316.8 Unmarked inspected products; moved rendering carcasses and parts passed between official establishments; moved for cooking into lard and tallow, such in commerce. 316.9 Products to be marked with official carcasses or parts may be rendered in marks. open kettles under the direct super- 316.10 Marking of meat food products with vision of a Program employee. Such official inspection legend and ingredient rendering shall be done during regular statement. hours of work and in compliance with 316.11 Special markings for certain meat the requirements as to temperature food products. and time specified in paragraph (a) of 316.12 Marking of equine carcasses and parts thereof. this section. 316.13 Marking of outside containers. [35 FR 15577, Oct. 3, 1970, as amended at 43 FR 316.14 Marking tank cars and tank trucks 25420, June 13, 1978] used in transportation of edible products. 316.15 Marking outside containers of ined- § 315.2 Carcasses and parts passed for ible grease, etc. cooking; utilization for food pur- 316.16 Custom prepared products to be poses after cooking. marked ‘‘Not for Sale.’’ AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, Carcasses and parts passed for cook- 2.55. ing may be used for the preparation of meat food products, provided all such SOURCE: 35 FR 15577, Oct. 3, 1970, unless carcasses or parts are heated to a tem- otherwise noted. ° perature not lower than 170 F. for a § 316.1 Authorization required to make period of not less than 30 minutes ei- devices bearing official marks. ther before being used in or during the No brand manufacturer, printer or preparation of the finished product. other person shall cast, print, litho- [37 FR 2661, Feb. 4, 1972] graph, or otherwise make or cause to
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be made any device containing any of- Territory exempted under paragraph ficial mark or simulation thereof with- 23(b) of the Act. out prior written authority therefor from the Administrator as provided for § 316.4 Marking devices; to be fur- in part 317 of this subchapter. nished by official establishments; control of. § 316.2 Approval required for official (a) The operator of each official es- marks. tablishment or official import inspec- No device containing any official tion establishment shall furnish such mark shall be made or caused to be ink brands, burning brands, and any made for use on any product until it other device for marking products with has been approved by the Adminis- official marks as the Administrator trator as provided for in part 317 of this may determine is necessary for mark- subchapter. ing products at such establishment. The official inspection legend on such a § 316.3 Use of official marks prohibited device shall be as prescribed in part 312 except under supervision of Pro- of this subchapter. gram employee; removal of official (b) All official devices for marking marks, when required. products with the official inspection (a) No person shall affix or place, or legend, or other official inspection cause to be affixed or placed, the offi- marks, including self-locking seals, cial inspection legend or any other offi- shall be used only under supervision of cial mark, or any abbreviation or sim- a Program employee, and, when not in ulation of any official mark, to or on use for marking shall be kept locked in any product, or container thereof, ex- properly equipped locks or compart- cept under the supervision of a Pro- ments, the keys of which shall not gram employee, or as authorized by leave the possession of a Program em- part 317 of this subchapter in connec- ployee, or the locker or compartment tion with the manufacture of contain- shall be sealed with an official seal of ers. the Department as prescribed in part (b) No person shall fill, or cause to be 312 of this subchapter. filled, in whole or in part, with any [35 FR 15577, Oct. 3, 1970, as amended at 36 FR product, any container bearing or in- 12004, June 24, 1971; 46 FR 38072, July 24, 1981] tended to bear any official mark, or any abbreviation or simulation of any § 316.5 Branding ink; to be furnished official mark, except under the super- by official establishments; approval vision of a Program employee. by Program; color. (c) Product bearing any official mark (a) The operator of each official es- shall not be canned, cooked, cured, tablishment shall furnish all ink for smoked, salted, packed, rendered, or marking products with the official otherwise prepared by any person for marks at such establishment. Such ink commercial purposes unless: must be made with harmless ingredi- (1) Such preparation is performed at ents that are approved for the purpose an official establishment; or by the Administrator. Samples of inks (2) Such preparation is conducted shall be submitted to the Program lab- under State or other governmental in- oratory from time to time as may be spection and the prepared product is deemed necessary by the inspector in marked to show that fact; or charge. (3) The official marks are removed, (b) Only ink approved for the purpose defaced, or otherwise destroyed before shall be used to apply ink brands bear- or during such preparation; or ing official marks to carcasses of cat- (4) The preparation of the product tle, sheep, swine, or goats and fresh consists solely of cutting up operations meat cuts derived therefrom. Any ink at any establishment exempted from containing F.D. & C. Violet No. 1 shall inspection under paragraph 301(c)(2) of not be considered an approved ink the Act or equal provisions of a law of within the meaning of this paragraph. a State or organized Territory or at (c) Green ink shall not be used to any establishment in an unorganized apply marks to carcasses of cattle,
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sheep, swine, or goats or fresh meat be transported in compliance with part cuts derived therefrom. 325 of this subchapter from one official (d) Except as provided in paragraphs establishment to another official es- (b) and (c) of this section, branding ink tablishment, for further processing, in of any color, approved for the purpose a railroad car, truck, or other closed by the Administrator in specific cases, container, if the railroad car, truck, or may be used to apply ink brands, bear- container is sealed with an official seal ing official marks, to processed meat of the Department (as prescribed in cuts derived from cattle, sheep, swine, part 312 of this subchapter) bearing the or goats. official inspection legend. (e) Only green ink approved for the (b) Products which have been in- purpose shall be used to apply ink spected and passed but do not bear the brands bearing official marks to car- official inspection legend may be re- casses and parts of carcasses and meat moved from an official establishment cuts derived from horses, mules, and in closed containers bearing the offi- other equines. cial inspection legend and all other in- (f) Ink used must assure legibility formation required by this part and and permanence of the markings and part 317 of this subchapter: Provided, the color of ink shall provide accept- That upon removal from such closed able contrast with the color of the container the product may not be fur- product to which it is applied. ther transported in commerce unless [35 FR 15577, Oct. 3, 1970, as amended at 38 FR such removal is made under the super- 9088, Apr. 10, 1973] vision of a Program employee and such product is reinspected by a Program § 316.6 Products not to be removed employee and packed under his super- from official establishments unless vision in containers bearing the official marked in accordance with the reg- inspection legend and all other infor- ulations. mation required by this part and part No person shall remove or cause to be 317 of this subchapter: And provided fur- removed from an official establishment ther, That unmarked product shall not any products which the regulations in be brought into an official establish- this subchapter require to be marked ment in an open container. in any way unless they are clearly and legibly marked in compliance with § 316.9 Products to be marked with of- such regulations. ficial marks. § 316.7 Marking devices not to be false (a) Each carcass which has been in- or misleading; style and size of let- spected and passed in an official estab- tering; approval required. lishment shall be marked at the time No brand or other marking device of inspection with the official inspec- shall be false or misleading. The letters tion legend containing the number of and figures thereon shall be of such the official establishment. style and type as will make a clear and (b) Except as provided otherwise in legible impression. All markings to be § 316.8, each primal part of a carcass applied to products in an official estab- and each liver, beef tongue, and beef lishment shall be approved prior to use heart which has been inspected and by the Administrator as provided for in passed shall be marked with the offi- § 317.3 of this subchapter, except that cial inspection legend containing the official markings prescribed by the number of the official establishment Federal meat grading regulations (7 before it leaves the establishment in CFR 53.19) need not be submitted to the which it is first inspected and passed, Administrator for approval. and each such inspected and passed product shall be marked with the offi- § 316.8 Unmarked inspected products; cial inspection legend containing the moved between official establish- number of the official establishment ments; moved in commerce. where it was last prepared. Additional (a) Unmarked products which have official marks of inspection may be ap- been inspected and passed but do not plied to products as desired to meet bear the official inspection legend may local conditions. Primal parts are the
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wholesale cuts of carcasses as cus- pacity, when shipped to another offi- tomarily distributed to retailers. The cial establishment for further process- round, flank, loin, rib, plate, brisket, ing or to a governmental agency, need chuck, and shank are primal parts of only have the official inspection legend beef carcasses. Veal, mutton, and goat and list of ingredients shown twice primal parts are the leg; flank, loin, throughout the contents of the con- rack, breast, and shoulder. The ham, tainer. When such products are shipped belly, loin, shoulder, and jowl are pork to another official establishment for primal parts. Equine primal parts are further processing, the inspector in the round, flank, loin, rib, plate, bris- charge at the point of origin shall iden- ket, chuck, and shank. tify the shipment to the inspector in (c) Beef livers shall be marked with charge at destination by means of the official inspection legend contain- Form MP 408–1. ing the number of the official estab- (c) The list of ingredients may be ap- lishment, at which the cattle involved plied by stamping, printing, using were slaughtered, on the convex sur- paper bands, tags, or tissue strips, or face of the thickest portion of the other means approved by the Adminis- organ. trator in specific cases. (d) Inspected and passed parts of car- (d) All cured products shall be casses which are not marked with the marked with the list of ingredients in official inspection legend under this accordance with part 317 of this sub- section shall not enter any official es- chapter. tablishment or be sold, transported, or [35 FR 15577, Oct. 3, 1970, as amended at 37 FR offered for sale or transportation, in 16863, Aug. 22, 1972; 38 FR 4385, Feb. 14, 1973; commerce, except as provided in § 316.8. 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, [35 FR 15577, Oct. 3, 1970, as amended at 36 FR 1979] 23720, Dec. 14, 1971] § 316.11 Special markings for certain § 316.10 Marking of meat food prod- meat food products. ucts with official inspection legend (a) Meat food products prepared in and ingredient statement. casing or link form (whether or not (a) Inspected and passed sausages and thereafter subdivided), other than sau- other products in casings or in link sage, which possess the characteristics form, of the ordinary ‘‘ring’’ variety or of or resemble sausage, shall bear on larger shall be marked with the official each link or piece the word ‘‘imita- inspection legend and list of ingredi- tion’’ prominently displayed: Provided, ents in accordance with part 317 of this That the following need not be so subchapter. The official marks re- marked if they bear on each link or quired by this section shall be branded piece the name of the product in ac- near each end of the sausage or similar cordance with § 317.2 of this subchapter: product prepared in casings when the Such products as coppa, capocollo, product is of a size larger than that lachschinken, bacon, pork loins, pork customarily sold at retail intact. shoulder butts, and similar cuts of (b) Inspected and passed sausage and meat which are prepared without added other products, in casings or in link substance other than curing materials form, of the smaller varieties, shall or condiments; meat rolls, bockwurst, bear one or more official inspection and similar products which do not con- legends and one or more lists of ingre- tain cereal or vegetables; headcheese, dients in accordance with part 317 of souse, sulze, scrapple, blood pudding, this subchapter on each kilogram (2.205 and liver pudding; and other products lbs.) of product, except where such such as loaves, chili con carne, and products leave the official establish- meat and cheese products when pre- ment completely enclosed in properly pared with sufficient cheese to give labeled immediate containers having a definite characteristics to the finished capacity of 5 kilograms (11.025 lbs.) or products: And provided further, That less and containing a single kind of imitation sausage packed in properly product: Provided, That such products labeled containers having a capacity of in properly labeled closed containers 3 pounds or less and of a kind usually exceeding 5 kilograms (11.025 lbs.) ca- sold at retail intact, need not bear the
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word ‘‘imitation’’ on each link or piece markings shall not be required if the if no other marking or labeling is ap- sausages are packed in properly labeled plied directly to the product. containers having a capacity of 3 (b) When cereal, vegetable starch, pounds or less and of a kind usually starchy vegetable flour, soy flour, soy sold at retail intact. Further, all mark- protein concentrate, isolated soy pro- ings otherwise required by this section tein, dried milk, nonfat dry milk, or (except those required by paragraph (a) calcium reduced dried skim milk is of this section) may be omitted from added to sausage in casing or in link the casings of sausage and other meat form within the limits prescribed in food products when these products are part 319 of this subchapter, the prod- to be processed in sealed metal con- ucts shall be marked with the name of tainers properly labeled in accordance each added ingredient, as for example with the requirements in part 317 of ‘‘cereal added,’’ ‘‘potato flour added,’’ this subchapter. ‘‘cereal and potato flour added,’’ ‘‘soy (f) When an approved antioxidant is flour added,’’ ‘‘isolated soy protein added to any meat food product as per- added,’’ ‘‘nonfat dry milk added,’’ ‘‘cal- mitted in parts 318 and 319 of this sub- cium reduced dried skim milk added,’’ chapter, the products shall be legibly or ‘‘cereal and nonfat dry milk added,’’ and conspicuously marked in an ap- as the case may be. proved manner identifying the specific (c)(1) When product is placed in a cas- antioxidant used by its common name ing to which artificial coloring is or approved abbreviation and the pur- thereafter applied, as permitted in part pose for which it is added, such as, 318 of this subchapter, the product ‘‘BHA, BHT, and Propylgallate added shall be legibly and conspicuously to help protect flavor.’’ marked by stamping or printing on the (g) Sausage of the dry varieties treat- casing the words ‘‘artificially colored.’’ ed with potassium sorbate or (2) If a casing is removed from prod- propylparaben (propyl p-hydroxyben- uct at an official establishment and zoate) as permitted by part 318 of this there is evidence of artificial coloring subchapter shall be marked as pre- on the surface of the product, the prod- scribed in § 317.8(b)(28) of this sub- uct from which the casing has been re- chapter). moved shall be marked by stamping di- rectly thereon the words ‘‘artificially § 316.12 Marking of equine carcasses colored.’’ and parts thereof. (3) The casing containing product need not be marked to show that it is (a) All inspected and passed equine colored if it is colored prior to its use carcasses and parts thereof prepared at as a covering for the product, and the any establishment shall be conspicu- coloring is of a kind and so applied as ously marked at the time of inspection not to be transferable to the product with the official inspection legend as and not to be misleading or deceptive prescribed in § 312.3 of this subchapter in any respect. and with other information prescribed (d) When an approved artificial for marking products in this part. smoke flavoring or an approved smoke (b) All equine carcasses and meat and flavoring is added to the formula of other parts thereof shall be marked to any meat food product as permitted in show the kinds of animals from which part 318 of this subchapter, the product they were derived, before the products shall be legibly and conspicuously are sold, transported, offered for sale or marked with the words ‘‘Artificial transportation, or received for trans- Smoke Flavoring Added’’ or ‘‘Smoke portation in commerce. Flavoring Added,’’ whichever may be applicable. § 316.13 Marking of outside containers. (e) Subject to the provisions in para- (a) Except as otherwise provided in graph (a) of this section, in the case of part 325 of this subchapter, when any sausage of the smaller varieties, the inspected and passed product for do- markings prescribed in this section mestic commerce is moved from an of- may be limited to links bearing the of- ficial establishment, the outside con- ficial inspection legend, and such tainer shall bear an official inspection
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legend as prescribed in part 312 of this erwise required under the regulations subchapter. in this subchapter. (b) When any product prepared in an (g) Stencils, box dies, labels, and official establishment for domestic brands may be used on shipping con- commerce has been inspected and tainers of properly labeled products passed and is enclosed in a cloth or and on such immediate containers, of other wrapping, such wrapping shall properly marked products, as tierces, bear the official inspection legend and barrels, drums, boxes, crates, and official establishment number applied large-size fiber-board containers, with- by the approved 21⁄2-inch rubber brand out approval as provided for in § 317.3 of in the form prescribed in part 312 of this subchapter: Provided, That the this subchapter: Provided, That the stencils, box dies, labels, and brands rubber brand may be omitted if the of- are not false or misleading and are ap- ficial inspection legend and official es- proved by the inspector in charge. The tablishment number on the product official inspection legend for use with itself are clearly legible through the such markings shall be approved by the wrapping or the wrapping is labeled in Administrator as provided for in part accordance with part 317 of this sub- 317 of this subchapter. chapter: Provided further, That plain unprinted wrappings, such as (h) The outside containers of livers stockinettes, cheesecloth, paper, and prepared as described in § 314.10(b), crinkled paper bags, for properly shall be marked as prescribed in marked products, which are used solely § 314.10(c) of this subchapter. to protect the product against soiling (i) The outside containers of any or excessive drying during transpor- equine product shall be marked to tation or storage, need not bear the of- show the kinds of animals from which ficial inspection legend. derived, when the products are sold, (c) The outside containers of prod- transported, offered for sale or trans- ucts for export shall be marked in com- ported, or received for transportation pliance with part 322 of this subchapter in commerce. as well as this part. [35 FR 15577, Oct. 3, 1970, as amended at 43 FR (d) Slack barrels used as outside con- 29268, July 7, 1978] tainers of products shall have a cloth or paper top covering bearing the offi- § 316.14 Marking tank cars and tank cial inspection legend containing the trucks used in transportation of ed- official establishment number. At the ible products. time of removal of the covering, the of- Each tank car and each tank truck ficial inspection legend shall be de- carrying inspected and passed product stroyed. from an official establishment shall (e) The outside containers of any bear a label containing the name of the product which has been inspected and product in accordance with § 317.2 of passed for cooking, pork which has this subchapter, the official inspection been refrigerated as provided in legend containing the number of the of- § 318.10(c) of this subchapter, and beef ficial establishment and the words which has been inspected and passed ‘‘date of loading,’’ followed by a suit- for refrigeration shall bear the mark- able space in which the date the tank ings and tag prescribed in § 325.7(b) of car or tank truck is loaded shall be in- this subchapter. serted. The label shall be located con- (f) The outside containers of glands spicuously and shall be printed on ma- and organs which are not used for terial of such character and so affixed human food purposes, such as those de- as to preclude detachment or efface- scribed in § 325.19 of this subchapter, ment upon exposure to the weather. shall be plainly marked with the Before the car or truck is removed phrase ‘‘For pharmaceutical purposes,’’ from the place where it is unloaded, ‘‘For organotherapeutic purposes’’ or the carrier shall remove or obliterate ‘‘For technical purposes,’’ as appro- such label. priate, with no reference to inspection, and need not bear other markings oth- [53 FR 28634, July 29, 1988]
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§ 316.15 Marking outside containers of 317.6 Approved labels to be used only on inedible grease, etc. products to which they are applicable. 317.7 Products for foreign commerce; print- (a) Outside containers of inedible ing labels in foreign language permis- grease, inedible tallow, or other ined- sible; other deviations. ible animal fat, or mixture of any such 317.8 False or misleading labeling or prac- articles, resulting from operations at tices generally; specific prohibitions and any official establishment shall be requirements for labels and containers. marked conspicuously with the word 317.9 Labeling of equine products. ‘‘inedible’’ prior to removal from the 317.10 Reuse of official inspection marks; reuse of containers bearing official point of filling. Containers, such as marks, labels, etc. tierces, barrels, and half barrels shall 317.11 Labeling, filling of containers, han- have both ends painted white with du- dling of labeled products to be only in rable paint, if necessary, to provide a compliance with regulations. contrasting background, and the word 317.12 Relabeling products; requirements. ‘‘inedible’’ shall be marked thereon in 317.13 Storage and distribution of labels and letters not less than 2 inches high, containers bearing official marks. while on tank cars and tank trucks the 317.14–317.15 [Reserved] letters shall be not less than 4 inches 317.16 Labeling and containers of custom prepared products. high. 317.17 Interpretation and statement of la- (b) Inspected rendered animal fat beling policy for cured products; special which is intended not to be used for labeling requirements concerning nitrate human food may also be marked ‘‘ined- and nitrite. ible’’ if handled as provided in para- 317.18 Quantity of contents labeling. graph (a) of this section and part 314 of 317.19 Definitions and procedures for deter- this subchapter. mining net weight compliance. 317.20 Scale requirements for accurate § 316.16 Custom prepared products to weights, repairs, adjustments, and re- be marked ‘‘Not for Sale.’’ placement after inspection. 317.21 Scales: testing of. Carcasses and parts therefrom that 317.22 Handling of failed product. are prepared on a custom basis under 317.23 [Reserved] § 303.1(a)(2) of this subchapter shall be 317.24 Packaging materials. marked at the time of preparation with the term ‘‘Not for Sale’’ in letters at Subpart B—Nutrition Labeling least three-eighths inch in height, ex- 317.300 Nutrition labeling of meat or meat cept that such products need not be so food products. marked if in immediate containers 317.301 [Reserved] properly labeled in accordance with the 317.302 Location of nutrition information. regulations in § 317.16 of this sub- 317.303–317.307 [Reserved] chapter. Ink used for marking such 317.308 Labeling of meat or meat food prod- products must comply with the re- ucts with number of servings. quirements of § 316.5. 317.309 Nutrition label content. 317.310–317.311 [Reserved] [35 FR 15577, Oct. 3, 1970, as amended at 38 FR 317.312 Reference amounts customarily con- 29214, Oct. 23, 1973] sumed per eating occasion. 317.313 Nutrient content claims; general principles. PART 317—LABELING, MARKING 317.314–317.342 [Reserved] DEVICES, AND CONTAINERS 317.343 Significant participation for vol- untary nutrition labeling. Subpart A—General 317.344 Identification of major cuts of meat products. Sec. 317.345 Guidelines for voluntary nutrition 317.1 Labels required; supervision by Pro- labeling of single-ingredient, raw prod- gram employee. ucts. 317.2 Labels: definition; required features. 317.346–317.353 [Reserved] 317.3 Approval of abbreviations of marks of 317.354 Nutrient content claims for ‘‘good inspection; preparation of marking de- source,’’ ‘‘high,’’ and ‘‘more’’. vices bearing inspection legend without 317.355 [Reserved] advance approval prohibited; exception. 317.356 Nutrient content claims for ‘‘light’’ 317.4 Labeling approval. or ‘‘lite’’. 317.5 Generically approved labeling. 317.357–317.359 [Reserved]
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317.360 Nutrient content claims for calorie removed following completion of the content. operations for which they were applied; 317.361 Nutrient content claims for the so- (5) Containers such as boil-in bags, dium content. trays of frozen dinners, and pie pans 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. which bear no information except com- 317.363 Nutrient content claims for pany brand names, trademarks, code ‘‘healthy’’. numbers, directions for preparation 317.364–317.368 [Reserved] and serving suggestions, and which are 317.369 Labeling applications for nutrient enclosed in a consumer size container content claims. that bears a label as described in § 317.2; 317.370–317.379 [Reserved] (6) Containers of products passed for 317.380 Label statements relating to useful- cooking or refrigeration and moved ness in reducing or maintaining body from an official establishment under weight. 317.381–317.399 [Reserved] § 311.1 of this subchapter. 317.400 Exemption from nutrition labeling. (b) Folders and similar coverings made of paper or similar materials, AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, whether or not they completely enclose 2.53. the product and which bear any writ- SOURCE: 35 FR 15580, Oct. 3, 1970, unless ten, printed, or graphic matter, shall otherwise noted. bear all features required on a label for an immediate container. Subpart A—General (c) No covering or other container which bears or is to bear a label shall § 317.1 Labels required; supervision by be filled, in whole or in part, except Program employee. with product which has been inspected (a) When, in an official establish- and passed in compliance with the reg- ment, any inspected and passed prod- ulations in this subchapter, which is uct is placed in any receptacle or cov- not adulterated and which is strictly in ering constituting an immediate con- accordance with the statements on the tainer, there shall be affixed to such label. No such container shall be filled, container a label as described in § 317.2 in whole or in part, and no label shall except that the following do not have be affixed thereto, except under super- to bear such a label. vision of a Program employee. (1) Wrappings of dressed carcasses and primal parts in an unprocessed § 317.2 Labels: definition; required fea- state, bearing the official inspection tures. legend, if such wrappings are intended (a) A label within the meaning of this solely to protect the product against part shall mean a display of any print- soiling or excessive drying during ing, lithographing, embossing, stickers, transportation or storage, and the seals, or other written, printed, or wrappings bear no information except graphic matter upon the immediate company brand names, trade marks, or container (not including package lin- code numbers which do not include any ers) of any product. information required by § 317.2; (b) Any word, statement, or other in- (2) Uncolored transparent coverings, formation required by this part to ap- such as cellophane, which bear no writ- pear on the label must be prominently ten, printed, or graphic matter and placed thereon with such conspicuous- which enclose any unpackaged or pack- ness (as compared with other words, aged product bearing all markings re- statements, designs, or devices, in the quired by part 316 of this subchapter labeling) and in such terms as to which are clearly legible through such render it likely to be read and under- coverings; stood by the ordinary individual under (3) Animal and transparent artificial customary conditions of purchase and casings bearing only the markings re- use. In order to meet this requirement, quired by part 316 of this subchapter; such information must appear on the (4) Stockinettes used as ‘‘operative principal display panel except as other- devices’’, such as those applied to cured wise permitted in this part. Except as meats in preparation for smoking, provided in § 317.7, all words, state- whether or not such stockinettes are ments, and other information required
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by or under authority of the Act to ap- be large enough to accommodate all pear on the label or labeling shall ap- the mandatory label information re- pear thereon in the English language: quired to be placed thereon by this part Provided, however, That in the case of and part 319 of this subchapter with products distributed solely in Puerto clarity and conspicuousness and with- Rico, Spanish may be substituted for out obscuring of such information by English for all printed matter except designs or vignettes or crowding. In de- the USDA inspection legend. termining the area of the principal dis- (c) Labels of all products shall show play panel, exclude tops, bottoms, the following information on the prin- flanges at tops and bottoms of cans, cipal display panel (except as otherwise and shoulders and necks of bottles or permitted in this part), in accordance jars. The principal display panel shall with the requirements of this part or, be: if applicable, part 319 of this sub- (1) In the case of a rectangular pack- chapter: age, one entire side, the area of which (1) The name of the product, which in is at least the product of the height the case of a product which purports to times the width of that side. be or is represented as a product for (2) In the case of a cylindrical or which a definition and standard of nearly cylindrical container: identity or composition is prescribed in (i) An area that is 40 percent of the part 319 of this subchapter, shall be the product of the height of the container name of the food specified in the stand- times the circumference of the con- ard, and in the case of any other prod- tainer, or uct shall be the common or usual name (ii) A panel, the width of which is of the food, if any there be, and if there one-third of the circumference and the is none, a truthful descriptive designa- height of which is as high as the con- tion, as prescribed in paragraph (e) of tainer: Provided, however, That if there this section; is immediately to the right or left of (2) If the product is fabricated from such principal display panel, a panel two or more ingredients, the word ‘‘in- which has a width not greater than 20 gredients’’ followed by a list of the in- percent of the circumference and a gredients as prescribed in paragraph (f) height as high as the container, and of this section; which is reserved for information pre- (3) The name and place of business of scribed in paragraphs (c) (2), (3), and the manufacturer, packer, or distribu- (5), such panel shall be known as the tor for whom the product is prepared, ‘‘20 percent panel’’ and such informa- as prescribed in paragraph (g) of this tion may be shown on that panel in section; lieu of showing it on the principal dis- (4) An accurate statement of the net play panel. quantity of contents, as prescribed in (3) In the case of a container of any paragraph (h) of this section; other shape, 40 percent of the total sur- (5) An official inspection legend and, face of the container. except as otherwise provided in para- (e) Any descriptive designation used graph (i) of this section, the number of as a product name for a product which the official establishment, in the form has no common or usual name shall required by part 312 of this subchapter; clearly and completely identify the (6) Any other information required product. Product which has been pre- by the regulations in this part or part pared by salting, smoking, drying, 319 of this subchapter. cooking, chopping, or otherwise shall (d) The principal display panel shall be so described on the label unless the be the part of a label that is most like- name of the product implies, or the ly to be displayed, presented, shown, or manner of packaging shows that the examined under customary conditions product was subjected to such prepara- of display for sale. Where packages tion. The unqualified terms ‘‘meat,’’ bear alternate principal display panels, ‘‘meat byproduct,’’ ‘‘meat food prod- information required to be placed on uct,’’ and terms common to the meat the principal display panel shall be du- industry but not common to consumers plicated on each principal display such as ‘‘picnic,’’ ‘‘butt,’’ ‘‘cala,’’ panel. The principal display panel shall ‘‘square,’’ ‘‘loaf,’’ ‘‘spread,’’ ‘‘delight,’’
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‘‘roll,’’ ‘‘plate,’’ ‘‘luncheon,’’ and ‘‘shortening.’’ ‘‘Animal fats’’ as used ‘‘daisy’’ shall not be used as names of a herein means fat derived from in- product unless accompanied with terms spected and passed cattle, sheep, swine, descriptive of the product or with a list or goats. of ingredients, as deemed necessary in (iv) When a product is coated with any specific case by the Administrator pork fat, gelatin, or other approved in order to assure that the label will substance and a specific declaration of not be false or misleading. such coating appears contiguous to the (f)(1) The list of ingredients shall name of the product, the ingredient show the common or usual names of statement need not make reference to the ingredients arranged in the de- the ingredients of such coating. scending order of predominance, except (v) When two meat ingredients com- as otherwise provided in this para- prise at least 70 percent of the meat graph. and meat byproduct ingredients of a (i) The terms spice, natural flavor, formula and when neither of the two natural flavoring, flavor and flavoring meat ingredients is less than 30 percent may be used in the following manner: by weight of the total meat and meat (A) The term ‘‘spice’’ means any aro- byproducts used, such meat ingredients matic vegetable substance in the may be interchanged in the formula whole, broken, or ground form, with without a change being made in the in- the exceptions of onions, garlic and gredients statement on labeling mate- celery, whose primary function in food rials: Provided, That the word ‘‘and’’ in is seasoning rather than nutritional lieu of a comma shall be shown be- and from which no portion of any vola- tween the declaration of such meat in- tile oil or other flavoring principle has gredients in the statement of ingredi- been removed. Spices include the spices ents. listed in 21 CFR 182.10, and 184. (vi)(A) Product ingredients which are (B) The term ‘‘natural flavor,’’ ‘‘nat- present in individual amounts of 2 per- ural flavoring,’’ ‘‘flavor’’ or ‘‘flavor- cent or less by weight may be listed in ing’’ means the essential oil, oleoresin, the ingredients statement in other essence or extractive, protein hydroly- than descending order of predomi- sate, distillate, or any product or nance: Provided, That such ingredients roasting, heating or enzymolysis, are listed by their common or usual which contains the flavoring constitu- names at the end of the ingredients ents derived from a spice, fruit or fruit statement and preceded by a quantify- juice, vegetable or vegetable juice, edi- ing statement, such as ‘‘Contains ble yeast, herb, bark, bud, root, leaf or lllll percent of lllll ,’’ ‘‘Less any other edible portion of a plant, than lllllpercent of lllll .’’ meat, seafood, poultry, eggs, dairy The percentage of the ingredient(s) products, or fermentation products shall be filled in with a threshold level thereof, whose primary function in of 2 percent, 1.5 percent, 1.0 percent, or food is flavoring rather than nutri- 0.5 percent, as appropriate. No ingredi- tional. Natural flavors include the nat- ent to which the quantifying statement ural essence or extractives obtained applies may be present in an amount from plants listed in 21 CFR 182.10, greater than the stated threshold. Such 182.20, 182.40, 182.50 and 184, and the a quantifying statement may also be substances listed in 21 CFR 172.510. The utilized when an ingredients statement term natural flavor, natural flavoring, contains a listing of ingredients by in- flavor or flavoring may also be used to dividual components. Each component designate spices, powered onion, pow- listing may utilize the required quan- dered garlic, and powdered celery. tifying statement at the end of each (ii) The term ‘‘corn syrup’’ may be component ingredients listing. used to designate either corn syrup or (B) Such ingredients may be adjusted corn syrup solids. in the product formulation without a (iii) The term ‘‘animal and vegetable change being made in the ingredients fats’’ or ‘‘vegetable and animal fats’’ statement on the labeling, provided may be used to designate the ingredi- that the adjusted amount complies ents of mixtures of such edible fats in with § 318.7(c)(4) and part 319 of this product designated ‘‘compound’’ or subchapter, and does not exceed the
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amount shown in the quantifying ter on the container, and shall be de- statement. Any such adjustments to clared in accordance with the provi- the formulation shall be provided to sions of this paragraph. the inspector-in-charge. (2) The statement as it is shown on a (2) On containers of frozen dinners, label shall not be false or misleading entrees, pizzas, and similar consumer and shall express an accurate state- packaged products in cartons the in- ment of the quantity of contents of the gredient statement may be placed on container. Reasonable variations the front riser panel: Provided, That caused by loss or gain of moisture dur- the words ‘‘see ingredients’’ followed ing the course of good distribution immediately by an arrow is placed on practices or by unavoidable deviations the principal display panel imme- in good manufacturing practices will diately above the location of such be recognized. Variations from stated statement without intervening print or quantity of contents shall be as pro- designs. vided in § 317.19. The statement shall (3) The ingredient statement may be not include any term qualifying a unit placed on the 20 percent panel adjacent of weight, measure, or count such as to the principal display panel and re- ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant served for required information, in the quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ case of a cylindrical or nearly cylin- or words of similar importance. drical container. (3) The statement shall be placed on (4) The ingredients statement may be the principal display panel within the placed on the information panel, ex- bottom 30 percent of the area of the cept as otherwise permitted in this panel in lines generally parallel to the subchapter. base: Provided, That on packages hav- (g)(1) The name or trade name of the ing a principal display panel of 5 square person that prepared the product may inches or less, the requirement for appear as the name of the manufac- placement within the bottom 30 per- turer or packer without qualification cent of the area of the label panel shall on the label. Otherwise the name of the not apply when the statement meets distributor of the product shall be the other requirements of this para- shown with a phrase such as ‘‘Prepared graph (h). In any case, the statement for * * *’’. The place of business of the may appear in more than one line. The manufacturer, packer, or distributor terms ‘‘net weight’’ or ‘‘net wt.’’ shall shall be shown on the label by city, be used when stating the net quantity State, and postal ZIP code when such of contents in terms of weight, and the business is listed in a telephone or city term ‘‘net contents’’ or ‘‘content’’ directory, and if not listed in such di- when stating the net quantity of con- rectory, then the place of business tents in terms of fluid measure. shall be shown by street address, city, (4) Except as provided in § 317.7, the State, and postal ZIP code. statement shall be expressed in terms (2) The name and place of business of of avoirdupois weight or liquid meas- the manufacturer, packer, or distribu- ure. Where no general consumer usage tor may be shown: to the contrary exists, the statement (i) On the principal display panel, or shall be in terms of liquid measure, if (ii) On the 20 percent panel adjacent the product is liquid, or in terms of to the principal display panel and re- weight if the product is solid, semisolid served for required information, in the viscous or a mixture of solid and liquid. case of a cylindrical or nearly cylin- For example, a declaration of 3⁄4-pound drical container, or avoirdupois weight shall be expressed (iii) On the front riser panel of frozen as ‘‘Net Wt. 12 oz.’’ except as provided food cartons, or for in paragraph (h)(5) of this section (iv) On the information panel. for random weight packages; a declara- (h)(1) The statement of net quantity tion of 11⁄2 pounds avoirdupois weight of contents shall appear on the prin- shall be expressed as ‘‘Net Wt. 24 oz. (1 cipal display panel of all containers to lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 lb.),’’ or be sold at retail intact, in conspicuous ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ and easily legible boldface print or (5) On packages containing 1 pound type in distinct contrast to other mat- or 1 pint and less than 4 pounds or 1
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gallon, the statement shall be ex- differential of 3 units to 1 unit (no pressed as a dual declaration both in more than 3 times as high as it is ounces and (immediately thereafter in wide). Heights pertain to upper case or parentheses) in pounds, with any re- capital letters. When upper and lower mainder in terms of ounces or common case or all lower case letters are used, or decimal fraction of the pound, or in it is the lower case letter ‘‘o’’ or its the case of liquid measure, in the larg- equivalent that shall meet the mini- est whole units with any remainder in mum standards. When fractions are terms of fluid ounces or common or used, each component numeral shall decimal fractions of the pint or quart, meet one-half the height standards. except that on random weight pack- (8) The statement shall appear as a ages the statement shall be expressed distinct item on the principal display in terms of pounds and decimal frac- panel and shall be separated by a space tions of the pound, for packages over 1 at least equal to the height of the let- pound, and for packages which do not tering used in the statement from exceed 1 pound the statement may be other printed label information appear- in decimal fractions of the pound in ing above or below the statement and lieu of ounces. Paragraph (h)(9) of this by a space at least equal to twice the section permits certain exceptions width of the letter ‘‘N’’ of the style of from the provisions of this paragraph type used in the quantity of contents for margarine packages, random statement from other printed label in- weight consumer size packages, and formation appearing to the left or right packages of less than 1⁄2 ounce net of the statement. It shall not include weight. Pargraph (h)(12) of this section any term qualifying a unit of weight, permits certain exceptions from the measure, or count such as, ‘‘jumbo provision of this paragraph for multi- quart,’’ ‘‘full gallon,’’ ‘‘giant quart,’’ unit packages. ‘‘when packed,’’ ‘‘Minimum’’ or words (6) The statement shall be in letters of similar import. and numerals in type size established (9) The following exemptions from in relationship to the area of the prin- the requirements contained in this cipal display panel of the package and paragraph (h) are hereby established: shall be uniform of all packages of sub- (i) Individually wrapped, random stantially the same size by complying weight consumer size packages shipped with the following type specifications: in bulk containers (as specified in para- (i) Not less than one-sixteenth inch graph (h)(11) of this section) and meat in height on packages, the principal products that are subject to shrinkage display panel of which has an area of 5 through moisture loss during good dis- square inches or less; tribution practices and are designated (ii) Not less than one-eighth inch in as gray area type of products as defined height on packages, the principal dis- under § 317.19 need not bear a net play panel of which has an area of more weight statement when shipped from than 5 but not more than 25 square an official establishment, provided inches; that a net weight shipping statement (iii) Not less than three-sixteenths which meets the requirements of para- inch in height on packages, the prin- graph (h)(2) of this section is applied to cipal display panel of which has an their shipping container prior to ship- area of more than 25 but not more than ping it from the official establishment. 100 square inches; Net weight statements so applied to (iv) Not less than one-quarter inch in the shipping container are exempt from height on packages, the principal dis- the type size, dual declaration, and play panel of which has an area of more placement requirements of this para- than 100 but not more than 400 square graph, if an accurate statement of net inches. weight is shown conspicuously on the (v) Not less than one-half inch in principal display panel of the shipping height on packages, the principal dis- container. The net weight also shall be play panel of which has an area of more applied directly to random weight con- than 400 square inches. sumer size packages prior to retail dis- (7) The ratio of height to width of let- play and sale. The net weight state- ters and numerals shall not exceed a ment on random weight consumer size
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packages for retail sale shall be exempt such representation, a statement of the from the type size, dual declaration, net quantity of each such serving. and placement requirements of this (11) As used in this section, a ‘‘ran- paragraph, if an accurate statement of dom weight consumer size package’’ is net weight is shown conspicuously on one which is one of a lot, shipment or the principal display panel of the pack- delivery of packages of the same prod- age. uct with varying weights and with no (ii) Individually wrapped and labeled fixed weight pattern. packages of less than 1⁄2 ounce net (12) On a multiunit retail package, a weight and random weight consumer statement of the net quantity of con- size packages shall be exempt from the tents shall appear on the outside of the requirements of this paragraph if they package and shall include the number are in a shipping container and the of individual units, the quantity of statement of net quantity of contents each individual unit, and in paren- on the shipping container meets the re- theses, the total net quantity of con- quirements of paragraph (h)(2) of this tents of the multiunit package in section; terms of avoirdupois or fluid ounces, (iii) Individually wrapped and labeled except that such declaration of total quantity need not be followed by an ad- packages of less than 1⁄2 ounce net weight bearing labels declaring net ditional parenthetical declaration in weight, price per pound, and total terms of the largest whole units and price, shall be exempt from the type subdivisions thereof, as required by size, dual declaration, and placement paragraph (h)(5) of this section. For the requirements of this paragraph, if an purposes of this section, ‘‘multiunit re- accurate statement of net weight is tail package’’ means a package con- shown conspicuously on the principal taining two or more individually pack- display panel of the package. aged units of the identical commodity and in the same quantity, with the in- (iv) Margarine in 1 pound rectangular dividual packages intended to be sold packages (except packages containing as part of the multiunit retail package whipped or soft margarine or packages but capable of being individually sold that contain more than four sticks) is in full compliance with all require- exempt from the requirements of para- ments of the regulations in this part. graphs (h) (3) and (5) of this section re- Open multiunit retail packages that do garding the placement of the state- not obscure the number of units and ment of the net quantity of contents the labeling thereon are not subject to within the bottom 30 percent of the this paragraph if the labeling of each principal display panel and that the individual unit complies with the re- statement be expressed both in ounces quirements of paragraphs (h) (2), (3), and in pounds, if the statement appears (6), and (8) of this section. as ‘‘1 pound’’ or ‘‘one pound’’ in a con- (i) The official establishment number spicuous manner on the principal dis- of the official establishment in which play panel. the product was processed under in- (v) Sliced shingle packed bacon in spection shall be placed as follows: rectangular packages is exempt from (1) Within the official inspection leg- the requirements of paragraphs (h)(3) end in the form required by part 312 of and (h)(5) of this section regarding the this subchapter; or placement of the statement of the net (2) Outside the official inspection leg- quantity of contents within the bottom end elsewhere on the exterior of the 30 percent of the principal display container or its labeling, e.g., the lid of panel, and that the statement be ex- a can, if shown in a prominent and leg- pressed both in ounces and in pounds, if ible manner in a size sufficient to in- the statement appears in a conspicuous sure easy visibility and recognition and manner on the principal display panel. accompanied by the prefix ‘‘EST’’; or (10) Labels for containers which bear (3) Off the exterior of the container, any representation as to the number of e.g., on a metal clip used to close cas- servings contained therein shall bear, ings or bags, or on the back of a paper contiguous to such representation, and label of a canned product, or on other in the same size type as is used for packaging or labeling material in the
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container, e.g., on aluminum pans and 318 of this subchapter such substance trays placed within containers, when a shall be declared on the label in a statement of its location is printed prominent manner and contiguous to contiguous to the official inspection the name of the product by the words legend, such as ‘‘EST. No. on Metal ‘‘Artificially colored’’ or ‘‘Artificial Clip’’ or ‘‘Est. No. on Pan’’, if shown in coloring added’’ or ‘‘With added artifi- a prominent and legible manner in a cial coloring.’’ When natural coloring size sufficient to insure easy visibility such as annatto is added to edible fats and recognition; or as permitted under part 318 of this sub- (4) On an insert label placed under a chapter, such substance shall be de- transparent covering if clearly visible clared on the label in the same manner and legible and accompanied by the by a phrase such as ‘‘Colored with prefix ‘‘EST’’. annatto.’’ (j) Labels of any product within any (6) When product is placed in a casing of the following paragraphs shall show to which artificial coloring is applied the information required by such para- as permitted under part 318 of this sub- graph for such product: chapter, there shall appear on the (1) A label for product which is an label, in a prominent manner and con- imitation of another food shall bear tiguous to the name of the product, the the word ‘‘imitation’’ immediately pre- words, ‘‘Artificially colored.’’ ceding the name of the food imitated (7) If a casing is removed from prod- and in the same size and style of letter- uct at an official establishment and ing as in that name and immediately there is evidence of artificial coloring thereafter the word ‘‘ingredients:’’ and on the surface of the product, there the names of the ingredients arranged shall appear on the label, in a promi- in the order of their predominance. nent manner and contiguous to the (2) If a product purports to be or is name of product, the words ‘‘Artifi- represented for any special dietary use cially colored.’’ by man, its label shall bear a state- (8) When a casing is colored prior to ment concerning its vitamin, mineral, and other dietary properties upon its use as a covering for product and which the claim for such use is based in the color is not transferred to the prod- whole or in part and shall be in con- uct enclosed in the casing, no reference formity with regulations (21 CFR part to color need appear on the label but 125) established pursuant to sections no such casing may be used if it is mis- 403, and 701 of the Federal Food, Drug, leading or deceptive with respect to and Cosmetic Act (21 U.S.C. 343, 371). color, quality, or kind of product, or (3) When an artificial smoke flavor- otherwise. ing or an smoke flavoring is added as (9) Product which bears or contains an ingredient in the formula of a meat any other artificial coloring, as per- food product, as permitted in part 318 mitted under part 318 of this sub- of this subchapter, there shall appear chapter, shall bear a label stating that on the label, in prominent letters and fact on the immediate container or if contiguous to the name of the product, there is none, on the product. a statement such as ‘‘Artificial Smoke (10) When an antioxidant is added to Flavoring Added’’ or ‘‘Smoke Flavor- product as permitted under part 318 of ing Added,’’ as may be applicable, and this subchapter, there shall appear on the ingredient statement shall identify the label in prominent letters and con- any artificial smoke flavoring or tiguous to the name of the product, a smoke flavoring so added as an ingredi- statement identifying the officially ap- ent in the formula of the meat food proved specific antioxidant by its com- product. mon name or abbreviation thereof and (4) When any other artificial flavor- the purpose for which it is added, such ing is permitted under part 318 of this as, ‘‘BHA, BHT, and Propylgallate subchapter to be added to a product, added to help protect flavor.’’ the ingredient statement shall identify (11) Containers of meat packed in it as ‘‘Artificial Flavoring.’’ borax or other preservative for export (5) When artificial coloring is added to a foreign country which permits the to edible fats as permitted under part use of such preservative shall, at the
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time of packing, be marked ‘‘for ex- ents or (b) the calcium content of a port,’’ followed on the next line by the serving of the meat food product would words ‘‘packed in preservative,’’ or be 20 percent of the U.S. RDA or more such equivalent statement as may be if the meat food product contained approved for this purpose by the Ad- only hand deboned ingredients. ministrator and directly beneath this (k) Packaged products which require there shall appear the word ‘‘establish- special handling to maintain their ment’’ or abbreviation thereof, fol- wholesome condition shall have promi- lowed by the number of the establish- nently displayed on the principal dis- ment at which the product is packed. play panel of the label the statement: The complete statement shall be ap- ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ plied in a conspicuous location and in ‘‘Perishable Keep Under Refrigera- letters not less than 1 inch in height. tion,’’ or such similar statement as the (12) Containers of other product Administrator may approve in specific packed in, bearing, or containing any cases. Products that are distributed chemical preservative shall bear a frozen during distribution and thawed label stating that fact. prior to or during display for sale at re- (13)(i) On the label of any ‘‘Mechani- tail shall bear the statement on the cally Separated (Species)’’ described in shipping container: ‘‘Keep Frozen.’’ § 319.5(a) of this subchapter, the name The consumer-size containers for such of such product shall be followed im- products shall bear the statement mediately by the phrase ‘‘for process- ‘‘Previously Handled Frozen for Your ing’’ unless such product has a protein Protection, Refreeze or Keep Refrig- content of not less than 14 percent and erated.’’ For all perishable canned a fat content of not more than 30 per- products the statement shall be shown cent. in upper case letters one-fourth inch in (ii) When any ‘‘Mechanically Sepa- height for containers having a net rated (Species)’’ described in § 319.5 of weight of 3 pounds or less, and for con- this subchapter is used as an ingredient tainers having a net weight over 3 in the preparation of a meat food prod- pounds, the statement shall be in upper uct and such ‘‘Mechanically Separated case letters at least one-half inch in (Species)’’ contributes 20 mg or more of height. calcium to a serving of such meat food (l) Safe handling instructions shall be product, the label of such meat food provided for: All meat and meat prod- product shall state the calcium content ucts of cattle, swine, sheep, goat, of such meat food product, determined horse, or other equine not heat proc- and expressed as the percentage of the essed in a manner that conforms to the U.S. Recommended Daily Allowance time and temperature combinations in (U.S. RDA) in a serving in accordance the Table for Time/Temperature Com- with 21 CFR 101.9(b)(1), (c)(7) (i) and bination For Cooked Beef, Roast Beef, (iv), and (e), as part of any nutrition and Cooked Corned Beef in § 318.17, or information included on such label, or that have not undergone other further if such meat food product does not bear processing that would render them nutrition labeling information, as part ready-to-eat; and all comminuted meat of a prominent statement in immediate patties not heat processed in a manner conjunction with the list of ingredi- that conforms to the time and tem- ents, as follows: ‘‘A ——— serving con- perature combinations in the Table for tains ——% of the U.S. RDA of cal- Permitted Heat-Processing Tempera- cium’’, with the blanks to be filled in, ture/Time Combinations For Fully- respectively, with the quantity of such Cooked Patties in § 318.23; except as ex- product that constitutes a serving and empted under paragraph (l)(4) of this the amount of calcium provided by section. such serving: Provided, That, calcium (1)(i) Safe handling instructions shall content need not be stated where (a) accompany every meat or meat prod- the percent of the U.S. RDA of calcium uct, specified in this paragraph (l) des- to be declared would not differ from tined for household consumers, hotels, the percent of the U.S. RDA that would restaurants, or similar institutions and be declared if the meat food product shall appear on the label. The informa- contained only hand deboned ingredi- tion shall be in lettering no smaller
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than one-sixteenth of an inch in size (iv) Keep hot foods hot. Refrigerate and shall be prominently placed with leftovers immediately or discard. (A such conspicuousness (as compared graphic illustration of a thermometer with other words, statements, designs shall be displayed next to the state- or devices in the labeling) as to render ment.) it likely to be read and understood by (4) Meat or meat products intended the ordinary individual under cus- for further processing at another offi- tomary conditions of purchase and use. cial establishment are exempt from the (ii) The safe handling information requirements prescribed in paragraphs shall be presented on the label under (l)(1) through (l)(3) of this section. the heading ‘‘Safe Handling Instruc- (m)(1) The information panel is that tions’’ which shall be set in type size part of a label that is the first surface larger than the print size of the ration- to the right of the principal display ale statement and handling statements panel as observed by an individual fac- as discussed in paragraphs (l)(2) and ing the principal display panel, with (l)(3) of this section. The safe handling the following exceptions: information shall be set off by a border (i) If the first surface to the right of and shall be one color type printed on the principal display panel is too small a single color contrasting background to accommodate the required informa- whenever practical. tion or is otherwise unusable label (2) The labels of the meat and meat space, e.g., folded flaps, tear strips, products specified in this paragraph (l) opening flaps, heat-sealed flaps, the shall include the following rationale next panel to the right of this part of statement as part of the safe handling the label may be used. instructions, ‘‘This product was pre- pared from inspected and passed meat (ii) If the package has one or more al- and/or poultry. Some food products ternate principal display panels, the in- may contain bacteria that could cause formation panel is to the right of any illness if the product is mishandled or principal display panel. cooked improperly. For your protec- (iii) If the top of the container is the tion, follow these safe handling in- principal display panel and the pack- structions.’’ This statement shall be age has no alternate principal display placed immediately after the heading panel, the information panel is any and before the safe handling state- panel adjacent to the principal display ments. panel. (3) Meat and meat products, specified (2) (i) Except as otherwise permitted in this paragraph (l), shall bear the la- in this part, all information required to beling statements: appear on the principal display panel (i) Keep refrigerated or frozen. Thaw or permitted to appear on the informa- in refrigerator or microwave. (Any por- tion panel shall appear on the same tion of this statement that is in con- panel unless there is insufficient space. flict with the product’s specific han- In determining the sufficiency of the dling instructions, may be omitted, available space, except as otherwise e.g., instructions to cook without prescribed in this part, any vignettes, thawing.) (A graphic illustration of a designs, and any other nonmandatory refrigerator shall be displayed next to information shall not be considered. If the statement.); there is insufficient space for all re- (ii) Keep raw meat and poultry sepa- quired information to appear on a sin- rate from other foods. Wash working gle panel, it may be divided between surfaces (including cutting boards), the principal display panel and the in- utensils, and hands after touching raw formation panel, provided that the in- meat or poultry. (A graphic illustra- formation required by any given provi- tion of soapy hands under a faucet sion of this part, such as the ingredi- shall be displayed next to the state- ents statement, is not divided and ap- ment.); pears on the same panel. (iii) Cook thoroughly. (A graphic il- (ii) All information appearing on the lustration of a skillet shall be dis- information panel pursuant to this sec- played next to the statement.); and tion shall appear in one place without
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intervening material, such as designs appropriate for other equine (nonhorse) or vignettes. carcasses and parts of other (nonhorse) equine carcasses) or § 312.7(a). [35 FR 15580, Oct. 3, 1970] (1) The certificate is a Food Safety EDITORIAL NOTE: For FEDERAL REGISTER ci- and Inspection Service form for signa- tations affecting § 317.2, see the List of Sec- ture by a Program employee and the tions Affected in the Finding Aids section of official establishment ordering the this volume. brand or other marking device, bearing § 317.3 Approval of abbreviations of a certificate serial number and a let- marks of inspection; preparation of terhead and the seal of the United marking devices bearing inspection States Department of Agriculture. The legend without advance approval certificate authorizes the making of prohibited; exception. only the brands or other marking de- (a) The Administrator may approve vices of the type and quantity listed on and authorize the use of abbreviations the certificate. of marks of inspection under the regu- (2) After signing the certificate, the lations in this subchapter. Such abbre- Program employee and the establish- viations shall have the same force and ment shall each keep a copy, and the effect as the respective marks for remaining two copies shall be given to which they are authorized abbrevia- the brand or other marking device tions. manufacturer. (b) Except for the purposes of prepar- (3) The manufacturer of the brands or ing and submitting a sample or sam- other marking devices shall engrave or ples of the same to the Administrator otherwise mark each brand or other for approval, no brand manufacturer, marking device with a permanent iden- printer, or other person shall cast, tifying serial number unique to it. The print, lithograph, or otherwise make manufacturer shall list on each of the any marking device containing any of- two copies of the certificate given to ficial mark or simulation thereof, or the manufacturer the number of each any label bearing any such mark or brand or other marking device author- simulation, without the written au- ized by the certificate. The manufac- thority therefor of the Administrator. turer shall retain one copy of the cer- However, when any such sample label, tificate for the manufacturer’s records or other marking device, is approved and return the remaining copy with by the Administrator, additional sup- the brands or other marking devices to plies of the approved label, or marking the Program employee whose name and address are given on the certificate as device, may be made for use in accord- the recipient. ance with the regulations in this sub- (4) In order that all such brands or chapter, without further approval by other marking devices bear identifying the Administrator. The provisions of numbers, within one year after June 24, this paragraph apply only to labels, or 1985, an establishment shall either re- other marking devices, bearing or con- place each such brand or other mark- taining an official inspection legend ing device which does not bear an iden- shown in § 312.2(b), § 312.3(a) (only the tifying number, or, under the direction legend appropriate for horse meat food of the inspector-in-charge, mark such products) or § 312.3(b) (only the legend brand or other marking device with a appropriate for other (nonhorse) equine permanent identifying number. meat food products), or any abbrevia- tions, copy or representation thereof. (Recordkeeping requirements approved by (c) No brand manufacturer or other the Office of Management and Budget under person shall cast or otherwise make, control number 0583–0015) without an official certificate issued in [35 FR 15580, Oct. 3, 1970, as amended at 50 FR quadruplicate by a Program employee, 21422, May 24, 1985] a brand or other marking device con- taining an official inspection legend, or § 317.4 Labeling approval. simulation thereof, shown in § 312.2(a), (a) No final labeling shall be used on § 312.3(a) (only the legend appropriate any product unless the sketch labeling for horse carcasses and parts of horse of such final labeling has been submit- carcasses), § 312.3(b) (only the legend ted for approval to the Food Labeling
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Division, Regulatory Programs, Food proval in the same manner as provided Safety and Inspection Service, and ap- for labeling in § 317.4(a), except that proved by such division, accompanied such devices which contain no ref- by FSIS form, Application for Approval erence to product and bear no mislead- of Labels, Marking, and Devices, ex- ing feature shall be used without sub- cept for generically approved labeling mission for approval as prescribed in authorized for use in § 317.5(b). The § 317.5(b)(7). management of the official establish- (f)(1) Consistent with the require- ment or establishment certified under ments of this section, temporary ap- a foreign inspection system, in accord- proval for the use of a final label or ance with part 327 of this subchapter, other final labeling that may otherwise must maintain a copy of all labeling be deemed deficient in some particular used, along with the product formula- may be granted by the Food Labeling tion and processing procedure, in ac- Division. Temporary approvals may be cordance with part 320 of this sub- granted for a period not to exceed 180 chapter. Such records shall be made calendar days, under the following con- available to any duly authorized rep- ditions: resentative of the Secretary upon re- (i) The proposed labeling would not quest. misrepresent the product; (b) The Food Labeling Division shall (ii) The use of the labeling would not permit submission for approval of only present any potential health, safety, or sketch labeling, as defined in § 317.4(d), dietary problems to the consumer; for all products, except as provided in § 317.5(b) (2)–(9) and except for tem- (iii) Denial of the request would cre- porary use of final labeling as pre- ate undue economic hardship; and scribed in paragraph (f) of this section. (iv) An unfair competitive advantage (c) All labeling required to be sub- would not result from the granting of mitted for approval as set forth in the temporary approval. § 317.4(a) shall be submitted in dupli- (2) Extensions of temporary approv- cate to the Food Labeling Division, als may also be granted by the Food Regulatory Programs, Food Safety and Labeling Division provided that the ap- Inspection Service, U.S. Department of plicant demonstrates that new cir- Agriculture, Washington, DC 20250. A cumstances, meeting the above cri- parent company for a corporation may teria, have developed since the original submit only one labeling application temporary approval was granted. (in duplicate form) for a product pro- (g) The inspector-in-charge shall ap- duced in other establishments that are prove meat carcass ink brands and owned by the corporation. meat food product ink and burning (d) ‘‘Sketch’’ labeling is a printer’s brands, which comply with parts 312 proof or equivalent which clearly and 316 of this subchapter. shows all labeling features, size, loca- tion, and indication of final color, as [60 FR 67454, Dec. 29, 1995] specified in § 317.2. FSIS will accept § 317.5 Generically approved labeling. sketches that are hand drawn, com- puter generated or other reasonable (a)(1) An official establishment or an facsimiles that clearly reflect and establishment certified under a foreign project the final version of the label- inspection system, in accordance with ing. Indication of final color may be part 327 of this subchapter, is author- met by: submission of a color sketch, ized to use generically approved label- submission of a sketch which indicates ing, as defined in paragraph (b) of this by descriptive language the final col- section, without such labeling being ors, or submission with the sketch of submitted for approval to the Food previously approved final labeling that Safety and Inspection Service in Wash- indicates the final colors. ington or the field, provided the label- (e) Inserts, tags, liners, pasters, and ing is in accordance with this section like devices containing printed or and shows all mandatory features in a graphic matter and for use on, or to be prominent manner as required in placed within, containers and coverings § 317.2, and is not otherwise false or of product shall be submitted for ap- misleading in any particular.
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(2) The Food Safety and Inspection tain no reference to product and bear Service shall select samples of generi- no misleading feature; cally approved labeling from the (8) Labeling for consumer test prod- records maintained by official estab- ucts not intended for sale; and lishments and establishments certified (9) Labeling which was previously ap- under foreign inspection systems, in proved by the Food Labeling Division accordance with part 327 of this sub- as sketch labeling, and the final label- chapter, as required in § 317.4, to deter- ing was prepared without modification mine compliance with labeling require- or with the following modifications: ments. Any finding of false or mislead- (i) All features of the labeling are ing labeling shall institute the pro- proportionately enlarged or reduced, ceedings prescribed in § 335.12. provided that all minimum size re- (b) Generically approved labeling is quirements specified in applicable reg- labeling which complies with the fol- ulations are met and the labeling is lowing: legible; (1) Labeling for a product which has (ii) The substitution of any unit of a product standard as specified in part measurement with its abbreviation or 319 of this subchapter or the Standards the substitution of any abbreviation and Labeling Policy Book and which with its unit of measurement, e.g., does not contain any special claims, ‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for such as quality claims, nutrient con- ‘‘ounce,’’ or of the word ‘‘pound’’ for tent claims, health claims, negative ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; claims, geographical origin claims, or (iii) A master or stock label has been guarantees, or which is not a domestic approved from which the name and ad- product labeled in a foreign language; dress of the distributor are omitted and (2) Labeling for single-ingredient such name and address are applied be- products (such as beef steak or lamb fore being used (in such case, the words chops) which does not contain any spe- ‘‘prepared for’’ or similar statement cial claims, such as quality claims, nu- must be shown together with the blank trient content claims, health claims, space reserved for the insertion of the negative claims, geographical origin name and address when such labels are claims, or guarantees, or which is not a offered for approval); domestic product labeled with a for- (iv) Wrappers or other covers bearing eign language; pictorial designs, emblematic designs (3) Labeling for containers of prod- or illustrations, e.g., floral arrange- ucts sold under contract specifications ments, illustrations of animals, fire- to Federal Government agencies, when works, etc. are used with approved la- such product is not offered for sale to beling (the use of such designs will not the general public, provided that the make necessary the application of la- contract specifications include specific beling not otherwise required); requirements with respect to labeling, (v) A change in the language or the and are made available to the inspec- arrangement of directions pertaining tor-in-charge; to the opening of containers or the (4) Labeling for shipping containers serving of the product; which contain fully labeled immediate (vi) The addition, deletion, or amend- containers, provided such labeling ment of a dated or undated coupon, a complies with § 316.13; cents-off statement, cooking instruc- (5) Labeling for products not in- tions, packer product code informa- tended for human food, provided they tion, or UPC product code information; comply with part 325 of this sub- (vii) Any change in the name or ad- chapter; dress of the packer, manufacturer or (6) Meat inspection legends, which distributor that appears in the signa- comply with parts 312 and 316 of this ture line; subchapter; (viii) Any change in the net weight, (7) Inserts, tags, liners, pasters, and provided the size of the net weight like devices containing printed or statement complies with § 317.2; graphic matter and for use on, or to be (ix) The addition, deletion, or amend- placed within containers, and coverings ment of recipe suggestions for the of products, provided such devices con- product;
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(x) Any change in punctuation; (xxiv) The addition or deletion of a (xi) Newly assigned or revised estab- direct translation of the English lan- lishment numbers for a particular es- guage into a foreign language for prod- tablishment for which use of the label- ucts marked ‘‘for export only.’’ ing has been approved by the Food La- [60 FR 67455, Dec. 29, 1995] beling Division, Regulatory Programs; (xii) The addition or deletion of open § 317.6 Approved labels to be used only dating information; on products to which they are ap- (xiii) A change in the type of packag- plicable. ing material on which the label is Labels shall be used only on products printed; for which they are approved, and only (xiv) Brand name changes, provided if they have been approved for such that there are no design changes, the products in accordance with § 317.3: Pro- brand name does not use a term that vided, That existing stocks of labels ap- connotes quality or other product char- proved prior to the effective date of acteristics, the brand name has no geo- this section and the quantity of which graphic significance, and the brand has been identified to the circuit super- name does not affect the name of the visor as being in storage on said date product; at the official establishment or other (xv) The deletion of the word ‘‘new’’ identified warehouse for the account of on new product labeling; the operator of the official establish- (xvi) The addition, deletion, or ment may be used until such stocks are amendment of special handling state- exhausted, but not later than 1 year ments, provided that the change is con- after the effective date of this section sistent with § 317.2(k); unless such labels conform to all the (xvii) The addition of safe handling requirements of this part and part 319 instructions as required by § 317.2(l); of this subchapter. The Administrator (xviii) Changes reflecting a change in may upon the show of good cause grant the quantity of an ingredient shown in individual extension of time as he the formula without a change in the deems necessary. order of predominance shown on the label, provided that the change in § 317.7 Products for foreign commerce; quantity of ingredients complies with printing labels in foreign language any minimum or maximum limits for permissible; other deviations. the use of such ingredients prescribed Labels to be affixed to packages of in parts 318 and 319 of this subchapter; products for foreign commerce may be (xix) Changes in the color of the la- printed in a foreign language and may beling, provided that sufficient con- show the statement of the quantity of trast and legibility remain; contents in accordance with the usage (xx) A change in the product vi- of the country to which exported and gnette, provided that the change does other deviations from the form of la- not affect mandatory labeling informa- beling required under this part may be tion or misrepresent the content of the approved for such product by the Ad- package; ministrator in specific cases: Provided, (xxi) A change in the establishment (a) That the proposed labeling ac- number by a corporation or parent cords to the specifications of the for- company for an establishment under eign purchaser, its ownership; (b) That it is not in conflict with the (xxii) Changes in nutrition labeling laws of the country to which the prod- that only involve quantitative adjust- uct is intended for export, and ments to the nutrition labeling infor- (c) That the outside container is la- mation, except for serving sizes, pro- beled to show that it is intended for ex- vided the nutrition labeling informa- port; but if such product is sold or of- tion maintains its accuracy and con- fered for sale in domestic commerce, sistency; all the requirements of this subchapter (xxiii) Deletion of any claim, and the apply. The inspection legend and the deletion of non-mandatory features or establishment number shall in all cases non-mandatory information; and appear in English but in addition, may
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appear literally translated in a foreign wick’’ and ‘‘irish’’ as applied to stews language. and the term ‘‘boston’’ as applied to pork shoulder butts need not be accom- § 317.8 False or misleading labeling or panied with the word ‘‘style,’’ ‘‘type,’’ practices generally; specific prohi- or ‘‘brand,’’ or a statement identifying bitions and requirements for labels the locality in which the product is and containers. prepared. (a) No product or any of its wrappers, (2) Such terms as ‘‘farm’’ or ‘‘coun- packaging, or other containers shall try’’ shall not be used on labels in con- bear any false or misleading marking, nection with products unless such label, or other labeling and no state- products are actually prepared on the ment, word, picture, design, or device farm or in the country: Provided, That which conveys any false impression or if the product is prepared in the same gives any false indication of origin or way as on the farm or in the country quality or is otherwise false or mis- these terms, if qualified by the word leading shall appear in any marking or ‘‘style’’ in the same size and style of other labeling. No product shall be lettering, may be used: Provided fur- wholly or partly enclosed in any wrap- ther, That the term ‘‘farm’’ may be per, packaging, or other container that used as part of a brand designation is so made, formed, or filled as to be when qualified by the word ‘‘brand’’ in misleading. the same size and style of lettering, (b) The labels and containers of prod- and followed with a statement identify- uct shall comply with the following ing the locality in which the product is provisions, as applicable: prepared: And Provided further, That (1) Terms having geographical sig- the provisions of this paragraph shall nificance with reference to a locality not apply to products prepared in ac- other than that in which the product is cordance with § 319.106 of this sub- prepared may appear on the label only chapter. Sausage containing cereal when qualified by the word ‘‘style,’’ shall not be labeled ‘‘farm style’’ or ‘‘type,’’ or ‘‘brand,’’ as the case may be, ‘‘country style,’’ and lard not rendered in the same size and style of lettering in an open kettle shall not be des- as in the geographical term, and ac- ignated as ‘‘farm style’’ or ‘‘country companied with a prominent qualifying style.’’ statement identifying the country, (3) The requirement that the label State, Territory, or locality in which shall contain the name and place of the product is prepared, using terms business of the manufacturer, packer, appropriate to effect the qualification. or distributor shall not relieve any es- When the word ‘‘style’’ or ‘‘type’’ is tablishment from the requirement that used, there must be a recognized style its label shall not be misleading in any or type of product identified with and particular. peculiar to the area represented by the (4) The term ‘‘spring lamb’’ or ‘‘genu- geographical term and the product ine spring lamb’’ is applicable only to must possess the characteristics of carcasses of new-crop lambs slaugh- such style or type, and the word tered during the period beginning in ‘‘brand’’ shall not be used in such a March and terminating not beyond the way as to be false or misleading: Pro- close of the week containing the first vided, That a geographical term which Monday in October. has come into general usage as a trade (5)(i) Coverings shall not be of such name and which has been approved by color, design, or kind as to be mislead- the Administrator as being a generic ing with respect to color, quality, or term may be used without the quali- kind of product to which they are ap- fications provided for in this para- plied. For example, transparent or graph. The terms ‘‘frankfurter,’’ ‘‘vi- semitransparent coverings for such ar- enna,’’ ‘‘bologna,’’ ‘‘lebanon bologna,’’ ticles as sliced bacon or fresh ‘‘braunschweiger,’’ ‘‘thuringer,’’ (uncooked) meat and meat food prod- ‘‘genoa,’’ ‘‘leona,’’ ‘‘berliner,’’ ‘‘hol- ucts shall not bear lines or other de- stein,’’ ‘‘goteborg,’’ ‘‘milan,’’ ‘‘polish,’’ signs of red or other color which give a ‘‘italian,’’ and their modifications, as false impression of leanness of the applied to sausages, the terms ‘‘bruns- product. Transparent or
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semitransparent wrappers, casings, or coloring, shall be designated as ‘‘spice coverings for use in packaging cured, and coloring’’, or ‘‘flavoring and color- cured and smoked, or cured and cooked ing’’, as the case may be, unless such sausage products, and sliced ready-to- ingredient is designated by its common eat meat food products may be color or usual name. tinted or bear red designs on 50 percent (ii) Any ingredient not designated in of such wrapper or covering: Provided, § 317.2(f)(1)(i) of this part whose func- That the transparent or tion is flavoring, either in whole or in semitransparent portion of the prin- part, must be designated by its com- cipal display panel is free of color tint- mon or usual name. Those ingredients ing and red designs: And provided fur- which are of livestock and poultry ori- ther, That the principal display panel gin must be designated by names that provides at least 20 percent unob- include the species and livestock and structed clear space, consolidated in poultry tissues from which the ingredi- one area so that the true nature and ents are derived. color of the product is visible to the (8) As used on labels of product, the consumer. term ‘‘gelatin’’ shall mean (i) the jelly (ii) Packages for sliced bacon that prepared in official establishments by have a transparent opening shall be de- cooking pork skins, tendons, or con- signed to expose, for viewing, the cut nective tissue from inspected and surface of a representative slice. Pack- passed product, and (ii) dry commercial ages for sliced bacon which meet the gelatin or the jelly resulting from its following specifications will be accept- use. ed as meeting the requirements of this (9) Product (other than canned prod- subparagraph provided the enclosed uct) labeled with the term ‘‘loaf’’ as bacon is positioned so that the cut sur- part of its name: face of the representative slice can be (i) If distributed from the official es- visually examined: tablishment in consumer size contain- (a) For shingle-packed sliced bacon, ers may be in any shape; the transparent window shall be de- (ii) If distributed in a container of a signed to reveal at least 70 percent of size larger than that sold intact at re- the length (longest dimension) of the tail the product shall be prepared in representative slice, and this window rectangular form, or as in paragraph shall be at least 11⁄2 inches wide. The (b)(9)(iii) of this section; transparent window shall be located (iii) If labeled as an ‘‘Old Fashioned not more than five-eighths inch from Loaf’’ shall be prepared in a traditional the top or bottom edge of a 1-pound or form, such as rectangular with rounded smaller package and not more than top or circular with flat bottom and three-fourths inch from either the top rounded top. or bottom edge of a package larger (10) The term ‘‘baked’’ shall apply than 1 pound. only to product which has been cooked (b) For stack-packed sliced bacon, by the direct action of dry heat and for the transparent window shall be de- a sufficient time to permit the product signed to reveal at least 70 percent of to assume the characteristics of a the length (longest dimension) of the baked article, such as the formation of representative slice and be at least 11⁄2 a brown crust on the surface, rendering inches wide. out of surface fat, and the (6) The word ‘‘fresh’’ shall not be caramelization of the sugar if applied. used on labels to designate product Baked loaves shall be heated to a tem- which contains any sodium nitrate, so- perature of at least 160 °F. and baked dium nitrite, potassium nitrate, or po- pork cuts shall be heated to an internal tassium nitrite, or which has been salt- temperature of at least 170 °F. ed for preservation. (11) When products such as loaves are (7)(i) No ingredient shall be des- browned by dipping in hot edible oil or ignated on the label as a spice, flavor- by a flame, the label shall state such ing, or coloring unless it is a spice, fla- fact, e.g., by the words ‘‘Browned in voring, or coloring, as the case may be. Hot Cottonseed Oil’’ or ‘‘Browned by a An ingredient that is both a spice and Flame,’’ as the case may be, appearing a coloring, or both a flavoring and a as part of the product name.
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(12) The term ‘‘meat’’ and the names shall be designated as ‘‘rendered pork of particular kinds of meat, such as fat’’ or ‘‘hardened rendered pork fat,’’ beef, veal, mutton, lamb, and pork, as the case may be. shall not be used in such manner as to (20) Oil, stearin, or stock obtained be false or misleading. from beef or mutton fats rendered at a (13) The word ‘‘ham,’’ without any temperature above 170 °F. shall not be prefix indicating the species of animal designated as ‘‘oleo oil,’’ ‘‘oleo stea- from which derived, shall be used in la- rin,’’ or ‘‘oleo stock,’’ respectively. beling only in connection with the hind (21) When not more than 20 percent of legs of swine. Ham shanks as such or beef fat, mutton fat, oleo stearin, vege- ham shank meat as such or the trim- table stearin, or hardened vegetable fat mings accruing in the trimming and shaping of hams shall not be labeled is mixed with lard or with rendered ‘‘ham’’ or ‘‘ham meat’’ without quali- pork fat, there shall appear on the fication. When used in connection with label, contiguous to and in the same a chopped product the term ‘‘ham’’ or size and style of lettering as the name ‘‘ham meat’’ shall not include the skin. of the product, the words ‘‘beef fat (14) The terms ‘‘shankless’’ and added,’’ ‘‘mutton fat added,’’ ‘‘oleo ste- ‘‘hockless’’ shall apply only to hams arin added,’’ ‘‘vegetable stearin added,’’ and pork shoulders from which the or ‘‘hardened vegetable fat added,’’ as shank or hock has been completely re- the case may be. If more than 20 per- moved, thus eliminating the entire cent is added, the product name shall tibia and fibula, or radius and ulna, re- refer to the particular animal fat or spectively, together with the overlying fats used, such as, ‘‘Lard and Beef muscle, skin, and other tissue. Fat.’’ The designation ‘‘vegetable fat’’ (15) Such terms as ‘‘meat extract’’ or is applicable to vegetable oil, vegetable ‘‘extract of beef’’ without qualification stearin, or a combination of such oil shall not be used on labels in connec- and stearin, whereas the designations tion with products prepared from or- ‘‘vegetable oil’’ and ‘‘vegetable stea- gans or other parts of the carcass, rin’’ shall be applicable only to the oil other than fresh meat. Extracts pre- and the stearin respectively, when used pared from any parts of the carcass in meat food products. other than fresh meat may be properly (22) Cooked, cured, or pickled pigs labeled as extracts with the true name feet, pigs knuckles, and similar prod- of the parts from which prepared. In the case of extract in fluid form, the ucts, shall be labeled to show that the word ‘‘fluid’’ shall also appear on the bones remain in the product, if such is label, as, for example, ‘‘fluid extract of the case. The designation ‘‘semi- beef.’’ boneless’’ shall not be used if less than (16) [Reserved] 50 percent of the total weight of bones (17) When any product is enclosed in has been removed. a container along with a packing sub- (23) When monoglycerides, stance such as brine, vinegar, or agar diglycerides, and/or polyglycerol esters jelly, a declaration of the packing sub- of fatty acids are added to rendered stance shall be printed prominently on animal fat or a combination of such fat the label as part of the name of the and vegetable fat, there shall appear on product, as for example, ‘‘frankfurts the label in a prominent manner and packed in brine,’’ ‘‘lamb tongue packed contiguous to the name of the product in vinegar,’’ or ‘‘beef tongue packed in a statement such as ‘‘With agar jelly,’’ as the case may be. The Monoglycerides and Diglycerides packing substance shall not be used in Added,’’ or ‘‘With Diglycerides and such a manner as will result in the con- Monoglycerides,’’ or ‘‘With Polyglyc- tainer being so filled as to be mislead- erol Esters of Fatty Acids’’ as the case ing. may be. (18) ‘‘Leaf lard’’ is lard prepared from (24) Section 407 of the Federal Food, fresh leaf fat. (19) When lard or hardened lard is Drug, and Cosmetic Act contains provi- mixed with rendered pork fat or hard- sions with respect to colored margarine ened rendered pork fat, the mixture
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or colored oleomargarine (21 U.S.C. 347) (25) When approved proteolytic en- which are set forth herein as footnote. 1 zymes as permitted in part 318 of this subchapter are used on steaks or other 1 ‘‘Sec. 407(a) Colored oleomargarine or col- raw meat cuts, there shall appear on ored margarine which is sold in the same the label, in a prominent manner, con- State or Territory in which it is produced tiguous to the product name, the state- shall be subject in the same manner and to ment, ‘‘Tenderized with [approved en- the same extent to the provisions of this Act zyme],’’ to indicate the use of such en- as if it had been introduced in interstate zymes. Any other approved substance commerce. (b) No person shall sell, or offer for sale, which may be used in the solution shall colored oleomargarine or colored margarine also be included in the statement. unless— When approved inorganic chlorides as (1) Such oleomargarine or margarine is permitted in part 318 of this subchapter packaged, are used on steaks or other raw meat (2) The net weight of the contents of any cuts there shall appear on the label in package sold in a retail establishment is one a prominent manner, contiguous to the pound or less, (3) There appears on the label of the pack- product name, the statement, ‘‘Tender- age (A) The word ‘oleomargarine’ or ‘mar- ized with (names of approved inorganic garine’ in type or lettering at least as large chloride(s))’’ to indicate the use of such as any other type or lettering on such label, inorganic chlorides. Any other ap- and (B) A full and accurate statement of all proved substance which may be in the the ingredients contained in such oleo- solution shall also be included in the margarine, or margarine, and statement. (4) Each part of the contents of the pack- (26) When dimethylpolysiloxan is age is contained in a wrapper which bears the word ‘oleomargarine’ or ‘margarine’ in added as an antifoaming agent to ren- type or lettering not smaller than 20-point dered fats, its presence shall be de- type. clared on the label contiguous to the The requirements of this subsection shall name of the product. Such declaration be in addition to and not in lieu of any of the shall read ‘‘Dimethylpolysiloxan other requirements of this Act. Added.’’ (c) No person shall possess in a form ready (27) When pizzas are formulated with for serving colored oleomargarine or colored margarine at a public eating place unless a crust containing calcium propionate or notice that oleomargarine or margarine is sodium propionate, there shall appear served is displayed prominently and con- on the label contiguous to the name of spicuously in such place and in such manner the product the statement ‘‘———— as to render it likely to be read and under- added to retard spoilage of crust’’ pre- stood by the ordinary individual being served ceded by the name of the preservative. in such eating place or is printed or is other- (28) Sausage of the dry varieties wise set forth on the menu in type or letter- treated with potassium sorbate or ing not smaller than that normally used to designate the serving of other food items. No propylparaben (propyl p-hydroxy- person shall serve colored oleomargarine or benzoate) as permitted by part 318 of colored margarine at a public eating place, this subchapter, shall be marked or la- whether or not any charge is made therefor, beled with a statement disclosing such unless (1) each separate serving bears or is treatment and the purpose thereof, accompanied by labeling identifying it as such as ‘‘dipped in a potassium sorbate oleomargarine or margarine, or (2) each sep- solution to retard mold growth.’’ arate serving thereof is triangular in shape. (29) Meat of goats shall be identified (d) Colored oleomargarine or colored mar- garine when served with meals at a public as goat meat or chevon. eating place shall at the time of such service (30) The term ‘‘Chitterlings’’ shall be exempt from the labeling requirements of apply to the large intestines of swine, section 343 of this Act (except subsection (a) or young bovine animals when preceded and (f) of section 343 of this title) if it com- with the word ‘‘Calf’’ or ‘‘Veal.’’ Meat plies with the requirements of subsection (b) food products that contain chitterlings of this section. or calf or veal chitterlings, in accord- (e) For the purpose of this section colored ance with § 318.6(b)(8) of this subchapter oleomargarine or colored margarine is oleo- margarine or margarine having a tint or shade containing more than one and six over red, measured in terms of Lovibond tenths degrees of yellow or of yellow and red tintometer scale or its equivalent’’ (21 U.S.C. collectively, but with an excess of yellow 347).
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shall be identified with product names carbonate (or glucono delta-lactone) that refer to such ingredients, as for are used together in a dry binding ma- instance, ‘‘Chitterling Loaf,’’ trix in restructured, formed meat food ‘‘Chitterling Pie,’’ or ‘‘Calf Chitterlings products, as permitted in part 318 of and Gravy,’’ and shall be packed in this subchapter, there shall appear on containers having a capacity of 3 the label contiguous to the product pounds or less and of a kind usually name, a statement to indicate the use sold at retail intact and bearing such of sodium alginate, calcium carbonate other information as is required by this and lactic acid and calcium carbonate part. (or glucono delta-lactone). (31) Products that contain blood from (37) [Reserved] livestock as permitted by part 318 of [35 FR 15580, Oct. 3, 1970] this subchapter shall be labeled with a name that includes the term ‘‘blood,’’ EDITORIAL NOTE: For FEDERAL REGISTER ci- and the specific kind of blood shall be tations affecting § 317.8, see the List of CFR Sections Affected in the Finding Aids sec- declared in the ingredient statement, tion of this volume. e.g., ‘‘Swine blood,’’ in the manner re- quired by this part. § 317.9 Labeling of equine products. (32) A calendar date may be shown on The immediate containers of any labeling when declared in accordance equine products shall be labeled to with the provisions of this subpara- show the kinds of animals from which graph: derived when the products are sold, (i) The calendar date shall express transported, offered for sale or trans- the month of the year and the day of portation or received for transpor- the month for all products and also the tation in commerce. year in the case of products hermeti- cally sealed in metal or glass contain- § 317.10 Reuse of official inspection ers, dried or frozen products, or any marks; reuse of containers bearing other products that the Administrator official marks, labels, etc. finds should be labeled with the year (a) No official inspection legend or because the distribution and marketing other official mark which has been pre- practices with respect to such products viously used shall be used again for the may cause a label without a year iden- identification of any product, except as tification to be misleading. provided for in paragraph (b) of this (ii) Immediately adjacent to the cal- section. endar date shall be a phrase explaining (b) All stencils, marks, labels, or the meaning of such date, in terms of other labeling on previously used con- ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use tainers, whether relating to any prod- before’’ date, with or without a further uct or otherwise, shall be removed or qualifying phrase, e.g., ‘‘For Maximum obliterated before such containers are Freshness’’ or ‘‘For Best Quality’’, and used for any product, unless such label- such phrases shall be approved by the ing correctly indicates the product to Administrator as prescribed in § 317.4. be packed therein and such containers (33) [Reserved] are refilled under the supervision of a (34) The terms ‘‘All,’’ ‘‘Pure,’’ Program employee. ‘‘100%,’’ and terms of similar connota- tion shall not be used on labels for § 317.11 Labeling, filling of containers, products to identify ingredient con- handling of labeled products to be tent, unless the product is prepared only in compliance with regula- solely from a single ingredient. tions. (35) When agar-agar is used in canned (a) No person shall in any official es- jellied meat food products, as per- tablishment apply or affix, or cause to mitted in part 318 of this subchapter, be applied or affixed, any label to any there shall appear on the label in a product prepared or received in such prominent manner, contiguous to the establishment, or to any container product name, a statement to indicate thereof, or fill any container at such an the use of agar-agar. establishment, except in compliance (36) When sodium alginate, calcium with the regulations in this sub- carbonate, and lactic acid and calcium chapter.
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(b) No covering or other container charge at destination concerning the shall be filled, in whole or in part, at date of shipment, quantity, and type of any official establishment with any labeling material involved. No such product unless it has been inspected material shall be used at the establish- and passed in compliance with the reg- ment to which it is shipped unless such ulations in this subchapter, is not adul- use conforms with the requirements of terated, and is strictly in accordance this subchapter. with the statements on the label, and such filling is done under the super- §§ 317.14–317.15 [Reserved] vision of a Program employee. (c) No person shall remove, or cause § 317.16 Labeling and containers of to be removed from an official estab- custom prepared products. lishment any product bearing a label Products that are custom prepared unless such label is in compliance with under § 303.1(a)(2) of this subchapter the regulations in this subchapter, or must be packaged immediately after any product not bearing a label re- preparation and must be labeled (in quired by such regulations. lieu of information otherwise required by this part 317) with the words ‘‘Not § 317.12 Relabeling products; require- For Sale’’ in lettering not less than ments. three-eighth inch in height. Such ex- When it is claimed by an official es- empted custom prepared products or tablishment that any of its products their containers may bear additional which bore labels bearing official labeling provided such labeling is not marks has been transported to a loca- false or misleading. tion other than an official establish- ment, and it is desired to relabel the [37 FR 4071, Feb. 26, 1972] product because the labels have be- come mutilated or otherwise damaged, § 317.17 Interpretation and statement of labeling policy for cured prod- a request for relabeling the product ucts; special labeling requirements shall be sent to the Administrator, ac- concerning nitrate and nitrite. companied with a statement of the rea- sons therefor. Labeling material in- (a) With respect to sections 1(n) (7), tended for relabeling inspected and (9), and (12) of the Act and § 317.2, any passed product shall not be transported substance mixed with another sub- from an official establishment until stance to cure a product must be iden- permission has been received from the tified in the ingredients statement on Administrator. The relabeling of in- the label of such product. For example, spected and passed product with labels curing mixtures composed of such in- bearing any official marks shall be gredients as water, salt, sugar, sodium done under the supervision of a Pro- phosphate, sodium nitrate, and sodium gram inspector. The official establish- nitrite or other permitted substances ment shall reimburse the Program, in which are added to any product, must accordance with the regulations of the be identified on the label of the prod- Department, for any cost involved in uct by listing each such ingredient in supervising the relabeling of such prod- accordance with the provisions of uct. § 317.2. (b) Any product, such as bacon and § 317.13 Storage and distribution of la- pepperoni, which is required to be la- bels and containers bearing official beled by a common or usual name or marks. descriptive name in accordance with Labels, wrappers, and containers § 317.2(c)(1) and to which nitrate or ni- bearing any official marks, with or trite is permitted or required to be without the establishment number, added may be prepared without nitrate may be transported from one official or nitrite and labeled with such com- establishment to any other official es- mon or usual name or descriptive name tablishment provided such shipments when immediately preceded with the are made with the prior authorization term ‘‘Uncured’’ as part of the product of the inspector in charge at point of name in the same size and style of let- origin, who will notify the inspector in tering as the product name, provided
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that the product is found by the Ad- (NIST) Handbook 133, ‘‘Checking the ministrator to be similar in size, fla- Net Contents of Packaged Goods,’’ vor, consistency, and general appear- Third Edition, September 1988, and ance to such product as commonly pre- Supplements 1, 2, 3, and 4 dated Sep- pared with nitrate or nitrite, or both. tember 1990, October 1991, October 1992, (c)(1) Products described in para- and October 1994, respectively, which graph (b) of this section or § 319.2 of are incorporated by reference, with the this subchapter, which contain no ni- exception of the NIST Handbook 133 trate or nitrite shall bear the state- and Supplements 1, 3, and 4 require- ment ‘‘No Nitrate or Nitrite Added.’’ ments listed in paragraphs (b) and (c) This statement shall be adjacent to the of this section. Those provisions incor- product name in lettering of easily porated by reference herein, are consid- readable style and at least one-half the ered mandatory requirements. This in- size of the product name. corporation was approved by the Direc- (2) Products described in paragraph tor of the Federal Register in accord- (b) of this section and § 319.2 of this ance with 5 U.S.C. 552(a) and 1 CFR subchapter shall bear, adjacent to the part 51. (These materials are incor- product name in lettering of easily porated as they exist on the date of ap- readable style and at least one-half the proval.) A notice of any change in the size of the product name, the state- Handbook cited herein will be pub- ment ‘‘Not Preserved—Keep Refrig- lished in the FEDERAL REGISTER. Copies erated Below 40 °F. At All Times’’ un- may be purchased from the Super- less they have been thermally proc- intendent of Documents, U.S. Govern- essed to Fo 3 or more; they have been ment Printing Office, Washington, DC fermented or pickled to pH of 4.6 or 20402. It is also available for inspection less; or they have been dried to a water at the Office of the Federal Register In- activity of 0.92 or less. formation Center, 800 North Capitol (3) Products described in paragraph Street NW., suite 700, Washington, DC (b) of this section and § 319.2 of this 20408. subchapter shall not be subject to the (b) The following NBS Handbook 133 labeling requirements of paragraphs (b) requirements are not incorporated by and (c) of this section if they contain reference. an amount of salt sufficient to achieve Chapter 2—General Considerations a brine concentration of 10 percent or more. 2.13.1 Polyethylene Sheeting and Film 2.13.2 Textiles [37 FR 16863, Aug. 22, 1972, as amended at 44 2.13.3 Mulch FR 48961, Aug. 21, 1979] Chapter 3—Methods of Test for Packages § 317.18 Quantity of contents labeling. Labeled by Weight Sections 317.18 through 317.22 of this 3.11. Aerosol Packages part prescribe the procedures to be fol- 3.14. Glazed Raw Seafood and Fish 3.15. Canned Coffee lowed for determining net weight com- 3.16. Borax pliance and prescribe the reasonable 3.17. Flour variations from the declared net weight on the labels of immediate con- CHAPTER 4—METHODS OF TEST FOR PACKAGES tainers of products in accordance with LABELED BY VOLUME § 317.2(h) of this part. 4.7. Milk 4.8. Mayonnaise and Salad Dressing [55 FR 49834, Nov. 30, 1990] 4.9. Paint, Varnish, and Lacquers—Nonaero- sol § 317.19 Definitions and procedures for 4.11. Peat Moss determining net weight compliance. 4.12. Bark Mulch (a) For the purpose of §§ 317.18 4.15. Ice Cream Novelties through 317.22 of this part, the reason- CHAPTER 5—METHODS OF TEST FOR PACKAGES able variations allowed, definitions, LABELED BY COUNT, LENGTH, AREA, THICK- and procedures to be used in determin- NESS, OR COMBINATIONS OF QUANTITIES ing net weight and net weight compli- 5.4. Polyethylene Sheeting ance are described in the National In- 5.5. Paper Plates stitute of Standards and Technology 5.6. Sanitary Paper Products
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5.7. Pressed and Blown Glass Tumblers and 3.11.4 Exhausting the Aerosol Container Stemware 3.11.5 The Determination of Net Contents: Part 2 APPENDIX D: PACKAGE NET CONTENTS Appendix A. Report Forms REGULATIONS D.1.1. U.S. Department of Health and [55 FR 49834, Nov. 30, 1990, as amended at 60 Human Services, Food and Drug Admin- FR 12884, March 9, 1995] istration D.1.2. Department of Agriculture, Food § 317.20 Scale requirements for accu- Safety and Inspection Service rate weights, repairs, adjustments, D.1.3. Federal Trade Commission and replacement after inspection. D.1.4. Environmental Protection Agency (a) All scales used to weigh meat D.1.5. U.S. Department of the Treasury, Bu- products sold or otherwise distributed reau of Alcohol, Tobacco, and Firearms in commerce in federally inspected (c) The following requirements of meat establishments shall be installed, Supplement 1, dated September 1990, maintained and operated to insure ac- Supplement 3, dated October 1992, and curate weights. Such scales shall meet Supplement 4, dated 1994, of NIST the applicable requirements contained Handbook 133 are not incorporated by in National Institute of Standards and reference. Technology Handbook 44, ‘‘Specifica- tions, Tolerances and Other Technical Supplement 1 Requirements for Weighing and Meas- Chapter 2 General Considerations uring Devices,’’ 1994 Edition, October 2.13.1. Polyethylene Sheeting and Film 1993, which is incorporated by ref- 2.13.2. Textiles erence. This incorporation was ap- 2.13.3. Mulch proved by the Director of the Federal Register in accordance with 5 U.S.C.. Chapter 3 Methods of Test for Packages 552(a) and 1 CFR part 51. (These mate- Labeled by Weight rials are incorporated as they exist on 3.11.4. Exhausting the Aerosol Container the date of approval.) Copies may be Chapter 4 Methods of Test for Packages purchased from the Superintendent of Labeled by Volume Documents, U.S. Government Printing Office, Washington, DC 20402. It is also 4.6.4. Method D: Determining the Net Con- available for inspection at the Office of tents of Compressed Gas in Cylinders 4.7. Milk the Federal Register Information Cen- 4.16. Fresh Oysters Labeled by Volume ter, 800 North Capitol Street NW., suite 700, Washington, DC 20408. Chapter 5 Methods of Test for Packages La- (b) All scales used to weigh meat beled by Count, Length, Area, Thickness, products sold or otherwise distributed or Combinations of Quantities in commerce or in States designated 5.4. Polyethylene Sheeting under section 301(c) of the Federal Supplement 3 Meat Inspection Act, shall be of suffi- cient capacity to weigh the entire unit Chapter 3 Methods of Test for Packages and/or package. Labeled by Weight (c) No scale shall be used at a feder- 3.17. Flour and Dry Pet Food ally inspected establishment to weigh meat products unless it has been found Chapter 5 Methods of Test for Packages La- upon test and inspection, as specified beled by Count, Length, Area, Thickness, in NIST Handbook 44, to provide accu- or Combination of Quantities rate weight. If a scale is reinspected or 5.4. Polyethylene Sheeting retested and found to be inaccurate, or 5.5. Paper Plates if any repairs, adjustments or replace- 5.8. Baler Twine ments are made to a scale, it shall not Appendix A. Forms and Worksheets be used until it has been inspected and Supplement 4 tested by a USDA official, or a State or local government weights and meas- 3.11 Aerosol Packages 3.11.1 Equipment ures official, or State registered or li- 3.11.2 Preparation for Test censed scale repair firm or person, and 3.11.3 The Determination of Net Contents: it must meet all accuracy require- Part 1 ments as specified in NIST Handbook
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44. If a USDA inspector has put a retain inence as the most conspicuous feature tag on a scale it can only be removed of a label. by a USDA inspector. As long as the [55 FR 49834, Nov. 30, 1990] tag is on the scale, it shall not be used. [55 FR 49834, Nov. 30, 1990, as amended at 60 § 317.23 [Reserved] FR 12884, Mar. 9, 1995] § 317.24 Packaging materials. § 317.21 Scales: testing of. (a) Edible products may not be pack- (a) The operator of each official es- aged in a container which is composed tablishment that weighs meat food in whole or in part of any poisonous or products shall cause such scales to be deleterious substances which may tested for accuracy, in accordance with render the contents adulterated or in- the technical requirements of NIST jurious to health. All packaging mate- Handbook 44, at least once during the rials must be safe for their intended calendar year. In cases where the use within the meaning of section 409 scales are found not to maintain accu- of the Federal Food, Drug, and Cos- racy between tests, more frequent tests metic Act, as amended (FFDCA). may be required and monitored by an (b) Packaging materials entering the authorized USDA program official. official establishment must be accom- (b) The operator of each official es- panied or covered by a guaranty, or tablishment shall display on or near statement of assurance, from the pack- each scale a valid certification of the aging supplier under whose brand name scale’s accuracy from a State or local and firm name the material is mar- government’s weights and measures keted to the official establishment. authority or from a State registered or The guaranty shall state that the ma- licensed scale repair firm or person, or terial’s intended use complies with the shall have a net weight program under FFDCA and all applicable food additive a Total Quality Control System or Par- regulations. The guaranty must iden- tial Quality Control Program in ac- tify the material, e.g., by the distin- cordance with § 318.4 of this subchapter. guishing brand name or code designa- tion appearing on the packaging mate- [55 FR 49834, Nov. 30, 1990, as amended at 62 rial shipping container; must specify FR 45024, Aug. 25, 1997] the applicable conditions of use, in- § 317.22 Handling of failed product. cluding temperature limits and any other pertinent limits specified under Any lot of product which is found to the FFDCA and food additive regula- be out of compliance with net weight tions; and must be signed by an author- requirements upon testing in accord- ized official of the supplying firm. The ance with § 317.19 shall be handled as guaranty may be limited to a specific follows: shipment of an article, in which case it (a) A lot tested in an official estab- may be part of or attached to the in- lishment and found not to comply with voice covering such shipment, or it net weight requirements may be re- may be general and continuing, in processed and must be reweighed and which case, in its application to any remarked to satisfy the net weight re- article or other shipment of an article, quirements of this section and be rein- it shall be considered to have been spected, in accordance with the re- given at the date such article was quirements of this part. shipped by the person who gives the (b) A lot tested outside of an official guaranty. Guaranties consistent with establishment and found not to comply the Food and Drug Administration’s with net weight requirements must be regulations regarding such guaranties reweighed and remarked with a proper (21 CFR 7.12 and 7.13) will be accept- net weight statement, provided that able. The management of the establish- such reweighing and remarking shall ment must maintain a file containing not deface, cover, or destroy any other guaranties for all food contact packag- marking or labeling required under ing materials in the establishment. this subchapter and the net quantity of The file shall be made available to Pro- contents is shown with the same prom- gram inspectors or other Department
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officials upon request. While in the of- termination, a hearing in accordance ficial establishment, the identity of all with applicable rules of practice will be packaging materials must be traceable held to resolve such dispute. Approval to the applicable guaranty. to use the materials pending the out- (c) The guaranty by the packaging come of the presentation of views or supplier will be accepted by Program hearing shall be denied if the Adminis- inspectors to establish that the use of trator determines that such use may material complies with the FFDCA and present an imminent hazard to public all applicable food additive regula- health. tions. (f) Periodically, the Administrator (d) The Department will mmnitor the will issue to inspectors a listing, by use of packaging material in official distinguishing brand name or code des- establishments to assure that the re- ignation, of packaging materials that quirements of paragraph (a) of this sec- have been reviewed and that fail to tion are met, and may question the meet the requirements of paragraph (a) basis for any guaranty described under of this section. Listed materials will paragraph (b) of this section. Official not be permitted for use in official es- establishments and packaging suppli- tablishments. If a subsequent review of ers providing written guaranties to any material indicates that it meets those official establishments will be the requirements of paragraph (a), the permitted an opportunity to provide material will be deleted from the list- information tm designated Department ing. officials as needed to verify the basis (g) Nothing in this section shall af- for any such guaranty. The required in- fect the authority of Program inspec- formation will include, but is not lim- tors to refuse a specific material if he/ ited to, manufacturing firm’s name, she determines the material may trade name or code designation for the render products adulterated or injuri- material, complete chemical composi- ous to health. tion, and use. Selection of a material for review does not in itself affect a [49 FR 2235, Jan. 19, 1984. Redesignated at 55 material’s acceptability. Materials FR 49833, Nov. 30, 1990] may continue to be used during the re- view period. However, if information Subpart B—Nutrition Labeling requested from the supplier is not pro- vided within the time indicated in the SOURCE: 58 FR 664, Jan. 6, 1993, unless oth- request—a minimum of 30 days—any erwise noted. applicable guaranty shall cease to be effective, and approval to continue § 317.300 Nutrition labeling of meat or using the specified packaging material meat food products. in official establishments may be de- (a) Nutrition labeling shall be pro- nied. The Administrator may extend vided for all meat or meat food prod- this time where reasonable grounds for ucts intended for human consumption extension are shown, as, for example, and offered for sale, except single-in- where data must be obtained from sup- gredient, raw products, in accordance pliers. with the requirements of § 317.309; ex- (e) The Administrator may dis- cept as exempted under § 317.400 of this approve for use in official subpart. establishmelts packaging materials whose use cannot be confirmed as com- (b) Nutrition labeling may be pro- plying with FFDCA and applicable food vided for single-ingredient, raw meat additive regulations. Before approval or meat food products in accordance to use a packaging material is finally with the requirements of §§ 317.309 and denied by the Administrator, the af- 317.345. Significant participation in vol- fected official establishment and the untary nutrition labeling shall be supplier of the material shall be given measured by the Agency in accordance notice and the opportunity to present with §§ 317.343 and 317.344 of this sub- their views to the Administrator. If the part. official establishment and the supplier [58 FR 664, Jan. 6, 1993, as amended at 60 FR do not accept the Administrator’s de- 176, Jan. 3, 1995]
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§ 317.301 [Reserved] which is expressed in a common house- hold measure that is appropriate to the § 317.302 Location of nutrition infor- product. When the product is specially mation. formulated or processed for use by in- (a) Nutrition information on a label fants or by toddlers, a serving or serv- of a packaged meat or meat food prod- ing size means an amount of food cus- uct shall appear on the label’s principal tomarily consumed per eating occasion display panel or on the information by infants up to 12 months of age or by panel, except as provided in paragraphs children 1 through 3 years of age, re- (b) and (c) of this section. spectively. (b) Nutrition information for gift (2) Except as provided in paragraphs packs may be shown at a location (b)(8), (b)(12), and (b)(14) of this section other than on the product label, pro- and for products that are intended for vided that the labels for these products weight control and are available only bear no nutrition claim. In lieu of on through a weight-control or weight- the product label, nutrition informa- maintenance program, serving size de- tion may be provided by alternate clared on a product label shall be deter- means such as product label inserts. mined from the ‘‘Reference Amounts (c) Meat or meat food products in Customarily Consumed Per Eating Oc- packages that have a total surface area casion—General Food Supply’’ (Ref- available to bear labeling greater than erence Amount(s)) that appear in 40 square inches but whose principal § 317.312(b) using the procedures de- display panel and information panel do scribed in this paragraph (b). For prod- not provide sufficient space to accom- ucts that are both intended for weight modate all required information may control and available only through a use any alternate panel that can be weight-control program, a manufac- readily seen by consumers for the nu- turer may determine the serving size trition information. In determining the that is consistent with the meal plan of sufficiency of available space for the the program. Such products must bear nutrition information, the space need- a statement, ‘‘for sale only through the ed for vignettes, designs, and other lll program’’ (fill in the blank with nonmandatory label information on the name of the appropriate weight- the principal display panel may be con- control program, e.g., Smith’s Weight sidered. Control), on the principal display [58 FR 664, Jan. 6, 1993, as amended at 59 FR panel. However, the Reference 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995] Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight- §§ 317.303–317.307 [Reserved] control products that are available only through a weight-control program § 317.308 Labeling of meat or meat qualify for nutrition claims. food products with number of servings. (3) The declaration of nutrient and food component content shall be on the The label of any package of a meat or basis of the product ‘‘as packaged’’ for meat food product that bears a rep- all products, except that single-ingre- resentation as to the number of dient, raw products may be declared on servings contained in such package the basis of the product ‘‘as consumed’’ shall meet the requirements of as set forth in § 317.345(a)(1). In addition § 317.2(h)(10). to the required declaration on the basis [58 FR 664, Jan. 6, 1993, as amended at 60 FR of ‘‘as packaged’’ for products other 176, Jan. 3, 1995] than single-ingredient, raw products, the declaration may also be made on § 317.309 Nutrition label content. the basis of ‘‘as consumed,’’ provided (a) All nutrient and food component that preparation and cooking instruc- quantities shall be declared in relation tions are clearly stated. to a serving as defined in this section. (4) For products in discrete units (b)(1) The term ‘‘serving’’ or ‘‘serving (e.g., hot dogs, and individually pack- size’’ means an amount of food cus- aged products within a multi-serving tomarily consumed per eating occasion package), and for products which con- by persons 4 years of age or older, sist of two or more foods packaged and
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presented to be consumed together products where the entire contents of where the ingredient represented as the the package is used to prepare large main ingredient is in discrete units discrete units that are usually divided (e.g., beef fritters and barbecue sauce), for consumption (e.g. pizza kit), and for the serving size shall be declared as fol- products which consist of two or more lows: foods packaged and presented to be (i) If a unit weighs 50 percent or less consumed together where the ingredi- of the Reference Amount, the serving ent represented as the main ingredient size shall be the number of whole units is a large discrete unit usually divided that most closely approximates the for consumption, the serving size shall Reference Amount for the product cat- be the fractional slice of the ready-to- egory. eat product (e.g., 1⁄8 quiche, 1⁄4 pizza) (ii) If a unit weighs more than 50 per- that most closely approximates the cent but less than 67 percent of the Reference Amount for the product cat- Reference Amount, the manufacturer egory. The serving size may be the may declare one unit or two units as fraction of the package used to make the serving size. the Reference Amount for the unpre- (iii) If a unit weighs 67 percent or pared product determined in § 317.312(d) more but less than 200 percent of the or the fraction of the large discrete Reference Amount, the serving size unit represented as the main ingredi- shall be one unit. ent plus proportioned minor ingredi- (iv) If a unit weighs 200 percent or ents used to make the Reference more of the Reference Amount, the Amount of the combined product deter- manufacturer may declare one unit as mined in § 317.312(c). In expressing the the serving size if the whole unit can fractional slice, manufacturers shall reasonably be consumed at a single use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions eating occasion. that can be generated by further divi- (v) For products that have Reference sion by 2 or 3. Amounts of 100 grams (or milliliter) or larger and are individual units within a (6) For nondiscrete bulk products multi-serving package, if a unit con- (e.g., whole roast beef, marinated beef tains more than 150 percent but less tenderloin, large can of chili), and for than 200 percent of the Reference products which consist of two or more Amount, the manufacturer may decide foods packaged and presented to be whether to declare the individual unit consumed together where the ingredi- as 1 or 2 servings. ent represented as the main ingredient (vi) For products which consist of is a bulk product (e.g., roast beef and two or more foods packaged and pre- gravy), the serving size shall be the sented to be consumed together where amount in household measure that the ingredient represented as the main most closely approximates the Ref- ingredient is in discrete units (e.g., erence Amount for the product cat- beef fritters and barbecue sauce), the egory and may be the amount of the serving size may be the number of dis- bulk product represented as the main crete units represented as the main in- ingredient plus proportioned minor in- gredient plus proportioned minor in- gredients used to make the Reference gredients used to make the Reference Amount for the combined product de- Amount for the combined product as termined in § 317.312(c). determined in § 317.312(c). (7) For labeling purposes, the term (vii) For packages containing several ‘‘common household measure’’ or individual single-serving containers, ‘‘common household unit’’ means cup, each of which is labeled with all re- tablespoon, teaspoon, piece, slice, frac- quired information including nutrition tion (e.g., 1⁄4 pizza), ounce (oz), or other labeling as specified in this section common household equipment used to (i.e., are labeled appropriately for indi- package food products (e.g., jar or vidual sale as single-serving contain- tray). In expressing serving size in ers), the serving size shall be 1 unit. household measures, except as speci- (5) For products in large discrete fied in paragraphs (b)(7)(iv), (v), and units that are usually divided for con- (vi) of this section, the following rules sumption (e.g., pizza), for unprepared shall be used:
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(i) Cups, tablespoons, or teaspoons (viii) When a serving size, determined shall be used wherever possible and ap- from the Reference Amount in propriate. Cups shall be expressed in 1⁄4- § 317.312(b) and the procedures described or 1⁄3-cup increments, tablespoons in in this section, falls exactly half way whole number of tablespoons for quan- between two serving sizes (e.g., 2.5 tities less than 1⁄4 cup but greater than tbsp), manufacturers shall round the or equal to 2 tablespoons (tbsp), 1, 11⁄3, serving size up to the next incremental 11⁄2, or 1 2⁄3 tbsp for quantities less than size. 2 tbsp but greater than or equal to 1 (8) A product that is packaged and tbsp, and teaspoons in whole number of sold individually and that contains less teaspoons for quantities less than 1 than 200 percent of the applicable Ref- tbsp but greater than or equal to 1 tea- erence Amount shall be considered to spoon (tsp), and in 1⁄4-tsp increments be a single-serving container, and the for quantities less than 1 tsp. entire content of the product shall be (ii) If cups, tablespoons or teaspoons labeled as one serving, except for prod- are not applicable, units such as piece, ucts that have Reference Amounts of slice, tray, jar, and fraction shall be 100 g (or mL) or larger, manufacturers used. may decide whether a package that (iii) If cups, tablespoons and contains more than 150 percent but less teaspoons, or units such as piece, slice, than 200 percent of the Reference tray, jar, or fraction are not applicable, Amount is 1 or 2 servings. Packages ounces may be used. Ounce measure- sold individually that contain 200 per- ments shall be expressed in 0.5-ounce cent or more of the applicable Ref- increments most closely approximat- erence Amount may be labeled as a sin- ing the Reference Amount with round- gle-serving if the entire content of the ing indicated by the use of the term package can reasonably be consumed ‘‘about’’ (e.g., about 2.5 ounces). at a single-eating occasion. (9) A label statement regarding a (iv) A description of the individual serving shall be the serving size ex- container or package shall be used for pressed in common household measures single-serving containers and meal- as set forth in paragraphs (b)(2) type products and for individually through (b)(8) of this section and shall packaged products within multi-serv- be followed by the equivalent metric ing containers (e.g., can, box, package, quantity in parenthesis (fluids in milli- meal, or dinner). A description of the liters and all other foods in grams), ex- individual unit shall be used for other cept for single-serving containers. products in discrete units (e.g., chop, (i) For a single-serving container, the slice, link, or patty). parenthetical metric quantity, which (v) For unprepared products where will be presented as part of the net the entire contents of the package is weight statement on the principal dis- used to prepare large discrete units play panel, is not required except that are usually divided for consump- where nutrition information is re- tion (e.g., pizza kit), the fraction or quired on a drained weight basis ac- portion of the package may be used. cording to paragraph (b)(11) of this sec- (vi) For products that consist of two tion. However, if a manufacturer vol- or more distinct ingredients or compo- untarily provides the metric quantity nents packaged and presented to be on products that can be sold as single- consumed together (e.g., ham with a servings, then the numerical value pro- glaze packet), the nutrition informa- vided as part of the serving size dec- tion may be declared for each compo- laration must be identical to the met- nent or as a composite. The serving ric quantity declaration provided as size may be provided in accordance part of the net quantity of contents with the provisions of paragraphs statement. (b)(4), (b)(5), and (b)(6) of this section. (ii) The gram or milliliter quantity (vii) For nutrition labeling purposes, equivalent to the household measure a teaspoon means 5 milliliters (mL), a should be rounded to the nearest whole tablespoon means 15 mL, a cup means number except for quantities that are 240 mL, and 1 oz in weight means 28 less than 5 g (mL). The gram (mL) grams (g). quantity between 2 and 5 g (mL) should
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be rounded to the nearest 0.5 g (mL) ers), the number of servings shall be and the g (mL) quantity less than 2 g the number of individual packages (mL) should be expressed in 0.1-g (mL) within the total package. increments. (v) For packages containing several (iii) In addition, serving size may be individually packaged multi-serving declared in ounce, in parenthesis, fol- units, the number of servings shall be lowing the metric measure separated determined by multiplying the number by a slash where other common house- of individual multi-serving units in the hold measures are used as the primary total package by the number of unit for serving size, e.g., 1 slice (28 g/ servings in each individual unit. 1 oz) for sliced bologna. The ounce (11) The declaration of nutrient and quantity equivalent to the metric food component content shall be on the quantity should be expressed in 0.1-oz basis of product as packaged or pur- increments. chased with the exception of products (iv) If a manufacturer elects to use that are packed or canned in water, abbreviations for units, the following brine, or oil but whose liquid packing abbreviations shall be used: tbsp for ta- medium is not customarily consumed. blespoon, tsp for teaspoon, g for gram, Declaration of the nutrient and food mL for milliliter, and oz for ounce. component content of products that (10) Determination of the number of are packed in liquid which is not cus- servings per container shall be based tomarily consumed shall be based on on the serving size of the product de- the drained solids. termined by following the procedures (12) Serving size for meal-type prod- described in this section. ucts as defined in § 317.313(l) shall be (i) The number of servings shall be the entire content (edible portion only) rounded to the nearest whole number of the package. except for the number of servings be- (13) Another column of figures may tween 2 and 5 servings and random be used to declare the nutrient and weight products. The number of food component information in the servings between 2 and 5 servings shall same format as required by § 317.309(e), be rounded to the nearest 0.5 serving. (i) Per 100 grams, 100 milliliters, or 1 Rounding should be indicated by the ounce of the product as packaged or use of the term ‘‘about’’ (e.g., about 2 purchased. servings; about 3.5 servings). (ii) Per one unit if the serving size of (ii) When the serving size is required a product in discrete units in a multi- to be expressed on a drained solids serving container is more than one basis and the number of servings varies unit. because of a natural variation in unit (14) If a product consists of assort- size (e.g., pickled pigs feet), the manu- ments of meat or meat food products facturer may state the typical number (e.g., variety packs) in the same pack- of servings per container (e.g., usually age, nutrient content shall be ex- 5 servings). pressed on the entire package contents (iii) For random weight products, a or on each individual product. manufacturer may declare ‘‘varied’’ for (15) If a product is commonly com- the number of servings per container bined with other ingredients or is provided the nutrition information is cooked or otherwise prepared before based on the Reference Amount ex- eating, and directions for such com- pressed in ounces. The manufacturer bination or preparations are provided, may provide the typical number of another column of figures may be used servings in parenthesis following the to declare the nutrient contents on the ‘‘varied’’ statement (e.g., varied (ap- basis of the product as consumed for proximately 8 servings per pound)). the product alone (e.g., a cream soup (iv) For packages containing several mix may be labeled with one set of individual single-serving containers, Daily Values for the dry mix (per serv- each of which is labeled with all re- ing), and another set for the serving of quired information including nutrition the final soup when prepared (e.g., per labeling as specified in this section serving of cream soup mix and 1 cup of (i.e., are labeled appropriately for indi- vitamin D fortified whole milk)): Pro- vidual sale as single-serving contain- vided, That the type and quantity of
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the other ingredients to be added to with 5 U.S.C. 552(a) and 1 CFR part 51. the product by the user and the specific It is available for inspection at the Of- method of cooking and other prepara- fice of the Federal Register, suite 700, tion shall be specified prominently on 800 North Capitol Street, NW., Wash- the label. ington, DC, or at the office of the FSIS (c) The declaration of nutrition infor- Docket Clerk, Room 3171, South Build- mation on the label or in labeling of a ing, 14th and Independence Avenue, meat or meat food product shall con- SW., Washington, DC. Copies of the in- tain information about the level of the corporation by reference are available following nutrients, except for those from the Product Assessment Division, nutrients whose inclusion, and the dec- Regulatory Programs, Food Safety and laration of amounts, is voluntary as Inspection Service, U.S. Department of set forth in this paragraph. No nutri- Agriculture, Room 329, West End Court ents or food components other than Building, Washington, DC 20250–3700; those listed in this paragraph as either (B) Using the general factors of 4, 4, mandatory or voluntary may be in- and 9 calories per gram for protein, cluded within the nutrition label. Ex- total carbohydrate, and total fat, re- cept as provided for in paragraph (f) or spectively, as described in USDA’s Ag- (g) of this section, nutrient informa- riculture Handbook No. 74 (Slightly re- tion shall be presented using the nutri- vised February 1973), pages 9–11, which ent names specified and in the follow- is incorporated by reference. Pages 9– ing order in the formats specified in 11, Agriculture Handbook No. 74 is in- paragraph (d) or (e) of this section. corporated as it exists on the date of (1) ‘‘Calories, total,’’ ‘‘Total cal- approval. This incorporation by ref- ories,’’ or ‘‘Calories’’: A statement of erence was approved by the Director of the caloric content per serving, ex- the Federal Register in accordance pressed to the nearest 5-calorie incre- with 5 U.S.C. 552(a) and 1 CFR part 51. ment up to and including 50 calories, (The availability of this incorporation and 10-calorie increment above 50 cal- by reference is given in paragraph ories, except that amounts less than 5 (c)(1)(i)(A) of this section.); calories may be expressed as zero. En- (C) Using the general factors of 4, 4, ergy content per serving may also be and 9 calories per gram for protein, expressed in kilojoule units, added in total carbohydrate less the amount of parenthesis immediately following the insoluble dietary fiber, and total fat, statement of the caloric content. respectively, as described in USDA’s (i) Caloric content may be calculated Agriculture Handbook No. 74 (Slightly by the following methods. Where either revised February 1973), pages 9–11, specific or general food factors are which is incorporated by reference in used, the factors shall be applied to the accordance with 5 U.S.C. 552(a) and 1 actual amount (i.e., before rounding) of CFR part 51. (The availability of this food components (e.g., fat, carbo- incorporation by reference is given in hydrate, protein, or ingredients with paragraph (c)(1)(i)(A) of this section.); specific food factors) present per serv- or ing. (D) Using data for specific food fac- (A) Using specific Atwater factors tors for particular foods or ingredients (i.e., the Atwater method) given in approved by the Food and Drug Admin- Table 13, page 25, ‘‘Energy Value of istration (FDA) and provided in parts Foods—Basis and Derivation,’’ by A. L. 172 or 184 of 21 CFR, or by other means, Merrill and B. K. Watt, United States as appropriate. Department of Agriculture (USDA), (ii) ‘‘Calories from fat’’: A statement Agriculture Handbook No. 74 (Slightly of the caloric content derived from revised February 1973), which is incor- total fat as defined in paragraph (c)(2) porated by reference. Table 13 of the of this section per serving, expressed to ‘‘Energy Value of Foods—Basis and the nearest 5-calorie increment, up to Derivation,’’ Agriculture Handbook No. and including 50 calories, and the near- 74 is incorporated as it exists on the est 10-calorie increment above 50 cal- date of approval. This incorporation by ories, except that label declaration of reference was approved by the Director ‘‘calories from fat’’ is not required on of the Federal Register in accordance products that contain less than 0.5
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gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when section per serving may be declared monounsaturated fat is declared, or voluntarily, expressed to the nearest 5- when a claim about fatty acids or cho- calorie increment, up to and including lesterol is made on the label or in la- 50 calories, and the nearest 10-calorie beling of a product other than one that increment above 50 calories, except meets the criteria in § 317.362(b)(1) for a that amounts less than 5 calories may claim for ‘‘fat free,’’ label declaration be expressed as zero. This statement of polyunsaturated fat is required. shall be indented under the statement Polyunsaturated fat content shall be of calories from fat as provided in para- indented and expressed as grams per graph (d)(5) of this section. serving to the nearest 0.5 (1⁄2)-gram in- (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A crement below 5 grams and to the near- statement of the number of grams of est gram increment above 5 grams. If total fat per serving defined as total the serving contains less than 0.5 gram, lipid fatty acids and expressed as the content shall be expressed as zero. triglycerides. Amounts shall be ex- (iii) ‘‘Monounsaturated fat’’ or pressed to the nearest 0.5 (1⁄2)-gram in- crement below 5 grams and to the near- ‘‘Monounsaturated’’ (VOLUNTARY): A est gram increment above 5 grams. If statement of the number of grams of the serving contains less than 0.5 gram, monounsaturated fat per serving de- the content shall be expressed as zero. fined as cis-monounsaturated fatty (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A acids may be declared voluntarily, ex- statement of the number of grams of cept that when polyunsaturated fat is saturated fat per serving defined as the declared, or when a claim about fatty sum of all fatty acids containing no acids or cholesterol is made on the double bonds, except that label dec- label or in labeling of a product other laration of saturated fat content infor- than one that meets the criteria in mation is not required for products § 317.362(b)(1) for a claim for ‘‘fat free,’’ that contain less than 0.5 gram of total label declaration of monounsaturated fat per serving if no claims are made fat is required. Monounsaturated fat about fat or cholesterol content, and if content shall be indented and expressed ‘‘calories from saturated fat’’ is not de- as grams per serving to the nearest 0.5 clared. Saturated fat content shall be (1⁄2)-gram increment below 5 grams and indented and expressed as grams per to the nearest gram increment above 5 serving to the nearest 0.5 (1⁄2)-gram in- grams. If the serving contains less than crement below 5 grams and to the near- 0.5 gram, the content shall be expressed est gram increment above 5 grams. If as zero. the serving contains less than 0.5 gram, (3) ‘‘Cholesterol’’: A statement of the the content shall be expressed as zero. cholesterol content per serving ex- (A) ‘‘Stearic Acid’’ (VOLUNTARY): A pressed in milligrams to the nearest 5- statement of the number of grams of milligram increment, except that label stearic acid per serving may be de- declaration of cholesterol information clared voluntarily, except that when a is not required for products that con- claim is made about stearic acid, label tain less than 2 milligrams of choles- declaration shall be required. Stearic terol per serving and make no claim acid content shall be indented under about fat, fatty acids, or cholesterol saturated fat and expressed to the content, or such products may state nearest 0.5 (1⁄2)-gram increment below 5 the cholesterol content as zero. If the grams and the nearest gram increment product contains 2 to 5 milligrams of above 5 grams. If the serving contains cholesterol per serving, the content
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may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of the serving contains greater than 140 soluble dietary fiber per serving may milligrams. be declared voluntarily except when a (5) ‘‘Potassium’’ (VOLUNTARY): A claim is made on the label or in label- statement of the number of milligrams ing about soluble fiber, label declara- of potassium per serving may be de- tion shall be required. Soluble fiber clared voluntarily, except that when a content shall be indented under dietary claim is made about potassium con- fiber and expressed to the nearest tent, label declaration shall be re- gram, except that if a serving contains quired. Potassium content shall be ex- less than 1 gram, the statement ‘‘Con- pressed as zero when the serving con- tains less than 1 gram’’ or ‘‘less than 1 tains less than 5 milligrams of potas- gram’’ may be used as an alternative, sium, to the nearest 5-milligram incre- and if the serving contains less than 0.5 ment when the serving contains 5 to gram, the content may be expressed as 140 milligrams of potassium, and to the zero. nearest 10-milligram increment when (B) ‘‘Insoluble fiber’’ (VOLUNTARY): the serving contains greater than 140 A statement of the number of grams of milligrams. insoluble dietary fiber per serving may (6) ‘‘Carbohydrate, total’’ or ‘‘Total be declared voluntarily except when a carbohydrate’’: A statement of the claim is made on the label or in label- number of grams of total carbohydrate ing about insoluble fiber, label declara- per serving expressed to the nearest tion shall be required. Insoluble fiber gram, except that if a serving contains content shall be indented under dietary less than 1 gram, the statement ‘‘Con- fiber and expressed to the nearest tains less than 1 gram’’ or ‘‘less than 1 gram, except that if a serving contains gram’’ may be used as an alternative, less than 1 gram, the statement ‘‘Con- or, if the serving contains less than 0.5 tains less than 1 gram’’ or ‘‘less than 1 gram, the content may be expressed as gram’’ may be used as an alternative, zero. Total carbohydrate content shall and if the serving contains less than 0.5 be calculated by subtraction of the sum gram, the content may be expressed as of the crude protein, total fat, mois- zero. ture, and ash from the total weight of (ii) ‘‘Sugars’’: A statement of the the product. This calculation method is number of grams of sugars per serving, described in USDA’s Agriculture Hand- except that label declaration of sugars book No. 74 (Slightly revised February content is not required for products 1973), pages 2 and 3, which is incor- that contain less than 1 gram of sugars porated by reference. Pages 2 and 3, Ag- per serving if no claims are made about riculture Handbook No. 74 is incor- sweeteners, sugars, or sugar alcohol porated as it exists on the date of ap- content. Sugars shall be defined as the proval. This incorporation by reference sum of all free mono- and disaccharides was approved by the Director of the (such as glucose, fructose, lactose, and Federal Register in accordance with 5 sucrose). Sugars content shall be in- U.S.C. 552(a) and 1 CFR part 51. (The dented and expressed to the nearest availability of this incorporation by gram, except that if a serving contains reference is given in paragraph less than 1 gram, the statement ‘‘Con- (c)(1)(i)(A) of this section.) tains less than 1 gram’’ or ‘‘less than 1 (i) ‘‘Dietary fiber’’: A statement of gram’’ may be used as an alternative, the number of grams of total dietary and if the serving contains less than 0.5 fiber per serving, indented and ex- gram, the content may be expressed as pressed to the nearest gram, except zero.
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(iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected tone or aldehyde group and whose use amino acid score of less than 40 ex- in the food is listed by FDA (e.g., pressed as a percent, either of the fol- mannitol or xylitol) or is generally rec- lowing shall be placed adjacent to the ognized as safe (e.g., sorbitol). In lieu declaration of protein content by of the term ‘‘sugar alcohol,’’ the name weight: The statement ‘‘not a signifi- of the specific sugar alcohol (e.g., cant source of protein,’’ or a listing ‘‘xylitol’’) present in the product may aligned under the column headed ‘‘Per- be used in the nutrition label, provided cent Daily Value’’ of the corrected that only one sugar alcohol is present amount of protein per serving, as de- in the product. Sugar alcohol content termined in paragraph (c)(7)(ii) of this shall be indented and expressed to the section, calculated as a percentage of nearest gram, except that if a serving the Daily Reference Value (DRV) or contains less than 1 gram, the state- Reference Daily Intake (RDI), as appro- ment ‘‘Contains less then 1 gram’’ or priate, for protein and expressed as per- ‘‘less than 1 gram’’ may be used as an cent of Daily Value. When the protein alternative, and if the serving contains quality in a product as measured by less than 0.5 gram, the content may be the Protein Efficiency Ratio (PER) is expressed as zero. less than 40 percent of the reference (iv) ‘‘Other carbohydrate’’ (VOL- standard (casein) for a product rep- UNTARY): A statement of the number resented or purported to be for infants, of grams of other carbohydrate per the statement ‘‘not a significant source serving may be declared voluntarily. of protein’’ shall be placed adjacent to Other carbohydrate shall be defined as the declaration of protein content. Pro- the difference between total carbo- tein content may be calculated on the hydrate and the sum of dietary fiber, basis of the factor of 6.25 times the ni- sugars, and sugar alcohol, except that trogen content of the food as deter- if sugar alcohol is not declared (even if mined by appropriate methods of anal- present), it shall be defined as the dif- ysis in accordance with § 317.309(h), ex- ference between total carbohydrate and cept when the procedure for a specific the sum of dietary fiber and sugars. food requires another factor. Other carbohydrate content shall be in- (i) A statement of the corrected dented and expressed to the nearest amount of protein per serving, as de- gram, except that if a serving contains termined in paragraph (c)(7)(ii) of this less than 1 gram, the statement ‘‘Con- section, calculated as a percentage of tains less than 1 gram’’ or ‘‘less than 1 the RDI or DRV for protein, as appro- gram’’ may be used as an alternative, priate, and expressed as percent of and if the serving contains less than 0.5 Daily Value, may be placed on the gram, the content may be expressed as label, except that such a statement zero. shall be given if a protein claim is (7) ‘‘Protein’’: A statement of the made for the product, or if the product number of grams of protein per serving is represented or purported to be for in- expressed to the nearest gram, except fants or children under 4 years of age. that if a serving contains less than 1 When such a declaration is provided, it gram, the statement ‘‘Contains less shall be placed on the label adjacent to than 1 gram’’ or ‘‘less than 1 gram’’ the statement of grams of protein and may be used as an alternative, and if aligned under the column headed ‘‘Per- the serving contains less than 0.5 gram, cent Daily Value,’’ and expressed to
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the nearest whole percent. However, value is above 1.00, it shall be set at the percentage of the RDI for protein 1.00. shall not be declared if the product is (iii) For the purpose of labeling with represented or purported to be for in- a percent of the DRV or RDI, a value of fants and the protein quality value is 50 grams of protein shall be the DRV less than 40 percent of the reference for adults and children 4 or more years standard. of age, and the RDI for protein for chil- (ii) The corrected amount of protein dren less than 4 years of age, infants, (grams) per serving for products rep- pregnant women, and lactating women resented or purported to be for adults shall be 16 grams, 14 grams, 60 grams, and children 1 or more years of age is and 65 grams, respectively. equal to the actual amount of protein (8) Vitamins and minerals: A state- (grams) per serving multiplied by the ment of the amount per serving of the amino acid score corrected for protein vitamins and minerals as described in digestibility. If the corrected score is this paragraph, calculated as a percent above 1.00, then it shall be set at 1.00. of the RDI and expressed as percent of The protein digestibility-corrected Daily Value. amino acid score shall be determined (i) For purposes of declaration of per- by methods given in sections 5.4.1, 7.2.1, cent of Daily Value as provided for in and 8 in ‘‘Protein Quality Evaluation, paragraphs (d) through (g) of this sec- Report of the Joint FAO/WHO Expert tion, products represented or purported Consultation on Protein Quality Eval- to be for use by infants, children less uation,’’ Rome, 1990, which is incor- than 4 years of age, pregnant women, porated by reference. Sections 5.4.1, or lactating women shall use the RDI’s 7.2.1, and 8 of the ‘‘Report of the Joint that are specified for the intended FAO/WHO Expert Consultation on Pro- group. For products represented or pur- tein Quality Evaluation,’’ as published ported to be for use by both infants and by the Food and Agriculture Organiza- children under 4 years of age, the per- tion of the United Nations/World cent of Daily Value shall be presented Health Organization, is incorporated as by separate declarations according to it exists on the date of approval. This paragraph (e) of this section based on incorporation by reference was ap- the RDI values for infants from birth proved by the Director of the Federal to 12 months of age and for children Register in accordance with 5 U.S.C. under 4 years of age. Similarly, the 552(a) and 1 CFR part 51. It is available percent of Daily Value based on both for inspection at the Office of the Fed- the RDI values for pregnant women eral Register, suite 700, 800 North Cap- and for lactating women shall be de- itol Street, NW., Washington, DC, or at clared separately on products rep- the office of the FSIS Docket Clerk, resented or purported to be for use by Room 3171, South Building, 14th and both pregnant and lactating women. Independence Avenue, SW., Washing- When such dual declaration is used on ton, DC. Copies of the incorporation by any label, it shall be included in all la- reference are available from the Prod- beling, and equal prominence shall be uct Assessment Division, Regulatory given to both values in all such label- Programs, Food Safety and Inspection ing. All other products shall use the Service, U.S. Department of Agri- RDI for adults and children 4 or more culture, Room 329, West End Court years of age. Building, Washington, DC 20250–3700. (ii) The declaration of vitamins and For products represented or purported minerals as a percent of the RDI shall to be for infants, the corrected amount include vitamin A, vitamin C, calcium, of protein (grams) per serving is equal and iron, in that order, and shall in- to the actual amount of protein clude any of the other vitamins and (grams) per serving multiplied by the minerals listed in paragraph (c)(8)(iv) relative protein quality value. The rel- of this section when they are added, or ative protein quality value shall be de- when a claim is made about them. termined by dividing the subject prod- Other vitamins and minerals need not uct’s protein PER value by the PER be declared if neither the nutrient nor value for casein. If the relative protein the component is otherwise referred to
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on the label or in labeling or advertis- Niacin, 20 milligrams ing and the vitamins and minerals are: Vitamin B6, 2.0 milligrams (A) Required or permitted in a stand- Folate, 0.4 milligram ardized food (e.g., thiamin, riboflavin, Vitamin B12, 6 micrograms and niacin in enriched flour) and that Biotin, 0.3 milligram standardized food is included as an in- Pantothenic acid, 10 milligrams gredient (i.e., component) in another Phosphorus, 1.0 gram product; or Iodine, 150 micrograms (B) Included in a product solely for Magnesium, 400 milligrams technological purposes and declared Zinc, 15 milligrams only in the ingredients statement. The Copper, 2.0 milligrams declaration may also include any of the (v) The following synonyms may be other vitamins and minerals listed in added in parenthesis immediately fol- paragraph (c)(8)(iv) of this section lowing the name of the nutrient or die- when they are naturally occurring in tary component: the food. The additional vitamins and minerals shall be listed in the order es- Vitamin C—Ascorbic acid tablished in paragraph (c)(8)(iv) of this Thiamin—Vitamin B1 section. Riboflavin—Vitamin B2 (iii) The percentages for vitamins Folate—Folacin and minerals shall be expressed to the Calories—Energy nearest 2-percent increment up to and (vi) A statement of the percent of vi- including the 10-percent level, the tamin A that is present as beta-caro- nearest 5-percent increment above 10 tene may be declared voluntarily. percent and up to and including the 50- When the vitamins and minerals are percent level, and the nearest 10-per- listed in a single column, the state- cent increment above the 50-percent ment shall be indented under the infor- level. Amounts of vitamins and min- mation on vitamin A. When vitamins erals present at less than 2 percent of and minerals are arrayed horizontally, the RDI are not required to be declared the statement of percent shall be pre- in nutrition labeling but may be de- sented in parenthesis following the dec- clared by a zero or by the use of an as- laration of vitamin A and the percent terisk (or other symbol) that refers to of Daily Value of vitamin A in the another asterisk (or symbol) that is product (e.g., ‘‘Percent Daily Value: placed at the bottom of the table and Vitamin A 50 (90 percent as beta-caro- that is followed by the statement tene)’’). When declared, the percent- ‘‘Contains less than 2 percent of the ages shall be expressed in the same in- Daily Value of this (these) nutrient crements as are provided for vitamins (nutrients).’’ Alternatively, if vitamin and minerals in paragraph (c)(8)(iii) of A, vitamin C, calcium, or iron is this section. present in amounts less than 2 percent (9) For the purpose of labeling with a of the RDI, label declaration of the nu- percent of the DRV, the following trient(s) is not required if the state- DRV’s are established for the following ment ‘‘Not a significant source of food components based on the reference lll (listing the vitamins or minerals caloric intake of 2,000 calories: omitted)’’ is placed at the bottom of Food component Unit of measurement DRV the table of nutrient values. (iv) The following RDI’s and nomen- Fat ...... grams (g) ...... 65 Saturated fatty acids ...... do ...... 20 clature are established for the follow- Cholesterol ...... milligrams (mg) ...... 300 ing vitamins and minerals which are Total carbohydrate ...... grams (g) ...... 300 essential in human nutrition: Fiber ...... do ...... 25 Sodium ...... milligrams (mg) ...... 2,400 Vitamin A, 5,000 International Units Potassium ...... do ...... 3,500 Vitamin C, 60 milligrams Protein ...... grams (g) ...... 50 Calcium, 1.0 gram Iron, 18 milligrams (d)(1) Nutrient information specified Vitamin D, 400 International Units in paragraph (c) of this section shall be Vitamin E, 30 International Units presented on products in the following Thiamin, 1.5 milligrams format, except on products on which Riboflavin, 1.7 milligrams dual columns of nutrition information
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are declared as provided for in para- from other information. No other infor- graph (e) of this section, on those prod- mation shall be highlighted. ucts on which the simplified format is (v) A hairline rule that is centered permitted to be used as provided for in between the lines of text shall separate paragraph (f) of this section, on prod- ‘‘Amount Per Serving’’ from the cal- ucts for infants and children less than orie statements required in paragraph 4 years of age as provided for in (d)(5) of this section and shall separate § 317.400(c), and on products in packages each nutrient and its corresponding that have a total surface area available percent of Daily Value required in to bear labeling of 40 or less square paragraphs (d)(7)(i) and (d)(7)(ii) of this inches as provided for in paragraph (g) section from the nutrient and percent of this section. of Daily Value above and below it. (i) The nutrition information shall be (2) The information shall be pre- set off in a box by use of hairlines and sented under the identifying heading of shall be all black or one color type, ‘‘Nutrition Facts’’ which shall be set in printed on a white or other neutral a type size larger than all other print contrasting background whenever prac- size in the nutrition label and, except tical. for labels presented according to the (ii) All information within the nutri- format provided for in paragraph (d)(11) tion label shall utilize: of this section, unless impractical, shall be set the full width of the infor- (A) A single easy-to-read type style, mation provided under paragraph (d)(7) (B) Upper and lower case letters, of this section. (C) At least one point leading (i.e., (3) Information on serving size shall space between two lines of text) except immediately follow the heading. Such that at least four points leading shall information shall include: be utilized for the information required (i) ‘‘Serving Size’’: A statement of by paragraphs (d)(7) and (d)(8) of this the serving size as specified in para- section, and graph (b)(9) of this section. (D) Letters should never touch. (ii) ‘‘Servings Per Container’’: The (iii) Information required in para- number of servings per container, ex- graphs (d)(3), (d)(5), (d)(7), and (d)(8) of cept that this statement is not re- this section shall be in type size no quired on single-serving containers as smaller than 8 point. Except for the defined in paragraph (b)(8) of this sec- heading ‘‘Nutrition Facts,’’ the infor- tion. mation required in paragraphs (d)(4), (4) A subheading ‘‘Amount Per Serv- (d)(6), and (d)(9) of this section and all ing’’ shall be separated from serving other information contained within the size information by a bar. nutrition label shall be in type size no (5) Information on calories shall im- smaller than 6 point. When provided, mediately follow the heading ‘‘Amount the information described in paragraph Per Serving’’ and shall be declared in (d)(10) of this section shall also be in one line, leaving sufficient space be- type no smaller than 6 point. tween the declaration of ‘‘Calories’’ (iv) The headings required by para- and ‘‘Calories from fat’’ to allow clear graphs (d)(2), (d)(4), and (d)(6) of this differentiation, or, if ‘‘Calories from section (i.e., ‘‘Nutrition Facts,’’ saturated fat’’ is declared, in a column ‘‘Amount per Serving,’’ and ‘‘% Daily with total ‘‘Calories’’ at the top, fol- Value*’’), the names of all nutrients lowed by ‘‘Calories from fat’’ (in- that are not indented according to re- dented), and ‘‘Calories from saturated quirements of paragraph (c) of this sec- fat’’ (indented). tion (i.e., Calories, Total fat, Choles- (6) The column heading ‘‘% Daily terol, Sodium, Potassium, Total carbo- Value,’’ followed by an asterisk (e.g., hydrate, and Protein), and the percent- ‘‘% Daily Value*’’), shall be separated age amounts required by paragraph from information on calories by a bar. (d)(7)(ii) of this section shall be high- The position of this column heading lighted by bold or extra bold type or shall allow for a list of nutrient names other highlighting (reverse printing is and amounts as described in paragraph not permitted as a form of highlight- (d)(7) of this section to be to the left of, ing) that prominently distinguishes it and below, this column heading. The
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column headings ‘‘Percent Daily (i) The footnote shall state: Percent Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may Daily Values are based on a 2,000 cal- be substituted for ‘‘% Daily Value.’’ orie diet. Your daily values may be (7) Except as provided for in para- higher or lower depending on your cal- graph (g) of this section, and except as orie needs. permitted by § 317.400(d)(2), nutrient in- Calories: 2,000 2,500 formation for both mandatory and any voluntary nutrients listed in paragraph Total fat ...... Less than .... 65 g ...... 80 g Saturated fat Less than .... 20 g ...... 25 g (c) of this section that are to be de- Cholesterol ... Less than .... 300 mg ...... 300 mg clared in the nutrition label, except vi- Sodium ...... Less than .... 2,400 mg ..... 2,400 mg tamins and minerals, shall be declared Total carbo- ...... 300 g ...... 375 g hydrate. as follows: Dietary fiber ...... 25 g ...... 30 g (i) The name of each nutrient, as specified in paragraph (c) of this sec- (ii) If the percent of Daily Value is tion, shall be given in a column and given for protein in the Percent of followed immediately by the quan- Daily Value column as provided in titative amount by weight for that nu- paragraph (d)(7)(ii) of this section, pro- trient appended with a ‘‘g’’ for grams tein shall be listed under dietary fiber, or ‘‘mg’’ for milligrams. and a value of 50 g shall be inserted on (ii) A listing of the percent of the the same line in the column headed DRV as established in paragraphs ‘‘2,000’’ and value of 65 g in the column (c)(7)(iii) and (c)(9) of this section shall headed ‘‘2,500.’’ be given in a column aligned under the (iii) If potassium is declared in the heading ‘‘% Daily Value’’ established column described in paragraph (d)(7)(i) in paragraph (d)(6) of this section with of this section, potassium shall be list- the percent expressed to the nearest ed under sodium and the DRV estab- whole percent for each nutrient de- lished in paragraph (c)(9) of this sec- clared in the column described in para- tion shall be inserted on the same line graph (d)(7)(i) of this section for which in the numeric columns. a DRV has been established, except (iv) The abbreviations established in that the percent for protein may be paragraph (g)(2) of this section may be omitted as provided in paragraph (c)(7) used within the footnote. of this section. The percent shall be (10) Caloric conversion information on a per-gram basis for fat, carbo- calculated by dividing either the hydrate, and protein may be presented amount declared on the label for each beneath the information required in nutrient or the actual amount of each paragraph (d)(9), separated from that nutrient (i.e., before rounding) by the information by a hairline. This infor- DRV for the nutrient, except that the mation may be presented horizontally percent for protein shall be calculated (i.e., ‘‘Calories per gram: Fat 9, Carbo- as specified in paragraph (c)(7)(ii) of hydrate 4, Protein 4’’) or vertically in this section. The numerical value shall columns. be followed by the symbol for percent (11)(i) If the space beneath the infor- (i.e., %). mation on vitamins and minerals is not (8) Nutrient information for vitamins adequate to accommodate the informa- and minerals shall be separated from tion required in paragraph (d)(9) of this information on other nutrients by a section, the information required in bar and shall be arrayed horizontally paragraph (d)(9) may be moved to the (e.g., Vitamin A 4%, Vitamin C 2%, right of the column required in para- Calcium 15%, Iron 4%) or may be listed graph (d)(7)(ii) of this section and set in two columns, except that when more off by a line that distinguishes it and than four vitamins and minerals are sets it apart from the percent of Daily declared, they may be declared verti- Value information. The caloric conver- cally with percentages listed under the sion information provided for in para- column headed ‘‘% Daily Value.’’ graph (d)(10) of this section may be pre- (9) A footnote, preceded by an aster- sented beneath either side or along the isk, shall be placed beneath the list of full length of the nutrition label. vitamins and minerals and shall be sep- (ii) If the space beneath the manda- arated from that list by a hairline. tory declaration of iron is not adequate
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to accommodate any remaining vita- components of the nutrition label up to mins and minerals to be declared or the and including the mandatory declara- information required in paragraph tion of iron, the nutrition label may be (d)(9) of this section, the remaining in- presented in a tabular display in which formation may be moved to the right the footnote required by paragraph and set off by a line that distinguishes (d)(9) of the section is given to the far it and sets it apart from the percent of right of the label, and additional vita- Daily Value information given to the mins and minerals beyond the four left. The caloric conversion informa- that are required (i.e., vitamin A, vita- tion provided for in paragraph (d)(10) of min C, calcium, and iron) are arrayed this section may be presented beneath horizontally following declarations of either side or along the full length of the nutrition label. the required vitamins and minerals. (iii) If there is not sufficient continu- (12) The following sample label illus- ous vertical space (i.e., approximately trates the provisions of paragraph (d) 3 inches) to accommodate the required of this section:
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(13)(i) Nutrition labeling on the outer used interchangeably for the same type label of packages of meat or meat food of food (e.g., meat salad containers) products that contain two or more may use an aggregate display. products in the same packages (e.g., (ii) Aggregate displays shall comply variety packs) or of packages that are with format requirements of paragraph
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(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 317.312(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language follow- tional column(s) either immediately ing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., ‘‘Pro- as packaged and according to the label tein/Proteinas 2 g’’). All required infor- serving size based on the Reference mation must be included in both lan- Amount in § 317.312(b) or as a footnote. guages. (A) If such additional quantitative (e) Nutrition information may be pre- information is given immediately adja- sented for two or more forms of the cent to the required quantitative infor- same product (e.g., both ‘‘raw’’ and mation, it shall be declared for all nu- ‘‘cooked’’) or for common combina- trients listed and placed immediately tions of foods as provided for in para- following and differentiated from the graph (b) of this section, or for dif- required quantitative information ferent units (e.g., per 100 grams) as pro- (e.g., separated by a comma). Such in- vided for in paragraph (b) of this sec- formation shall not be put in a sepa- tion, or for two or more groups for which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as pack- ‘‘Amount Per Serving,’’ there shall be aged for only those nutrients that are two or more column headings accu- present in different amounts than the rately describing the forms of the same amounts declared in the required quan- product (e.g., ‘‘raw’’ and ‘‘roasted’’), titative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40 Amount in § 317.312(b) shall be to the calories, 65 mg sodium, 6 g total carbo- left of the numeric columns. hydrate (6 g sugars), and 4 g protein). (2) When the dual labeling is pre- (ii) Total fat and its quantitative sented for two or more forms of the amount by weight shall be followed by same product, for combinations of an asterisk (or other symbol) (e.g., foods, or for different units, total cal- ‘‘Total fat (2 g)*’’) referring to another ories and calories from fat (and cal- asterisk (or symbol) at the bottom of ories from saturated fat, when de- the nutrition label identifying the clared) shall be listed in a column and form(s) of the product for which quan- indented as specified in paragraph titative information is presented.
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(4) Information required in para- headings set forth in paragraph (e)(1) of graphs (d)(7)(ii) and (d)(8) of this sec- this section. tion shall be presented under the sub- (5) The following sample label illus- heading ‘‘% DAILY VALUE’’ and in trates the provisions of paragraph (e) columns directly under the column of this section:
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(f)(1) Nutrition information may be forth herein when any required nutri- presented in a simplified format as set ents, other than the core nutrients
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(i.e., calories, total fat, sodium, total are based on a 2,000 calorie diet’’ and, if carbohydrate, and protein), are present the term ‘‘Daily Value’’ is not spelled in insignificant amounts. An insignifi- out in the heading, a statement that cant amount shall be defined as that ‘‘DV’’ represents ‘‘Daily Value.’’ amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 317.302(a) by one or more of the follow- clude information on the following nu- ing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient Serving size—Serv size values and that is followed by the Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat graph (g) of this section and in Polyunsaturated fat—Polyunsat fat § 317.400(c) and (d), nutrient informa- Cholesterol—Cholest tion declared in the simplified format Total carbohydrate—Total carb shall be presented in the same manner Dietary fiber—Fiber as specified in paragraphs (d) or (e) of Soluble fiber—Sol fiber this section, except that the footnote Insoluble fiber—Insol fiber required in paragraph (d)(9) of this sec- Sugar alcohol—Sugar alc tion is not required. When the footnote Other carbohydrate—Other carb is omitted, an asterisk shall be placed (3) Omitting the footnote required in at the bottom of the label followed by paragraph (d)(9) of this section and the statement ‘‘Percent Daily Values placing another asterisk at the bottom
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of the label followed by the statement with 5 U.S.C. 552(a) and 1 CFR part 51. ‘‘Percent Daily Values are based on a Copies may be purchased from the 2,000 calorie diet’’ and, if the term AOAC International, 2200 Wilson Blvd., ‘‘Daily Value’’ is not spelled out in the suite 400, Arlington, VA 22201. It is also heading, a statement that ‘‘DV’’ rep- available for inspection at the Office of resents ‘‘Daily Value.’’ the Federal Register Information Cen- (4) Presenting the required nutrition ter, suite 700, 800 North Capitol Street, information on any other label panel. NW., Washington, DC. (h) Compliance with this section (3) Two classes of nutrients are de- shall be determined as follows: fined for purposes of compliance: (1) A production lot is a set of food (i) Class I. Added nutrients in for- production consumer units that are tified or fabricated foods; and from one production shift. Alter- (ii) Class II. Naturally occurring (in- natively, a collection of consumer digenous) nutrients. If any ingredient units of the same size, type, and style which contains a naturally occurring produced under conditions as nearly (indigenous) nutrient is added to a uniform as possible, designated by a food, the total amount of such nutrient common container code or marking, in the final food product is subject to constitutes a production lot. Class II requirements unless the same (2) The sample for nutrient analysis nutrient is also added, which would shall consist of a composite of a mini- make the total amount of such nutri- mum of six consumer units, each from ent subject to Class I requirements. a production lot. Alternatively, the (4) A product with a label declaration sample for nutrient analysis shall con- of a vitamin, mineral, protein, total sist of a composite of a minimum of six carbohydrate, dietary fiber, other car- consumer units, each randomly chosen bohydrate, polyunsaturated or to be representative of a production monounsaturated fat, or potassium lot. In each case, the units may be indi- shall be deemed to be misbranded vidually analyzed and the results of the under section 1(n) of the Federal Meat analyses averaged, or the units would Inspection Act (21 U.S.C. 601(n)(1)) un- be composited and the composite ana- less it meets the following require- lyzed. In both cases, the results, wheth- ments: er an average or a single result from a (i) Class I vitamin, mineral, protein, composite, will be considered by the dietary fiber, or potassium. The nutri- Agency to be the nutrient content of a ent content of the composite is at least composite. All analyses shall be per- equal to the value for that nutrient de- formed by appropriate methods and clared on the label. procedures used by the Department for (ii) Class II vitamin, mineral, pro- each nutrient in accordance with the tein, total carbohydrate, dietary fiber, ‘‘Chemistry Laboratory Guidebook,’’ other carbohydrate, polyunsaturated or, if no USDA method is available and or monounsaturated fat, or potassium. appropriate for the nutrient, by appro- The nutrient content of the composite priate methods for the nutrient in ac- is at least equal to 80 percent of the cordance with the 1990 edition of the value for that nutrient declared on the ‘‘Official Methods of Analysis’’ of the label; Provided, That no regulatory ac- AOAC International, formerly Associa- tion will be based on a determination tion of Official Analytical Chemists, of a nutrient value which falls below 15th ed., which is incorporated by ref- this level by an amount less than the erence, unless a particular method of variability generally recognized for the analysis is specified in § 317.309(c), or, if analytical method used in that product no USDA, AOAC, or specified method is at the level involved, and inherent nu- available and appropriate, by other re- trient variation in a product. liable and appropriate analytical pro- (5) A product with a label declaration cedures as so determined by the Agen- of calories, sugars, total fat, saturated cy. The ‘‘Official Methods of Analysis’’ fat, cholesterol, or sodium shall be is incorporated as it exists on the date deemed to be misbranded under section of approval. This incorporation by ref- 1(n) of the Federal Meat Inspection Act erence was approved by the Director of (21 U.S.C. 601(n)(1)) if the nutrient con- the Federal Register in accordance tent of the composite is greater than 20
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percent in excess of the value for that (Reference Amount(s)), as set forth in nutrient declared on the label; Pro- paragraph (b) of this section, are: vided, That no regulatory action will be (1) The Reference Amounts are cal- based on a determination of a nutrient culated for persons 4 years of age or value which falls above this level by an older to reflect the amount of food cus- amount less than the variability gen- tomarily consumed per eating occasion erally recognized for the analytical by persons in this population group. method used in that product at the These Reference Amounts are based on level involved, and inherent nutrient data set forth in appropriate national variation in a product. food consumption surveys. (6) The amount of a vitamin, mineral, (2) The Reference Amounts are cal- protein, total carbohydrate, dietary culated for an infant or child under 4 fiber, other carbohydrate, polyunsat- years of age to reflect the amount of urated or monounsaturated fat, or po- food customarily consumed per eating tassium may vary over labeled occasion by infants up to 12 months of amounts within good manufacturing age or by children 1 through 3 years of practice. The amount of calories, sug- age, respectively. These Reference ars, total fat, saturated fat, choles- Amounts are based on data set forth in terol, or sodium may vary under la- appropriate national food consumption beled amounts within good manufac- surveys. Such Reference Amounts are turing practice. to be used only when the product is (7) Compliance will be based on the specially formulated or processed for metric measure specified in the label use by an infant or by a child under 4 statement of serving size. years of age. (8) The management of the establish- (3) An appropriate national food con- ment must maintain records to support sumption survey includes a large sam- the validity of nutrient declarations ple size representative of the demo- contained on product labels. Such graphic and socioeconomic characteris- records shall be made available to the tics of the relevant population group inspector or any duly authorized rep- and must be based on consumption resentative of the Agency upon re- data under actual conditions of use. quest. (4) To determine the amount of food (9) The compliance provisions set customarily consumed per eating occa- forth in paragraph (h) (1) through (8) of sion, the mean, median, and mode of this section shall not apply to single- the consumed amount per eating occa- ingredient, raw meat (including ground sion were considered. beef) products, including those that have been previously frozen, when nu- (5) When survey data were insuffi- trition labeling is based on the most cient, FSIS took various other sources current representative data base values of information on serving sizes of food contained in USDA’s National Nutrient into consideration. These other sources Data Bank or its published form, the of information included: Agriculture Handbook No. 8 series (i) Serving sizes used in dietary guid- available from the Government Print- ance recommendations or rec- ing Office. ommended by other authoritative sys- tems or organizations; (Paperwork requirements were approved by (ii) Serving sizes recommended in the Office of Management and Budget under comments; control number 0583–0088) (iii) Serving sizes used by manufac- [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, turers and grocers; and 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995] (iv) Serving sizes used by other coun- tries. §§ 317.310–317.311 [Reserved] (6) Because they reflect the amount customarily consumed, the Reference § 317.312 Reference amounts customar- Amount and, in turn, the serving size ily consumed per eating occasion. declared on the product label are based (a) The general principles followed in on only the edible portion of food, and arriving at the reference amounts cus- not bone, seed, shell, or other inedible tomarily consumed per eating occasion components.
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(7) The Reference Amount is based on TABLE 1.ÐREFERENCE AMOUNTS CUSTOMARILY the major intended use of the product CONSUMED PER EATING OCCASIONÐINFANT (e.g., a mixed dish measurable with a AND TODDLER FOODS 1,2,3 cup as a main dish and not as a side Reference dish). Product category amount (8) The Reference Amounts for prod- Infant & Toddler Foods: ucts that are consumed as an ingredi- Dinner Dry Mix ...... 15 g ent of other products, but that may Dinner, ready-to-serve, strained type ...... 60 g also be consumed in the form in which Dinner, soups, ready-to-serve junior type ...... 110 g Dinner, stew or soup ready-to-serve toddlers 170 g they are purchased (e.g., ground beef), Plain meats and meat sticks, ready-to-serve .. 55 g are based on use in the form purchased. 1 These values represent the amount of food customarily (9) FSIS sought to ensure that foods consumed per eating occasion and were primarily derived from the 1977±1978 and the 1987±1988 Nationwide Food that have similar dietary usage, prod- Consumption Surveys conducted by the U.S. Department of uct characteristics, and customarily Agriculture. 2 Unless otherwise noted in the Reference Amount column, consumed amounts have a uniform Ref- the Reference Amounts are for the ready-to-serve or almost erence Amount. ready-to-serve form of the product (i.e., heat and serve). If not listed separately, the Reference Amount for the unprepared (b) The following Product Categories form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form. and Reference Amounts shall be used 3 Manufacturers are required to convert the Reference as the basis for determining serving Amount to the label serving size in a household measure most appropriate to their specific product using the proce- sizes for specific products: dures established by regulation.
TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5
Reference Reference Product category amount amount Ready-to-serve Ready-to-cook
Egg mixtures, (western style omelet, souffle, egg foo young ...... 110 g n/a. Lard, margarine, shortening ...... 1 tbsp n/a. Salad and potato toppers; e.g., bacon bits ...... 7 g n/a. Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) ...... 15 g 54 g=bacon. 30 g = breakfast strips. Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio 30 g n/a. of less than 2:1; e.g., pepperoni. Snacks; e.g., meat snack food sticks ...... 30 g n/a. Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crum- 55 g n/a. bles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings. Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation 55 g n/a. 75 frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, g=uncooked smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet. sausage. Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of 85 g 114 g. meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pu- reed adult foods. Canned meats, canned beef, canned pork. 4 ...... 55 g n/a. Entrees with sauce, barbecued meats in sauce ...... 140 g n/a. Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, 140 g (plus 55 g n/a. pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, for products gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with with sauce top- meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada. pings) Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with 1 cup n/a. meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta. SaladsÐpasta or potato, potato salad with bacon, macaroni and meat salad ...... 140 g n/a. SaladsÐall other meat, salads, ham salad ...... 100 g n/a. SoupsÐall varieties ...... 245 g n/a. Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with 125 g n/a. meatballs. Minor main entree sauce; e.g., pizza sauce with meat, gravy ...... 1¤4 cup n/a. Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat..
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TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5ÐContinued
Reference Reference Product category amount amount Ready-to-serve Ready-to-cook
As reconstituted: Amount to make one Reference Amount of the final dish; e.g., Gravy ...... 1¤4 cup n/a. Major main entree type sauce ...... 125 g n/a. Soup ...... 245 g n/a. Entree measurable with a cup ...... 1 cup n/a. 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977±78 and the 1987±88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appro- priate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 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. 5 Pizza sauce is part of the pizza and is not considered to be sauce topping.
(c) For products that have no Ref- (d) If a product requires further prep- erence Amount listed in paragraph (b) aration, e.g., cooking or the addition of of this section for the unprepared or water or other ingredients, and if para- the prepared form of the product and graph (b) of this section provides a Ref- that consist of two or more foods pack- erence Amount for the product in the aged and presented to be consumed to- prepared form, then the Reference gether (e.g., lunch meat with cheese Amount for the unprepared product and crackers), the Reference Amount shall be determined using the following for the combined product shall be de- rules: termined using the following rules: (1) Except as provided for in para- (1) For bulk products, the Reference graph (d)(2) of this section, the Ref- Amount for the combined product shall erence Amount for the unprepared be the Reference Amount, as estab- product shall be the amount of the un- lished in paragraph (b) of this section, prepared product required to make the for the ingredient that is represented Reference Amount for the prepared as the main ingredient plus propor- product as established in paragraph (b) tioned amounts of all minor ingredi- of this section. ents. (2) For products where the entire (2) For products where the ingredient contents of the package is used to pre- represented as the main ingredient is pare one large discrete unit usually di- one or more discrete units, the Ref- vided for consumption, the Reference erence Amount for the combined prod- Amount for the unprepared product uct shall be either the number of small shall be the amount of the unprepared discrete units or the fraction of the product required to make the fraction large discrete unit that is represented of the large discrete unit closest to the as the main ingredient that is closest Reference Amount for the prepared to the Reference Amount for that in- product as established in paragraph (b) gredient as established in paragraph (b) of this section. of this section plus proportioned (e) The Reference Amount for an imi- amounts of all minor ingredients. tation or substitute product or altered (3) If the Reference Amounts are in product as defined in § 317.313(d), such compatible units, they shall be as a ‘‘low calorie’’ version, shall be the summed (e.g., ingredients in equal vol- same as for the product for which it is umes such as tablespoons). If the Ref- offered as a substitute. erence Amounts are in incompatible (f) The Reference Amounts set forth units, the weights of the appropriate in paragraphs (b) through (e) of this volumes should be used (e.g., grams of section shall be used in determining one ingredient plus gram weight of ta- whether a product meets the criteria blespoons of a second ingredient). for nutritional claims. If the serving
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size declared on the product label dif- sheets, suitably identified. If such data fers from the Reference Amount, and has already been submitted with an the product meets the criteria for the earlier labeling application from the claim only on the basis of the Ref- applicant, the present labeling applica- erence Amount, the claim shall be fol- tion must provide the data. lowed by a statement that sets forth (5) The labeling application must be the basis on which the claim is made. signed by the applicant or by his or her That statement shall include the Ref- attorney or agent, or (if a corporation) erence Amount as it appears in para- by an authorized official. graph (b) of this section followed, in (6) The labeling application shall in- parentheses, by the amount in common clude a statement signed by the person household measure if the Reference responsible for the labeling applica- Amount is expressed in measures other tion, that to the best of his or her than common household measures. knowledge, it is a representative and (g) The Administrator, on his or her balanced submission that includes un- own initiative or on behalf of any in- favorable information, as well as favor- terested person who has submitted a able information, known to him or her labeling application, may issue a pro- pertinent to the evaluation of the la- posal to establish or amend a Product beling application. Category or Reference Amount identi- (7) Labeling applications for a new fied in paragraph (b) of this section. Reference Amount and/or Product Cat- (1) Labeling applications and sup- egory shall be accompanied by the fol- porting documentation to be filed lowing data which shall be submitted under this section shall be submitted in the following form to the Director, in quadruplicate, except that the sup- Food Labeling Division, Regulatory porting documentation may be submit- Programs, Food Safety and Inspection ted on a computer disc copy. If any Service, Washington, DC 20250: part of the material submitted is in a foreign language, it shall be accom- ———————————————————————— panied by an accurate and complete (Date) English translation. The labeling appli- The undersigned, llllll submits this cation shall state the applicant’s post labeling application pursuant to 9 CFR office address. 317.312 with respect to Reference Amount and/or Product Category. (2) Pertinent information will be con- Attached hereto, in quadruplicate, or on a sidered as part of an application on the computer disc copy, and constituting a part basis of specific reference to such infor- of this labeling application, are the follow- mation submitted to and retained in ing: the files of the Food Safety and Inspec- (i) A statement of the objective of the la- tion Service. However, any reference to beling application; unpublished information furnished by a (ii) A description of the product; person other than the applicant will (iii) A complete sample product label in- not be considered unless use of such in- cluding nutrition label, using the format es- formation is authorized (with the un- tablished by regulation; derstanding that such information may (iv) A description of the form in which the product will be marketed; in whole or part be subject to release (v) The intended dietary uses of the prod- to the public) in a written statement uct with the major use identified (e.g., ham signed by the person who submitted it. as a luncheon meat); Any reference to published information (vi) If the intended use is primarily as an should be accompanied by reprints or ingredient in other foods, list of foods or food photostatic copies of such references. categories in which the product will be used (3) The availability for public disclo- as an ingredient with information on the sure of labeling applications, along prioritization of the use; with supporting documentation, sub- (vii) The population group for which the mitted to the Agency under this sec- product will be offered for use (e.g., infants, children under 4 years of age); tion will be governed by the rules spec- (viii) The names of the most closely-relat- ified in subchapter D, title 9. ed products (or in the case of foods for spe- (4) Data accompanying the labeling cial dietary use and imitation or substitute application, such as food consumption foods, the names of the products for which data, shall be submitted on separate they are offered as substitutes);
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(ix) The suggested Reference Amount (the ases are controlled for or, if not possible to amount of edible portion of food as con- control, how they affect interpretation of re- sumed, excluding bone, skin or other inedible sults. components) for the population group for (D) The methodology used to collect or which the product is intended with full de- process data including study design, sam- scription of the methodology and procedures pling procedures, materials used (e.g., ques- that were used to determine the suggested tionnaire, interviewer’s manual), procedures Reference Amount. In determining the Ref- used to collect or process data, methods or erence Amount, general principles and fac- procedures used to control for unbiased esti- tors in paragraph (a) of this section should mates, and procedures used to correct for be followed. nonresponse, should be fully documented. (x) The suggested Reference Amount shall (xiii) A statement concerning the feasibil- be expressed in metric units. Reference ity of convening associations, corporations, Amounts for foods shall be expressed in consumers, and other interested parties to grams except when common household units engage in negotiated rulemaking to develop such as cups, tablespoons, and teaspoons are a proposed rule. more appropriate or are more likely to pro- Yours very truly, mote uniformity in serving sizes declared on product labels. For example, common house- Applicant ——————————————— hold measures would be more appropriate if By ——————————————————— products within the same category differ (Indicate authority) substantially in density such as mixed dishes measurable with a cup. (8) Upon receipt of the labeling appli- (A) In expressing the Reference Amount in cation and supporting documentation, grams, the following general rules shall be the applicant shall be notified, in writ- followed: ing, of the date on which the labeling (1) For quantities greater than 10 grams, application was received. Such notice the quantity shall be expressed in nearest 5 shall inform the applicant that the la- grams increment. (2) For quantities less than 10 grams, exact beling application is undergoing Agen- gram weights shall be used. cy review and that the applicant shall (B) [Reserved] subsequently be notified of the Agen- (xi) A labeling application for a new sub- cy’s decision to consider for further re- category of food with its own Reference view or deny the labeling application. Amount shall include the following addi- (9) Upon review of the labeling appli- tional information: cation and supporting documentation, (A) Data that demonstrate that the new subcategory of food will be consumed in the Agency shall notify the applicant, amounts that differ enough from the Ref- in writing, that the labeling applica- erence Amount for the parent category to tion is either being considered for fur- warrant a separate Reference Amount. Data ther review or that it has been sum- must include sample size, and the mean, marily denied by the Administrator. standard deviation, median, and modal con- (10) If the labeling application is sumed amount per eating occasion for the summarily denied by the Adminis- product identified in the labeling application trator, the written notification shall and for other products in the category. All data must be derived from the same survey state the reasons therefor, including data. why the Agency has determined that (B) Documentation supporting the dif- the proposed Reference Amount and/or ference in dietary usage and product charac- Product Category is false or mislead- teristics that affect the consumption size ing. The notification letter shall in- that distinguishes the product identified in form the applicant that the applicant the labeling application from the rest of the may submit a written statement by products in the category. way of answer to the notification, and (xii) In conducting research to collect or process food consumption data in support of that the applicant shall have the right the labeling application, the following gen- to request a hearing with respect to eral guidelines should be followed. the merits or validity of the Adminis- (A) Sampled population selected should be trator’s decision to deny the use of the representative of the demographic and socio- proposed Reference Amount and/or economic characteristics of the target popu- Product Category. lation group for which the food is intended. (i) If the applicant fails to accept the (B) Sample size (i.e., number of eaters) should be large enough to give reliable esti- determination of the Administrator mates for customarily consumed amounts. and files an answer and requests a (C) The study protocol should identify po- hearing, and the Administrator, after tential biases and describe how potential bi- review of the answer, determines the
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initial determination to be correct, the ment by way of answer to the notifica- Administrator shall file with the Hear- tion, and that the applicant shall have ing Clerk of the Department the notifi- the right to request a hearing with re- cation, answer, and the request for a spect to the merits or validity of the hearing, which shall constitute the Administrator’s decision to deny the complaint and answer in the proceed- use of the proposed Reference Amount ing, which shall thereafter be con- and/or Product Category. ducted in accordance with the Depart- (A) If the applicant fails to accept ment’s Uniform Rules of Practice. the determination of the Adminis- (ii) The hearing shall be conducted trator and files an answer and requests before an administrative law judge a hearing, and the Administrator, after with the opportunity for appeal to the review of an answer, determines the Department’s Judicial Officer, who initial determination to be correct, the shall make the final determination for Administrator shall file with the Hear- the Secretary. Any such determination ing Clerk of the Department the notifi- by the Secretary shall be conclusive cation, answer, and the request for a unless, within 30 days after receipt of hearing, which shall constitute the notice of such final determination, the complaint and answer in the proceed- applicant appeals to the United States ing, which shall thereafter be con- Court of Appeals for the circuit in ducted in accordance with the Depart- which the applicant has its principal ment’s Uniform Rules of Practice. place of business or to the United (B) The hearing shall be conducted States Court of Appeals for the District before an administrative law judge of Columbia Circuit. with the opportunity for appeal to the (11) If the labeling application is not Department’s Judicial Officer, who summarily denied by the Adminis- shall make the final determination for trator, the Administrator shall publish the Secretary. Any such determination in the FEDERAL REGISTER a proposed by the Secretary shall be conclusive rule to amend the regulations to au- unless, within 30 days after receipt of thorize the use of the Reference the notice of such final determination, Amount and/or Product Category. The the applicant appeals to the United proposal shall also summarize the la- States Court of Appeals for the circuit beling application, including where the in which the applicant has its principal supporting documentation can be re- place of business or to the United viewed. The Administrator’s proposed States Court of Appeals for the District rule shall seek comment from consum- of Columbia Circuit. ers, the industry, consumer and indus- (ii) If the Reference Amount and/or try groups, and other interested per- Product Category is approved, the sons on the labeling application and Agency shall notify the applicant, in the use of the proposed Reference writing, and shall also publish in the Amount and/or Product Category. FEDERAL REGISTER a final rule amend- After public comment has been re- ing the regulations to authorize the ceived and reviewed by the Agency, the use of the Reference Amount and/or Administrator shall make a determina- Product Category. tion on whether the proposed Reference Amount and/or Product Category shall (Paperwork requirements were approved by be approved for use on the labeling of the Office of Management and Budget under meat food products. control number 0583–0088) (i) If the Reference Amount and/or [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, Product Category is denied by the Ad- 1993 as amended at 58 FR 47627, Sept. 10, 1993; ministrator, the Agency shall notify 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, the applicant, in writing, of the basis 1995] for the denial, including the reason why the Reference Amount and/or § 317.313 Nutrient content claims; gen- Product Category on the labeling was eral principles. determined by the Agency to be false (a) This section applies to meat or or misleading. The notification letter meat food products that are intended shall also inform the applicant that the for human consumption and that are applicant may submit a written state- offered for sale.
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(b) A claim which, expressly or by ally inferior to unless it is labeled as implication, characterizes the level of an ‘‘imitation.’’ a nutrient (nutrient content claim) of (1) If there is a difference in perform- the type required in nutrition labeling ance characteristics that materially pursuant to § 317.309, may not be made limits the use of the product, the prod- on a label or in labeling of that product uct may still be considered a substitute unless the claim is made in accordance if the label includes a disclaimer adja- with the applicable provisions in this cent to the most prominent claim as subpart. defined in paragraph (j)(2)(iii) of this (1) An expressed nutrient content section, informing the consumer of claim is any direct statement about such difference (e.g., ‘‘not rec- the level (or range) of a nutrient in the ommended for frying’’). product, e.g., ‘‘low sodium’’ or ‘‘con- (2) This disclaimer shall be in easily tains 100 calories.’’ legible print or type and in a size no (2) An implied nutrient content claim less than that required by § 317.2(h) for is any claim that: the net quantity of contents state- (i) Describes the product or an ingre- ment, except where the size of the dient therein in a manner that sug- claim is less than two times the re- gests that a nutrient is absent or quired size of the net quantity of con- present in a certain amount (e.g., tents statement, in which case the dis- ‘‘high in oat bran’’); or claimer statement shall be no less than (ii) Suggests that the product, be- one-half the size of the claim but no cause of its nutrient content, may be smaller than 1⁄16-inch minimum height, useful in maintaining healthy dietary except as permitted by § 317.400(d)(2). practices and is made in association (e)(1) Because the use of a ‘‘free’’ or with an explicit claim or statement ‘‘low’’ claim before the name of a prod- about a nutrient (e.g., ‘‘healthy, con- uct implies that the product differs tains 3 grams (g) of fat’’). from other products of the same type (3) Except for claims regarding vita- by virtue of its having a lower amount mins and minerals described in para- of the nutrient, only products that graph (q)(3) of this section, no nutrient have been specially processed, altered, content claims may be made on prod- formulated, or reformulated so as to ucts intended specifically for use by in- lower the amount of the nutrient in fants and children less than 2 years of the product, remove the nutrient from age unless the claim is specifically pro- the product, or not include the nutri- vided for in subpart B of this part. ent in the product, may bear such a (4) Reasonable variations in the spell- claim (e.g., ‘‘low sodium beef noodle ing of the terms defined in applicable soup’’). provisions in this subpart and their (2) Any claim for the absence of a nu- synonyms are permitted provided these trient in a product, or that a product is variations are not misleading (e.g., low in a nutrient when the product has ‘‘hi’’ or ‘‘lo’’). not been specially processed, altered, (c) Information that is required or formulated, or reformulated to qualify permitted by § 317.309 to be declared in for that claim shall indicate that the nutrition labeling, and that appears as product inherently meets the criteria part of the nutrition label, is not a nu- and shall clearly refer to all products trient content claim and is not subject of that type and not merely to the par- to the requirements of this section. If ticular brand to which the labeling at- such information is declared elsewhere taches (e.g., ‘‘lard, a sodium free on the label or in labeling, it is a nutri- food’’). ent content claim and is subject to the (f) A nutrient content claim shall be requirements for nutrient content in type size and style no larger than claims. two times that of the statement of (d) A ‘‘substitute’’ product is one identity and shall not be unduly promi- that may be used interchangeably with nent in type style compared to the another product that it resembles, i.e., statement of identity. that it is organoleptically, physically, (g) Labeling information required in and functionally (including shelf life) §§ 317.313, 317.354, 317.356, 317.360, 317.361, similar to, and that it is not nutrition- 317.362, and 317.380, whose type size is
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not otherwise specified, is required to duced,’’ ‘‘less’’ (or ‘‘fewer’’), and be in letters and/or numbers no less ‘‘more’’ claims. than 1⁄16 inch in height, except as per- (1) To bear a relative claim about the mitted by § 317.400(d)(2). level of a nutrient, the amount of that (h) [Reserved] nutrient in the product must be com- (i) Except as provided in § 317.309 or in pared to an amount of nutrient in an paragraph (q)(3) of this section, the appropriate reference product as speci- label or labeling of a product may con- fied in this paragraph (j). tain a statement about the amount or (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and percentage of a nutrient if: ‘‘more’’ claims, the reference product (1) The use of the statement on the may be a dissimilar product within a product implicitly characterizes the product category that can generally be level of the nutrient in the product and substituted for one another in the diet is consistent with a definition for a or a similar product. claim, as provided in subpart B of this (B) For ‘‘light,’’ ‘‘reduced,’’ and part, for the nutrient that the label ad- ‘‘added’’ claims, the reference product dresses. Such a claim might be, ‘‘less shall be a similar product, and than 10 g of fat per serving;’’ (ii)(A) For ‘‘light’’ claims, the ref- (2) The use of the statement on the erence product shall be representative product implicitly characterizes the level of the nutrient in the product and of the type of product that includes the is not consistent with such a defini- product that bears the claim. The nu- tion, but the label carries a disclaimer trient value for the reference product adjacent to the statement that the shall be representative of a broad base product is not ‘‘low’’ in or a ‘‘good of products of that type; e.g., a value in source’’ of the nutrient, such as ‘‘only a representative, valid data base; an 200 milligrams (mg) sodium per serv- average value determined from the top ing, not a low sodium product.’’ The three national (or regional) brands, a disclaimer must be in easily legible market basket norm; or, where its nu- print or type and in a size no less than trient value is representative of the required by § 317.2(h) for the net quan- product type, a market leader. Firms tity of contents, except where the size using such a reference nutrient value of the claim is less than two times the as a basis for a claim, are required to required size of the net quantity of provide specific information upon contents statement, in which case the which the nutrient value was derived, disclaimer statement shall be no less on request, to consumers and appro- than one-half the size of the claim but priate regulatory officials. 1 no smaller than ⁄16-inch minimum (B) For relative claims other than height, except as permitted by ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ § 317.400(d)(2); claims, the reference product may be (3) The statement does not in any the same as that provided for ‘‘light’’ way implicitly characterize the level of in paragraph (j)(1)(ii)(A) of this section the nutrient in the product and it is or it may be the manufacturer’s regu- not false or misleading in any respect lar product, or that of another manu- (e.g., ‘‘100 calories’’ or ‘‘5 grams of fat’’), in which case no disclaimer is re- facturer, that has been offered for sale quired. to the public on a regular basis for a (4) ‘‘Percent fat free’’ claims are not substantial period of time in the same authorized by this paragraph. Such geographic area by the same business claims shall comply with § 317.362(b)(6). entity or by one entitled to use its (j) A product may bear a statement trade name, provided the name of the that compares the level of a nutrient in competitor is not used on the labeling the product with the level of a nutrient of the product. The nutrient values in a reference product. These state- used to determine the claim when com- ments shall be known as ‘‘relative paring a single manufacturer’s product claims’’ and include ‘‘light,’’ ‘‘re- to the labeled product shall be either
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the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and vided that the resulting labeling is in- (B) This statement shall appear adja- ternally consistent (i.e., that the val- cent to the most prominent claim or to ues stated in the nutrition informa- the nutrition information. tion, the nutrient values in the accom- (3) A relative claim for decreased lev- panying information, and the declara- els of a nutrient may not be made on tion of the percentage of nutrient by the label or in labeling of a product if which the product has been modified the nutrient content of the reference are consistent and will not cause con- product meets the requirement for a sumer confusion when compared), and ‘‘low’’ claim for that nutrient. that the actual modification is at least (k) The term ‘‘modified’’ may be used equal to the percentage specified in the in the statement of identity of a prod- definition of the claim. uct that bears a relative claim that (2) For products bearing relative complies with the requirements of this claims: part, followed immediately by the (i) The label or labeling must state name of the nutrient whose content the identity of the reference product has been altered (e.g., ‘‘modified fat and the percent (or fraction) of the ‘product’ ’’). This statement of identity amount of the nutrient in the reference must be immediately followed by the product by which the nutrient has been comparative statement such as ‘‘con- modified, (e.g., ‘‘50 percent less fat tains 35 percent less fat than ‘reference than ‘reference product’ ’’ or ‘‘1⁄3 fewer product’.’’ The label or labeling must calories than ‘reference product’ ’’); and also bear the information required by (ii) This information shall be imme- paragraph (j)(2) of this section in the diately adjacent to the most prominent manner prescribed. claim in easily legible boldface print or (l) For purposes of making a claim, a type, in distinct contrast to other ‘‘meal-type product’’ shall be defined printed or graphic matter, that is no as a product that: less than that required by § 317.2(h) for (1) Makes a significant contribution net quantity of contents, except where to the diet by weighing at least 6 the size of the claim is less than two ounces, but no more than 12 ounces per times the required size of the net quan- serving (container), and tity of contents statement, in which (2) Contains ingredients from two or case the referral statement shall be no more of the following four food groups: less than one-half the size of the claim, (i) Bread, cereal, rice and pasta group, but no smaller than 1⁄16-inch minimum height, except as permitted by (ii) Fruits and vegetables group, § 317.400(d)(2). (iii) Milk, yogurt, and cheese group, and (iii) The determination of which use (iv) Meat, poultry, fish, dry beans, of the claim is in the most prominent eggs, and nuts group, and location on the label or labeling will be (3) Is represented as, or is in a form made based on the following factors, commonly understood to be a break- considered in order: fast, lunch, dinner, meal, main dish, (A) A claim on the principal display entree, or pizza. Such representations panel adjacent to the statement of may be made either by statements, identity; photographs, or vignettes. (B) A claim elsewhere on the prin- (m) [Reserved] cipal display panel; (n) Nutrition labeling in accordance (C) A claim on the information panel; with § 317.309, shall be provided for any or food for which a nutrient content claim (D) A claim elsewhere on the label or is made. labeling. (o) Compliance with requirements for (iv) The label or labeling must also nutrient content claims shall be in ac- bear: cordance with § 317.309(h). (A) Clear and concise quantitative in- (p)(1) Unless otherwise specified, the formation comparing the amount of reference amount customarily con- the subject nutrient in the product per sumed set forth in § 317.312(b) through
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(e) shall be used in determining wheth- (7) Implied nutrient content claims er a product meets the criteria for a may be used as part of a brand name, nutrient content claim. If the serving provided that the use of the claim has size declared on the product label dif- been authorized by FSIS. Labeling ap- fers from the reference amount cus- plications requesting approval of such tomarily consumed, and the amount of a claim may be submitted pursuant to the nutrient contained in the labeled § 317.369. serving does not meet the maximum or [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, minimum amount criterion in the defi- 1993, as amended at 58 FR 47627, Sept. 10, nition for the descriptor for that nutri- 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, ent, the claim shall be followed by the Sept. 1, 1994; 60 FR 187, Jan. 3, 1995] criteria for the claim as required by § 317.312(f) (e.g., ‘‘very low sodium, 35 §§ 317.314–317.342 [Reserved] mg or less per 55 grams’’). (2) The criteria for the claim shall be § 317.343 Significant participation for immediately adjacent to the most voluntary nutrition labeling. prominent claim in easily legible print (a) In evaluating significant partici- or type and in a size that is no less pation for voluntary nutrition labeling, than that required by § 317.2(h) for net FSIS will consider only the major cuts quantity of contents, except where the of single-ingredient, raw meat prod- size of the claim is less than two times ucts, as identified in § 317.344, including the required size of the net quantity of those that have been previously frozen. contents statement, in which case the (b) FSIS will judge a food retailer to criteria statement shall be no less than be participating at a significant level if one-half the size of the claim but no the retailer provides nutrition labeling smaller than 1⁄16-inch minimum height, information for at least 90 percent of except as permitted by § 317.400(d)(2). the major cuts of single-ingredient, (q) The following exemptions apply: raw meat products, listed in § 317.344, (1) Nutrient content claims that have that it sells, and if the nutrition label not been defined by regulation and that is consistent in content and format appear as part of a brand name that with the mandatory program, or nutri- was in use prior to November 27, 1991, tion information is displayed at point- may continue to be used as part of that of-purchase in an approriate manner. brand name, provided they are not (c) To determine whether there is sig- false or misleading under section 1(n) nificant participation by retailers of the Act (21 U.S.C. 601(n)(1)). under the voluntary nutrition labeling (2) [Reserved] guidelines, FSIS will select a rep- (3) A statement that describes the resentative sample of companies allo- percentage of a vitamin or mineral in cated by type and size. the food, including foods intended spe- (d) FSIS will find that significant cifically for use by infants and children participation by food retailers exists if less than 2 years of age, in relation to at least 60 percent of all companies a Reference Daily Intake (RDI) as de- that are evaluated are participating in fined in § 317.309 may be made on the accordance with the guidelines. label or in the labeling of a food with- (e) FSIS will evaluate significant out a regulation authorizing such a participation of the voluntary program claim for a specific vitamin or mineral. every 2 years beginning in May 1995. (4) The requirements of this section (1) If significant participation is do not apply to infant formulas and found, the voluntary nutrition labeling medical foods, as described in 21 CFR guidelines shall remain in effect. 101.13(q)(4). (2) If significant participation is not (5) [Reserved] found, FSIS shall initiate rulemaking (6) Nutrient content claims that were to require nutrition labeling on those part of the name of a product that was products under the voluntary program. subject to a standard of identity as of November 27, 1991, are not subject to § 317.344 Identification of major cuts the requirements of paragraph (b) of of meat products. this section whether or not they meet The major cuts of single-ingredient, the definition of the descriptive term. raw meat products are: Beef chuck
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blade roast, beef loin top loin steak, point-of-purchase materials all of the beef rib roast large end, beef round eye requirements of the mandatory nutri- round steak, beef round top round tion labeling program apply. However, steak, beef round tip roast, beef chuck if only nutrition information—and not arm pot roast, beef loin sirloin steak, a nutrition claim—is supplied on point- beef round bottom round steak, beef of-purchase materials: brisket (whole, flat half, or point half), (i) The requirements of the manda- beef rib steak small end, beef loin ten- tory nutrition labeling program apply, derloin steak, ground beef regular but the nutrition information may be without added seasonings, ground beef supplied on an ‘‘as packaged’’ or ‘‘as about 17% fat, pork loin chop, pork consumed,’’ basis; loin country style ribs, pork loin top (ii) The listing of percent of Daily loin chop boneless, pork loin rib chop, Value for the nutrients (except vita- pork spareribs, pork loin tenderloin, mins and minerals specified in pork loin sirloin roast, pork shoulder § 317.309(c)(8)) and footnote required by blade steak, pork loin top roast § 317.309(d)(9) may be omitted; and boneless, ground pork, lamb shank, (iii) The point-of-purchase materials lamb shoulder arm chop, lamb shoulder are not subject to any of the format re- blade chop, lamb rib roast, lamb loin quirements. chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, (b) [Reserved] veal shoulder blade steak, veal rib (c) The declaration of nutrition infor- roast, veal loin chop, and veal cutlets. mation may be presented in a sim- plified format as specified in § 317.309(f) [58 FR 664, Jan. 6, 1993, as amended at 59 FR for the mandatory nutrition labeling 45196, Sept. 1, 1994] program. § 317.345 Guidelines for voluntary nu- (d) The nutrition label data should be trition labeling of single-ingredient, based on either the raw or cooked edi- raw products. ble portions of meat cuts with external (a) Nutrition information on the cuts cover fat at trim levels reflecting cur- of single-ingredient, raw meat prod- rent marketing practices. If data are ucts, including those that have been based on cooked portions, the methods previously frozen, shall be provided in used to cook the products must be the following manner: specified and should be those which do (1) If a retailer or manufacturer not add nutrients from other ingredi- chooses to provide nutrition informa- ents such as flour, breading, and salt. tion on the label of these products, Additional nutritional data may be these products shall be subject to all presented on an optional basis for the requirements of the mandatory nutri- raw or cooked edible portions of the tion labeling program, except that nu- separable lean of meat cuts. trition labeling may be declared on the (e) Nutrient data that are the most basis of either ‘‘as consumed’’ or ‘‘as current representative data base values packaged.’’ In addition, the declaration contained in USDA’s National Nutrient of the number of servings per container Data Bank or its published form, the need not be included in nutrition label- Agriculture Handbook No. 8 series, ing of single-ingredient, raw meat may be used for nutrition labeling of products (including ground beef), in- single-ingredient, raw meat products cluding those that have been pre- (including ground beef), including viously frozen. those that have been previously frozen. (2) A retailer may choose to provide These data may be composite data that nutrition information at the point-of- reflect different quality grades of beef purchase, such as by posting a sign, or or other variables affecting nutrient by making the information readily content. Alternatively, data that re- available in brochures, notebooks, or flect specific grades or other variables leaflet form in close proximity to the may be used, except that if data are food. The nutrition labeling informa- used on labels attached to a product tion may also be supplemented by a which is labeled as to grade of meat or video, live demonstration, or other other variables, the data must rep- media. If a nutrition claim is made on resent the product in the package when
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such data are contained in the rep- (2) The terms defined in paragraph resentative data base. When data are (b)(1) of this section may be used on used on labels attached to a product, the label or in labeling of a meal-type the data must represent the edible product as defined in § 317.313(l), pro- meat tissues present in the package. vided that: (f) If the nutrition information is in (i) The product contains a food that accordance with paragraph (e) of this meets the definition of ‘‘high’’ in para- section, a nutrition label or labeling graph (b)(1) of this section; and will not be subject to the Agency com- (ii) The label or labeling clearly iden- pliance review under § 317.309(h), unless tifies the food that is the subject of the a nutrition claim is made on the basis claim (e.g., ‘‘the serving of broccoli in of the representative data base values. this meal is high in vitamin C’’). (g) Retailers may use data bases that (c) ‘‘Good Source’’ claims. (1) The they believe reflect the nutrient con- terms ‘‘good source,’’ ‘‘contains,’’ or tent of single-ingredient, raw meat ‘‘provides’’ may be used on the label or products (including ground beef), in- in labeling of products, except meal- cluding those that have been pre- type products as described in viously frozen; however, such labeling § 317.313(l), provided that the product shall be subject to the compliance pro- contains 10 to 19 percent of the RDI or cedures of paragraph (e) of this section the DRV per reference amount cus- and the requirements specified in this tomarily consumed. subpart for the mandatory nutrition (2) The terms defined in paragraph labeling program. (c)(1) of this section may be used on the [58 FR 664, Jan. 6, 1993, as amended at 58 FR label or in labeling of a meal-type 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995] product as defined in § 317.313(l), pro- vided that: § 317.346–317.353 [Reserved] (i) The product contains a food that meets the definition of ‘‘good source’’ § 317.354 Nutrient content claims for in paragraph (c)(1) of this section; and ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ (ii) The label or labeling clearly iden- (a) General requirements. Except as tifies the food that is the subject of the provided in paragraph (e) of this sec- claim (e.g., ‘‘the serving of sweet pota- tion, a claim about the level of a nutri- toes in this meal is a good source of ent in a product in relation to the Ref- fiber’’). erence Daily Intake (RDI) or Daily Ref- (d) Fiber claims. (1) If a nutrient con- erence Value (DRV) established for tent claim is made with respect to the that nutrient (excluding total carbo- level of dietary fiber, i.e., that the hydrate) in § 317.309(c), may only be product is high in fiber, a good source made on the label or in labeling of the of fiber, or that the product contains product if: ‘‘more’’ fiber, and the product is not (1) The claim uses one of the terms ‘‘low’’ in total fat as defined in defined in this section in accordance § 317.362(b)(2) or, in the case of a meal- with the definition for that term; type product, is not ‘‘low’’ in total fat (2) The claim is made in accordance as defined in § 317.362(b)(3), then the la- with the general requirements for nu- beling shall disclose the level of total trient content claims in § 317.313; and fat per labeled serving size (e.g., ‘‘con- (3) The product for which the claim is tains 12 grams (g) of fat per serving’’); made is labeled in accordance with and § 317.309. (2) The disclosure shall appear in im- (b) ‘‘High’’ claims. (1) The terms mediate proximity to such claim and ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source be in a type size no less than one-half of’’ may be used on the label or in la- the size of the claim. beling of products, except meal-type (e) ‘‘More’’ claims. (1) A relative claim products as defined in § 317.313(l), pro- using the terms ‘‘more’’ and ‘‘added’’ vided that the product contains 20 per- may be used on the label or in labeling cent or more of the RDI or the DRV per to describe the level of protein, vita- reference amount customarily con- mins, minerals, dietary fiber, or potas- sumed. sium in a product, except meal-type
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products as defined in § 317.313(l), pro- it replaces is declared adjacent to the vided that: most prominent claim or to the nutri- (i) The product contains at least 10 tion information (e.g., ‘‘fiber content of percent more of the RDI or the DRV ‘reference product’ is 2 g per 3 oz; ‘this for protein, vitamins, minerals, dietary product’ contains 5 g per 3 oz’’). fiber, or potassium (expressed as a per- [60 FR 189, Jan. 3, 1995] cent of the Daily Value) per reference amount customarily consumed than an § 317.355 [Reserved] appropriate reference product as de- scribed in § 317.313(j)(1); and § 317.356 Nutrient content claims for (ii) As required in § 317.313(j)(2) for ‘‘light’’ or ‘‘lite.’’ relative claims: (a) General requirements. A claim (A) The identity of the reference using the terms ‘‘light’’ or ‘‘lite’’ to de- product and the percent (or fraction) scribe a product may only be made on that the nutrient is greater relative to the label or in labeling of the product the RDI or DRV are declared in imme- if: diate proximity to the most prominent (1) The claim uses one of the terms such claim (e.g., ‘‘contains 10 percent defined in this section in accordance more of the Daily Value for fiber than with the definition for that term; ‘reference product’ ’’); and (B) Quantitative information com- (2) The claim is made in accordance paring the level of the nutrient in the with the general requirements for nu- product per labeled serving size with trient content claims in § 317.313; and that of the reference product that it re- (3) The product for which the claim is places is declared adjacent to the most made is labeled in accordance with prominent claim or to the nutrition in- § 317.309. formation (e.g., ‘‘fiber content of ‘ref- (b) ‘‘Light’’ claims. The terms ‘‘light’’ erence product’ is 1 g per serving; ‘this or ‘‘lite’’ may be used on the label or in product’ contains 4 g per serving’’). labeling of products, except meal-type (2) A relative claim using the terms products as defined in § 317.313(l), with- ‘‘more’’ and ‘‘added’’ may be used on out further qualification, provided the label or in labeling to describe the that: level of protein, vitamins, minerals, di- (1) If the product derives 50 percent etary fiber, or potassium in meal-type or more of its calories from fat, its fat products as defined in § 317.313(l), pro- content is reduced by 50 percent or vided that: more per reference amount customar- (i) The product contains at least 10 ily consumed compared to an appro- percent more of the RDI or the DRV priate reference product as described in for protein, vitamins, minerals, dietary § 317.313(j)(1); or fiber, or potassium (expressed as a per- (2) If the product derives less than 50 cent of the Daily Value) per 100 g of percent of its calories from fat: product than an appropriate reference (i) The number of calories is reduced product as described in § 317.313(j)(1); by at least one-third (331⁄3 percent) per and reference amount customarily con- (ii) As required in § 317.313(j)(2) for sumed compared to an appropriate ref- relative claims: erence product as described in (A) The identity of the reference § 317.313(j)(1); or product and the percent (or fraction) (ii) Its fat content is reduced by 50 that the nutrient is greater relative to percent or more per reference amount the RDI or DRV are declared in imme- customarily consumed compared to the diate proximity to the most prominent appropriate reference product as de- such claim (e.g., ‘‘contains 10 percent scribed in § 317.313(j)(1); and more of the Daily Value for fiber per 3 (3) As required in § 317.313(j)(2) for rel- ounces (oz) than does ‘reference prod- ative claims: uct’ ’’), and (i) The identity of the reference prod- (B) Quantitative information com- uct and the percent (or fraction) that paring the level of the nutrient in the the calories and the fat were reduced meal-type product per specified weight are declared in immediate proximity to with that of the reference product that the most prominent such claim (e.g.,
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‘‘1⁄3 fewer calories and 50 percent less sented in uniform type size, style, fat than the market leader’’); and color, and prominence; and (ii) Quantitative information com- (ii) As required in § 317.313(j)(2) for paring the level of calories and fat con- relative claims: tent in the product per labeled serving (A) The identity of the reference size with that of the reference product product and the percent (or fraction) that it replaces is declared adjacent to that the sodium was reduced are de- the most prominent claim or to the nu- clared in immediate proximity to the trition information (e.g., ‘‘lite ‘this most prominent such claim (e.g., ‘‘50 product’—200 calories, 4 grams (g) fat; percent less sodium than the market regular ‘reference product’—300 cal- leader’’); and ories, 8 g fat per serving’’); and (B) Quantitative information com- (iii) If the labeled product contains paring the level of sodium per labeled less than 40 calories or less than 3 g fat serving size with that of the reference per reference amount customarily con- product it replaces is declared adjacent sumed, the percentage reduction for to the most prominent claim or to the that nutrient need not be declared. nutrition information (e.g., or ‘‘lite (4) A ‘‘light’’ claim may not be made ‘this product’—170 mg sodium per serv- on a product for which the reference ing; regular ‘reference product’—350 mg product meets the definition of ‘‘low per serving’’). fat’’ and ‘‘low calorie.’’ (3) Except for meal-type products as (c)(1)(i) A product for which the ref- defined in § 317.313(l), a ‘‘light in so- erence product contains 40 calories or dium’’ claim may not be made on a less and 3 g fat or less per reference product for which the reference prod- amount customarily consumed may uct meets the definition of ‘‘low in so- use the terms ‘‘light’’ or ‘‘lite’’ without dium.’’ further qualification if it is reduced by (d)(1) The terms ‘‘light’’ or ‘‘lite’’ 50 percent or more in sodium content may be used on the label or in labeling compared to the reference product; and of a meal-type product as defined in (ii) As required in § 317.313(j)(2) for § 317.313(l), provided that: relative claims: (i) The product meets the definition (A) The identity of the reference of: product and the percent (or fraction) (A) ‘‘Low in calories’’ as defined in that the sodium was reduced are de- § 317.360(b)(3); or clared in immediate proximity to the (B) ‘‘Low in fat’’ as defined in most prominent such claim (e.g., ‘‘50 § 317.362(b)(3); and percent less sodium than the market (ii)(A) A statement appears on the leader’’); and principal display panel that explains (B) Quantitative information com- whether ‘‘light’’ is used to mean ‘‘low paring the level of sodium per labeled fat,’’ ‘‘low calories,’’ or both (e.g., serving size with that of the reference ‘‘Light Delight, a low fat meal’’); and product it replaces is declared adjacent (B) The accompanying statement is to the most prominent claim or to the no less than one-half the type size of nutrition information (e.g., ‘‘lite ‘this the ‘‘light’’ or ‘‘lite’’ claim. product’—500 milligrams (mg) sodium (2)(i) The terms ‘‘light in sodium’’ or per serving; regular ‘reference prod- ‘‘lite in sodium’’ may be used on the uct’—1,000 mg sodium per serving’’). label or in labeling of a meal-type (2)(i) A product for which the ref- product as defined in § 317.313(l), pro- erence product contains more than 40 vided that the product meets the defi- calories or more than 3 g fat per ref- nition of ‘‘low in sodium’’ as defined in erence amount customarily consumed § 317.361(b)(5)(i); and may use the terms ‘‘light in sodium’’ (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- or ‘‘lite in sodium’’ if it is reduced by dium’’ are presented in uniform type 50 percent or more in sodium content size, style, color, and prominence. compared to the reference product, pro- (3) The term ‘‘light’’ or ‘‘lite’’ may be vided that ‘‘light’’ or ‘‘lite’’ is pre- used in the brand name of a product to sented in immediate proximity with describe the sodium content, provided ‘‘in sodium’’ and the entire term is pre- that:
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(i) The product is reduced by 50 per- product is not ‘‘low in sodium’’ as de- cent or more in sodium content com- fined in § 317.361(b)(4), the statement pared to the reference product; ‘‘not a low sodium food,’’ shall appear (ii) A statement specifically stating adjacent to the nutrition information that the product is ‘‘light in sodium’’ and the information required to accom- or ‘‘lite in sodium’’ appears: pany a relative claim shall appear on (A) Contiguous to the brand name; the label or labeling as specified in and § 317.313(j)(2). (B) In uniform type size, style, color, [60 FR 189, Jan. 3, 1995] and prominence as the product name; and §§ 317.357–317.359 [Reserved] (iii) As required in § 317.313(j)(2) for relative claims: § 317.360 Nutrient content claims for (A) The identity of the reference calorie content. product and the percent (or fraction) (a) General requirements. A claim that the sodium was reduced are de- about the calorie or sugar content of a clared in immediate proximity to the product may only be made on the label most prominent such claim; and or in labeling of the product if: (B) Quantitative information com- paring the level of sodium per labeled (1) The claim uses one of the terms serving size with that of the reference defined in this section in accordance product it replaces is declared adjacent with the definition for that term; to the most prominent claim or to the (2) The claim is made in accordance nutrition information. with the general requirements for nu- (e) Except as provided in paragraphs trient content claims in § 317.313; and (b) through (d) of this section, the (3) The product for which the claim is terms ‘‘light’’ or ‘‘lite’’ may not be made is labeled in accordance with used to refer to a product that is not § 317.309. reduced in fat by 50 percent, or, if ap- (b) Calorie content claims. (1) The plicable, in calories by 1⁄3 or, when terms ‘‘calorie free,’’ ‘‘free of calories,’’ properly qualified, in sodium by 50 per- ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- cent unless: out calories,’’ ‘‘trivial source of cal- (1) It describes some physical or ories,’’ ‘‘negligible source of calories,’’ organoleptic attribute of the product or ‘‘dietarily insignificant source of such as texture or color and the infor- calories’’ may be used on the label or mation (e.g., ‘‘light in color’’ or ‘‘light in labeling of products, provided that: in texture’’) so stated, clearly conveys (i) The product contains less than 5 the nature of the product; and calories per reference amount cus- (2) The attribute (e.g., ‘‘color’’ or tomarily consumed and per labeled ‘‘texture’’) is in the same style, color, serving size; and and at least one-half the type size as (ii) If the product meets this condi- the word ‘‘light’’ and in immediate tion without the benefit of special proximity thereto. processing, alteration, formulation, or (f) If a manufacturer can dem- reformulation to lower the caloric con- onstrate that the word ‘‘light’’ has tent, it is labeled to clearly refer to all been associated, through common use, products of its type and not merely to with a particular product to reflect a the particular brand to which the label physical or organoleptic attribute to attaches. the point where it has become part of (2) The terms ‘‘low calorie,’’ ‘‘few cal- the statement of identity, such use of ories,’’ ‘‘contains a small amount of the term ‘‘light’’ shall not be consid- calories,’’ ‘‘low source of calories,’’ or ered a nutrient content claim subject ‘‘low in calories’’ may be used on the to the requirements in this part. label or in labeling of products, except (g) The term ‘‘lightly salted’’ may be meal-type products as defined in used on a product to which has been § 317.313(l), provided that: added 50 percent less sodium than is (i)(A) The product has a reference normally added to the reference prod- amount customarily consumed greater uct as described in § 317.313(j)(1)(i)(B) than 30 grams (g) or greater than 2 ta- and (j)(1)(ii)(B), provided that if the blespoons (tbsp) and does not provide
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more than 40 calories per reference ‘‘331⁄3 percent fewer calories than our amount customarily consumed; or regular ‘product’ ’’); and (B) The product has a reference (B) Quantitative information com- amount customarily consumed of 30 g paring the level of calories in the prod- or less or 2 tbsp or less and does not uct per labeled serving size with that of provide more than 40 calories per ref- the reference product that it replaces erence amount customarily consumed is declared adjacent to the most promi- and per 50 g (for dehydrated products nent claim or to the nutrition informa- that must be reconstituted before typi- tion (e.g., ‘‘calorie content has been re- cal consumption with water or a dilu- duced from 150 to 100 calories per serv- ent containing an insignificant ing’’). amount, as defined in § 317.309(f)(1), of (iii) Claims described in paragraph all nutrients per reference amount cus- (b)(4) of this section may not be made tomarily consumed, the per-50-g cri- on the label or in labeling of products terion refers to the ‘‘as prepared’’ if the reference product meets the defi- form). nition for ‘‘low calorie.’’ (ii) If the product meets these condi- (5) The terms defined in paragraph tions without the benefit of special (b)(4) of this section may be used on processing, alteration, formulation, or the label or in labeling of a meal-type reformulation to lower the caloric con- product as defined in § 317.313(l), pro- tent, it is labeled to clearly refer to all vided that: products of its type and not merely to (i) The product contains at least 25 the particular brand to which the label percent fewer calories per 100 g of prod- attaches. uct than an appropriate reference prod- (3) The terms defined in paragraph uct as described in § 317.313(j)(1); and (b)(2) of this section may be used on (ii) As required in § 317.313(j)(2) for the label or in labeling of a meal-type relative claims: product as defined in § 317.313(l), pro- (A) The identity of the reference vided that: product and the percent (or fraction) (i) The product contains 120 calories that the calories differ between the two or less per 100 g of product; and products are declared in immediate (ii) If the product meets this condi- proximity to the most prominent such tion without the benefit of special claim (e.g., ‘‘calorie reduced ‘product’, processing, alteration, formulation, or 25% less calories per ounce (oz) (or 3 oz) reformulation to lower the calorie con- than our regular ‘product’ ’’); and tent, it is labeled to clearly refer to all (B) Quantitative information com- products of its type and not merely to paring the level of calories in the prod- the particular brand to which it at- uct per specified weight with that of taches. the reference product that it replaces (4) The terms ‘‘reduced calorie,’’ ‘‘re- is declared adjacent to the most promi- duced in calories,’’ ‘‘calorie reduced,’’ nent claim or to the nutrition informa- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or tion (e.g., ‘‘calorie content has been re- ‘‘lower in calories’’ may be used on the duced from 110 calories per 3 oz to 80 label or in labeling of products, except calories per 3 oz’’). meal-type products as defined in (iii) Claims described in paragraph § 317.313(l), provided that: (b)(5) of this section may not be made (i) The product contains at least 25 on the label or in labeling of products percent fewer calories per reference if the reference product meets the defi- amount customarily consumed than an nition for ‘‘low calorie.’’ appropriate reference product as de- (c) Sugar content claims. (1) Terms scribed in § 317.313(j)(1); and such as ‘‘sugar free,’’ ‘‘free of sugar,’’ (ii) As required in § 317.313(j)(2) for ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without relative claims: sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of (A) The identity of the reference sugar,’’ ‘‘negligible source of sugar,’’ or product and the percent (or fraction) ‘‘dietarily insignificant source of that the calories differ between the two sugar’’ may reasonably be expected to products are declared in immediate be regarded by consumers as terms proximity to the most prominent such that represent that the product con- claim (e.g., lower calorie ‘product’— tains no sugars or sweeteners, e.g.,
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‘‘sugar free,’’ or ‘‘no sugar,’’ as indicat- (v) The product bears a statement ing a product which is low in calories that the product is not ‘‘low calorie’’ or significantly reduced in calories. or ‘‘calorie reduced’’ (unless the prod- Consequently, except as provided in uct meets the requirements for a ‘‘low’’ paragraph (c)(2) of this section, a prod- or ‘‘reduced calorie’’ product) and that uct may not be labeled with such terms directs consumers’ attention to the nu- unless: trition panel for further information (i) The product contains less than 0.5 on sugar and calorie content. g of sugars, as defined in (3) Paragraph (c)(1) of this section § 317.309(c)(6)(ii), per reference amount shall not apply to a factual statement customarily consumed and per labeled that a product, including products in- serving size or, in the case of a meal- tended specifically for infants and chil- type product, less than 0.5 g of sugars dren less than 2 years of age, is un- per labeled serving size; sweetened or contains no added sweet- (ii) The product contains no ingredi- eners in the case of a product that con- ent that is a sugar or that is generally tains apparent substantial inherent understood by consumers to contain sugar content, e.g., juices. sugars unless the listing of the ingredi- (4) The terms ‘‘reduced sugar,’’ ‘‘re- ent in the ingredients statement is fol- duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less lowed by an asterisk that refers to the sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in statement below the list of ingredients, sugar’’ may be used on the label or in which states: ‘‘Adds a trivial amount of labeling of products, except meal-type sugar,’’ ‘‘adds a negligible amount of products as defined in § 317.313(l), pro- sugar,’’ or ‘‘adds a dietarily insignifi- vided that: cant amount of sugar;’’ and (i) The product contains at least 25 (iii)(A) It is labeled ‘‘low calorie’’ or percent less sugars per reference ‘‘reduced calorie’’ or bears a relative amount customarily consumed than an claim of special dietary usefulness la- appropriate reference product as de- beled in compliance with paragraphs scribed in § 317.313(j)(1); and (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- (ii) As required in § 317.313(j)(2) for tion; or relative claims: (B) Such term is immediately accom- (A) The identity of the reference panied, each time it is used, by either product and the percent (or fraction) the statement ‘‘not a reduced calorie that the sugars differ between the two product,’’ ‘‘not a low calorie product,’’ products are declared in immediate or ‘‘not for weight control.’’ proximity to the most prominent such (2) The terms ‘‘no added sugar,’’ claim (e.g., ‘‘this product contains 25 ‘‘without added sugar,’’ or ‘‘no sugar percent less sugar than our regular added’’ may be used only if: product’’); and (i) No amount of sugars, as defined in (B) Quantitative information com- § 317.309(c)(6)(ii), or any other ingredi- paring the level of the sugar in the ent that contains sugars that function- product per labeled serving size with ally substitute for added sugars is that of the reference product that it re- added during processing or packaging; places is declared adjacent to the most (ii) The product does not contain an prominent claim or to the nutrition in- ingredient containing added sugars formation (e.g., ‘‘sugar content has such as jam, jelly, or concentrated been lowered from 8 g to 6 g per serv- fruit juice; ing’’). (iii) The sugars content has not been (5) The terms defined in paragraph increased above the amount present in (c)(4) of this section may be used on the the ingredients by some means such as label or in labeling of a meal-type the use of enzymes, except where the product as defined in § 317.313(l), pro- intended functional effect of the proc- vided that: ess is not to increase the sugars con- (i) The product contains at least 25 tent of a product, and a functionally percent less sugars per 100 g of product insignificant increase in sugars results; than an appropriate reference product (iv) The product that it resembles as described in § 317.313(j)(1); and and for which it substitutes normally (ii) As required in § 317.313(j)(2) for contains added sugars; and relative claims:
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(A) The identity of the reference (iii) If the product meets these condi- product and the percent (or fraction) tions without the benefit of special that the sugars differ between the two processing, alteration, formulation, or products are declared in immediate reformulation to lower the sodium con- proximity to the most prominent such tent, it is labeled to clearly refer to all claim (e.g., ‘‘reduced sugar ‘product’— products of its type and not merely to 25% less sugar than our regular ‘prod- the particular brand to which the label uct’ ’’); and attaches. (B) Quantitative information com- (2) The terms ‘‘very low sodium’’ or paring the level of the nutrient in the ‘‘very low in sodium’’ may be used on product per specified weight with that the label or in labeling of products, ex- of the reference product that it re- cept meal-type products as defined in places is declared adjacent to the most § 317.313(l), provided that: prominent claim or to the nutrition in- (i)(A) The product has a reference formation (e.g., ‘‘sugar content has amount customarily consumed greater been reduced from 17 g per 3 oz to 13 g than 30 grams (g) or greater than 2 ta- per 3 oz’’). blespoons (tbsp) and contains 35 mg or [60 FR 191, Jan. 3, 1995] less sodium per reference amount cus- tomarily consumed; or § 317.361 Nutrient content claims for (B) The product has a reference the sodium content. amount customarily consumed of 30 g (a) General requirements. A claim or less or 2 tbsp or less and contains 35 about the level of sodium in a product mg or less sodium per reference may only be made on the label or in la- amount customarily consumed and per beling of the product if: 50 g (for dehydrated products that must (1) The claim uses one of the terms be reconstituted before typical con- defined in this section in accordance sumption with water or a diluent con- with the definition for that term; taining an insignificant amount, as de- (2) The claim is made in accordance fined in § 317.309(f)(1), of all nutrients with the general requirements for nu- per reference amount customarily con- trient content claims in § 317.313; and sumed, the per-50-g criterion refers to (3) The product for which the claim is the ‘‘as prepared’’ form); and made is labeled in accordance with (ii) If the product meets these condi- § 317.309. tions without the benefit of special (b) Sodium content claims. (1) The processing, alteration, formulation, or terms ‘‘sodium free,’’ ‘‘free of sodium,’’ reformulation to lower the sodium con- ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without tent, it is labeled to clearly refer to all sodium,’’ ‘‘trivial source of sodium,’’ products of its type and not merely to ‘‘negligible source of sodium,’’ or the particular brand to which the label ‘‘dietarily insignificant source of so- attaches. dium’’ may be used on the label or in (3) The terms defined in paragraph labeling of products, provided that: (b)(2) of this section may be used on (i) The product contains less than 5 the label or in labeling of a meal-type milligrams (mg) of sodium per ref- product as defined in § 317.313(l), pro- erence amount customarily consumed vided that: and per labeled serving size or, in the (i) The product contains 35 mg or less case of a meal-type product, less than 5 of sodium per 100 g of product; and mg of sodium per labeled serving size; (ii) If the product meets this condi- (ii) The product contains no ingredi- tion without the benefit of special ent that is sodium chloride or is gen- processing, alteration, formulation, or erally understood by consumers to con- reformulation to lower the sodium con- tain sodium unless the listing of the in- tent, it is labeled to clearly refer to all gredient in the ingredients statement products of its type and not merely to is followed by an asterisk that refers to the particular brand to which the label the statement below the list of ingredi- attaches. ents, which states: ‘‘Adds a trivial (4) The terms ‘‘low sodium,’’ ‘‘low in amount of sodium,’’ ‘‘adds a negligible sodium,’’ ‘‘little sodium,’’ ‘‘contains a amount of sodium’’ or ‘‘adds a dietarily small amount of sodium,’’ or ‘‘low insignificant amount of sodium’’; and source of sodium’’ may be used on the
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label and in labeling of products, ex- (A) The identity of the reference cept meal-type products as defined in product and the percent (or fraction) § 317.313(l), provided that: that the sodium differs between the (i)(A) The product has a reference two products are declared in imme- amount customarily consumed greater diate proximity to the most prominent than 30 g or greater than 2 tbsp and such claim (e.g., ‘‘reduced sodium contains 140 mg or less sodium per ref- ‘product’, 50 percent less sodium than erence amount customarily consumed; regular ‘product’ ’’); and or (B) Quantitative information com- (B) The product has a reference paring the level of sodium in the prod- amount customarily consumed of 30 g uct per labeled serving size with that of or less or 2 tbsp or less and contains 140 the reference product that it replaces mg or less sodium per reference is declared adjacent to the most promi- amount customarily consumed and per nent claim or to the nutrition informa- 50 g (for dehydrated products that must tion (e.g., ‘‘sodium content has been be reconstituted before typical con- lowered from 300 to 150 mg per serv- sumption with water or a diluent con- taining an insignificant amount, as de- ing’’). fined in § 317.309(f)(1), of all nutrients (iii) Claims described in paragraph per reference amount customarily con- (b)(6) of this section may not be made sumed, the per-50-g criterion refers to on the label or in labeling of a product the ‘‘as prepared’’ form); and if the nutrient content of the reference (ii) If the product meets these condi- product meets the definition for ‘‘low tions without the benefit of special sodium.’’ processing, alteration, formulation, or (7) The terms defined in paragraph reformulation to lower the sodium con- (b)(6) of this section may be used on tent, it is labeled to clearly refer to all the label or in labeling of a meal-type products of its type and not merely to product as defined in § 317.313(l), pro- the particular brand to which the label vided that: attaches. (i) The product contains at least 25 (5) The terms defined in paragraph percent less sodium per 100 g of product (b)(4) of this section may be used on than an appropriate reference product the label or in labeling of a meal-type as described in § 317.313(j)(1); and product as defined in § 317.313(l), pro- (ii) As required in § 317.313(j)(2) for vided that: relative claims: (i) The product contains 140 mg or (A) The identity of the reference less sodium per 100 g of product; and product and the percent (or fraction) (ii) If the product meets these condi- that the sodium differs between the tions without the benefit of special two products are declared in imme- processing, alteration, formulation, or diate proximity to the most prominent reformulation to lower the sodium con- such claim (e.g., ‘‘reduced sodium tent, it is labeled to clearly refer to all ‘product’—30% less sodium per 3 oz products of its type and not merely to than our ‘regular product’ ’’); and the particular brand to which the label attaches. (B) Quantitative information com- (6) The terms ‘‘reduced sodium,’’ ‘‘re- paring the level of sodium in the prod- duced in sodium,’’ ‘‘sodium reduced,’’ uct per specified weight with that of ‘‘less sodium,’’ ‘‘lower sodium,’’ or the reference product that it replaces ‘‘lower in sodium’’ may be used on the is declared adjacent to the most promi- label or in labeling of products, except nent claim or to the nutrition informa- meal-type products as defined in tion (e.g., ‘‘sodium content has been re- § 317.313(l), provided that: duced from 220 mg per 3 oz to 150 mg (i) The product contains at least 25 per 3 oz’’). percent less sodium per reference (iii) Claims described in paragraph amount customarily consumed than an (b)(7) of this section may not be made appropriate reference product as de- on the label or in labeling of products scribed in § 317.313(j)(1); and if the nutrient content of the reference (ii) As required in § 317.313(j)(2) for product meets the definition for ‘‘low relative claims: sodium.’’
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(c) The term ‘‘salt’’ is not synony- label or in labeling of products, pro- mous with ‘‘sodium.’’ Salt refers to so- vided that: dium chloride. However, references to (i) The product contains less than 0.5 salt content such as ‘‘unsalted,’’ ‘‘no gram (g) of fat per reference amount salt,’’ ‘‘no salt added’’ are potentially customarily consumed and per labeled misleading. serving size or, in the case of a meal- (1) The term ‘‘salt free’’ may be used type product, less than 0.5 g of fat per on the label or in labeling of products labeled serving size; only if the product is ‘‘sodium free’’ as (ii) The product contains no added in- defined in paragraph (b)(1) of this sec- gredient that is a fat or is generally tion. understood by consumers to contain (2) The terms ‘‘unsalted,’’ ‘‘without fat unless the listing of the ingredient added salt,’’ and ‘‘no salt added’’ may in the ingredients statement is fol- be used on the label or in labeling of lowed by an asterisk that refers to the products only if: statement below the list of ingredients, (i) No salt is added during processing; which states: ‘‘Adds a trivial amount of (ii) The product that it resembles and fat,’’ ‘‘adds a negligible amount of fat,’’ for which it substitutes is normally or ‘‘adds a dietarily insignificant processed with salt; and amount of fat’’; and (iii) If the product is not sodium free, (iii) If the product meets these condi- the statement, ‘‘not a sodium free tions without the benefit of special product’’ or ‘‘not for control of sodium processing, alteration, formulation, or in the diet’’ appears adjacent to the nu- reformulation to lower the fat content, trition information of the product it is labeled to clearly refer to all prod- bearing the claim. ucts of its type and not merely to the (3) Paragraph (c)(2) of this section particular brand to which the label at- shall not apply to a factual statement taches. that a product intended specifically for (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ infants and children less than 2 years ‘‘contains a small amount of fat,’’ ‘‘low of age is unsalted, provided such state- source of fat,’’ or ‘‘little fat’’ may be ment refers to the taste of the product used on the label and in labeling of and is not false or otherwise mislead- products, except meal-type products as ing. defined in § 317.313(l), provided that: [60 FR 192, Jan. 3, 1995] (i)(A) The product has a reference amount customarily consumed greater § 317.362 Nutrient content claims for than 30 g or greater than 2 tablespoons fat, fatty acids, and cholesterol con- (tbsp) and contains 3 g or less of fat per tent. reference amount customarily con- (a) General requirements. A claim sumed; or about the level of fat, fatty acid, and (B) The product has a reference cholesterol in a product may only be amount customarily consumed of 30 g made on the label or in labeling of or less or 2 tbsp or less and contains 3 products if: g or less of fat per reference amount (1) The claim uses one of the terms customarily consumed and per 50 g (for defined in this section in accordance dehydrated products that must be re- with the definition for that term; constituted before typical consumption (2) The claim is made in accordance with water or a diluent containing an with the general requirements for nu- insignificant amount, as defined in trient content claims in § 317.313; and § 317.309(f)(1), of all nutrients per ref- (3) The product for which the claim is erence amount customarily consumed, made is labeled in accordance with the per-50-g criterion refers to the ‘‘as § 317.309. prepared’’ form). (b) Fat content claims. (1) The terms (ii) If the product meets these condi- ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ tions without the benefit of special ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ processing, alteration, formulation, or ‘‘trivial source of fat,’’ ‘‘negligible reformulation to lower the fat content, source of fat,’’ or ‘‘dietarily insignifi- it is labeled to clearly refer to all prod- cant source of fat’’ may be used on the ucts of its type and not merely to the
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particular brand to which the label at- (i) The product contains at least 25 taches. percent less fat per 100 g of product (3) The terms defined in paragraph than an appropriate reference product (b)(2) of this section may be used on as described in § 317.313(j)(1); and the label or in labeling of a meal-type (ii) As required in § 317.313(j)(2) for product as defined in § 317.313(l), pro- relative claims: vided that: (A) The identity of the reference (i) The product contains 3 g or less of product and the percent (or fraction) total fat per 100 g of product and not that the fat differs between the two more than 30 percent of calories from products are declared in immediate fat; and proximity to the most prominent such (ii) If the product meets these condi- claim (e.g., ‘‘reduced fat ‘product’, 33 tions without the benefit of special percent less fat per 3 oz than our regu- processing, alteration, formulation, or lar ‘product’ ’’); and reformulation to lower the fat content, (B) Quantitative information com- it is labeled to clearly refer to all prod- paring the level of fat in the product ucts of its type and not merely to the per specified weight with that of the particular brand to which the label at- reference product that it replaces is de- taches. clared adjacent to the most prominent (4) The terms ‘‘reduced fat,’’ ‘‘re- such claim or to the nutrition informa- duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ tion (e.g., ‘‘fat content has been re- ‘‘lower fat,’’ or ‘‘lower in fat’’ may be duced from 8 g per 3 oz to 5 g per 3 oz’’). used on the label or in labeling of prod- (iii) Claims described in paragraph ucts, except meal-type products as de- (b)(5) of this section may not be made fined in § 317.313(l), provided that: on the label or in labeling of a product (i) The product contains at least 25 if the nutrient content of the reference percent less fat per reference amount product meets the definition for ‘‘low customarily consumed than an appro- fat.’’ priate reference product as described in (6) The term ‘‘lll percent fat free’’ § 317.313(j)(1); and may be used on the label or in labeling (ii) As required in § 317.313(j)(2) for of products, provided that: relative claims: (i) The product meets the criteria for (A) The identity of the reference ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of product and the percent (or fraction) this section; that the fat differs between the two (ii) The percent declared and the products are declared in immediate words ‘‘fat free’’ are in uniform type proximity to the most prominent such size; and claim (e.g., ‘‘reduced fat—50 percent (iii) A ‘‘100 percent fat free’’ claim less fat than our regular ‘product’ ’’); may be made only on products that and meet the criteria for ‘‘fat free’’ in para- (B) Quantitative information com- graph (b)(1) of this section, that con- paring the level of fat in the product tain less than 0.5 g of fat per 100 g, and per labeled serving size with that of the that contain no added fat. reference product that it replaces is de- (iv) A synonym for ‘‘lll percent clared adjacent to the most prominent fat free’’ is ‘‘lll percent lean.’’ claim or to the nutrition information (c) Fatty acid content claims. (1) The (e.g., ‘‘fat content has been reduced terms ‘‘saturated fat free,’’ ‘‘free of from 8 g to 4 g per serving’’). saturated fat,’’ ‘‘no saturated fat,’’ (iii) Claims described in paragraph ‘‘zero saturated fat,’’ ‘‘without satu- (b)(4) of this section may not be made rated fat,’’ ‘‘trivial source of saturated on the label or in labeling of a product fat,’’ ‘‘negligible source of saturated if the nutrient content of the reference fat,’’ or ‘‘dietarily insignificant source product meets the definition for ‘‘low of saturated fat’’ may be used on the fat.’’ label or in labeling of products, pro- (5) The terms defined in paragraph vided that: (b)(4) of this section may be used on (i) The product contains less than 0.5 the label or in labeling of a meal-type g of saturated fat and less than 0.5 g product as defined in § 317.313(l), pro- trans fatty acids per reference amount vided that: customarily consumed and per labeled
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serving size or, in the case of a meal- all products of its type and not merely type product, less than 0.5 g of satu- to the particular brand to which the rated fat and less than 0.5 g trans fatty label attaches. acids per labeled serving size; (4) The terms ‘‘reduced saturated (ii) The product contains no ingredi- fat,’’ ‘‘reduced in saturated fat,’’ ‘‘satu- ent that is generally understood by rated fat reduced,’’ ‘‘less saturated consumers to contain saturated fat un- fat,’’ ‘‘lower saturated fat,’’ or ‘‘lower less the listing of the ingredient in the in saturated fat’’ may be used on the ingredients statement is followed by an label or in labeling of products, except asterisk that refers to the statement meal-type products as defined in below the list of ingredients, which § 317.313(l), provided that: states: ‘‘Adds a trivial amount of satu- (i) The product contains at least 25 rated fat,’’ ‘‘adds a negligible amount percent less saturated fat per reference of saturated fat,’’ or ‘‘adds a dietarily amount customarily consumed than an insignificant amount of saturated fat;’’ appropriate reference product as de- and scribed in § 317.313(j)(1); and (iii) If the product meets these condi- (ii) As required in § 317.313(j)(2) for tions without the benefit of special relative claims: processing, alteration, formulation, or (A) The identity of the reference reformulation to lower saturated fat product and the percent (or fraction) content, it is labeled to clearly refer to that the saturated fat differs between all products of its type and not merely the two products are declared in imme- to the particular brand to which the diate proximity to the most prominent label attaches. such claim (e.g., ‘‘reduced saturated fat (2) The terms ‘‘low in saturated fat,’’ ‘product’, contains 50 percent less satu- ‘‘low saturated fat,’’ ‘‘contains a small rated fat than the national average for amount of saturated fat,’’ ‘‘low source ‘product’ ’’); and of saturated fat,’’ or ‘‘a little saturated (B) Quantitative information com- fat’’ may be used on the label or in la- paring the level of saturated fat in the beling of products, except meal-type product per labeled serving size with products as defined in § 317.313(l), pro- that of the reference product that it re- vided that: places is declared adjacent to the most (i) The product contains 1 g or less of prominent claim or to the nutrition in- saturated fat per reference amount cus- formation (e.g., ‘‘saturated fat reduced tomarily consumed and not more than from 3 g to 1.5 g per serving’’). 15 percent of calories from saturated (iii) Claims described in paragraph fat; and (c)(4) of this section may not be made (ii) If the product meets these condi- on the label or in labeling of a product tions without benefit of special proc- if the nutrient content of the reference essing, alteration, formulation, or re- product meets the definition for ‘‘low formulation to lower saturated fat con- saturated fat.’’ tent, it is labeled to clearly refer to all (5) The terms defined in paragraph products of its type and not merely to (c)(4) of this section may be used on the the particular brand to which the label label or in labeling of a meal-type attaches. product as defined in § 317.313(l), pro- (3) The terms defined in paragraph vided that: (c)(2) of this section may be used on the (i) The product contains at least 25 label or in labeling of a meal-type percent less saturated fat per 100 g of product as defined in § 317.313(l), pro- product than an appropriate reference vided that: product as described in § 317.313(j)(1); (i) The product contains 1 g or less of and saturated fat per 100 g and less than 10 (ii) As required in § 317.313(j)(2) for percent calories from saturated fat; relative claims: and (A) The identity of the reference (ii) If the product meets these condi- product and the percent (or fraction) tions without the benefit of special that the saturated fat differs between processing, alteration, formulation, or the two products are declared in imme- reformulation to lower saturated fat diate proximity to the most prominent content, it is labeled to clearly refer to such claim (e.g., ‘‘reduced saturated fat
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‘product’,’’ ‘‘50 percent less saturated (v) If the product meets these condi- fat than our regular ‘product’ ’’); and tions only as a result of special proc- (B) Quantitative information com- essing, alteration, formulation, or re- paring the level of saturated fat in the formulation, the amount of cholesterol product per specified weight with that is reduced by 25 percent or more from of the reference product that it re- the reference product it replaces as de- places is declared adjacent to the most scribed in § 317.313(j)(1) and for which it prominent claim or to the nutrition in- substitutes as described in § 317.313(d) formation (e.g., ‘‘saturated fat content that has a significant (e.g., 5 percent or has been reduced from 2.5 g per 3 oz to more of a national or regional market) 1.5 g per 3 oz’’). market share. As required in (iii) Claims described in paragraph § 317.313(j)(2) for relative claims: (c)(5) of this section may not be made (A) The identity of the reference on the label or in labeling of a product product and the percent (or fraction) if the nutrient content of the reference that the cholesterol was reduced are product meets the definition for ‘‘low declared in immediate proximity to the saturated fat.’’ most prominent such claim (e.g., ‘‘cho- (d) Cholesterol content claims. (1) The lesterol free ‘product’, contains 100 per- terms ‘‘cholesterol free,’’ ‘‘free of cho- cent less cholesterol than ‘reference lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without product’ ’’); and (B) Quantitative information com- cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial paring the level of cholesterol in the source of cholesterol,’’ ‘‘negligible product per labeled serving size with source of cholesterol,’’ or ‘‘dietarily in- that of the reference product that it re- significant source of cholesterol’’ may places is declared adjacent to the most be used on the label or in labeling of prominent claim or to the nutrition in- products, provided that: formation (e.g., ‘‘contains no choles- (i) The product contains less than 2 terol compared with 30 mg in one serv- milligrams (mg) of cholesterol per ref- ing of ‘reference product’ ’’). erence amount customarily consumed (2) The terms ‘‘low in cholesterol,’’ and per labeled serving size or, in the ‘‘low cholesterol,’’ ‘‘contains a small case of a meal-type product as defined amount of cholesterol,’’ ‘‘low source of in § 317.313(l), less than 2 mg of choles- cholesterol,’’ or ‘‘little cholesterol’’ terol per labeled serving size; may be used on the label or in labeling (ii) The product contains no ingredi- of products, except meal-type products ent that is generally understood by as defined in § 317.313(l), provided that: consumers to contain cholesterol, un- (i)(A) If the product has a reference less the listing of the ingredient in the amount customarily consumed greater ingredients statement is followed by an than 30 g or greater than 2 tbsp: asterisk that refers to the statement (1) The product contains 20 mg or less below the list of ingredients, which of cholesterol per reference amount states: ‘‘Adds a trivial amount of cho- customarily consumed; and lesterol,’’ ‘‘adds a negligible amount of (2) The product contains 2 g or less of cholesterol,’’ or ‘‘adds a dietarily insig- saturated fat per reference amount cus- nificant amount of cholesterol’’; tomarily consumed; or (iii) The product contains 2 g or less (B) If the product has a reference of saturated fat per reference amount amount customarily consumed of 30 g customarily consumed or, in the case or less or 2 tbsp or less: of a meal-type product as defined in (1) The product contains 20 mg or less § 317.313(l), 2 g or less of saturated fat of cholesterol per reference amount per labeled serving size; and customarily consumed and per 50 g (for (iv) If the product meets these condi- dehydrated products that must be re- tions without the benefit of special constituted before typical consumption processing, alteration, formulation, or with water or a diluent containing an reformulation to lower cholesterol con- insignificant amount, as defined in tent, it is labeled to clearly refer to all § 317.309(f)(1), of all nutrients per ref- products of its type and not merely to erence amount customarily consumed, the particular brand to which it at- the per-50-g criterion refers to the ‘‘as taches; or prepared’’ form); and
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(2) The product contains 2 g or less of (4) The terms ‘‘reduced cholesterol,’’ saturated fat per reference amount cus- ‘‘reduced in cholesterol,’’ ‘‘cholesterol tomarily consumed. reduced,’’ ‘‘less cholesterol,’’ ‘‘lower (ii) If the product meets these condi- cholesterol,’’ or ‘‘lower in cholesterol’’ tions without the benefit of special may be used on the label or in labeling processing, alteration, formulation, or of products or products that substitute reformulation to lower cholesterol con- for those products as specified in tent, it is labeled to clearly refer to all § 317.313(d), excluding meal-type prod- products of its type and not merely to ucts as defined in § 317.313(l), provided the particular brand to which the label that: attaches; or (i) The product has been specifically (iii) If the product contains 20 mg or formulated, altered, or processed to re- less of cholesterol only as a result of duce its cholesterol by 25 percent or special processing, alteration, formula- more from the reference product it re- tion, or reformulation, the amount of places as described in § 317.313(j)(1) and cholesterol is reduced by 25 percent or for which it substitutes as described in more from the reference product it re- § 317.313(d) that has a significant (e.g., 5 places as described in § 317.313(j)(1) and percent or more of a national or re- for which it substitutes as described in gional market) market share; § 317.313(d) that has a significant (e.g., 5 (ii) The product contains 2 g or less percent or more of a national or re- of saturated fat per reference amount gional market) market share. As re- customarily consumed; and quired in § 317.313(j)(2) for relative (iii) As required in § 317.313(j)(2) for claims: relative claims: (A) The identity of the reference (A) The identity of the reference product and the percent (or fraction) product and the percent (or fraction) that the cholesterol has been reduced that the cholesterol has been reduced are declared in immediate proximity to are declared in immediate proximity to the most prominent such claim (e.g., the most prominent such claim (e.g., ‘‘25 percent less cholesterol than ‘ref- ‘‘low cholesterol ‘product’, contains 85 erence product’ ’’); and percent less cholesterol than our regu- (B) Quantitative information com- lar ‘product’ ’’); and paring the level of cholesterol in the (B) Quantitative information com- product per labeled serving size with paring the level of cholesterol in the that of the reference product that it re- product per labeled serving size with places is declared adjacent to the most that of the reference product that it re- prominent claim or to the nutrition in- places is declared adjacent to the most formation (e.g., ‘‘cholesterol lowered prominent claim or to the nutrition in- from 55 mg to 30 mg per serving’’). formation (e.g., ‘‘cholesterol lowered (iv) Claims described in paragraph from 30 mg to 5 mg per serving’’). (d)(4) of this section may not be made (3) The terms defined in paragraph on the label or in labeling of a product (d)(2) of this section may be used on if the nutrient content of the reference the label or in labeling of a meal-type product meets the definition for ‘‘low product as defined in § 317.313(l), pro- cholesterol.’’ vided that: (5) The terms defined in paragraph (i) The product contains 20 mg or less (d)(4) of this section may be used on of cholesterol per 100 g of product; the label or in labeling of a meal-type (ii) The product contains 2 g or less product as defined in § 317.313(l), pro- of saturated fat per 100 g of product; vided that: and (i) The product has been specifically (iii) If the product meets these condi- formulated, altered, or processed to re- tions without the benefit of special duce its cholesterol by 25 percent or processing, alteration, formulation, or more from the reference product it re- reformulation to lower cholesterol con- places as described in § 317.313(j)(1) and tent, it is labeled to clearly refer to all for which it substitutes as described in products of its type and not merely to § 317.313(d) that has a significant (e.g., 5 the particular brand to which the label percent or more of a national or re- attaches. gional market) market share;
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(ii) The product contains 2 g or less product is labeled in accordance with of saturated fat per 100 g of product; § 317.309 and § 317.313. and (b)(1) The product shall meet the re- (iii) As required in § 317.313(j)(2) for quirements for ‘‘low fat’’ and ‘‘low relative claims: saturated fat,’’ as defined in § 317.362, (A) The identity of the reference except that single-ingredient, raw product and the percent (or fraction) products may meet the total fat and that the cholesterol has been reduced saturated fat criteria for ‘‘extra lean’’ are declared in immediate proximity to in § 317.362. the most prominent such claim (e.g., (2) The product shall not contain ‘‘25% less cholesterol than ‘reference more than 60 milligrams (mg) of cho- product’ ’’); and lesterol per reference amount cus- (B) Quantitative information com- tomarily consumed, per labeled serving paring the level of cholesterol in the size, and, only for foods with reference product per specified weight with that amounts customarily consumed of 30 of the reference product that it re- grams (g) or less or 2 tablespoons (tbsp) places is declared adjacent to the most or less, per 50 g, and, for dehydrated prominent claim or to the nutrition in- products that must be reconstituted formation (e.g., ‘‘cholesterol content with water or a diluent containing an has been reduced from 35 mg per 3 oz to insignificant amount, as defined in 25 mg per 3 oz). § 317.309(f)(1), of all nutrients, the per- (iv) Claims described in paragraph 50-g criterion refers to the prepared (d)(5) of this section may not be made form, except that: on the label or in labeling of a product (i) A meal-type product, as defined in if the nutrient content of the reference § 317.313(l), and including meal-type product meets the definition for ‘‘low products that weigh more than 12 cholesterol.’’ ounces (oz) per serving (container), (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. shall not contain more than 90 mg of (1) The term ‘‘lean’’ may be used on the cholesterol per labeled serving size; label or in labeling of a product, pro- and vided that the product contains less (ii) Single-ingredient, raw products than 10 g of fat, 4.5 g or less of satu- may meet the cholesterol criterion for rated fat, and less than 95 mg of choles- ‘‘extra lean’’in § 317.362. terol per 100 g of product and per ref- (3) The product shall not contain erence amount customarily consumed more than 360 mg of sodium, except for individual foods, and per 100 g of that it shall not contain more than 480 product and per labeled serving size for mg of sodium during the first 24 meal-type products as defined in months of implementation, per ref- § 317.313(l). erence amount customarily consumed, (2) The term ‘‘extra lean’’ may be per labeled serving size, and, only for used on the label or in labeling of a foods with reference amounts cus- product, provided that the product con- tomarily consumed of 30 g or less or 2 tains less than 5 g of fat, less than 2 g tbsp or less, per 50 g, and, for dehy- of saturated fat, and less than 95 mg of drated products that must be reconsti- cholesterol per 100 g of product and per tuted with water or a diluent contain- reference amount customarily con- ing an insignificant amount, as defined sumed for individual foods, and per 100 in § 317.309(f)(1), of all nutrients, the g of product and per labeled serving per-50-g criterion refers to the prepared size for meal-type products as defined form, except that: in § 317.313(l). (i) A meal-type product, as defined in [60 FR 193, Jan. 3, 1995] § 317.313(l), and including meal-type products that weigh more than 12 oz § 317.363 Nutrient content claims for per serving (container), shall not con- ‘‘healthy.’’ tain more than 480 mg of sodium, ex- (a) The term ‘‘healthy,’’ or any other cept that it shall not contain more derivative of the term ‘‘health,’’ may than 600 mg of sodium during the first be used on the labeling of any meat or 24 months of implementation, per la- meat food product, provided that the beled serving size; and
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(ii) The requirements of this para- (d) Pertinent information will be graph (b)(3) do not apply to single-in- considered as part of an application on gredient, raw products. the basis of specific reference to such (4) The product shall contain 10 per- information submitted to and retained cent or more of the Reference Daily In- in the files of the Food Safety and In- take or Daily Reference Value as de- spection Service. However, any ref- fined in § 317.309 for vitamin A, vitamin erence to unpublished information fur- C, iron, calcium, protein, or fiber per nished by a person other than the ap- reference amount customarily con- plicant will not be considered unless sumed prior to any nutrient addition, use of such information is authorized except that: (with the understanding that such in- (i) A meal-type product, as defined in formation may in whole or part be sub- § 317.313(l), and including meal-type ject to release to the public) in a writ- products that weigh at least 6 oz but ten statement signed by the person less than 10 oz per serving (container), who submitted it. Any reference to shall meet the level for two of the nu- published information should be ac- trients per labeled serving size; and companied by reprints or photostatic (ii) A meal-type product, as defined copies of such references. in § 317.313(l), and including meal-type (e) If nonclinical laboratory studies products that weigh 10 oz or more per accompany a labeling application, the serving (container), shall meet the applicant shall include, with respect to level for three of the nutrients per la- each nonclinical study included with beled serving size. the application, either a statement [59 FR 24228, May 10, 1994, as amended at 60 that the study has been, or will be, FR 196, Jan. 3, 1995] conducted in compliance with the good laboratory practice regulations as set §§ 317.364–317.368 [Reserved] forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in § 317.369 Labeling applications for nu- compliance with such regulations, a trient content claims. brief statement of the reason for the (a) This section pertains to labeling noncompliance. applications for claims, express or im- (f) If clinical investigations accom- plied, that characterize the level of any pany a labeling application, the appli- nutrient required to be on the label or cant shall include, with respect to each in labeling of product by this subpart. clinical investigation included with the (b) Labeling applications included in application, either a statement that this section are: the investigation was conducted in (1) Labeling applications for a new compliance with the requirements for (heretofore unauthorized) nutrient con- institutional review set forth in part 56 tent claim, of chapter 1, title 21, or was not subject (2) Labeling applications for a syn- to such requirements in accordance onymous term (i.e., one that is consist- with § 56.194 or § 56.105, and that it was ent with a term defined by regulation) conducted in compliance with the re- for characterizing the level of a nutri- quirements for informed consents set ent, and forth in part 50 of chapter 1, title 21. (3) Labeling applications for the use (g) The availability for public disclo- of an implied claim in a brand name. sure of labeling applications, along (c) Labeling applications and sup- with supporting documentation, sub- porting documentation to be filed mitted to the Agency under this sec- under this section shall be submitted tion will be governed by the rules spec- in quadruplicate, except that the sup- ified in subchapter D, title 9. porting documentation may be submit- (h) The data specified under this sec- ted on a computer disc copy. If any tion to accompany a labeling applica- part of the material submitted is in a tion shall be submitted on separate foreign language, it shall be accom- sheets, suitably identified. If such data panied by an accurate and complete has already been submitted with an English translation. The labeling appli- earlier labeling application from the cation shall state the applicant’s post applicant, the present labeling applica- office address. tion must provide the data.
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(i) The labeling application must be data and information to the extent necessary signed by the applicant or by his or her to demonstrate that consumers can be ex- attorney or agent, or (if a corporation) pected to understand the meaning of the by an authorized official. term under the proposed conditions of use. (iii) Analytical data that demonstrates the (j) The labeling application shall in- amount of the nutrient that is present in the clude a statement signed by the person products for which the claim is intended. responsible for the labeling applica- The assays should be performed on rep- tion, that to the best of his or her resentative samples in accordance with knowledge, it is a representative and 317.309(h). If no USDA or AOAC methods are balanced submission that includes un- available, the applicant shall submit the favorable information, as well as favor- assay method used, and data establishing the validity of the method for assaying the nu- able information, known to him or her trient in the particular food. The validation pertinent to the evaluation of the la- data shall include a statistical analysis of beling application. the analytical and product variability. (k)(1) Labeling applications for a new (iv) A detailed analysis of the potential ef- nutrient content claim shall be accom- fect of the use of the proposed claim on food panied by the following data which consumption, and any corresponding changes shall be submitted in the following in nutrient intake. The analysis shall spe- cifically address the intake of nutrients that form to the Director, Food Labeling have beneficial and negative consequences in Division, Regulatory Programs, Food the total diet. If the claim is intended for a Safety and Inspection Service, Wash- specific group within the population, the ington, DC 20250. analysis shall specifically address the die- tary practices of such group, and shall in- ———————————————————————— clude data sufficient to demonstrate that the (Date) dietary analysis is representative of such The undersigned, lllll, submits this group. labeling application pursuant to 9 CFR Yours very truly, 317.369 with respect to (statement of the claim and its proposed use). Applicant ——————————————— Attached hereto, in quadruplicate, or on a By ——————————————————— computer disc copy, and constituting a part (Indicate authority) of this labeling application, are the follow- (2) Upon receipt of the labeling appli- ing: (i) A statement identifying the nutrient cation and supporting documentation, content claim and the nutrient that the the applicant shall be notified, in writ- term is intended to characterize with respect ing, of the date on which the labeling to the level of such nutrient. The statement application was received. Such notice shall address why the use of the term as pro- shall inform the applicant that the la- posed will not be misleading. The statement beling application is undergoing Agen- shall provide examples of the nutrient con- cy review and that the applicant shall tent claim as it will be used on labels or la- subsequently be notified of the Agen- beling, as well as the types of products on which the claim will be used. The statement cy’s decision to consider for further re- shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels the Agency shall notify the applicant, or labeling, as well as any factors that would in writing, that the labeling applica- make the use of the term inappropriate. tion is either being considered for fur- (ii) A detailed explanation supported by ther review or that it has been sum- any necessary data of why use of the food component characterized by the claim is of marily denied by the Administrator. importance in human nutrition by virtue of (4) If the labeling application is sum- its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to reasons therefor, including why the the public will derive from use of the claim Agency has determined that the pro- as proposed and why such benefit is not posed nutrient content claim is false or available through the use of existing terms misleading. The notification letter defined by regulation. If the claim is in- tended for a specific group within the popu- shall inform the applicant that the ap- lation, the analysis shall specifically address plicant may submit a written state- nutritional needs of such group, and sci- ment by way of answer to the notifica- entific data sufficient for such purpose, and tion, and that the applicant shall have
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the right to request a hearing with re- for the denial, including the reason spect to the merits or validity of the why the claim on the labeling was de- Administrator’s decision to deny the termined by the Agency to be false or use of the proposed nutrient content misleading. The notification letter claim. shall also inform the applicant that the (i) If the applicant fails to accept the applicant may submit a written state- determination of the Administrator ment by way of answer to the notifica- and files an answer and requests a tion, and that the applicant shall have hearing, and the Administrator, after the right to request a hearing with re- review of the answer, determines the spect to the merits or validity of the initial determination to be correct, the Administrator’s decision to deny the Administrator shall file with the Hear- use of the proposed nutrient content ing Clerk of the Department the notifi- claim. cation, answer, and the request for a (A) If the applicant fails to accept hearing, which shall constitute the the determination of the Adminis- complaint and answer in the proceed- trator and files an answer and requests ing, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall constitute the shall make the final determination for complaint and answer in the proceed- the Secretary. Any such determination ing, which shall thereafter be con- by the Secretary shall be conclusive ducted in accordance with the Depart- unless, within 30 days after receipt of ment’s Uniform Rules of Practice. notice of such final determination, the (B) The hearing shall be conducted applicant appeals to the United States before an administrative law judge Court of Appeals for the circuit in with the opportunity for appeal to the which the applicant has its principal Department’s Judicial Officer, who place of business or to the United shall make final determination for the States Court of Appeals for the District Secretary. Any such determination by of Columbia Circuit. the Secretary shall be conclusive un- (5) If the labeling application is not less, within 30 days after receipt of the summarily denied by the Adminis- notice of such final determination, the trator, the Administrator shall publish applicant appeals to the United States in the FEDERAL REGISTER a proposed Court of Appeals for the circuit in rule to amend the regulations to au- which the applicant has its principal thorize the use of the nutrient content place of business or to the United claim. The proposal shall also summa- States Court of Appeals for the District rize the labeling application, including of Columbia Circuit. where the supporting documentation (ii) If the claim is approved, the can be reviewed. The Administrator’s Agency shall notify the applicant, in proposed rule shall seek comment from writing, and shall also publish in the consumers, the industry, consumer and FEDERAL REGISTER a final rule amend- industry groups, and other interested ing the regulations to authorize the persons on the labeling application and use of the claim. the use of the proposed nutrient con- (l)(1) Labeling applications for a syn- tent claim. After public comment has onymous term shall be accompanied by been received and reviewed by the the following data which shall be sub- Agency, the Administrator shall make mitted in the following form to the Di- a determination on whether the pro- rector, Food Labeling Division, Regu- posed nutrient content claim shall be latory Programs, Food Safety and In- approved for use on the labeling of spection Service, Washington, DC 20250: meat and meat food products. ———————————————————————— (i) If the claim is denied by the Ad- (Date) ministrator, the Agency shall notify The undersigned, llllll submits this the applicant, in writing, of the basis labeling application pursuant to 9 CFR
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317.369 with respect to (statement of the syn- ther review or that it has been sum- onymous term and its proposed use in a nu- marily denied by the Administrator. trient content claim that is consistent with (4) If the labeling application is sum- an existing term that has been defined under subpart B of part 317). marily denied by the Administrator, Attached hereto, in quadruplicate, or on a the written notification shall state the computer disc copy, and constituting a part reasons therefor, including why the of this labeling application, are the follow- Agency has determined that the pro- ing: posed synonymous term is false or mis- (i) A statement identifying the synony- leading. The notification letter shall mous term, the existing term defined by a inform the applicant that the applicant regulation with which the synonymous term is claimed to be consistent, and the nutrient may submit a written statement by that the term is intended to characterize the way of answer to the notification, and level of. The statement shall address why the that the applicant shall have the right use of the synonymous term as proposed will to request a hearing with respect to not be misleading. The statement shall pro- the merits or validity of the Adminis- vide examples of the nutrient content claim trator’s decision to deny the use of the as it will be used on labels or labeling, as proposed synonymous term. well as the types of products on which the (i) If the applicant fails to accept the claim will be used. The statement shall also specify whether any limitations not applica- determination of the Administrator ble to the use of the defined term are in- and files an answer and requests a tended to apply to the use of the synony- hearing, and the Administrator, after mous term. review of the answer, determines the (ii) A detailed explanation supported by initial determination to be correct, the any necessary data of why use of the pro- Administrator shall file with the Hear- posed term is requested, including whether ing Clerk of the Department the notifi- the existing defined term is inadequate for the purpose of effectively characterizing the cation, answer, and the request for a level of a nutrient. This explanation shall hearing, which shall constitute the also state what nutritional benefit to the complaint and answer in the proceed- public will derive from use of the claim as ing, which shall thereafter be con- proposed, and why such benefit is not avail- ducted in accordance with the Depart- able through the use of existing terms de- ment’s Uniform Rules of Practice. fined by regulation. If the claim is intended (ii) The hearing shall be conducted for a specific group within the population, the analysis shall specifically address nutri- before an administrative law judge tional needs of such group, scientific data with the opportunity for appeal to the sufficient for such purpose, and data and in- Department’s Judicial Officer, who formation to the extent necessary to dem- shall make the final determination for onstrate that consumers can be expected to the Secretary. Any such determination understand the meaning of the term under by the Secretary shall be conclusive the proposed conditions of use. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant ——————————————— applicant appeals to the United States By ——————————————————— Court of Appeals for the circuit in (Indicate authority) which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL beling application is undergoing Agen- REGISTER a notice informing the public cy review and that the applicant shall that the synonymous term has been ap- subsequently be notified of the Agen- proved for use. cy’s decision to consider for further re- (m)(1) Labeling applications for the view or deny the labeling application. use of an implied nutrient content (3) Upon review of the labeling appli- claim in a brand name shall be accom- cation and supporting documentation, panied by the following data which the Agency shall notify the applicant, shall be submitted in the following in writing, that the labeling applica- form to the Director, Food Labeling tion is either being considered for fur- Division, Regulatory Programs, Food
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Safety and Inspection Service, Wash- ther review or that it has been sum- ington, DC 20250: marily denied by the Administrator. (4) If the labeling application is sum- ———————————————————————— (Date) marily denied by the Administrator, the written notification shall state the The undersigned, llllll submits this labeling application pursuant to 9 CFR reasons therefor, including why the 317.369 with respect to (statement of the im- Agency has determined that the pro- plied nutrient content claim and its proposed posed implied nutrient content claim is use in a brand name). false or misleading. The notification Attached hereto, in quadruplicate, or on a letter shall inform the applicant that computer disc copy, and constituting a part the applicant may submit a written of this labeling application, are the follow- statement by way of answer to the no- ing: tification, and that the applicant shall (i) A statement identifying the implied nu- trient content claim, the nutrient the claim have the right to request a hearing is intended to characterize, the correspond- with respect to the merits or validity ing term for characterizing the level of such of the Administrator’s decision to deny nutrient as defined by a regulation, and the the use of the proposed implied nutri- brand name of which the implied claim is in- ent content claim. tended to be a part. The statement shall ad- (i) If the applicant fails to accept the dress why the use of the brand-name as pro- determination of the Administrator posed will not be misleading. The statement and files an answer and requests a shall provide examples of the types of prod- ucts on which the brand name will appear. It hearing, and the Administrator, after shall also include data showing that the ac- review of the answer, determines the tual level of the nutrient in the food would initial determination to be correct, the qualify the label of the product to bear the Administrator shall file with the Hear- corresponding term defined by regulation. ing Clerk of the Department the notifi- Assay methods used to determine the level of cation, answer, and the request for a a nutrient shall meet the requirements stat- hearing, which shall constitute the ed under labeling application format in para- complaint and answer in the proceed- graph (k)(1)(iii) of this section. (ii) A detailed explanation supported by ing, which shall thereafter be con- any necessary data of why use of the pro- ducted in accordance with the Depart- posed brand name is requested. This expla- ment’s Uniform Rules of Practice. nation shall also state what nutritional ben- (ii) The hearing shall be conducted efit to the public will derive from use of the before an administrative law judge brand name as proposed. If the branded prod- with the opportunity for appeal to the uct is intended for a specific group within Department’s Judicial Officer, who the population, the analysis shall specifi- shall make the final determination for cally address nutritional needs of such group and scientific data sufficient for such pur- the Secretary. Any such determination pose. by the Secretary shall be conclusive Yours very truly, unless, within 30 days after receipt of notice of such final determination, the Applicant ——————————————— applicant appeals to the United States By ——————————————————— Court of Appeals for the circuit in (2) Upon receipt of the labeling appli- which the applicant has its principal cation and supporting documentation, place of business or to the United the applicant shall be notified, in writ- States Court of Appeals for the District ing, of the date on which the labeling of Columbia Circuit. application was received. Such notice (5) If the labeling application is not shall inform the applicant that the la- summarily denied by the Adminis- beling application is undergoing Agen- trator, the Administrator shall publish cy review and that the applicant shall a notice of the labeling application in subsequently be notified of the Agen- the FEDERAL REGISTER seeking com- cy’s decision to consider for further re- ment on the use of the implied nutrient view or deny the labeling application. content claim. The notice shall also (3) Upon review of the labeling appli- summarize the labeling application, in- cation and supporting documentation, cluding where the supporting docu- the Agency shall notify the applicant, mentation can be reviewed. The Ad- in writing, that the labeling applica- ministrator’s notice shall seek com- tion is either being considered for fur- ment from consumers, the industry,
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consumer and industry groups, and content claim has been approved for other interested persons on the label- use. ing application and the use of the im- (Paperwork requirements were approved by plied nutrient content claim. After the Office of Management and Budget under public comment has been received and control number 0583–0088) reviewed by the Agency, the Adminis- trator shall make a determination on [58 FR 664, Jan. 6, 1993, as amended at 59 FR whether the implied nutrient content 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995] claim shall be approved for use on the §§ 317.370–317.379 [Reserved] labeling of meat food products. (i) If the claim is denied by the Ad- § 317.380 Label statements relating to ministrator, the Agency shall notify usefulness in reducing or maintain- the applicant, in writing, of the basis ing body weight. for the denial, including the reason (a) General requirements. Any product why the claim on the labeling was de- that purports to be or is represented termined by the Agency to be false or for special dietary use because of use- misleading. The notification letter fulness in reducing body weight shall shall also inform the applicant that the bear: applicant may submit a written state- (1) Nutrition labeling in conformity ment by way of answer to the notifica- with § 317.309 of this subpart, unless ex- tion, and that the applicant shall have the right to request a hearing with re- empt under that section, and spect to the merits or validity of the (2) A conspicuous statement of the Administrator’s decision to deny the basis upon which the product claims to use of the proposed implied nutrient be of special dietary usefulness. content claim. (b) Nonnutritive ingredients. (1) Any (A) If the applicant fails to accept product subject to paragraph (a) of this the determination of the Adminis- section that achieves its special die- trator and files an answer and requests tary usefulness by use of a nonnutri- a hearing, and the Administrator, after tive ingredient (i.e., one not utilized in review of the answer, determines the normal metabolism) shall bear on its initial determination to be correct, the label a statement that it contains a Administrator shall file with the Hear- nonnutritive ingredient and the per- ing Clerk of the Department the notifi- centage by weight of the nonnutritive cation, answer, and the request for a ingredient. hearing, which shall thereafter be con- (2) A special dietary product may ducted in accordance with the Depart- contain a nonnutritive sweetener or ment’s Uniform Rules of Practice. other ingredient only if the ingredient (B) The hearing shall be conducted is safe for use in the product under the before an administrative law judge applicable law and regulations of this with the opportunity for appeal to the chapter. Any product that achieves its Department’s Judicial Officer, who special dietary usefulness in reducing shall make the final determination for or maintaining body weight through the Secretary. Any such determination the use of a nonnutritive sweetener by the Secretary shall be conclusive shall bear on its label the statement unless, within 30 days after receipt of required by paragraph (b)(1) of this sec- the notice of such final determination, tion, but need not state the percentage the applicant appeals to the United by weight of the nonnutritive sweet- States Court of Appeals for the circuit ener. If a nutritive sweetener(s) as well in which the applicant has its principal as nonnutritive sweetener(s) is added, place of business or to the United the statement shall indicate the pres- States Court of Appeals for the District ence of both types of sweetener; e.g., of Columbia Circuit. ‘‘Sweetened with nutritive sweetener(s) (ii) If the claim is approved, the and nonnutritive sweetener(s).’’ Agency shall notify the applicant, in (c) ‘‘Low calorie’’ foods. A product writing, and shall also publish in the purporting to be ‘‘low calorie’’ must FEDERAL REGISTER a notice informing comply with the criteria set forth for the public that the implied nutrient such foods in § 317.360.
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(d) ‘‘Reduced calorie’’ foods and other (i) A food product, for the purposes of comparative claims. A product purport- the small business exemption, is de- ing to be ‘‘reduced calorie’’ or other- fined as a formulation, not including wise containing fewer calories than a distinct flavors which do not signifi- reference food must comply with the cantly alter the nutritional profile, criteria set forth for such foods in sold in any size package in commerce. § 317.360(b) (4) and (5). (ii) For purposes of this paragraph, a (e) ‘‘Label terms suggesting usefulness small business is any single-plant facil- as low calorie or reduced calorie foods’’. ity or multi-plant company/firm that (1) Except as provided in paragraphs employs 500 or fewer people and pro- (e)(2) and (e)(3) of this section, a prod- duces no more than the following uct may be labeled with terms such as amounts of pounds of the product ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- qualifying the firm for exemption from ened,’’ or ‘‘sweetened with nonnutri- this subpart: tive sweetener’’ only if the claim is not (A) During the first year of imple- false or misleading, and the product is mentation of nutrition labeling, from labeled ‘‘low calorie’’ or ‘‘reduced cal- July 1994 to July 1995, 250,000 pounds or orie’’ or bears another comparative cal- less, orie claim in compliance with the ap- (B) During the second year of imple- plicable provisions in this subpart. mentation of nutrition labeling, from (2) Paragraph (e)(1) of this section July 1995 to July 1996, 175,000 pounds or shall not apply to any use of such less, and terms that is specifically authorized by (C) During the third year of imple- regulation governing a particular food, mentation and subsequent years there- or, unless otherwise restricted by regu- after, 100,000 pounds or less. lation, to any use of the term ‘‘diet’’ (iii) For purposes of this paragraph, that clearly shows that the product is calculation of the amount of pounds shall be based on the most recent 2- offered solely for a dietary use other year average of business activity. than regulating body weight, e.g., ‘‘for Where firms have been in business less low sodium diets.’’ than 2 years or where products have (3) Paragraph (e)(1) of this section been produced for less than 2 years, shall not apply to any use of such reasonable estimates must indicate terms on a formulated meal replace- that the annual pounds produced will ment or other product that is rep- not exceed the amounts specified. resented to be of special dietary use as (2) Products intended for further a whole meal, pending the issuance of a processing, provided that the labels for regulation governing the use of such these products bear no nutrition claim terms on foods. or nutrition information, (f) ‘‘Sugar free’’ and ‘‘no added sugar’’. (3) Products that are not for sale to Criteria for the use of the terms ‘‘sugar consumers, provided that the labels for free’’ and ‘‘no added sugar’’ are pro- these products bear no nutrition claims vided for in § 317.360(c). or nutrition information, [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (4) Products in small packages that 1993, as amended at 58 FR 47627, Sept. 10, are individually wrapped packages of 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. less than 1⁄2 ounce net weight, provided 3, 1995] that the labels for these products bear no nutrition claims or nutrition infor- §§ 317.381–317.399 [Reserved] mation, (5) Products custom slaughtered or § 317.400 Exemption from nutrition la- prepared, beling. (6) Products intended for export, and (a) The following meat or meat food (7) The following products prepared products are exempt from nutrition la- and served or sold at retail provided beling: that the labels or the labeling of these (1) Food products produced by small products bear no nutrition claims or businesses provided that the labels for nutrition information: these products bear no nutrition claims (i) Ready-to-eat products that are or nutrition information, packaged or portioned at a retail store
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or similar retail-type establishment; quired information shall be in a type and size no smaller than 6 point or all (ii) Multi-ingredient products (e.g., upper case type of 1⁄16-inch minimum sausage) processed at a retail store or height, except that individual serving- similar retail-type establishment. size packages of meat products that (b) Restaurant menus generally do have a total area available to bear la- not constitute labeling or fall within beling of 3 square inches or less may the scope of these regulations. provide all required information in a (c)(1) Foods represented to be specifi- type size no smaller than 1⁄32-inch mini- cally for infants and children less than mum height. 2 years of age shall bear nutrition la- [58 FR 664, Jan. 6, 1993, as amended at 58 FR beling as provided in paragraph (c)(2) of 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; this section, except such labeling shall 60 FR 196, Jan. 3, 1995] not include calories from fat, calories from saturated fat, saturated fat, ste- aric acid, polyunsaturated fat, PART 318—ENTRY INTO OFFICIAL monounsaturated fat, and cholesterol. ESTABLISHMENTS; REINSPECTION (2) Foods represented or purported to AND PREPARATION OF PROD- be specifically for infants and children UCTS less than 4 years of age shall bear nu- trition labeling except that: Subpart A—General (i) Such labeling shall not include declarations of percent of Daily Value Sec. 318.1 Products and other articles entering for total fat, saturated fat, cholesterol, official establishments. sodium, potassium, total carbohydrate, 318.2 Reinspection, retention, and disposal and dietary fiber; of meat and poultry products at official (ii) Nutrient names and quantitative establishments. amounts by weight shall be presented 318.3 Designation of places of receipt of in two separate columns; products and other articles for reinspec- (iii) The heading ‘‘Percent Daily tion. Value’’ required in § 317.309(d)(6) shall 318.4 Preparation of products to be offi- be placed immediately below the quan- cially supervised; responsibilities of offi- titative information by weight for pro- cial establishments; plant operated qual- ity control. tein; 318.5 Requirements concerning procedures. (iv) The percent of the Daily Value 318.6 Requirements concerning ingredients for protein, vitamins, and minerals and other articles used in preparation of shall be listed immediately below the products. heading ‘‘Percent Daily Value’’; and 318.7 Approval of substances for use in the (v) Such labeling shall not include preparation of products. the footnote specified in § 317.309(d)(9). 318.8 Preservatives and other substances (d)(1) Products in packages that have permitted in product for export only; a total surface area available to bear handling; such product not to be used for labeling of less than 12 square inches domestic food purposes. 318.9 Samples of products, water, dyes, are exempt from nutrition labeling, chemicals, etc., to be taken for examina- provided that the labeling for these tion. products bear no nutrition claims or 318.10 Prescribed treatment of pork and other nutrition information. The man- products containing pork to destroy ufacturer, packer, or distributor shall trichinae. provide, on the label of packages that 318.11 [Reserved] qualify for and use this exemption, an 318.12 Manufacture of dog food or similar address or telephone number that a uninspected article at official establish- consumer can use to obtain the re- ments. quired nutrition information (e.g., 318.13 Mixtures containing product but not amendable to the Act. ‘‘For nutrition information call 1–800– 318.14 Adulteration of product by polluted 123–4567’’). water; procedure for handling. (2) When such products bear nutri- 318.15 Tagging chemicals, preservatives, ce- tion labeling, either voluntarily or be- reals, spices, etc., ‘‘U.S. retained.’’ cause nutrition claims or other nutri- 318.16 Pesticide chemicals and other resi- tion information is provided, all re- dues in products.
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318.17 Requirements for the production of United States outside an official estab- cooked beef, roast beef, and cooked lishment, may enter any official estab- corned beef. lishment subject in other respects to 318.18 Handling of certain material for me- the same restrictions as apply to do- chanical processing. 318.19 Compliance procedure for cured pork mestic product. Products received in products. an official establishment during the 318.20 Use of animal drugs. Program employees absence shall be 318.21 Accreditation of chemistry labora- identified and maintained in a manner tories. acceptable to such employee. Product 318.22 Determination of added water in entering any official establishment cooked sausages. shall not be used or prepared thereat 318.23 Heat-processing procedures, cooking until it has been reinspected in accord- instructions, and cooling, handling, and storage requirements for uncured meat ance with § 318.2. Any product origi- patties. nally prepared at any official establish- 318.24 Compliance procedures for meat de- ment may not be returned into any rived from advanced meat/bone separa- part of such establishment, except the tion machinery and recovery systems. receiving area approved under § 318.3, until it has been reinspected by the in- Subparts B—F [Reserved] spector. (b) No slaughtered poultry or poultry Subpart G—Canning and Canned product shall be brought into an offi- Products cial establishment unless it has been 318.300 Definitions. (1) previously inspected and passed and 318.301 Containers and closures. is identified as such in accordance with 318.302 Thermal processing. the requirements of the Poultry Prod- 318.303 Critical factors and the application ucts Inspection Act (21 U.S.C. 451 et of the process schedule. seq.) and the regulations thereunder, 318.304 Operations in the thermal processing area. and has not been prepared other than 318.305 Equipment and procedures for heat in an establishment inspected under processing systems. said Act, or (2) has been inspected and 318.306 Processing and production records. passed and is identified as such in ac- 318.307 Record review and maintenance. cordance with the requirements of a 318.308 Deviations in processing. State law. 318.309 Finished product inspection. (c) Every article for use as an ingre- 318.310 Personnel and training. dient in the preparation of meat food 318.311 Recall procedure. products, when entering any official es- AUTHORITY: 7 U.S.C. 38f, 450, 1901–1906; 21 tablishment and at all times while it is U.S.C. 601–695; 7 CFR 2.18, 2.53. in such establishment, shall bear a label showing the name of the article, Subpart A—General the amount or percentage therein of any substances restricted by this part SOURCE: 35 FR 15586, Oct. 3, 1970, unless or part 317 of this subchapter, and a list otherwise noted. of ingredients in the article if com- posed of two or more ingredients: Pro- § 318.1 Products and other articles en- vided, That in the case of articles re- tering official establishments. ceived in tank car lots, only one such (a) Except as otherwise provided in label shall be used to identify each lot. paragraphs (g) and (h) of this section or In addition, the label must show the § 318.12, no product shall be brought name and address of the shipper. into an official establishment unless it (d) Containers of preparations which has been prepared only in an official es- enter any official establishment for use tablishment and previously inspected in hog scalding water or in denuding of and passed by a Program employee, tripe shall bear labels showing the and is identified by an official inspec- chemical names of the preparations. In tion legend as so inspected and passed. the case of any preparation containing Notwithstanding the foregoing provi- any of the chemicals which are specifi- sions of this subparagraph, product im- cally limited by § 318.7(c)(4) as to ported in accordance with part 327 of amount permitted to be used, the la- this subchapter and not prepared in the bels on the containers must also show
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the percentage of each such chemical State not designated in § 331.2 of this in the preparation and must provide di- subchapter may be received by official lution directions which prescribe the establishments for storage and dis- maximum allowable use concentration tribution solely in intrastate com- of the preparations. merce. The presence of such State in- (e) Dyes, chemicals, or other sub- spected products must not create any stances the use of which is restricted unsanitary condition or otherwise re- to certain products may be brought sult in adulteration of any products at into or kept in an official establish- the official establishment or interfere ment only if such products are pre- with the conduct of inspection under pared thereat. No prohibited dye, this subchapter. In addition, such chemical, preservative, or other sub- State inspected products must be stance shall be brought into or kept in stored separately and apart from the an official establishment. federally inspected products in the offi- (f) [Reserved] cial establishment. (g) Glands and organs, such as (i) The operator of the official estab- cotyledons, ovaries, prostate glands, lishment shall furnish such informa- tonsils, spinal cords, and detached lym- tion as is necessary to determine the phatic, pineal, pituitary, parathyroid, origin of any product or other article suprarenal, pancreatic and thyroid entering the official establishment. glands, used in preparing pharma- Such information shall include, but is ceutical, organotherapeutic, or tech- not limited to, the name and address of nical products and which are not used the seller or supplier, transportation as human food (whether or not pre- company, agent, or broker involved in pared at official establishments) may the sale or delivery of the product or be brought into and stored in edible article in question. product departments of inspected es- (j) Any product or any poultry or tablishments if packaged in suitable poultry product or other article that is containers so that the presence of such brought into an official establishment glands and organ will in no way inter- contrary to any provision of this sec- fere with the maintenance of sanitary tion may be required by the Adminis- conditions or constitute an inter- trator to be removed immediately from ference with inspection. Glands or or- such establishment by the operator gans which are regarded as human food thereof, and failure to comply with products, such as livers, testicles, and such requirement shall be deemed a thymus glands, may be brought into of- violation of this regulation. If any ficial establishments for pharma- slaughtered poultry or poultry prod- ceutical, organotherapeutic or tech- ucts or other articles are received at an nical purposes, only if U.S. inspected official establishment and are sus- and passed and so identified. Lungs and pected of being adulterated or mis- lung lobes derived from livestock branded under the Poultry Products In- slaughtered in any establishment may spection Act or the Federal Food, not be brought into any official estab- Drug, and Cosmetic Act, or applicable lishment except as provided in State laws, the appropriate govern- § 318.12(a). mental authorities will be notified. (h)(1) Carcasses of game animals, and [35 FR 15586, Oct. 3, 1970, as amended at 36 FR carcasses derived from the slaughter by 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; any person of livestock of his own rais- 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, ing in accordance with the exemption 1984] provisions of paragraph 23(a) of the Act, and parts of such carcasses, may § 318.2 Reinspection, retention, and be brought into an official establish- disposal of meat and poultry prod- ment for preparation, packaging, and ucts at official establishments. storing in accordance with the provi- (a) All products and all slaughtered sions of § 303.1(a)(2) of this subchapter. poultry and poultry products brought (2) Meat, meat byproducts, and meat into any official establishment shall be food products bearing official marks identified by the operator of the offi- showing that they were inspected and cial establishment at the time of re- passed under State inspection in any ceipt at the official establishment and
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shall be subject to reinspection by a be deferred if a product has become Program employee at the official es- soiled or unclean by falling on the floor tablishment in such manner and at or in any other accidental way or if the such times as may be deemed necessary product is affected with any other con- to assure compliance with the regula- dition which the inspector deems capa- tions in this subchapter. ble of correction, in which case the (b) All products, whether fresh, product shall be cleaned (including cured, or otherwise prepared, even trimming if necessary) or otherwise though previously inspected and handled in a manner approved by the passed, shall be reinspected by Pro- inspector to assure that it will not be gram employees as often as they may adulterated or misbranded and shall deem necessary in order to ascertain then be presented for reinspection and that they are not adulterated or mis- disposal in accordance with this sec- branded at the time they enter or leave tion. If upon final inspection, the prod- official establishments and that the re- uct is found to be neither adulterated quirements of the regulations in this nor misbranded, the inspector shall re- subchapter are complied with. move the U.S. retained tag. If a prod- (c) Reinspection may be accom- uct is found upon reinspection to be plished through use of statistically misbranded, it shall be held under a sound sampling plans that assure a U.S. retained tag, or a U.S. detention high level of confidence. The circuit su- tag as provided in part 329 of this sub- pervisor shall designate the type of chapter, pending correction of the mis- plan and the program employee shall branding or issuance of an order under select the specific plan to be used in section 7 of the Act to withhold from accordance with instructions issued by use the labeling or container of the the Administrator. 1 (d) A U.S. retained tag shall be product, or the institution of a judicial placed by a Program employee at the seizure action under section 403 of Act time of reinspection at any official es- or other appropriate action. The in- tablishment on all products which are spector shall make a complete record suspected on such reinspection of being of each transaction under this para- adulterated or misbranded, and such graph and shall report his action to the products shall be held for further in- area supervisor. spection. Such tags shall be removed [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, only by authorized Program employ- 1971] ees. When further inspection is made, if the product is found to be adulterated, § 318.3 Designation of places of receipt all official inspection legends or other of products and other articles for official marks for which the product is reinspection. found to be ineligible under the regula- Every official establishment shall tions in this subchapter, shall be re- designate, with the approval of the cir- moved or defaced and the product will cuit supervisor, a dock or place at be subject to condemnation and dis- which products and other articles sub- posal in accordance with part 314 of ject to reinspection under § 318.2 shall this subchapter, except that a deter- be received, and such products and ar- mination regarding adulteration may ticles shall be received only at such dock or place. 1 Further information concerning sampling plans which have been adopted for specific § 318.4 Preparation of products to be products may be obtained from the Circuit officially supervised; responsibil- Supervisors of Program circuits. These sam- ities of official establishments; pling plans are developed for individual prod- plant operated quality control. ucts by the Washington staff and will be dis- tributed for field use as they are developed. (a) All processes used in curing, pick- The type of plan applicable depends on fac- ling, rendering, canning, or otherwise tors such as whether the product is in con- preparing any product in official estab- tainers, stage of preparation, and procedures followed by the establishment operator. The lishments shall be supervised by Pro- specific plan applicable depends on the kind gram employees unless such prepara- of product involved, such as liver, oxtails, tion is conducted as a custom oper- etc. ation exempted from inspection under
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§ 303.1(a)(2) of this subchapter in any of- adhere to the requirements of the sys- ficial establishment or consists of oper- tem as approved by the Department; ations that are exempted from inspec- that all the establishment’s data, anal- tion under § 303.1(d) of this subchapter yses, and information generated by its and are conducted in a retail store in quality control system will be main- an establishment subject to inspection tained to enable the Department to only because the State or Territory in monitor compliance and available to which the establishment is located is Department personnel; that plant qual- designated under paragraph 301(c) of ity control personnel will have author- the Act. No fixtures or appliances, such ity to halt production or shipping of as tables, trucks, trays, tanks, vats, product in cases where the submitted machines, implements, cans, or con- quality control system requires it; and tainers of any kind, shall be used un- that the owner or operator (or his/her less they are of such materials and con- designee) will be available for consulta- struction as will not contaminate or tion at any time Department personnel otherwise adulterate the product and consider it necessary. are clean and sanitary. All steps in the (2) In the case of an establishment preparation of edible products shall be having one or more full-time persons conducted carefully and with strict whose primary duties are related to the cleanliness in rooms or compartments quality control system, an organiza- separate from those used for inedible tional chart showing that such people products. ultimately report to an establishment (b) It shall be the responsibility of official whose quality control respon- the operator of every official establish- sibilities are independent of or not pre- ment to comply with the Act and the dominantly production responsibil- regulations in this subchapter. In order ities. In the case of an establishment to carry out this responsibility effec- which does not have full-time quality tively, the operator of the establish- control personnel, information indicat- ment shall institute appropriate meas- ing the nature of the duties and respon- ures to assure the maintenance of the sibilities of the person who will be re- establishment and the preparation, sponsible for the quality control sys- marking, labeling, packaging and other tem. handling of its products strictly in ac- (3) A list identifying those parts and cordance with the sanitary and other sections of the Federal meat inspection requirements of this subchapter. The regulations which are applicable to the effectiveness of such measures will be operations of the establishment apply- subject to review by the Department. ing for approval of a quality control (c) Applying for Total Plant Quality system. This list shall also identify Control. Any owner or operator of an which part of the quality control sys- official establishment preparing meat tem will serve to maintain compliance food product who has a total plant with the applicable regulations. quality control system or plan for con- (4) Detailed information concerning trolling such product, after ante- the manner in which the system will mortem and post-mortem inspection, function. Such information should in- through all stages of preparation, may clude, but not necessarily be limited request the Administrator to evaluate to, questions of raw material control, it to determine whether or not that the critical check or control points, system is adequate to result in product the nature and frequency of tests to be being in compliance with the require- made, the nature of charts and other ments of the Act and therefore qualify records that will be used, the length of as a U.S. Department of Agriculture time such charts and records will be (USDA) Total Plant Quality Control maintained in the custody of the offi- Establishment. Such a request shall, as cial establishment, the nature of defi- a minimum, include: ciencies the quality control system is (1) A letter to the Administrator designed to identify and control, the from the establishment owner of opera- parameters or limits which will be tor stating the company’s basis and used, and the points at which correc- purpose for seeking an approved qual- tive action will occur and the nature of ity control system and willingness to such corrective action—ranging from
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least to most severe: Provided, That, on the basis of the evaluation, that the subsequent to approval of the total total quality control system will result plant quality control system by the in finished products controlled in this Administrator, the official establish- manner being in full compliance with ment may produce a new product for the requirements of the Act and regu- test marketing provided labeling for lations thereunder, the total quality the product has been approved by the control system will be approved and Administrator, the inspector in charge plans will be made for implementation has determined that the procedures for under departmental supervision. preparing the product will assure that (2) In any situation where the system all Federal requirements are met, and is found by the Administrator to be un- the production for test marketing does acceptable, formal notification shall be not exceed 6 months. Such new product shall not be produced at that establish- given to the applicant of the basis for ment after the 6-month period unless the denial. The applicant will be af- approval of the quality control system forded an opportunity to modify the for that product has been received from system in accordance with the notifica- the Administrator. tion. The applicant shall also be af- (d) Partial Quality Control Programs. forded an opportunity to submit a writ- (1) Any owner or operator of an official ten statement in response to this noti- establishment preparing meat food fication of denial and a right to request products who is required to have a a hearing with respect to the merits or quality control program for a product validity of the denial. If the applicant operation, or part of an operation shall requests a hearing and the Adminis- make the written program and data trator, after review of the answer, de- and information generated by the pro- termines the initial determination to gram available to Program employees. be correct, he shall file with the Hear- (2)(i) This quality control program ing Clerk of the Department the notifi- shall include, as appropriate for the op- cation, answer and the request for eration which the program concerns, hearing, which shall constitute the detailed information on: raw material complaint and answer in the proceed- control, the critical check or control ing, which shall thereafter be con- points, the nature and frequency of ducted in accordance with Rules of tests to be made, the charts and Practice which shall be adopted for records that will be used, the length of this proceeding. time such charts and records will be (3) The establishment owner or oper- maintained in the custody of the offi- ator shall be responsible for the effec- cial establishment, the limits that will tive operation of the approved total be used and the points at which correc- plant quality control system to assure tive action will be taken to prevent re- compliance with the requirements of currence of a loss of control, and the the Act and regulations thereunder. nature of the corrective action—rang- ing from the least to the most severe. The Secretary shall continue to pro- vide the Federal inspection necessary (ii) This quality control program shall ensure that the product, oper- to carry out his responsibilities under ation, or part of an operation which it the Act. concerns is in control and that applica- (f) Labeling Logo. Owners and opera- ble product or label limits are being tors of official establishments having a met. Process control is to be deter- total plant quality control system ap- mined by generally recognized statis- proved under the provisions of para- tical process control procedures. graph (c) of this section, may only use, (e) Evaluation and Approval of Total as a part of any labeling, the following Plant Quality Control. (1) The Adminis- logo. Any labeling bearing the logo and trator shall evaluate the material pre- any wording of explanation with re- sented in accordance with the provi- spect to this logo shall be approved as sions of paragraph (c) of this section. If required by parts 316 and 317 of this it is determined by the Administrator, subchapter.
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there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total establish- ment quality control system has been terminated in accordance with the pro- visions of this section, an application and request for approval of the same or a modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date. (h)(1) Operating Schedule Under Total (g) Termination of Total Plant Quality Plant Quality Control. An official estab- Control. (1) The approval of a total lishment with an approved total plant plant quality control system may be quality control system may request ap- terminated at any time by the owner proval for an operating schedule of up or operator of the official establish- to 12 consecutive hours per shift. Per- ment upon written notice to the Ad- mission will be granted provided that: ministrator. (i) The official establishment has sat- (2) The approval of a total plant qual- isfactorily operated under a total plant ity control system may be terminated quality control system for at least 1 upon the establishment’s receipt of a year. written notice from the Administrator (ii) All products prepared and pack- under the following conditions: aged, or processed after the end of 8 (i) If adulterated or misbranded meat hours of inspection shall only be a con- food product is found by the Adminis- tinuation of the processing monitored trator to have been prepared for or dis- by the inspector and being conducted tributed in commerce by the subject during the last hour of inspection. establishment. In such case, oppor- (iii) All immediate containers of tunity will be provided to the estab- products prepared and packaged shall lishment owner or operator to present bear code marks that are unique to any views to the Administrator within 30 period of production beyond the 8 hours days of the date of terminating the ap- of inspection. The form of such code proval. In those instances where there is conflict of facts, a hearing, under ap- marks will remain constant from day plicable Rules of Practice, will be pro- to day, and a facsimile of the code vided to the establishment owner or marks and their meaning shall be pro- operator to resolve the conflict. The vided to the inspector. Administrator’s termination of ap- (2) Application. Applications shall be proval shall remain in effect pending submitted to the Regional Director and the final determination of the proceed- shall specify how the conditions in ing. § 318.4(h)(1) have been or will be met. (ii) If the establishment fails to com- (3) Monitoring by Inspectors. In order ply with the quality control system or to verify that an establishment is pre- program to which it has agreed after paring and shipping product in accord- being notified by letter from the Ad- ance with the approved total plant ministrator or his designee. Prior to quality control system and the Act and such termination, opportunity will be regulations after the 8 hours of inspec- provided to the establishment owner or tion, the official establishment may be operator to present views to the Ad- provided overtime inspection services ministrator within 30 days of the date at the discretion of the circuit super- of the letter. In those instances where visor and charged for such services.
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(Reporting requirements were approved by (g) Clotted blood shall be removed the Office of Management and Budget under from hog hearts before they are control number 0583–0015) shipped from the official establishment [35 FR 15586, Oct. 3, 1970, as amended at 36 FR or used in the preparation of meat food 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; products. 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. (h) Beef rounds, beef bungs, beef 25, 1997; 62 FR 54759, Oct. 22, 1997] middles, beef bladders, calf rounds, hog § 318.5 Requirements concerning pro- bungs, hog middles, and hog stomachs cedures. which are to be used as containers of (a)(1) Care shall be taken to assure any meat food product shall be pre- that product is not adulterated when sented for inspection, turned with the placed in freezers. If there is doubt as fat surface exposed. to the soundness of any frozen product, (i) Portions of casings which show in- the inspector will require the defrost- fection with Oesophagostomum or ing and reinspection of a sufficient other nodule-producing parasite, and quantity thereof to determine its ac- weasands infected with the larvae of tual condition. Hypoderma lineatum, shall be rejected, (2) Frozen product may be defrosted except that when the infestation is in water or pickle in a manner and slight and the nodules and larvae are with the use of facilities which are ac- removed, the casing or weasand may be ceptable to the inspector. Before such passed. product is defrosted, a careful exam- [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, ination shall be made to determine its 1971] condition. If necessary, this examina- tion shall include defrosting of rep- § 318.6 Requirements concerning in- resentative samples by means other gredients and other articles used in than in water or pickle. preparation of products. (b) Product, such as pork tenderloins, (a) All ingredients and other articles brains, sweetbreads, stew, or chop used in the preparation of any product suey, shall not be packed in hermeti- shall be clean, sound, healthful, whole- cally sealed metal or glass containers, some, and otherwise such as will not unless subsequently heat processed or otherwise treated to preserve the prod- result in the product being adulterated. uct in a manner approved by the Ad- Official establishments shall furnish ministrator in specific cases. inspectors accurate information on all (c) Care shall be taken to remove procedures involved in product prepa- bones and parts of bones from product ration including product composition which is intended for chopping. and any changes in such procedures es- (d) Heads for use in the preparation sential for inspectional control of the of meat food products shall be split and product. the bodies of the teeth, the turbinated (b)(1) The only animal casings that and ethmoid bones, ear tubes, and horn may be used as containers of product butts removed, and the heads then are those from cattle, sheep, swine, or thoroughly cleaned. goats. (e) Kidneys for use in the preparation (2) Casings for products shall be care- of meat food products shall first be fully inspected by Program employees. freely sectioned and then thoroughly Only those casings which have been soaked and washed. All detached kid- carefully washed and thoroughly neys, including beef kidneys with de- flushed with clean water immediately tached kidney fat, shall be inspected before stuffing and are suitable for con- before being used in or shipped from tainers, are clean, and are passed on the official establishment. such inspection shall be used, except (f) Cattle paunches and hog stomachs that preflushed animal casings packed for use in the preparation of meat food in salt or salt and glycerine solution or products shall be thoroughly cleaned other approved medium may be used on all surfaces and parts immediately without additional flushing provided after being emptied of their contents, they are found to be clean and other- which shall follow promptly their re- wise acceptable and are thoroughly moval from the carcasses. rinsed before use.
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(3) Hog and sheep casings intended (other than shell eggs) which have not for use as containers of product may be been so inspected and passed for whole- treated by soaking in or applying someness shall not be used in the prep- thereto sound, fresh pineapple juice or aration of such meat food products. papain or bromelin or pancreatic ex- (10) Dry milk products which are in- tract to permit the enzymes contained tended for use as ingredients of meat in these substances to act on the cas- food products shall be considered ac- ings to make them less resistant. The ceptable for such use only when pro- casings shall be handled in a clean and duced in a plant approved by the De- sanitary manner throughout and the partment under the regulations in 7 treatment shall be followed by washing CFR part 58, and when found to be and flushing the casings with water sound and otherwise acceptable when sufficiently to effectively remove the presented for use. Dry milk products substance used and terminate the enzy- prepared in a plant not so approved matic action. shall not be used in the preparation of (4) On account of the invariable pres- such meat food products. ence of bone splinters, detached spinal (11) [Reserved] cords shall not be used in the prepara- (12) Ingredients for use in any prod- tion of edible product other than for uct may not bear or contain any pes- rendering where they constitute a suit- ticide chemical or other residues in ex- able raw material. cess of level permitted in § 318.16. (5) Testicles if handled as an edible (13) Use of ‘‘Mechanically Separated product may be shipped from the offi- (Kind of Poultry),’’ as defined in cial establishment as such, but they § 381.173 of this chapter, in the prepara- shall not be used as an ingredient of a tion of meat food products shall accord meat food product. with § 381.174 and all other applicable (6) Tonsils shall be removed and shall provisions of this subchapter. not be used as ingredients of meat food products. [35 FR 15586, Oct. 3, 1970, as amended at 38 FR (7) Blood from livestock prepared in 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; accordance with § 310.20 of this sub- 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, chapter may be used as an ingredient 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, Nov. 3, 1995] of a meat food product for which a standard is prescribed in part 319 of § 318.7 Approval of substances for use this subchapter, if permitted by such in the preparation of products. standard, and may be used in any meat food product for which no such stand- (a)(1) No substance may be used in ard is prescribed in part 319 of this sub- the preparation of any product unless chapter if it is a common and usual in- it is approved in paragraph (c)(4) of this gredient of such product. section or elsewhere in part 318 or in (8) Intestines shall not be used as in- part 319 of this subchapter, or by the gredients in any meat food product for Administrator in specific cases. which a standard is prescribed in part (2) Approval of new substances or 319 of this subchapter and shall not be new uses or new levels of use of ap- used in other products unless the prod- proved substances may be granted by ucts are labeled in accordance with the Administrator if: § 317.8(b)(3) of this subchapter. (i) The substance has been previously (9) Poultry products and egg products approved by the Food and Drug Admin- (other than shell eggs) which are in- istration (FDA) for use in meat or tended for use as ingredients of meat meat food products as a food additive, food products shall be considered ac- color additive, or as a substance gen- ceptable for such use only when identi- erally recognized as safe and is listed fied as having been inspected and in title 21 of the Code of Federal Regu- passed for wholesomeness by the De- lations, parts 73, 74, 81, 172, 173, 179, 182 partment under the regulations in 7 or 184. CFR part 59 or 9 CFR part 362 or 381 (ii) Its use is in compliance with ap- and when found to be sound and other- plicable FDA requirements; and wise acceptable when presented for use. (iii) The Administrator has deter- Poultry products and egg products mined that:
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(A) The use of the substance will not spectrometry before being considered render the product in which it is used positive. If, during the interval re- adulterated or misbranded or otherwise quired for the Department to analyze not in compliance with the require- the confirmatory samples by gas ments of the Act; and chromotography and mass spectrom- (B) Its use is functional and suitable etry, changes are made in processing for the product and it is permitted for procedures which are expected to result use at the lowest level necessary to ac- in no confirmable levels of complish the stated technical effect as nitrosamines in pumped bacon pro- determined in specific cases. duced by these new procedures, an es- (3) Whenever the Administrator de- tablishment may submit samples to termines that approval of a new sub- USDA for analysis upon prior notifica- stance or new use or new level of use of tion and arrangements with USDA. If, an approved substance should be grant- however, an establishment furnishes ed in accordance with paragraph (a)(2) USDA with laboratory results from of this section, the Administrator shall testing five consecutive lots of pumped issue a final rule amending the chart of bacon produced under the new proce- substances in paragraph (c)(4) of this dures and the testing is performed by section to include the additional sub- the USDA methodology and proce- stance or new use of the substance, and dures, those results will be utilized in any technical effect or change in level making the determination concerning of use of the substance. the product produced under the new (4) No product shall bear or contain procedures. Should the results of these any substance which would render it tests reveal that confirmable levels of adulterated or misbranded, or which is nitorosamines are not indicated in any not approved in part 318 or part 319 of of the five consecutive lots, the con- this subchapter, or by the Adminis- firmation analysis by USDA shall be trator in specific cases. terminated and the establishment shall (b) Requirements for the use of ni- revert to normal monitoring status. In trite and sodium ascorbate or sodium the event the test results continue to erythorbate (isoascorbate) in bacon. indicate nitrosamines, however, USDA Nitrates shall not be used in curing shall proceed in its confirmation anal- bacon. ysis on the original samples taken for (1) Pumped bacon. With respect to confirmation. If any one of the original bacon injected with curing ingredients samples collected by USDA for con- and massaged bacon: sodium nitrite firmation if found to contain confirm- shall be used at 120 parts per million able levels of nitrosamines, all pumped (PPM) ingoing or an equivalent bacon in the producing establishment amount of potassium nitrite shall be and all future production will be re- used (148 PPM ingoing); and 550 PPM of tained. The Department shall sample sodium ascorbate or sodium and analyze such retained pumped erythorbate (isoascorbate) shall be bacon for nitrosamines on a lot by lot used. Sodium ascorbate or sodium basis. A production lot shall be that erythorbate have a molecular weight of pumped bacon produced by the estab- approximately 198. Hydrated forms of lishment in any single shift. Samples these substances shall be adjusted to from any lot of pumped bacon under re- attain the equivalent of 550 PPM of so- tention found to contain nitrosamines dium ascorbate or sodium erythorbate. at a confirmable level shall cause the (2) The Department shall collect lot of pumped bacon to be disposed of samples of pumped bacon from produc- in a manner to assure it will not form ing plants and analyze them for the nitrosamines when cooked. Such dis- level of nitrosamines by the Thermal posal may include incorporation of the Energy Analyzer (TEA). In the event uncooked pumped bacon as an ingredi- that a TEA analysis indicates that a ent of another meat food product pro- confirmable level of nitrosamines vided it is processed for eating without might be present, additional samples further preparation in a manner to pre- shall be collected and analyzed by gas clude the formation of nitrosamines. chromatography. Presumptive positive Bacon subsequently produced shall not results must be confirmed by mass be retained because of nitrosamines if
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the operator of the establishment (4) The Department shall collect makesadjustments in the processing of samples of bacon from plants producing the product and laboratory results ob- under paragraph (b)(3) of this section tained by TEA analysis of samples and analyze them for the level of from five consecutive normal sized lots nitrosamines. Samples shall be ran- of pumped bacon indicates that the domly selected throughout the produc- product being produced contains no tion of a lot. The actual sampling plans confirmable levels of nitrosamines. and methods of analysis that are used These tests from five consecutive nor- will result in approximately the same mal sized lots of pumped bacon shall be likelihood as under paragraph (b)(2) of conducted by the Department: Pro- this section of having a presumptive vided, however, That if the establish- positive result when the true mean ment furnishes the Department with level of nitrosamines in a production the results of tests conducted under lot is 10 ppb. In the event of a presump- the methodology and procedures used tive positive result, the plant shall be- by the Department, such test results come subject to the provisions of para- will be utilized in making the deter- graph (b)(2) of this section. mination concerning the nitrosamine (5) Immersion cured bacon. Immersion content of the product. All tests of cured bacon may be placed in a brine pumped bacon for nitrosamines under solution containing salt, nitrite and this subparagraph shall be made on flavoring material or in a container pumped bacon cooked 340 °F. for 3 min- with salt, nitrite and flavoring mate- utes on each side. In order to deter- rial. Sodium nitrite shall not exceed mine that no confirmable levels of 120 ppm ingoing or an equivalent nitrosamines are present in a sample amount of potassium nitrite (148 ppm tested, the testing must be performed ingoing) based on the actual or esti- by methodology and procedures that mated skin-free green weight of the would detect the presence of any bacon bellies. nitrosamines at 10 PPB. (6) Bacon made with dry curing mate- (3) Notwithstanding the provisions of rials. With respect to bacon made with paragraph (b)(1) of this section, sodium dry curing materials, the product shall nitrite may be used at: be cured by applying a premeasured (i) 100 ppm ingoing (potassium nitrite amount of cure mixture to the bacon at 123 ppm ingoing); and 500 ppm so- belly surfaces, completely covering the dium ascorbate or sodium erythorbate surfaces. Sodium nitrite shall not ex- (isoascorbate) shall be used; provided ceed 200 ppm ingoing or an equivalent that the establishment has a partial amount of potassium nitrite (246 ppm quality control program as provided in ingoing) in dry cured bacon based on § 318.4(d) that results in compliance the actual or estimated skin-free green with this provision, or weight of the bacon belly. (ii) A predetermined level between 40 (c) Under appropriate declaration as and 80 ppm (potassium nitrite at a required in parts 316 and 317 of this sub- level between 49 and 99 ppm); 550 ppm chapter, the following substances may sodium ascorbate or sodium be added to products: erythorbate (isoascorbate); and addi- (1) Common salt, approved sugars tional sucrose or other similar fer- (sucrose, cane or beet sugar), maple mentable carbohydrate at a minimum sugar, dextrose, invert sugar, honey, of 0.7 percent and an inoculum of lactic corn syrup solids, (corn syrup, glucose acid producing bacteria such as syrup and fructose), wood smoke, vin- Pediococcus acetolactii or other bacteria egar, flavorings, spices, sodium nitrate, demonstrated to be equally effective in sodium nitrite, potassium nitrate, po- preventing the growth of botulinum tassium nitrite, and other substances toxin at a level sufficient for the pur- specified in the chart in paragraph pose of preventing the growth of botu- (c)(4) of this section may be added to linum toxin; provided that the estab- products under conditions, if any, spec- lishment has a partial quality control ified in this part or in part 317 of this program as provided in § 318.4(d) that subchapter. results in compliance with this provi- (2) Other harmless artificial sion. flavorings may be added to products
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with the approval of the Administrator (4) The substances specified in the in specific cases. following chart are acceptable for use (3) Coloring matter and dyes other in the preparation of products, pro- than those specified in the chart in vided they are used for the purposes in- paragraph (c)(4) of this section may be dicated, within the limits of the applied to products, mixed with ren- amounts stated and under other condi- dered fat, applied to natural and artifi- tions specified in this part and part 317 cial casings, and applied to such cas- of this subchapter. In addition to the ings enclosing products, if approved by substances listed in the following the Administrator in specific cases. chart, part 319 of this subchapter speci- When any coloring matter or dye is ap- fies other substances that are accept- plied to casings, there shall be no pene- tration of coloring into the product. able in preparing specified products.
Class of substance Substance Purpose Products Amount
Acidifiers ...... Acetic acid ...... To adjust acidity ...... Various 2 ...... Sufficient for purpose.3 Citric acid ...... do ...... do ...... Do. Glucono delta-lactone ...... do ...... do ...... Do. Lactic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Tartaric acid ...... do ...... do ...... Do. Anti-coagulants ...... Citric acid ...... To prevent clotting .... Fresh blood of live- 0.2 percent with or without stock. water. When Water is used to make a solution of citric acid added to blood of live- stock, not more than 2 parts of water to 1 part of citric acid shall be used. Sodium citrate ...... do...... do...... Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to blood of livestock, not more than 2 parts of water to 1 part of sodium citrate shall be used. Antifoaming agent .. Methyl polysilicone ...... To retard foaming ...... Soups ...... 10 parts per million. Rendered fats ...... Do. Curing pickle ...... 50 parts per million.
Antioxidants and BHA (butylated hydroxy- To retard rancidity ..... Dry sausage ...... 0.003 percent .006 percent oxygen intercep- anisole). based on in com- tors. total weight. bination. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.006 percent butylhydroquinone). in com- bination only with BHA and/or BHT. BHA (butylated hydroxy- ...... do ...... Rendered animal fat 0.01 percent 0.02 percent anisole). or a combination of in com- such fat and vege- bination. table fat. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Glycine ...... do ...... do ...... do ...... Propyl gallate ...... do ...... do ...... do ...... Resin guaiac ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in com- bination only with BHA and/or BHT.
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Tocopherols ...... do ...... do ...... 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as ``lard'' or ``rendered pork fat.'' ...... do ...... Dry sausage, semidry Not to exceed 0.03 percent sausage, dried based on fat content. Not meats, uncooked or used in combination with cooked fresh sau- other antioxidants. sage made with beef and/or pork, uncooked or cooked Italian sau- sage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausage, pregrilled beef pat- ties, and restruc- tured meats.
BHA (butylated hydroxy- ...... do ...... Fresh pork, sausage, 0.01 percent 0.02 percent anisole). brown and serve based on in com- sausages, fresh fat content. bination Italian sausage based on products, pregrilled fat content. beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in com- bination only with BHA and/or BHT based on fat con- tent. BHA (butylated hydroxy- ...... do ...... Dried meats ...... 0.01 percent 0.01 percent anisole). based on in com- total weight. bination. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.01 percent butylhydroquinone). in com- bination only with BHA and/or BHT.
BHA (butylated hydroxy- ...... do ...... Margarine or oleo- 0.02 percent (by wt. of the anisole). margarine. finished product) individ- ually or in combination with other antioxidants approved for use in margarine. BHT (butylated ...... do ...... do ...... Do. hydroxytol-) uene). Octyl gallate ...... do ...... do ...... Do. Propyl gallate ...... do ...... do ...... Do. Dodecyl gallate ...... do ...... do ...... Do. Ascorbyl palmitate ...... do ...... do ...... Do. 245
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Ascorbyl stearate ...... do ...... do ...... Do. TBHQ (tertiary ...... do ...... do ...... 0.02 percent alone or in com- butylhydroqui- bination only with BHA and/ none). or BHT based on fat or oil content.
Class of substance Substance Purpose Products Amount
Binders and ex- Agar-agar ...... To stabilize and thick- Thermally processed 0.25 percent of finished prod- tenders. en. canned jellied meat uct. food products Algin ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. A mixture of sodium al- To bind meat pieces Restructured meat Sodium alginate not to ex- ginate, calcium car- food products. ceed 1.0 percent; calcium bonate and calcium carbonate not to exceed lactate/lactic acid (or 0.2 percent; and lactic acid/ glucono delta-lactone) calcium lactate (or glucono delta-lactone) not to ex- ceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 per- cent of product at formula- tion. Ingredients of mixture must be added dry. Bread ...... To bind and extend Bockwurst ...... 3.5 percent individually or col- product. lectively with other binders. Calcium reduced dried ...... do ...... Sausages as provided Do. skim milk. in part 319...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders. spaghetti with meat and sauce and similar products Carrageenan ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. Carboxymethyl cellulose ...... do ...... Baked pies ...... Do. (cellulose gum) Cereal ...... To bind and extend Sausages as provided 3.5 percent individually or col- product. in part 319, lectively with other binders. bockwurst ...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans Dried milk ...... do ...... Sausage as provided 3.5 percent individually or col- in part 319. lectively with other binders...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans Enzyme (rennet) treated To bind and extend Sausages as provided 3.5 percent total finished calcium reduced dried product. in part 319. product. (Calcium lactate skim milk and calcium required at rate of 10 per- lactate cent of binder)...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5 (Calcium lactate re- quired at rate of 10 percent of binder). Enzyme (rennet) treated ...... do ...... Imitation sausages, Sufficient for purpose in ac- sodium caseinate and nonspecific loaves, cordance with 21 CFR calcium lactate soups, stews 172.5. (Calcium lactate re- quired at rate of 25 percent of binder). Gums, vegetable ...... do ...... Egg roll ...... Sufficient for purpose in ac- cordance with 21 CFR 172.5.
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Class of substance Substance Purpose Products Amount
Methyl cellulose ...... To extend and to sta- Meat and vegetable 0.15 percent. bilize product (also patties. carrier) Isolated soy protein ...... To bind and extend Sausage as provided 2 percent. product. in Part 319, bockwurst ...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans ...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Sodium caseinate ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 182.1748 and 21 CFR 172.5...... do ...... do ...... Sausage as provided 2 percent in accordance with in Part 319.. 21 CFR 182.1748...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders in accord- ance with 21 CFR 182.1748...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders in accord- and sauce and ance with 21 CFR similar products 182.1748. Dry or dried whey ...... To bind or thicken ..... Sausage as provided 3.5 percent individually or col- in Part 319, lectively with other binders bockwurst and extenders. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans, pork or beef and extenders. with barbecue sauce Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c...... do ...... To bind meat pieces Restructured meat 3.5 percent individually or col- food products, lectively with other binders whole muscle meat and extenders. In accord- cuts ance with 21 CFR 184.1979c. Soy flour ...... To bind and extend Sausage as provided 3.5 percent individually or col- product. in Part 319, lectively with other binders bockwurst and extenders. Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders.
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Class of substance Substance Purpose Products Amount
Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Soy protein concentrate ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Xanthan gum ...... To maintain uniform Meat sauces, gravies Sufficient for purpose in ac- viscosity; suspen- or sauces and cordance with 21 CFR sion of particulate meats, canned or 172.5. matter, emulsion frozen and/or refrig- stability; freeze- erated meat salads, thaw stability. canned or frozen meat stews, canned chili or chili with beans, pizza top- ping mixes and bat- ter or breading mixes. Carrageenan ...... To prevent purging of Cured pork products Not to exceed 1.5 percent of brine solution. as provided in 9 product formulation; not CFR 319.104. permitted in combination with other binders ap- proved for use in cured pork products; in accord- ance with 21 CFR 172.620, 172.623, and 172.626. Food starch modified ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders ap- proved for use in cured pork products; in accord- ance with 21 CFR 172.892. Sodium caseinate ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders ap- proved for use in cured pork products; in accord- ance with 21 CFR 182.1748. Isolated soy protein ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders ap- proved for use in cured pork products. Carrageenan, Locust To prevent purging of Cured pork products In combination, not to exceed bean gum, and Xan- solution.. as provided in 9 0.5 percent of product for- than gum blend.. CFR 319.104(d).. mulation; not permitted in combination with other binders approved for use in cured pork products; in ac- cordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695. Bleaching agent ..... Hydrogen peroxide ...... To remove color ...... Tripe (substance must be removed from product by rinsing with clear water).
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Class of substance Substance Purpose Products Amount
Catalysts (sub- Nickel ...... To accelerate chemi- Rendered animal fats Do. stances must be cal reaction. or a combination of eliminated during such fats and vege- process). table fats. Sodium amide ...... Rearrangement of ...... do ...... Do. fatty acid radicals. Sodium methoxide ...... do ...... do ...... Do. Coloring agents Alkanet, annatto, caro- To color casings or Sausage casings, ole- Sufficient for purpose (may (natural). tene cochineal, green rendered fats; omargarine, short- be mixed with approved ar- chlorophyl, saffron marking and brand- ening, marking or tificial dyes or harmless and tumeric. ing product. branding ink on inert material such as com- product. mon salt and sugar). Coloring agents (ar- Color additives listed in ...... do ...... do ...... Sufficient for purpose (may tificial). 21 CFR Part 74, Sub- be mixed with approved part A of Part 82, natural coloring matters or Subpart B (operator harmless inert material must furnish evidence such as common salt or to inspector in charge sugar). that color additive has been certified for use in connection with foods by the Food and Drug Administra- tion). Titanium dioxide ...... do ...... Canned ham salad 0.5 percent. spread and creamed type canned products. Curing accelerators' Ascorbic acid ...... To accelerate color Cured pork and beef 75 oz to 100 gal pickle at 10 must be used fixing or preserve cuts, cured percent pump level; 3¤4 oz only in combina- color during storage. comminuted meat to 100 lb meat or meat by- tion with curing food product. product; 10 percent solu- agents. tion to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addi- tion of a significant amount of moisture to the product.) Erythorbic acid ...... do ...... do ...... Do. Fumaric acid ...... To accelerate color Cured, comminuted 0.065 percent (or 1 oz to 100 fixing. meat or meat food lb) of the weight of the products. meat or meat byproducts, before processing. Glucone delta lactone ... To accelerate color Cured, comminuted 8 oz to each 100 lb of meat fixing. meat or meat food or meat byproduct. product. Genoa salami ...... 16 oz to 100 lb of meat (1.0 percent). Sodium acid ...... do ...... Frankfurters, wieners, Not to exceed, alone or in pyrophosphate. vienna, bologna, combination with other cur- garlic bologna, ing accelerators, the follow- knockwurst, and ing: 8 oz in 100 lb of the similar products. meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product. Sodium ascorbate ...... To accelerate color Cured pork and beef 87.5 oz to 100 gal pickle at fixing or preserve cuts, cured 10 percent pump level; 7¤8 color during storage. comminuted meat oz to 100 lb meat or meat food product. byproduct; 10 percent solu- tion to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addi- tion of a significant amount of moisture to the product.) Sodium erythorbate ...... do ...... do ...... Do.
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Class of substance Substance Purpose Products Amount
Citric acid or sodium cit- ...... do ...... do ...... May be used in cured prod- rate. ucts or in 10 percent solu- tion used to spray surfaces of cured cuts prior to pack- aging to replace up to 50 percent of the ascorbic acid, erythorbic acid, so- dium ascorbate, or sodium erythorbate that is used. Curing agents ...... Sodium or potassium ni- Source of nitrite ...... Cured products other 7 lb to 100 gal pickle; 31¤2 oz trate. than bacon. Ni- to 100 lb meat (dry cure); trates may not be 23¤4 oz to 100 lb chopped used in baby, jun- meat. ior, and toddler foods. Sodium or potassium ni- To fix color ...... Cured products. 2 lb to 100 gal pickle at 10 trite. (Supplies of so- Nitrites may not be percent pump level; 1 oz to dium nitrite and po- used in baby, jun- 100 lb meat (dry cure); 1¤4 tassium nitrite and ior, or toddler foods. oz to 100 lb chopped meat mixtures containing and/or meat byproduct. The them must be kept use of nitrites, nitrates, or securely under the combination shall not result care of a responsible in more than 200 parts per employee of the es- million of nitrite, calculated tablishment. The spe- as sodium nitrite, in fin- cific nitrite content of ished product. Except that such supplies must nitrites may be used in be known and clearly bacon only in accordance marked accordingly). with paragraph (b) of this section. Denuding agents; Lime (calcium oxide, To denude mucous Tripe ...... Sufficient for purpose. may be used in calcium hydroxide) membranes. combination. Sodium carbonate...... do ...... do. Do. Must be removed Sodium Citrate ...... do ...... do ...... Do. from tripe by rins- Sodium gluconate ...... do ...... do ...... Do. ing with potable Sodium hydroxide ...... do ...... do ...... Do. water.. Sodium persulfate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Trisodium phosphate ...... do...... do. Do. Emulsifying agents Acetylated To emulsify product ... Shortening ...... Do. monoglycerides. Diacetyl tartaric acid ...... do ...... Rendered animal fat Do. esters of mono- and or a combination of diglycerides. such fat with vege- table fat. Glycerol-lacto stearate, ...... do ...... do ...... Do. oleate, or palmitate. Lecithin ...... To emulsify product Oleomargarine, short- 0.5 percent in oleomargarine; (also as an Anti- ening, various meat use in other productsÐsuf- oxidant). food products. ficient amount for emulsi- fication. Mono and diglycerides To emulsify product ... Rendered animal fat Sufficient for purpose in lard (glycerol palmitate, or a combination of and shortening; 0.5 percent etc.). such fat with vege- in oleomargarine. table fat; oleo- margarine. Mono and diglycerides ...... do ...... Margarine or oleo- 0.5 percent. of fatty acids margarine. esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the so- dium sulfoacetate de- rivatives of these mono and diglycerides.
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Class of substance Substance Purpose Products Amount
Polygylcerol esters of ...... do ...... Rendered animal fat Sufficient for purpose for ren- fatty acids or a combination of dered animal fat or com- (polygylcerol esters of such fat with vege- bination with vegetable fat; fatty acids are re- table fat when use 0.5 percent for oleo- stricted to those up to is not precluded by margarine. and including the standards of iden- decaglycerol esters tity or composition; and otherwise meet- oleomargaine. ing the requirements of § 172.854(a) of the Food Additive Regula- tions). 1,2-propylene glycol ...... do ...... Margarine or oleo- 2.0 percent. esters of fatty acids. margarine. Polysorbate 80 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 60 sorbitan monooleate). baked goods, bak- the combined total shall not ing mixes, icings, exceed 1 percent. fillings, and top- pings and in the fry- ing of foods. Propylene glycol mono ...... do ...... Rendered animal fat Sufficient for purpose. and diesters of fats or a combination of and fatty acids. such fat with vege- table fat. Polysorbate 60 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 80 sorbitan monostea- baked goods, bak- the combined total shall not rate). ing mixes, icings, exceed 1 percent. fillings, and top- pings and in the fry- ing of foods. Stearyl-2-lactylic acid ...... do ...... Shortening to be used 3.0 percent. for cake icings and fillings. Stearyl monoglyceridyl ...... do ...... Shortening ...... Sufficient for purpose. citrate. Film forming agents A mixture consisting of To reduce cooler Freshly dressed meat Formulation may not exceed water, sodium algi- shrinkage and help carcasses. Such 1.5% of hot carcass weight nate, calcium chlo- protect surface. carcasses must when applied. Chilled ride, sodium bear a statement weight may not exceed hot carboxymethyl-cel- ``Protected with a weight. lulose, and corn syrup film of water, corn solids. syrup solids, so- dium alginate, cal- cium chloride and sodium carboxymethyl-cel- lulose. Flavoring agents; Artificial smoke flavoring To flavor product ...... Various 2 ...... Do. protectors and developers. Smoke flavoring ...... do ...... do ...... Do. Autolyzed yeast extract ...... do ...... do ...... Do. Harmless bacteria start- To develop flavor ...... Dry sausage, pork 0.5 percent. ers of the acidophilus roll, thuringer, leb- type, lactic acid start- anon bologna, er or culture of cervelat, and salami. Pediococcus cerevisiae. Harmless lactic acid To prevent growth of Bacon ...... Sufficient for purpose. producing bacteria. Clostridium botu- linum. Benzoic acid (sodium, To retard flavor rever- Margarine or oleo- 0.1 percent individually, or if potassium and cal- sion. margarine. used in combination or with cium salts). sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
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Class of substance Substance Purpose Products Amount
Calcium lactate ...... To protect flavor ...... Cooked semi-dry and 0.6 percent in product formu- dry products includ- lation. ing sausage, imita- tion sausage, and non-specific meat food sticks. Citric acid ...... Flavoring ...... Chili con carne ...... Sufficient for purpose. Corn syrup solids, corn To flavor ...... Sausage, hamburger, Sufficient for purpose. syrup, glucose syrup. meat loaf, luncheon meat, chopped or pressed ham. Dextrose ...... To flavor product ...... Sausage, ham and Sufficient for purpose. cured products. Diacetyl ...... do ...... Oleomargarine ...... Do. Disodium guanylate ...... do ...... Various 2 ...... Do. Disodium inosinate ...... do ...... do ...... Do. Hydrolyzed plant protein ...... do ...... do ...... Do. Isopropyl citrate ...... To protect flavor ...... Oleomargarine ...... 0.02 percent. Malt syrup ...... To flavor product ...... Cured products ...... 2.5 percent. Milk protein hydrolysate ...... do ...... Various 2 ...... Sufficient for purpose. Monosodium glutamate ...... do ...... do ...... Do. Monoammonium glu- ...... do ...... do ...... Do. tamate. Sodium sulfoacetate de- ...... do ...... do ...... 0.5 percent. rivative of mono and diglycerides. Sodium tripoly-phos- To help protect flavor ``Fresh Beef,'' 2 ``Beef 0.5 percent of total product. phate. for Further Cook- ing,'' ``Cooked Beef,'' Beef Patties, Meat Loaves, Meat Toppings, and simi- lar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or fro- zen after process- ing. Mixtures of sodium ...... do ...... do ...... Do. tripolyphosphate and sodium metaphosphate, insol- uble; and sodium polyphosphates, glassy. Sorbitol ...... To flavor, to facilitate Cooked sausage la- Not to exceed 2 percent of the removal of cas- beled frankfurter, the weight of the formula, ings from product, frank, furter, wiener, excluding the formula and to reduce and knockwurst; weight of water or ice, carmelization and cured pork and when used in accordance charring. pork products, as with 21 CFR 184.1835. provided in part 319 of this subchapter. Starter distillate ...... To help protect flavor Oleomargarine ...... Sufficient for purpose. Stearyl citrate ...... To protect flavor ...... do ...... 0.15 percent. Sugars (sucrose and To flavor product ...... Various 2 ...... Sufficient for purpose. dextrose). Potassium lactate ...... To flavor product ...... Various meat and Not to exceed 2 percent of meat food products, formulation; in accordance except infant for- with 21 CFR 184.1639. mula and infant food.2 Sodium lactate ...... do ...... do ...... Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1768. Sodium acetate ...... To flavor products ..... Various ...... Not to exceed 0.12 percent of formulate in accordance Sodium diacetate ...... do ...... do ...... Not to exceed 0.1 percent of formulate in accordance with 21 CFR 184.1754 Gases ...... Carbon dioxide solid To cool product ...... Chopping of meat, Do. (dry ice). packaging of prod- uct.
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Class of substance Substance Purpose Products Amount
Liquid nitrogen ...... Contact freeze ...... Various ...... Sufficient for purpose Nitrogen ...... To exclude oxygen .... Sealed container ...... Do. Hog scald agents; Caustic soda ...... To remove hair ...... Hog carcasses ...... Do. must be removed Dimethylpolysiloxane ...... do ...... do ...... Do. by subsequent Dioctyl sodium sulfo- ...... do ...... do ...... Do. cleaning oper- succinate. ations. Disodium-calcium ethyl- ...... do...... do. Do. enediamine- tetraacetate. Disodium phosphate ...... do ...... do ...... Do. Ethylenediamine- ...... do ...... do ...... Do. tetraacetic acid (so- dium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide). Potassium hydroxide ...... do ...... do ...... Do. Propylene glycol ...... do ...... do ...... Do. Soap (prepared by the ...... do ...... do ...... Do. reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils). Sodium acid ...... do ...... do ...... Do. pyrophosphate. Sodium carbonate ...... do ...... do ...... Do. Sodium dodecylbenzene ...... do ...... do ...... Do. sulfonate. Sodium gluconate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. hexametaphosphate. Sodium lauryl sulfate ...... do ...... do ...... Do. Sodium mono and ...... do ...... do ...... Do. dimethylnaphthalene sulfonate (molecular weight 245±260). Sodium n-alkylbenzene ...... do ...... do ...... Do. sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16. Sodium pyrophosphate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sucrose ...... do ...... do ...... Do. Triethanolamine ...... do ...... do ...... Do. dodecylbenzene sulfonate. Trisodium phosphate ...... do ...... do ...... Do. Miscellaneous ...... Ascorbic acid, erythorbic To delay discoloration Fresh beef cuts, fresh Not to exceed, singly or in acid, citric acid, so- lamb cuts, and combination, 500 ppm or dium ascorbate and fresh pork cuts. 1.8 mg/sq inch of product sodium citrate, singly surface of ascorbic acid (in or in combination accordance with 21 CFR under quality control. 182.3013), erythorbic acid (in accordance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of prod- uct surface of citric acid (in accordance with 21 CFR 182.6033), or sodium cit- rate (in accordance with 21 CFR 182.6751). d- and dl- To inhibit nitrosamine Pump-cured bacon .... 500 ppm; by injection or sur- alphatocopherol. formation. face application.
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Class of substance Substance Purpose Products Amount
Potassium sorbate ...... To retard mold growth Dry sausage ...... 10 percent in water solution may be applied to casings after stuffing or casings may be dipped in a 10 per- cent water solution prior to stuffing. Silicon dioxide ...... Processing aid/dis- Tocopherol-containing At level not to exceed 4.0 persant. bacon curing pre- percent in the dry mix. mixes. Sorbic acid (sodium, po- To preserve product Margarine or oleo- 0.1 percent individually, or if tassium, and calcium and to retard mold margarine. used in combination or with salts). growth. benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). Calcium disodium, To preserve product ...... do ...... 75 parts per million by weight EDTA (calcium diso- and to protect flavor. of the finished oleo- dium ethylene- margarine or margarine. diaminetetraacetate). Propyl paraben (propyl To retard mold growth Dry sausage ...... 3.5 percent in water solution p-hydroxybenzoate). may be applied to casings after stuffing, or casings may be dipped in solution prior to stuffing. Sodium bicarbonate ...... To neutralize excess Rendered fats, soups, Sufficient for purpose. acidity, cleaning curing pickle. vegetables. Calcium propionate ...... To retard mold growth Pizza crust ...... 0.32 percent alone or in com- bination based on weight of the flour brace used. Sodium propionate ...... do ...... do ...... Do. Sodium hydroxide ...... To decrease the Meat food products May be used only in com- amount of cooked containing phos- bination with phosphates in out juices. phates. a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not ex- ceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product. Disodium phosphate ...... do ...... Meat food products 5 percent of phosphate in except where other- pickle at 10 percent pump wise prohibited by level; 0.5 percent of phos- the Federal meat phate in product (only clear inspection regula- solution may be injected tions. into product). Monosodium phosphate ...... do ...... do ...... Do. Sodium metaphosphate, ...... do ...... do ...... Do. insoluble. Sodium polyphosphate, ...... do ...... do ...... Do. glassy. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sodium pyrophosphate ...... do ...... do ...... Do. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Dipotassium phosphate ...... do ...... do ...... Do. Monopotassium phos- ...... do ...... do ...... Do. phate. Potassium ...... do ...... do ...... Do. tripolyphosphate. Potassium ...... do ...... do ...... Do. pyrophosphate. Citric acid (sodium and To acidify ...... Margarine or oleo- Sufficient for purpose. potassium salts). margarine. Lactic acid (sodium and ...... do ...... do ...... Do. potassium salts). L±Tartaric acid (sodium ...... do ...... do ...... Do. and sodium potas- sium salts). Adipic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Hydrochloric acid ...... do ...... do ...... Do. Sodium bicarbonate ...... To alkalize ...... do ...... Do.
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Class of substance Substance Purpose Products Amount
Sodium carbonate ...... do ...... do ...... Do. Sodium hydroxide ...... do ...... do ...... Do. Potassium carbonate ...... do ...... do ...... Do. Potassium bicarbonate ...... do ...... do ...... Do. Citric acid ...... To preserve cured Cured pork cuts ...... Not to exceed 30 percent in color during storage. water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 182.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be ap- plied only once to the prod- uct.) Sodium citrate buffered To inhibit the growth Cured and uncured, Not to exceed 1.3 percent of with citric acid to a pH of micro-organisms processed whole- the formulation weight of of 5.6. and retain product muscle meat food the product in accordance flavor during stor- products, e.g., ham. with 21 CFR 184.1751. age. Glycerine ...... Humecant ...... Shelf stable (Can Be Not to exceed 2 percent of stored at room tem- the formulation weight of perature) meat the product in accordance snacks.. with 21 CFR 182.1320 Proteolytic enzymes Aspergillus oryzae ...... To soften tissues ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or in- jected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavusoryzae ...... do ...... do ...... Do. group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Refining agents Acetic acid ...... To separate fatty Rendered fats ...... Sufficient for purpose. (must be elimi- acids and glycerol. nated during process of manu- facturing). Bicarbonate of soda ...... do ...... do ...... Do. Carbon (purified char- To aid in refining of ...... do ...... Do. coal). animal fats. Caustic soda (sodium To refine fats ...... do ...... Do. hydroxide). Diatomaceous earth; ...... do ...... do ...... Do. Fuller's earth. Sodium carbonate ...... do ...... do ...... Do. Tannic acid ...... do ...... do ...... Do. Rendering agents .. Tricalcium phosphate .... To aid rendering ...... Animal fats ...... Do. Trisodium phosphate ...... do ...... do ...... Do. Sources of radiation Ionizing radiation limited To control Trichinella Pork carcasses, or Minimum absorbed dose of to gamma rays from spiralis. fresh or previously 0.3 kiloGray (30 kilorads) to cobalt-60 or cesium- frozen cuts of pork a maximum absorbed dose 137. carcasses that have of 1 kiloGray (100 kilorads). not been cured or heat-processed. Artificial sweetners Saccharin ...... To sweeten product .. Bacon ...... 0.01 percent. Synergists (used in Citric acid ...... To increase effective- Any product permitted Not to exceed 0.01 percent combination with ness of antioxidants. to contain anti- based on fat content. antioxidants). oxidants as pro- vided in this part. Malic acid ...... do ...... Lard and shortening .. 0.01 percent based on total weight in combination with antioxidants. Monoisopropyl citrate ...... do ...... Lard, shortening, ole- 0.02 percent. omargarine, fresh pork sausage, dried meats. Phosphoric acid ...... do ...... Lard and shortening .. 0.01 percent.
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Class of substance Substance Purpose Products Amount
Monoglyceride citrate ...... do ...... Lard, shortening, 0.02 percent. fresh pork sausage, dried meats. Tenderizing agents Aspergillus oryzae ...... To soften tissue ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or in- jected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavus ...... do ...... do ...... Do. oryzae group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Potassium chloride ...... do ...... do ...... Not more than 3 percent of a 2.0 molar solution. Magnesium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Calcium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Potassium, magnesium ...... do ...... do ...... A solution of approved inor- or calcium chloride. ganic chlorides injected into or applied to raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. 1 [Reserved] 2 Information as to the specific products for which use of this substance is approved may be obtained upon inquiry addressed to the Standards and Labeling Division, Meat and Poultry Inspection Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. 3 Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to ac- complish the desired technical effect as determined in specific cases prior to label approval under § 317.4.
(d) No substance may be used in or on sodium benzoate may be used in or on any product if it conceals damage or any product only as provided in the inferiority or makes the product ap- chart in § 318.7(c)(4) or as approved by pear to be better or of greater value the Administrator in specific cases. than it is. Therefore: (Approved by the Office of Management and (1) Paprika or oleoresin paprika may Budget under control number 0583–008) not be used in or on fresh meat, such as steaks, or comminuted fresh meat food [35 FR 15586, Oct. 3, 1970] products, such as chopped and formed EDITORIAL NOTE: For FEDERAL REGISTER ci- steaks or patties; or in any other meat tations affecting § 318.7, see the List of CFR food products consisting of fresh meat Sections Affected in the Finding Aids sec- (with or without seasoning), except tion of this volume. chorizo sausage, and except other meat EFFECTIVE DATE NOTE: At 62 FR 61620, food products in which paprika or oleo- Nov. 19, 1997, § 318.7(c)(4) was amended by resin paprika is permitted as an ingre- adding the entry for ‘‘Carrageenan, Locust dient in a standard of identity or com- bean gum, and Xanthan gum blend’’ under position in part 319 of this subchapter. the class ’’Binders and extenders’’, effective January 20, 1998. (2) Sorbic acid, calcium sorbate, so- dium sorbate, and other salts of sorbic § 318.8 Preservatives and other sub- acid may not be used in cooked sausage stances permitted in product for ex- or any other product; sulfurous acid port only; handling; such product and salts of sulfurous acid may not be not to be used for domestic food used in or on any product and niacin or purposes. nicotinamide may not be used in or on (a) Preservatives and other sub- fresh product; except that potassium stances not permitted in domestic sorbate, propylparaben (propyl p-hy- product under the regulations in this droxybenzoate), calcium propionate, subchapter may be used in the prepara- sodium propionate, benzoic acid, and tion and packing of product intended
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for export provided the product (1) ac- (g) At all times, the identity of meat cords to the specifications or direc- to which borax has been added shall be tions of the foreign purchaser; (2) is not effectively maintained. In no case shall in conflict with the laws of the country such meat, nor any trimmings or fat to which it is intended for export; and derived from such meat, whether un- (3) is labeled on the outside container washed or washed, or otherwise treat- to show that it is intended for export, ed, be diverted to domestic use. and is otherwise labeled as required by (h) Salt used for bulking meat pre- this subchapter for such export prod- viously packed in borax may not again uct. be used in an edible products depart- (b) The preparation and packing of ment other than in connection with export product as provided for in para- the packing of meat in borax. Only graph (a) of this section shall be done metal equipment should be used for in a manner acceptable to the inspec- handling such meat. Particularly effec- tor in charge so that the identity of tive cleansing will be required if wood- the export product is maintained con- en equipment such as trucks, washing clusively and the preparation of domes- tic product is adequately protected. vats, etc., is used. Boxes from which The preservatives and other substances boraxed meat has been removed may be not permitted in domestic product used for repacking meat in borax, but shall be stored in a room or compart- their use as containers for other meat ment separate from areas used to store will be dependent upon the effective re- other supplies and shall be held under moval of all traces of borax. Program lock. Use of the preservatives (i) The following instructions pertain or other substances shall be under the to export cured pork packed in borax direct supervision of a Program em- for the account of Federal agencies. ployee. The meat may be packed in borax in a (c) The packing of all articles under room in which there is borax-free meat, paragraph (a) of this section shall be provided proper care is taken to see conducted under the direct supervision that the borax-free meat is not affected of a Program employee. by the borax. Under the same condi- (d) No article prepared or packed for tion, meat packed in borax may be re- export under paragraph (a) of this sec- ceived, unpacked, defrosted, soaked, tion shall be sold or offered for sale for washed, smoked, and repacked in a domestic use or consumption, but un- room where there is other meat. How- less exported shall be destroyed for ever, meat originally packed in borax food purposes under the direct super- shall at all times be subject to the re- vision of a Program employee. strictions of meat so packed, even (e) The contents of the container of though repacked without borax. After any article prepared or packed for ex- packing or repacking, borax packed port under paragraph (a) of this section meat may be stored in a room with shall not be removed, in whole or in meat not packed in borax, provided a part, from such container prior to ex- reasonable degree of separation is portation, except under the supervision maintained between the two classes of of a Program employee. If such con- product. tents are removed prior to exportation, then the article shall be either re- [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, packed, in accordance with the provi- 1971, as amended at 38 FR 29214, Oct. 23, 1973] sions of paragraphs (b) and (c) of this section, or destroyed for food purposes § 318.9 Samples of products, water, under the direct supervision of a Pro- dyes, chemicals, etc., to be taken for examination. gram employee. (f) Permission must be obtained from Samples of products, water, dyes, the Administrator before meats packed chemicals, preservatives, spices, or in borax are shipped from one official other articles in any official establish- establishment to another or to an unof- ment shall be taken, without cost to ficial establishment for storage, except the Program, for examination, as often such meat prepared for the account of as may be deemed necessary for the ef- Federal agencies. ficient conduct of the inspection.
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§ 318.10 Prescribed treatment of pork smoked hams, and smoked pork shoul- and products containing pork to de- der picnics which are specially pre- stroy trichinae. pared for distribution in tropical cli- (a)(1) All forms of fresh pork, includ- mates or smoked hams delivered to the ing fresh unsmoked sausage containing Armed Services); ground meat mix- pork muscle tissue, and pork such as tures containing pork and beef, veal, bacon and jowls, other than those cov- lamb, mutton, or goat meat and other ered by paragraph (b) of this section, product consisting of mixtures of pork are classed as products that are cus- and other ingredients, which the Ad- tomarily well cooked in the home or ministrator determines at the time the elsewhere before being served to the labeling for the product is submitted consumer. Therefore, the treatment of for approval in accordance with part such products for the destruction of 317 of the regulations in this sub- trichinae is not required. chapter or upon subsequent reevalua- (2) Pork from carcasses or carcass tion of the product, would be prepared parts that have been found free of in such a manner that the product trichinae as described under paragraph might be eaten rare or without thor- (e) or (f) of this section is not required ough cooking because of the appear- to be treated for the destruction of ance of the finished product or other- trichinae. wise. Cured boneless pork loins shall be (b) Products named in this para- subjected to prescribed treatment for graph, and products of the character destruction of trichinae prior to being hereof, containing pork muscle tissue shipped from the establishment where (not including pork hearts, pork stom- cured. achs, and pork livers), or the pork mus- (c) The treatment shall consist of cle tissue which forms an ingredient of heating, refrigerating, or curing, as fol- such products, shall be effectively lows: heated, refrigerated, or cured to de- (1) Heating. (i) All parts of the pork stroy any possible live trichinae, as muscle tissue shall be heated according prescribed in this section at the official to one of the time and temperature establishment where such products are combinations in the following table: prepared: Bologna, frankfurter, vienna, Minimum internal temperature and other cooked sausage; smoked sau- De- Minimum sage; knoblauch sausage; mortadella; grees time all forms of summer or dried sausage, Degrees fahrenheit centi- including mettwurst; flavored pork grade sausages such as those containing wine 120 ...... 49.0 21 hours. or similar flavoring materials; cured 122 ...... 50.0 9.5 hours. 124 ...... 51.1 4.5 hours. pork sausage; sausage containing cured 126 ...... 52.2 2 hours. and/or smoked pork; cooked loaves; 128 ...... 53.4 1 hour. roasted, baked, boiled, or cooked hams, 130 ...... 54.5 30 minutes. pork shoulders, or pork shoulder pic- 132 ...... 55.6 15 minutes. 134 ...... 56.7 6 minutes. nics; Italian-style hams; Westphalia- 136 ...... 57.8 3 minutes. style hams; smoked boneless pork 138 ...... 58.9 2 minutes. shoulder butts; cured meat rolls; 140 ...... 60.0 1 minute. 142 ...... 61.1 1 minute. capocollo (capicola, capacola); coppa; 144 ...... 62.2 Instant. fresh or cured boneless pork shoulder butts, hams, loins, shoulders, shoulder (ii) Time and temperature shall be picnics, and similar pork cuts, in cas- monitored by a calibrated recording in- ings or other containers in which strument that meets the requirements ready-to-eat delicatessen articles are of paragraph (d) of this section, except customarily enclosed (excepting for paragraph (c)(1)(iv). Scotch-style hams); breaded pork prod- (iii) The time to raise product tem- ucts; cured boneless pork loins; perature from 60 ° F. to 120 ° F shall not boneless back bacon; bacon used for exceed 2 hours unless the product is wrapping around patties, steaks and cured or fermented. similar products; and smoked pork cuts (iv) Time, in combination with tem- such as hams, shoulders, loins, and peratures of 138 ° F to 143 ° F, need not pork shoulder picnics (excepting be monitored if the product’s minimum
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thickness exceeds 2 inches (5.1 cm) and throughout will be promptly reduced to refrigeration of the product does not not higher than 5 °F., ¥10 °F., or ¥20 begin within 5 minutes of attaining 138 °F., as the case may be. ° F (58.9 ° C). (iv) In lieu of the methods prescribed (v) The establishment shall use pro- in Table 1, the treatment may consist cedures which insure the proper heat- of commercial freeze drying or con- ing of all parts of the product. It is im- trolled freezing, at the center of the portant that each piece of sausage, meat pieces, in accordance with the each ham, and other product treated by times and temperatures specified in heating in water be kept entirely sub- Table 2. merged throughout the heating period; and that the largest pieces in a lot, the TABLE 2ÐALTERNATE PERIODS OF FREEZING AT innermost links of bunched sausage or TEMPERATURES INDICATED other massed articles, and pieces placed in the coolest part of a heating Maximum internal temperature cabinet or compartment or vat be in- Minimum Degrees Time cluded in the temperature tests. Degrees Fahrenheit centi- grade (2) Refrigerating. At any stage of prep- aration and after preparatory chilling 0 ...... ¥17.8 106 hours. to a temperature of not above 40 °F. or ¥5 ...... ¥20.6 82 hours. preparatory freezing, all parts of the ¥10 ...... ¥23.3 63 hours. muscle tissue of pork or product con- ¥15 ...... ¥26.1 48 hours. taining such tissue shall be subjected ¥20 ...... ¥28.9 35 hours. ¥25 ...... ¥31.7 22 hours. continuously to a temperature not ¥30 ...... ¥34.5 8 hours. higher than one of those specified in ¥35 ...... ¥37.2 1¤2 hour. table 1, the duration of such refrigera- tion at the specified temperature being (v) During the period of refrigeration dependent on the thickness of the meat the product shall be kept separate from or inside dimensions of the container. other products and in the custody of the Program in rooms or compart- TABLE 1ÐREQUIRED PERIOD OF FREEZING AT ments equipped and made secure with TEMPERATURE INDICATED an official Program lock or seal. The Temperature °F. Group 1 (Days) Group 2 (Days) rooms or compartments containing product undergoing freezing shall be 5 20 30 equipped with accurate thermometers ¥10 10 20 ¥20 6 12 placed at or above the highest level at which the product undergoing treat- (i) Group 1 comprises product in sepa- ment is stored and away from refrig- rate pieces not exceeding 6 inches in erating coils. After completion of the thickness, or arranged on separate prescribed freezing of pork to be used racks with the layers not exceeding 6 in the preparation of product covered inches in depth, or stored in crates or by paragraph (b) of this section the boxes not exceeding 6 inches in depth, pork shall be kept under close super- or stored as solidly frozen blocks not vision of an inspector until it is pre- exceeding 6 inches in thickness. pared in finished form as one of the (ii) Group 2 comprises product in products enumerated in paragraph (b) pieces, layers, or within containers, the of this section or until it is transferred thickness of which exceeds 6 inches but under Program control to another offi- not 27 inches, and product in contain- cial establishment for preparation in ers including tierces, barrels, kegs, and such finished form. cartons having a thickness not exceed- (vi) Pork which has been refrigerated ing 27 inches. as specified in this subparagraph may (iii) The product undergoing such re- be transferred in sealed railroad cars, frigeration or the containers thereof sealed motortrucks, sealed trailers, or shall be so spaced while in the freezer sealed closed containers to another of- as will insure a free circulation of air ficial establishment at the same or an- between the pieces of meat, layers, other location, for use in the prepara- blocks, boxes, barrels, and tierces in tion of product covered by paragraph order that the temperature of the meat (b) of this section. Such vehicles and
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containers shall be sealed and trans- rials are added to the meat. Sausage exceed- ported between official establishments ing 31⁄2 inches, but not exceeding 4 inches, in in accordance with § 325.7 of this sub- diameter at the time of stuffing, shall be chapter. held in a drying room, following smoking as (3) Curing—(i) Sausage. The sausage above indicated, not less than 25 days at a temperature not lower than 45 °F., but in no may be stuffed in animal casings, case shall the sausage be released from the hydrocellulose casings, or cloth bags. drying room in less than 33 days from the During any stage of treating the sau- time the curing materials are added to the sage for the destruction of live meat. trichinae, except as provided in Method Method No. 3. The meat shall be ground or 5, these coverings shall not be coated chopped into pieces not exceeding three- with paraffin or like substance, nor fourths of an inch in diameter. A dry-curing shall any sausage be washed during any mixture containing not less than 31⁄3 pounds prescribed period of drying. In the of salt to each hundredweight of the preparation of sausage, one of the fol- unstuffed sausage shall be thoroughly mixed lowing methods may be used: with the ground or chopped meat. After ad- mixture with the salt and other curing mate- Method No. 1. The meat shall be ground or rials and before stuffing, the ground or chopped into pieces not exceeding three- chopped meat shall be held at a temperature fourths of an inch in diameter. A dry-curing not lower than 34 °F. for not less than 36 mixture containing not less than 31⁄3 pounds hours. After being stuffed, the sausage shall of salt to each hundredweight of the be held at a temperature not lower than 34 unstuffed sausage shall be thoroughly mixed °F. for an additional period of time sufficient with the ground or chopped meat. After to make a total of not less than 144 hours being stuffed, sausage having a diameter not from the time the curing materials are added exceeding 31⁄2 inches, measured at the time of to the meat, or the sausage shall be held for stuffing, shall be held in a drying room not the time specified in a pickle-curing medium less than 20 days at a temperature not lower of not less than 50° strength (salometer read- than 45 °F., except that in sausage of the va- ing) at a temperature not lower than 44 °F. riety known as pepperoni, if in casings not Finally, sausage having a diameter not ex- 1 exceeding 13⁄8 inches in diameter measured at ceeding 3 ⁄2 inches, measured at the time of the time of stuffing, the period of drying stuffing, shall be smoked for not less than 12 may be reduced to 15 days. In no case, how- hours. The temperature of the smokehouse ever, shall the sausage be released from the during this period at no time shall be lower drying room in less than 25 days from the than 90 °F.; and for 4 consecutive hours of time the curing materials are added, except this period the smokehouse shall be main- that sausage of the variety known as tained at a temperature not lower than 128 pepperoni, if in casings not exceeding the °F. Sausage exceeding 31⁄2 inches, but not ex- size specified, may be released at the expira- ceeding 4 inches, in diameter at the time of tion of 20 days from the time the curing ma- stuffing shall be smoked, following the pre- terials are added. Sausage in casings exceed- scribed curing, for not less than 15 hours. ing 31⁄2 inches, but not exceeding 4 inches, in The temperature of the smokehouse during diameter at the time of stuffing, shall be the 15-hour period shall at no time be lower held in a drying room not less than 35 days than 90 °F., and for 7 consecutive hours of at a temperature not lower than 45 °F., and this period the smokehouse shall be main- in no case shall the sausage be released from tained at a temperature not lower than 128 the drying room in less than 40 days from the °F. In regulating the temperature of the time the curing materials are added to the smokehouse for the treatment of sausage meat. under this method, the temperature of 128 Method No. 2. The meat shall be ground or °F. shall be attained gradually during a pe- chopped into pieces not exceeding three- riod of not less than 4 hours. fourths of an inch in diameter. A dry-curing Method No. 4. The meat shall be ground or mixture containing not less than 31⁄3 pounds chopped into pieces not exceeding one-fourth of salt to each hundredweight of the of an inch in diameter. A dry-curing mixture unstuffed sausage shall be thoroughly mixed containing not less than 21⁄2 pounds of salt to with the ground or chopped meat. After each hundredweight of the unstuffed sausage being stuffed, sausage having a diameter not shall be thoroughly mixed with the ground exceeding 31⁄2 inches, measured at the time of or chopped meat. After admixture with the stuffing, shall be smoked not less than 40 salt and other curing materials and before hours at a temperature not lower than 80 °F., stuffing, the ground or chopped sausage shall and finally held in a drying room not less be held as a compact mass, not more than 6 than 10 days at a temperature not lower than inches in depth, at a temperature not lower 45 °F. In no case, however, shall the sausage than 36 °F. for not less than 10 days. At the be released from the drying room in less termination of the holding period, the sau- than 18 days from the time the curing mate- sage shall be stuffed in casings or cloth bags
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not exceeding 31⁄3 inches in diameter, meas- the drying period. During the drying period, ured at the time of stuffing. After being the sausage shall be held in a drying room at stuffed, the sausage shall be held in a drying a temperature not lower than 50 (10.0 ° F. room at a temperature not lower than 45 °F. (10.0 ° C) for a period of time determined by for the remainder of a 35-day period, meas- Tables 3A, 3B, and 4. The length of the dry- ured from the time the curing materials are ing period, established in (c)(3)(i)(A), may be added to the meat. At any time after stuff- modified as provided in paragraphs ing, if the establishment operator deems it (c)(3)(i)(B) and (c)(3)(i)(C) of this section. desirable, the product may be heated in a water bath for a period not to exceed 3 hours at a temperature not lower than 85 °F., or TABLE 3AÐSAUSAGE DRYING ROOM TIMES BY subjected to smoking at a temperature not METHOD NO. 6 lower than 80 °F., or the product may be both heated and smoked as specified. The time Days 1 in dry- consumed in heating and smoking, however, Diameter of casing at time of stuffing ing shall be in addition to the 35-day holding pe- room2 riod specified. Method No. 5. The meat shall be ground or Up to: chopped into pieces not exceeding three- 1 inches ...... 14 fourths of an inch in diameter. A dry-curing 11¤2 inches ...... 15 2 inches ...... 16 mixture containing not less than 31⁄3 pounds of salt to each hundredweight of the 21¤2 inches ...... 18 unstuffed sausage shall be thoroughly mixed 3 inches ...... 20 with the ground or chopped meat. After 31¤2 inches ...... 23 being stuffed, the sausage shall be held for 4 inches ...... 25 1 not less than 65 days at a temperature not 4 ¤2 inches ...... 30 lower than 45 °F. The coverings for sausage 5 inches ...... 35 1 prepared according to this method may be 5 ¤2 inches ...... 43 coated at any stage of the preparation before 6 inches ...... 50 or during the holding period with paraffin or 1 The drying room times for flattened or oval sausages shall other substance approved by the Adminis- use a diameter derived by measuring the circumference and trator. dividing by 3.14 (pi). 2 Drying room time may be modified as set forth in Tables Method No. 6. (A) Basic requirements. The 3B and 4. meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in di- (B) Reduction in Drying Room Time. During ameter. A dry-curing mixture containing not the holding period, the sausage may be less than 3.33 pounds of salt to each hundred- smoked or fermented. If the temperature is weight of the unstuffed sausage, excluding increased to 70 ° F. (21.1 ° C) or higher, while the weight of dry ingredients, shall be thor- the sausage is being held after adding curing oughly mixed with the ground or chopped materials but before the drying period, the meat. After the curing mixture has been subsequent drying room times prescribed for added, the sausage shall be held for two time this method may be reduced according to the periods, a holding period and a drying period. schedule in Table 3B. No interpolation of val- The holding period will be for a minimum of ues is permissible. 48 hours at a room temperature not lower than 35 ° F. This holding period requirement may be fulfilled totally or in part before the drying period and then the remainder, if any, after the drying period or as an extension of
TABLE 3BÐPERCENTAGE REDUCTION IN DRYING ROOM TIME (TABLE 3A) PERMITTED BY HOLDING TIMES AND TEMPERATURES PRIOR TO DRYING 1
Minimum Temperature 2 Minimum Time 70 ° F 75 ° F 80 ° F 85 ° F 90 ° F 95 ° F 100 ° F 105 ° F 110 ° F 120 ° F 21.1 ° C 23.9 ° C 26.7 ° C 29.5 ° C 32.2 ° C 35.0 ° C 37.9 ° C 40.6 ° C 43.3 ° C 48.9 ° C
24 hours ...... 4 5 8 10 15 23 37 57 90 3 100 48 hours ...... 9 12 18 25 35 49 88 3 100 3 100 100 72 hours ...... 14 19 28 39 55 74 3 100 100 100 100 96 hours ...... 19 26 38 53 75 98 100 100 100 100 120 hours ...... 24 33 48 67 95 3 100 100 100 100 100
1 In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the required total drying time. Example: Sausage stuffed in 3″ diameter casing requires 20 days in the drying room (from Drying Room Times, Table 3A). If allowed to ferment, after addition of curing materials, at 80 ° F. for 48 hours, the 20 day drying time may be reduced 18% (from Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room, therefore, will be 17 days.
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2 Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a mois- ture-protein ratio of 2.3:1 or less. Internal product temperature shall be used for all other sausages. 3 Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no dry- ing room period is required for products so treated.
(C) Reduced Salt Content—Drying Room dry the product according to paragraph (B) Times. Salt content of less than 3.33 pounds or (C) below. for each hundredweight of sausage formula- (B) Holding, Heating, and Drying Treatment, tion, excluding dry ingredients, (such as Large Sausages. Except as permitted in (C) salts, sugars, and spices), may be permitted below, the establishment shall subject sau- provided the drying time is increased accord- sages in casings not exceeding 105 mm in di- ing to the schedule contained in Table 4. ameter, at the time of stuffing, to all of the following minimum chamber temperatures TRICHINA TREATMENT OF SAUSAGE BY METHOD and time periods. NO. 6; TREATMENT SCHEDULE FOR SAUSAGES 105 MIL- TABLE 4ÐREDUCED SALT CONTENTÐDRYING LIMETERS (41¤8 INCHES) OR LESS IN DIAMETER ROOM TIMES [Required percentage increase in drying room time (table 3A) Minimum chamber temperature Minimum time for added salt of less than 3.33 pounds per hundredweight ° ° (hours) of sausage] ( F) ( C) 50 10 12 Increase 90 32.2 1 1 in drying Minimum pounds of salt added to sausage room 100 37.8 1 time 2 110 43.3 1 120 48.9 1 3.3 ...... 1 125 51.7 7 3.2 ...... 4 3.1 ...... 7 Following the preceding treatment, the es- 3.0 ...... 10 tablishment shall dry the sausages at a tem- 2.9 ...... 13 perature not lower than 50 °F (10 °C) for not 2.8 ...... 16 less than 7 days. 2.7 ...... 19 (C) Heating and Drying Treatment, Small 2.6 ...... 22 Sausages. Alternatively, the establishment 2.5 ...... 25 may subject sausages in casings not exceed- 2.4 ...... 28 2.3 ...... 31 ing 55 mm in diameter, at the time of stuff- 2.2 ...... 34 ing, to all of the following minimum cham- 2.1 ...... 37 ber temperatures and time periods. 2.0 ...... 40 TREATMENT SCHEDULE FOR SAUSAGES 55 MILLI- 1 Calculate the salt content for column 1 as follows: Multiply 1 the pounds of salt in the sausage formulation by 100. Then di- METERS (2 ¤8 INCHES) OR LESS IN DIAMETER vide this number by the total weight of sausage formulation minus the weight of dry ingredients and round down to the Minimum chamber temperature next lowest 0.1%. Percents may be substituted for pounds. Minimum time Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. (°F) (°C) (hours) wine, 1 lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium nitrite total weight is 127.872 lbs. 50 10 12 (3.56×100)/(127.872¥3.56¥2¥.8¥.012)=356/121.5=2.93 100 37.8 1 Therefore, the sausage drying time must be increased by 125 51.7 6 13 percent. 2 In computing the days to be added to the required total Following the preceding heat treatment, the drying time, fractions shall be rounded to the next higher whole number and added to the required total drying time. Ex- establishment shall dry the sausages at a ample: Sausage stuffed in 31¤2 inch diameter casing requires temperature not lower than 50 °F (10 °C) for 23 days in the drying room (from Drying Room Times). If the not less than 4 days. quantity of salt added per hundredweight of sausage is 2 pounds instead of 3.33 pounds, the drying room time must be increased by 40 percent (from Reduced Salt Content-Drying (ii) Capocollo (capicola, capacola). Room Times), or 9.2 days. The 9.2 is rounded up to 10 days Boneless pork butts for capocollo shall and is added to the 23 days to equal 33 days. The total dry- ing time required in the drying room, therefore, will be 33 be cured in a dry-curing mixture con- days. taining not less than 41⁄2 pounds of salt per hundredweight of meat for a period Method No. 7, Dry Sausages. (A) General Re- of not less than 25 days at a tempera- quirements. The establishment shall use meat ture not lower than 36 °F. If the curing particles reduced in size to no more than 1/ materials are applied to the butts by 4 inch in diameter. The establishment shall add a curing mixture containing no less than the process known as churning, a small 2.7 pounds of salt per hundred pounds of meat quantity of pickle may be added. Dur- and mix it uniformly throughout the prod- ing the curing period the butts may be uct. The establishment shall hold, heat, and overhauled according to any of the
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usual processes of overhauling, includ- remove salt from the meat except that su- ing the addition of pickle or dry salt if perficial washing may be allowed. The prod- desired. The butts shall not be sub- ucts shall finally be dried or smoked at a jected during or after curing to any time and temperature not less than a com- bination prescribed in Table 5 of Method No. treatment designed to remove salt 3. from the meat, except that superficial Method No. 2. [Reserved] washing may be allowed. After being Method No. 3. (A) Curing. (Other than bag stuffed, the product shall be smoked curing): Establishments shall cure hams and for a period of not less than 30 hours at shoulders by using a cure mixture containing a temperature not lower than 80 °F., not less than 70 percent salt by weight to and shall finally be held in a drying cover all exposed muscle tissue and to pack room not less than 20 days at a tem- the hock region. Total curing time consists ° of a mandatory cure contact time and an op- perature not lower than 45 F. tional equalization time. (iii) Coppa. Boneless pork butts for (B) Cure Contact Time. This is the cure con- coppa shall be cured in a dry-curing tact period, during which the establishment mixture containing not less than 41⁄2 shall keep exposed muscle tissue coated with pounds of salt per hundredweight of the cure mixture at least 28 days but for no meat for a period of not less than 18 less than 1.5 days per pound of ham or shoul- days at a temperature not lower than der. Overhaul is optional so long as the ex- ° posed muscle tissue remains coated with cur- 36 F. If the curing mixture is applied ing mixture. to the butts by the process known as (C) Equalization. The establishment may churning, a small quantity of pickle provide an equalization period after the min- may be added. During the curing period imum cure contact period in (B) above to the butts may be overhauled according permit the absorbed salt to permeate the to any of the usual processes of over- product’s inner tissues. Equalization is the hauling, including the addition of pick- time after the excess cure has been removed le or dry salt if desired. The butts shall from the product at the end of the cure con- tact period until the product is placed in the not be subjected during or after curing drying room and the drying period begins. to any treatment designed to remove The total curing time (equalization plus cure salt from the meat, except that super- contact) shall be at least 40 days and in no ficial washing may be allowed. After case less than 2 days per pound of an uncured being stuffed, the product shall be held ham or shoulder. in a drying room not less than 35 days (D) Removing Excess Cure. After the re- at a temperature not lower than 45 °F. quired cure contact period, the establish- ment may remove excess cure mixture from (iv) Hams and pork shoulder picnics. In the product’s surface mechanically or by the curing of hams and pork shoulder rinsing up to 1 minute with water, but not by picnics, one of the methods below shall soaking. be used. For calculating days per (E) Bag Curing. Bag curing is a traditional pound, the establishment shall use the ham curing technique in which the manufac- weight of the heaviest ham or picnic in turer wraps the ham and all of the cure mix- the lot. ture together in kraft paper then hangs them individually. The paper keeps the extra cure Method No. 1. The hams and pork shoulder mixture in close contact with the product picnics shall be cured by a dry-salt curing making reapplication of salt unnecessary, process not less than 40 days at a tempera- and it protects the product from mites and ture no lower than 36 °F. The products shall insects. Establishments may employ the bag be laid down in salt, not less than 4 pounds curing method as an alternative to (A) to each hundredweight of product, the salt through (D) above. An establishment which being applied in a thorough manner to the elects to use the bag curing method shall lean meat of each item. When placed in cure, apply a cure mixture containing at least 6 the products may be pumped with pickle if pounds of salt per 100 pounds of uncured desired. At least once during the curing proc- product. The establishment shall rub the ess, the products shall be overhauled (turned curing mixture into the exposed muscle tis- over for the application of additional cure) sue, pack the hock region with the curing and additional salt applied, if necessary, so mixture, and use uncoated wrapping paper to that the lean meat of each item is thor- wrap the product together with any remain- oughly covered. After removal from cure, the ing curing mixture. The bag cured product products may be soaked in water at a tem- shall remain wrapped throughout the curing perature not higher than 70 °F for not more period and may or may not remain wrapped than 15 hours, during which time the water during the drying period. In any case, the may be changed once, but they shall not be curing period shall be at least 40 days but subjected to any other treatment designed to not less than 2 days per pound of an uncured
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ham or shoulder. After curing, the cured (G) Drying. After the curing period, estab- product shall be exposed to a drying time lishments shall use one of three procedures and temperature prescribed in Table 5. for drying: (F) Curing Temperature. During the curing (1) The establishment shall subject the period the establishment shall use one of the product to a controlled room temperature following procedures: for a minimum time and minimum tempera- (1) The establishment shall control the ture combination prescribed in Table 5 or for room temperature at not less than 35 ° F (1.7 a set of such combinations in which the total ° C) nor greater than 45 ° F (7.2 ° C) for the of the fractional periods (in column 4 of first 1.5 days per pound of an uncured ham or Table 5) exceeds 1.5. shoulder, and not less than 35 ° F (1.7 ° C) nor (2) Establishments using uncontrolled greater than 60 ° F (15.6 ° C) for the remain- room temperatures shall monitor and record der of the curing period. the internal product temperature. The dry- (2) The establishment shall monitor and ing period shall be complete when, from the record daily product temperature. The room days which can be counted as curing time, temperature need not be controlled but days one of the time/temperature combinations of on which the product temperature drops Table 5 is satisfied or when the total of the below 35 ° F (1.7 ° C) shall not be counted as fractional values for the combinations ex- curing time. If the product temperature ex- ceeds 1.5. ceeds 45 ° F (7.2 ° C) within the first period of (3) Establishments using uncontrolled 1.5 days per pound of an uncured ham or room temperatures shall dry the product for shoulder or if it exceeds 60 ° F (15.6 ° C) for a minimum of 160 days including the entire the remainder of the curing period, the es- months of June, July, and August. This pro- tablishment shall cool the product back to cedure is obviously dependent on local cli- the 45 ° F (7.2 ° C) maximum during the first matic conditions and no problem exists with period or 55 ° F (12.8 ° C) maximum during respect to current producers who use this the remainder of the period. procedure. Future applicants shall dem- (3) The establishment shall begin curing onstrate that their local monthly average product only between the dates of December temperatures and the local monthly mini- 1 and February 13. The room temperature mum temperatures are equal to or warmer need not be controlled, but the establish- than the normal average temperatures and ment shall monitor and record daily room normal minimum temperatures compiled by temperatures, and days in which the room the National Oceanic and Atmospheric Ad- temperature drops below 35 ° F (1.7 ° C) shall ministration for Boone, North Carolina, sta- not be counted as curing time. tion 31–0977, 1951 through 1980.
MONTHLY TEMPERATURES (° F) FOR BOONE NC, 1951±1980
Jan. Feb. Mar. Apr. May June July Aug. Sep.
Normal average temperatures
32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6
Normal minimum temperatures
22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6
Drying Times and Temperatures for TABLE 5.ÐMINIMUM DRYING DAYS AT A Trichina Inactivation in Hams and MINIMUM TEMPERATURE*ÐContinued Shoulders Minimum Drying Temperature Fractional Minimum days period for TABLE 5.ÐMINIMUM DRYING DAYS AT A at drying tem- Degrees fahr- Degrees perature one day of MINIMUM TEMPERATURE* enheit centigrade drying
Minimum Drying Temperature Fractional 95 ...... 35.0 9 .11 Minimum days 90 ...... 32.2 11 .091 at drying tem- period for Degrees fahr- Degrees one day of 85 ...... 29.4 18 .056 enheit centigrade perature drying 80 ...... 26.7 25 .040 130 ...... 54.4 1.5 .67 75 ...... 23.9 35 .029 125 ...... 51.7 2 .50 * Interpolation of these times or temperatures is not accept- 120 ...... 48.9 3 .33 able; establishments wishing to use temperatures or times not 115 ...... 46.1 4 .25 in this Table shall first validate their efficacy as provided by 110 ...... 43.3 5 .20 318.10(c)(4) of this section. 105 ...... 40.6 6 .17 100 ...... 37.8 7 .14
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Method No. 4. ples from the first 12 lots of production as follows: From each lot, (A) Cure: Establishments shall cure hams (i) One sample shall be taken from each of and shoulders by using a cure mixture con- 5 or more hams; taining not less than 71.5 percent salt by (ii) Each sample shall be taken from the weight to cover all exposed muscle tissue biceps femoris. As an alternative to the use and to pack the hock region. Establishments of the biceps femoris, the Agency shall con- may substitute potassium chloride (KCl) for sider other method(s) of sampling the dry- up to half of the required salt on an equal cured hams to determine the minimum in- weight basis. ternal brine concentration, as long as the es- (B) Curing. Establishments shall apply the tablishment proposes it and submits data cure at a rate not less than 5.72 pounds of and other information to establish its suffi- salt and KCl per hundred pounds of fresh ciency to the Director of the Processed Prod- meat. The cure shall be applied in either ucts Inspection Division; three or four approximately equal amounts (iii) Each sample shall weigh no less than (two or three overhauls) at separate times 100 grams; during the first 14 days of curing. (iv) The samples shall be combined as one (C) Cure Contact Time. Establishments shall composite sample and sealed in a water keep the product in contact with the cure vapor proof container; mixture for no less than 2 days per pound of (v) The composite sample shall be submit- an uncured ham or shoulder but for at least ted to a laboratory accredited under the pro- 30 days. Establishments shall maintain the visions of § 318.21 to be analyzed for salt and curing temperature at no less than 35° F (1.7° water content using methods from the ‘‘Offi- C) during the cure contact time. cial Methods of Analysis of the Association (D) Equalization. After the cure contact pe- of Official Analytical Chemists (AOAC),’’ riod, establishments shall provide an added 15th Edition, 1990, Section 983.18 (page 931) equalization period of no less than 1 day per and Section 971.19 (page 933) which are incor- pound of an uncured ham or shoulder but at porated by reference. This incorporation by least 14 days. Equalization is the time after reference was approved by the Director of the excess cure has been removed from the the Federal Register in accordance with 5 product, the end of the cure contact period, U.S.C. 552(a) and 1 CFR part 51. Copies may and before the drying period begins. Estab- be obtained from the Association of Official lishments may substitute additional cure Analytical Chemists, suite 400–BW, 2200 Wil- contact days for an equal number of equali- son Boulevard, Arlington, VA 22201–3301. Cop- zation days. ies may be inspected at the Office of the (E) Removing Excess Cure. After the re- FSIS Hearing Clerk, room 3171, South Agri- quired cure contact period, the establish- culture Building, Food Safety and Inspection ment may remove excess cure mixture from Service, U.S. Department of Agriculture, the product’s surface mechanically or by Washington, DC 20250 or at the Office of the rinsing up to 1 minute with water, but not by Federal Register, 800 North Capitol Street, soaking. NW., suite 700, Washington, DC 20408. If the (F) Drying. After the curing period, estab- time between sampling and submittal of the lishments shall use one of the controlled composite sample to the accredited labora- temperature methods for drying listed in tory will exceed 8 hours, then the establish- Method No. 3 of this subparagraph. ment shall freeze the composite sample im- mediately after the samples are combined; Method No. 5 (vi) Once the laboratory results for the composite sample are received, the manufac- (A) Curing. The establishment shall cure turer shall calculate the internal brine con- the ham to a minimum brine concentration centration by multiplying the salt con- of 6 percent by the end of the drying period. centration by 100 and then dividing that fig- Brine concentration is calculated as 100 ure by the sum of the salt and water con- times the salt concentration divided by the centrations; sum of the salt and water concentrations. (vii) Compliance is established when the × Percent brine=100 [salt]/([salt]+[water]) samples from the first 12 lots of production The Agency will accept the brine con- have a minimum internal brine concentra- centration in the biceps femoris as a reason- tion of 6 percent. Lots being tested to estab- able estimate of the minimum brine con- lish compliance shall be held until the inter- centration in the ham. nal brine concentration has been determined (B) Drying and Total Process Times. The es- and found to be at least 6 percent. If the min- tablishment shall dry the cured ham at a imum internal brine concentration is less minimum temperature of 55 °F (13 °C) for at than 6 percent, the lot being tested shall be least 150 days. The total time of drying plus held until the establishment brings the lot curing shall be at least 206 days. into compliance by further processing. (C) Ensuring an Acceptable Internal Brine (2) To maintain compliance, the establish- Concentration. (1) To establish compliance, ment shall take samples, have the samples the establishment shall take product sam- analyzed, and perform the brine calculations
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as set forth above from one lot every 13 son Boulevard, Arlington, VA 22201–3301. Cop- weeks. Lots being tested to maintain compli- ies may be inspected at the Office of the ance shall not be held. If the minimum inter- FSIS Hearing Clerk, room 3171, South Agri- nal brine concentration is less than 6 percent culture Building, Food Safety and Inspection in a lot being tested to maintain compliance, Service, U.S. Department of Agriculture, the establishment shall develop and propose Washington, DC 20250 or at the Office of the steps acceptable to FSIS to ensure that the Federal Register, 800 North Capitol Street, process is corrected. NW., suite 700, Washington, DC. If the time (3) Accredited laboratory results and the between sampling and submittal of the com- brine calculations shall be placed on file at posite sample to the accredited laboratory the establishment and available to Program will exceed 8 hours, then the establishment employees for review. shall freeze the composite sample imme- diately after the samples are combined; Method No. 6 (vi) Compliance is established when the (A) Curing. The establishment shall cure samples from the first 12 lots of production the ham to a minimum brine concentration have a minimum internal brine concentra- of 6 percent by the end of the drying period. tion of 6 percent. Lots being tested to estab- Brine concentration is calculated as 100 lish compliance shall be held until the inter- times the salt concentration divided by the nal brine concentration has been determined sum of the salt and water concentrations. and found to be at least 6 percent. If the min- Percent brine = 100 × [salt] / ([salt] + [water]) imum internal brine concentration is less The Agency will accept the brine con- than 6 percent, the lot being tested shall be centration in the biceps femoris as a reason- held until the establishment brings the lot able estimate of the minimum brine con- into compliance by further processing. centration. (2) To maintain compliance, the establish- (B) Drying and Total Process Times. The es- ment shall take samples, have the samples tablishment shall dry the cured ham at a analyzed, and perform the brine calculations minimum temperature of 110 ° F (43 ° C) for as set forth above from one lot every 13 at least 4 days. The total time of drying plus weeks. Lots being tested to maintain compli- curing shall be at least 34 days. ance shall not be held. If the minimum inter- (c) Ensuring an Acceptable Internal Brine nal brine concentration is less than 6 percent Concentration. in a lot being tested to maintain compliance, (1) To establish compliance the establish- the establishment shall develop and propose ment shall take product samples from the steps acceptable to FSIS to ensure that the first 12 lots of production as follows: From process is corrected. each lot, (3) Accredited laboratory results and the (i) One sample shall be taken from each of brine calculations shall be placed on file in 5 or more hams; the establishment and available to Program (ii) Each sample shall be taken from the employees for review. biceps femoris. As an alternative to the use (v) Boneless pork loins and loin ends. of the biceps femoris, the Agency will con- In lieu of heating or refrigerating to sider other methods of sampling the dry- cured hams to determine internal brine con- destroy possible live trichinae in centration, as long as the establishment pro- boneless loins, the loins may be cured poses it and submits data and other informa- for a period of not less than 25 days at tion to establish its sufficiency to the Direc- a temperature not lower than 36 °F. by tor of the Processed Products Inspection Di- the use of one of the following meth- vision; ods: (iii) Each sample shall weigh no less than 100 grams; Method No. 1. Application of a dry-salt cur- (iv) The samples shall be combined as one ing mixture containing not less than 5 composite sample and sealed in a water pounds of salt to each hundredweight of vapor proof container; meats. (v) The composite sample shall be submit- Method No. 2. Application of a pickle solu- ted to a laboratory accredited under the pro- tion of not less than 80° strength (salometer) visions of § 318.21 to be analyzed for salt and on the basis of not less than 60 pounds of water content using methods from the ‘‘Offi- pickle to each hundredweight of meat. cial Methods of Analysis of the Association Method No. 3. Application of a pickle solu- of Official Analytical Chemists (AOAC),’’ tion added to the dry-salt cure prescribed as 15th Edition, 1990, section 983.18 (page 931) Method No. 1 in this subdivision (v) provided and section 971.19 (page 933) which are incor- the pickle solution is not less than 80° porated by reference. This incorporation by strength (salometer). reference was approved by the Director of After removal from cure, the loins may be the Federal Register in accordance with 5 soaked in water for not more than 1 hour at U.S.C. 552(a) and 1 CFR part 51. Copies may a temperature not higher than 70 °F. or be obtained from the Association of Official washed under a spray but shall not be sub- Analytical Chemists, suite 400–BW, 2200 Wil- jected, during or after the curing process, to
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any other treatment designed to remove (2) The establishment shall use the salt. services of a laboratory approved by Following curing, the loins shall be the Administrator for all required test- smoked for not less than 12 hours. The mini- ing. Such approval shall be based on mum temperature of the smokehouse during this period at no time shall be lower than 100 adequacy of facilities, reagents, and °F., and for 4 consecutive hours of this period equipment, and on demonstration of the smokehouse shall be maintained at a continuing competency and reliability temperature not lower than 125 °F. in performing the pooled sample diges- Finally, the product shall be held in a dry- tion technique for trichinae. ing room for a period of not less than 12 days (3) The establishment shall sample no at a temperature not lower than 45 °F. less than 5 grams of diaphragm muscle (4) The Administrator shall consider or tongue tissue from each carcass or additional processing methods upon pe- no less than 10 grams of other muscle tition by manufacturers, and shall ap- tissue. Samples may be pooled but a prove any such method upon his/her de- pool shall not consist of more than 100 termination that it can be properly grams of sample. Sampling and sample monitored by an inspector and that the preparation are subject to inspection safety of such methods is adequately supervision. documented by data which has been de- (4) Pork or products made from test- veloped by following an experimental ed pork shall not be released as tri- protocol previously reviewed and ac- china free from the official establish- cepted by the Department. ment without treatment until the in- (d) General instructions: When nec- spector in charge receives a laboratory essary to comply with the require- report that the tested pork is free of ments of this section, the trichina cysts. smokehouses, drying rooms, and other (f) Approval of other tests for trichinosis compartments used in the treatment of in pork. The Administrator shall con- pork to destroy possible live trichinae sider any additional analytical method shall be suitably equipped, by the oper- for trichinosis upon petition by a man- ator of the official establishment, with ufacturer, and may approve that meth- accurate automatic recording ther- od upon the determination that it will mometers. Circuit supervisors are au- detect at least 98 percent of swine bear- thorized to approve for use in sausage ing cysts present at a tissue density smokehouses, drying rooms, and other equal to or less than one cyst per gram compartments, such automatic record- of muscle from the diaphragm pillars at a 95 percent confidence level. Any ing thermometers as are found to give such petitions shall be supported by satisfactory service and to disapprove any data and other information that and require discontinuance of use, for the Administrator finds necessary. No- purposes of the regulations in this sub- tice of any approval shall be given in chapter, any thermometers (including the FEDERAL REGISTER, and the ap- any automatic recording thermom- proved method will be incorporated eters) of the establishment that are into this section. found to be inaccurate or unreliable. (e) The requirements for using the [35 FR 15586, Oct. 3, 1970, as amended at 38 FR pooled sample digestion technique to 31517; Nov. 15, 1973; 39 FR 40580, Nov. 19, 1974; analyze pork for the presence of tri- 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21, china cysts are: 1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR 33633, July 30, 1992; 57 FR (1) The establishment shall submit 56440, Nov. 30, 1992] for the approval of the Regional Direc- tor its proposed procedure for identify- § 318.11 [Reserved] ing and pooling carcasses, collecting and pooling samples, testing samples § 318.12 Manufacture of dog food or (including the name and address of the similar uninspected article at offi- laboratory), communicating test re- cial establishments. sults, retesting individual carcasses, (a) When dog food, or similar and maintaining positive identification uninspected article is manufactured in and clear separation of pork found to an edible product department, there be trichina-free from untested pork or shall be sufficient space allotted and trichina-positive pork. adequate equipment provided so that
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the manufacture of the uninspected ar- ible product departments and inedible ticle in no way interferes with the han- product departments. Sufficient space dling or preparation of edible products. must be allotted and adequate equip- Where necessary to avoid adulteration ment provided so that the manufacture of edible products, separate equipment of the uninspected article does not shall be provided for the uninspected interfere with the proper functioning of article. To assure the maintenance of the other operations at the establish- sanitary conditions in the edible prod- ment. Except as provided in § 314.11 of uct departments, the operations inci- this subchapter, nothing in this para- dent to the manufacture of the graph shall be construed as permitting uninspected article will be subject to any deviation from the requirement the same sanitary requirements that that dead animals, condemned prod- apply to all operations in edible prod- ucts, and similar materials of whatever uct departments. The manufacture of origin, must be placed in the inedible the uninspected article shall be limited product rendering equipment, and to those hours during which the estab- without undue delay. The manufacture lishment operates under inspectional of the uninspected article must be such supervision; and there shall be no han- as not to interfere with the mainte- dling, other than receiving at the offi- nance of general sanitary conditions on cial establishment, of any of the prod- the premises, and it shall be subject to uct ingredient of the uninspected arti- inspectional supervision similar to cle, other than during the regular that exercised over other inedible prod- hours of inspection. The materials used uct departments. There shall be no in the manufacture of the uninspected movement of any product from an ined- article shall not be used so as to inter- ible product department to any edible fere with the inspection of edible prod- product department. Trucks, barrels, uct or the maintenance of sanitary and other equipment shall be cleaned conditions in the department or render before being returned to edible product any edible product adulterated. The departments from inedible product de- meat, meat byproducts, and meat food partments. Unoffensive material pre- product ingredients of the uninspected pared outside edible product depart- article may be admitted into any edi- ments may be stored in, and distrib- ble products department of an official uted from, edible product departments establishment only if they are U.S. In- only if packaged in clean, properly spected and Passed. Products within identified, sealed containers. § 314.11 of this subchapter or parts of (c) Animal food shall be distin- carcasses of kinds not permitted under guished from articles of human food, so the regulations in this subchapter to be as to avoid distribution of such animal prepared for human food (e.g., lungs or food as human food. To accomplish intestines), which are produced at any this, such animal food shall be labeled official establishment, may be brought or otherwise identified in accordance into the inedible products department with § 325.11(d) of this subchapter. of any official establishment for use in [35 FR 15586, Oct. 3, 1970, as amended at 36 FR uninspected articles under this section. 11639, June 17, 1971; 53 FR 24679, June 30, 1988] The uninspected article may be stored in, and distributed from, edible product § 318.13 Mixtures containing product departments: Provided, That adequate but not amendable to the Act. facilities are furnished, there is no in- Mixtures containing product but not terference with the maintenance of classed as a meat food product under sanitary conditions, and such article is the Act shall not bear the inspection properly identified. legend or any abbreviation or represen- (b) When dog food or similar tation thereof unless manufactured uninspected article is manufactured in under the food inspection service pro- a part of an official establishment vided for in part 350 of subchapter B of other than an edible product depart- this chapter. When such mixtures are ment, the area in which the article is manufactured in any part of an official manufactured shall be separated from establishment, the sanitation of that edible product departments in the man- part of the establishment shall be su- ner required for separation between ed- pervised by Program employees, and
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the manufacture of such mixtures shall (ii) Immerse in 212 °F. water, bring not cause any deviation from the re- temperature of the water back to 212 quirement of § 318.1. °F. and maintain the temperature at 212 °F. for 5 minutes, then remove con- [35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973] tainers from water and cool them to 95 °F. and dry thoroughly. § 318.14 Adulteration of product by (3) After handling as described in polluted water; procedure for han- paragraph (c)(2) of this section, the dling. containers may be relacquered, if nec- (a) In the event there is polluted essary, and then relabeled with ap- water (including but not limited to proved labels applicable to the product flood water) in an official establish- therein. ment, all products and ingredients for (4) The identity of the canned prod- use in the preparation of such products uct shall be maintained throughout all that have been rendered adulterated by stages of the rehandling operations to the water shall be condemned. insure correct labeling of the contain- (b) After the polluted water has re- ers. ceded from an official establishment, [35 FR 15586, Oct. 3, 1970, as amended at 38 FR all walls, ceilings, posts, and floors of 34455, Dec. 14, 1973] the rooms and compartments involved, including the equipment therein, shall, § 318.15 Tagging chemicals, preserva- under the supervision of an inspector, tives, cereals, spices, etc., ‘‘U.S. re- be cleaned thoroughly by the official tained.’’ establishment personnel. An adequate When any chemical, preservative, ce- supply of hot water under pressure is real, spice, or other substance is in- essential to make such cleaning effec- tended for use in an official establish- tive. After cleaning, a solution of so- ment, it shall be examined by a Pro- dium hypochlorite containing approxi- gram employee and if found to be unfit mately one-half of 1 percent available or otherwise unacceptable for the use chlorine (5,000 p/m) or other equivalent intended, or if final decision regarding disinfectant approved by the Adminis- acceptance is deferred pending labora- trator 1 shall be applied to the surface tory or other examination, the em- of the rooms and equipment and rinsed ployee shall attach a ‘‘U.S. retained’’ with potable water before use. tag to the substance or container (c) Hermetically sealed containers of thereof. The substance so tagged shall product which have been contaminated be kept separate from other substances by polluted water shall be examined as the circuit supervisor may require promptly by the official establishment and shall not be used until the tag is under supervision of an inspector and removed, and such removal shall be rehandled as follows: made only by a Program employee (1) Separate and condemn all product after a finding that the substance can in damaged or extensively rusted con- be accepted, or, in the case of an unac- tainers. ceptable substance, when it is removed (2) Remove paper labels and wash the from the establishment. remaining containers in warm soapy water, using a brush where necessary § 318.16 Pesticide chemicals and other to remove rust or other foreign mate- residues in products. rial. Disinfect these containers by ei- (a) Nonmeat ingredients. Residues of ther of the following methods: pesticide chemicals, food additives and (i) Immerse in a solution of sodium color additives or other substances in hypochlorite containing not less than or on ingredients (other than meat, 100 p/m of available chlorine or other meat byproducts, and meat food prod- equivalent disinfectant approved by ucts) used in the formulation of prod- the Administrator, 1 rinse in potable ucts shall not exceed the levels per- water, and dry thoroughly; or mitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat 1 A list of approved disinfectants is avail- able upon request to Scientific Services, Safety and Inspection Service, U.S. Depart- Meat and Poultry Inspection Program, Food ment of Agriculture, Washington, DC 20250.
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ingredients must otherwise be in com- TABLE FOR TIME/TEMPERATURE COMBINATION pliance with the requirements under FOR COOKED BEEF, ROAST BEEF, AND that Act. COOKED CORNED BEEFÐContinued (b) Products, and meat, meat byproduct, or other meat food product ingredients. Minimum internal temperature Minimum processing time in minutes after minimum Products, and products used as ingredi- Degrees Fahr- Degrees Cen- temperature is reached ents of products, shall not bear or con- enheit tigrade tain any pesticide chemical, food addi- 145 62.8 Instantly tives, or color additive residue in ex- cess of the level permitted under the (b) Cooked beef, including sectioned Federal Food, Drug, and Cosmetic Act and formed roasts and chunked and and the regulations in this subchapter, formed roasts, and cooked corned beef or any other substance that is prohib- shall be moist cooked throughout the ited by such regulations or that other- process or, in the case of roast beef or wise makes the products adulterated. corned beef to be roasted, cooked as (c) Standards and procedures. Instruc- provided in paragraph (c) of this sec- tions specifying the standards and pro- tion. The moist cooking may be accom- cedures for determining when ingredi- plished by (1) placing the meat in a ents of finished products are in compli- sealed, moisture impermeable bag, re- ance with this section shall be issued moving the excess air, and cooking, (2) to the inspectors by the Administrator. completely immersing the meat, Copies of such instructions will be unbagged, in water throughout the en- made available to interested persons tire cooking process, or (3) using a upon request made to the Adminis- sealed oven or steam injection to raise trator. the relative humidity above 90 percent throughout the cooking process. § 318.17 Requirements for the produc- tion of cooked beef, roast beef, and (c) Roast beef or corned beef to be cooked corned beef. roasted shall be cooked by one of the following methods: (a) Cooked beef and roast beef, in- (1) Heating roasts of 10 pounds or cluding sectioned and formed roasts more in an oven maintained at 250 °F and chunked and formed roasts, and ° cooked corned beef shall be prepared by (121 C) or higher throughout the proc- one of the time and temperature com- ess; binations in the following table. The (2) Heating roasts of any size to a stated temperature is the minimum minimum internal temperature of 145 which shall be produced and main- °F (62.8 °C) in an oven maintained at tained in all parts of each piece of any temperature if the relative humid- meat for at least the stated time: ity of the oven is maintained either by continuously introducing steam for 50 TABLE FOR TIME/TEMPERATURE COMBINATION percent of the cooking time or by use FOR COOKED BEEF, ROAST BEEF, AND of a sealed oven for over 50 percent of COOKED CORNED BEEF the cooking time, or if the relative hu- midity of the oven is maintained at 90 Minimum internal temperature Minimum processing time percent or above for at least 25 percent in minutes after minimum Degrees Fahr- Degrees Cen- temperature is reached of the total cooking time, but in no enheit tigrade case less than 1 hour; or 130 54.4 121 (3) Heating roasts of any size in an 131 55.0 97 oven maintained at any temperature 132 55.6 77 that will satisfy the internal tempera- 133 56.1 62 134 56.7 47 ture and time requirements of para- 135 57.2 37 graph (a) of this section if the relative 136 57.8 32 humidity of the oven is maintained at 137 58.4 24 90 percent or above for at least 25 per- 138 58.9 19 139 59.5 15 cent of the total cooking time, but in 140 60.0 12 no case less than 1 hour. 141 60.6 10 The relative humidity may be 142 61.1 8 143 61.7 6 achieved by use of steam injection or 144 62.2 5 by sealed ovens capable of producing
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and maintaining the required relative (5) Any other critical control points humidity. in the procedures which could affect (d)(1) Except as provided in para- the safety of the product. graph (d)(2) of this section, establish- (6) In lieu of recording devices, the ments producing cooked beef, roast alternate means permitted by beef, or cooked corned beef shall have § 318.17(d)(2) of providing evidence to in- sufficient monitoring equipment, in- spection personnel that the finished cluding recording devices, to assure product will be prepared in compliance that the time (within 1 minute), the with temperature or humidity require- temperature (within 1 °F), and relative ments. humidity (within 5 percent) limits of (7) Any other alternate procedure these processes are being met. Data used that is permitted in this section. (g) The establishment shall maintain from the recording devices shall be records and reports which document made available to a program employee the time, temperature, and humidity upon request. at which any cooked beef, roast beef, or (2) In lieu of recording devices, estab- cooked corned beef is cooked and lishments may propose in the written cooled at the establishment. Such procedures prescribed in paragraph (f) records shall be kept by the establish- of this section, an alternative means of ment for 6 months or for such further providing inspection personnel with period as the Administrator may re- evidence that finished product has been quire for purposes of any investigation prepared in compliance with the hu- or litigation under the Act, by written midity requirements of paragraphs (b) notice to the person required to keep and (c) of this section, and the 145 °F such records. Such records shall be (62.8 °C) temperature requirements of made available to the inspector or any paragraph (a) of this section. duly authorized representative of the (e) Each package of finished product Secretary upon request. shall be plainly and permanently (h) The handling and processing of marked on the immediate container cooked beef, roast beef, and cooked with the date of production either in corned beef before, during, and after code or with the calendar date. cooking shall be such as to prevent the (f) In order to assure that cooked finished product from being adulter- beef, roast beef, and cooked corned beef ated. As a minimum, they shall be are handled, processed, and stored controled as follows: under sanitary conditions, the estab- (1) The establishment shall notify the lishment shall submit a set of written inspector-in-charge which processing procedures through the inspector-in- procedure will be used on each lot, in- charge for approval by the Regional Di- cluding time and temperature. rector. The written procedures shall in- (2) In order to assure uniform heat clude the following information: penetration and consequent adequate (1) The temperature to which raw fro- cooking of each piece of beef, individ- ual pieces of raw product in any one lot zen product is thawed and the time re- shall either not vary in weight by more quired. than 2 pounds or not vary in thickness (2) The lot identification procedure by more than 2 inches at the thickest for lots of product during processing. part. Alternate methods of assuring (3) The storage time and temperature uniform heat penetration may be sub- combinations which the establishment mitted in writing for approval to the intends to use before cooking, the Regional Director. cooking time and temperature the es- (3) A water-based solution that is tablishment intends to use, and the used for injecting or immersing the time, if any, the establishment intends meat shall be refrigerated to 50 °F (10 to wait after cooking and before cool- °C) or lower from the time it contacts ing. the meat, and shall be filtered each (4) If a code, instead of the calendar time it is recirculated or reused. date, is used on the immediate con- (4) A nonmeat ingredient, including tainer of the finished product, its the water-based solution in (h)(3) meaning shall also be included. above, which has contacted meat shall
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be discarded at the end of that day’s product has been cooked shall contact production unless it is in continuous the Regional Director to determine the contact with one batch of product. disposition of that retained product. (5) Product prepared for cooking (i) Cooked beef, roast beef, and shall be entered into the cooking cycle cooked corned beef shall be so handled within 2 hours of completion of as to assure that the product is not re- precooking preparation, or be placed contaminated by direct contact with immediately in a cooler at a tempera- raw product. To prevent direct con- ° ° ture of 40 F (4.4 C) or lower. tamination of the cooked product, es- (6) The time and temperature re- tablishments shall: quirements shall be met before any (1) Physically separate areas where product in the lot is removed from the cooking units. Unless otherwise speci- raw product is handled from areas fied in the written procedures approved where exposed cooked product is han- in accordance with paragraph (f) of this dled, using a solid impervious floor to section, the heat source shall not be ceiling wall; or shut off until these requirements are (2) Handle raw and exposed cooked met. product at different times, with a (7) Other than incidental contact cleaning of the entire area after the caused by water currents during im- raw material handling is completed mersion cooking or cooling, product and prior to the handling of cooked shall be placed so that it does not product in that area; or touch or overlap other products. This (3) Submit a written procedure for provision does not apply to product approval through the inspector-in- that is stirred or agitated to assure charge to the Circuit Supervisor detail- uniform heat transfer. ing the steps to be taken which would (8) Temperature sensing devices shall avoid recontamination of cooked prod- be so placed that they monitor product uct by raw product during processing. in the coldest part of the cooking unit; (j) To prevent indirect contamination and when an oven temperature is re- of cooked product: quired by paragraph (c) of this section, (1) Any work surface, machine, or the oven temperature shall also be monitored in the coldest part of the tool which contacts raw product shall cooking unit. be thoroughly cleaned and sanitized (9) If a humidity sensing device is re- with a solution germicidally equiva- quired in an oven, it shall be placed so lent to 50 ppm chlorine before it con- that it measures humidity in either the tacts cooked product; oven chamber or at the exit vent. (2) Employees shall wash their hands (10) Chilling shall begin within 90 and sanitize them with a solution ger- minutes after the cooking cycle is micidally equivalent to 50 ppm chlo- completed. rine whenever they enter the heat (i) All product shall be chilled from processed product area or before pre- 120 °F (48.8 °C) to 55 °F (12.7 °C) in no paring to handle cooked product, and more than 6 hours. as frequently as necessary during oper- (ii) Chilling shall continue and the ations to avoid product contamination; product shall not be packed for ship- and ment until it has reached 40 °F (4.4 °C). (3) Outer garments, including aprons, (11) Any establishment that has expe- smocks, and gloves, shall be especially rienced a cooking process deviation identified as restricted for use in during preparation of product may ei- cooked product areas only, changed at ther reprocess the product completely, least daily, and hung in a designated continue the heating to 145 °F (62.8 °C), location when the employee leaves the or contact the Regional Director for a review of the process schedule for ade- area. quacy and, if needed, for a cooking (k) Cooked product shall not be schedule to finish that one batch of stored in the same room as raw product product. unless it is first packaged in a sealed, (12) An establishment that has expe- water-tight container or is otherwise rienced a cooling deviation after the protected by a covering that has been
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approved, upon written request, by the is traditional for bone-in product, and does Circuit Supervisor. not fit into Group I, Group II, or Group III shall be placed in this Group. (Approved by the Office of Management and Budget under control number 0583–0015) (3) A lot is that product from one pro- duction shift. [48 FR 24316, June 1, 1983] (4) A production rate is frequency of production, expressed in days per week. § 318.18 Handling of certain material for mechanical processing. (5) Protein fat free percentage, protein fat free content, PFF percentage, PFF Material to be processed into ‘‘Me- content or PFF of a product means the chanically Separated (Species)’’ shall meat protein (indigenous to the raw, be so processed within 1 hour from the unprocessed pork cut) content ex- time it is cut or separated from car- pressed as a percent of the non-fat por- casses or parts of carcasses, except tion of the finished product. that such product may be held for no (b) Normal Compliance Procedures. The more than 72 hours at 40 °F. (4 °C.) or Department shall collect samples of less, or held indefinitely at 0 °F. (¥18 cured pork products and analyze them °C.) or less. ‘‘Mechanically Separated for their PFF content. Analyses shall (Species)’’ shall, directly after being be conducted in accordance with the processed, be used as an ingredient in a meat food product except that it may ‘‘Official Methods of Analysis of the be held prior to such use for no more Association of Official Analytical than 72 hours at 40 °F. (4 °C.) or less or Chemists §§ 950.46, and 928.08 (Chapter 39).1 The ‘‘Official Methods of Analysis indefinitely at 0 °F. (¥18 °C.) or less. of the Association of Official Analyt- [43 FR 26423, June 20, 1978, as amended at 47 ical Chemists,’’ 15th edition, 1990, is in- FR 28256, June 29, 1982] corporated by reference with the ap- proval of the Director of the Federal § 318.19 Compliance procedure for cured pork products. Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Each analyt- (a) Definitions. For the purposes of ical result shall be recorded and evalu- this section: ated to determine whether future sam- (1) A product is that cured pork arti- pling of product Groups within an offi- cle which is contained within one cial establishment shall be periodic or Group as defined in paragraph (a)(2) of daily under the provisions of paragraph this section and which purports to (b)(1) of this section, and if the affected meet the criteria for a single product lot and subsequent production of like designated under the heading ‘‘Product product shall be U.S. retained, or ad- Name and Qualifying Statements’’ in ministratively detained, as appro- the chart in § 319.104 or the chart in priate, as provided in paragraph (b)(2) § 319.105. of this section.2 (2) A Product Group or a Group means one of the following: 1 A copy of the ‘‘Official Methods of Analy- Group I, consisting of cured pork products sis of the Association of Official Analytical which have been cooked while imperviously Chemists,’’ 15th edition, 1990, is on file with encased. Any product which fits into the the Director, Office of the Federal Register, Group will be placed in this Group regardless and may be purchased from the Association of any other considerations. of Official Analytical Chemists, Inc., 2200 Group II, consisting of cured pork products Wilson Boulevard, Suite 400, Arlington, Vir- which have been water cooked. Any product ginia 22201. which does not fit into Group I but does fit 2 Rules for Rounding: into Group II will be placed into Group II re- 1. Laboratory results for percent meat pro- gardless of any other considerations. tein and fat will be reported to the second Group III, consisting of boneless smoke- decimal place (hundredths). house heated cured pork products. Any 2. PFF and Sample Values for charting boneless product that does not fit into Group purposes will be calculated from the reported I or Group II shall be placed in Group III. laboratory results to the second decimal Group IV, consisting of bone-in or semi- place. Rounding of calculations to reach two boneless smokehouse heated cured pork decimal places will be done by the following products. Any product that is not completely rule: boneless or still contains all the bone which Continued
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(1) Criteria to determine sampling fre- Group Value exceed 1.00. When calcula- quency of Product Groups. For each offi- tion of a Group Value results in a fig- cial plant preparing cured pork prod- ure greater than 1.00, the Group Value ucts, Product Groups shall be sampled shall be 1.00 and all previous Sample periodically or daily. Analytical re- Values shall be ignored in determining sults shall be evaluated and the sam- future Group Values. pling frequency determined as follows: (vi) The frequency of sampling of a (i) Determine the difference between Group shall be periodic when the Group the individual PFF analysis and the Value is greater than ¥1.40 (e.g., ¥1.39, applicable minimum PFF percentage ¥1.14, 0, 0.50, etc.) and shall be daily requirement of § 319.104 or § 319.105. The when the Group Value is ¥1.40 or less resulting figure shall be negative when (e.g., ¥1.40, ¥1.45, ¥1.50, etc.); pro- the individual sample result is less vided, however, that once daily sam- than the applicable minimum PFF per- pling has been initiated, it shall con- centage requirement and shall be posi- tinue until the Group Value is 0.00 or tive when the individual sample result greater, and each of the last seven is greater than the applicable mini- Sample Values is ¥1.65 or greater (e.g., mum PFF percentage requirement. ¥1.63, ¥1.50, etc.), and there is no (ii) Divide the resulting number by other product within the affected the standard deviation assigned to the Group being U.S. retained as produced, Product Group represented by the sam- under provisions of paragraph (b)(2) or ple to find the Standardized Difference. (c). The standard deviation assigned to (2) Criteria for U.S. retention or admin- Groups I and II is 0.75 and to Groups III istrative detention of cured pork products and IV is 0.91. for further analysis. Cured prok prod- (iii) Add 0.25 to the Standardized Dif- ucts shall be U.S. retained, or adminis- ference to find the Adjusted Standard- tratively detained, as appropriate, ized Difference. when prescribed by paragraphs (b)(2) (i) (iv) Use the lesser of 1.90 and the Ad- or (ii) of this section as follows: justed Standardized Difference as the (i) Absolute Minimum PFF Require- Sample Value. ment. In the event that an analysis of (v) Cumulatively total Sample Val- an individual sample indicates a PFF ues to determine the Group Value. The content below the applicable minimum first Sample Value in a Group shall be requirement of § 319.104 or § 319.105 by the Group Value, and each succeeding 2.3 or more percentage points for a Group Value shall be determined by Group I or II product, or 2.7 or more adding the most recent Sample Value percentage points for a Group III or IV to the existing Group Value; provided, product, the lot from which the sample however, that in no event shall the was collected shall be U.S. retained if in an official establishment and shall All values of five-thousandths (0.005) or be subject to administrative detention more will be rounded up to the next highest if not in an official establishment un- hundredth. All values of less than five-thou- less returned to an official establish- sandths (0.005) will be dropped. ment and there U.S. retained. Any sub- 3. For compliance with the Absolute Mini- sequently produced lots of like product mum PFF requirements, the PFF will be and any lots of like product for which rounded to the first decimal place (tenths). production dates cannot be established Rounding of calculations to reach one deci- mal place will be done by the following rule: shall be U.S. retained or subject to ad- All PFF values of five-hundredths (0.05) or ministrative detention. Such adminis- more will be rounded up to the next highest tratively detained product shall be tenth. All PFF values of less than five-hun- handled in accordance with part 329 of dredths (0.05) will be dropped. this subchapter, or shall be returned to 4. For product disposition (pass-fail of a an official establishment and subjected minimum PFF standard for retained prod- to the provisions of paragraph (c)(1) (i) uct) the average PFF calculation will be or (ii) of this section, or shall be re- rounded to the first decimal place. Individ- ual PFF Values will be calculated to the labeled in compliance with the applica- nearest hundredth as in (2) above. The aver- ble standard, under the supervision of a age, however, will be rounded to the nearest program employee, at the expense of tenth as in (3) above. the product owner. Disposition of such
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U.S. retained product shall be in ac- paragraph (c)(1), subsequently produced cordance with paragraph (c) of this sec- lots of like product shall continue to be tion. U.S. retained until discontinued pursu- (ii) Product Value requirement. The ant to paragraph (c)(2) of this section. Department shall maintain, for each (c) Compliance procedure during prod- product prepared in an official estab- uct retention. When a product lot is U.S. lishment, a Product Value. Except as retained under the provisions of para- provided in paragraph (c)(2) of this sec- graph (b)(2) of this section, the Depart- tion, calculation of the Product Value ment shall collect three randomly se- and its use to determine if a product lected samples from each such lot and shall be U.S. retained shall be as fol- analyze them individually for PFF con- lows: tent. The PFF content of the three (A) Determine the difference between samples shall be evaluated to deter- the individual PFF analysis and appli- mine disposition of the lot as provided cable minimum PFF percentage re- in paragraph (c)(1) of this section and quirement of § 319.104 and § 319.105. The the action to be taken on subsequently resulting figure shall be negative when produced lots of like product as pro- the individual sample result is less vided in paragraph (c)(2) of this sec- than the applicable minimum PFF per- tion.3 centage requirement and shall be posi- (1) A product lot which is U.S. re- tive when the individual sample result tained under the provisions of para- is greater than the applicable mini- graph (b)(2) of this section may be re- mum PFF percentage requirement. leased for entry into commerce pro- (B) Divide the difference determined vided one of the following conditions is in paragraph (b)(2)(ii)(A) of this section met: by the standard deviation assigned to (i) The average PFF content of the the product’s Group in paragraph three samples randomly selected from (b)(1)(ii) of this section to find the the lot is equal to or greater than the standardized difference. applicable minimum PFF percentage (C) Use the lesser of 1.65 and the required by § 319.104 or § 319.105. Further standardized difference as the Sample processing to remove moisture for the Value. purpose of meeting this provision is (D) Cumulatively total Sample Val- permissible. In lieu of further analysis ues to determine the Product Value. to determine the effects of such proc- The first Sample Value of a product essing, each 0.37 percent weight reduc- shall be the Product Value, and each tion due to moisture loss resulting succeeding Product Value shall be de- from the processing may be considered termined by adding the most recent the equivalent of a 0.1 percent PFF Sample Value to the existing Product gain. Value; provided, however, that in no (ii) The lot of the product is relabeled event shall the Product Value exceed to conform to the provisions of § 319.104 1.15. When calculation of a Product or § 319.105, under the supervision of a Value results in a figure greater than program employee. 1.15, the Product Value shall be 1.15, (iii) The lot is one that has been pre- and all previous Sample Values shall be pared subsequent to preparation of the ignored in determining future Product lot which, under the provisions of para- Values. graph (c)(2) of this section, resulted in (E) Provided daily group sampling is discontinuance of U.S. retention of new in effect pursuant to the provisions of lots of like product. Such lot may be paragraph (b)(1) of this section, and released for entry into commerce prior provided further the Product Value is ¥1.65 or less (e.g., ¥1.66), the affected 3 If the processor does not wish to have the lot (if within the official establish- product evaluated in this manner, alternate ment) and all subsequent lots of like sampling plans may be used provided such product prepared by and still within plans have been formulated by the processor and approved by the Administrator prior to the official establishment shall be U.S. evaluation by the three-sample criteria, and retained and further evaluated under provided the analyses specified in such plans paragraph (c) of this section. Except are performed at the expense of the proc- for release of individual lot pursuant to essor.
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to receipt of analytical results for graph (b)(2)(i) of this section. Should which sampling has been conducted. an individual sample fail to meet its Upon receipt of such results, they shall Absolute Minimum PFF requirement, be subjected to the provisions of para- the 5-day count shall begin anew. graphs (b)(2)(i) and (c)(2) of this sec- (vii) When U.S. retention of new lots tion. is discontinued under the above provi- (2) The PFF content of three ran- sions, maintenance of the Product domly selected samples from each U.S. Value shall revert to the provisions of retained lot shall be used to maintain paragraph (b)(2)(ii) of this section. the Product Value described in para- (3) For purposes of this section, the graph (c)(2)(ii). The manner and effect plant owner or operator shall have the of such maintenance shall be as fol- option of temporarily removing a prod- lows: (i) Find the average PFF content of the three samples. uct from its Product Group, provided (ii) Determine the difference between product lots are being U.S. retained, as that average and the applicable mini- produced, and provided further that the mum PFF percentage requirement of average production rate of the product, § 319.104 or § 319.105. The resulting figure over the 8-week period preceding the shall be negative when the average of week in which the first U.S. retained the sample results is less than the ap- lot was prepared, is not greater than 20 plicable minimum PFF percentage re- percent of the production rate of its quirement and shall be positive when Group. When a product is thus removed the average of the sample results is from its Group, analytical results of greater than the applicable minimum product samples shall not cause daily PFF requirements. sampling of the Group. When pursuant (iii) Divide the resulting figure by to paragraph (c)(2)(vi) of this section, the standard deviation assigned to the new lots of the product are no longer product’s Group in paragraph (b)(1)(ii) being U.S. retained, the product shall of this section, to find the standardized again be considered with its Group. difference. (d) Adulterated and misbranded prod- (iv) Use the lesser of 1.30 and the ucts. Products not meeting specified standardized difference as the Sample PFF requirements, determined accord- Value. ing to procedures set forth in this sec- (v) Add the first Sample Value thus tion, may be deemed adulterated under calculated to the latest Product Value section 1(m)(8) of the Act (21 U.S.C. calculated under the provisions of 601(m)(8)) and misbranded under sec- paragraph (c)(2)(ii) of this section to tion 1(n) of the Act (21 U.S.C. 601(n)). find the new Product Value. To find (e) Quality control. Cured pork prod- each succeeding Product Value, add the ucts bearing on their labeling the most recent Sample Value to the exist- statement ‘‘X% of Weight is Added In- ing Product Value; provided, however, gredients’’ shall be prepared only under that in no event shall the Product a quality control system or program in Value exceed 1.15. When the addition of a Sample Value to an existing Product accordance with § 318.4 of this sub- Value results in a figure greater than chapter. With respect to any other 1.15, the Product Value shall be 1.15 and cured pork product, official establish- all previous Sample Values shall be ig- ments may institute quality control nored in determining future Product procedures under § 318.4 of this sub- Values. chapter. Cured pork products produced (vi) New lots of like product shall in such establishments may be exempt continue to be retained pending dis- from the requirements of this section, position in accordance with paragraph provided inplant quality control proce- (c)(1) of this section until, after 5 days dures are shown to attain the same or of production, the Product Value is 0.00 higher degree of compliance as the pro- or greater, and the PFF content of no cedures set forth in this section; pro- individual sample from a U.S. retained vided, however, that all cured pork lot is less than the Absolute Minimum products produced shall be subject to PFF requirement specified in para- the applicable Absolute Minimum PFF
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content requirement, regardless of any Analytical Chemists,’’ 15th edition, quality control procedures in effect. 1990.1 The ‘‘Official Methods of Analy- sis of the Association of Official Ana- [49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 59 FR 33642, June 30, lytical Chemists,’’ 15th edition, 1990, is 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, incorporated by reference with the ap- Aug. 25, 1997] proval of the Director of the Federal Register in accordance with 5 U.S.C. § 318.20 Use of animal drugs. 552(a) and 1 CFR part 51. Animal drug residues are permitted Chemical residue misidentification— see in meat and meat food products if such ‘‘correct chemical residue identifica- residues are from drugs which have tion’’ definition. been approved by the Food and Drug Coefficient of variation (CV)— The Administration and any such drug resi- standard deviation of a distribution of dues are within tolerance levels ap- analytical values multiplied by 100, and proved by the Food and Drug Adminis- divided by the mean of those values. tration, unless otherwise determined Comparison Mean—The average, for a by the Administrator and listed herein. sample, of all accredited and FSIS lab- oratories’ average results, each of [50 FR 32165, Aug. 9, 1985] which has a large deviation measure of zero, except when only two labora- § 318.21 Accreditation of chemistry laboratories. tories perform the analysis, as in the case of split sample analysis by both an (a) Definitions—Accredited laboratory— accredited laboratory and an FSIS lab- A non-Federal analytical laboratory oratory. In the latter case, the com- that has met the requirements for ac- parison mean is the average of the two creditation specified in this section laboratories’ results. For food chem- and hence, at an establishment’s dis- istry, a result for a laboratory is the cretion, may be used in lieu of an FSIS obtained analytical value; for chemical laboratory for analyzing official regu- residues, a result is the logarithmic latory samples. Payment for the analy- transformation of the obtained analyt- sis of official samples is to be made by ical value. the establishment using the accredited Correct chemical residue identifica- laboratory. tion—Correct identification by a lab- Accreditation—Determination by oratory of a chemical residue whose FSIS that a laboratory is qualified to concentration, in a sample, is equal to analyze official samples of product sub- or greater than the minimum reporting ject to regulations in this subchapter level for that residue, as determined by and part 381 of this chapter for the the median of all positive analytical presence and amount of all four food values obtained by laboratories analyz- chemistry analytes (protein, moisture, ing the sample. Failure of a laboratory fat, and salt); or a determination by to report the presence such a chemical FSIS that a laboratory is qualified to residue is considered a misidentifi- analyze official samples of product sub- cation. In addition, reporting the pres- ject to regulations in this subchapter ence of a residue at a level equal to or and part 381 of this chapter for the above the minimum reporting level presence and amount of one of several that is not reported by 90 percent or classes of chemical residue, in accord- more of all other laboratories analyz- ance with the requirements of the Ac- ing the sample, is considered a credited Laboratory Program. Accredi- tations are granted separately for the misidentification. CUSUM—A class of statistical proce- food chemistry analysis of official sam- ples and for the analysis of such sam- dures for assessing whether or not a ples for any one of the several classes of chemical residue. A laboratory may 1 A copy of the ‘‘Official Methods of Analy- hold more than one accreditation. sis of the Association of Official Analytical AOAC methods—Methods of chemical Chemists,’’ 15th edition, 1990, is on file with the Director, Office of the Federal Register, analysis, Chapter 39, Association of Of- and may be purchased from the Association ficial Analytical Chemists (AOAC), of Official Analytical Chemists, Inc., 2200 published in the ‘‘Official Methods of Wilson Boulevard, Suite 400, Arlington, Vir- Analysis of the Association of Official ginia 22201.
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process is ‘‘in control’’. Each CUSUM which an analytical result will be used value is constructed by accumulating to assess a laboratory’s quantification incremental values obtained from ob- capability. This concentration is an es- served results of the process, and then timate of the smallest concentration determined to either exceed or fall for which the average coefficient of within acceptable limits for that proc- variation (CV) for reproducibility (i.e., ess. The initial CUSUM values for each combined within and between labora- laboratory whose application for ac- tory variability) does not exceed 20 per- creditation is accepted are set at zero. cent. (See Table 2) The four CUSUM procedures are: Minimum reporting level—The number (1) Positive systemic laboratory dif- such that if any obtained analytical ference CUSUM (CUSUM–P)—monitors value equals or exceeds this number, how consistently an accredited labora- then the residue is reported together tory gets numerically greater results with the obtained analytical value. than the comparison mean; Official Sample—A sample selected by (2) Negative systematic laboratory a Program employee in accordance difference CUSUM (CUSUM–N)—mon- with FSIS procedures for regulatory itors how consistently an accredited use. laboratory gets numerically smaller Probation— The period commencing results than the comparison mean; with official notification to an accred- (3) Variability CUSUM (CUSUM–V)— ited laboratory that its check or split monitors the average ‘‘total discrep- sample results no longer satisfy the ancy’’ (i.e., the combination of the ran- performance requirements specified in dom fluctuations and systematic dif- this rule, and ending with official noti- ferences) between an accredited labora- fication that accreditation is either tory’s results and the comparison fully restored, suspended, or revoked. mean; QA (quality assurance) recovery—The (4) Individual large discrepancy ratio of a laboratory’s unadjusted ana- CUSUM (CUSUM–D)—monitors the lytical value of a check sample residue magnitude and frequency of large dif- to the residue level fortified by the ferences between the results of an ac- FSIS laboratory that prepared the credited laboratory and the comparison sample, multiplied by 100. (See Table mean. 2.) Individual large deviation—An analyt- QC (quality control) recovery—The ical result from a non-Federal labora- ratio of a laboratory’s unadjusted ana- tory that differs from the sample com- lytical value of a quality control stand- parison mean by more than would be ard to the fortification level of the expected assuming normal laboratory standard, multiplied by 100. (See Table variability. 2.) Initial accreditation check sample—A Refusal of Accreditation—An action sample prepared and sent by an FSIS taken when a laboratory which is ap- laboratory to a non-Federal laboratory plying for accreditation is denied the to ascertain if the non-Federal labora- accreditation. tory’s analytical capability meets the Responsibly connected—Any individual standards for granting accreditation. who or entity which is a partner, offi- Interlaboratory accreditation mainte- cer, director, manager, or owner of 10 nance check sample—A sample prepared per centum or more of the voting stock and sent by FSIS to a non-Federal lab- of the applicant or recipient of accredi- oratory to assist in determining if ac- tation or an employee in a managerial ceptable levels of analytical capability or executive capacity or any employee are being maintained by the accredited who conducts or supervises the chemi- laboratory. cal analysis of FSIS official samples. Large deviation measure—A measure Revocation of Accreditation—An action that quantifies an unacceptably large taken against a laboratory which re- difference between a non-Federal lab- moves its right to analyze official sam- oratory’s analytical result and the ples. sample comparison mean. Split sample— An official sample di- Minimum proficiency level—The mini- vided into duplicate portions, one por- mum concentration of a residue at tion to be analyzed by an accredited
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laboratory (for official regulatory pur- lationship. A laboratory that is report- poses) and the other portion by an ing, on average, numerically greater FSIS laboratory (for comparison pur- results than the comparison mean has poses). a positive systematic laboratory dif- Standardizing Constant—The number ference and, conversely, numerically which is the result of a mathematical smaller results indicate a negative sys- adjustment to the ‘‘standardized tematic laboratory difference. value.’’ Specifically, the number equals Variability— Random fluctuations in the square root of the expected vari- a laboratory’s processes that cause its ance of the difference between the ac- analytical results to deviate from a credited or applying laboratory’s result true value. and the comparison mean on a sample, Variance—The expected average of taking into consideration the standard- the squared differences of sample re- izing value, the correlation and number sults from an expected sample mean. of repeated results by a laboratory on a sample, and the number of laboratories TABLE 1.ÐSTANDARDIZING VALUES FOR FOOD that analyzed the sample. CHEMISTRY Standardized Difference—The quotient [By product class and analyte] of the difference between a laboratory’s Product/ result on a sample and the comparison Moisture Protein 1 Fat 2 Salt 3 mean of the sample divided by the Class standardizing constant. Cured Standardizing Value—A number rep- Pork/ resenting the performance standard de- Cann- ed viation of an individual result (see Ta- Ham .. 0.50 0.060 0.26 (0.30) 0.127 bles 1 and 2 and footnotes to the Tables Ground for determining exact procedures for Beef .. 0.71 0.060 (0.35) 0.127 calculation). Other .... 0.57 0.060 0.26 (0.30) 0.127 Suspension of Accreditation—Action 1 To obtain the standardizing value for a sample the appro- taken against a laboratory which tem- priate entry in this column is multiplied by X0.65 where X is the comparison mean of the sample. porarily removes its right to analyze 2 To obtain the standardizing value for a sample, the appro- official samples. Suspension of accredi- priate entry in this column is multiplied by X0.25, where X is the comparison mean of the sample. The appropriate entry is tation ends when accreditation is ei- equal to the value in parentheses when X is equal to or great- ther fully restored or revoked. er than 12.5 percent, otherwise it is equal to 0.26. 3 To obtain the standardizing value for a sample, when the Systematic laboratory difference—A comparison mean of the sample, X, is less than 1.0 percent, comparison of one laboratory’s results the standardizing value equals 0.127, otherwise the appro- priate entry is multiplied by X0.25. When X is equal to or great- with the comparison means on samples er than 4.0 percent for dry salami and pepperoni products, the that shows, on average, a consistent re- standardizing value equals 0.22.
TABLE 2.ÐMINIMUM PROFICIENCY LEVELS, PERCENT EXPECTED RECOVERIES (QC AND QA), AND STANDARDIZING VALUES FOR CHEMICAL RESIDUES
Minimum pro- Percent expected Standardizing Class of residues recovery (QC and 3 ficiency level QA) value
Chlorinated Hydrocarbons:1 Aldrin ...... 0.10 ppm 80±110 0.20 Benzene Hexachloride ...... 0.10 ppm 80±110 0.20 Chlordane ...... 0.30 ppm 80±110 0.20 Dieldrin ...... 0.10 ppm 80±110 0.20 DDT ...... 0.15 ppm 80±110 0.20 DDE ...... 0.10 ppm 80±110 0.20 TDE ...... 0.15 ppm 80±110 0.20 Endrin ...... 0.10 ppm 80±110 0.20 Heptachlor ...... 0.10 ppm 80±110 0.20 Heptachlor Epoxide ...... 0.10 ppm 80±110 0.20 Lindane ...... 0.10 ppm 80±110 0.20 Methoxychlor ...... 0.50 ppm 80±110 0.20 Toxaphene ...... 1.00 ppm 80±110 0.20 Hexachlorobenzene ...... 0.10 ppm 80±110 0.20 Mirex ...... 0.10 ppm 80±110 0.20 Nonachlor ...... 0.15 ppm 80±110 0.20 Polychlorinated Biphenyls: 0.50 ppm 80±110 0.20 Arsenic 2 ...... 0.20 ppm 90±105 0.25 Sulfonamides 2 ...... 0.08 ppm 70±120 0.25
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TABLE 2.ÐMINIMUM PROFICIENCY LEVELS, PERCENT EXPECTED RECOVERIES (QC AND QA), AND STANDARDIZING VALUES FOR CHEMICAL RESIDUESÐContinued
Minimum pro- Percent expected Standardizing Class of residues recovery (QC and 3 ficiency level QA) value
Volatile Nitrosamine 2 ...... 5 ppm 70±110 0.25 1 Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical residues. 2 Laboratory statistics are only computed for specific chemical residues. 3 The standardizing value of all initial accreditation and probationary check samples computations is 0.15.
(b) Laboratories accredited for analysis and shall be credited to the account of protein, moisture, fat, and salt content from which the expenses of the labora- of meat and meat products— tory accreditation program are paid. (1) Applying for accreditation. Applica- (iii) Annually on the anniversary tion for accreditation shall be made on date of each accreditation, FSIS will designated forms provided by FSIS, or issue a bill in the amount specified in otherwise in writing, by the owner or 9 CFR 391.5. manager of a non-Federal analytical (iv) Bills are payable upon receipt by laboratory and sent to the Accredited check, bank draft, or money order, Laboratory Program, room 516–A, made payable to the U.S. Department Annex Building, Food Safety and In- of Agriculture, and become delinquent spection Service, U.S. Department of 30 days from the date of the bill. Ac- Agriculture, 300 12th Street SW., Wash- ington, DC 20250–3700, and shall specify creditation will be terminated without the kinds of accreditation that are further procedure for having a delin- wanted by the owner or manager of the quent account. The fee(s) paid shall be laboratory. A laboratory whose accred- nonrefundable and shall be credited to itation has been refused or revoked the account from which the expenses of may reapply for accreditation after 60 the Accredited Laboratory Program days from the effective date of that ac- are paid. tion, and must provide written docu- (v) The accreditation of a laboratory mentation specifying what corrections that was accredited by FSIS on or be- were made. fore December 13, 1993 and was not on (i) At the time that an Application probation and whose accreditation on for Accreditation is filed with the Ac- that date was not in suspension or rev- credited Laboratory Program, FSIS, ocation shall be continued, provided and annually thereafter upon receipt of that such laboratory reapply for ac- the bill issued by FSIS on the anniver- creditation in accordance with the pro- sary date of each accreditation, the visions of this paragraph (b)(1) by Jan- management of a laboratory shall re- uary 12, 1994 (30 days after the effective imburse the program at the rate speci- date of this section), and that the re- fied in 9 CFR 391.5 for the cost of each application be accepted by the Agency. accreditation that is sought for the The CUSUM values for such laboratory laboratory or that the laboratory will be reset at zero upon acceptance of holds. its reapplication. The accreditation of (ii) Simultaneously with the initial a laboratory that is on probation shall application for accreditation, the man- be continued, provided that the labora- agement of a laboratory shall forward a check, bank draft, or money order in tory reapply for accreditation by Feb- the amount specified in 9 CFR 391.5 ruary 11, 1994 (60 days after the effec- made payable to the U.S. Department tive date of this section), that the re- of Agriculture along with the com- application be accepted by the Agency, pleted application for the accredita- and that the laboratory satisfy the tion(s) sought by the laboratory. Ac- terms of the probation. creditation will not be granted or con- (2) Criteria for obtaining accreditation. tinued, without further procedure, for Non-Federal analytical laboratories failure to pay the accreditation fee(s). may be accredited for the analyses of The fee(s) paid shall be nonrefundable moisture, protein, fat, and salt content
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of meat and meat food products. Ac- the standard deviation of the standard- creditation will be given only if the ap- ized differences. plying laboratory successfully satisfies (B) Variability: The estimated stand- the requirements presented below, for ard deviation of the standardized dif- all four analytes. This accreditation ferences must not exceed 1.15. authorizes official FSIS acceptance of (C) Individual large deviations: One the analytical test results provided by hundred times the average of the large these laboratories on official samples. deviation measures of the individual To obtain FSIS accreditation for mois- samples must be less than 5.0.3 ture, protein, fat, and salt analyses, a (iii) Allow inspection of the labora- non-Federal analytical laboratory tory by FSIS officials prior to the de- must: termination of granting accredited sta- (i) Be supervised by a person holding, tus. as a minimum, a bachelor’s degree in (iv) Pay the accreditation fee by the either chemistry, food science, food date required. technology, or a related field and hav- (3) Criteria for maintaining accredita- ing 1 year’s experience in food chem- tion. To maintain accreditation for istry, or equivalent qualifications, as moisture, protein, fat, and salt analy- determined by the Administrator. ses, a non-Federal analytical labora- (ii) Demonstrate acceptable levels of tory must: systematic laboratory difference, vari- (i) Report analytical results of the ability, and individual large deviations moisture, protein, fat, and salt content in the analyses of moisture, protein, of official samples, weekly, on des- fat, and salt content using AOC meth- ignated forms to the FSIS Eastern ods. An applying laboratory will suc- Laboratory, College Station Road, P.O. cessfully demonstrate these capabili- Box 6085, Athens, GA 30604, or to the ties if its moisture, protein, fat, and address designated by the Quality Sys- salt results from a 36 check sample ac- tems Branch, FSIS Chemistry Division. creditation study each satisfy the cri- (ii) Maintain laboratory quality con- teria presented below.2 If the labora- trol records for the most recent 3 years tory’s analysis of an analyte (or that samples have been analyzed under analytes) from the first set of 36 check this Program. samples does not meet the criteria for (iii) Maintain complete records of the obtaining accreditation, a second set of receipt, analysis, and disposition of of- 36 check samples will be provided with- ficial samples for the most recent 3 in 30 days following the date of receipt years that samples have been analyzed by FSIS of a request from the applying under this Program. laboratory. The second set of samples (iv) Maintain a standards book, shall be analyzed for only the which is a permanently bound book analyte(s) for which unacceptable ini- with sequentially numbered pages, con- tial results had been obtained by the taining all readings and calculations laboratory. If the results of the second for standardization of solutions, deter- set of samples do not meet the accredi- mination of recoveries, and calibration tation criteria, the laboratory may re- of instruments. All entries are to be apply after a 60-day waiting period, dated and signed by the analyst imme- commencing from the date of refusal of diately upon completion of the entry accreditation by FSIS. At that time, a and by his/her supervisor within 2 new application, all fees, and all docu- working days. The standards book is to mentation of corrective action re- be retained for a period of 3 years after quired for accreditation must be sub- the last entry is made. mitted. (v) Analyze interlaboratory accredi- (A) Systematic laboratory difference: tation maintenance check samples and The absolute value of the average return the results to FSIS within 3 standardized difference must not ex- ceed 0.73 minus the product of 0.17 and 3 A result will have a large deviation meas- ure equal to zero when the absolute value of 2 All statistical computations are rounded the result’s standardized difference, (d), is to the nearest tenth, except where otherwise less than 2.5, and otherwise a measure equal noted. to 1–(2.5/d)4.
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weeks of sample receipt. This must be tween the accredited laboratory’s re- done whenever requested by FSIS and sult and that of the FSIS laboratory at no cost to FSIS. for each split or interlaboratory ac- (vi) Inform the Accredited Labora- creditation maintenance check sample tory Program, room 516–A, Annex is used to determine a CUSUM value, Building, Food Safety and Inspection designated as CUSUM–P. This value is Service, U.S. Department of Agri- computed and evaluated as follows: culture, 300 12th Street, SW., Washing- (i) Determine the CUSUM increment ton, DC 20250–3700, by certified or reg- for the sample. The CUSUM increment istered mail, within 30 days, when is set equal to: there is any change in the laboratory’s ownership, officers, directors, super- 2.0, if the standardized difference is greater visory personnel, or other responsibly than 1.6, connected individual or entity. ¥2.0, if the standardized difference is less than ¥1.6, (vii) Permit any duly authorized rep- or resentative of the Secretary to perform the standardized difference minus 0.4, if the both announced and unannounced on- standardized difference lies between ¥1.6 site laboratory reviews of facilities and and 2.4, inclusive. records during normal business hours, and to copy any records pertaining to (ii) Compute the new CUSUM–P the laboratory’s participation in the value. The new CUSUM–P value is ob- Accredited Laboratory Program. tained by adding algebraically, the CUSUM increment to the last pre- (viii) Use official AOAC methods 4 on official and check samples. The ‘‘Offi- viously computed CUSUM–P value. If cial Methods of Analysis of the Asso- this computation yields a value small- ciation of Official Analytical Chem- er than 0, the new CUSUM–P value is ists,’’ 15th edition, 1990, is incorporated set equal to 0. [CUSUM–P values are by reference with the approval of the initialized at zero; that is, the CUSUM– Director of the Federal Register in ac- P value associated with the first sam- cordance with 5 U.S.C. 552(a) and 1 CFR ple is set equal to the CUSUM incre- part 51. ment for that sample.] (ix) Demonstrate that acceptable (iii) Evaluate the new CUSUM–P limits of systematic laboratory dif- value. The new CUSUM–P value must ference, variability, and individual not exceed 5.2. large deviations are being maintained (2) Negative systematic laboratory dif- in the analyses of moisture, protein, ference: The standardized difference be- fat, and salt content. An accredited tween the accredited laboratory’s re- laboratory will successfully dem- sult and that of the FSIS laboratory onstrate the maintenance of these ca- for each split or interlaboratory ac- pabilities if its moisture, protein, fat, creditation maintenance check sample and salt results from interlaboratory is used to determine a CUSUM value, accreditation maintenance check sam- designated as CUSUM–N. This value is ples and/or split samples satisfy the computed and evaluated as follows: criteria presented below.5 (i) Determine the CUSUM increment (A) Systematic laboratory difference: for the sample. The CUSUM increment (1) Positive systematic laboratory dif- is set equal to: ference: The standardized difference be- 2.0, if the standardized difference is greater than 1.6, 4 A copy of the ‘‘Official Methods of Analy- sis of the Association of Analytical Chem- ¥2.0, if the standardized difference is less ists,’’ 15th edition, 1990, is on file with the than ¥2.4, Director, Office of the Federal Register, and or may be purchased from the Association of the standardized difference plus 0.4, if the Official Analytical Chemists, Inc., 2200 Wil- standardized difference lies between ¥2.4 and son Boulevard, Suite 400, Arlington, Virginia 1.6, inclusive. 22201. 5 All statistical computations are rounded (ii) Compute the new CUSUM–N to the nearest tenth, except where otherwise value. The new CUSUM–N value is ob- noted. tained by subtracting, algebraically,
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the CUSUM increment to the last pre- tained by adding, algebraically, the viously computed CUSUM–N value. If CUSUM increment to the last pre- this computation yields a value small- viously computed CUSUM–D value. If er than 0, the new CUSUM–N value is this computation yields a value less set equal to 0. [CUSUM–N values are that 0, the new CUSUM–D value is set initialized at zero; that is, the CUSUM– equal to 0. [CUSUM–D values are N value associated with the first sam- initialized at zero; that is, the CUSUM– ple is set equal to the CUSUM incre- D value associated with the first sam- ment for that sample.] ple is set equal to the CUSUM incre- (iii) Evaluate the new CUSUM–N ment for that sample.] value. The new CUSUM–N value must (3) Evaluate the new CUSUM–D not exceed 5.2. value. The new CUSUM–D value must (B) Variability: The absolute value of not exceed 1.0. the standardized difference between (x) Meet the following requirements the accredited laboratory’s result and if placed on probation pursuant to that of the FSIS laboratory for each paragraph (e) of this section: split sample or interlaboratory accred- (A) Send all official samples that itation maintenance check sample is have not been analyzed as of the date used to determine a CUSUM value, des- of written notification of probation to ignated as CUSUM–V. This value is a specified FSIS laboratory by certified computed and evaluated as follows: mail or private carrier or, as an alter- (1) Determine the CUSUM increment native, to an accredited laboratory ap- for the sample. The CUSUM increment proved for food chemistry. Mailing ex- is set equal to the larger of ¥0.4 and penses will be paid by FSIS. the absolute value of the standardized (B) Analyze a set of check samples difference minus 0.9. If this computa- similar to those used for initial accred- tion yields a value larger than 1.6, the itation, and submit the analytical re- increment is set equal to 1.6. sults to FSIS within 3 weeks of receipt (2) Compute the new CUSUM–V of the samples. value. The new CUSUM–V value is ob- (C) Satisfy criteria for check samples tained by adding, algebraically, the specified in paragraphs (b)(2)(ii) (A), CUSUM increment to the last pre- (B), and (C) of this section. viously computed CUSUM–V value. If (xi) Expeditiously report analytical this computation yields a value less results of official samples to the FSIS than 0, the new CUSUM–V value is set Eastern Laboratory, College Station equal to 0. [CUSUM–V values are Road, P.O. Box 6085, Athens, GA 30604, initialized at zero; that is, the CUSUM– or to the address designated by the V value associated with the first sam- Quality Systems Branch, FSIS Chem- ple is set equal to the CUSUM incre- istry Division. The Federal inspector ment for that sample.] at any establishment may assign the (3) Evaluate the new CUSUM–V analysis of official samples to an FSIS value. The new CUSUM–V value must laboratory if, in the inspector’s judg- not exceed 4.3. ment, there are delays in receiving test (C) Large deviations: The large devi- results on official samples from an ac- ation measure of the accredited labora- credited laboratory. tory’s result for each split sample or (xii) Pay the required accreditation interlaboratory accreditation mainte- fee when it is due. nance check sample is used to deter- (c) Laboratories accredited for analysis mine a CUSUM value, designated as of a class of chemical residues in meat and CUSUM–D.6 This value is computed and meat food products. evaluated as follows: (1) Applying for accreditation. Applica- (1) Determine the CUSUM increment tion for accreditation shall be made on for the sample. The CUSUM increment designated forms provided by FSIS, or is set equal to the value of the large de- otherwise in writing, by the owner or viation measure minus 0.025. manager of the non-Federal analytical (2) Compute the new CUSUM–D laboratory and sent to the Accredited value. The new CUSUM–D value is ob- Laboratory Program, room 516–A, Annex Building, Food Safety and In- 6 See footnote 3. spection Service, U.S. Department of
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Agriculture, 300 12th Street, SW., that date was not in suspension or rev- Washington, DC 20250–3700, and shall ocation shall be continued, provided specify the kinds of accreditation that that such laboratory reapply for ac- are wanted by the owner or manager of creditation in accordance with the pro- the laboratory. A laboratory whose ac- visions of this paragraph (c)(1), by Jan- creditation has been refused or revoked uary 12, 1994 (30 days of the effective may reapply for accreditation after 60 date of this section), and that the re- days from the effective date of that ac- application be accepted by the Agency. tion, and must provide written docu- The CUSUM values for such laboratory mentation specifying what corrections will be reset at zero upon acceptance of were made. its reapplication. The accreditation of (i) At the time that an Application a laboratory that is on probation shall for Accreditation is filed with the Ac- be continued, provided that such lab- credited Laboratory Program, FSIS, oratory reapply for accreditation by and annually thereafter upon receipt of February 11, 1994 (60 days of the effec- the bill issued by FSIS on the anniver- tive date of this section), that the re- sary date of each accreditation, the application be accepted by the Agency, management of a laboratory shall re- and that the laboratory satisfy the imburse the program at the rate speci- terms of the probation. fied in 9 CFR 391.5 for the cost of each (2) Criteria for obtaining accreditation. accreditation that is sought for the Non-Federal analytical laboratories laboratory or that the laboratory may be accredited for the analysis of a holds. class of chemical residues in meat and (ii) Simultaneously with the initial meat food products. Accreditation will application for accreditation, the man- be given only if the applying labora- agement of a laboratory shall forward tory successfully satisfies the require- a check, bank draft, or money order in ments presented below. This accredita- the amount specified in 9 CFR 391.5 tion authorizes official FSIS accept- made payable to the U.S. Department ance of the analytical test results pro- of Agriculture along with the com- vided by these laboratories on official pleted application for the accredita- samples. To obtain FSIS accreditation tion(s) sought for the laboratory. Ac- for the analysis of a class of chemical creditation will not be granted or con- residues, a non-Federal analytical lab- tinued, without further procedure, for oratory must: failure to pay the accreditation fee(s). (i) Be supervised by a person holding, The fee(s) paid shall be nonrefundable as a minimum, a bachelor’s degree in and shall be credited to the account from which the expenses of the labora- either chemistry, food science, food tory accreditation program are paid. technology, or a related field. Further, (iii) Annually on the anniversary either the supervisor or the analyst as- date of each accreditation, FSIS will signed to analyze the sample must issue a bill in the amount specified in have 3 years’ experience determining 9 CFR 391.5. analytes at or below part per million (iv) Bills are payable upon receipt by levels, or equivalent qualifications, as check, bank draft, or money order, determined by the Administrator. made payable to the U.S. Department (ii) Demonstrate acceptable limits of of Agriculture, and become delinquent systematic laboratory difference, vari- 30 days from the date of the bill. Ac- ability, individual large deviations, re- creditation will be terminated without coveries, and proper identification in further procedure for having a delin- the analysis of the class of chemical quent account. The fee(s) paid shall be residues for which application was nonrefundable and shall be credited to made, using FSIS approved procedures. the account from which the expenses of An applying laboratory will success- the Accredited Laboratory Program fully demonstrate these capabilities if are paid. its analytical results for each specific (v) The accreditation of a laboratory chemical residue provided in a check that was accredited by FSIS on or be- sample accreditation study containing fore December 13, 1993 and was not on a minimum of 14 samples satisfy the probation and whose accreditation on criteria presented in this paragraph
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(c)(2)(ii).7 In addition, if the laboratory given in Table 2 under the column enti- is requesting accreditation for the tled ‘‘Percent Expected Recovery.’’ analysis of chlorinated hydrocarbons, (E) QC recovery: All QC recoveries all analytical results for the residue must lie within the range given in class must collectively satisfy the cri- Table 2 under ‘‘Percent Expected Re- teria. [Conformance to criteria (c)(2)(ii) covery.’’ Supporting documentation (A), (B), (C), (D), (E), and (F) will only must be made available to FSIS upon be determined when six or more ana- request. lytical results with associated com- (F) Correct identification: There must parison means at or above the loga- be correct identification of all chemi- rithm of the minimum proficiency cal residues in all samples. level are available.] If the results of (iii) Allow inspection of the labora- the first set of check samples do not tory by FSIS officials prior to the de- meet these criteria for obtaining ac- termination of granting accredited sta- creditation, a second set of at least 14 tus. samples will be provided within 30 days (iv) Pay the accreditation fee by the following the date of receipt by FSIS of date required. a request from the applying laboratory. (3) Criteria for maintaining accredita- If the results of the second set of sam- tion. To maintain accreditation for ples do not meet accreditation criteria, analysis of a class of chemical residues, the laboratory may reapply after a 60- a non-Federal analytical laboratory day waiting period, commencing from must: the date of refusal of accreditation by (i) [Reserved] FSIS. At that time, a new application, (ii) Maintain laboratory quality con- all fees, and all documentation of cor- trol records for the most recent 3 years rective action required for accredita- that samples have been analyzed under tion must be submitted. this Program. (A) Systematic laboratory difference: (iii) Maintain complete records of the The absolute value of the average receipt, analysis, and disposition of of- standardized difference must not ex- ficial samples for the most recent 3 ceed 1.67 (2.00 if there are less than 12 years that samples have been analyzed analytical results) minus the product under the Program. of 0.29 and the standard deviation of (iv) Maintain a standards book, the standardized differences. which is a permanently bound book (B) Variability: The standard devi- with sequentially numbered pages, con- ation of the standardized differences taining all readings and calculations must not exceed a computed limit. for standardization of solutions, deter- This limit is a function of the number mination of recoveries, and calibration of analytical results used in the com- of instruments. All entries are to be putation of the standard deviation, and dated and signed by the analyst imme- of the amount of variability associated diately upon completion of the entry with the results from the participating and by his/her supervisor within 2 FSIS laboratories. working days. The standards book is to (C) Individual large deviations: One be retained for a period of 3 years after hundred times the average of the large the last entry is made. deviation measures of the individual (v) Analyze interlaboratory accredi- analytical results must be less than tation maintenance check samples and 8 5.0. return the results to FSIS within 3 (D) QA recovery: The average of the weeks of sample receipt. This must be QA recoveries of the individual analyt- done whenever requested by FSIS and ical results must lie within the range at no cost to FSIS. (vi) Inform the Accredited Labora- 7 All statistical computations are rounded tory Program, room 516–A, Annex to the nearest tenth, except where otherwise Building, Food Safety and Inspection noted. Service, U.S. Department of Agri- 8 A result will have a large deviation meas- ure equal to zero when the absolute value of culture, 300 12th Street, SW., Washing- the result’s standardized difference, (d), is ton, DC 20250–3700, by certified or reg- less than 2.5 and otherwise a measure equal istered mail, within 30 days of any 1–(2.5/d)4. change in the laboratory’s ownership,
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officers, directors, supervisory person- value is computed and evaluated as fol- nel, or any other responsibly connected lows: individual or entity. (i) Determine the CUSUM increment (vii) Permit any duly authorized rep- for the sample. The CUSUM increment resentative of the Secretary to perform is set equal to: both announced and unannounced on- site laboratory reviews of facilities and 2.0, if the standardized difference is greater than 2.5, records during normal business hours, ¥2.0, if the standardized difference is less and to copy any records pertaining to than ¥1.5, the laboratory’s participation in the or Accredited Laboratory Program. (viii) Use analytical procedures des- the standardized difference minus 0.5, if the ignated and approved by FSIS. standardized difference lies between ¥1.5 and 2.5, inclusive. (ix) Demonstrate that acceptable limits of systematic laboratory dif- (ii) Compute the new CUSUM–P ference, variability, and individual value. The new CUSUM–P value is ob- large deviations are being maintained tained by adding, algebraically, the in the analysis of samples, in the chem- CUSUM increment to the last pre- ical residue class for which accredita- viously computed CUSUM–P value. If tion was granted. A laboratory will this computation yields a value small- successfully demonstrate the mainte- er than 0, the new CUSUM–P value is nance of these capabilities if its ana- set equal to 0. [CUSUM–P values are lytical results for each specific chemi- initialized at zero; that is, the CUSUM– cal residue found in interlaboratory ac- P value associated with the first sam- creditation maintenance check sam- ple is set equal to the CUSUM incre- ples and/or split samples satisfy the ment for that sample.] criteria presented in this paragraph (iii) Evaluate the new CUSUM–P (c)(3)(ix).9,10 In addition, if the labora- value. The new CUSUM–P value must tory is accredited for the analysis of not exceed 4.8. chlorinated hydrocarbons, all analyt- (2) Negative systematic laboratory dif- ical results for the residue class must ference: The standardized difference be- collectively satisfy the criteria. tween the accredited laboratory’s re- (A) Systematic laboratory difference: sult and that of the FSIS laboratory (1) Positive systematic laboratory dif- for each split and/or interlaboratory ference: The standardized difference be- accreditation maintenance check sam- tween the accredited laboratory’s re- ple is used to determine a CUSUM sult and that of the FSIS laboratory value, designated as CUSUM–N.12 This for each split and/or interlaboratory value is computed and evaluated as fol- accreditation maintenance check sam- lows: ple is used to determine a CUSUM (i) Determine the CUSUM increment value, designated as CUSUM–P.11 This for the sample. The CUSUM increment is set equal to: 9 All statistical computations are rounded to the nearest tenth, except where otherwise 2.0, if the standardized difference is greater noted. than 1.5, 10 An analytical result will only be used in ¥2.0, if the standardized difference is less the statistical evaluation of the laboratory if than ¥2.5, the associated comparison mean is equal to or or greater than the logarithm of the mini- the standardized difference plus 0.5, if the mum proficiency level for the residue. standardized difference lies between ¥2.5 11 When determining compliance with this and 1.5, inclusive. criterion for all chlorinated hydrocarbon re- sults in a sample collectively, the following (ii) Compute the new CUSUM–N statistical procedure must be followed to ac- value. The new CUSUM–N value is ob- count for the correlation of analytical re- tained by subtracting, algebraically, sults within a sample: the average of the standardized differences of the analytical re- sults within the sample, divided by a con- constant is a function of the number of ana- stant, is used in place of a single standard- lytical results used to compute the average ized difference to determine the CUSUM–P standardized difference. (or CUSUM–N) value for the sample. The 12 See footnote 11.
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the CUSUM increment to the last pre- laboratory accreditation maintenance viously computed CUSUM–N value. If check sample is used to determine a this computation yields a value small- CUSUM value, designated as CUSUM– er than 0, the new CUSUM–N value is D.14 This value is computed and evalu- set equal to 0. [CUSUM–N values are ated as follows: initialized at zero; that is, the CUSUM– (1) Determine the CUSUM increment N value associated with the first sam- for the sample. The CUSUM increment ple is set equal to the CUSUM incre- is set equal to the large deviation ment for that sample.] measure minus 0.025. (iii) Evaluate the new CUSUM–N (2) Compute the new CUSUM–D value. The new CUSUM–N value must value. The new CUSUM–D is obtained not exceed 4.8. by adding, algebraically, the CUSUM (B) Variability: The absolute value of increment to the last previously com- the standardized difference between puted CUSUM–D value. If this com- the accredited laboratory’s result and putation yields a value less than 0, the that of the FSIS laboratory for each new CUSUM–D value is set equal to 0. split and/or interlaboratory accredita- [CUSUM–D values are initialized at tion maintenance check sample is used zero; that is, the CUSUM–D value asso- to determine a CUSUM value, des- ciated with the first sample is set equal ignated as CUSUM–V.13 This value is to the CUSUM increment for that sam- computed and evaluated as follows: ple.] (1) Determine the CUSUM increment (3) Evaluate the new CUSUM–D for the sample. The CUSUM increment value. The new CUSUM–D value must is set equal to the larger of ¥0.4 and not exceed 1.0. the absolute value of the standardized (x) Meet the following requirements difference minus 0.9. If this computa- if placed on probation pursuant to tion yields a value larger than 1.6, the paragraph (e) of this section: increment is set equal to 1.6. (A) Send all official samples that (2) Compute the new CUSUM–V have not been analyzed as of the date value. The new CUSUM–V value is ob- of written notification of probation to tained by adding, algebraically, the a specified FSIS laboratory by certified CUSUM increment to the last pre- mail or private carrier or, as an alter- viously computed CUSUM–V value. If native, to an accredited laboratory ac- this computation yields a value less credited for this specific chemical resi- than 0, the new CUSUM–V value is set due. Mailing expense will be paid by equal to 0. [CUSUM–V values are FSIS. initialized at zero; that is, the CUSUM– (B) Analyze a set of check samples V value associated with the first sam- similar to those used for initial accred- ple is set equal to the CUSUM incre- itation, and submit analytical results ment for that sample.] to FSIS within 3 weeks of receipt of (3) Evaluate the new CUSUM–V the samples. value. The new CUSUM–V value must (C) Satisfy criteria for check samples not exceed 4.3. as specified in paragraphs (c)(2)(ii) (A), (C) Large Deviations: The large devi- (B), (C), (D), (E), and (F) of this section. ation measure of the accredited labora- (xi) Expeditiously report analytical tory’s result for each split and/or inter- results of official samples to the East- ern Laboratory, College Station Road, 13 When determining compliance with this P.O. Box 6085, Athens, GA 30604, or to criterion for all chlorinated hydrocarbon re- the address designated by the Quality sults in a sample collectively, the following Systems Branch, FSIS Chemistry Divi- statistical procedure must be followed to ac- sion. The Federal inspector at any es- count for the correlation of analytical re- tablishment may assign the analysis of sults within a sample: the square root of the official samples to an FSIS laboratory sum of the within sample variance and the average standardized difference of the sam- if, in the judgment of the inspector, ple, divided by a constant, is used in place of the absolute value of the standardized dif- 14 A result will have a large deviation ference to determine the CUSUM–V value for measure equal to zero when the absolute the sample. The constant is a function of the value of the result’s standardized difference, number of analytical results used to com- (d), is less than 2.5, and otherwise a measure pute the average standardized difference. equal to 1¥(2.5/d)4.
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there are delays in receiving test re- er than 0, the new CUSUM–P value is sults on official samples from an ac- set equal to 0. [CUSUM–P values are credited laboratory. initialized at zero; that is, the CUSUM– (xii) Every QC recovery associated P value associated with the first sam- with reporting of official samples must ple is set equal to the CUSUM incre- be within the appropriate range given ment for that sample.] in Table 2 under ‘‘Percent Expected Re- (iii) Evaluate the new CUSUM–P covery.’’ Supporting documentation value. The new CUSUM–P value must must be made available to FSIS upon not exceed 4.8. request. (2) Negative systematic laboratory dif- (xiii) Demonstrate that acceptable ference: The standardized difference be- levels of systematic laboratory dif- tween the accredited laboratory’s re- ference, variability, individual large sult and the comparison mean for each deviations, recoveries, and proper iden- interlaboratory accreditation mainte- tification are being maintained in the nance check sample is used to deter- analysis of interlaboratory accredita- mine a CUSUM value, designated as tion maintenance check samples, in CUSUM–N.16 This value is computed the chemical residue class for which and evaluated as follows: accreditation was granted. A labora- (i) Determine the CUSUM increment tory will successfully demonstrate the for the sample. The CUSUM increment maintenance of these capabilities if its is set equal to: analytical results for each specific 2.0, if the standardized difference is greater chemical residue found in interlabora- than 1.5, tory accreditation maintenance check ¥2.0, if the standardized difference is less samples satisfy the criteria presented than ¥2.5, below. In addition, if the laboratory is or accredited for the analysis of the standardized difference plus 0.5, if the chlorinated hydrocarbons, all analyt- standardized difference lies between ¥2.5 and ical results for the residue class must 1.5, inclusive. collectively satisfy the criteria. (ii) Compute the new CUSUM–N (A) Systematic laboratory difference— value. The new CUSUM–N value is ob- (1) Positive systematic laboratory dif- tained by subtracting, algebraically, ference: The standardized difference be- the CUSUM increment to the last pre- tween the accredited laboratory’s re- viously computed CUSUM–N value. If sult and the comparison mean for each this computation yields a value small- interlaboratory accreditation mainte- er than 0, the new CUSUM–N value is nance check sample is used to deter- set equal to 0. [CUSUM–N values are mine a CUSUM value, designated as initialized at zero; that is, the CUSUM– 15 CUSUM–P. This value is computed N value associated with the first sam- and evaluated as follows: ple is set equal to the CUSUM incre- (i) Determine the CUSUM increment ment for that sample.] for the sample. The CUSUM increment (iii) Evaluate the new CUSUM–N is set equal to: value. The new CUSUM–N value must 2.0, if the standardized difference is greater not exceed 4.8. than 2.5, (B) Variability: The absolute value of ¥2.0, if the standardized difference is less the standardized difference between than ¥1.5, the accredited laboratory’s result and or the comparison mean for each interlab- the standardized difference minus 0.5, if the oratory accreditation maintenance standardized difference lies between ¥1.5 and check sample is used to determine a 2.5, inclusive. CUSUM value, designated as CUSUM– (ii) Compute the new CUSUM–P V.17 This value is computed and evalu- value. The new CUSUM–P value is ob- ated as follows: tained by adding, algebraically, the (1) Determine the CUSUM increment CUSUM increment to the last pre- for the sample. The CUSUM increment viously computed CUSUM–P value. If is set equal to the larger of ¥0.4 or the this computation yields a value small- 16 See footnote 11. 15 See footnote 11. 17 See footnote 13.
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absolute value of the standardized dif- (F) Not more than 2 residue ference minus 0.9. If this computation misidentifications in any 8 consecutive yields a value larger than 1.6, the in- check samples. crement is set equal to 1.6. (xiv) Pay the accreditation fee when (2) Compute the new CUSUM–V it is due. value. The new CUSUM–V value is ob- (d) Refusal of accreditation. Upon a de- tained by adding, algebraically, the termination by the Administrator, a CUSUM increment to the last pre- laboratory shall be refused accredita- viously computed CUSUM–V value. If tion for the following reasons: this computation yields a value less (1) A laboratory shall be refused ac- than 0, the new CUSUM–V value is set creditation for moisture, protein, fat, equal to 0. [CUSUM–V values are and salt analysis for failure to meet initialized at zero; that is, the CUSUM– the requirements of paragraph (b)(1) or V value associated with the first sam- (b)(2) of this section. ple is set equal to the CUSUM incre- (2) A laboratory shall be refused ac- ment for that sample.] creditation for chemical residue analy- (3) Evaluate the new CUSUM–V value. The new CUSUM–V value must sis for failure to meet the requirements not exceed 4.3. of paragraph (c)(1) or (c)(2) of this sec- (C) Large deviations: The large devi- tion. ation measure of the accredited labora- (3) A laboratory shall be refused sub- tory’s result for each interlaboratory sequent accreditation for failure to re- accreditation maintenance check sam- turn to an FSIS laboratory, by cer- ple is used to determine a CUSUM tified mail or private carrier, all offi- value, designated as CUSUM–D.18 This cial samples which have not been ana- value is computed and evaluated as fol- lyzed as of the notification of a loss of lows: accreditation. (1) Determine the CUSUM increment (4) A laboratory shall be refused ac- for the sample. The CUSUM increment creditation if the applicant or any indi- is set equal to the value of the large de- vidual or entity responsibly connected viation measure minus 0.025. with the applicant has been convicted (2) Compute the new CUSUM–D of or is under indictment or if charges value. The new CUSUM–D is obtained on an information have been brought by adding, algebraically, the CUSUM against the applicant or responsibly increment to the last previously com- connected individual or entity in any puted CUSUM–D value. If this com- Federal or State court concerning the putation yields a value less than 0, the following violations of law: new CUSUM–D value is set equal to 0. (i) Any felony. [CUSUM–D values are initialized at (ii) Any misdemeanor based upon ac- zero; that is, the CUSUM–D value asso- quiring, handling, or distributing of ciated with the first sample is set equal unwholesome, misbranded, or decep- to the CUSUM increment for that sam- tively packaged food or upon fraud in ple.] connection with transactions in food. (3) Evaluate the new CUSUM–D (iii) Any misdemeanor based upon a value. The new CUSUM–D value must false statement to any governmental not exceed 1.0. agency. (D) Each QC Recovery is within the (iv) Any misdemeanor based upon the range given in Table 2 under ‘‘Percent offering, giving or receiving of a bribe Expected Recovery’’. Supporting docu- or unlawful gratuity. mentation must be made available to FSIS upon request. (e) Probation of accreditation. Upon a (E) Not more than 1 residue determination by the Administrator, a misidentification in any 2 consecutive laboratory shall be placed on probation check samples. for the following reasons: (1) If the laboratory fails to complete more than one interlaboratory accredi- 18 A result will have a large deviation measure equal to zero when the absolute tation maintenance check sample anal- value of the result’s standardized difference, ysis within 12 consecutive months as (d), is less than 2.5, and otherwise a measure required by paragraphs (b)(3)(v) and equal to 1¥(2.5/d)4. (c)(3)(v) of this section.
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(2) If the laboratory fails to meet any graph (c) of this section shall have the of the criteria set forth in paragraphs accreditation to perform this analysis (b)(3)(v) and ((b)(3)(ix) and (c)(3)(v) and revoked if it fails to meet any of the (c)(3)(ix) of this section. requirements in paragraph (c)(3) of this (f) Suspension of accreditation. The ac- section except for the following cir- creditation of a laboratory shall be sus- cumstances. If the accredited labora- pended if the laboratory or any individ- tory fails to meet any of the criteria ual or entity responsibly connected set forth in paragraphs (c)(3)(v), with the laboratory is indicted or if (c)(3)(ix), and (c)(3)(xiii) of this section charges on an information have been and it has not so failed during the 12 brought against the laboratory or re- months preceding its failure to meet sponsibly connected individual or en- the criteria, it shall be placed on pro- tity in any Federal or State court con- bation, but if it has so failed at any cerning any of the following violations time during those 12 months, its ac- of law: creditation will be revoked. (1) Any felony. (3) An accredited laboratory shall (2) Any misdemeanor based upon ac- have its accreditation revoked if the quiring, handling or distributing of un- Administrator determines that the lab- wholesome, misbranded, or deceptively oratory or any responsibly connected packaged food or upon fraud in connec- individual or any agent or employee tion with transactions in food. has: (3) Any misdemeanor based upon a (i) Altered any official sample or ana- false statement to any governmental lytical finding, or, agency. (ii) Substituted any analytical result (4) Any misdemeanor based upon the from any other laboratory for its own. offering, giving or receiving of a bribe (4) An accredited laboratory shall or unlawful gratuity. have its accreditation revoked if the (g) Revocation of accreditation. The ac- laboratory or any individual or entity creditation of a laboratory shall be re- responsibly connected with the labora- voked for the following reasons: tory is convicted in a Federal or State (1) An accredited laboratory which is court of any of the following violations accredited to perform analysis under of law: paragraph (b) of this section shall have (i) Any felony. its accreditation revoked for failure to (ii) Any misdemeanor based upon ac- meet any of the requirements of para- quiring, handling, or distributing of graph (b)(3) of this section except for unwholesome, misbranded, or decep- the following circumstances. If the ac- tively packaged food or upon fraud in credited laboratory fails to meet the connection with transactions in food. criteria for reporting the analytical re- (iii) Any misdemeanor based upon a sults on interlaboratory accreditation false statement to any governmental maintenance check samples as set agency. forth in paragraph (b)(3)(v) of this sec- (iv) Any misdemeanor based upon the tion or if, at any time, the CUSUM re- offering, giving or receiving of a bribe sults from the analysis of such inter- or unlawful gratuity. laboratory accreditation maintenance (h) Notification and hearings. Accredi- check samples and/or split samples tation of any laboratory shall be re- have not satisfied the criteria specified fused, suspended, or revoked under the in paragraph (b)(3)(ix) of this section conditions previously described herein. and there have been, during the pre- The owner or operator of the labora- vious 12 months, no other occasions on tory shall be sent written notice of the which such CUSUM results have not refusal, suspension, or revocation of ac- satisfied such criteria, the laboratory creditation by the Administrator. In shall be placed on probation; but if such cases, the laboratory owner or op- there have been such other occasions erator will be provided an opportunity during those 12 months, the labora- to present, within 30 days of the date of tory’s accreditation will be revoked. the notification, a statement challeng- (2) An accredited laboratory which is ing the merits or validity of such ac- accredited to perform analysis for a tion and to request an oral hearing class of chemical residues under para- with respect to the denial, suspension,
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or revocation decision. An oral hearing by the Group 2 protein-contributing in- shall be granted if there is any dispute gredients; and of material fact joined in such respon- (4) Subtracting one pecent from the sive statement. The proceeding shall total percentage of protein calculated thereafter be conducted in accordance in (b)(3)); and with the applicable rules of practice (5) Subtracting the remaining per- which shall be adopted for the proceed- centage of protein calculated in (b)(3) ing. Any such refusal, suspension, or from the total protein content deter- revocation shall be effective upon the mined in (b)(2); and receipt by the laboratory of the notifi- (6) Calculating the percentage of in- cation and shall continue in effect digenous water in the cooked sausage until final determination of the matter by multiplying the percentage of pro- by the Administrator. tein determined in (b)(5) by 4, (This (Reporting and recordkeeping requirements amount is the percentage of water at- approved by the Office of Management and tributable to Group 1 protein-contrib- Budget under control number 0583–0015) uting ingredients and one percent of [52 FR 2185, Jan. 20, 1987, as amended at 58 Group 2 protein-contributing ingredi- FR 65260, 65262–65264, Dec. 13, 1993; 59 FR ents in a cooked sausage.); and 33642, June 30, 1994; 59 FR 66448, Dec. 27, 1994; (7) Subtracting the percentage of 60 FR 10305, Feb. 24, 1995] water calculated in (b)(6) from the total percentage of water determined § 318.22 Determination of added water in (b)(1). (This amount is the percent- in cooked sausages. age of added water in a cooked sau- (a) For purposes of this section, the sage.) 1 following definitions apply. (1) Cooked sausage. Cooked sausage is [55 FR 7299, Mar. 1, 1990] any product described in § 319.140 and § 318.23 Heat-processing procedures, §§ 319.180–319.182 of this chapter. cooking instructions, and cooling, (2) Group 1 Protein-Contributing Ingre- handling, and storage requirements dients. Ingredients of livestock or poul- for uncured meat patties. try origin from muscle tissue which is (a) Definitions. For purposes of this skeletal or which is found in the edible section, the following definitions shall organs, with or without the accom- apply: panying and overlying fat, and the por- tions of bone, skin, sinew, nerve, and (1) Comminuted. A processing term de- blood vessels which normally accom- scribing the reduction in size of pieces pany the muscle tissue and which are of meat, including chopping, flaking, not separated from it in the process of grinding, or mincing, but not including dressing; meat byproducts; mechani- chunking or sectioning. cally separated (species); and poultry (2) Heat-processed. Treatment by a products; except those ingredients heat source, including, but not limited processed by hydrolysis, extraction, to, frying, broiling, baking, or roast- concentrating or drying. ing, which results in a fully-cooked, (3) Group 2 Protein-Contributing Ingre- partially-cooked, or char-marked prod- dients. Ingredients from Gorup 1 pro- uct. tein-contributing ingredients processed (3) Patty. A shaped and formed, by hydrolysis, extraction, concentrat- comminuted, flattened cake of meat ing, or drying, or any other ingredient food product. which contributes protein. (b) The amount of added water in 1 The equation for the narrative description cooked sausage is calculated by: of the calculation for added water is as fol- (1) Determining by laboratory analy- lows: AW=TW-(TP-(P-1.0))4, Where sis the total percentage of water con- AW=Added Water, TW-Total Water Deter- tained in the cooked sausage; and mined by Laboratory Analysis, TP=Total (2) Determining by laboratory analy- Protein Determined by Laboratory Analysis, P=Protein Contributed by Group 2 Protein- sis the total percentage of protein con- Contributing Ingredients, 1.0=Percent Allow- tained in the cooked sausage; and ance for Group 2 Protein-Contributing Ingre- (3) Calculating the percentage of pro- dients, 4=Moisture-Protein Ratio for Cooked tein in the cooked sausage contributed Sausage.
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(b) Processing procedures for heat-proc- essing and are contained in paragraph essed patties. Fully-cooked, partially- (b)(1)(ii) and (iii) of this section. cooked, or char-marked patties shall (iii) The internal temperature meas- be processed as follows: uring device shall be accurate within 1 (1) Heat processing. (i) Official estab- °F. lishments which manufacture fully- (3) Cooking instruction label require- cooked patties shall utilize one of the ment. (i) Partially-cooked patties shall heat-processing procedures in Table A bear the labeling statement ‘‘Partially- of this paragraph: cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 TABLE A.ÐPERMITTED HEAT-PROCESSING TEM- °F)’’. The labeling statement shall be PERATURE/TIME COMBINATIONS FOR FULLY- adjacent to the product name, at least COOKED PATTIES one-half the size of the largest letter in the product name, and prominently Minimum internal temperature at the Minimum holding center of each patty time after maxi- placed with such conspicuousness (as mum temperature compared with other words, state- Degrees is reached ments, designs or devices in the label- Time ing) as to render it likely to be read Fahrenheit or Centigrade (Min- or (Sec- and understood by the ordinary indi- utes) onds) vidual under customary conditions of 151 ...... 66.1 ...... 0.68 41 purchase and use. 152 ...... 66.7 ...... 54 32 (ii) Char-marked patties. Product 153 ...... 67.2 ...... 43 26 shall bear the labeling statement 154 ...... 67.8 ...... 34 20 ‘‘Uncooked, Char-marked: For Safety, 155 ...... 68.3 ...... 27 16 156 ...... 68.9 ...... 22 13 Cook Until Well Done (Internal Meat 157 (and up) ...... 69.4 (and up) ...... 17 10 Temperature 160 °F)’’. The labeling statement shall be adjacent to the (ii) Official establishments which product name, at least one-half the size manufacture partially-cooked patties of the largest letter in the product shall raise the internal temperature at name, and prominently placed with the center of each patty to a minimum such conspicuousness (as compared internal temperature of 140 °F. and with other words, statements, designs then cool it to a maximum internal or devices in the labeling) as to render temperature of 40 °F within 2 hours. it likely to be read and understood by (iii) Official establishments which the ordinary individual under cus- manufacture char-marked patties (if tomary conditions of purchase and use. marked by a heat source) may raise the (4) Sanitary handling and storage prac- temperature at the center of each tices. Fully-cooked patties shall be han- patty, but not above 70 °F, when the dled in accordance with the following char-marks are applied to the patty. provisions so as to assure that the pat- The process of char-marking the patty ties are not recontaminated. and cooling the patty to a maximum (i) To prevent direct contamination internal temperature of 40 °F shall be of fully-cooked patties, official estab- completed within 2 hours or less. lishments shall: (iv) The official establishment shall (A) Physically separate areas where measure the holding time and tempera- unpackaged, fully-cooked patties are ture of at least one heat-processed handled from areas where less-than- patty from each production line each fully-cooked products are handled hour of production to assure control of using a solid impervious floor to ceil- the heat process. The temperature ing wall; or measuring device shall be accurate (B) Handle unpackaged, fully-cooked within 1 °F. patties and less-than-fully-cooked (2) Cooling. (i) Fully-cooked patties product at different times, and clean- shall be cooled to an internal tempera- ing the entire area after handling other ture of 40 °F or below within 2 hours products before handling unpackaged, after heat-processing. fully-cooked patties; or (ii) Cooling requirements for par- (C) Submit a written procedure tially-cooked and char-marked patties through the inspector-in-charge to the are combined with those for heat-proc- Regional Director detailing the steps
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to be taken which would avoid re- temperature and time combinations in contamination of fully-cooked patties paragraph (b)(1)(i) in this section, pro- by less-than-fully-cooked cooked prod- vided this does not violate the final uct during processing. product’s standard of composition, (ii) To prevent indirect contamina- upset the order of predominance of in- tion of fully-cooked patties: gredients, or perceptibly affect the nor- (A) Any work surface, machine, or mal product characteristics, or (iii) tool which contacts other product shall relabel the affected product as a par- be cleaned and sanitized before it con- tially-cooked patty product, if it meets tacts unpackaged fully-cooked patties. the partially-cooked requirements in The sanitizer shall be germicidally paragraph (b)(1)(ii) of this section. equivalent to 50 ppm chlorine. (3) In addition, in the case of a cool- (B) Employees shall wash their hands with soap and water and sanitize their ing deviation, contact the Regional Di- hands whenever they enter the fully- rector to determine the disposition of cooked patty area or before handling the product. unpackaged, fully-cooked patties. They [58 FR 41151, Aug. 2, 1993] must also wash and sanitize their hands whenever they become contami- § 318.24 Compliance procedures for nated during operations to avoid con- meat derived from advanced meat/ tamination of fully-cooked patties. The bone separation machinery and re- sanitizer shall be germicidally equiva- covery systems. lent to 50 ppm chlorine. (a) The product resulting from the (C) All employee outer garments, in- separating process shall not have a cal- cluding aprons, smocks, and gloves cium content exceeding 0.15 percent or shall be identified as restricted for use 150 mg/100 gm of product within a toler- in the fully-cooked area only. The em- ance of 0.03 percent or 30 mg, as pre- ployee shall change garments at least scribed in § 301.2(rr)(2) of this sub- daily. The garments shall be hung in a chapter. designated location before the em- ployee leaves the area. (b) To verify the calcium content in (iii) Fully-cooked patties stored in meat derived from advanced meat/bone the same room with other product, separation machinery and recovery shall first be packaged or covered to systems, a compliance program con- prevent microbial contamination. sisting of the following parameters (iv) Fully-cooked, partially-cooked, shall be followed by manufacturers of and char-marked patties shall be meat defined in § 301.2(rr)(2) of this sub- stored at a chamber temperature of 40 chapter. °F or below. (1) An analysis of a sample of at least (c) Requirements for handling heating 1 pound from each lot shall be per- or cooling deviations. (1) If for any rea- formed by the operator of the estab- son a heating or cooling deviation has lishment or his or her agent. For pur- occurred, the official establishment poses of this paragraph, a lot shall con- shall investigate and identify the sist of the meat derived from advanced cause; take steps to assure that the de- meat/bone separation machinery and viation will not recur; and place on file recovery systems, designated as such in the official establishment, available by the operator of the establishment or to any duly authorized representative his or her agent, from the product pro- of the Secretary, a report of the inves- duced from a single species of livestock tigation, the cause of the deviation, in no more than one continuous shift of and the steps taken to prevent recur- rence; and up to 12 hours. Individual results from (2) In addition, in the case of a heat- the chemical analyses shall be com- ing deviation, the official establish- pared to the calcium limit, prescribed ment may (i) reprocess the affected in paragraph (a) of this section, in product, by a method in paragraph order to demonstrate compliance. If (b)(1)(i) in this section, or (ii) use the compliance is not demonstrated, that affected product as an ingredient in an- is, if any single analytical result is other product processed to one of the
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more than 0.18 percent,1 2 before prod- Subparts B—F [Reserved] uct from a production lot that is still at the establishment or one that is sub- Subpart G—Canning and Canned sequently produced can be considered to be in compliance, at least three sam- Products ples from that production lot shall be taken and analyzed for calcium, either SOURCE: 51 FR 45619, Dec. 19, 1986, unless separately, or, at the option of the es- otherwise noted. tablishment, as a composite (i.e., com- § 318.300 Definitions. bining the three samples for analysis). The average of the results or the com- (a) Abnormal container. A container posite result must be less than or equal with any sign of swelling or product to 0.15 percent. Taking three samples leakage or any evidence that the con- from each subsequently produced lot tents of the unopened container may be and analyzing them in order to dem- spoiled. onstrate compliance shall continue (b) Acidified low acid product. A until five consecutive lots have mean canned product which has been formu- or composite results less than or equal lated or treated so that every compo- to 0.15 percent. If the statistical evi- nent of the finished product has a pH of dence indicates that a production lot is 4.6 or lower within 24 hours after the not in compliance with the calcium completion of the thermal process un- limit, as prescribed in § 301.2(rr)(2) of less data are available from the estab- this subchapter, the lot must be la- lishment’s processing authority dem- beled as MS(S) and meet all of the re- onstrating that a longer time period is quirements for MS(S) in § 319.5 of this safe. subchapter. (c) Bleeders. Small orifices on a retort (2) The management of the establish- through which steam, other gasses, and ment must maintain records to support condensate are emitted from the retort the validity of the calcium content (as throughout the entire thermal process. a measure of bone solids) to assure the (d) Canned product. A meat food prod- process is in control. Such records uct with a water activity above 0.85 shall be made available to the inspec- which receives a thermal process either tor or any other duly authorized rep- before or after being packed in a her- resentative of the Agency upon re- metically sealed container. Unless oth- quest. (Recordkeeping requirements erwise specified, the term ‘‘product’’ as were approved by the Office of Manage- used in this subpart G shall mean ment and Budget under control number ‘‘canned product.’’ 0583–0095.) (e) Closure technician. The individ- ual(s) identified by the establishment [59 FR 62561, Dec. 6, 1994] as being trained to perform specific container integrity examinations as re- quired by this subpart and designated by the establishment to perform such examinations. (f) Code lot. All production of a par- 1 The value 0.18 percent was derived by ticular product in a specific size con- multiplying by 3 the expected analytical tainer marked with a specific con- standard deviation obtained by FSIS labora- tainer code. tories on the approved chemical procedure (g) Come-up time. The elapsed time, for measuring calcium which uses including venting time (if applicable), Ethylenediaminetetraacetic acid (EDTA) as provided in the ‘‘Official Methods of Analysis between the introduction of the heat- of the AOAC International’’ (formerly the ing medium into a closed retort and Association of Official Analytical Chemists), the start of process timing. 15th Ed. (1990). 2 Individual or an average of results shall be rounded to the nearest 0.01 percent cal- cium.
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(h) Critical factor. Any characteristic, (m) Low acid product. A canned prod- condition or aspect of a product, con- uct in which any component has a pH tainer, or procedure that affects the value above 4.6. adequacy of the process schedule. Criti- (n) Process schedule. The thermal cal factors are established by process- process and any specified critical fac- ing authorities. tors for a given canned product re- (i) Headspace. That portion of a con- quired to achieve shelf stability. tainer not occupied by the product. (o) Process temperature. The minimum (1) Gross headspace. The vertical dis- temperature(s) of the heating medium tance between the level of the product to be maintained as specified in the (generally the liquid surface) in an up- process schedule. (p) Process time. The intended time(s) right rigid container and the top edge a container is to be exposed to the of the container (i.e., the flange of an heating medium while the heating me- unsealed can, the top of the double dium is at or above the process tem- seam on a sealed can, or the top edge of perature(s). an unsealed jar). (q) Processing authority. The person(s) (2) Net headspace. The vertical dis- or organization(s) having expert knowl- tance between the level of the product edge of thermal processing require- (generally the liquid surface) in an up- ments for foods in hermetically sealed right rigid container and the inside containers, having access to facilities surface of the lid. for making such determinations, and (j) Hermetically sealed containers. Air- designated by the establishment to per- tight containers which are designed form certain functions as indicated in and intended to protect the contents this subpart. against the entry of microorganisms (r) Program employee. Any inspector during and after thermal processing. or other individual employed by the (1) Rigid container. A container, the Department or any cooperating agency shape or contour of which, when filled who is authorized by the Secretary to and sealed, is neither affected by the do any work or perform any duty in enclosed product nor deformed by ex- connection with the Program (see ternal mechanical pressure of up to 10 § 301.2(f)). pounds per square inch gauge (0.7 kg/ (s) Retort. A pressure vessel designed cm2) (i.e., normal firm finger pressure). for thermal processing of product (2) Semirigid container. A container, packed in hermetically sealed contain- the shape or contour of which, when ers. filled and sealed, is not significantly (t) Seals. Those parts of a semirigid affected by the enclosed product under container and lid or of a flexible con- normal atmospheric temperature and tainer that are fused together in order pressure, but can be deformed by exter- to hermetically close the container. nal mechanical pressure of less than 10 (u) Shelf stability. The condition pounds per square inch gauge (0.7 kg/ achieved by application of heat, suffi- cient, alone or in combination with cm2) (i.e., normal firm finger pressure). other ingredients and/or treatments, to (3) A container, the Flexible container. render the product free of microorga- shape or contour of which, when filled nisms capable of growing in the prod- and sealed, is significantly affected by uct at nonrefrigerated conditions (over the enclosed product. 50 °F or 10 °C) at which the product is (k) Incubation tests. Tests in which intended to be held during distribution the thermally processed product is and storage. Shelf stability and shelf kept at a specific temperature for a stable are synonymous with commer- specified period of time in order to de- cial sterility and commercially sterile, termine if outgrowth of microorga- respectively. nisms occurs. (v) Thermal process. The heat treat- (l) Initial temperature. The tempera- ment necessary to achieve shelf stabil- ture, determined at the initiation of a ity as determined by the establish- thermal process cycle, of the contents ment’s processing authority. It is of the coldest container to be proc- quantified in terms of: essed. (1) Time(s) and temperature(s); or
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(2) Minimum product temperature. of production, immediately following (w) Venting. The removal of air from every jam in the closing machine and a retort before the start of process tim- after closing machine adjustment (in- ing. cluding adjustment for changes in con- (x) Water activity. The ratio of the tainer size). water vapor pressure of the product to (2) Teardown examinations. Teardown the vapor pressure of pure water at the examinations of double seams formed same temperature. by each closing machine head shall be performed by a closure technician at a § 318.301 Containers and closures. frequency sufficient to ensure proper (a) Examination and cleaning of empty closure. These examinations should be containers. (1) Empty containers, clo- made at intervals of not more than 4 sures, and flexible pouch roll stock hours of continuous closing machine shall be evaluated by the establish- operation. At least one container from ment to ensure that they are clean and each closing head shall be examined on free of structural defects and damage the packer’s end during each regular that may affect product or container examination period. Examination re- integrity. Such an examination should sults along with any necessary correc- be based upon a statistical sampling tive actions, such as adjusting or re- plan. pairing the closing machine, shall be (2) All empty containers, closures, promptly recorded by the closure tech- and flexible pouch roll stock shall be nician. The establishment shall have stored, handled, and conveyed in such a container specification guidelines for manner that will prevent soiling and double seam integrity on file and avail- damage that could affect the hermetic able for review by Program employees. condition of the sealed container. A teardown examination of the can (3) Just before filling, rigid contain- maker’s end shall be performed on at ers shall be cleaned to prevent incorpo- least one container selected from each ration of foreign matter into the fin- closing machine during each examina- ished product. Closures, semirigid con- tion period except when teardown ex- tainers, preformed flexible pouches, aminations are made on incoming and flexible pouch roll stock contained empty containers or when, in the case in original wrappings do not need to be of self-manufactured containers, the cleaned before use. containers are made in the vicinity of (b) Closure examinations for rigid con- the establishment and the container tainers (cans)—(1) Visual examinations. A plant records are made available to closure technician shall visually exam- Program employees. Additional tear- ine the double seams formed by each down examinations on the packer’s end closing machine head. When seam de- should be made at the beginning of pro- fects (e.g., cutovers, sharpness, duction, immediately following every knocked down flanges, false seams, jam in a closing machine and after droops) are observed, necessary correc- closing machine adjustment (including tive actions, such as adjusting or re- adjustment for a change in container pairing the closing machine, shall be size). The following procedures shall be taken. In addition to the double seams, used in teardown examinations of dou- the entire container shall be examined ble seams: for product leakage or obvious defects. (i) One of the following two methods A visual examination shall be per- shall be employed for dimensional formed on at least one container from measurements of the double seam. each closing machine head, and the ob- (a) Micrometer measurement. For cylin- servations, along with any corrective drical containers, measure the follow- actions, shall be recorded. Visual ex- ing dimensions (Figure 1) at three aminations shall be conducted with points approximately 120 degrees apart sufficient frequency to ensure proper on the double seam excluding and at closure and should be conducted at least one-half inch from the side seam least every 30 minutes of continuous juncture: closing machine operation. Additional (1) Double seam length—W; visual examinations shall be made by (2) Double seam thickness—S; the closure technician at the beginning (3) Body hook length—BH; and
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(4) Cover hook length—CH. Maximum and minimum values for each dimensional measurement shall be recorded by the closure technician.
(b) Seamscope or seam projector. Re- used to obtain the required measure- quired measurements of the seam in- ments. clude thickness, body hook, and over- (ii) Seam tightness. Regardless of the lap. Seam thickness shall be obtained dimensional measurement method used by micrometer. For cylindrical con- to measure seam dimensions, at a min- tainers, at least two locations, exclud- imum, the seam(s) examined shall be ing the side seam juncture, shall be
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stripped to assess the degree of wrin- essary corrective actions, such as ad- kling. justing or repairing the closing ma- (iii) Side seam juncture rating. Regard- chine, shall be promptly recorded by less of the dimensional measurement the closure technician. The establish- method used to measure seam dimen- ment shall have specification guide- sions, the cover hook shall be stripped lines for closure integrity on file and to examine the cover hook droop at the available for review by Program em- juncture for containers having side ployees. Additional closure examina- seams. tions should be made at the beginning (iv) Examination of noncylindrical con- of production, immediately following tainers. Examination of noncylindrical every jam in the closing machine, and containers (e.g., square, rectangular, after closing machine adjustment (in- ‘‘D’’-shaped, and irregularly-shaped) cluding adjustment for a change in shall be conducted as described in para- container size). graphs (b)(2) (i), (ii), and (iii) of this (d) Closure examinations for semirigid section except that the required dimen- and flexible containers—(1) Heat seals— sional measurements shall be made on (i) Visual examinations. A closure tech- the double seam at the points listed in nician shall visually examine the seals the establishment’s container speci- formed by each sealing machine. When fication guidelines. sealing defects are observed, necessary (c) Closure examinations for glass con- corrective actions, such as adjusting or (1) A clo- tainers— Visual examinations. repairing the sealing machine, shall be sure technician shall visually assess taken and recorded. In addition to ex- the adequacy of the closures formed by amining the heat seals, the entire con- each closing machine. When closure de- tainer shall be examined for product fects, such as loose or cocked caps, leakage or obvious defects. Visual ex- fractured or cracked containers and aminations shall be performed before low vacuum jars, are observed, nec- and after the thermal processing oper- essary corrective actions, such as ad- ation and with sufficient frequency to justing or repairing the closing ma- ensure proper closure. These examina- chine shall be taken and recorded. In tions should be conducted at least in addition to the closures, the entire container shall be examined for de- accordance with a statistical sampling fects. Visual examinations shall be plan. All defects noted and corrective made with sufficient frequency to en- actions taken shall be promptly re- sure proper closure and should be con- corded. ducted at least every 30 minutes of con- (ii) Physical tests. Tests determined tinuous closing machine operation. Ad- by the establishment as necessary to ditional visual examinations shall be assess container integrity shall be con- made by the closure technician and the ducted by the closure technician at a observations recorded at the beginning frequency sufficient to ensure proper of production, immediately following closure. These tests shall be performed every jam in the closing machine, and after the thermal processing operation after closing machine adjustment (in- and should be made at least every 2 cluding adjustment for a change in hours of continuous production. The container size). establishment’s acceptance guidelines (2) Closure examinations and tests. De- for each test procedure shall be on file pending upon the container and clo- and available for review by Program sure, tests shall be performed by a clo- employees. Test results along with any sure technician at a frequency suffi- necessary corrective actions, such as cient to ensure proper closure. These adjusting or repairing the sealing ma- examinations should be made either chine, shall be recorded. before or after thermal processing and (2) Double seams on semirigid or at intervals of not more than 4 hours of flexible containers shall be examined continuous closing machine operation. and the results recorded as provided in At least one container from each clos- paragraph (b) of this section. Any addi- ing machine shall be examined during tional measurements specified by the each regular examination period. Ex- container manufacturer shall also be amination results along with any nec- made and recorded.
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(e) Container coding. Each container ing any associated incubation tests, shall be marked with a permanent, leg- shall be made available by the estab- ible, identifying code mark. The mark lishment to the Program employee shall, at a minimum, identify in code upon request. the product (unless the product name (c) Submittal of process information. (1) lithographed or printed elsewhere on Prior to the processing of canned prod- the container) and the day and year uct for distribution in commerce, the the product was packed. establishment shall provide the inspec- (f) Handling of containers after closure. tor at the establishment with a list of (1) Containers and closures shall be the process schedules (including alter- protected from damage which may nate schedules) along with any addi- cause defects that are likely to affect tional applicable information, such as the hermetic condition of the contain- the retort come-up operating proce- ers. The accumulation of stationary dures and critical factors. containers on moving conveyors should (2) Letters or other written commu- be minimized to avoid damage to the nications from a processing authority containers. recommending all process schedules (2) The maximum time lapse between shall be maintained on file by the es- closing and initiation of thermal proc- tablishment. Upon request by Program essing shall be 2 hours. However, the employees, the establishment shall Administrator may specify a shorter make available such letters or written period of time when considered nec- communications (or copies thereof). If essary to ensure product safety and critical factors are identified in the stability. A longer period of time be- process schedule, the establishment tween closing and the initiation of shall provide the inspector with a copy thermal processing may be permitted of the procedures for measuring, con- by the Administrator. trolling, and recording these factors, (Approved by the Office of Management and along with the frequency of such meas- Budget under control number 0583–0015) urements, to ensure that the critical factors remain within the limits used § 318.302 Thermal processing. to establish the process schedule. Once (a) Process schedules. Prior to the submitted, the process schedules and processing of canned product for dis- associated critical factors and the pro- tribution in commerce, an establish- cedures for measuring (including the ment shall have a process schedule (as frequency), controlling, and recording defined in § 318.300(n) of this subpart) of critical factors shall not be changed for each canned meat product to be without the prior written submittal of packed by the establishment. the revised procedures (including sup- (b) Source of process schedules. (1) porting documentation) to the inspec- Process schedules used by an establish- tor at the establishment. ment shall be developed or determined (Approved by the Office of Management and by a processing authority. Budget under control number 0583–0015) (2) Any change in product formula- tion, ingredients, or treatments that § 318.303 Critical factors and the appli- are not already incorporated in a proc- cation of the process schedule. ess schedule and that may adversely af- fect either the product heat penetra- Critical factors specified in the proc- tion profile or sterilization value re- ess schedule shall be measured, con- quirements shall be evaluated by the trolled and recorded by the establish- establishment’s processing authority. ment to ensure that these factors re- If it is determined that any such main within the limits used to estab- change adversely affects the adequacy lish the process schedule. Examples of of the process schedule, the processing factors that are often critical to proc- authority shall amend the process ess schedule adequacy may include: schedule accordingly. (a) General. (1) Maximum fill-in (3) Complete records concerning all weight or drained weight; aspects of the development or deter- (2) Arrangement of pieces in the con- mination of a process schedule, includ- tainer;
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(3) Container orientation during ther- tablishment at the time the processing mal processing; cycle begins to assure that the tem- (4) Product formulation; perature of the contents of every con- (5) Particle size; tainer to be processed is not lower than (6) Maximum thickness for flexible, the minimum initial temperature spec- and to some extent semirigid contain- ified in the process schedule. Thermal ers during thermal processing; processing systems which subject the (7) Maximum pH; filled and sealed containers to water at (8) Percent salt; any time before process timing begins (9) Ingoing (or formulated) nitrite shall be operated to assure that such level (ppm); water will not lower the temperature (10) Maximum water activity; and of the product below the minimum ini- (11) Product consistency or viscosity. tial temperature specified in the proc- (b) Continuous rotary and batch agitat- ess schedule. ing retorts. (1) Minimum headspace; and (d) Timing devices. Devices used to (2) Retort reel speed. time applicable thermal processing op- (c) Hydrostatic retorts. (1) Chain or eration functions or events, such as conveyor speed. process schedule time, come-up time (d) Steam/air retorts. (1) Steam/air and retort venting, shall be accurate to ratio; and assure that all such functions or events (2) Heating medium flow rate. are achieved. Pocket watches and wrist § 318.304 Operations in the thermal watches are not considered acceptable processing area. timing devices. Analog and digital clocks are considered acceptable. If (a) Posting of processes. Process sched- ules (or operating process schedules) such clocks do not display seconds, all for daily production, including mini- required timed functions or events mum initial temperatures and operat- shall have at least a 1-minute safety ing procedures for thermal processing factor over the specified thermal proc- equipment, shall be posted in a con- essing operation times. Temperature/ spicuous place near the thermal proc- time recording devices shall correspond essing equipment. Alternatively, such within 15 minutes to the time of the information shall be available to the day recorded on written records re- thermal processing system operator quired by § 318.306. and the inspector. (e) Measurement of pH. Unless other (b) Process indicators and retort traffic methods are approved by the Adminis- control. A system for product traffic trator, potentiometric methods using control shall be established to prevent electronic instruments (pH meters) product from bypassing the thermal shall be used for making pH determina- processing operation. Each basket, tions when a maximum pH value is crate or similar vehicle containing un- specified as a critical factor in a proc- processed product, or at least one visi- ess schedule. ble container in each vehicle, shall be (Approved by Office of Management and plainly and conspicuously marked with Budget under control number 0583–0015) a heat sensitive indicator that will vis- ually indicate whether such unit has been thermally processed. Exposed § 318.305 Equipment and procedures for heat processing systems. heat sensitive indicators attached to container vehicles shall be removed be- (a) Instruments and controls common to fore such vehicles are refilled with un- different thermal processing systems—(1) processed product. Container loading Indicating temperature devices. Each re- systems for crateless retorts shall be tort shall be equipped with at least one designed to prevent unprocessed prod- indicating temperature device that uct from bypassing the thermal proc- measures the actual temperature with- essing operation. in the retort. The indicating tempera- (c) Initial temperature. The initial ture device, not the temperature/time temperature of the contents of the recording device, shall be used as the coldest container to be processed shall reference instrument for indicating the be determined and recorded by the es- process temperature.
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(i) Mercury-in-glass thermometers. A ment shall be provided. For example, a mercury-in-glass thermometer shall lock or a notice from management have divisions that are readable to 1F posted at or near the recording device °(or 0.5C°) and whose scale contains not warning that only authorized persons more than 17F°/inch (or 4.0C°/cm) of are permitted to make adjustments, graduated scale. Each mercury-in-glass are satisfactory means for preventing thermometer shall be tested for accu- unauthorized changes. Air-operated racy against a known accurate stand- temperature controllers shall have ade- ard upon installation and at least once quate filter systems to ensure a supply a year to ensure its accuracy. Records of clean, dry air. The recorder timing that specify the date, standard used, mechanism shall be accurate. test method, and the person or testing (i) Chart-type devices. Devices using authority performing the test shall be charts shall be used only with the cor- maintained on file by the establish- rect chart. Each chart shall have a ment and made available to Program working scale of not more than 55F°/ employees. A mercury-in-glass ther- inch (or 12C°/cm) within a range of 20F mometer that has a divided mercury °(or 11C°) of the process temperature. column or that cannot be adjusted to Chart graduations shall not exceed 2F the standard shall be repaired and test- degrees (or 1C degree) within a range of ed for accuracy before further use, or 10F degrees (or 5C degrees) of the proc- replaced. ess temperature. Multipoint plotting (ii) Other devices. In lieu of mercury- chart-type devices shall print tempera- in-glass thermometers, the Adminis- ture readings at intervals that will as- trator, upon request, will consider sure that the parameters of the process other indicating temperature devices, time and process temperature have such as resistance temperature detec- been met. The frequency of recording tors. Any such device that is approved should not exceed 1-minute intervals. shall, upon installation and at least (ii) Other devices. In lieu of chart-type once a year thereafter, be tested for ac- devices, the Administrator will con- curacy against a known accurate sider for approval other recording de- standard. Records that specify the vices upon request. date, standard used, test method, and (3) Steam controllers. Each retort shall the person or testing authority per- be equipped with an automatic steam forming the test shall be maintained controller to maintain the retort tem- on file by the establishment and made perature. This may be a recording/con- available to Program employees. Any trolling instrument when combined such device which cannot be adjusted with a temperature/time recording de- to the standard shall be replaced, or re- vice. paired and tested for accuracy before (4) Air valves. All air lines connected further use. to retorts designed for pressure proc- (2) Temperature/time recording devices. essing in steam shall be equipped with Each thermal processing system shall a globe valve or other equivalent-type be equipped with at least one tempera- valve or piping arrangement that will ture/time recording device to provide a prevent leakage of air into the retort permanent record of temperatures during the process cycle. within the thermal processing system. (5) Water valves. All retort water lines This recording device may be combined that are intended to be closed during a with the steam controller and may be a process cycle shall be equipped with a recording/controlling instrument. globe valve or other equivalent-type When compared to the known accurate valve or piping arrangement that will indicating temperature device, the re- prevent leakage of water into the re- cording accuracy shall be equal to or tort during the process cycle. better than 1F °(or 0.5C°) at the process (b) Pressure processing in steam—(1) temperature. The temperature record- Batch still retorts. (i) The basic require- ing chart should be adjusted to agree ments and recommendations for indi- with, but shall never be higher than, cating temperature devices and tem- the known accurate indicating tem- perature/time recording devices are de- perature device. A means of preventing scribed in paragraphs (a) (1) and (2) of unauthorized changes in the adjust- this section. Additionally, bulb sheaths
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or probes of indicating temperature de- mentation from the manufacturer or vices and probes of temperature/time from a processing authority dem- recording devices shall be installed ei- onstrating that the bleeders accom- ther within the retort shell or in exter- plish removal of air and circulate the nal wells attached to the retort. Exter- steam within the retort. This informa- nal wells shall be connected to the re- tion shall be maintained on file by the tort through at least a 3⁄4 inch (1.9 cm) establishment and made available to diameter opening and equipped with a Program employees for review. All 1⁄16 inch (1.6 mm) or larger bleeder bleeders shall be arranged in a way opening so located as to provide a con- that enables the retort operator to ob- stant flow of steam past the length of serve that they are functioning prop- the bulb or probe. The bleeder for ex- erly. Vertical retorts shall have at ternal wells shall emit steam continu- least one bleeder opening located in ously during the entire thermal proc- the portion of the retort opposite the essing period. steam inlet. All bleeders shall be ar- (ii) Steam controllers are required as ranged so that the retort operator can described under paragraph (a)(3) of this observe that they are functioning prop- section. erly. In retorts having a steam inlet (iii) Steam inlet. The steam inlet to above the level of the lowest container, each retort shall be large enough to a bleeder shall be installed in the bot- provide steam for proper operation of tom of the retort to remove conden- the retort, and shall enter at a point to sate. The condensate bleeder shall be facilitate air removal during venting. so arranged that the retort operator (iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be employ bottom retort crate supports. checked with sufficient frequency to Baffle plates shall not be used in the ensure adequate removal of conden- bottom of retorts. sate. Visual checks should be per- (v) Steam spreader. Perforated steam formed at intervals of not more than 15 spreaders, if used, shall be maintained minutes and the results recorded. to ensure they are not blocked or oth- Intermittent condensate removal sys- erwise inoperative. Horizontal still re- tems shall be equipped with an auto- torts shall be equipped with perforated matic alarm system that will serve as steam spreaders that extend the full a continuous monitor of condensate length of the retort unless the ade- bleeder functioning. The automatic quacy of another arrangement is docu- alarm system shall be tested at the be- mented by heat distribution data or ginning of each shift for proper func- other documentation from a processing tioning and the results recorded. If the authority. Such information shall be alarm system is not functioning prop- maintained on file by the establish- erly, it must be repaired before the re- ment and made available to Program tort is used. employees for review. (vii) Stacking equipment—(a) Equip- (vi) Bleeders and condensate removal. ment for holding or stacking containers in Bleeders, except those for external retorts. Crates, trays, gondolas, carts, wells of temperature devices, shall and other vehicles for holding or stack- have 1⁄8 inch (or 3 mm) or larger open- ing product containers in the retort ings and shall be wide open during the shall be so constructed to ensure steam entire process, including the come-up circulation during the venting, come- time. For horizontal still retorts, up, and process times. The bottom of bleeders shall be located within ap- each vehicle shall have perforations at proximately 1 foot (or 30 cm) of the least 1 inch (2.5 cm) in diameter on 2 outermost locations of containers at inch (or 5 cm) centers or the equivalent each end along the top of the retort. unless the adequacy of another ar- Additional bleeders shall be located rangement is documented by heat dis- not more than 8 feet (2.4 m) apart along tribution data or other documentation the top. Bleeders may be installed at from a processing authority and such positions other than those specified information is maintained on file by above, as long as the establishment has the establishment and made available heat distribution data or other docu- to Program employees for review.
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(b) Divider plates. Whenever one or pipes from the maximum number of re- more divider plates are used between torts to be vented simultaneously. any two layers of containers or placed (c) Some typical installations and op- on the bottom of a retort vehicle, the erating procedures are described below. establishment shall have on file docu- Other retort installations, vent piping mentation that the venting procedure arrangements, operating procedures or allows the air to be removed from the auxiliary equipment such as divider retort before timing of the thermal plates may be used provided there is process is started. Such documentation documentation that the air is removed shall be in the form of heat distribu- from the retort before the process is tion data or documentation from a started. Such documentation shall be processing authority. This information in the form of heat distribution data or shall be made available to Program other documentation from the equip- employees for review. ment manufacturer or processing au- (viii) Bleeder and vent mufflers. If muf- thority. This information shall be flers are used on bleeders or vent sys- maintained on file by the establish- tems, the establishment shall have on ment and made available to Program file documentation that the mufflers employees for review. do not impede the removal of air from (d) For crateless retort installations, the retort. Such documentation shall the establishment shall have heat dis- consist of either heat distribution data tribution data or other documentation or documentation from the muffler from the equipment manufacturer or manufacturer or from a processing au- from a processing authority that dem- thority. This information shall be onstrates that the venting procedure made available to Program employees used accomplishes the removal of air for review. and condensate. This information shall (ix) Vents—(a) Vents shall be located be maintained on file by the establish- in that portion of the retort opposite ment and made available to Program the steam inlet and shall be designed, employees for review. installed, and operated in such a way (e) Examples of typical installations that air is removed from the retort be- and operating procedures that comply fore timing of the thermal process is with the requirements of this section started. Vents shall be controlled by a are as follows: gate, plug cock, or other full-flow valve (1) Venting horizontal retorts. which shall be fully opened to permit (i) Venting through multiple 1 inch rapid removal of air from retorts dur- (2.5 cm) vents discharging directly to ing the venting period. the atmosphere. (b) Vents shall not be connected to a closed drain system without an atmos- pheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross- sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be connected to a closed drain without an atmospheric break in the Specifications (Figure 1): One, 1-inch (2.5 cm) line. A manifold header connecting vent for every 5 feet (1.5 m) of retort length, vents or manifolds from several still equipped with a gate, plug cock, or other retorts shall lead to the atmosphere. full-flow valve and discharging to atmos- The manifold header shall not be con- phere. The end vents shall not be more than 21⁄2 feet (or 75 cm) from ends of retort. Vent- trolled by a valve and shall be of a size ing method (Figure 1): Vent valves shall be such that the cross-sectional area is at wide open for at least 5 minutes and to at least equal to the total cross-sectional least 225 °F (or 107 °C), or at least 7 minutes area of all connecting retort manifold and to at least 220 °F (or 104.5 °C).
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(ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.
Specifications (Figure 4): A 21⁄2 inch (6.4 cm) vent equipped with a 21⁄2 inch (6.4 cm) gate, plug cock, or other full-flow valve and lo- cated within 2 feet (61 cm) of the center of Specifications (Figure 2): One, 1-inch (2.5 cm) the retort. vent for every 5 feet (1.5 m) of retort length; Venting method (Figure 4): The vent valve vents not over 21⁄2 feet (or 75 cm) from ends shall be wide open for at least 4 minutes and of retort; size of manifold for retorts less to at least 220 °F (or 104.5 °C). than 15 feet (4.6 m) in length, 21⁄2 inches (6.4 cm), and for retorts 15 feet (4.6 m) and over (2) Venting vertical retorts. in length, 3 inches (7.6 cm). (i) Venting through a 11⁄2 inch (3.8 cm) Venting method (Figure 2): The manifold overflow. vent gate, plug cock, or other full-flow valve shall be wide open for at least 6 minutes and to at least 225 °F (or 107 °C) or for at least 8 minutes and to at least 220 °F (or 104.5 °C). (iii) Venting through water spreaders.
Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 21⁄2 inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 11⁄2 inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length, 2 inches (or 5 cm). The number of holes shall be such that their total cross-sec- tional area is equal to the cross-sectional area of the vent pipe inlet. Venting method (Figure 3): The gate, plug Figure 5. cock, or other full-flow valve on the water Specifications (Figure 5): A 11⁄2 inch (3.8 cm) spreader vent shall be wide open for at least overflow pipe equipped with a 11⁄2 inch (3.8 5 minutes and to at least 225 °F (or 107 °C), or cm) gate, plug cock, or other full-flow valve for at least 7 minutes and to at least 220 °F and with not more than 6 feet (1.8 m) of 11⁄2 (or 104.5 °C). inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold (iv) Venting through a single 21⁄2 inch header. (6.4 cm) top vent for retorts not exceed- Venting method (Figure 5): The vent valve ing 15 feet (4.6 m) in length. shall be wide open for at least 4 minutes and
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to at least 218 °F (or 103.5 °C), or for at least (ii) Venting through a single 1 inch 5 minutes and to at least 215 °F (or 101.5 °C). (2.5 cm) side or top vent.
Specifications (Figure 6 or 7): A 1 inch (2.5 probes. The bleeder for external wells cm) vent in lid or top side, equipped with a shall emit steam continuously during gate, plug cock, or other full-flow valve and the entire thermal processing period. discharging directly into the atmosphere or to a manifold header. (ii) Steam controllers are required as Venting method (Figure 6 or 7): The vent described in paragraph (a)(3) of this valve shall be wide open for at least 5 min- section. utes and to at least 230 °F (110 °C), or for at (iii) Steam inlet. The steam inlet to least 7 minutes and to at least 220 °F (or 104.5 each retort shall be large enough to °C). provide steam for proper operation of (2) Batch agitating retorts. (i) The the retort and shall enter at a point(s) basic requirements for indicating tem- to facilitate air removal during vent- perature devices and temperature/time ing. recording devices are described in para- (iv) Bleeders. Bleeders, except those graphs (a) (1) and (2) of this section. for external wells of temperature de- Additionally, bulb sheaths or probes of vices, shall be 1⁄8 inch (or 3 mm) or larg- indicating temperature devices and er and shall be wide open during the probes of temperature/time recording entire process including the come-up devices shall be installed either within time. Bleeders shall be located within the retort shell or in external wells at- approximately 1 foot (or 30 cm) of the tached to the retort. External wells outermost location of containers, at shall be connected to the retort each end along the top of the retort. through at least a 3⁄4 inch (1.9 cm) di- Additional bleeders shall be located ameter opening and equipped with a 1⁄16 not more than 8 feet (2.4 m) apart along (1.6 mm) or larger bleeder opening so the top. Bleeders may be installed at located as to provide a constant flow of positions other than those specified steam past the length of the bulbs or above, as long as the establishment has
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heat distribution data or other docu- shift by checking the retort or reel mentation from the manufacturer or speed using an accurate stopwatch. A from a processing authority that the means of preventing unauthorized bleeders accomplish removal of air and speed changes on retorts shall be pro- circulate the steam within the retort. vided. For example, a lock or a notice This information shall be maintained from management posted at or near on file by the establishment and made the speed adjustment device warning available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is function- graphs (a) (1) and (2) of this section. ing properly. The condensate bleeder Additionally, bulb sheaths or probes of shall be checked with sufficient fre- indicating temperature devices and quency to ensure adequate removal of probes of temperature/time recording condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) di- an automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s) speed shall be determined and recorded to facilitate air removal during vent- at least once during process timing of ing. each retort load processed. Alter- (iv) Bleeders. Bleeders, except those natively, a recording tachometer can for external wells of temperature de- be used to provide a continuous record vices, shall be 1⁄8 inch (3.2 mm) or larg- of the speed. The accuracy of the re- er and shall be wide open during the cording tachometer shall be deter- entire process, including the come-up mined and recorded at least once per time. B!eeders shall be located within
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approximately 1 foot (or 30 cm) of the retort is started, and checked and re- outermost location of containers at corded at intervals not to exceed 4 each end along the top of the retort. hours to ensure that the correct retort Additional bleeders shall be located speed is maintained. Alternatively, a not more than 8 feet (2.4 m) apart along recording tachometer may be used to the top of the retort. Bleeders may be provide a continuous record of the installed at positions other than those speed. If a recording tachometer is specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who deve!oped the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time record- er shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient shall be located in the steam dome frequency to ensure adequate removal near the steam/water interface. Where of condensate. Visual checks should be the process schedule specifies mainte- performed at intervals of not more nance of particular water temperatures than 15 minutes and the results re- in the hydrostatic water legs, at least corded. Intermittent condensate re- one indicating temperature device moval systems shall be equipped with shall be located in each hydrostatic an automatic alarm system that will water leg so that it can accurately serve as a continuous monitor of con- measure water temperature and be eas- densate bleeder functioning. The auto- ily read. The temperature/time re- matic alarm system shall be tested at corder probe shall be installed either the beginning of each shift for proper within the steam dome or in a well at- functioning and the results recorded. If tached to the dome. Each probe shall the alarm system is not functioning have a 1⁄16 inch (1.6 mm) or larger bleed- properly, it must be repaired before the er opening which emits steam continu- retort is used. ously during the processing period. Ad- (vi) Retort speed timing. The rota- ditional temperature/time recorder tional speed of the retort shall be spec- probes shall be installed in the hydro- ified in the process schedule. The speed static water legs if the process sched- shall be adjusted as specified, and re- ule specifies maintenance of particular corded by the establishment when the temperatures in these water legs.
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(ii) Steam controllers are required as ity. This information shall be main- described in paragraph (a)(3) of this tained on file by the establishment and section. made available to Program employees (iii) Steam inlet. The steam inlets for review. shall be large enough to provide steam (c) Pressure processing in water—(1) for proper operation of the retort. Batch still retorts. (i) The basic require- (iv) Bleeders. Bleeder openings 1⁄4 inch ments for indicating temperature de- (or 6 mm) or larger shall be located in vices and temperature/time recording the steam chamber(s) opposite the devices are described in paragraphs point of steam entry. Bleeders shall be (a)(1) and (2) of this section. Addition- wide open and shall emit steam con- ally, bulbs or probes of indicating tem- tinuously during the entire process, in- perature devices shall be located in cluding the come-up time. All bleeders such a position that they are beneath shall be arranged in such a way that the surface of the water throughout the operator can observe that they are the process. On horizontal retorts, the functioning properly. indicating temperature device bulb or (v) Venting. Before the start of proc- essing operations, the retort steam probe shall be inserted directly into chamber(s) shall be vented to ensure the retort shell. In both vertical and removal of air. Heat distribution data horizontal retorts, the indicating tem- or other documentation from the man- perature device bulb or probe shall ex- ufacturer or from a processing author- tend directly into the water a mini- ity demonstrating that the air is re- mum of 2 inches (or 5 cm) without a moved from the retort prior to process- separable well or sleeve. In vertical re- ing shall be kept on file at the estab- torts equipped with a recorder/control- lishment and made available to Pro- ler, the controller probe shall be lo- gram employees for review. cated at the bottom of the retort below (vi) Conveyor speed. The conveyor the lowest crate rest in such a position speed shall be calculated to obtain the that the steam does not strike it di- required process time and recorded by rectly. In horizontal retorts so the establishment when the retort is equipped, the controller probe shall be started. The speed shall be checked and located between the water surface and recorded at intervals not to exceed 4 the horizontal plane passing through hours to ensure that the correct con- the center of the retort so that there is veyor speed is maintained. A recording no opportunity for direct steam im- device may be used to provide a contin- pingement on the controller probe. Air- uous record of the conveyor speed. operated temperature controllers shall When a recording device is used, the have filter systems to ensure a supply speed shall be manually checked of clean, dry air. against an accurate stopwatch at least (ii) Pressure recording device. Each re- once per shift by the establishment. A tort shall be equipped with a pressure means of preventing unauthorized recording device which may be com- speed changes of the conveyor shall be bined with a pressure controller. provided. For example, a lock or a no- (iii) are required as tice from management posted at or Steam controllers near the speed adjustment device warn- described in paragraph (a)(3) of this ing that only authorized persons are section. permitted to make adjustments are (iv) Heat distribution. Heat distribu- satisfactory means of preventing unau- tion data or other documentation from thorized changes. the equipment manufacturer or a proc- (vii) Bleeders and vent mufflers. If muf- essing authority demonstrating uni- flers are used on bleeders or vent sys- form heat distribution within the re- tems, the establishment shall have doc- tort shall be kept on file at the estab- umentation that the muffler do not im- lishment and made available to Pro- pede the removal of air from the retort. gram employees for review. Such documentation shall consist of ei- (v) Crate supports. A bottom crate ther heat distribution data or other support shall be used in vertical re- documentation from the muffler manu- torts. Baffle plates shall not be used in facturer or from a processing author- the bottom of the retort.
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(vi) Stacking equipment. For filled distribution within the retort shall be flexible containers and, where applica- documented by heat distribution data ble, semirigid containers, stacking or other documentation from a process- equipment shall be designed to ensure ing authority, and such data shall be that the thickness of the filled contain- maintained on file by the establish- ers does not exceed that specified in ment and made available to Program the process schedule and that the con- employees for review. tainers do not become displaced and (x) Water recirculation. When a water overlap or rest on one another during recirculation system is used for heat the thermal process. distribution, the water shall be drawn (vii) Drain valve. A nonclogging, from the bottom of the retort through water-tight drain valve shall be used. a suction manifold and discharged Screens shall be installed over all drain through a spreader that extends the openings. length or circumference of the top of (viii) Water level. There shall be a the retort. The holes in the water means of determining the water level spreader shall be uniformly distrib- in the retort during operation (i.e., by uted. The suction outlets shall be pro- using a gauge, electronic sensor, or tected with screens to keep debris from sight glass indicator). For retorts re- entering the recirculation system. The quiring complete immersion of con- pump shall be equipped with a pilot tainers, water shall cover the top layer light or a similar device to warn the of containers during the entire come- operator when it is not running, and up time and thermal processing periods with a bleeder to remove air when and should cover the top layer of con- starting operations. Alternatively, a tainers during cooling. For retorts flow-meter alarm system can be used using cascading water or water sprays, to ensure proper water circulation. The the water level shall be maintained adequacy of water circulation for within the range specified by the retort maintaining uniform heat distribution manufacturer or processing authority within the retort shall be documented during the entire come-up, thermal by heat distribution or other docu- processing, and cooling periods. A mentation from a processing authority means to ensure that water circulation continues as specified throughout the and such data shall be maintained on come-up, thermal processing, and cool- file by the establishment and made ing periods shall be provided. The re- available to Program employees for re- tort operator shall check and record view. Alternative methods for recir- the water level at intervals to ensure it culation of water in the retort may be meets the specified processing param- used, provided there is documentation eters. in the form of heat distribution data or (ix) Air supply and controls. In both other documentation from a processing horizontal and vertical still retorts, a authority maintained on file by the es- means shall be provided for introducing tablishment and made available to compressed air or steam at the pres- Program employees for review. sure required to maintain container in- (xi) Cooling water entry. In retorts for tegrity. Compressed air and steam processing product packed in glass jars, entry shall be controlled by an auto- the incoming cooling water should not matic pressure control unit. A non- directly strike the jars, in order to return valve shall be provided in the minimize glass breakage by thermal air supply line to prevent water from shock. entering the system. Overriding air or (2) Batch agitating retorts. (i) The steam pressure shall be maintained basic requirements and recommenda- continuously during the come-up, ther- tions for indicating temperature de- mal processing, and cooling periods. If vices and temperature/time recording air is used to promote circulation, it devices are described in paragraphs (a) shall be introduced into the steam line (1) and (2) of this section. Additionally, at a point between the retort and the the indicating temperature device bulb steam control valve at the bottom of or probe shall extend directly into the the retort. The adequacy of the air cir- water without a separable well or culation for maintaining uniform heat sleeve. The recorder/controller probe
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shall be located between the water sur- riods. If air is used to promote circula- face and the horizontal plane passing tion, it shall be introduced into the through the center of the retort so that steam line at a point between the re- there is no opportunity for steam to di- tort and the steam control valve at the rectly strike the controller bulb or bottom of the retort. The adequacy of probe. the air circulation for maintaining uni- (ii) Pressure recording device. Each re- form heat distribution within the re- tort shall be equipped with a pressure tort shall be documented by heat dis- recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required data shall be maintained on file by the as described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from tort or reel speed timing shall be the equipment manufacturer or a proc- checked before process timing begins essing authority shall be kept on file and, if needed, adjusted as specified in by the establishment and made avail- the process schedule. In addition, the able to Program employees for review. rotational speed shall be determined (v) Stacking equipment. All devices and recorded at least once during proc- used for holding product containers ess timing of each retort load proc- (e.g., crates, trays, divider plates) shall essed. Alternatively, a recording ta- be so constructed to allow the water to chometer can be used to provide a con- circulate around the containers during tinuous record of the speed. The accu- the come-up and thermal process peri- racy of the recording tachometer shall ods. be determined and recorded at least (vi) Drain valve. A nonclogging, once per shift by the establishment by water-tight drain valve shall be used. checking the retort or reel speed using Screens shall be installed over all drain an accurate stopwatch. A means of pre- openings. venting unauthorized speed changes on (vii) Water level. There shall be a retorts shall be provided. For example, means of determining the water level a lock or a notice from management in the retort during operation (i.e., by posted at or near the speed adjustment using a gauge, electronic sensor, or device warning that only authorized sight glass indicator). Water shall com- persons are permitted to make adjust- pletely cover all containers during the ments are satisfactory means of pre- entire come-up, thermal processing, venting unauthorized changes. and cooling periods. A means to ensure (x) Water recirculation. If a water re- that water circulation continues as circulation system is used for heat dis- specified throughout the come-up, tribution, it shall be installed in such a thermal processing, and cooling periods manner that water will be drawn from shall be provided. The retort operator the bottom of the retort through a suc- shall check and record the adequacy of tion manifold and discharged through a the water level with sufficient fre- spreader which extends the length of quency to ensure it meets the specified the top of the retort. The holes in the processing parameters. water spreader shall be uniformly dis- (viii) Air supply and controls. Retorts tributed. The suction outlets shall be shall be provided with a means for in- protected with screens to keep debris troducing compressed air or steam at from entering the recirculation sys- the pressure required to maintain con- tem. The pump shall be equipped with tainer integrity. Compressed air and a pilot light or a similar device to warn steam entry shall be controlled by an the operator when it is not running and automatic pressure control unit. A with a bleeder to remove air when nonreturn valve shall be provided in starting operations. Alternatively, a the air supply line to prevent water flow-meter alarm system can be used from entering the system. Overriding to ensure proper water circulation. The air or steam pressure shall be main- adequacy of water circulation for tained continuously during the come- maintaining uniform heat distribution up, thermal processing, and cooling pe- within the retort shall be documented
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by heat distribution data or other doc- (5) The Administrator shall be noti- umentation from a processing author- fied immediately by the official estab- ity, and such data shall be maintained lishment of any such system in use or on file by the establishment and made placed into use on or after the effective available to Program employees for re- date of this rule. view. Alternative methods for recir- (e) Atmospheric cookers—(1) Tempera- culation of water in the retort may be ture/time recording device. Each atmos- used provided there is documentation pheric cooker (e.g., hot water bath) in the form of heat distribution data or shall be equipped with at least one other documentation from a processing temperature/time recording device in authority maintained on file by the es- accordance with the basic require- tablishment and made available to ments described in paragraph (a)(2) of Program employees for review. this section. (xi) Cooling water entry. In retorts for (2) Heat distribution. Each atmos- processing product packed in glass jars, pheric cooker shall be equipped and op- the incoming cooling water should not erated to ensure uniform heat distribu- directly strike the jars, in order to tion throughout the processing system minimize glass breakage by thermal during the thermal process. Heat dis- shock. tribution data or other documentation (d) Pressure processing with steam/air from the manufacturer or a processing mixtures in batch retorts. (1) The basic authority demonstrating uniform heat requirements for indicating tempera- distribution within the cooker shall be ture devices and temperature/time re- kept on file by the establishment and cording devices are described in para- made available to Program employees graphs (a) (1) and (2) of this section. for review. Additionally, bulb sheaths or probes (f) Other systems. All other systems for indicating temperature devices and not specifically delineated in this sec- temperature/time recording devices or tion and used for the thermal process- controller probes shall be inserted di- ing of canned product will be evaluated rectly into the retort shell in such a on a case-by-case basis by the position that steam does not strike Adminstrator. Systems will be ap- them directly. proved if they are found to conform to (2) Steam controllers are required as the applicable requirements of this sec- described in paragraph (a)(3) of this tion and to produce shelf stable prod- section. ucts consistently and uniformly. (3) Recording pressure controller. A re- (g) Equipment maintenance. (1) Upon cording pressure controller shall be installation, all instrumentation and used to control the air inlet and the controls shall be checked by the estab- steam/air mixture outlet. lishment for proper functioning and ac- (4) Circulation of steam/air mixtures. A curacy and, thereafter, at any time means shall be provided for the circula- their functioning or accuracy is sus- tion of the steam/air mixture to pre- pect. vent formation of low-temperature (2) At least once a year each thermal pockets. The efficiency of the circula- processing system shall be examined by tion system shall be documented by an individual not directly involved in heat distribution data or other docu- daily operations to ensure the proper mentation from a processing authority, functioning of the system as well as all and such data shall be maintained on auxiliary equipment and instrumenta- file by the establishment and made tion. In addition, each thermal process- available to Program employees for re- ing system should be examined before view. The circulation system shall be the resumption of operation following checked to ensure its proper function- an extended shutdown. ing and shall be equipped with a pilot (3) Air and water valves that are in- light or a similar device to warn the tended to be closed during thermal operator when it is not functioning. processing shall be checked by the es- Because of the variety of existing de- tablishment for leaks. Defective valves signs, reference shall be made to the shall be repaired or replaced as needed. equipment manufacturer for details of (4) Vent and bleeder mufflers shall be installation, operation, and control. checked and maintained or replaced by
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the establishment to prevent any re- the frequency and site(s) of sampling, duction in vent or bleeder efficiency. and the corrective actions taken when (5) When water spreaders are used for water quality standards are not met. venting, a maintenance schedule shall (i) Post-process handling of containers be developed and implemented to as- Containers shall be handled in a man- sure that the holes are maintained at ner that will prevent damage to the their original size. hermetic seal area. All worn and frayed (6) Records shall be kept on all main- belting, can retarders, cushions, and tenance items that could affect the the like shall be replaced with non- adequacy of the thermal process. porous materials. To minimize con- Records shall include the date and type tainer abrasions, particularly in the of maintenance performed and the per- seal area, containers should not remain son conducting the maintenance. stationary on moving conveyors. All (h) Container cooling and cooling water. (1) Potable water shall be used post-process container handling equip- for cooling except as provided for in ment should be kept clean so there is paragraphs (h) (2) and (3) of this sec- no buildup of microorganisms on sur- tion. faces in contact with the containers. (2) Cooling canal water shall be (Approved by the Office of Management and chlorinated or treated with a chemical Budget under control number 0583–0015) approved by the Administrator as hav- ing a bactericidal effect equivalent to § 318.306 Processing and production chlorination. There shall be a measur- records. able residual of the sanitizer in the water at the discharge point of the At least the following processing and canal. Cooling canals shall be cleaned production information shall be re- and replenished with potable water to corded by the establishment: date of prevent the buildup of organic matter production; product name and style; and other materials. container code; container size and (3) Container cooling waters that are type; and the process schedule, includ- recycled or reused shall be handled in ing the minimum initial temperature. systems that are so designed, operated, Measurements made to satisfy the re- and maintained so there is no buildup quirements of § 318.303 regarding the of microorganisms, organic matter, control of critical factors shall be re- and other materials in the systems and corded. In addition, where applicable, in the waters. System equipment, such the following information and data as pipelines, holding tanks and cooling shall also be recorded: towers, shall be constructed and in- (a) Processing in steam—(1) Batch still stalled so that they can be cleaned and retorts. For each retort batch, record inspected. In addition, the establish- the retort number or other designa- ment shall maintain, and make avail- tion, the approximate number of con- able to Program employees for review, tainers or the number of retort crates information on at least the following: per retort load, product initial tem- (i) System design and construction; perature, time steam on, the time and (ii) System operation including the temperature vent closed, the start of rates of renewal with fresh, potable process timing, time steam off, and the water and the means for treating the water so that there is a measurable re- actual processing time. The indicating sidual of an acceptable sanitizer, per temperature device and the tempera- paragraph (h)(2) of this section, in the ture recorder shall be read at the same water at the point where the water time at least once during process tim- exits the container cooling vessel; ing and the observed temperatures re- (iii) System maintenance including corded. procedures for the periodic cleaning (2) Batch agitating retorts. In addition and sanitizing of the entire system; to recording the information required and for batch, still steam retorts in para- (iv) Water quality standards, such as graph (a)(1) of this section, record the microbiological, chemical and phys- functioning of the condensate bleed- ical, monitoring procedures including er(s) and the retort or reel speed.
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(3) Continuous rotary retorts. Record tion, the approximate number of con- the retort system number, the approxi- tainers or number of retort crates per mate total number of containers re- retort load, product initial tempera- torted, product initial temperature, ture, time steam on, the start of proc- time steam on, the time and tempera- ess timing, water level, water recir- ture vent closed, time process tempera- culation rate (if critical), overriding ture reached, the time the first can en- pressure maintained, time steam off, ters and the time the last can exits the and actual processing time. The indi- retort. The retort or reel speed shall be cating temperature device and the determined and recorded at intervals temperature recorder shall be read at not to exceed 4 hours. Readings of the the same time at least once during indicating temperature device(s) and process timing and the observed tem- temperature recorder(s) shall be made peratures recorded. and recorded at the time the first con- (2) Batch agitating retorts. In addition tainer enters the retort and thereafter to recording the information required with sufficient frequency to ensure in paragraph (b)(1) of this section, compliance with the process schedule. record the retort or reel speed. These observations should be made and recorded at intervals not exceeding 30 (c) Processing in steam/air mixtures. minutes of continuous retort oper- For each retort batch, record the re- ation. Functioning of the condensate tort number or other designation, the bleeder(s) shall be observed and re- approximate number of containers or corded at the time the first container number of retort crates per retort load, enters the retort and thereafter as product initial temperature, time specified in § 318.305(b)(3)(v). steam on, venting procedure, if appli- (4) Hydrostatic retorts. Record the re- cable, the start of process timing, tort system number, the approximate maintenance of circulation of the total number of containers retorted, steam/air mixture, air flow rate or product initial temperature, time forced recirculation flow rate (if criti- steam on, the time and temperature cal), overriding pressure maintained, vent(s) closed, time process tempera- time steam off, and actual processing ture reached, time first containers time. The indicating temperature de- enter the retort, time last containers vice and the temperature recorder shall exit the retort, and, if specified in the be read at the same time at least once process schedule, measurements of during process timing and the observed temperatures in the hydrostatic water temperatures recorded. legs. Readings of the temperature indi- (d) Atmospheric cookers—(1) Batch-type cating device, which is located in the systems. For each cooker batch, record steam/water interface, and the tem- the cooker number or other designa- perature recording device shall be ob- tion and the approximate number of served and the temperatures recorded containers. In addition, record all criti- at the time the first containers enter cal factors of the process schedule such the steam dome. Thereafter, these in- as cooker temperature, initial tem- struments shall be read and the tem- perature, the time the thermal process peratures recorded with sufficient fre- cycle begins and ends, hold time, and quency to ensure compliance with the the final internal product temperature. temperature specified in the process (2) Continuous-type systems. Record schedule and should be made at least the cooker number or other designa- every hour of continuous retort oper- tion, the time the first containers ation. Container conveyor speed, and enter and the last containers exit a for agitating hydrostatic retorts, the cooker, and the approximate total rotative chain speed, shall be deter- number of containers processed. In ad- mined and recorded at intervals of suf- dition, record all critical factors of the ficient frequency to ensure compliance process schedule such as the initial with the process schedule and should temperature, cooker speed, and final be performed at least every 4 hours. internal product temperature. (b) Processing in water—(1) Batch still retorts. For each retort batch, record (Approved by the Office of Management and the retort number or other designa- Budget under control number 0583–0015)
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§ 318.307 Record review and mainte- necessary, the segregation of specific nance. production lots that may have been (a) Process records. Charts from tem- contaminated or are otherwise unsound perature/time recording devices shall for their intended use. be identified by production date, con- (e) Retention of records. Copies of all tainer code, processing vessel number processing and production records re- or other designation, and other data as quired in § 318.306 shall be retained for necessary to enable correlation with no less than 1 year at the establish- the records required in § 318.306. Each ment, and for an additional 2 years at entry on a record shall be made at the the establishment or other location time the specific event occurs, and the from which the records can be made recording individual shall sign or ini- available to Program employees within tial each record form. No later than 1 3 working days. working day after the actual process, the establishment shall review all (Approved by the Office of Management and Budget under control number 0583–0015) processing and production records to ensure completeness and to determine if all product received the process § 318.308 Deviations in processing. schedule. All records, including the (a) Whenever the actual process is temperature/time recorder charts and less than the process schedule or when critical factor control records, shall be any critical factor does not comply signed or initialed and dated by the with the requirements for that factor person conducting the review. All proc- as specified in the process schedule, it essing and production records required shall be considered a deviation in proc- in this subpart shall be made available essing. to Program employees for review. (b) Deviations in processing (or proc- (b) Automated process monitoring and ess deviations) shall be handled under recordkeeping. When requested by an es- quality control as provided in para- tablishment, the Administrator will graph (c) of this section or shall be consider the approval of automated handled in accordance with paragraph process monitoring and recordkeeping (d) of this section. systems. An approved system, alone or in combination with written records, (c) Any partial quality control pro- shall be designed and operated in a gram or any portion of a total quality manner which will ensure compliance control system for handling process de- with the applicable requirements of viations shall be prepared in accord- § 318.306. ance with § 318.4. (c) Container closure records. Written (d) Handling process deviations with- records of all container closure exami- out an approved quality control pro- nations shall specify the container gram. (1) Deviations identified in-process. code, the date and time of container If a deviation is noted at any time be- closure examination, the measure- fore the completion of the intended ment(s) obtained, and any corrective process schedule, the establishment actions taken. Records shall be signed shall: or initialed by the container closure (i) Immediately reprocess the prod- technician and shall be reviewed and uct using the full process schedule; or signed by the establishment within 1 (ii) Use an appropriate alternate working day after the actual produc- process schedule provided such a proc- tion to ensure that the records are ess schedule has been established in ac- complete and that the closing oper- cordance with § 318.302 (a) and (b) and is ations have been properly controlled. filed with the inspector in accordance All container closure examination with § 318.302(c); or records required in this subpart shall (iii) Hold the product involved and be made available to Program employ- have the deviation evaluated by a proc- ees for review. essing authority to assess the safety (d) Distribution of product. Records and stability of the product. Upon com- shall be maintained by the establish- pletion of the evaluation, the establish- ment identifying initial distribution of ment shall provide the inspector the the finished product to facilitate, if following:
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(a) A complete description of the de- ule, the reel shall be stopped and the viation along with all necessary sup- following actions shall be taken: porting documentation; (1) For temperature drops of less (b) A copy of the evaluation report; than 10 ° F (or 5.5 ° C) either, (i) all con- and tainers in the retort shall be given an (c) A description of any product dis- emergency still process (developed per position actions, either taken or pro- § 318.302(b)) before the reel is restarted; posed. (ii) container entry to the retort shall (iv) Product handled in accordance be prevented and an emergency agitat- with paragraph (d)(1)(iii) of this section ing process (developed per § 318.302(b)) shall not be shipped from the establish- shall be used before container entry to ment until the Program has reviewed the retort is restarted; or (iii) container all of the information submitted and entry to the retort shall be prevented approved the product disposition ac- and the reel restarted to empty the re- tions. tort. The discharged containers shall (v) If an alternate process schedule is be reprocessed, repacked and reproc- used that is not on file with the inspec- essed, or destroyed. Product to be de- tor or if an alternate process schedule stroyed shall be handled as ‘‘U.S. In- is immediately calculated and used, spected and Condemned’’, as defined in the product shall be set aside for fur- § 318.2(ee) of this subchapter, and dis- ther evaluation in accordance with posed of in accordance with part 314 of paragraphs (d)(1)(iii) and (iv) of this this subchapter. section. (2) For temperature drops of 10 ° F (or (vi) When a deviation occurs in a con- 5.5 ° C) or more, all containers in the tinuous rotary retort, the product shall retort shall be given an emergency still be handled in accordance with para- process (developed per § 318.302(b)). The graphs (d)(1)(iii) and (iv) of this section time the reel was stopped and the time or in accordance with the following the retort was used for a still retort procedures: process shall be marked on the tem- (a) Emergency stops. perature/time recording device by the (1) When retort jams or breakdowns establishment and entered on the other occur during the processing operations, all containers shall be given an emer- production records required in § 318.306. gency still process (developed per Alternatively, container entry to the § 318.302(b)) before the retort is cooled retort shall be prevented and the reel or the retort shall be cooled promptly restarted to empty the retort. The dis- and all containers removed and either charged containers shall be either re- reprocessed, repacked and reprocessed, processed, repacked and reprocessed, or or destroyed. Regardless of the proce- destroyed. Product to be destroyed dure used, containers in the retort in- shall be handled as ‘‘U.S. Inspected and take valve and in transfer valves be- Condemned’’, as defined in § 301.2(ee) of tween retort shells at the time of a jam this subchapter, and disposed of in ac- or breakdown shall be removed and ei- cordance with part 314 of this sub- ther reprocessed, repacked and reproc- chapter. essed and or destroyed. Product to be (2) Deviations identified through record destroyed shall be handled as ‘‘U.S. In- review. Whenever a deviation is noted spected and Condemned’’, as defined in during review of the processing and § 301.2(ttt) of this subchapter, and dis- production records required by § 318.307 posed of in accordance with part 314 of (a) and (b), the establishment shall this subchapter. hold the product involved and the devi- (2) The time the retort reel stopped ation shall be handled in accordance and the time the retort is used for an with paragraphs (d)(1) (iii) and (iv) of emergency still retort process shall be this section. noted on the temperature/time record- (e) Process deviation file. The estab- ing device and entered on the other lishment shall maintain full records re- production records required in § 318.306. garding the handling of each deviation. (b) Temperature drops. When the re- Such records shall include, at a mini- tort temperature drops below the tem- mum, the appropriate processing and perature specified in the process sched- production records, a full description of
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the corrective actions taken, the eval- °F (or 39.5 °C) for more than 2 hours, uation procedures and results, and the the incubation test(s) shall be termi- disposition of the affected product. nated, the temperature lowered to Such records shall be maintained in a within the required range, and new separate file or in a log that contains sample containers incubated for the re- the appropriate information. The file quired time. or log shall be retained in accordance (iii) Product requiring incubation. with § 318.307(e) and shall be made Shelf stable product requiring incuba- available to Program employees upon tion includes: request. (a) Low acid products as defined in § 318.300(m); and (Approved by the Office of Management and Budget under control number 0583–0015) (b) Acidified low acid products as de- fined in § 318.300(b). [51 FR 45619, Dec. 19, 1986, as amended at 53 (iv) Incubation samples. (a) From each FR 49848, Dec. 12, 1988; 62 FR 45025, Aug. 25, load of product processed in a batch- 1997] type thermal processing system (still or agitation), the establishment shall § 318.309 Finished product inspection. select at least one container for incu- (a) Finished product inspections shall bation. be handled under quality control as (b) For continuous rotary retorts, hy- provided in paragraph (b) or paragraph drostatic retorts, or other continuous- (c) of this section or shall be handled in type thermal processing systems, the accordance with paragraph (d) of this establishment shall select at least one section. container per 1,000 for incubation. (b) Any partial quality control pro- (c) Only normal-appearing containers gram for finished product inspection shall be selected for incubation. shall be prepared in accordance with (v) Incubation time. Canned product § 318.4 of this part. requiring incubation shall be incubated (c) That portion of a total quality for not less than 10 days (240 hours) control system for finished product in- under the conditions specified in para- spection shall be prepared in accord- graph (d)(1)(ii) of this section. ance with § 318.4 of this part. (vi) Incubation checks and record main- (d) Handling finished product inspec- tenance. Designated establishment em- tions without an approved quality con- ployees shall visually check all con- trol program. tainers under incubation each working (1) Incubation of shelf stable canned day and the inspector shall be notified product—(i) Incubator. The establish- when abnormal containers are de- ment shall provide incubation facilities tected. All abnormal containers should which include an accurate tempera- be allowed to cool before a final deci- ture/time recording device, an indicat- sion on their condition is made. For ing temperature device, a means for each incubation test the establishment the circulation of the air inside the in- shall record at least the product name, cubator to prevent temperature vari- container size, container code, number ations, and a means to prevent unau- of containers incubated, in and out thorized entry into the facility. The dates, and incubation results. The es- Program is responsible for the security tablishment shall retain such records, of the incubator. along with copies of the temperature/ (ii) Incubation temperature. The incu- time recording charts, in accordance bation temperature shall be main- with § 318.307(e). tained at 95±5 °F (35±2.8 °C). If the incu- (vii) Abnormal containers. The finding bation temperature falls below 90 °F (or of abnormal containers (as defined in 32 °C) or exceeds 100 °F (or 38 °C) but § 318.300(a)) among incubation samples does not reach 103 °F (or 39.5 °C), the is cause to officially retain at least the incubation temperature shall be ad- code lot involved. justed within the required range and (viii) Shipping. No product shall be the incubation time extended for the shipped from the establishment before time the sample containers were held the end of the required incubation pe- at the deviant temperature. If the incu- riod except as provided in this para- bation temperature is at or above 103 graph or paragraph (b) or (c) of this
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section. An establishment wishing to recall of all canned product covered by ship product prior to the completion of this subpart. Upon request, the recall the required incubation period shall procedure shall be made available to submit a written proposal to the area Program employees for review. supervisor. Such a proposal shall in- clude provisions that will assure that (Approved by the Office of Management and Budget under control number 0583–0015) shipped product will not reach the re- tail level of distribution before sample incubation is completed and that prod- PART 319—DEFINITIONS AND uct can be returned promptly to the es- STANDARDS OF IDENTITY OR tablishment should such action be COMPOSITION deemed necessary by the incubation test results. Upon receipt of written Subpart A—General approval from the area supervisor, product may be routinely shipped pro- Sec. vided the establishment continues to 319.1 Labeling and preparation of standard- comply with all requirements of this ized products. subpart. 319.2 Products and nitrates and nitrites. (2) Container condition—(i) Normal 319.5 Mechanically Separated (Species). containers. Only normal-appearing con- 319.6 Limitations with respect to use of Me- chanically Separated (Species). tainers shall be shipped from an estab- lishment as determined by an appro- Subpart B—Raw Meat Products priate sampling plan or other means acceptable to Program employees. 319.15 Miscellaneous beef products. (ii) Abnormal containers. When abnor- 319.29 Miscellaneous pork products. mal containers are detected by any means other than incubation, the es- Subpart C—Cooked Meats tablishment shall inform the inspector, 319.80 Barbecued meats. and the affected code lot(s) shall not be 319.81 Roast beef parboiled and steam roast- shipped until the Program has deter- ed. mined that the product is safe and sta- ble. Such a determination will take Subpart D—Cured Meats, Unsmoked and into account the cause and level of Smoked abnormals in the affected lot(s) as well as any product disposition actions ei- 319.100 Corned beef. ther taken or proposed by the estab- 319.101 Corned beef brisket. lishment. 319.102 Corned beef round and other corned beef cuts. (Approved by the Office of Management and 319.103 Cured beef tongue. Budget under control number 0583–0015) 319.104 Cured pork products. 319.105 ‘‘Ham patties,’’ ‘‘Chopped ham,’’ [51 FR 45619, Dec. 19, 1986, as amended at 57 ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ and simi- FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, lar products. 1992; 62 FR 45025, Aug. 25, 1997] 319.106 ‘‘Country Ham,’’ ‘‘Country Style Ham,’’ ‘‘Dry Cured Ham,’’ ‘‘Country Pork § 318.310 Personnel and training. Shoulder,’’ ‘‘Country Style Pork Shoul- All operators of thermal processing der,’’ and ‘‘Dry Cured Pork Shoulder.’’ systems specified in § 318.305 and con- 319.107 Bacon. tainer closure technicians shall be under the direct supervision of a person Subpart E—Sausage Generally: Fresh who has successfully completed a Sausage school of instruction that is generally 319.140 Sausage. recognized as adequate for properly 319.141 Fresh pork sausage. training supervisors of canning oper- 319.142 Fresh beef sausage. ations. 319.143 Breakfast sausage. [51 FR 45619, Dec. 19, 1986] 319.144 Whole hog sausage. 319.145 Italian sausage products. § 318.311 Recall procedure. Subpart F—Uncooked, Smoked Sausage Establishments shall prepare and maintain a current procedure for the 319.160 Smoked pork sausage.
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Subpart G—Cooked Sausage Subpart P—Fats, Oils, Shortenings
319.180 Frankfurters, frank, furter, hotdog, 319.700 Margarine or oleomargarine. weiner, vienna, bologna, garlic bologna, 319.701 Mixed fat shortening. knockwurst, and similar products. 319.702 Lard, leaf lard. 319.181 Cheesefurters and similar products. 319.703 Rendered animal fat or mixture 319.182 Braunschweiger and liver sausage or thereof. liverwurst. Subpart Q—Meat Soups, Soup Mixes, Subpart H [Reserved] Broths, Stocks, Extracts
Subpart I—Semi-Dry Fermented Sausage 319.720 Meat extract. 319.721 Fluid extract of meat. [Reserved] Subpart R—Meat Salads and Meat Spreads Subpart J—Dry Fermented Sausage [Reserved] 319.760 Deviled ham, deviled tongue, and similar products. Subpart K—Luncheon Meat, Loaves and 319.761 Potted meat food product and dev- Jellied Products iled meat food product. 319.762 Ham spread, tongue spread, and 319.260 Luncheon meat. similar products. 319.261 Meat loaf. Subpart S—Meat Baby Foods [Reserved] Subpart L—Meat Specialties, Puddings and Nonspecific Loaves Subpart T—Dietetic Meat Foods [Reserved]
319.280 Scrapple. Subpart U—Miscellaneous 319.281 Bockwurst. 319.880 Breaded products. 319.881 Liver meat food products. Subpart M—Canned, Frozen, or Dehydrated Meat Food Products AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. 319.300 Chili con carne. SOURCE: 35 FR 15597, Oct. 3, 1970, unless 319.301 Chili con carne with beans. otherwise noted. 319.302 Hash. 319.303 Corned beef hash. 319.304 Meat stews. Subpart A—General 319.305 Tamales. 319.306 Spaghetti with meatballs and sauce, § 319.1 Labeling and preparation of spaghetti with meat and sauce, and simi- standardized products. lar products. Labels for products for which stand- 319.307 Spaghetti sauce with meat. ards of identity or composition are pre- 319.308 Tripe with milk. scribed in this part shall show the ap- 319.309 Beans with frankfurters in sauce, propriate product name, an ingredient sauerkraut with wieners and juice, and statement, and other label information similar products. in accordance with the special provi- 319.310 Lima beans with ham in sauce, sions, if any, in this part, and other- beans with ham in sauce, beans with bacon in sauce, and similar products. wise in accordance with the general la- 319.311 Chow mein vegetables with meat, beling provisions in part 317 of this and chop suey vegetables with meat. subchapter, and such products shall be 319.312 Pork with barbecue sauce and beef prepared in accordance with the special with barbecue sauce. provisions, if any, in this part and oth- 319.313 Beef with gravy and gravy with beef. erwise in accordance with the general provisions in this subchapter. Any Subpart N—Meat Food Entree Products, product for which there is a common or Pies, and Turnovers usual name must consist of ingredients and be prepared by the use of proce- 319.500 Meat pies. dures common or usual to such prod- Subpart O—Meat Snacks, Hors d’Oeuvres, ucts insofar as specific ingredients or Pizza, and Specialty Items procedures are not prescribed or pro- hibited by the provisions of this sub- 319.600 Pizza. chapter.
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§ 319.2 Products and nitrates and bone particle size, calcium, and PER nitrites. requirements of this paragraph, it may Any product, such as frankfurters also be used in the formulation of meat and corned beef, for which there is a food products in accordance with standard in this part and to which ni- § 319.6. trate or nitrite is permitted or required (b)–(d) [Reserved] to be added, may be prepared without (e)(1) An essential amino acid con- nitrate or nitrite and labeled with such tent of at least 33 percent of the total standard name when immediately pre- amino acids presents in ‘‘Mechanically ceded with the term ‘‘Uncured’’ in the Separated (Species)’’ shall be accepted same size and style of lettering as the as evidence of compliance with the pro- rest of such standard name: Provided, tein quality requirement set forth in That the product is found by the Ad- paragraph (a) of this section. For pur- ministrator to be similar in size, fla- poses of this paragraph, essential vor, consistency, and general appear- amino acid content includes isoleucine, ance to such product as commonly pre- leucine, lysine, methionine, pared with nitrate and nitrite: And pro- phenylalanine, threonine, and valine vided further, That labeling for such content, and the total amino acids product complies with the provisions of present include isoleucine, leucine, ly- § 317.17(c) of this subchapter. sine, methionine, phenylalanine, threo- nine, valine, tyrosine, arginine, histi- [44 FR 48961, Aug. 21, 1979] dine, alanine, aspartic acid, glutamic acid, glycine, proline, serine, and § 319.5 Mechanically Separated (Spe- hydroxyproline content. cies). (2) A prerequisite for label approval (a) Mechanically Separated (Species) for products consisting of or containing is any finely comminuted product re- ‘‘Mechanically Separated (Species)’’ is sulting from the mechanical separation that such ‘‘Mechanically Separated and removal of most of the bone from (Species)’’ shall have been produced by attached skeletal muscle of livestock an establishment under an establish- carcasses and parts of carcasses and ment quality control system. Such a meeting the other provisions of this plant quality control system shall pro- paragraph. Examples of such product vide the controls and information nec- are ‘‘Mechanically Separated Beef’’, essary to assure that the product will ‘‘Mechanically Separated Veal’’, ‘‘Me- meet the requirements described in chanically Separated Pork’’, and ‘‘Me- § 319.5(a) and to enable establishment chanically Separated Lamb’’. At least personnel and program employees to 98 percent of the bone particles present monitor the system for effectiveness. in such product shall have a maximum The system shall include a written de- size no greater than 0.5 millimeter in scription of the methods used by the their greatest dimension and there establishment to maintain uniformity shall be no bone particles larger than of the raw ingredients used in manufac- 0.85 millimeter in their greatest dimen- turing product, to control the handling sion. The product resulting from the and processing of the raw ingredients separating process shall not have a cal- and the finished product, and shall con- cium content exceeding 0.75 percent, as tain provisions for chemical analyses a measure of a bone solids content of of the product and other procedures to not more than 3 percent, and shall have determine and assure compliance with a minimum PER of 2.5 (except as modi- standards for the product. For purposes fied in paragraph (e)(1) of this section). of this paragraph, a lot shall consist of Such product also shall have a protein the ‘‘Mechanically Separated (Spe- content of not less than 14 percent and cies)’’ designated as such by the opera- a fat content of not more than 30 per- tor of the establishment or his or her cent, or it shall be deemed to be prod- agent from the product produced from uct for processing. Such product failing a single species of livestock in no more to meet the bone particle size, calcium, than one continuous shift of up to 12 or PER requirements of this paragraph hours. All units of any lot must be shall only be used in producing animal available for inspection by program fats. Where such product meets the employees. Analysis of a sample of at
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least 1 pound from each lot to verify methods of analysis may be submitted contents of fat, protein, and calcium in to the Administrator to determine ‘‘Mechanically Separated (Species)’’ their acceptability based upon their ac- shall be performed by the operator of curacy, repeatability, reproducibility, the establishment or his or her agent and lowest level of reliable measure- to assure that finished product will ment, as demonstrated by at least 3 meet the requirements in § 319.5(a), ex- laboratories. Copies of AOAC’s ‘‘Offi- cept that such analyses with respect to cial Methods’’ may be obtained from: fat, protein, and calcium content shall AOAC, 2200 Wilson Boulevard, Suite be required to be performed with re- 400, Arlington, VA 22201. Copies of spect to only one randomly selected lot USDA’s Chemistry Laboratory Guide- of every five lots if the preceding ten book may be obtained from: Super- analyses and all such analyses per- intendent of Documents, Government formed by the Department during the Printing Office, Washington, DC 20402. preceding ten analyses period establish This incorporation by reference was ap- compliance with the requirements of proved by the Director of the FEDERAL § 319.5(a), and that no analyses with re- REGISTER on December 30, 1981 and spect to fat or protein content shall be March 15, 1982. These materials are in- required where the finished product is corporated as they exist on the date of represented as product for processing. the approval. A notice of any change in An analysis of a sample of at least 1 the sections of the AOAC methods or pound to verify essential amino acid the Chemistry Laboratory Guidebook content and/or protein efficiency ratio cited herein will be published in the in ‘‘Mechanically Separated (Species)’’ FEDERAL REGISTER.) The plant quality shall be performed by the operator of control system shall be subject to peri- the establishment or his or her agent odic review, and the approval of such at the rate of at least one per month system may be terminated in accord- during production to assure that fin- ance with § 318.4(g)(2) of this sub- ished product will meet the require- chapter. ments of § 319.5(a), except that such analyses with respect to essential [47 FR 28256, June 29, 1982, as amended at 54 amino acid content and/or protein effi- FR 40631, Oct. 3, 1989; 59 FR 33642, June 30, ciency ratio shall be required to be per- 1994; 62 FR 45026, Aug. 25, 1997] formed only once every 6 months if the preceding three analyses and all such § 319.6 Limitations with respect to use of Mechanically Separated (Spe- analyses performed by the Department cies). during the preceding three analyses pe- riod establish compliance with the re- (a) Meat food products required to be quirements of § 319.5(a). Finished prod- prepared from one species shall not uct samples shall be analyzed in ac- contain Mechanically Separated (Spe- cordance with ‘‘Official Methods of cies) of any other species. Analysis of the Association of Official (b) Mechanically Separated (Species) Analytical Chemists,’’ (AOAC), 15th described in § 319.5 that has a protein edition, 1990, §§ 960.39, 976.21, 928.08 content of not less than 14 percent and (Chapter 39), and 940.33 (Chapter 45), a fat content of not more than 30 per- which is incorporated by reference, or cent may constitute up to 20 percent of if no AOAC method is available, in ac- the livestock and poultry product por- cordance with the ‘‘Chemistry Labora- tion of any meat food product except tory Guidebook,’’ U.S. Department of those listed in paragraph (d) of this Agriculture, Washington, DC, March section. 1986 edition, sections 6.011–6.013, Re- (c) Mechanically Separated (Species) vised June 1987 (pages 6–35 through 6– for processing described in § 319.5 may 65). The ‘‘Official Methods of Analysis constitute up to 20 percent of the live- of the Association of Official Analyt- stock and poultry product portion of ical Chemists,’’ 15th edition, 1990, is in- any meat food product that is subject corporated by reference with the ap- to a definition and standard of identity proval of the Director of the Federal or composition in part 319 which estab- Register in accordance with 5 U.S.C. lishes a maximum limit on the fat con- 552(a) and 1 CFR part 51. Alternative tent of such meat food product except
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those listed in paragraph (d) of this Separated (Species) used in accordance section. with § 319.6, and/or partially defatted (d) Mechanically Separated (Species) beef fatty tissue may be used without and Mechanically Separated (Species) added water or with added water only for processing described in § 319.5 shall in amounts such that the product char- not be used in baby, junior, or toddler acteristics are essentially that of a foods, ground beef, hamburger, fab- meat pattie. ricated steaks (§ 319.15 (a), (b), and (d)), (d) Fabricated steak. Fabricated beef barbecued meats (§ 319.80), roast beef- steaks, veal steaks, beef and veal parboiled and steam roasted (§ 319.81), steaks, or veal and beef steaks, and corned (cured) beef cuts (§§ 319.100— similar products, such as those labeled 319.103), certain cured pork products ‘‘Beef Steak, Chopped, Shaped, Fro- (§§ 319.104 (a)–(e) and 319.106), tripe with zen,’’ ‘‘Minute Steak, Formed, Wafer milk (§ 319.308), lima beans with ham Sliced, Frozen,’’ ‘‘Veal Steaks, Beef and similar products (§ 319.310), beef Added, Chopped—Molded—Cubed—Fro- with gravy and gravy with beef zen, Hydrolyzed Plant Protein, and (§ 319.313), and meat pies (§ 319.500). Flavoring’’ shall be prepared by comminuting and forming the product [47 FR 28257, June 29, 1982] from fresh and/or frozen meat, with or without added fat, of the species indi- Subpart B—Raw Meat Products cated on the label. Such products shall not contain more than 30 percent fat § 319.15 Miscellaneous beef products. and shall not contain added water, (a) Chopped beef, ground beef. binders or extenders. Beef cheek meat ‘‘Chopped Beef’’ or ‘‘Ground Beef’’ shall (trimmed beef cheeks) may be used in consist of chopped fresh and/or frozen the preparation of fabricated beef beef with or without seasoning and steaks only in accordance with the without the addition of beef fat as conditions prescribed in paragraph (a) such, shall not contain more than 30 of this section. percent fat, and shall not contain (e) Partially defatted beef fatty tissue. added water, phosphates, binders, or ‘‘Partially Defatted Beef Fatty Tissue’’ extenders. When beef cheek meat is a beef byproduct derived from the (trimmed beef cheeks) is used in the low temperature rendering (not exceed- ° preparation of chopped or ground beef, ing 120 F.) of fresh beef fatty tissue. the amount of such cheek meat shall Such product shall have a pinkish color be limited to 25 percent; and if in ex- and a fresh odor and appearance. cess of natural proportions, its pres- [35 FR 15597, Oct. 3, 1970, as amended at 38 FR ence shall be declared on the label, in 29215, Oct. 23, 1973; 43 FR 26424, June 20, 1978; the ingredient statement required by 47 FR 10784, Mar. 12, 1982; 47 FR 28257, June § 317.2 of this subchapter, if any, and 29, 1982] otherwise contiguous to the name of § 319.29 Miscellaneous pork products. the product. (b) Hamburger. ‘‘Hamburger’’ shall (a) Partially defatted pork fatty tissue. consist of chopped fresh and/or frozen ‘‘Partially Defatted Pork Fatty Tis- beef with or without the addition of sue’’ is a pork byproduct derived from beef fat as such and/or seasoning, shall the low temperature rendering (not ex- not contain more than 30 percent fat, ceeding 120 °F.) of fresh pork fatty tis- and shall not contain added water, sue, exclusive of skin. Such product phosphates, binders, or extenders. Beef shall have a pinkish color and a fresh cheek meat (trimmed beef cheeks) may odor and appearance. be used in the preparation of ham- burger only in accordance with the Subpart C—Cooked Meats conditions prescribed in paragraph (a) of this section. § 319.80 Barbecued meats. (c) Beef patties. ‘‘Beef Patties’’ shall Barbecued meats, such as product la- consist of chopped fresh and/or frozen beled ‘‘Beef Barbecue’’ or ‘‘Barbecued beef with or without the addition of Pork,’’ shall be cooked by the direct beef fat as such and/or seasonings. action of dry heat resulting from the Binders or extenders, Mechanically burning of hard wood or the hot coals
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therefrom for a sufficient period to as- meat ingredient in preparation of this sume the usual characteristics of a bar- product when trimmed as specified in becued article, which include the for- § 319.81. When beef cheek meat, beef mation of a brown crust on the surface head meat, or beef heart meat is used and the rendering of surface fat. The in preparation of this product, its pres- product may be basted with a sauce ence shall be reflected in the statement during the cooking process. The weight of ingredients required by part 317 of of barbecued meat shall not exceed 70 this subchapter. The application of cur- percent of the weight of the fresh ing solution to beef cuts, other than uncooked meat. briskets, which are intended for bulk corned beef shall not result in an in- § 319.81 Roast beef parboiled and crease in the weight of the finished steam roasted. cured product of more than 10 percent ‘‘Roast Beef Parboiled and Steam over the weight of the fresh uncured Roasted’’ shall be prepared so that the meat. weight of the finished product, exclud- [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, ing salt and flavoring material, shall 1971, as amended at 38 FR 29215, Oct. 23, 1973] not exceed 70 percent of the fresh beef weight. Beef cheek meat and beef head § 319.101 Corned beef brisket. meat from which the overlying glan- In preparing ‘‘Corned Beef Brisket,’’ dular and connective tissues have been the application of curing solution to removed, and beef heart meat, exclu- the beef brisket shall not result in an sive of the heart cap may be used indi- increase in the weight of the finished vidually or collectively to the extent of cured product of more than 20 percent 5 percent of the meat ingredients in the over the weight of the fresh uncured preparation of canned product labeled brisket. If the product is cooked, the ‘‘Roast Beef Parboiled and Steam weight of the finished product shall not Roasted.’’ When beef cheek meat, beef exceed the weight of the fresh uncured head meat, or beef heart meat is used brisket. in the preparation of this product, its presence shall be reflected in the state- § 319.102 Corned beef round and other ment of ingredients required by part corned beef cuts. 317 of this subchapter. In preparing ‘‘Corned Beef Round’’ and other corned beef cuts, except [35 FR 15597, Oct. 3, 1970, as amended at 38 FR ‘‘Corned Beef Briskets,’’ the curing so- 29215, Oct. 23, 1973] lution shall be applied to pieces of beef weighing not less than one pound and Subpart D—Cured Meats, such application shall not result in an Unsmoked and Smoked increased weight of the cured beef product of more than 10 percent over § 319.100 Corned beef. the weight of the fresh uncured beef ‘‘Corned Beef’’ shall be prepared from cut. If the product is cooked, the beef briskets, navels, clods, middle weight of the finished product shall not ribs, rounds, rumps, or similar cuts exceed the weight of the fresh uncured using one or a combination of the cur- beef cut. ing ingredients specified in § 318.7(c) (1) and (4) of this subchapter. Canned prod- § 319.103 Cured beef tongue. uct labeled ‘‘Corned Beef’’ shall be pre- In preparing ‘‘Cured Beef Tongue,’’ pared so that the weight of the finished the application of curing solution to product, excluding cure, salt, and fla- the fresh beef tongue shall not result in voring material, shall not exceed 70 an increase in the weight of the cured percent of the fresh beef weight. beef tongue of more than 10 percent Corned beef other than canned shall be over the weight of the fresh uncured cured in pieces weighing not less than beef tongue. 1 pound, and if cooked, its weight shall not exceed the weight of the fresh § 319.104 Cured pork products. uncured beef. Beef cheek meat, beef (a) Cured pork products, including head meat and beef heart meat may be hams, shoulders, picnics, butts and used to the extent of 5 percent of the loins, shall comply with the minimum
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meat Protein Fat Free (PFF) percent- for labeling of packages of 1 pound or age requirements set forth in the fol- less, provided such lettering is at least lowing chart: one-third the size and of the same color and style as the product name. Minimum Type of cured meat PFF Product name and qualifying (c) Cured pork product prepared pur- pork product percent- statements suant to this section shall be subject to age1 the compliance procedures in § 318.19 of Cooked ham, 20.5 (Common and usual). this subchapter. loin2. 18.5 (Common and usual) with nat- (d) The binders provided in ural juices. § 318.7(c)(4) of this subchapter for use in 17.0 (Common and usual) water cured pork products may be used singly added. <17.0 (Common and usual) and in those cured pork products labeled as water productÐX% of ‘‘Ham water added’’ and ‘‘Ham and weight is added ingredi- water product—X% of weight is added ents.3 Cooked shoul- 20.0 (Common and usual). ingredients.’’ These binders are not der, butt, pic- permitted to be used in combination nic2. with one or more such binders ap- 18.0 (Common and usual) with nat- ural juices. proved for use in cured pork products. 16.5 (Common and usual) water When any such substance is added to added. these products, the substance shall be <16.5 (Common and usual) and water productÐX% of designated in the ingredients state- weight is added ingredi- ment by its common or usual name in ents.3 order of predominance. Uncooked cured 18.0 Uncooked (common and ham, loin. usual). [49 FR 14879, Apr. 13, 1984, as amended at 50 < 18.0 Uncooked (common and FR 9792, Mar. 12, 1985; 53 FR 5151, Feb. 22, usual) and water productÐ X% of weight is added in- 1988; 57 FR 42888, Sept. 17, 1992; 62 FR 45026, gredients.3 Aug. 25, 1997] Uncooked cured 17.5 Uncooked (common and shoulder, butt, usual). § 319.105 ‘‘Ham patties,’’ ‘‘Chopped picnic. ham,’’ ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ <17.5 Uncooked (common and usual) and water productÐ and similar products. X% of weight is added in- (a) Finely divided (chopped, ground, gredients.3 flaked, chipped) cured ham products 1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw unprocessed pork such as ‘‘Ham patties,’’ ‘‘Chopped expressed as a percent of the non-fat portion of the finished ham,’’ ‘‘Pressed ham,’’ and ‘‘Spiced product; and compliance shall be determined under § 318.19 of this subchapter for domestic cured pork product and ham’’ shall comply with minimum § 327.23 of this subchapter for imported cured pork product. meat Protein Fat Free (PFF) percent- 2 The term ``cooked'' is not appropriate for use on labels of cured pork products heated only for the purpose of destruc- age requirements set forth in the fol- tion of possible live trichinae. 3 Processors may immediately follow this qualifying state- lowing chart: ment with a list of the ingredients in descending order of pre- dominance rather than having the traditional ingredients state- Product ment. In any case, the maximum percent of added sub- Minimum Type of cured pork product meat PFF name and stances in the finished product on a total weight percentage 1 qualifying basis would be inserted as the X value; e.g., Ham and Water percentage statements ProductÐ20% of Weight is Added Ingredients. A prerequisite for label approval of these products is a quality control ``Ham Patties,'' ``Chopped program. Ham,'' ``Pressed Ham,'' and (b) Cured pork products for which ``Spiced Ham'' ...... 19.5 (Common and usual). there is a qualifying statement re- ``Ham Patties,'' ``Chopped quired in paragraph (a) of this section Ham,'' ``Pressed Ham,'' and shall bear that statement as part of the ``Spiced Ham'' ...... 17.5 (Common product name in lettering not less than and usual) with natural 3 ⁄8 inch in height, or in lettering not juices. less than one-third the size of the larg- ``Ham Patties,'' ``Chopped est letter in the product name if it is in Ham,'' ``Pressed Ham,'' and the same color and style of print and ``Spiced Ham'' ...... 16.0 (Common and usual) on the same color background as the water product name. However, the Adminis- added. trator may approve smaller lettering
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from a single piece of meat conforming Minimum Product Type of cured pork product meat PFF name and to the definition of ‘‘ham,’’ as specified 1 qualifying percentage statements in § 317.8(b)(13) of this subchapter, or from a single piece of meat from a pork ``Ham Patties,'' ``Chopped Ham,'' ``Pressed Ham,'' and shoulder. They are prepared in accord- ``Spiced Ham'' ...... <16.0 (Common ance with paragraph (c) of this section and usual) by the dry application of salt (NaCl), or and water productÐ by the dry application of salt (NaCl) (x)% of and one or more of the optional ingre- weight is dients as specified in paragraph (d) of added this section. They may not be injected ingredients.2 with curing solutions nor placed in cur- 1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw, unprocessed ing solutions. pork expressed as a percent of the nonfat portion of the fin- (b) The product must be treated for ished product; and compliance shall be determined under sec- tion 318.19 of this subchapter. the destruction of possible live 2 Processors may immediately follow this qualifying state- trichinae in accordance with such ment with a list of the ingredients in descending order of pre- dominance rather than having the traditional ingredients state- methods as may be approved by the Ad- ment. In any case, the maximum percent of added sub- ministrator upon request in specific in- stances in the finished product on a total weight percentage basis would be inserted as the X value; e.g., Ham and Water stances and none of the provisions of ProductÐ20% of Weight is Added Ingredients. A prerequisite this standard can be interpreted as dis- for label approval of these products is a quality control program. charging trichinae treatment require- ments. (b) Cured pork products prepared (c)(1) The entire exterior of the ham under this section except ‘‘Ham pat- or pork shoulder shall be coated by the ties’’ may contain finely chopped ham dry application of salt or by the dry ap- shank meat to the extent of 25 percent plication of salt combined with other over that normally present in boneless ingredients as permitted in paragraph ham. Mechanically Separated (Species) (d) of this section. Product may be used in accordance with § 319.6. (2) Additional salt, or salt mixed with (c) Cured pork product prepared pur- other permitted ingredients, may be re- suant to this section shall be subject to applied to the product as necessary to the compliance procedures in § 318.19 of insure complete penetration. this subchapter, and those cured pork (3) When sodium or potassium ni- products prepared under this section trate, or sodium or potassium nitrite, for which there is a qualifying state- or a combination thereof, is used, the ment required shall comply with the application of salt shall be in sufficient requirements of § 319.104(b) of this sub- quantity to insure that the finished chapter. product has an internal salt content of (d) In addition to the other require- at least 4 percent. ments of this section, ‘‘Ham Patties’’ (4) When no sodium nitrate, potas- may not contain more than 35 percent sium nitrate, sodium nitrite, potas- fat, by analysis. sium nitrite or a combination thereof is used, the application of salt shall be [49 FR 14880, Apr. 13, 1984, as amended at 53 in sufficient quantity to insure that FR 5151, Feb. 22, 1988; 62 FR 45026, Aug. 25, 1997] the finished product has a brine con- centration of not less than 10 percent § 319.106 ‘‘Country Ham,’’ ‘‘Country or a water activity of not more than Style Ham,’’ ‘‘Dry Cured Ham,’’ 0.92. ‘‘Country Pork Shoulder,’’ ‘‘Country (5) For hams or pork shoulders la- Style Pork Shoulder,’’ and ‘‘Dry beled ‘‘country’’ or ‘‘country style,’’ Cured Pork Shoulder.’’ the combined period for curing and salt (a) ‘‘Country Ham,’’ ‘‘Country Style equalization shall not be less than 45 Ham,’’ or ‘‘Dry Cured Ham,’’ and days for hams, and shall not be less ‘‘Country Pork Shoulder,’’ ‘‘Country than 25 days for pork shoulders; the Style Pork Shoulder,’’ or ‘‘Dry Cured total time for curing salt equalization, Pork Shoulder.’’ are the uncooked, and drying shall not be less than 70 cured, dried, smoked or unsmoked days for hams, and shall not be less meat food products made respectively than 50 days for pork shoulders. During
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the drying and smoking period, the in- consisting partly of poultry, sausage is ternal temperature of the product must the coarse or finely comminuted meat not exceed 95 °F., provided that such food product prepared from one or temperature requirement shall not more kinds of meat or meat and meat apply to product dried or smoked under byproducts, containing various natural climatic conditions. amounts of water as provided for else- (6) For hams or pork shoulders la- where in this part, and usually sea- beled ‘‘dry cured,’’ the combined period soned with condimented proportions of for curing and salt equalization shall condimental substances, and fre- not be less than 45 days for hams, and quently cured. Certain sausage as pro- shall not be less than 25 days for pork vided for elsewhere in this part may shoulders; and the total time for cur- contain binders and extenders as pro- ing, salt equalization, and drying shall vided in § 318.7(c)(4) of this subchapter. not be less than 55 days for hams and Sausage may not contain phosphates shall not be less than 40 days for pork except that phosphates listed in shoulders. § 318.7(c)(4) of this subchapter may be (7) The weight of the finished hams used in cooked sausage. To facilitate and pork shoulders covered in this sec- chopping or mixing or to dissolve the tion shall be at least 18 percent less usual curing ingredients, water or ice than the fresh uncured weight of the may be used in the preparation of sau- article. sage which is not cooked in an amount (d) The optional ingredients for prod- not to exceed 3 percent of the total in- ucts covered in this section are: gredients in the formula. Cooked sau- (1) Nutritive sweeteners, spices, sages such as Polish sausage, cotto sa- seasonings and flavorings. lami, braunschweiger, liver sausage, (2) Sodium or potassium nitrate and and similar cooked sausage products sodium or potassium nitrite if used as may contain no more than 10 percent prescribed in this section and in ac- of added water in the finished product. cordance with § 318.7(c)(4) of this sub- Sausage may contain Mechanically chapter. Separated (Species) used in accordance [42 FR 3299, Jan. 18, 1977] with § 319.6.
EFFECTIVE DATE NOTE: At 46 FR 1257, Jan. [55 FR 34683, Aug. 24, 1990] 6, 1981, the Department announced that the temperature and time period provisions of § 319.141 Fresh pork sausage. § 319.106 (c)(5) and (c)(6) have not been in ef- fect since November 17, 1980, and will not be ‘‘Fresh Pork Sausage’’ is sausage pre- enforced pending future Agency action in the pared with fresh pork or frozen pork or matter. However, ham and pork shoulders both, but not including pork byprod- must continue to be prepared in compliance ucts, and may contain Mechanically with all other provisions of § 319.106 in order Separated (Species) in accordance with to be labeled ‘‘country ham,’’ ‘‘country style § 319.6, and may be seasoned with ham,’’ or ‘‘dry cured ham,’’ and ‘‘country condimental substances as permitted pork shoulder,’’ ‘‘country style pork shoul- under part 318 of this subchapter. The der,’’ or ‘‘dry cured pork shoulder.’’ finished product shall not contain more § 319.107 Bacon. than 50 percent fat. To facilitate chop- ping or mixing, water or ice may be The weight of cured pork bellies used in an amount not to exceed 3 per- ready for slicing and labeling as cent of the total ingredients used. ‘‘Bacon’’ shall not exceed the weight of the fresh uncured pork bellies. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26424, June 20, 1978; 47 FR 28257, 28258, June [49 FR 14880, Apr. 13, 1984] 29, 1982] Subpart E—Sausage Generally: § 319.142 Fresh beef sausage. Fresh Sausage ‘‘Fresh Beef Sausage’’ is sausage pre- pared with fresh beef or frozen beef, or § 319.140 Sausage. both, but not including beef byprod- Except as otherwise provided in this ucts, and may contain Mechanically section, or under the Poultry Products Separated (Species) used in accordance Inspection Act with respect to products with § 319.6, and may be seasoned with
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condimental substances as permitted (2) or (3) of this section, and shall con- under part 318 of this subchapter. The tain salt, pepper, and either fennel or finished product shall not contain more anise, or a combination of fennel and than 30 percent fat. To facilitate chop- anise. Such products may contain any ping or mixing, water or ice may be or all of the optional ingredients listed used in an amount not to exceed 3 per- in paragraph (b) of this section. cent of the total ingredients used. (1) ‘‘Italian Sausage’’ shall be pre- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR pared with fresh or frozen pork, or pork 26424, June 20, 1978; 47 FR 28257, June 29, 1982] and pork fat, and may contain Me- chanically Separated (Species) in ac- § 319.143 Breakfast sausage. cordance with § 319.6. ‘‘Breakfast sausage’’ is sausage pre- (2) ‘‘Italian Sausage with Beef,’’ pared with fresh and/or frozen meat; or ‘‘Italian Sausage with Veal,’’ or fresh and/or frozen meat and meat by- ‘‘Italian Sausage with Beef and Veal,’’ products, and may contain Mechani- shall be prepared so that fresh or fro- cally Separated (Species) in accordance zen pork constitutes the major portion with § 319.6, and may be seasoned with of the meat content requirement of condimental substances as permitted this paragraph. Mechanically Sepa- in part 318 of this subchapter. The fin- rated (Species) may be used in accord- ished product shall not contain more ance with § 319.6. When pork muscle tis- than 50 percent fat. To facilitate chop- sue is combined with beef or veal, or ping or mixing, water or ice may be both, in the preparation of bulk-packed used in an amount not to exceed 3 per- products, or patties, it shall be treated cent of the total ingredients used. for the destruction of possible live Binders or extenders may be added as trichinae in accordance with § 318.10 of provided in § 318.7(c)(4) of this sub- this subchapter. chapter. (3) ‘‘Italian Beef Sausage’’ or ‘‘Kosher Italian Beef Sausage’’ shall be prepared [55 FR 34683, Aug. 24, 1990] with fresh or frozen beef or beef and beef fat. ‘‘Italian Veal Sausage’’ or § 319.144 Whole hog sausage. ‘‘Kosher Italian Veal Sausage’’ shall be ‘‘Whole Hog Sausage’’ is sausage pre- prepared with fresh or frozen veal or pared with fresh and/or frozen meat veal and veal fat. Mechanically Sepa- from swine in such proportions as are rated (Species) may be used in accord- normal to a single animal, and may in- ance with § 319.6. clude any Mechanically Separated (4) Italian sausage products made in (Species) produced from the animal and conformance with the provisions of used in accordance with § 319.6, and paragraphs (a) (1), (2), and (3) of this may be seasoned with condimental sub- section, and with paragraphs (b) and (c) stances as permitted under part 318 of of this section, may contain sodium ni- this subchapter. The finished product trite or potassium nitrite in amounts shall not contain more than 50 percent not to exceed those allowed in the fat. To facilitate chopping or mixing, chart following § 318.7(c)(4), provided water or ice may be used in an amount that such products are labeled with the not to exceed 3 percent of the total in- word ‘‘cured’’ in the product name, gredients used. such as ‘‘Cured Italian Sausage.’’ The [35 FR 15597, Oct. 3, 1970, as amended at 43 FR word ‘‘cured’’ shall be displayed on the 26424, June 20, 1978; 47 FR 28257, 28258, June product label in the same size and style 29, 1982] of lettering as other words in the prod- uct name. § 319.145 Italian sausage products. (b) Optional ingredients permitted in (a) Italian sausage products are cured Italian sausage products include: or uncured sausages containing at least (1) Spices (including paprika) and 85 percent meat, or combination of flavorings. meat and fat, with the total fat con- (2) Water or ice to facilitate chopping tent constituting not more than 35 per- or mixing, but not to exceed 3 percent cent of the finished product. Such prod- of the total weight of all ingredients ucts shall be prepared in accordance including the water. with the provisions of paragraph (a) (1), (3) Red or green peppers, or both.
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(4) Dehydrated or fresh onions, gar- Subpart G—Cooked Sausage lic, and parsley. (5) Sugar, dextrose, corn syrup, corn § 319.180 Frankfurter, frank, furter, syrup solids, and glucose syrup. hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and (6) Monosodium glutamate and anti- similar products. oxidants in accordance with the chart of substances in § 318.7(c)(4) of this sub- (a) Frankfurter, frank, furter, hot- dog, wiener, vienna, bologna, garlic bo- chapter. logna, knockwurst and similar cooked (c) If Italian sausage products are sausages are comminuted, semisolid cooked or smoked, determination of sausages prepared from one or more compliance with the provisions of para- kinds of raw skeletal muscle meat or graphs (a) and (b) of this section shall raw skeletal muscle meat and raw or be based on the uncooked or unsmoked cooked poultry meat, and seasoned and product. The product before cooking or cured, using one or more of the curing smoking shall contain no more than 3 agents in accordance with § 318.7(c) of percent water as specified in paragraph this chapter. They may or may not be (b)(2) of this section. Product which is smoked. The finished products shall cooked shall be labeled with the word not contain more than 30 percent fat. ‘‘cooked’’ in the product name, such as Water or ice, or both, may be used to ‘‘Cooked Italian Sausage’’ or ‘‘Cooked facilitate chopping or mixing or to dis- Cured Italian Sausage.’’ Product which solve the curing ingredients but the is smoked shall be labeled with the sausage shall contain no more than 40 word ‘‘smoked’’ in the product name, percent of a combination of fat and such as ‘‘Smoked Italian Sausage’’ or added water. These sausage products may contain only phosphates approved ‘‘Smoked Cured Italian Sausage.’’ The under part 318 of this chapter. Such words ‘‘cooked’’ and ‘‘smoked’’ shall be products may contain raw or cooked displayed on the product label in the poultry meat and/or Mechanically Sep- same size and style of lettering as arated (Kind of Poultry) without skin other words in the product name. and without kidneys and sex glands [41 FR 2630, Jan. 19, 1976, as amended at 43 used in accordance with § 381.174, not in FR 26424, June 20, 1978; 47 FR 28257, 28258, excess of 15 percent of the total ingre- June 29, 1982; 49 FR 46533, Nov. 27, 1984] dients, excluding water, in the sausage, and Mechanically Separated (Species) used in accordance with § 319.6. Such Subpart F—Uncooked, Smoked poultry meat ingredients shall be des- Sausage ignated in the ingredient statement on the label of such sausage in accordance § 319.160 Smoked pork sausage. with the provisions of § 381.118 of this ‘‘Smoked Pork Sausage’’ is pork sau- chapter. sage that is smoked with hardwood or (b) Frankfurter, frank, furter, hot- other approved nonresinous materials. dog, wiener, vienna, bologna, garlic bo- It may be seasoned with condimental logna, knockwurst and similar cooked substances as permitted in part 318 of sausages that are labeled with the this subchapter. The finished product phrase ‘‘with byproducts’’ or ‘‘with va- shall not contain more than 50 percent riety meats’’ in the product name are fat. To facilitate chopping or mixing, comminuted, semisolid sausages con- water, or ice may be used in an amount sisting of not less than 15 percent of one or more kinds of raw skeletal mus- not to exceed 3 percent of the total in- cle meat with raw meat byproducts, or gredients used. not less than 15 percent of one or more [35 FR 15597, Oct. 3, 1970, as amended at 47 FR kinds of raw skeletal muscle meat with 28258, June 29, 1982] raw meat byproducts and raw or
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cooked poultry products; and seasoned such sausage products are prepared in and cured, using one or more of the part with Mechanically Separated curing ingredients in accordance with (Species) in accordance with § 319.6, § 318.7(c) of this chapter. They may or they shall be labeled in accordance may not be smoked. Partially defatted with § 317.2(j)(13) of this subchapter. pork fatty tissue or partially defatted (d) A cooked sausage as defined in beef fatty tissue, or a combination of paragraph (b) of this section shall be both, may be used in an amount not ex- labeled by its generic name, e.g., frank- ceeding 15 percent of the meat and furter, frank, furter, hotdog, wiener, meat byproducts or meat, meat by- vienna, bologna, garlic bologna, or products, and poultry products ingredi- knockwurst, in conjunction with the ents. The finished products shall not phrase ‘‘with byproducts’’ or ‘‘with va- contain more than 30 percent fat. Water or ice, or both, may be used to riety meats’’ with such supplemental facilitate chopping or mixing to dis- phrase shown in a prominent manner solve the curing and seasoning ingredi- directly contiguous to the generic ents, the sausage shall contain no more name and in the same color on an iden- than 40 percent of a combination of fat tical background. and added water. These sausage prod- (e) One or more of the binders and ex- ucts may contain only phosphates ap- tenders as provided in § 318.7(c)(4) of proved under part 318 of this chapter. this subchapter may be used in cooked These sausage products may contain sausage otherwise complying with poultry products and/or Mechanically paragraph (a) or (b) of this section. Separated (Kind of Poultry) used in ac- When any such substance is added to cordance with § 381.174, individually or these products, the substance shall be in combination, not in excess of 15 per- designated in the ingredients state- cent of the total ingredients, excluding ment by its common or usual name in water, in the sausage, and may contain order of predominance. Mechanically Separated (Species) used (f) Cooked sausages shall not be la- in accordance with § 319.6. Such poultry beled with terms such as ‘‘All Meat’’ or products shall not contain kidneys or ‘‘All (Species),’’ or otherwise to indi- sex glands. The amount of poultry skin cate they do not contain nonmeat in- present in the sausage must not exceed gredients or are prepared only from the natural proportion of skin present meat. on the whole carcass of the kind of (g) For the purposes of this section: poultry used in the sausage, as speci- Poultry meat means deboned chicken fied in § 381.117(d) of this chapter. The poultry products used in the sausage meat or turkey meat, or both, without shall be designated in the ingredient skin or added fat; poultry products statement on the label of such sausage mean chicken or turkey, or chicken in accordance with the provisions of meat or turkey meat as defined in § 381.118 of this chapter. Meat byprod- § 381.118 of this chapter, or poultry by- ucts used in the sausage shall be des- products as defined in § 381.1 of this ignated individually in the ingredient chapter; and meat byproducts (or vari- statement on the label for such sausage ety meats), mean pork stomachs or in accordance with § 317.2 of this chap- snouts; beef, veal, lamb, or goat tripe; ter. beef, veal, lamb, goat, or pork hearts, (c) A cooked sausage as defined in tongues, fat, lips, weasands, and paragraph (a) of this section shall be spleens; and partially defatted pork labeled by its generic name, e.g., frank- fatty tissue, or partially defatted beef furter, frank, furter, hotdog, wiener, fatty tissue. vienna, bologna, garlic bologna, or knockwurst. When such sausage prod- [38 FR 14742, June 5, 1973; 38 FR 22621, Aug. 23, 1973; 38 FR 24640, Sept. 10, 1973, as amend- ucts are prepared with meat from a sin- ed at 43 FR 26424, June 20, 1978; 45 FR 10318, gle species of cattle, sheep, swine, or Feb. 15, 1980; 47 FR 10784, Mar. 12, 1982; 47 FR goats they shall be labeled with the 26374, June 18, 1982; 47 FR 28257, June 29, 1982; term designating the particular species 53 FR 8428, Mar. 15, 1988; 55 FR 34683, Aug. 24, in conjunction with the generic name, 1990; 56 FR 41448, Aug. 21, 1991; 60 FR 55982, e.g., ‘‘Beef Frankfurter,’’ and when Nov. 3, 1995]
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§ 319.181 Cheesefurters and similar with § 319.6. Binders and extenders products. maybe used as permitted in § 319.140. If ‘‘Cheesefurters’’ and similar products prepared from components of a single are products in casings which resemble species, the product name may reflect frankfurters except that they contain that species, e.g., ‘‘Pork Liver Sau- sufficient cheese to give definite char- sage.’’ acteristics to the finished article. They [47 FR 36108, Aug. 19, 1982] may contain binders and extenders as provided in § 318.7(c)(4) of this sub- chapter. Limits on use as provided in Subpart H [Reserved] § 318.7 are intended to be exclusive of the cheese constituent. When any such Subpart I—Semi-Dry Fermented substance is added to these products, Sausage [Reserved] the substance shall be designated in the ingredients statement by its com- Subpart J—Dry Fermented mon or usual name in order of predomi- nance. These products shall contain no Sausage [Reserved] more than 40 percent of a combination of fat and added water, and no more Subpart K—Luncheon Meat, than 30 percent fat and shall comply Loaves and Jellied Products with the other provisions for cooked sausages that are in this subchapter. § 319.260 Luncheon meat. [55 FR 34683, Aug. 24, 1990, as amended at 56 ‘‘Luncheon Meat’’ is a cured, cooked FR 41448, Aug. 21, 1991] meat food product made from comminuted meat. Mechanically Sepa- § 319.182 Braunschweiger and liver rated (Species) may be used in accord- sausage or liverwurst. ance with § 319.6. To facilitate chopping (a) ‘‘Braunschweiger’’ is a cooked or mixing or to dissolve the usual cur- sausage made from fresh, cured, and/or ing ingredients, water or ice may be frozen pork, beef, and/or veal and at used in the preparation of luncheon least 30 percent pork, beef, and/or veal meat in an amount not to exceed 3 per- livers computed on the weight of the cent of the total ingredients. fresh livers. It may also contain pork and/or beef fat. Mechanically Sepa- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] rated (Species) may be used in accord- ance with § 319.6. Binders and extenders § 319.261 Meat loaf. may be used as permitted in § 319.140. The product may have a smoked taste ‘‘Meat Loaf’’ is a cooked meat food characteristic, which may be imparted product in loaf form made from by use of smoked meats, smoke flavor- comminuted meat. Mechanically Sepa- ing or smoking. If prepared from com- rated (Species) may be used in accord- ponents of a single species, the product ance with § 319.6. To facilitate chopping name may reflect the species, e.g., or mixing, water or ice may be used in ‘‘Beef Braunschweiger.’’ Braun- an amount not to exceed 3 percent of schweiger may also be labeled as any of the total ingredients used. the following: ‘‘Braunschweiger—A [35 FR 15597, Oct. 3, 1970, as amended at 43 FR Liver Sausage,’’ ‘‘Braunschweiger—A 26425, June 20, 1978; 47 FR 28257, June 29, 1982] Liverwurst,’’ or ‘‘Braunschweiger (Liver Sausage)’’ or ‘‘Braunschweiger (Liverwurst).’’ Subpart L—Meat Specialties, (b) ‘‘Liver Sausage’’ or ‘‘Liverwurst’’ Puddings and Nonspecific Loaves is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or § 319.280 Scrapple. veal and at least 30 percent pork, beef, ‘‘Scrapple’’ shall contain not less veal, sheep, and/or goat livers com- than 40 percent meat and/or meat by- puted on the weight of the fresh livers. products computed on the basis of the It may also contain pork and/or beef fresh weight, exclusive of bone. Me- byproducts. Mechanically Separated chanically Separated (Species) may be (Species) may be used in accordance used in accordance with § 319.6. The
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meal or flour used may be derived from (8) Sugars (sucrose and dextrose). grain and/or soybeans. (9) Binders and extenders may be added as provided in § 318.7(c)(4) of this [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] subchapter. When any such substance is added to bockwurst, the substance § 319.281 Bockwurst. shall be designated in the ingredients (a) Bockwurst is an uncured, statement by its common or usual comminuted meat food product which name in order of predominance. may or may not be cooked. It contains (c) If bockwurst is cooked or par- meat, milk or water or a combination tially cooked, the composition of the thereof, eggs, vegetables, and any of raw mix from which it is prepared shall the optional ingredients listed in para- be used in determining whether it graph (b) of this section; and is pre- meets the requirements of this section. pared in accordance with the provi- [40 FR 18542, Apr. 29, 1975, as amended at 41 sions of paragraphs (a)(1), (2), (3), and FR 18089, Apr. 30, 1976; 43 FR 26425, June 20, (4) of this section. 1978; 45 FR 10318, Feb. 15, 1980; 47 FR 26374, (1) Meat shall constitute not less June 18, 1982; 47 FR 28257, 28258, June 29, 1982; than 70 percent of the total weight of 55 FR 34683, Aug. 24, 1990; 56 FR 41448, Aug. 21, 1991] the product and shall consist of pork or a mixture of pork and veal, pork and beef, or pork, veal, and beef. Such meat Subpart M—Canned, Frozen, or shall be fresh or fresh frozen meat. Dehydrated Meat Food Products Pork may be omitted when the specie § 319.300 Chili con carne. or species of meat used in the product is identified in the product name (e.g., ‘‘Chili con carne’’ shall contain not Veal Bockwurst, Beef Bockwurst, or less than 40 percent of meat computed Beef and Veal Bockwurst). Mechani- on the weight of the fresh meat. Me- cally Separated (Species) may be used chanically Separated (Species) may be in accordance with § 319.6. used in accordance with § 319.6. Head (2) The ‘‘milk’’ may be fresh whole meat, cheek meat, and heart meat ex- milk, dried milk, nonfat dry milk, cal- clusive of the heart cap may be used to cium reduced dried skim milk, enzyme the extent of 25 percent of the meat in- (rennet) treated calcium reduced dried gredients under specific declaration on skim milk and calcium lactate, or any the label. The mixture may contain combination thereof. binders and extenders as provided in (3) ‘‘Eggs’’ refer to whole eggs that § 318.7(c)(4) of this subchapter. are fresh, frozen, or dried. [55 FR 34684, Aug. 24, 1990] (4) ‘‘Vegetables’’ refer to onions, chives, parsley, and leeks, alone or in § 319.301 Chili con carne with beans. any combination. Chili con carne with beans shall con- (b) Bockwurst may contain one or tain not less than 25 percent of meat more of the following optional ingredi- computed on the weight of the fresh ents: meat. Mechanically Separated (Spe- (1) Pork fat. cies) may be used in accordance with (2) Celery, fresh or dehydrated. § 319.6. Head meat, cheek meat, or heart (3) Spices, flavorings. meat exclusive of the heart cap may be (4) Salt. used to the extent of 25 percent of the (5) Egg whites, fresh, frozen, or dried. meat ingredients, and its presence (6) Corn syrup solids, corn syrup, or shall be reflected in the statement of glucose syrup with a maximum limit of ingredients required by part 317 of this 2 percent individually or collectively, subchapter. The mixture may contain calculated on a dry basis. The maxi- binders and extenders as provided in mum quantities of such ingredients § 318.7(c)(4) of this subchapter. shall be computed on the basis of the total weight of the ingredients. [55 FR 34684, Aug. 24, 1990] (7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein § 319.302 Hash. hydrolysate, and monosodium glu- ‘‘Hash’’ shall contain not less than 35 tamate. percent of meat computed on the
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weight of the cooked and trimmed vidually or collectively to the extent of meat. The weight of the cooked meat 5 percent of the meat ingredients; used in this calculation shall not ex- (2) Onions, including fresh onions, de- ceed 70 percent of the weight of the hydrated onions, or onion powder; uncooked fresh meat. Mechanically (3) Garlic, including fresh garlic, de- Separated (Species) may be used in ac- hydrated garlic, or garlic powder; cordance with § 319.6. (4) Water; (5) Beef broth or beef stock; [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] (6) Monosodium glutamate; (7) Hydrolyzed plant protein; § 319.303 Corned beef hash. (8) Beef fat; (9) Mechanically Separated (Species) (a) ‘‘Corned Beef Hash’’ is the semi- when derived from carcasses of cattle solid food product in the form of a com- may be used in accordance with § 319.6. pact mass which is prepared with beef, (c) The finished product shall not potatoes, curing agents, seasonings, contain more than 15 percent fat nor and any of the optional ingredients more than 72 percent moisture. listed in paragraph (b) of this section, (d)(1) When any ingredient specified in accordance with the provisions of in paragraph (b)(1) of this section is paragraphs (a) (1), (2), (3) and (4) of this used, the label shall bear the following section and the provisions of paragraph applicable statement: ‘‘Beef cheek (c) of this section. meat constitutes 5 percent of the meat (1) Either fresh beef, cured beef, or ingredient,’’ or ‘‘Beef head meat con- canned corned beef or a mixture of two stitutes 5 percent of the meat ingredi- or more of these ingredients, may be ent,’’ or ‘‘Beef heart meat constitutes 5 used, and the finished product shall percent of the meat ingredient.’’ When contain not less than 35 percent of beef two or more of the ingredients are computed on the weight of the cooked used, the words ‘‘Constitutes 5 percent and trimmed beef. The weight of the of meat ingredient’’ need only appear cooked meat used in this calculation once. shall not exceed 70 percent of the (2) Whenever the words ‘‘corned beef weight of the uncooked fresh meat. hash’’ are featured on the label so con- (2) ‘‘Potatoes’’ refers to fresh pota- spicuously as to identify the contents, toes, dehydrated potatoes, cooked de- the statements prescribed in paragraph hydrated potatoes, or a mixture of two (d)(1) of this section shall immediately or more of these ingredients. and conspicuously precede or follow (3) The curing agents that may be such name without intervening writ- used are salt, sodium nitrate, sodium ten, printed, or other graphic matter. nitrite, potassium nitrate, or potas- sium nitrite, or a combination of two [35 FR 15597, Oct. 3, 1970, as amended at 43 FR or more of these ingredients. When so- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] dium nitrate, or sodium nitrite, potas- § 319.304 Meat stews. sium nitrate, or potassium nitrite is used it shall be used in amounts not ex- Meat stews such as ‘‘Beef Stew’’ or ceeding those specified in § 318.7 (c)(4) ‘‘Lamb Stew’’ shall contain not less of this subchapter. than 25 percent of meat of the species (4) The seasonings that may be used, named on the label, computed on the singly or in combination, are salt, weight of the fresh meat. Mechanically sugar (sucrose or dextrose), spice, and Separated (Species) may be used in ac- flavoring, including essential oils, cordance with § 319.6. oleoresins, and other spice extractives. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR (b) Corned beef hash may contain one 26425, June 20, 1978; 47 FR 28257, June 29, 1982] or more of the following optional in- gredients: § 319.305 Tamales. (1) Beef cheek meat and beef head ‘‘Tamales’’ shall be prepared with at meat from which the overlying glan- least 25 percent meat computed on the dular and connective tissues have been weight of the uncooked fresh meat in removed, and beef heart meat, exclu- relation to all ingredients of the sive of the heart cap, may be used indi- tamales. When tamales are packed in
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sauce or gravy, the name of the prod- § 319.309 Beans with frankfurters in uct shall include a prominent reference sauce, sauerkraut with wieners and to the sauce or gravy; for example, juice, and similar products. ‘‘Tamales With Sauce’’ or ‘‘Tamales ‘‘Beans with Frankfurters in Sauce,’’ With Gravy.’’ Product labeled ‘‘Sauerkraut with Wieners and Juice,’’ ‘‘Tamales With Sauce’’ or ‘‘Tamales and similar products shall contain not With Gravy’’ shall contain not less less than 20 percent frankfurters or than 20 percent meat, computed on the wieners computed on the weight of the weight of the uncooked fresh meat in smoked and cooked sausage prior to its relation to the total ingredients mak- inclusion with the beans or sauerkraut. ing up the tamales and sauce or the tamales and gravy. Mechanically Sepa- § 319.310 Lima beans with ham in rated (Species) may be used in accord- sauce, beans with ham in sauce, ance with § 319.6. beans with bacon in sauce, and similar products. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR ‘‘Lima Beans with Ham in Sauce,’’ 26425, June 20, 1978; 47 FR 28257, 28258, June ‘‘Beans with Ham in Sauce,’’ ‘‘Beans 29, 1982] with Bacon in Sauce,’’ and similar § 319.306 Spaghetti with meatballs and products shall contain not less than 12 sauce, spaghetti with meat and percent ham or bacon computed on the sauce, and similar products. weight of the smoked ham or bacon prior to its inclusion with the beans ‘‘Spaghetti with Meatballs and and sauce. Sauce’’ and ‘‘Spaghetti with Meat and Sauce,’’ and similar products shall con- § 319.311 Chow mein vegetables with tain not less than 12 percent of meat meat, and chop suey vegetables computed on the weight of the fresh with meat. meat. Mechanically Separated (Spe- ‘‘Chow Mein Vegetables with Meat’’ cies) may be used in accordance with and ‘‘Chop Suey Vegetables with Meat’’ § 319.6. The presence of the sauce or shall contain not less than 12 percent gravy constituent shall be declared meat computed on the weight of the prominently on the label as part of the uncooked fresh meat prior to its inclu- name of the product. Meatballs may be sion with the other ingredients. Me- prepared with farinaceous material and chanically Separated (Species) may be with other binders and extenders as used in accordance with § 319.6. provided in § 318.7(c)(4) of this sub- chapter. [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 43 FR 26425, June 20, 1978; [55 FR 34684, Aug. 24, 1990] 47 FR 28257, June 29, 1982]
§ 319.307 Spaghetti sauce with meat. § 319.312 Pork with barbecue sauce and beef with barbecue sauce. ‘‘Spaghetti Sauce with Meat’’ shall contain not less than 6 percent of meat ‘‘Pork with Barbecue Sauce’’ and computed on the weight of the fresh ‘‘Beef with Barbecue Sauce’’ shall con- meat. Mechanically Separated (Spe- tain not less than 50 percent meat of cies) may be used in accordance with the species specified on the label, com- § 319.6. puted on the weight of the cooked and trimmed meat. Mechanically Sepa- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR rated (Species) may be used in accord- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] ance with § 319.6. The weight of the cooked meat used in this calculation § 319.308 Tripe with milk. shall not exceed 70 percent of the ‘‘Tripe with Milk’’ shall be prepared uncooked weight of the meat. If so that the finished canned article, ex- uncooked meat is used in formulating clusive of the cooked-out juices and the products, they shall contain at milk, will contain at least 65 percent least 72 percent meat computed on the tripe. The product shall be prepared weight of the fresh uncooked meat. with not less than 10 percent milk. [51 FR 32059, Sept. 9, 1986]
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§ 319.313 Beef with gravy and gravy under § 938.06 (Chapter 33) of the ‘‘Indi- with beef. rect Methods’’ in ‘‘Official Methods of ‘‘Beef with Gravy’’ and ‘‘Gravy with Analysis of the Association of Official Beef’’ shall not be made with beef Analytical Chemists’’, 15th edition, which, in the aggregate for each lot 1990.2 The ‘‘Official Methods of Analy- contains more than 30 percent sis of the Association of Official Ana- trimmable fat, that is, fat which can be lytical Chemists,’’ 15th edition, 1990, is removed by thorough, practicable trim- incorporated by reference with the ap- ming and sorting. proval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is produced Subpart N—Meat Food Entree from one or more of the ingredients Products, Pies, and Turnovers designated in paragraph (a)(1) of this section, and one or more of the ingredi- § 319.500 Meat pies. ents designated in paragraph (a)(2) of Meat pies such as ‘‘Beef Pie,’’ ‘‘Veal this section, to which may be added Pie,’’ and ‘‘Pork Pie’’ shall contain one or more of the optional ingredients meat of the species specified on the designated in paragraph (b) of this sec- label, in an amount not less than 25 tion. Margarine or oleomargarine con- percent of all ingredients including tains Vitamin A as provided for in crust and shall be computed on the paragraph (a)(3) of this section. basis of the fresh uncooked meat. (1) Edible fats and oils or mixtures of these, whose origin is vegetable or ren- Subpart O—Meat Snacks, Hors dered animal fats from cattle, sheep, d’Oeuvres, Pizza, and Spe- swine or goats. cialty Items (2)(i) Water; milk; milk products in- cluding, but not limited to, the liquid, § 319.600 Pizza. condensed, or dry form of whey, re- (a) ‘‘Pizza with Meat’’ is a bread base duced lactose whey, reduced minerals meat food product with tomato sauce, whey, or whey protein concentrate, cheese, and meat topping. It shall con- non-lactose-containing whey compo- tain cooked meat made from not less nents, casein, or caseinate; or other than 15 percent raw meat. Mechani- suitable edible protein, including albu- cally Separated (Species) may be used min, vegetable proteins, or soy protein in accordance with § 319.6. isolate; or any mixture of two or more (b) ‘‘Pizza with Sausage’’ is a bread of the articles designated in this sub- base meat food product with tomato paragraph, in amounts not greater sauce, cheese, and not less than 12 per- than reasonably required to accomplish cent cooked sausage or 10 percent dry the desired effect. sausage; e.g., pepperoni. Mechanically (ii) The articles designated in this Separated (Species) may be used in ac- subparagraph shall be pasteurized and cordance with § 319.6. then may be subjected to the action of harmless bacterial starters. One or [35 FR 15597, Oct. 3, 1970, as amended at 43 FR more of the articles designated in this 26425, June 20, 1978; 47 FR 28257, June 29, 1982] subparagraph is intimately mixed with the edible fat or oil ingredients, or Subpart P—Fats, Oils, Shortenings both, to form a solidified or liquid emulsion. § 319.700 Margarine or oleomargarine.1 (3) Vitamin A in such quantity that (a) Margarine or oleomargarine is the the finished margarine or oleo- food in plastic form or liquid emulsion, margarine contains not less than 15,000 containing not less than 80 percent fat determined by the method prescribed 2 A copy of the ‘‘Official Methods of Analy- sis of the Association of Official Analytical 1 Insofar as the standard contains provi- Chemists,’’ 15th edition, 1990, is on file with sions relating to margarine or oleomargarine the Director, Office of the Federal Register, which does not contain any meat food prod- and may be purchased from the Association ucts, such provisions merely reflect the ap- of Official Analytical Chemists, Inc., 2200 plicable standard under the Federal Food, Wilson Boulevard, Suite 400, Arlington, Vir- Drug, and Cosmetic Act. ginia 22201.
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International Units (IU) of ViTamin A of this subparagraph, provitamine A per pound or 33,000 IU per kilogram. (beta-carotene) shall also be deemed to (b)(1) Vitamin D in such quantity be a coloring agent. that the finished margarine or oleo- (8) Flavoring substances in amounts margarine contains not less than 1,500 sufficient for purpose. IU of Vitamin D per pound or 3,300 IU (9) Acidulants identified in per kilogram. § 318.7(c)(4) of this chapter, in amounts (2) Salt (sodium chloride); or potas- sufficient for purpose: adipic acid; cit- sium chloride for dietary margarine or ric and lactic acids and their potassium oleomargarine. and sodium salts; phosphoric acid; L- (3) Nutritive carbohydrate sweeten- tartaric acid and its sodium and so- ers. dium-potassium salts; and hydrochloric (4) Emulsifiers identified in acid. § 318.7(c)(4) of this chapter, within these (10) Alkalizers identified in maximum amounts in percent by § 318.7(c)(4) of this chapter, in amounts weight of the finished food: Mono- and sufficient for purpose: potassium bicar- diglycerides of fatty acids esterified bonate, potassium carbonate, sodium with any or all of the following acids: bicarbonate, sodium carbonate, and so- acetic, acetyltartaric, citric, lactic, dium hydroxide. tartaric, and their sodium and calcium (11) For the purposes of this section, salts, 0.5 percent; such mono- and the term ‘‘milk’’ unqualified means diglycerides in combination with the milk from cows. If any milk other than sodium sulfoacetate derivatives there- cow’s milk is used in whole or in part, of, 0.5 percent; polyglycerol esters of the animal source shall be identified in fatty acids, 0.5 percent; 1,2-propylene conjunction with the word ‘‘milk’’ in glycol esters of fatty acids, 2 percent; the ingredient statement. lecithin, 0.5 percent. [48 FR 52697, Nov. 22, 1983, as amended at 50 (5) Preservatives identified in FR 3739, Jan. 28, 1985; 54 FR 40632, Oct. 3, 1989; § 318.7(c)(4) of this chapter, within these 59 FR 33642, June 30, 1994] maximum amounts in percent by weight of the finished food: Sorbic § 319.701 Mixed fat shortening. acid, benzoic acid and their sodium, po- Shortening prepared with a mixture tassium, and calcium salts, individ- of meat fats and vegetable oils may be ually, 0.1 percent, or in combination, identified either as ‘‘Shortening Pre- 0.2 percent, expressed as the acids; cal- pared with Meat Fats and Vegetable cium disodium EDTA, 0.0075 percent; Oils’’ or ‘‘Shortening Prepared with stearyl citrate, 0.15 percent; isopropyl Vegetable Oils and Meat Fats’’ depend- citrate mixture, 0.02 percent. ing on the predominance of the fat and (6) Antioxidants identified in oils used, or the product may be la- § 318.7(c)(4) of this chapter, within these beled ‘‘Shortening’’ when accompanied maximum amounts in percent by by an ingredient statement with ingre- weight of the finished food: propyl, dients listed in descending order of pre- octyl and dodecyl gallates, BHT dominance. (butylated hydroxytoluene), BHA (butylated hydroxyanisole), ascorbyl § 319.702 Lard, leaf lard. palmitate, ascorbyl stearate, all indi- (a) Lard is the fat rendered from vidually or in combination, 0.02 per- clean and sound edible tissues from cent. Instead of these antioxidants, swine. The tissues may be fresh, frozen, TBHQ (tertiary butylhydroquinone), cooked, or prepared by other processes alone or in combination only with BHT approved by the Administrator in spe- and/or BHA, with a maximum 0.02 per- cific cases, upon his determination cent by weight of the fat and oil con- that the use of such processes will not tent. result in the adulteration or misbrand- (7) Coloring agents identified in ing of the lard. The tissues shall be rea- § 318.7(c)(4) of this chapter, in amounts sonably free from blood, and shall not sufficient for purpose.3 For the purpose of the Federal Food, Drug, and Cosmetic Act, 3 Colored margarine or oleomargarine is as amended (21 U.S.C. 347), as reflected in also subject to the provisions of section 407 § 317.8(h)(24) of this subchapter.
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include stomachs, livers, spleens, kid- § 319.721 Fluid extract of meat. neys, and brains, or settlings and Fluid extract of meat (e.g., ‘‘Fluid skimmings. ‘‘Leaf Lard’’ is lard pre- Extract of Beef’’) shall contain not pared from fresh leaf (abdominal) fat. more than 50 percent of moisture. (b) Lard (when properly labeled) may be hardened by the use of lard stearin or hydrogenated lard or both and may Subpart R—Meat Salads and Meat contain refined lard and deodorized Spreads lard, but the labels of such lard shall state such facts, as applicable. § 319.760 Deviled ham, deviled tongue, and similar products. (c) Products labeled ‘‘Lard’’ or ‘‘Leaf Lard’’ must have the following identity (a) ‘‘Deviled Ham’’ is a semiplastic and quality characteristics to insure cured meat food product made from good color, odor, and taste of finished finely comminuted ham and containing product: condiments. Mechanically Separated (1) Color ...... White when solid, Maximum 3.0 (Species) may be used in accordance red units in a 51¤4 inch cell on with § 319.6. Deviled ham may contain the Lovibond scale. added ham fat: Provided, That the total (2) Odor and taste ...... Characteristic and free from for- fat content shall not exceed 35 percent eign odors and flavors. (3) Free fatty acid ...... Maximum 0.5 percent (as oleic) of the finished product. The moisture or 1.0 acid value, as milligrams content of deviled ham shall not exceed KOH per gram of sample. that of the fresh unprocessed meat. (4) Peroxide value ...... Maximum 5.0 (as milliequivalents of peroxide per kilogram fat). (b) The moisture content of ‘‘Deviled (5) Moisture and volatile Maximum 0.2 percent. Tongue’’ and similar products shall not matter. exceed that of the fresh, unprocessed (6) Insoluble impurities .... By appearance of liquid, fat or meat. maximum 0.05 percent. (d) Product found upon inspection [35 FR 15597, Oct. 3, 1970, as amended at 43 FR not to have the characteristics speci- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] fied in paragraph (c) of this section but § 319.761 Potted meat food product found to be otherwise sound and in and deviled meat food product. compliance with paragraph (a) of this section may be further processed for ‘‘Potted Meat Food Product’’ and the purpose of achieving such charac- ‘‘Deviled Meat Food Product’’ shall not teristics. contain cereal, vegetable flour, nonfat dry milk, or similar substances. The [43 FR 25420, June 13, 1978] amount of water added to potted meat food product and deviled meat food § 319.703 Rendered animal fat or mix- product shall be limited to that nec- ture thereof. essary to replace moisture lost during ‘‘Rendered Animal Fat,’’ or any mix- processing. ture of fats containing edible rendered animal fat, shall contain no added § 319.762 Ham spread, tongue spread, water, except that ‘‘Puff Pastry Short- and similar products. ening’’ may contain not more than 10 ‘‘Ham Spread,’’ ‘‘Tongue Spread,’’ percent of water. and similar products shall contain not [35 FR 15597, Oct. 3, 1970, as amended at 43 FR less than 50 percent of the meat ingre- 25420, June 13, 1978] dient named, computed on the weight of the fresh meat. Other meat and fat Subpart Q—Meat Soups, Soup may be used to give the desired spread- ing consistency provided it does not de- Mixes, Broths, Stocks, Extracts tract from the character of the spreads § 319.720 Meat extract. named. Mechanically Separated (Spe- cies) may be used in accordance with Meat extract (e.g., ‘‘Beef Extract’’) § 319.6. shall contain not more than 25 percent of moisture. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982]
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Subpart S—Meat Baby Foods freezing, packaging, or labeling any [Reserved] carcasses, or parts or products of car- casses, of any such animals, for use as human food or animal food; Subpart T—Dietetic Meat Foods (2) Any person that engages in the [Reserved] business of buying or selling (as a meat broker, wholesaler, or otherwise), or Subpart U—Miscellaneous transporting in commerce, or storing in or for commerce, or importing, any § 319.880 Breaded products. carcasses, or parts or products of car- The amount of batter and breading casses, of any such animals; used as a coating for breaded product (3) Any person that engages in busi- shall not exceed 30 percent of the ness, in or for commerce, as a renderer, weight of the finished breaded product. or engages in the business of buying, selling, or transporting in commerce, § 319.881 Liver meat food products. or importing, any dead, dying, dis- Meat food products characterized and abled, or diseased cattle, sheep, swine, labeled as liver products such as liver goats, horses, mules, or other equines, loaf, liver cheese, liver spread, liver or parts of the carcasses of any such mush, liver paste, and liver pudding animals that died otherwise than by shall contain not less than 30 percent slaughter. of pork, beef, sheep, or goat livers com- (b) The required records are: puted on the fresh weight of the livers. (1) Records, such as bills of sale, in- voices, bills of lading, and receiving [36 FR 12004, June 24, 1971] and shipping papers, giving the follow- ing information with respect to each PART 320—RECORDS, transaction in which any livestock or REGISTRATION, AND REPORTS carcass, part thereof, meat or meat food product is purchased, sold, Sec. shipped, received, transported, or oth- 320.1 Records required to be kept. erwise handled by said person in con- 320.2 Place of maintenance of records. nection with any business subject to 320.3 Record retention period. 320.4 Access to and inspection of records, fa- the Act: cilities and inventory; copying and sam- (i) The name or description of the pling. livestock or article; 320.5 Registration. (ii) The net weight of the livestock or 320.6 Information and reports required from article; official establishment operators. (iii) The number of outside contain- 320.7 Reports by consignees of allegedly ers (if any); adulterated or misbranded products; sale (iv) The name and address of the or transportation as violations. buyer of livestock or article sold by AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, such person, and the name and address 2.53. of the seller of livestock or articles SOURCE: 35 FR 15603, Oct. 3, 1970, unless purchased by such person; otherwise noted. (v) The name and address of the con- signee or receiver (if other than the § 320.1 Records required to be kept. buyer); (a) Every person (including every (vi) The method of shipment; firm or corporation) within any of the (vii) The date of shipment; and classes specified in paragraph (a) (1), (viii) The name and address of the (2), or (3) of this section is required by carrier. the Act to keep records which will (ix) In the case of a person belonging fully and correctly disclose all trans- to the class specified in paragraph actions involved in his or its business (a)(1), and engaged, for commerce, in subject to the Act: the business of slaughtering any swine (1) Any person that engages, for com- for use as human or animal food, the merce, in the business of slaughtering name and address (including the city any cattle, sheep, swine, goats, horses, and state, or the township, county, and mules, or other equines, or preparing, state) of each person from whom the
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person belonging to the class so speci- § 320.2 Place of maintenance of fied purchased or otherwise obtained records. each swine, and the telephone number, Every person engaged in any business if available, of the person from whom described in § 320.1 and required by this the swine were purchased or otherwise part to keep records shall maintain obtained, and all serial numbers and such records at the place where such other approved means of identification business is conducted except that if appearing on all test swine selected at such person conducts such business at antemortem inspection by FSIS rep- multiple locations, he may maintain resentatives for residue testing. such records at his headquarters’ of- (2) Shipper’s certificates and permits fice. When not in actual use, all such required to be kept by shippers and records shall be kept in a safe place at carriers of articles under part 325 of the prescribed location in accordance this subchapter. with good commercial practices. (3) A record of seal numbers required § 320.3 Record retention period. to be kept by consignees of inedible products shipped under unofficial seals (a) Every record required to be main- under § 325.11(b) or (e) of this sub- tained under this part shall be retained chapter, and a record of new consignees for a period of 2 years after December of inedible products diverted under 31 of the year in which the transaction § 325.11(e) of this subchapter. to which the record relates has oc- (4) Records of processing procedures curred and for such further period as for cooked beef and roast beef as re- the Administrator may require for pur- quired in § 318.17(d). poses of any investigation or litigation (5) Guaranties provided by suppliers under the Act, by written notice to the of packaging materials under § 317.20. person required to keep such records under this part. (6) Records of canning as required by (b) Records of canning as required in subpart G of this subchapter A, 9 CFR subpart G of this subchapter A, 9 CFR chapter III. chapter III, shall be retained as re- (7) Sample results and calculation re- quired in § 318.307(e); except that sults as required by processing proce- records required by § 318.302 (b) and (c) dures to destroy trichinae in shall be retained as required by those § 318.10(c)(3)(iv) (Methods 5 and 6). sections. (8) Records of nutrition labeling as required by subpart B, part 317, of this [35 FR 15603, Oct. 3, 1970, as amended at 51 FR subchapter. 45633, Dec. 19, 1986] (9) Records as required in § 318.23(b) § 320.4 Access to and inspection of rec- and (c). ords, facilities and inventory; copy- (10) Records of calcium content in ing and sampling. meat derived from advanced meat/bone Every person (including every firm or separation machinery and meat recov- corporation) within any of the classes ery systems as required by § 318.24 of specified in § 320.1 shall upon the pres- this subchapter. entation of official credentials by any (11) Records of all labeling, along duly authorized representative of the with the product formulation and proc- Secretary, during ordinary business essing procedures, as prescribed in hours, permit such representative to § 317.4 and § 317.5. enter his or its place of business and (Approved by the Office of Management and examine the records required to be Budget under control number 0583–0015) kept by § 320.1 and the facilities and in- ventory pertaining to the business of [35 FR 15603, Oct. 3, 1970, as amended at 36 FR such person subject to the Act, and to 12004, June 24, 1971; 37 FR 1229, Jan. 27, 1972; copy all such records and to take rea- 43 FR 30793, July 18, 1978; 47 FR 746, Jan. 7, sonable samples of the inventory upon 1982; 47 FR 17274, Apr. 22, 1982; 49 FR 2235, payment of the fair market value Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 53 FR 40387, Oct. 14, 1988; 57 FR 27877, June 22, 1992; therefor. Any necessary facilities 58 FR 675, Jan. 6, 1993; 58 FR 41152, Aug. 2, (other than reproduction equipment) 1993; 59 FR 6897, Feb. 14, 1994; 59 FR 62562, for such examination and copying of Dec. 6, 1994; 60 FR 67456, Dec. 29, 1995] records and for such examination and
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sampling of inventory shall be afforded § 320.6 Information and reports re- to such authorized representative of quired from official establishment the Secretary. operators. (a) The operator of each official es- § 320.5 Registration. tablishment shall furnish to Program (a) Except as provided in paragraph employees accurate information as to (c) of this section, every person that all matters needed by them for making engages in business in or for commerce, their daily reports of the amount of as a meat broker, renderer, or animal products prepared or handled in the de- food manufacturer, or engages in busi- partments of the establishment to ness in commerce as a wholesaler of which they are assigned and such re- any carcasses, or parts or products of ports concerning sanitation, manda- the carcasses, or any livestock, wheth- tory microbiological testing, and other er intended for human food or other aspects of the operations of the estab- purposes, or engages in business as a lishment and the conduct of inspection, public warehouseman storing any such as may be required by the Adminis- articles in or for commerce, or engages trator in special cases. in the business of buying, selling, or (b) The operator of each official es- transporting in commerce, or import- tablishment shall report quarterly the ing, any dead, dying, disabled, or dis- number of pounds of meat and meat eased livestock, or parts of the car- food product produced at that estab- casses of any such livestock that died lishment. The report shall be made on otherwise than by slaughter, shall reg- a form furnished by the Administrator ister with the Administrator, giving and shall be submitted to an inspector such information as is required, includ- at the establishment. Each report shall ing his name, and the address of each cover a calendar quarter and shall be place of business at which, and all filed within 15 days after the end of trade names under which he conducts each quarter. (c) The operator of each official es- such business, by filing with the Ad- tablishment shall also make such other ministrator, Food Safety and Inspec- reports as the Administrator may from tion Service, U.S. Department of Agri- time to time require under the Act. culture, Washington, DC 20250, a form containing such information within 90 [35 FR 15603, Oct. 3, 1970, as amended at 45 FR days after the effective date hereof or 76968, Nov. 21, 1980; 61 FR 38866, July 25, 1996] after such later date as he begins to en- gage in such business if not engaged § 320.7 Reports by consignees of alleg- therein upon said effective date. All in- edly adulterated or misbranded products; sale or transportation as formation submitted shall be current violations. and correct. The registration form shall be obtained from the Compliance Whenever the consignee of any prod- Programs, Regulatory Programs, Food uct which bears an official inspection Safety and Inspection Service, U.S. De- legend refuses to accept delivery of partment of Agriculture, Washington, such product on the grounds that it is DC 20250. adulterated or misbranded, the con- signee shall notify the Inspector in (b) Whenever any change is made in Charge, Meat and Poultry Inspection the name of, or address of any place of Program, Food Safety and Inspection business at which, or any trade name Service, U.S. Department of Agri- under which a registrant conducts his culture, of the kind, quantity, source, business, he shall report such change in and present location of the product and writing to the Administrator within 15 the respects in which it is alleged to be days after making the change. adulterated or misbranded, and it will (c) The registration requirements be a violation of the Act for any person prescribed in this section shall not to sell or transport, or offer for sale or apply to persons conducting any of the transportation, or receive for transpor- businesses specified in this section only tation, in commerce, any such product at an official establishment. which is capable of use as human food [35 FR 15603, Oct. 3, 1970, as amended at 57 FR and is adulterated or misbranded at the 53982, Nov. 16, 1992] time of such sale, transportation, offer,
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or receipt: Provided, however, That any for human food), when he determines such allegedly adulterated or mis- that such cooperation would effectuate branded product may be transported to the purposes of the Act. the official establishment from which (c) Such cooperation may include ad- it had been transported, in accordance visory assistance, technical and labora- with § 325.10 of this subchapter. tory assistance and training, and finan- cial aid. The Federal contribution to PART 321—COOPERATION WITH any State (or Territory) may not ex- STATES AND TERRITORIES ceed 50 percent of the estimated total cost of the cooperative State (or Terri- Sec. torial) program. A cooperative pro- 321.1 Assistance to State and Territorial gram under this section is called a programs. State-Federal program. 321.2 Cooperation of States in Federal pro- grams. [35 FR 15604, Oct. 3, 1970] AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, § 321.2 Cooperation of States in Fed- 2.55. eral programs. § 321.1 Assistance to State and Terri- Under the ‘‘Talmadge-Aiken Act’’ of torial programs. September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize (a) The Administrator is authorized employees and facilities of any State under paragraph (a) of section 301 of in carrying out Federal functions the Act, when he determines it would under the Federal Meat Inspection Act. effectuate the purposes of the Act, to A cooperative program for this purpose cooperate with any State (including is called a Federal-State program. Puerto Rico) or any organized Terri- tory in developing and administering [35 FR 15604, Oct. 3, 1970] the meat inspection program of such jurisdiction with a view to assuring PART 322—EXPORTS 1 that it imposes and enforces require- ments at least equal to those under Ti- Sec. tles I and IV of the Act, with respect to 322.1 Manner of affixing stamps and mark- establishments at which products are ing products for export. prepared for use as human food solely 322.2 Export certificates; instructions con- for distribution within such jurisdic- cerning issuance. tion, and with respect to the products 322.3 Transferring products for export. 322.4 Clearance of vessels and transpor- of such establishments. Such coopera- tation without certificate prohibited; ex- tion is authorized if the jurisdiction ceptions. has enacted a law imposing mandatory 322.5 Uninspected tallow, stearin, oleo oil, ante-mortem and post-mortem inspec- etc., not to be exported unless certified tion, reinspection, and sanitation re- as prescribed. quirements at least equal to the Fed- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, eral requirements with respect to all or 2.55. certain classes of persons engaged in SOURCE: 35 FR 15604, Oct. 3, 1970, unless slaughtering livestock or otherwise otherwise noted. preparing products solely for distribu- tion within such jurisdiction. § 322.1 Manner of affixing stamps and (b) The Administrator is also author- marking products for export. ized under paragraph (a) of section 301 (a) The outside container (including of the Act to cooperate with any State cloth wrappings) of any inspected and (including Puerto Rico) or any orga- passed product for export, except ship nized Territory in developing and ad- ministering programs under the laws of such jurisdiction containing authori- 1 Attention is directed to the requirements ties at least equal to those in Title II of part 325 of this subchapter, governing transportation, and to the requirements of of the Act (relating to records; reg- § 318.8 of this subchapter that products pre- istration of specified classes of opera- pared under that section for export be de- tors; dead, dying, disabled, or diseased stroyed for food purposes before being sold or livestock; and products not intended offered for sale for domestic use.
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stores, small quantities exclusively for show in the left hand margin the num- the personal use of the consignee and ber of the certificate which supersedes not for sale or distribution, and ship- it, as follows: ‘‘Superseded by No. ments by and for the U.S. Armed ——’’. Forces, shall be marked with an offi- (d) The original of the certificate cial export stamp, as shown in § 312.8 of shall be delivered to the shipper and this subchapter, bearing the number of may be furnished by him to the con- the export certificate. signee for purposes of effecting the (b) Each tank car of inspected and entry of product into the foreign coun- passed lard or similar edible product, and each door of each railroad car or try of destination. other closed means of conveyance, con- (e) The duplicate of the certificate taining inspected and passed loose shall be delivered to the shipper and product shipped directly to a foreign shall be delivered by the shipper to the country, shall be marked with an offi- agent of the railroad or other carrier cial export stamp, as shown in § 312.8 of which transports the consignment from this subchapter, bearing the number of the United States otherwise than by the export certificate. water, or to the chief officer of the ves- [42 FR 11825, Mar. 1, 1977, as amended at 50 sel on which the export shipment is FR 25204, June 18, 1985] made, or to the vessel’s agent and shall be used only by such carrier and only § 322.2 Export certificates; instructions for the purpose of effecting the trans- concerning issuance. portation of the consignment certified. (a) Upon application of the exporter, The chief officer of the vessel or the the inspector in charge is authorized to vessel’s agent, shipper or shipper’s issue official export certificates for agent shall file such duplicate with the shipments of inspected and passed Customs officer within four (4) business product to any foreign country. Certifi- days of the clearance of the vessel at cates should be issued at the time the the time of filing the complete mani- products leave the official establish- fest. In the interim period, the vessel ment; if not issued at that time they will be cleared by Customs on the basis may be issued later only after identi- of a statement, under the shipper’s or fication and reinspection of the prod- agent’s letterhead, containing the ucts. number of boxes, the number of (b) Official export certificates shall pounds, the product name and the be issued with serial numbers and in triplicate form. Quadruplicate certifi- USDA export certificate number that cates may be issued for any expor- covers the shipment of the product. No tation on request of the exporter. Each clearance shall be given to a vessel car- certificate shall show the names of the rying meat products unless either the exporter and the consignee, the des- duplicate of the certificate or the pre- tination, the number and types of scribed statement referencing the cer- packages, the shipping marks, the tificate has been presented to Customs. kinds of products, and the weight of (f) The triplicate of the certificate the products in accordance with § 317.2 shall be retained in the circuit file. of this subchapter. (g) Under no circumstances shall the (c) Only one certificate shall be original or the triplicate of such cer- issued for each consignment, except tificate be used for the purpose pre- that for sufficient reasons new certifi- scribed by paragraph (e) of this section cates in lieu of the original certificates for the duplicate. may be issued. A certificate issued in (h) Upon request, official export cer- lieu of another shall show in the left tificates may be issued by inspectors hand margin the notation ‘‘Issued in for export consignments of product of lieu of * * *’’, and the number of the official establishments not under their certificate which is superseded. The supervision, provided the consignments certificate that is superseded when an- other is issued in lieu thereof, shall if are first identified as having been available, be surrendered to the inspec- ‘‘U.S. inspected and passed’’ and are tor in charge and marked by him to found to be neither adulterated nor
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misbranded, and marked as required by PART 325—TRANSPORTATION § 322.1. [35 FR 15604, Oct. 3, 1970, as amended at 42 FR Sec. 11826, Mar. 1, 1977; 51 FR 31938, Sept. 8, 1986] 325.1 Transactions in commerce prohibited without official inspection legend or cer- § 322.3 Transferring products for ex- tificate when required; exceptions; and port. vehicle sanitation requirements. 325.2 Parcel post and ferries deemed car- When inspected and passed products riers. for export are transferred from tank 325.3 Product transported within the United cars to other containers on vessels, States as part of export movement. such transfer shall be done in accord- 325.4 [Reserved] ance with the provisions of part 350 of 325.5 Unmarked inspected product trans- subchapter B of this chapter. ported under official seal between official establishments for further processing; certificate. § 322.4 Clearance of vessels and trans- 325.6 Shipment of paunches between official portation without certificate pro- establishments under official seal; cer- hibited; exceptions. tificate. No clearance shall be given to any 325.7 Shipment of products requiring special vessel having on board any product supervision between official establish- destined to any foreign country, and no ments under official seal; certificate. person operating any vessel, and no 325.8 Transportation and other transactions concerning certain undenatured lungs or railroad or other carrier, shall receive lung lobes from official establishments for transportation or transport from or in commerce; provisions and restric- the United States to any foreign coun- tions. try, any products, unless and until an 325.9 [Reserved] official export certificate covering the 325.10 Handling of products which may have same has been issued and delivered as become adulterated or misbranded; au- provided in this part; except in the case thorization and other requirements. of inspected and passed ship stores and 325.11 Inedible articles: denaturing and other means of identification; excep- not more than 50 pounds of inspected tions. and passed product for the exclusive 325.12 [Reserved] personal use of the consignee and not 325.13 Denaturing procedures. for sale or distribution, and except for 325.14 Certificates, retention by carrier. exempted product eligible for expor- 325.15 Evidence of proper certification re- tation under the provisions of the Act quired on waybills; transfer bills, etc., and the regulations in this subchapter for shipment by connecting carrier; and inedible product that is not capa- forms of statement. 325.16 Official seals; forms, use, and break- ble of use as human food and is eligible ing. for exportation under other provisions 325.17 Loading or unloading products in of said regulations. sealed railroad cars, trucks, etc., en route prohibited; exception. [38 FR 18868, July 16, 1973] 325.18 Diverting of shipments, breaking of seals, and reloading by carrier in emer- § 322.5 Uninspected tallow, stearin, gency; reporting to Regional Director. oleo oil, etc., not to be exported un- 325.19 Provisions inapplicable to specimens less certified as prescribed. for laboratory examination, etc., or to No tallow, stearin, oleo oil, or the naturally inedible articles. rendered fat derived from the carcasses 325.20 Transportation and other trans- of livestock, that has not been in- actions concerning dead, dying, disabled, spected and passed, and so marked in or diseased livestock, and parts of car- casses of livestock that died otherwise compliance with the regulations in this than by slaughter. subchapter shall be exported, unless 325.21 Means of conveyance in which dead, the product has been denatured as re- dying, disabled, or diseased livestock and quired by § 314.5 or § 325.13 of this sub- parts of carcasses thereof shall be trans- chapter or identified and marked as ported. prescribed by § 325.11 of this sub- AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. chapter. 601–695; 7 CFR 2.17, 2.55.
[35 FR 15604, Oct. 3, 1970, as amended at 47 FR SOURCE: 35 FR 15605, Oct. 3, 1970, unless 17274, Apr. 22, 1982] otherwise noted.
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§ 325.1 Transactions in commerce pro- placed therein will not become adulter- hibited without official inspection ated. Any cleaning compound, lye, soda legend or certificate when required; solution, or other chemical used in exceptions; and vehicle sanitation cleaning the means of conveyance must requirements. be thoroughly removed from the means (a) No person shall sell, transport, of conveyance prior to its use. Such offer for sale or transportation, or re- means of conveyance onto which prod- ceive for transportation, in commerce, uct is loaded, being loaded, or intended any product which is capable of use as to be loaded, shall be subject to inspec- human food unless the product and its tion by an inspector at any official es- container, if any, bear the official in- tablishment. The decision whether or spection legend as required under parts not to inspect a means of conveyance 316 and 317 of this subchapter or such in a specific case, and the type and ex- product is exempted from the require- tent of such inspection shall be at the ment of inspection under part 303 of Program’s discretion and shall be ade- this subchapter. quate to determine if product in such (b)(1) No carrier shall transport or re- conveyance is, or when moved could be- ceive for transportation in commerce come, adulterated. Circumstances of (including transportation in the course transport that can be reasonably an- of importation) and no person shall ticipated shall be considered in making offer for transportation any carcass, said determination. These include, but part thereof, meat or meat food prod- are not limited to, weather conditions, uct until a certificate, if required for duration and distance of trip, nature of such transportation by this part, is product covering, and effect of restow- made and furnished to the carrier in age at stops en route. Any means of one of the forms prescribed in this conveyance found upon such inspection part. to be in such condition that product (2) Product imported into the United placed therein could become adulter- States may be transported and offerred ated shall not be used until such condi- or received for transportation if such tion which could cause adulteration is product is conveyed in railroad cars, corrected. Product placed in any means trucks or other means of conveyance, of conveyance that is found by the in- prior to inspection, to an authorized spector to be in such condition that the place of inspection, as provided in product may have become adulterated § 327.6 of this part. shall be removed from the means of (c) No person, engaged in the busi- conveyance and handled in accordance ness of buying, selling, freezing, stor- with § 318.2(d) of this subchapter. ing, or transporting, in or for com- merce, meat or meat food products ca- [35 FR 15605, Oct. 3, 1970, as amended at 41 FR pable of use as human food, or import- 23700, June 11, 1976; 47 FR 17274, Apr. 22, 1982; ing such articles, shall transport, offer 56 FR 65180, Dec. 16, 1991] for transportation, or receive for trans- portation in commerce or in any State § 325.2 Parcel post and ferries deemed carriers. designated under § 331.2 of this sub- chapter, any such meat or meat food (a) For the purposes of this sub- product which is capable of use as chapter, the United States parcel post human food and is not wrapped, pack- shall be deemed a carrier, and the pro- aged, or otherwise enclosed to prevent visions of this subchapter relating to adulteration by airborne contami- transportation by carrier shall apply, nants, unless the railroad car, truck, or so far as they may be applicable, to other means of conveyance in which transportation by parcel post. the product is contained or transported (b) For the purposes of this sub- is completely enclosed with tight fit- chapter, the operator of every ferry ting doors or other covers for all open- shall be deemed a carrier, and the pro- ings. In all cases, the means of convey- visions of this subchapter relating to ance shall be reasonably free of foreign transportation by carrier shall apply to matter (such as dust, dirt, rust, or transportation by ferry of any products other articles or residues), and free of loaded on a truck or other vehicle, or chemical residues, so that product otherwise moved by such ferry.
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§ 325.3 Product transported within the Meat and Poultry Inspection Programs of United States as part of export said Department, and the means of convey- movement. ance has been sealed by him with official U.S. Government seals Nos. —— and ——. When any shipment of any product is offered to any carrier for transpor- tation within the United States as a Kind of product Amount and weight part of an export movement, the same ———————————————————————— certificate shall be required as if the ———————————————————————— shipment were destined to a point ———————————————————————— within the United States. (Signature of shipper) § 325.4 [Reserved] (Address of shipper) § 325.5 Unmarked inspected product transported under official seal be- When paunches are offered for trans- tween official establishments for portation under this paragraph, the further processing; certificate. initial carrier shall require, and the (a) Any product which has been in- shipper shall make in duplicate and de- spected and passed may be transported liver to the carrier, one copy of a cer- from one official establishment to an- tificate in duplicate in the form set out other for further processing without in § 325.5(b), appropriately modified. each article being marked with the of- Certificates in this form or copies ficial inspection legend, if it is so thereof need not be forwarded to any transported in a railroad car, official or office of the Department, motortruck, or other means of convey- but the original of the certificate shall ance which is sealed by a Program em- be retained by the carrier and a copy ployee with an official seal of the De- shall be retained by the shipper in ac- partment prescribed in § 312.5(a) of this cordance with part 320 of this sub- subchapter. Unless 25 percent or more chapter. If the shipper is also the car- of the contents of each car or other rier, he shall nevertheless execute and means of conveyance consists of prod- retain the certificate in accordance uct not marked with the inspection with part 320 of this subchapter. legend, transportation will not be per- (c) The signature of the shipper or his mitted under this paragraph. agent shall be written in full. This cer- (b) When articles are offered for tificate may be stamped upon or incor- transportation under paragraph (a) of porated in any form ordinarily used in this section, the initial carrier shall re- the transportation of product. Certifi- quire, and the shipper shall make in cates in this form or copies thereof duplicate and deliver to the carrier, need not be forwarded to any official or one copy of a certificate in the follow- office of the Department. The original ing form: 1 of the certificate required by this sec- Date lllll, 19l tion shall be retained by the carrier Name of carrier ——————————————— Establishment number of consignor ———— and a copy shall be retained by the Point of shipment —————————————— shipper in accordance with part 320 of Establishment number of consignee ———— this subchapter. If the shipper is also Destination ————————————————— the carrier, he shall nevertheless exe- Car number and initials ——————————— cute and retain the certificate in ac- License number of other means of convey- cordance with part 320 of this sub- ance ———————————————————— chapter. I hereby certify that the following de- scribed product has been U.S. inspected and § 325.6 Shipment of paunches between passed by the U.S. Department of Agri- official establishments under offi- culture; and that it is not marked ‘‘U.S. in- cial seal; certificate. spected and passed,’’ but has been placed in the means of conveyance specified above Cattle and sheep paunches which under the supervision of an employee of the have been made clean and from which the mucous membrane has not been re- 1 For convenience in filing, it is requested moved may be transported from one of- that these certificates be made on paper 51⁄2 ficial establishment to another official x 8 inches in size. establishment for further processing,
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only under an official seal of the De- other product in the vehicle is un- partment as prescribed in § 312.5(a) of marked. For each consignment there this subchapter. shall be promptly issued and forwarded by the inspector to the inspector in § 325.7 Shipment of products requiring charge at destination, a report on the special supervision between official form entitled ‘‘Notice of Unmarked establishments under official seal; Meats Shipped in Sealed Cars,’’ appro- certificate. priately modified to show the char- (a) Products passed for cooking, pork acter of the containers, and that the that has been refrigerated to destroy contents are restricted. A duplicate trichinae, and beef that is to be refrig- copy shall be retained in the program erated to destroy cysticerci, may be files. shipped loose from one official estab- (c) When products are offered for lishment to any other official estab- transportation under this section, the lishment, for further handling in ac- initial carrier shall require and the cordance with part 318 of this sub- shipper shall make in duplicate and de- chapter, in railroad cars, trucks, or liver to the carrier one copy of a cer- other means of conveyance sealed with tificate in the form set out in § 325.5(b). the official seal of the Department as Certificates in this form or copies prescribed in § 325.16: Provided, That in thereof need not be forwarded to any the case of railroad cars, the receiving official or office of the Department, establishment has railroad facilities but the original of the certificate shall for unloading the products directly be retained by the carrier and a copy into the establishment. shall be retained by the shipper in ac- (b) When such restricted product is cordance with part 320 of this sub- shipped from one official establishment chapter. If the shipper is also the car- to another official establishment in the rier, he shall nevertheless execute and same railroad car or other means of retain the certificate in accordance conveyance with other product, such with part 320 of this subchapter. restricted product shall be packed in [35 FR 15605, Oct. 3, 1970, as amended at 39 FR individual closed containers as herein- 20187, June 7, 1974] after provided. Containers shall be sealed by firmly applying a pressure § 325.8 Transportation and other sensitive tape around each container in transactions concerning certain two directions and stamping the inter- undenatured lungs or lung lobes section of the tape with the marking from official establishments or in device described in § 312.2(a) of this sub- commerce; provisions and restric- chapter for use on burlap, muslin, etc. tions. (21⁄2-inch rubber brand). Such tape must (a) Lungs or lung lobes, other than possess the adhesive property to actu- those condemned under § 310.16(b) of ally remove a portion of the container this subchapter, that are prepared at surface when the tape is removed. Al- any official establishment, may be ternatively, an inelastic, nonmetallic sold, transported, offered for sale or strap which will retain a legible im- transportation, or received for trans- print of the marking device (21⁄2-inch portation from the establishment, in rubber brand) may be used. The im- commerce or otherwise, without dena- print of the marking device shall be turing as prescribed in § 314.1 or § 314.3 placed partially on the strap and par- of this subchapter: Provided: tially on the container. Such restricted (1) The lungs or lung lobes are sold, product shall be marked ‘‘U.S. passed transported, or offered for sale or for cooking’’ or ‘‘pork product —— transportation to, or received for °F.——days refrigeration’’ or ‘‘beef transportation by: An animal food passed for refrigeration,’’ as the case manufacturer for use in manufacturing may be. In addition, a ‘‘U.S. retained’’ animal food; a zoo, mink farm, or other tag shall be securely affixed to each establishment for use as animal food container of product passed for cooking without further processing; a ware- and of beef passed for refrigeration. house in the United States for storage The means of conveyance shall not be and subsequent movement to such a sealed unless at least 25 percent of the manufacturer or establishment in the
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United States, or from one warehouse (d) All such lungs or lung lobes, if in- to another for the account of and sub- tended for animal food, are subject to sequent movement to such a manufac- the Federal Food, Drug, and Cosmetic turer or establishment, or for export, Act. for nonhuman food purposes. [43 FR 43445, Sept. 26, 1978] (2) The boxes or other containers used for shipping the undenatured § 325.9 [Reserved] lungs or lung lobes are closed with nylon filament tape, metallic on non- § 325.10 Handling of products which metallic straps, round wire, or other may have become adulterated or similar materials that securely effect misbranded; authorization and other requirements. closure of such containers, and the con- tainers are permanently identified in (a) When it is claimed that any in- at least 2-inch (5 cm) high lettering spected and passed product, marked with the statement ‘‘(Species) Lungs— with an inspection legend, has become Not Intended for Human Food.’’ In lieu adulterated or misbranded after it has of securely closing the immediate con- been transported from an official es- tainer with any of the above materials, tablishment, such product may be a 1-inch (2.5 cm) wide bright orange transported in commerce to an official band, imprinted around the length and establishment after oral permission is width of the container may be used. obtained from the area supervisor of the area in which that offical establish- (3) The name and place of business of ment is located. The transportation of the packer or distributor shall be the product may be to the official es- shown on the immediate container of tablishment from which it had been the product. In addition, the country of transported or to another official es- origin shall be shown on the immediate tablishment designated by the person container of imported lungs or lung desiring to handle the product. The lobes. transportation shall be authorized only (b) Lungs or lung lobes, other than for the purpose of officially determin- those condemned under a State law or ing if the product has become adulter- regulation at least equal to § 310.16(b) ated or misbranded and making the ap- of this subchapter, that are prepared at propriate disposition. The area super- any State inspected establishment may visor shall make a record of the au- be sold, transported, offered for sale, or thorization and such other information transportation or received for trans- which will effectively identify the ship- portation from that establishment, in ment and shall provide a copy of the commerce, without denaturing as pre- record to the inspector at the estab- scribed under section 201 of the Act, lishment receiving the product. The provided the State law or regulations shipper shall be furnished a copy of the permit such disposition and provided authorization record upon request. there is compliance with the provisions (b) Upon the arrival of the shipment of paragraph (a) of this section. at the official establishment, a careful (c) Foreign establishments shall be inspection shall be made of the product eligible to export lungs or lung lobes, by a Program inspector, and if it is other than those condemned for rea- found that the article is not adulter- sons set forth in § 310.16(b) of this sub- ated, the same may be received into chapter, to the United States from the establishment; but if the article is such foreign country under this sec- found to be adulterated, it shall at tion, only if such establishments are once be stamped ‘‘U.S. inspected and certified and approved for export of condemned’’ and disposed of in accord- products to the United States under ance with part 314 of this subchapter, part 327 of this subchapter, and such and if it is found to be misbranded, it product complies with the applicable shall be handled in accordance with regulations for preventing the intro- § 318.2(d) of this subchapter: Provided, duction into the United States of dis- That when a product is found to be af- eases (9 CFR 94), in addition to the re- fected with one of the correctable con- quirements of paragraph (a) of this sec- ditions specified in § 318.2(d) of this sub- tion. chapter, in respect to which rehandling
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is permitted, it may be transported solely by the consignee for manufac- from the official establishment to an- turing purposes of nonhuman food arti- other official establishment for such cles and may not be further sold or rehandling as is necessary to assure shipped without first receiving ap- that the product is not adulterated or proval of the Regional Director: And misbranded when finally released. The provided further, That such fat intended transportation of such a product from for export and stored at a terminal an official establishment shall be done point prior to export will be subject to in a manner prescribed in each specific review by Program employees to assure case by the Administrator. that it is exported as inedible. [35 FR 15605, Oct. 3, 1970, as amended at 47 FR (3) When transported in commerce, or 17274, Apr. 22, 1982] imported, such inedible rendered fat shall be marked conspicuously with the § 325.11 Inedible articles: denaturing words ‘‘technical animal fat not in- and other means of identification; tended for human food’’ on the ends of exceptions. the shipping containers, in letters not (a) Except as provided in § 325.8 and less than 2 inches high; in the case of § 325.10, no carcass, part of a carcass, shipping containers such as drums, rendered grease, tallow, or other fat de- tierces, barrels, and half barrels, and rived from the carcasses of livestock, not less than 4 inches high in the case or other meat food product, that has of tank cars and trucks. All shipping not been inspected and passed at an of- containers shall have both ends painted ficial establishment under the provi- with a durable paint, if necessary, to sions of this subchapter and is not ex- provide a contrasting background for empted from such inspection, and no the required marking. carcass, part of a carcass, fat or other (4) Such inedible rendered fat shall be meat food product that is adulterated transported only in sealed shipping or misbranded, shall be offered for containers bearing unofficial seals ap- transportation in commerce by any plied by the shipper, which shall in- person unless it is handled in accord- clude the identification number as- ance with paragraph (b), (c), (d), or (e) signed by said Director for the permit of this section or is denatured or other- holder. The number shall appear on the wise identified as prescribed in § 325.13, bill of lading or other transportation § 314.1, § 314.3, § 314.9, § 314.10, or § 314.11 documents for the shipment. The con- of this subchapter. signees in the United States must re- (b) Inedible rendered animal fats tain the seals in their records as pre- from official or other establishments in scribed in part 320 of this subchapter. the United States having the physical (5) Any diversion or effort to divert characteristics of a meat food product inedible rendered fat contrary to the fit for human food may be transported provisions of this paragraph (b) or in commerce without denaturing, if the other violation of the provisions of this following conditions are met: section may result in the revocation of (1) Such inedible rendered fat shall the permit for shipment of technical not be bought, sold, transported, or of- animal fat at the discretion of the Ad- fered for sale or offered for transpor- ministrator. tation in commerce, or imported, ex- (c) Inedible rendered animal fat de- cept by rendering companies, dealers, rived from condemned or other inedible brokers, or others who obtain a num- materials at official or other establish- bered permit for such activities from ments in the United States may be the Regional Director. transported in commerce if mixed with (2) Such inedible rendered animal fat low grade offal or other materials may be so distributed only if consigned which render the fat readily distin- to a domestic manufacturer of tech- guishable from an article of human nical articles other than for human food, and if the outside container bears food or to an export terminal for expor- the word ‘‘inedible.’’ tation or storage for exportation as an (d)(1) Except as provided in para- inedible article, and provided, in the graphs (d)(2), (3), and (4) of this section, case of such fat consigned to a domes- or in §§ 314.10 and 314.11 of this sub- tic manufacturer, the product is for use chapter, no animal food prepared, in
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whole or in part, from materials de- unit, whether stated on a single line or rived from the carcasses of livestock in more than one line, and the letters de- an official establishment or elsewhere, noting the article’s intended use for shall be bought, sold, transported, of- animal food are at least as high, wide, fered for sale or transportation, or re- and thick as the letters indicating the ceived for transportation, in com- presence of material derived from any merce, or imported, unless: livestock carcass. However, when the (i) It is properly identified as animal label bears on its principal display food; panel a vignette which pictures, in (ii) It is not represented as being a clearly recognizable form and size, one human food; and or more animals of the species for (iii) It has been denatured as pre- which the article’s name indicates the scribed in § 325.13(a)(2) so as to be read- article is intended, the letters used to ily distinguishable from an article of state the article’s intended use shall be human food. at least one-half as high, wide, and (2) Notwithstanding the provisions of thick as the letters used in the arti- paragraph (d)(1) of this section, an ani- cle’s name or other letters indicating mal food that consists of less than 5 percent of parts or products of the car- the presence of material derived from casses of livestock and that is not rep- any livestock carcass, but shall not be 1 resented by labeling or appearance or less than ⁄8 inches high. The letters otherwise as being a human food or as used to state the article’s intended use a product of the meat food industry may be separated from the article’s need not be denatured in accordance name by the vignette. with § 325.13(a)(2). (iii) Letters used to denote the in- (3) Notwithstanding the provisions of tended use of the article must contrast paragraph (d)(1) of this section, animal as markedly with their background as food packed in hermetically sealed, re- the letters indicating the presence in tort processed, conventional retail-size the article of livestock carcass-source containers, and retail-size packages of material contrast with their back- semi-moist animal food need not be de- ground. natured in accordance with § 325.13(a)(2) (4) The requirements of this part do if the name of the article clearly con- not apply to livestock or poultry feeds veys the article’s intended use for ani- manufactured from processed livestock mal food and appeared on the label in a byproducts (such as meat meal tank- conspicuous manner. age, meat and bone meal, blood meal, (i) Except as provided in paragraph and feed grade animal fat), or to proc- (ii) of paragraph (d)(3), the name of the essed dry animal food. article must be stated on the label as (e) Except for inedible rendered ani- ‘‘Animal Food,’’ ‘‘Pet Food,’’ or mal fats and lungs or lung lobes, ined- ‘‘(name of species) Food’’ (e.g., ‘‘Dog ible products (including condemned Food’’ or ‘‘Cat Food’’). To be consid- products only if condemned for causes ered conspicuous, the name of the arti- specified in § 314.11 of this subchapter) cle, wherever it appears on the label, must be in letters at least twice as which were prepared at any official es- high, wide, and thick as the letters in- tablishment, or at any State inspected dicating the presence in the article of establishment in any State not listed any ingredients derived from the car- in § 331.2 of this subchapter, and which casses of livestock. have the physical characteristics of a (ii) Notwithstanding the provisons of product fit for human food, may be paragraph (i) of this paragraph (d)(3), transported from an official establish- the article’s name may be stated on ment or in commerce, without denatur- the label to show that it is or contains ing as required by this subchapter, if livestock-source material and that the the following conditions are met: article is for animals; e.g., ‘‘Horsemeat (1) The shipper must have obtained a for Pets’’ or ‘‘Beef Stew for Dogs’’: Pro- numbered permit for such activity vided, That the entire name of the arti- from the appropriate Regional Direc- cle is stated, wherever it appears on tor, as identified in § 301.2 of this sub- the label, as an individual, contiguous chapter. Such permit may be obtained
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upon written application to the appro- or other violation of the provisions of priate Regional Director and his deter- this section may result in the revoca- mination that the proposed transpor- tion of the permit for shipment of ined- tation would be authorized under this ible products under this paragraph (e), paragraph (e). The application shall at the discretion of the Administrator. state the name and address of the ap- plicant, a description of the type of his [47 FR 17274, Apr. 22, 1982, as amended at 49 FR 47478, Dec. 5, 1984] business operations, and the purpose of making such application. § 325.12 [Reserved] (2) Such inedible products may be transported under this paragraph (e) § 325.13 Denaturing procedures. only if consigned to a manufacturer in the United States of articles other (a) Carcasses, parts thereof, meat and than for human food and if the product meat food products (other than ren- is for use solely by the consignee for dered animal fats) that have been manufacturing articles not for human treated in accordance with the provi- food. Such products may not be trans- sions of this paragraph shall be consid- ported in commerce to any consignee ered denatured for the purposes of the other than the one to which they were regulations in this part, except as oth- originally shipped unless prior notice erwise provided in part 314 of this sub- of the diversion is given to the appro- chapter for articles condemned at offi- priate Regional Director and a record cial establishments. identifying the new consignee is main- (1) The following agents are pre- tained by the shipper as required by scribed for denaturing carcasses, parts § 320.1 of this subchapter. thereof, meat or meat food products (3) When transported from an official which are affected with any condition establishment or in commerce under that would result in their condemna- this paragraph (e), the outside con- tion and disposal under part 314 of this tainer of such inedible products shall subchapter if they were at an official be marked conspicuously with the establishment: Crude carbolic acid; words ‘‘Inedible—Not Intended for cresylic disinfectant; a formula con- Human Food’’ in letters not less than 2 sisting of 1 part FD&C green No. 3 inches high, in the case of containers, coloring, 40 parts water, 40 parts liquid such as cartons, drums, tierces, bar- detergent, and 40 parts oil of citronella, rels, and half barrels, and not less than or other proprietary substance ap- 4 inches high in the case of tank cars proved by the Administrator in specific and trucks used to transport such prod- cases. 3 ucts not in other containers. (2) Except as provided in paragraphs (4) Such inedible products shall be (a)(3), (4), and (5) of this section, the transported from an official establish- following agents are prescribed for de- ment or in commerce under this para- naturing other carcasses, parts thereof, graph (e) only in railroad cars, trucks, meat and meat food products, for or containers which bear unofficial which denaturing is required by this seals applied by the shipper, which part: FD&C green No. 3 coloring; FD&C shall include the identification number blue No. 1 coloring; FD&C blue No. 2 assigned to the permit holder and an coloring; finely powdered charcoal; or individual seal serial number assigned other proprietary substance approved by the shipper; and the product so by the Administrator in specific cases. 3 transported shall be accompanied by an (3) Tripe may be denatured by dip- invoice or bill of lading specifying the ping it in a 6 percent solution of tannic permit holder’s identification number. acid for 1 minute followed by immer- The consignee in the United States sion in a water bath, then immersing it must retain a record of the identifica- tion and serial numbers shown on the 3 seals in his records as prescribed in Information as to approval of any propri- etary denaturing substance may be obtained part 320 of this subchapter. from the Technical Services, Meat and Poul- (5) Any diversion, or effort to divert, try Inspection, Food Safety and Inspection undenatured, inedible product contrary Service, U.S. Department of Agriculture, to the provisions of this paragraph (e) Washington, DC 20250.
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for 1 minute in a solution of 0.022 per- (b) Inedible rendered animal fats cent FD&C yellow No. 5 coloring; shall be denatured by thoroughly mix- (4) Meat may be denatured by dipping ing therein denaturing oil, No. 2 fuel it in a solution of 0.0625 percent tannic oil, brucine dissolved in a mixture of acid, followed by immersion in a water alcohol and pine oil or oil of rosemary, bath, then dipping it in a solution of finely powdered charcoal, or any pro- 0.0625 percent ferric acid; and prietary denaturing agent approved for (5) When meat, meat byproducts, or the purpose by the Administrator in meat food products are in ground form, specific cases. The charcoal shall be 4 percent by weight of coarsely ground used in no less quantity than 100 parts hard bone, which shall be in pieces no per million and shall be of such char- smaller than the opening size specified acter that it will remain suspended in- for No. 5 mesh in the standards issued definitely in the liquid fat. Sufficient by the U.S. Bureau of Standards or 6 of the chosen identifying agents shall percent by weight of coarsely ground be used to give the rendered fat so dis- hard bone, which shall be in pieces no tinctive a color, odor, or taste that it smaller than the opening size specified cannot be confused with an article of for No. 8 mesh in said Standards, uni- human food. formly incorporated with the product [35 FR 15605, Oct. 3, 1970, as amended at 41 FR may be used in lieu of the agents pre- 22930, June 8, 1976; 44 FR 67626, Nov. 27, 1979] scribed in paragraph (a)(2) of this sec- tion. § 325.14 Certificates, retention by car- (6) Before the denaturing agents are rier. applied to articles in pieces more than All original certificates delivered to 4 inches in diameter, the pieces shall a carrier in accordance with this part be freely slashed or sectioned. (If the shall be filed separate and apart from articles are in pieces not more than 4 all its other papers and records or iden- inches in diameter, slashing or section- tified in such a manner as to be readily ing will not be necessary.) The applica- checked by Department employees. tion of any of the denaturing agents Every certificate required to be main- listed in paragraph (a)(1) or (2) of this tained under this part shall be retained section to the outer surface of molds or for a period of 2 years after December blocks of boneless meat, meat byprod- 31 of the year in which the transaction ucts, or meat food products shall not has occurred. be adequate. The denaturing agent must be mixed intimately with all of § 325.15 Evidence of proper certifi- the material to be denatured, and must cation required on waybills; trans- be applied in such quantity and manner fer bills, etc., for shipment by con- that it cannot easily and readily be re- necting carrier; forms of statement. moved by washing or soaking. A suffi- (a) All waybills, transfer bills, run- cient amount of the appropriate agent ning slips, conductor’s cards, or other shall be used to give the material a dis- papers accompanying a shipment, in tinctive color, odor, or taste so that the course of importation or otherwise such material cannot be confused with in commerce, of any product shall have an article of human food. embodied therein, stamped thereon, or (7) Carcasses (other than viscera), attached thereto a signed statement parts thereof, cuts of meat, and which shall be evidence to connecting unground pieces of meat darkened by carriers that the proper shipper’s cer- charcoal or other black dyes shall be tificate, as required by § 325.5, § 325.6, or deemed to be denatured pursuant to § 325.7, is on file with the initial carrier. this section only if they contain at No connecting carrier shall receive for least that degree of darkness depicted transportation or transport in the by diagram 1 of the Meat Denaturing 1 Guide (MP Form 91). Minnesota 55403. Diagrams 2 and 3 of the Meat Denaturing Guide are for comparison 1 Copies of MP Form 91 may be obtained, purposes only. The Meat Denaturing Guide without charge, by writing to the Adminis- has been approved for incorporation by ref- trative Operations Branch, Food Safety and erence by the Director, Office of the FED- Inspection Service, U.S. Department of Agri- ERAL REGISTER, and is on file at the FEDERAL culture, 123 East Grant Street, Minneapolis, REGISTER library.
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course of importation or otherwise in And provided further, That the product commerce any product unless the way- is transported to and from such ware- bill, transfer bill, running slip, conduc- house, and under official seal as pro- tor’s card, or other papers accompany- vided in § 325.5 and stored in such ing the same includes the signed state- rooms at such warehouse. ment in the following form: ———————————————————————— § 325.18 Diverting of shipments, break- ing of seals, and reloading by car- (Name of transportation company) rier in emergency; reporting to Re- U.S. inspected and passed, as evidenced by gional Director. shipper’s certificate on file with initial car- rier. (a) Shipments of inspected and passed (signed) ——————————————————— product that bear the inspection legend Agent may be diverted from the original des- (b) Signatures of agents to state- tination without a reinspection of the ments required under this section shall articles, provided the waybills, transfer be written in full. bills, running slips, conductor’s card, or other papers accompanying the ship- [47 FR 17276, Apr. 22, 1982] ments are marked, stamped, or have § 325.16 Official seals; forms, use, and attached thereto signed statements in breaking. accordance with § 325.15. (b) In case of wreck or similar ex- (a) The official seals required by this traordinary emergency, the Depart- part shall be those prescribed in ment seals on a railroad car or other § 312.5(a) of this subchapter. means of conveyance containing any (b) Except as provided in § 325.18(b), inspected and passed product may be official seal affixed under this part broken by the carrier, and if necessary, shall be affixed or broken only by Pro- the articles may be reloaded into an- gram employees, and no person other other means of conveyance, or the than a Program employee shall affix, detach, break, change, or tamper with shipment may be diverted from the any such seal in any way whatever. original destination, without another Commission of any such acts contrary shipper’s certificate; but in all such to this regulation is a criminal offense. cases the carrier shall immediately re- port the facts by telephone or tele- § 325.17 Loading or unloading prod- graph to the Regional Director in the ucts in sealed railroad cars, trucks, area in which the emergency occurs. etc., en route prohibited; exception. Such report shall include the following Unloading any product from an offi- information: cially sealed railroad car, truck, or (1) Nature of the emergency. other means of conveyance containing (2) Place where seals were broken. any unmarked product or loading any (3) Original points of shipment and product or any other commodity in the destination. means of conveyance while en route (4) Number and initial of the original from one official establishment to an- car or truck. other official establishment is not per- (5) Number and initials of the car or mitted, except that product trans- truck into which the articles are re- ported under § 325.5 from one official es- loaded. tablishment to another for further (6) New destination of the shipment. processing may be unloaded and stored (7) Kind and amount of articles. in transit at any approved warehouse [35 FR 15605, Oct. 3, 1970, as amended at 42 FR which is operated under the identifica- 39087, Aug. 2, 1977] tion service provided under the regula- tions in part 350 of subchapter B of this § 325.19 Provisions inapplicable to chapter and which has railroad facili- specimens for laboratory examina- ties or a receiving dock for unloading tion, etc., or to naturally inedible the product directly into such ware- articles. house: Provided, That the product is The provisions of this part do not stored in rooms which are of such size apply: and type as will not result in adultera- (a) To specimens of product sent to tion or misbranding of the product: or by the Department of Agriculture or
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divisions thereof in Washington, DC, or the Federal requirements for purposes elsewhere, for laboratory examination, of paragraph 301(c) of the Act; 4 exhibition purposes, or other official (c) Buy in commerce or import any use; dead, dying, disabled, or diseased live- (b) To material released for edu- stock or parts of the carcasses of any cational, research and other nonfood livestock that died otherwise than by purposes, as prescribed in § 314.9 of this slaughter, unless he is an animal food subchapter; manufacturer or renderer and is reg- (c) To glands and organs for use in istered as required by part 320 of this preparing pharmaceutical, subchapter, or is the operator of an es- organotherapeutic, or technical prod- tablishment inspected as required by ucts and not used for human food, as paragraph (b) of this section and such described in § 318.1(g) of this sub- livestock or parts of carcasses are to be chapter; delivered to establishments eligible to (d) To material or specimens of prod- receive them under paragraph (b) of uct for laboratory examination, re- this section; search, or other nonhuman food pur- (d) Unload en route to any establish- poses, when authorized by the Adminis- ment eligible to receive them under trator, and under conditions prescribed paragraph (b) of this section, any dead, by him in specific cases; and dying, disabled, or diseased livestock (e) To articles that are naturally in- or parts of the carcasses of any live- edible by humans, such as hoofs, horns, stock that died otherwise than by and hides in their natural state. slaughter, which are transported in commerce or imported by any such per- § 325.20 Transportation and other son: Provided, That any such dead, transactions concerning dead, dying, disabled, or diseased livestock, dying, disabled, or diseased live- or parts of carcasses may be unloaded stock, and parts of carcasses of live- from a means of conveyance en route stock that died otherwise than by where necessary in case of a wreck or slaughter. otherwise extraordinary emergency, No person engaged in the business of and may be reloaded into another buying, selling, or transporting in com- means of conveyance; but in all such merce, or importing any dead, dying, cases, the carrier shall immediately re- disabled or diseased animals or parts of port the facts by telegraph or tele- the carcasses of any animals that died phone to the Compliance Staff, Meat otherwise than by slaughter shall: and Poultry Inspection Field Oper- (a) Buy, sell, transport, or offer for ations, Food Safety and Inspection sale or transportation, in commerce, or Service, U.S. Department of Agri- import any dead livestock if its hide or culture, Washington, DC 20250. skin has been removed; (e) Load into any means of convey- (b) Sell, transport, offer for sale or ance containing any dead, dying, dis- transportation, or receive for transpor- abled, or diseased livestock, or parts of tation, in commerce, any dead, dying, the carcasses of any livestock that died disabled, or diseased livestock, or parts otherwise than by slaughter, while in of the carcasses of any livestock that the course of importation or other died otherwise than by slaughter, un- transportation in commerce any live- less such livestock and parts are con- stock or parts of carcasses not within signed and delivered, without avoidable delay, to establishments of animal food 4 A list of such registrants, States, and manufacturers, renderers, or collection amendments thereof, will be published in the stations that are registered as required Federal Register, and information concern- by part 320 of this subchapter, or to of- ing the registration status of particular ani- ficial establishments that operate mal food manufacturers, renderers, or collec- under Federal inspection, or to estab- tion stations, or the status of particular lishments that operate under a State States or Territories may also be obtained or Territorial inspection system ap- from the Director, Administrative Manage- ment Staff, Food Safety and Inspection proved by the Secretary as one that Service, U.S. Department of Agriculture, imposes requirements at least equal to Washington, DC 20250.
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the foregoing description or any other 327.6 Products for importation; program in- products or other commodities. spection, time, and place; application for approval of facilities as official import [35 FR 15605, Oct. 3, 1970, as amended at 42 FR inspection establishment; refusal or 42309, Aug. 23, 1977] withdrawal of approval; official numbers. 327.7 Products for importation; movement § 325.21 Means of conveyance in which prior to inspection; handling; bond; as- dead, dying, disabled, or diseased sistance. livestock and parts of carcasses 327.8 Import products; equipment and thereof shall be transported. means of conveyance used in handling to All vehicles and other means of con- be maintained in sanitary condition. veyance used by persons subject to 327.9 Burlap wrapping for foreign meat. 327.10 Samples; inspection of consignments; § 325.20 for transporting in commerce or refusal of entry; marking. importing, any dead, dying, disabled, 327.11 Receipts to importers for import and diseased livestock or parts of car- product samples. casses of livestock that died otherwise 327.12 Foreign canned or packaged products than by slaughter shall be leak-proof bearing trade labels; sampling and in- and so constructed and equipped as to spection. permit thorough cleaning and sanitiz- 327.13 Foreign products offered for importa- ing. The means of conveyance so used tion; reporting of findings to customs; in conveying such livestock, or parts handling of articles refused entry. 327.14 Marking of products and labeling of thereof, shall be cleaned and dis- immediate containers thereof for impor- infected prior to use in the transpor- tation. tation of any product intended for use 327.15 Outside containers of foreign prod- as human food. The cleaning procedure ucts; marking and labeling; application shall include the complete removal of official inspection legend. from the means of conveyance of any 327.16 Small importations for importer’s fluid, parts, or product of such dead, own consumption; requirements. dying, disabled, or diseased livestock 327.17 Returned U.S. inspected and marked products. and the thorough application of a dis- 327.18 Products offered for entry and en- infectant to the interior surfaces of the tered to be handled and transported as cargo space. Substances permitted for domestic; exception. such use are: 327.19 Specimens for laboratory examina- (a) ‘‘Liquified phenol’’ (U.S.P. tion and similar purposes. strength 87 percent phenol) in the pro- 327.20 Importation of foreign inedible fats. portion of at least 6 fluid ounces to 1 327.21 Inspection procedures for chilled gallon of water. fresh and frozen boneless manufacturing meat. (b) ‘‘Cresylic disinfectant’’ in the pro- 327.22 [Reserved] portion of not less than 4 fluid ounces 327.23 Compliance procedure for cured pork to 1 gallon of water; and such other dis- products offered for entry. infectants as are approved by the Ad- 327.24 Appeals; how made. ministrator in specific cases. The use 327.25 Disposition procedures for product of ‘‘cresylic disinfectant’’ is permitted condemned or ordered destroyed under subject to the conditions prescribed in import inspection. § 71.10(b) of this title. 327.26 Official import inspection marks and devices.
AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, PART 327—IMPORTED PRODUCTS 2.53.
Sec. SOURCE: 35 FR 15610, Oct. 3, 1970, unless 327.1 Definitions; application of provisions. otherwise noted. 327.2 Eligibility of foreign countries for im- portation of products into the United § 327.1 Definitions; application of pro- States. visions. 327.3 No product to be imported without (a) When used in this part, the fol- compliance with applicable regulations. lowing terms shall be construed to 327.4 Imported products; foreign certificates mean: required. 327.5 Importer to make application for in- (1) Import (imported). To bring within spection of products for entry; informa- the territorial limits of the United tion required; ‘‘streamlined’’ inspection States whether that arrival is accom- procedures for Canadian product. plished by land, air, or water.
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(2) For product from eligible coun- § 327.2 Eligibility of foreign countries tries other than Canada: for importation of products into the (i) Offer(ed) for entry. The point at United States. which the importer presents the im- (a)(1) Whenever it shall be deter- ported product to the Program for rein- mined by the Administrator that the spection. system of meat inspection maintained (ii) Entry (entered). The point at by any foreign country, with respect to which imported product offered for establishments preparing products in entry receives reinspection and is such country for export to the United marked with the offical mark of in- States, insures compliance of such es- spection in accordance with § 327.26 of tablishments and their products with this subchapter. requirements equivalent to all the in- spection, building construction stand- (3) For product from Canada: ards, and all other provisions of the (i) Offer(ed) for entry from establish- Act and the regulations in this sub- ments participating in the ‘‘stream- chapter which are applied to official es- lined’’ inspection procedures. The point tablishments in the United States, and at which an official of the Canadian their products, and that reliance can be meat inspection system contacts the placed upon certificates required under Import Field Office for an inspection this part from authorities of such for- assignment. eign country, notice of that fact will be (ii) Offer(ed) for entry from non- given by including the name of such participating establishments. The foreign country in paragraph (b) of this point at which the importer presents section. Thereafter, products prepared the imported product to the Program in such establishments which are cer- for reinspection. tified and approved in accordance with (iii) Entry (entered) for product not paragraph (a)(3) of this section, shall be subject to reinspection. When the con- eligible so far as this subchapter is con- tainers or the products themselves if cerned for importation into the United not in containers are marked with the States from such foreign country after Canadian port stamp and upon the fil- applicable requirements of this sub- ing of Customs Form 7533 at the port of chapter have been met. (2) The determination of accept- entry or at the nearest customhouse in ability of a foreign meat inspection accordance with 19 CFR part 123. system for purposes of this section (iv) Entry (entered) for product sub- shall be based on an evaluation of the ject to reinspection. When the contain- foreign program in accordance with the ers or the products themselves if not in following requirements and procedures: containers are marked with the Cana- (i) The system shall have a program dian export stamp and the foreign in- organized and administered by the na- spection certificate accompanying the tional government of the foreign coun- product is stamped as ‘‘Inspected and try. The system as implemented must Passed’’ by the import inspector. provide standards equivalent to those (b) The provisions of this part shall of the Federal system of meat inspec- apply to products derived from cattle, tion in the United States with respect sheep, swine, goats, horses, mules, and to: other equines, if capable of use as (A) Organizational structure and human food. Compliance with the con- staffing, so as to insure uniform en- ditions for importation of products forcement of the requisite laws and under this part does not excuse the regulations in all establishments need for compliance with applicable re- throughout the system at which prod- quirements under other laws, including ucts are prepared for export to the United States; the provisions in parts 94, 95, and 96 of (B) Ultimate control and supervision chapter I of this title. by the national government over the [35 FR 15610, Oct. 3, 1970, as amended at 36 FR official activities of all employees or 12004, June 24, 1971; 54 FR 41048, Oct. 5, 1989] licensees of the system;
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(C) The assignment of competent, (G) Official controls over condemned qualified inspectors; material until destroyed or removed (D) Authority and responsibility of and thereafter excluded from the estab- national inspection officials to enforce lishment; the requisite laws and regulations gov- (H) A Hazard Analysis and Critical erning meat inspection and to certify Control Point (HACCP) system, as set or refuse to certify products intended forth in part 417 of this chapter. for export; (I) Other matters for which require- (E) Adequate administrative and ments are contained in the Act or regu- technical support; lations in this subchapter. (F) The inspection, sanitation, qual- (iii) Countries desiring to establish ity, species verification, and residue eligibility for importation of product standards applied to products produced into the United States may request a in the United States. determination of eligibility by present- (G) Other requirements of adequate ing copies of the laws and regulations inspection service as required by the on which the foreign meat inspection regulations in this subchapter. system is based and such other infor- mation as the Administrator may re- (ii) The legal authority for the sys- quire with respect to matters enumer- tem and the regulations thereunder ated in paragraphs (a)(2) (i) and (ii) of shall impose requirements equivalent this section. Determination of eligi- to those governing the system of meat bility is based on a study of the docu- inspection organized and maintained in ments and other information presented the United States with respect to: and an initial review of the system in (A) Ante-mortem inspection of ani- operation by a representative of the mals for slaughter and inspection of Department using the criteria listed in methods of slaughtering and handling paragraphs (a)(2) (i) and (ii) of this sec- in connection with slaughtering which tion. Maintenance of eligibility of a shall be performed by veterinarians or country for importation of products by other employees or licensees of the into the United States depends on the system under the direct supervision of results of periodic reviews of the for- the veterinarians; eign meat inspection system in oper- (B) Post-mortem inspection of car- ation by a representative of the De- casses and parts thereof at time of partment, and the timely submission of slaughter, performed by veterinarians such documents and other information or other employees or licensees of the related to the conduct of the foreign system under the direct supervision of inspection system, including informa- veterinarians; tion required by paragraph (e) of sec- (C) Official controls by the national tion 20 of the Act, as the Administrator government over establishment con- may find pertinent to and necessary for struction, facilities, and equipment; the determinations required by this (D) Direct and continuous official su- section of the regulations. pervision of slaughtering and prepara- (iv) The foreign inspection system tion of product, by the assignment of must maintain a program to assure inspectors to establishments certified that the requirements referred to in under paragraph (a)(3) of this section, this section, equivalent to those of the to assure that adulterated or mis- Federal system of meat inspection in branded product is not prepared for ex- the United States, are being met. The port to the United States; program as implemented must provide (E) Complete separation of establish- for the following: ments certified under subparagraph (3) (A) Periodic supervisory visits by a of this paragraph from establishments representative of the foreign inspection not certified and the maintenance of a system not less frequent than one such single standard of inspection and sani- visit per month to each establishment tation throughout all certified estab- certified in accordance with paragraph lishments; (a)(3) of this section to assure that re- (F) Requirements for sanitation at quirements referred to in (A) through certified establishments and for sani- (H) of paragraph (a)(2)(ii) of this sec- tary handling of product; tion are being met: Provided, That such
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visits are not required with respect to establishment for importation of its any establishment during a period products into the United States if he when the establishment is not operat- has information that such establish- ing or is not engaged in producing ment does not comply with the require- products for exportation to the United ments listed in paragraphs (a)(2) (i) and States; (ii) of this section or if he cannot ob- (B) Written reports prepared by the tain current information concerning representative of the foreign inspection such establishment. The Administrator system who has conducted a super- will provide reasonable notice to the visory visit, documenting his or her foreign government of the proposed findings with respect to the require- termination of eligibility of any for- ments referred to in (A) through (H) of eign establishment for importation of paragraph (a)(2)(ii) of this section, cop- its products into the United States un- ies of which shall be made available to less, in his judgment, delay in termi- the representative of the Department nating its eligibility could result in the at the time of that representative’s re- importation of adulterated or mis- view upon request by that representa- branded product. Certifications of offi- tive to a responsible foreign meat in- cial establishments by the responsible spection official: Provided, That such official of the foreign meat inspection reports are not required with respect to system shall be in the following form: any establishment during a period when the establishment is not operat- FOREIGN OFFICIAL MEAT ESTABLISHMENT ing or is not engaged in producing CERTIFICATE products for exportation to the United I hereby certify that the establishment(s) States; and listed below fully comply (complies) with re- (C) Random sampling of internal or- quirements of (specify foreign country) gans and fat of carcasses at the point equivalent to all the inspection, building construction standards, and other require- of slaughter and the testing of such or- ments for the slaughter and preparation of gans and fat, for such residues having the carcasses, parts thereof, meat and meat been identified by the exporting coun- food products of cattle, sheep, swine, goats, try’s meat inspection authorities or by and equines applied to official establish- this Agency as potential contaminants, ments in the United States under the Fed- in accordance with sampling and ana- eral Meat Inspection Act and otherwise meet lytical techniques approved by the Ad- (meets) the requirements of § 327.2(a) of the ministrator: Provided, That such test- regulations governing meat inspection of the U.S. Department of Agriculture. ing is required only on samples taken from carcasses from which meat or Control numbers Name Address!!rsr meat food products intended for impor- tation into the United States are pro- duced. (3) Only those establishments that are determined and certified to the De- partment by a responsible official of Date ————————————————————— the foreign meat inspection system as Signature ————————————————— fully meeting the requirements of Official Title ——————————————— paragraphs (a)(2) (i) and (ii) of this sec- tion are eligible to have their products (4) Product of cattle, sheep, swine, imported into the United States. Eligi- and goats from foreign countries not bility of certified establishments is listed in paragraph (b) of this section subject to review by the Department and product of equines from countries (including observations of the estab- not listed in paragraph (c) of this sec- lishments by Program representatives tion is not eligible for importation into at times prearranged with the officials the United States, except as provided of the foreign meat inspection system). by § 327.16 or § 327.17. The listing of any Certifications of establishments must foreign country under this section may be renewed annually. Notwithstanding be withdrawn whenever it shall be de- certification by a foreign official, the termined by the Administrator that Administrator may, at his discretion, the system of meat inspection main- terminate the eligibility of any foreign tained by such foreign country does
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not assure compliance with require- Sections Affected in the Finding Aids sec- ments equivalent to all the inspection, tion of this volume. building construction standards, and other requirements of the Act and the § 327.3 No product to be imported regulations in this subchapter as ap- without compliance with applicable plied to official establishments in the regulations. United States; or that reliance cannot (a) No product offered for importa- be placed upon certificates required tion from any foreign country shall be under this part from authorities of admitted into the United States if it is such foreign country; or that, for lack adulterated or misbranded or does not of current information concerning the comply with all the requirements of system of meat inspection being main- this subchapter that would apply to it tained by such foreign country, such if it were a domestic product. foreign country should be required to (b) No cooked or partially cooked reestablish its eligibility for listing. meat or meat trimmings, either in sep- (b) It has been determined that prod- arable pieces or molded into larger uct of cattle, sheep, swine, and goats forms, shall be permitted entry except from the following countries covered by foreign meat inspection certificates under the following conditions: of the country of origin as required by (1) A complete procedure for prepar- § 327.4, except fresh, chilled, or frozen ing and handling the product in the or other product ineligible for importa- foreign country and en route to the tion into the United States from coun- United States shall be submitted by tries in which the contagious and com- the exporter or his authorized agent to municable disease of rinderpest or of the Administrator and determined by foot-and-mouth disease or of African the Administrator to be adequate to swine fever exists as provided in part 94 assure that the product will not be of this title, is eligible under the regu- adulterated or misbranded at the time lations in this subchapter for entry of offer for entry. into the United States after inspection (2) A system acceptable to the Ad- and marking as required by the appli- ministrator (upon his determination cable provisions of this part. that the system will provide a reliable Argentina, Australia, Austria, Belgium, indication of the kinds and numbers of Belize, Brazil, Canada, Costa Rica, Czech microorganisms present) for the micro- Republic, Denmark, Dominican Republic, biological testing of the finished prod- El Salvador, England and Wales, Finland, uct shall be installed by the processor, France, Germany (Federal Republic), Gua- temala, Honduras, Hungary, Iceland, Ire- the product is subjected to such test- land (Eire), Italy, Japan, Mexico, Nether- ing, and the results thereof are fur- lands, New Zealand, Nicaragua, Northern nished to the Administrator and are Ireland, Norway, Paraguay, Poland, Repub- acceptable to him as showing that the lic of China, (Taiwan), Republic of Croatia, product has been prepared and handled Republic of Slovenia, Romania, Scotland, in a sanitary manner. Spain, Sweden, Switzerland, Uruguay, Ven- ezuela, Yugoslavia. (c) [Reserved] (c) It has been determined that prod- [35 FR 15610, Oct. 3, 1970, as amended at 38 FR uct of equines from the following coun- 29215, Oct. 23, 1973; 54 FR 41048, Oct. 5, 1989; 56 tries, covered by foreign meat inspec- FR 38335, Aug. 13, 1991; 57 FR 27906, June 23, tion certificates of the country of ori- 1992] gin as required by § 327.4, is eligible § 327.4 Imported products; foreign cer- under the regulations in this sub- tificates required. chapter for importation into the United States after inspection and (a) Except as provided in § 327.16, each marking as required by the applicable consignment containing any fresh provisions of this part. meat or fresh meat byproducts con- signed to the United States from a for- Argentina, Canada, New Zealand, Paraguay. eign country shall be accompanied by a [35 FR 15610, Oct. 3, 1970] foreign-meat-inspection certificate for EDITORIAL NOTE: For FEDERAL REGISTER fresh meat and meat byproducts in the citations affecting § 327.2, see the List of CFR following form:
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ORIGINAL of their products into the United States, were handled in a sanitary manner, and were OFFICIAL MEAT-INSPECTION CERTIFICATE FOR prepared under the continuous supervision of FRESH MEAT AND MEAT BYPRODUCTS an inspector under control of the national Place —————— (City) —————— (Coun- meat inspection system and that said meat try) Date ——— food products are not adulterated or mis- branded as defined by the regulations gov- I hereby certify that the meat and meat erning meat inspection of the U.S. Depart- byproducts herein described were derived ment of Agriculture, and are otherwise in from livestock which received ante-mortem compliance with requirements equivalent to and post-mortem veterinary inspections at those in the Federal Meat Inspection Act and time of slaughter in plants certified for im- said regulations. portation of their products into the United States and are not adulterated or mis- I further certify that all products herein branded as defined by the regulations gov- described that are prepared customarily to erning meat inspection of the U.S. Depart- be eaten without cooking and contain mus- ment of Agriculture; and that said products cle tissue of pork were treated for destruc- have been handled in a sanitary manner in tion of trichnae as prescribed in § 318.10 of this country and are otherwise in compliance the Meat Inspection Regulations of the U.S. with requirements equivalent to those in the Department of Agriculture. Federal Meat Inspection Act and said regula- Species of live- Number of tions. Kind of product stock derived pieces or Weight from containers Species of live- Number of Kind of product stock derived pieces or Weight from containers
Identification marks on products and con- tainers —————————————————— Identification marks on products and con- tainers —————————————————— Consignor —————————————————— Address ——————————————————— Consignor —————————————————— Establishment number ——————————— Address ——————————————————— Consignee —————————————————— Establishment number ——————————— Destination ————————————————— Consignee —————————————————— Shipping marks ——————————————— Destination ————————————————— (Signature) ————————————————— Shipping marks ——————————————— (Signature) ————————————————— (Name of official authorized by the national (Name of official authorized by the national foreign government to issue inspection cer- foreign government to issue inspection cer- tificates for meat food product exported to tificates for meat and meat byproducts ex- the United States) ported to the United States) (Official title) ———————————————— (Official title) ———————————————— (c) Each foreign meat-inspection cer- (b) Except as provided in § 327.16, each tificate shall bear the official seal of consignment containing any meat food the national government agency re- product consigned to the United States sponsible for the inspection of the from a foreign country shall be accom- product and be signed and issued by an panied by a foreign-meat-inspection official authorized to sign and issue certificate for meat food products in such certificates by the national gov- the following form: ernment of the foreign country in which the product is inspected. ORIGINAL (d) Each foreign meat-inspection cer- OFFICIAL MEAT-INSPECTION CERTIFICATE FOR tificate shall be in both the English MEAT FOOD PRODUCTS language and the language of the for- eign country of origin. Place —————— (City) —————— (Coun- try) —————— Date ——— (e) Except for product subject to pro- cedures in § 327.5(d)(l), the foreign meat I hereby certify that the meat food prod- ucts herein described were derived from live- inspection certificate required by this stock which received ante-mortem and post- section to accompany each consign- mortem veterinary inspections at time of ment containing any product shall be slaughter in plants certified for importation delivered by the consignee, or his
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agent, in the United States to the Pro- (2) If the AIIS designates the consign- gram import inspector at the place of ment for reinspection, the representa- inspection, and inspection of the prod- tive shall: uct will not be commenced prior to (i) Select samples in accordance with such delivery. USDA sampling tables.3 (ii) Identify and place samples in the [35 FR 15610, Oct. 3, 1970, as amended at 54 FR 274, Jan. 5, 1989; 60 FR 38668, July 28, 1995] vehicle for easy removal and reinspec- tion by an import inspector. § 327.5 Importer to make application (3) In the event that any one of the for inspection of products for entry; requirements provided in (d)(2) of this information required; ‘‘streamlined’’ section is not met, reinspection of the inspection procedures for Canadian consignment shall be conducted by a product. Program import inspector in accord- (a) Except for importers of Canadian ance with established procedures pro- products, each importer shall apply for vided in the regulations for other im- inspection of any product offered for ported products. entry by contacting the Import Field [54 FR 274, Jan. 5, 1989, as amended at 54 FR Office covering the location where im- 41048, Oct. 5, 1989] port inspection will take place. The Import Field Office will provide spe- § 327.6 Products for importation; pro- cific application instructions (See gram inspection, time and place; § 301.2 (yyy)). application for approval of facilities as official import inspection estab- (b) The application should be made as lishment; refusal or withdrawal of long as possible in advance of the an- approval; official numbers. ticipated arrival of each consignment, except in case of consignments of prod- (a)(1) Except as provided in ucts expressly exempted from inspec- §§ 327.5(d)(1), 327.16 and 327.17, all prod- ucts offered for entry from any foreign tion by §§ 327.16 and 327.17, and in the country shall be reinspected by a Pro- case of product imported from Canada. gram inspector before they shall be al- (c) Except in the case of product im- lowed entry into the United States. ported from Canada, each application (2) Every lot of product shall rou- shall state the approximate date on tinely be given visual inspection by a which the consignment is due to arrive Program import inspector for appear- at such port in the United States, the ance and condition, and checked for name of the ship or other carrier trans- certification and label compliance, ex- porting it, the name of the country cept as provided in 327.5(d)(1). from which the product was, or is to (3) The computerized Automated Im- be, shipped, the place where inspection port Information System (AIIS) shall is desired in accordance with § 327.6, the be consulted for reinspection instruc- quantity and kind of product, and tions. The AIIS will assign reinspection whether it is fresh, cured, canned or levels and procedures based on estab- otherwise prepared. In case of consign- lished sampling plans or established ments arriving in the United States by sampling plans and established product water, the application shall also state and plant history. the port of first arrival in the United (4) When the inspector deems it nec- States. essary, the inspector may sample and (d) For participating Canadian estab- inspect lots not designated by AIIS. lishments, an official of the Canadian (b) All products, required by this part meat inspection system shall contact to be inspected, shall be inspected only the participating Import Field Office at an official establishment or at an of- for an inspection assignment (See ficial import inspection establishment § 301.2 (yyy)). (1) If the Automated Import Informa- 3 A copy of the sampling tables is available, tion System (AIIS) does not designate upon request, from the Import Inspection Di- the consignment for reinspection, the vision, International Programs, Food Safety consignment may be transported to its and Inspection Service, U.S. Department of consignee for further distribution. Agriculture, Washington, DC 20250.
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approved by the Administrator as pro- termined that the establishment does vided in this section. Such approved of- not meet such requirements, approval ficial import inspection establishments of the establishment as an official im- will be listed in the Directory of Meat port inspection establishment may be and Poultry Inspection Program Estab- refused in accordance with the applica- lishments, Circuits and Officials, pub- ble rules of practice. A written notice, lished by the Food Safety and Inspec- specifying the premises to which the tion Service. The listing will cat- approval applies, shall be given to each egorize the kind or kinds of product 2 applicant granted approval. When ap- which may be inspected at each official proval is refused for any such reason, import inspection establishment, based the applicant shall be informed of the on the adequacy of the facilities for action and the reason therefor. Ap- making such inspections and handling proval may also be refused in accord- such products in a sanitary manner. ance with section 401 of the act and ap- (c) Owners or operators of establish- plicable rules of practice. ments, other than official establish- (g) Approval of an official import in- ments, who want to have import in- spection establishment may be with- spections made at their establish- drawn in accordance with applicable ments, shall apply to the Adminis- rules of practice if it is determined trator for approval of their establish- that the sanitary conditions are such ments for such purpose. Application that the product is rendered adulter- shall be made on a form furnished by ated, that such action is authorized by the Program, Food Safety and Inspec- section 21(b) of the Federal Water Pol- tion Service, U.S. Department of Agri- lution Control Act, as amended (84 culture, Washington, DC, and shall in- Stat. 91), or that the requirements of clude all information called for by that paragraph (e) of this section were not form. complied with. Approval may also be (d) Approval for Federal import in- withdrawn in accordance with section spection shall be in accordance with 401 of the Act and applicable rules of part 304 of this subchapter. practice. (e) Owners or operators of establish- (h) A special official number shall be ments at which import inspections of assigned to each official import inspec- product are to be made shall furnish tion establishment. Such number shall adequate sanitary facilities and equip- be used to identify all products in- ment for examination of such product. spected and passed for entry at the es- The requirements of §§ 304.2(e), 307.1, tablishment. 307.2 (b), (d), (f), (h), (k), and (l) and (i) A sampling inspection shall be 308.3, 308.4, 308.5, 308.6, 308.7, 308.8, 308.9, made, as provided in paragraph (a) of 308.11, 308.13, 308.14, and 308.15 of this this section, of foreign chilled fresh or subchapter shall apply as conditions frozen fresh meat, including defrosting for approval of establishments as offi- if necessary to determine its condition. cial import inspection establishments Inspection standards for foreign chilled to the same extent and in the same fresh or frozen fresh meat shall be the manner as they apply with respect to same as those used for domestic chilled official establishments. fresh or frozen fresh meat. (See § 327.21) (f) The Administrator is authorized (j) Imported canned products are re- to approve any establishment as an of- quired to be sound, healthful, properly ficial import inspection establishment labeled, wholesome, and otherwise not provided that an application has been adulterated at the time the products filed and drawings have been submitted are offered for importation into the in accordance with the requirements of United States. Provided other require- paragraphs (c) and (d) of this section ments of this part are met, the deter- and he determines that such establish- mination of the acceptability of the ment meets the requirements under product and the condition of the con- paragraph (e) of this section. If it is de- tainers shall be based on the results of an examination of a statistical sample 1 [Reserved] drawn from the consignment as pro- 2 For example: Canned product, boneless vided in paragraph (a) of this section. If meat, carcasses and cuts. the inspector determines, on the basis
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of the sample examination, that the § 327.7 Products for importation; product does not meet the require- movement prior to inspection; han- ments of the Act and regulations there- dling; bond; assistance. under, the consignment shall be re- (a) No product required by this part fused entry. However, a consignment to be inspected shall be moved, prior to rejected for container defects but oth- inspection from any port, or, if arriv- erwise acceptable may be reoffered for ing by water from the wharf where first inspection under the following condi- unloaded, to any place other than the tions: place designated by, or in accordance (1) If the defective containers are not with, this part as the place where the indicative of an unsafe and unstable same shall be inspected. product as determined by the Adminis- (b) No product required by this part trator; to be inspected shall be conveyed, prior (2) If the number and kinds of con- to inspection, from any port, or, if ar- tainer defects found in the original riving by water, from the wharf where sample do not exceed the limits speci- first unloaded, in any manner other than in compliance with this part. fied for this purpose in FSIS guide- (c) No product required by this part lines; and to be inspected shall be delivered to (3) If the defective containers in the the consignee or his agent prior to in- consignment have been sorted out and spection, unless the consignee shall exported or destroyed under the super- furnish a bond, in form prescribed by vision of an inspector. the Secretary of the Treasury, condi- (k) Program inspectors or Customs tioned that the product shall be re- officers at border or seaboard ports turned, if demanded, to the collector of shall report the sealing of cars, trucks, the port where the same is offered for or other means of conveyance, and the clearance through the customs. sealing or identification of containers (d) The consignee or his agent shall of foreign product on Form MP–410 to provide such assistance as Program in- Program area supervisors at points spectors may require for the handling where such product is to be inspected. and marking of product offered for (l) Representative samples of canned entry. product designated by the Adminis- [35 FR 15610, Oct. 3, 1970, as amended at 37 FR trator in instructions to inspectors 21928, Oct. 17, 1972; 51 FR 37707, Oct. 24, 1986; shall be incubated under supervision of 56 FR 65180, Dec. 16, 1991] such inspectors in accordance with § 318.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), § 327.8 Import products; equipment (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of and means of conveyance used in handling to be maintained in sani- this subchapter. The importers or his/ tary condition. her agent shall provide the necessary Compartments of steamships, sailing incubation facilities in accordance vessels, railroad cars, and other means with § 318.309(d)(1)(i) of this subchapter. of conveyance transporting any prod- (m) Sampling plans and acceptance uct to the United States, and all levels as prescribed in paragraphs (j) trucks, chutes, platforms, racks, ta- and (l) of this section may be obtained, bles, tools, utensils, and all other de- upon request, from International Pro- vices used in moving and handling any grams, Food Safety and Inspection product offered for importation into Service, U.S. Department of Agri- the United States, shall be maintained culture, Washington, DC 20250. in a sanitary condition.
[35 FR 15610, Oct. 3, 1970, as amended at 37 FR § 327.9 Burlap wrapping for foreign 21927, Oct. 17, 1972; 38 FR 29215, Oct. 23, 1973; meat. 49 FR 36818, Sept. 20, 1984; 51 FR 37707, Oct. 24, 1986; 51 FR 45633, Dec. 19, 1986; 54 FR 274, Burlap shall not be used as a wrap- Jan. 5, 1989; 54 FR 41048, Oct. 5, 1989; 62 FR ping for foreign meat unless the meat 45026, Aug. 25, 1997] is first wrapped with a good grade of
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paper or cloth of a kind which will pre- form of a letter and shall include the vent contamination with lint or other following: foreign material. (i) That stamping under this part will be limited to those lots of product § 327.10 Samples; inspection of con- which can be inspected on the day that signments; refusal of entry; mark- certificates for the product are exam- ing. ined; (a) Program inspectors may take, (ii) That all product which has been without cost to the United States, for pre-stamped will be stored in the facil- laboratory examination, samples of ity where the import inspection will any product which is subject to analy- occur; sis, from each consignment offered for (iii) That inspection marks applied importation, except that such samples under this part will be removed from shall not be taken of any product of- any lot of product subsequently refused fered for importation under § 327.16. entry on the day the product is re- (b) Except for product offered for jected; and entry from Canada, the outside con- (iv) That the establishment will tainers of all products offered for entry maintain a daily stamping log contain- from any foreign country and accom- ing the following information for each panied with a foreign inspection cer- lot of product: the date of inspection, tificate as required by this part, which, the country of origin, the foreign es- upon reinspection by import inspectors tablishment number, the product are found not to be adulterated or mis- name, the number of units, the ship- branded and are otherwise eligible for ping container marks, and the MP–410 entry into the United States under this number covering the product to be in- part, or the products themselves if not spected. The daily stamping log must in containers, shall be marked with the be retained by the establishment in ac- official inspection legend prescribed in cordance with the requirements of § 327.26 of this part. Except for Cana- § 320.3. (2) An establishment’s controlled pre- dian product, all other products so stamping privilege may be cancelled marked, in compliance with this part, orally or in writing by the inspector shall be entered into the United States, who is supervising its enforcement insofar as such entry is regulated whenever the inspector finds that the under the Act. establishment has failed to comply (c) Product which is inspected and re- with the provisions of this part or any jected shall be marked ‘‘U.S. Refused conditions imposed pursuant thereto. If Entry’’ as shown in § 327.26(c). Such the cancellation is oral, the decision marks shall be applied to the shipping and the reasons therefor shall be con- container or the product itself if not in firmed in writing, as promptly as cir- a container. cumstances allow. Any person whose (d) The inspection legend may be controlled pre-stamping privilege has placed on containers of product before been cancelled may appeal the decision completion of official import inspec- to the Administrator, in writing, with- tion if the containers are being in- in ten (10) days after receiving written spected by an import inspector who re- notification of the cancellation. The ports directly to an Import Field Office appeal shall state all of the facts and Supervisor; the product is not required reasons upon which the person relies to to be held at the establishment pending show that the controlled pre-stamping the receipt of laboratory test results; privilege was wrongfully cancelled. The and a written procedure for controlled Administrator shall grant or deny the stamping, submitted by the import es- appeal, in writing, stating the reasons tablishment and approved by the Direc- for such decision, as promptly as cir- tor, Import Inspection Division, is on cumstances allow. If there is a conflict file at the import inspection facility as to any material fact, a hearing shall where the inspection is to be per- be held to resolve such conflict. Rules formed. of practice concerning such a hearing (1) The written procedure for con- will be adopted by the Administrator. trolled pre-stamping should be in the The cancellation of the controlled pre-
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stamping privilege will be in effect ucts as required by § 327.6 (a) and (j) of until there is a final determination of this part. the proceeding. [35 FR 15610, Oct. 3, 1970, as amended at 49 FR (Approved by the Office of Management and 36818, Sept. 20, 1984] Budget under control number 0583–0015) § 327.13 Foreign products offered for [35 FR 15610, Oct. 3, 1970, as amended at 53 FR importation; reporting of findings 17014, May 13, 1988; 54 FR 41048, Oct. 5, 1989] to customs; handling of articles re- fused entry. § 327.11 Receipts to importers for im- (a)(1) Program inspectors shall report port product samples. their findings as to any product which In order that importers may be as- has been inspected in accordance with sured that samples of foreign products this part, to the Director of Customs at collected for laboratory examination the original port of entry where the are to be used exclusively for that pur- same is offered for clearance through pose, official receipts shall be issued Customs inspection. and delivered to importers, or their (2) When product has been identified agents, by inspectors for all samples of as ‘‘U.S. refused entry, ’’ the inspector foreign products collected. The official shall request the Director of Customs receipt shall be prepared in duplicate, to refuse admission to such product over the signature of the inspector who and to direct that it be exported by the collects the samples, and shall show owner or consignee within the time the name of the importer, country of specified in this section, unless the origin, quantity and kind of product owner or consignee, within the speci- collected, date of collection, and that fied time, causes it to be destroyed by the sample was collected for laboratory disposing of it under the supervision of examination. The duplicate copy of the a Program employee so that the prod- receipt shall be retained by the inspec- uct can no longer be used as human tors as their office record. food, or by converting it to animal food [35 FR 15610, Oct. 3, 1970, as amended at 51 FR uses, if permitted by the Food and 37707, Oct. 24, 1986] Drug Administration. The owner or consignee of the refused entry product § 327.12 Foreign canned or packaged shall not transfer legal title to such products bearing trade labels; sam- product, except to a foreign consignee pling and inspection. for direct and immediate exportation, (a) Samples of foreign canned or or to an end user, e.g., an animal food packaged products bearing on their im- manufacturer or a renderer, for de- mediate containers trade labels which struction for human food purposes. have not been approved under § 317.3 of ‘‘Refused entry’’ product must be deliv- this subchapter shall be collected and ered to and used by the manufacturer forwarded to the laboratory by the or renderer within the 45-day time Program inspector for examination, limit. Even if such title is illegally and the products shall be held pending transferred, the subsequent purchaser receipt of the report of the laboratory will still be required to export the findings and the results of the exam- product or have it destroyed as speci- ination of trade labels and the marks fied in the notice under paragraph on shipping containers. (a)(5) of this section. (b) Foreign canned or packaged prod- (3) No lot of product which has been ucts bearing trade labels and other refused entry may be subdivided during markings which have been approved disposition pursuant to paragraph under § 317.3 of this subchapter shall be (a)(2) of this section, except that re- inspected for soundness and checked moval and destruction of any damaged for net weight. Samples may be col- or otherwise unsound product from a lected for laboratory examination, but lot destined for reexportation is per- the products may be released under mitted under supervision of USDA customs’ bond pending the report of prior to exportation. Additionally, laboratory findings. such refused entry lot may not be (c) Samples shall be taken from for- shipped for export from any port other eign canned products or packaged prod- than that through which the product
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came into the United States, without quently designated ‘‘U.S. Refused the expressed consent of the Adminis- Entry’’ or found in any respect not to trator based on full information con- comply with the requirements in this cerning the product’s disposition, in- part. cluding the name of the vessel and the (c) All charges for storage, cartage, date of export. For the purposes of this and labor with respect to any product paragraph, the term ‘‘lot’’ shall refer which was imported contrary to the to that product indentified on MP Act shall be paid by the owner or con- Form 410 in the original request for in- signee, and in default of such payment spection for importation pursuant to shall constitute a lien against such § 327.5. product and any other product there- (4) Product which has been refused after imported by or for such owner or entry solely because of misbranding, in consignee. lieu of exportation or destruction pur- [35 FR 15610, Oct. 3, 1970, as amended at 48 FR suant to paragraph (a)(2) of this sec- 15889, Apr. 13, 1983; 49 FR 29568, July 23, 1984; tion, may be brought into compliance 50 FR 19907, May 13, 1985; 53 FR 17015, May 13, with the requirements of this part, 1988; 54 FR 50735, Dec. 11, 1989] under supervision of an authorized rep- resentative of the Administrator. § 327.14 Marking of products and la- (5) The owner or consignee shall have beling of immediate containers 45 days after notice is given by FSIS to thereof for importation. the Director of Customs at the original (a) Product which is offered for im- port of entry to take the action re- portation, and which is susceptible of quired in paragraph (a)(2) of this sec- marking, shall, whether or not en- tion for ‘‘refused entry’’ product. Ex- closed in an immediate container, bear tension beyond the 45-day period may the name of the country of origin, pre- be granted by the Administrator when ceded by the words ‘‘product of’’; the extreme circumstances warrant it; e.g., establishment number assigned by the a dock workers’ strike or an unforesee- foreign meat inspection system and able vessel delay. certified to the Program; and such (6) If the owner or consignee fails to other markings as are necessary for take the required action within the compliance with part 316 of this sub- time specified under paragraph (a)(5) of chapter. When such markings are im- this section, the Department will take prints of stamps or brands made with such action as may be necessary to ef- branding ink, such ink shall be harm- fectuate its order to have the product less and shall create permanent im- destroyed for human food purposes. prints. In case the name of the country The Department shall seek court costs of origin appears as part of an official and fees, storage, and proper expense in mark of the national foreign govern- the appropriate legal forum. ment and such name is prominently (7) No product which has been refused and legibly displayed, the words ‘‘prod- entry and exported to another country uct of’’ may be omitted. pursuant to paragraph (a)(2) of this sec- (b) In addition to the marking of tion may be returned to the United products required under paragraph (a) States under any circumstance. Any of this section, the immediate con- such product so returned to the United tainer of any product offered for impor- States shall be subject to administra- tation: tive detention in accordance with sec- (1) Shall bear a label showing in ac- tion 402 of the Act and seizure and con- cordance with § 317.2 of this subchapter demnation in accordance with section all information required by that sec- 403 of the Act. tion (except that the establishment (b) Upon the request of the Director number assigned by the foreign meat of Customs at the port where a product inspection system and certified to the is offered for clearance through the Program and the official inspection customs, the consignee of the product mark of the foreign meat inspection shall, at the consignee’s own expense, system shall be shown instead of the immediately return to the Director official inspection legend of the United any product which has been delivered States) and in addition the name of the to consignee under § 327.7 and subse- country of origin preceded by the
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words ‘‘product of,’’ immediately under (2) The name of the country of origin; the name or descriptive designation of and the product as required by § 317.2: Pro- (3) The establishment number as- vided, That such establishment number signed by the foreign meat inspection may be omitted from a label system and certified to the Program. lithographed directly on a can if said (b) All labeling used with an outside number is lithographed or embossed container of foreign product must be elsewhere on the can; and approved in accordance with part 317 of (2) Shall, if such immediate con- this subchapter. tainer is a sealed metal container, have (c) Except for product offered for the establishment number assigned by entry from Canada, all outside contain- the foreign meat inspection authority ers of products which have been in- and certified by the Program embossed spected and passed in accordance with or lithographed on the sealed metal this part shall be marked by a Program container, and such establishment import inspector or under a Program number shall not be covered or ob- import inspector’s supervision with the scured by any label or other means. official import meat inspection mark (c) All marks and other labeling for prescribed in § 327.26. use on or with immediate containers, [35 FR 15610, Oct. 3, 1970, as amended at 51 FR as well as private brands on carcasses 37707, Oct. 24, 1986; 54 FR 41048, Oct. 5, 1989] or parts of carcasses, shall be approved by the Food Safety and Inspection § 327.16 Small importations for import- Service in accordance with part 317 of er’s own consumption; require- this subchapter before products bearing ments. such marks, labeling, or brands will be Any product in a quantity of 50 entered into the United States. The pounds or less which was purchased by marks of inspection of foreign systems the importer outside the United States embossed on metal containers or for his/her own consumption, is eligible branded on carcasses or parts thereof to be imported into the United States need not be submitted to the Food from any country without compliance Safety and Inspection Service for ap- with the provisions in other sections of proval, and such marks of inspection this part but subject to applicable re- put on stencils, box dies, labels, and quirements under other laws, including brands may be used on such immediate the regulations in part 94 of this title. containers as tierces, barrels, drums, However, Program employees may in- boxes, crates, and large-size fiberboard spect any product imported under this containers of foreign products without section to determine whether it is such marks of inspection being submit- within the class eligible to be imported ted for approval, provided the mark- under this paragraph. ings made by such articles are applica- ble to the product and are not false or [54 FR 41048, Oct. 5, 1989] misleading. § 327.17 Returned U.S. inspected and [35 FR 15610, Oct. 3, 1970, as amended at 51 FR marked products. 37707, Oct. 24, 1986; 60 FR 67456, Dec. 29, 1995] U.S. inspected and passed and so § 327.15 Outside containers of foreign marked products exported to and re- products; marking and labeling; ap- turned from foreign countries will be plication of official inspection leg- admitted into the United States with- end. out compliance with this part upon no- (a) The outside container in which tification to and approval of the Dep- any immediate container of foreign uty Administrator, International Pro- product is shipped to the United States grams, Food Safety and Inspection shall bear, in English, in a prominent Service, U.S. Department of Agri- and legible manner: culture, Washington, DC 20250, in spe- (1) The name or descriptive designa- cific cases. tion of the product in accordance with [35 FR 15610, Oct. 3, 1970, as amended at 51 FR § 317.2 of this subchapter; 37707, Oct. 24, 1986]
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§ 327.18 Products offered for entry and § 327.21 Inspection procedures for entered to be handled and trans- chilled fresh and frozen boneless ported as domestic; exception. manufacturing meat. (a) All products, after entry into the (a) Definitions; sampling; standards. (1) United States, shall be deemed and Frozen boneless manufacturing meat is treated as domestic products and shall meat, frozen in the fresh state from be subject to the applicable provisions cattle, sheep, swine, goats, horses, of the Act and the regulations in this mules, or other equines that has all subchapter and the applicable require- bone removed and is cut into pieces or ments under the Federal Food, Drug trimmings, frozen into a compact and Cosmetic Act, except that products block of any shape and suitable for imported under § 327.16 are required to slicing or chopping in the manufactur- comply only with the requirements of ing of meat food products. As used in that Act and § 327.16 of this subchapter. this section, the term ‘‘frozen’’ in- (b) Products entered in accordance cludes ‘‘chilled fresh,’’ and ‘‘lot’’ means with this part may, subject to the pro- any amount of frozen boneless manu- visions of part 318 of this subchapter, facturing meat of one species, simi- be taken into official establishments larly packaged, shipped from one es- and be mixed with or added to any tablishment, and offered for import in- product in such establishments which spection under one or more foreign in- has been inspected and passed therein. spection certificates. (2) Imported frozen boneless manu- (c) Imported product which has been facturing meat shall be sampled as re- inspected, passed, and marked under quired by § 327.6(a) of this part, and the this part may be transported in the samples defrosted for inspection. The course of importation or subsequently Program import inspector, or in the in commerce only upon compliance case of Canadian product subject to with part 325 of this subchapter. procedures described in § 327.5(d)(1), the [35 FR 15610, Oct. 3, 1970, as amended at 41 FR Canadian representative will select 18089, Apr. 30, 1976; 54 FR 41049, Oct. 5, 1989] from a lot the appropriate number of cartons specified by the table of sam- § 327.19 Specimens for laboratory ex- pling plans. The total sample for in- amination and similar purposes. spection will consist of the necessary The provisions in this part do not number of 12-pound units drawn from apply to specimens of products for lab- these cartons. The 12-pound units se- oratory examination, research, or simi- lected will be completely defrosted and lar purposes when authorized importa- examined. tion by the Administrator under condi- (b) Lots refused entry. Reinspection tions specified by him in specific cases, (including resampling) will be provided including requirements of denaturing for any lot of frozen boneless manufac- or other identification to deter their turing meat which was refused entry use for human food. Authorization will under this section on the basis of the not be given for the importation of any original evaluation of the sample products contrary to the provisions of thereof, upon appeal from the inspec- part 94 of this chapter. tor’s initial decision. [35 FR 15610, Oct. 3, 1970, as amended at 49 FR § 327.20 Importation of foreign ined- 36819, Sept. 20, 1984; 51 FR 44901, Dec. 15, 1986; ible fats. 54 FR 275, Jan. 5, 1989; 57 FR 27906, June 23, No inedible grease, inedible tallow, 1992] or other inedible rendered fat shall be imported into the United States unless § 327.22 [Reserved] it has been first denatured as pre- § 327.23 Compliance procedure for scribed in § 327.25 of this part and the cured pork products offered for containers marked as prescribed by entry. § 316.15 of this subchapter or unless it is (a) Definitions. For the purposes of identified and handled as prescribed by this section: § 325.11 (b) or (c) of this subchapter. (1) A Product is that cured pork arti- [54 FR 41049, Oct. 5, 1989] cle which is contained within one
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Group as defined in paragraph (a)(2) of arithmetic average of PFF Standard- this section and which purports to ized Differences from either 36 or 100 meet the criteria for a single product consecutively sampled lots of product designated under the heading ‘‘Product entering the United States from a Name and Qualifying Statements’’ in given producing country. the chart in § 319.104 or § 319.105 of this (7) A PFF Standardized Weighted Aver- subchapter. age of the Country’s Products is an esti- (2) A Product Group or a Group means mate of the average of the PFF Stand- one of the following: ardized Differences from either 36 or (i) Group I, consisting of cured pork 100 consecutively sampled lots, ad- products which have been cooked while justed for the size of the lot, of dif- imperviously encased. Any product ferent types of cured pork product en- that fits into the Group shall be placed tering the United States from a given in this Group regardless of any other producing country. A Standardized considerations. Weighted Average is computed by mul- (ii) Group II, consisting of cured pork tiplying the PFF Standardized Dif- products which have been water ference calculated for each lot by the cooked. Any product that does not fit number of pounds of product in each into Group I but does fit into Group II lot, adding those results together, and shall be placed into Group II regardless dividing the sum by the total weight of of any other considerations. product from all the lots making up (iii) Group III, consisting of boneless, the average. smokehouse heated cured pork prod- (8) The Appropriate Standard Deviation ucts. Any boneless product that does is based on within lot variability. That not fit into Group I or II shall be assigned to Groups I and II = 0.75 per- placed in Group III. cent PFF and that assigned to Groups (iv) Group IV, consisting of bone-in III and IV = 0.91 percent PFF. or semi-boneless smokehouse heated (9) A Lot is all product of one type cured pork products. Any product that from one establishment presented by is not completely boneless or still con- tains all the bone which is traditional an importer as the unit for inspection for bone-in product and does not fit at the Port of Entry. into Group I, II, or III shall be placed (b) Normal monitoring procedures. Ex- in this Group. cept for product imported from Canada, (3) Protein Fat-Free Percentage, Protein the Department shall collect sample(s) Fat-Free Content, PFF Percentage, PFF of cured pork product on a random Content or PFF of a product means the basis from lots offered for entry at the meat protein (indigenous to the raw, Port of Entry and, after analyzing the unprocessed pork cut) content ex- sample for fat and indigenous protein pressed as a percent of the non-fat por- content, calculate the PFF percentage. tion of the finished product. The product shall not be held pending (4) A PFF Standardized Difference is laboratory results during the monitor- the PFF of the sample minus the mini- ing phase. The PFF percentage for each mum PFF requirement, set forth in sample shall be considered along with § 319.104 and § 319.105 of this subchapter, the cumulative results of prior samples for the product being analyzed, divided to assess the effectiveness of a coun- by the Appropriate Standard Deviation try’s overall compliance program and for the product group. to determine the course of action for (5) The Absolute Minimum PFF Re- subsequent lots of product. quirement is that no laboratory result (1) Factors determining whether a of an individual sample for PFF con- country’s inspection system is func- tent be below the applicable minimum tioning adequately: requirement of § 319.104 or § 319.105 of (i) The PFF percentage for each sam- this subchapter by 2.3 or more percent- ple must not be below the minimum age points for a Group I or II product PFF requirement by 2.3 percentage or 2.7 or more percentage points for a points for cured pork products in Group III or IV product. Groups I and II or 2.7 percentage points (6) A PFF Standardized Arithmetic Av- for cured pork products in Groups III erage of the Country’s Products is the and IV.
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(ii) Both of the PFF Standardized turned to normal monitoring proce- Averages, Arithmetic and Weighted, dures in accordance with paragraph for the last 100 consecutive lots of all (c)(2), and countries may be returned to cured pork products from the country normal monitoring procedures in ac- must be equal to or greater than zero. cordance with paragraph (c)(3). The count for the 100 consecutive lots (1) If a lot is subject to retention pro- starts with the lots arriving from that cedures under this section, the Depart- country after April 15, 1985. ment shall collect five randomly se- (iii) Both of the PFF Standardized lected sample units from each lot and Averages, Arithmetic and Weighted, determine the PFF of each sample for the last 36 consecutive lots of all unit. The lot may be released into com- cured pork products from the country merce if: must be above the lowest 5 percent of (i) The average PFF percentage of the Normal distribution. This mini- the five randomly selected sample mum value is minus 0.28 (¥0.28) for the units is equal to or greater than the Arithmetic Average and depends on the applicable minimum PFF percentage production volume for the Weighted required by § 319.104 or § 319.105 of this Average. subchapter, or (2) Actions when calculations indi- (ii) The product is relabeled under cate that processing procedures in a the supervision of a program employee country are out-of-compliance: so that it conforms to the provisions of (i) If the PFF level of a sample taken § 319.104 or § 319.105 of this subchapter. during normal monitoring procedures (2) If product from a foreign estab- is found to be as low as the Absolute lishment is subject to retention proce- Minimum PFF Requirement, the coun- dures under this section, the foreign es- try of origin shall be notified; the lot tablishment may be returned to nor- involved shall be retained if still avail- mal monitoring procedures when: able in an official establishment or subject to detention or other actions (i) Ten consecutively presented lots pursuant to the Act; and all subse- of that cured pork product from that quently presented lots of that cured establishment have been sampled as pork product from the same foreign es- provided in paragraph (c)(1) of this sec- tablishment shall be held under reten- tion and the average of each set of five tion until the provisions of paragraph sample units representing each lot (c) are satisfied. have been found to be equal to or (ii) If either of the PFF Standardized greater than the required minimum Averages, Arithmetic or Weighted, for PFF percentage; and the last 100 consecutive lots falls below (ii) The PFF percentage of each sam- zero or either of the PFF Standardized ple unit (50 in all) is above the Abso- Averages for the last 36 consecutive lute Minimum PFF Percentage. lots falls below the upper 95 percent of (3) If a country is subject to reten- the Normal distribution, all available tion procedures under this section, the cured pork product from the foreign country shall be returned to normal country shall be subject to administra- monitoring procedures when: tive retention and all subsequently pre- (i) Twenty-five consecutively pre- sented lots of cured pork product from sented lots of cured pork product have the foreign country shall be held under been sampled as required in paragraph retention until the provisions of para- (c)(1) of this section and the average of graph (c) are satisfied. The country of each set of five sample units represent- origin shall be notified, and shall be ing each lot have been found to be subject to other actions pursuant to equal to or greater than the required the Act. minimum PFF percentage; and (c) Retention. When lots of cured pork (ii) The PFF percentage of each sam- product are under retention they shall ple unit (125 in all) is above the Abso- be refused entry and reexported in ac- lute Minimum PFF Percentage; and cordance with § 327.13 of this sub- (iii) Both of the PFF Standardized chapter unless they can be released in Averages for 36 consecutive lots are in accordance with the provisions of para- the required percentage of the Normal graph (c)(1), establishments may be re- distribution; and
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(iv) Both of the PFF Standardized bolic acid; cresylic disinfectant; a for- Averages for 100 consecutive lots are mula consisting of 1 part FD&C green zero or higher. No. 3 coloring, 40 parts water, 40 parts (4) The sample units collected under liquid detergent, and 40 parts oil of cit- retention procedures as provided in ronella, or other proprietary substance paragraph (c)(2) of this section will not approved by the Administrator in spe- be included in the PFF standardized cific cases.1 averages for 36 and 100 consecutive (2) Meat may be denatured by dipping lots. it in a solution of 0.0625 percent tannic (d) Adulterated and Misbranded Prod- acid, followed by immersion in a water ucts. Products not meeting specified bath, then dipping it in a solution of PFF requirements, determined accord- 0.0625 percent ferric acid; and except as ing to procedures set forth in this sec- provided in paragraphs (a) (3) and (5) of tion, may be deemed adulterated under this section, the following agents are section 1(m)(8) of the Act (21 U.S.C. prescribed for denaturing other car- 601(m)(8)) and misbranded under sec- casses, parts thereof, meat and meat tion 1(n) of the Act (21 U.S.C. 601(n)). food products, for which denaturing is (e) Activities requiring additional required by this part: FD&C green No. inspectional supervision, such as re- 3 coloring; FD&C blue No. 1 coloring; labeling, shall be at the importer’s ex- FD&C blue No. 2 coloring; finely pow- pense. In addition, if the importer dered charcoal; or other proprietary wishes, he or she may have samples substance approved by the Adminis- analyzed at an accredited laboratory. trator in specific cases.1 Carcasses [50 FR 9792, Mar. 12, 1985, as amended at 54 (other than viscera), parts thereof, cuts FR 41049, Oct. 5, 1989] of meat, and unground pieces of meat darkened by charcoal or other black § 327.24 Appeals; how made. dyes shall be deemed to be denatured Any appeal from a decision of any pursuant to this section only if they program employee shall be made to his/ contain at least that degree of dark- her immediate supervisor having juris- ness depicted by diagram 1 of the Meat diction over the subject matter of the Denaturing Guide (MP Form 91).2 appeal, except as otherwise provided in (3) Tripe may be denatured by dip- the applicable rules of practice. ping it in a 6 percent solution of tannic acid for 1 minute followed by immer- [51 FR 37707, Oct. 24, 1986, as amended at 60 sion in a water bath, then immersing it FR 67456, Dec. 29, 1995] for 1 minute in a solution of 0.022 per- § 327.25 Disposition procedures for cent FD&C yellow No. 5 coloring. product condemned or ordered de- (4) When meat, meat byproducts, or stroyed under import inspection. meat food products are in ground form, (a) Carcasses, parts thereof, meat and 4 percent by weight of coarsely ground meat food products (other than ren- hard done, which shall be in pieces no dered animal fats) that have been smaller than the opening size specified treated in accordance with the provi- sions of this section shall be considered 1 Information as to approval of any propri- denatured for the purposes of the regu- etary denaturing substance may be obtained lations in this part, except as other- from the Meat and Poultry Inspection Tech- nical Services, Food Safety and Inspection wise provided in part 314 of this sub- Service, U.S. Department of Agriculture, chapter for articles condemned at offi- Washington, DC 20250. cial establishments or at official im- 2 Copies of MP Form 91 may be obtained, port inspection establishments. without charge, by writing to the Adminis- (1) The following agents are pre- trative Operations Branch, Food Safety and scribed for denaturing carcasses, parts Inspection Service, U.S. Department of Agri- thereof, meat or meat food products culture, 123 East Grant Street, Minneapolis, which are affected with any condition Minnesota 55403. Diagrams 2 and 3 of the that would result in their condemna- Meat Denaturing Guide are for comparison purposes only. The Meat Denaturing Guide tion and disposal under part 314 of this has been approved for incorporation by ref- subchapter if they were at an official erence by the Director, Office of the Federal establishment or at an official import Register, and is on file at the Federal Reg- inspection establishment: Crude car- ister Library.
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for No. 5 mesh in the standards issued § 327.26 Official import inspection by the U.S. Bureau of Standards or 6 marks and devices. percent by weight of coarsely ground (a) When import inspections are per- hard bone, which shall be in pieces no formed in official import inspection es- smaller than the opening size specified tablishments, the official inspection for No. 8 mesh in said Standards, uni- legend to be applied to imported meat formly incorporated with the product, and meat food products shall be in the may be used in lieu of the agents pre- appropriate form 1 as herein specified. scribed in paragraph (a)(2) of this sec- tion. (5) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or section- ing will not be necessary.) The applica- tion of any of the denaturing agents listed in paragraph (a) (1) or (2) of this section to the outer surface of molds or blocks or boneless meat, meat by-prod- ucts, or meat food products shall not be adequate. The denaturing agent For application to cattle, sheep, swine, and goat carcasses, primal must be mixed intimately with all the parts, and cuts, not in containers. material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be re- moved by washing or soaking. A suffi- cient amount of the appropriate agent shall be used to give the material a dis- tinctive color, odor, or taste so that such material cannot be confused with an article of human food. (b) Inedible rendered animal fats shall be denatured by thoroughly mix- ing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any pro- prietary denaturing agent approved for the purpose by the Administrator in specific cases. The charcoal shall be used in no less quantity than 100 parts per million and shall be of such char- For application to outside containers acter that it will remain suspended in- of meat and meat food products pre- definitely in the liquid fat. Sufficient pared from cattle, sheep, swine, and of the chosen identifying agents shall goats. be used to give the rendered fat so dis- tinctive a color, odor, or taste that it 1 The number ‘‘I–38’’ is given as an example cannot be confused with an article of only. The establishment number of the offi- human food. cial import inspecton establishment where the imported product is inspected shall be [51 FR 37707, Oct. 24, 1986] used in lieu thereof.
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For application to outside containers For application to horse carcasses, of equine meat food products. (b) Except for product offered for primal parts, and cuts, not in contain- entry from Canada, when import in- ers. spections are performed in official es- tablishments the official inspection legend to be applied to meat and meat food products offered for entry shall be the appropriate form as specified in §§ 312.2 and 312.3 of this subchapter. (c) When products are refused entry into the United States, the official mark to be applied to the products re- fused entry shall be in the following form:
For application to outside containers of horsemeat food products. (d) Devices for applying ‘‘United States Refused Entry’’ marks shall be furnished to Program inspectors by the Department. (e) The ordering and manufacture of brands containing official inspection legends shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations. [51 FR 37708, Oct. 24, 1986, as amended at 54 FR 41049, Oct. 5, 1989]
PART 329—DETENTION; SEIZURE AND CONDEMNATION; CRIMI- NAL OFFENSES For application to mule and other (nonhorse) equine carcasses, primal Sec. 329.1 Article or livestock subject to admin- parts, and cuts, not in containers. istrative detention.
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329.2 Method of detention; form of detention tained’’ tag (FSIS Form 8400–2) to such tag. article or livestock. 329.3 Notification of detention to the owner of the article or livestock detained, or [55 FR 47842, Nov. 16, 1990] the owner’s agent, and person having custody. § 329.3 Notification of detention to the 329.4 Notification of governmental authori- owner of the article or livestock de- ties having jurisdiction over article or tained, or the owner’s agent, and livestock detained; form of written noti- person having custody. fication. (a) When any article or livestock is 329.5 Movement of article or livestock de- detained under this part, an authorized tained; removal of official marks. representative of the Secretary shall: 329.6 Articles or livestock subject to judi- (1) Orally notify the immediate cus- cial seizure and condemnation. todian of the article or livestock de- 329.7 Procedure for seizure, condemnation and disposition. tained, and 329.8 Authority for condemnation or seizure (2) Promptly furnish a copy of a com- under other provisions of law. pleted ‘‘Notice of Detention’’ (FSIS 329.9 Criminal offenses. Form 8080–1) to the immediate custo- dian of the detained article or live- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, stock. 2.55. (b) If the owner of the detained arti- SOURCE: 35 FR 15617, Oct. 3, 1970, unless cle or livestock, or the owner’s agent, otherwise noted. is not the immediate custodian at the time of detention and if the owner, or § 329.1 Article or livestock subject to owner’s agent, can be ascertained and administrative detention. notified, an authorized representative Any carcass, part of a carcass, meat of the Secretary shall furnish a copy of or meat food product of livestock, or the completed ‘‘Notice of Detention’’ article exempted from the definition of to the owner or the owner’s agent. meat food product, or any dead, dying, Such copy shall be served, as soon as disabled, or diseased livestock is sub- possible, by delivering the notification ject to detention for a period not to ex- to the owner, or the owner’s agent, or ceed 20 days when found by any author- by certifying and mailing the notifica- ized representative of the Secretary tion to the owner, or the owner’s agent, upon any premises where it is held for at his or her last known residence or the purposes of, or during or after dis- principal office or place of business. tribution in, commerce or it is other- wise subject to Title I or II of the Act, [55 FR 47842, Nov. 16, 1990] and there is reason to believe that: § 329.4 Notification of governmental (a) Any such article is adulterated or authorities having jurisdiction over misbranded and is capable of use as article or livestock detained; form human food; or of written notification. (b) Any such article has not been in- Within 48 hours after the detention of spected, in violation of the provisions any livestock or article pursuant to of Title I of the Act, any other Federal this part, an authorized representative law, or the laws of any State or Terri- of the Secretary shall give oral or writ- tory, or the District of Columbia; or ten notification of such detention to (c) Any such article or livestock has any Federal authorities not connected been or is intended to be, distributed in with the Program, and any State or violation of the provisions of Title I of other governmental authorities, having the Act, any other Federal law, or the jurisdiction over such livestock or arti- laws of any State or Territory, or the cle. In the event notification is given District of Columbia. orally, it shall be confirmed in writing, as promptly as circumstances permit. § 329.2 Method of detention; form of detention tag. § 329.5 Movement of article or live- An authorized representative of the stock detained; removal of official Secretary shall detain any article or marks. livestock to be detained under this (a) No article or livestock detained in part, by affixing an official ‘‘U.S. De- accordance with the provisions in this
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part shall be moved by any person from or offered or received for distribution the place at which it is located when so in violation of the Act, or detained, until released by an author- (b) Is capable of use as human food ized representative of the Secretary: and is adulterated or misbranded, or Provided, That any such article or live- (c) In any other way is in violation of stock may be moved from the place at the Act. which it is located when so detained, for refrigeration, freezing, or storage § 329.7 Procedure for seizure, con- purposes if such movement has been demnation, and disposition. approved by an authorized representa- Any article or livestock subject to tive of the Secretary: And provided fur- seizure and condemnation under this ther, That the article or livestock so part shall be liable to be proceeded moved will be detained by an author- against and seized and condemned, and ized representative of the Secretary after such movement until such time disposed of, at any time, on an appro- as the detention is terminated. priate pleading in any United States (b) Upon terminating the detention district court, or other proper court of such article or livestock, an author- specified in section 404 of the Act, ized representative of the Secretary within the jurisdiction of which the ar- shall: ticle or livestock is found. (1) Orally notify the immediate cus- todian of the released article or live- § 329.8 Authority for condemnation or stock, and seizure under other provisions of law. (2) Furnish copies of a completed ‘‘Notice of Termination of Detention’’ The provisions of this part relating (FSIS Form 8400–1) to the persons noti- to seizure, condemnation and disposi- fied when the article or livestock was tion of articles or livestock do not der- detained. The notice shall be served by ogate from authority for condemnation either delivering the notice to such or seizure conferred by other provisions persons or by certifying and mailing of the Act, or other laws. the notice to such persons at their last known residences or principal offices § 329.9 Criminal offenses. or places of business. The Act contains criminal provisions (c) All official marks may be required with respect to numerous offenses spec- by such representative to be removed ified in the Act, including but not lim- from such article or livestock before it ited to bribery of Program employees, is released unless it appears to the sat- receipt of gifts by Program employees, isfaction of the representative that the and forcible assaults on, or other inter- article or livestock is eligible to retain ference with, Program employees while such marks. engaged in, or on account of, the per- [35 FR 15617, Oct. 3, 1970, as amended at 36 FR formance of their official duties under 12004, June 24, 1971; 39 FR 36000, Oct. 7, 1974; the Act. 55 FR 47842, Nov. 16, 1990]
§ 329.6 Articles or livestock subject to PART 331—SPECIAL PROVISIONS judicial seizure and condemnation. FOR DESIGNATED STATES AND Any carcass, part of a carcass, meat TERRITORIES; AND FOR DESIGNA- or meat food product, or any dead, TION OF ESTABLISHMENTS WHICH dying, disabled, or diseased livestock, ENDANGER PUBLIC HEALTH AND that is being transported in commerce FOR SUCH DESIGNATED ESTAB- or is otherwise subject to Title I or II LISHMENTS of the Act, or is held for sale in the United States after such transpor- Sec. tation, is subject to seizure and con- 331.1 Definition of ‘‘State.’’ demnation, in a judicial proceeding 331.2 Designation of States under paragraph pursuant to section 403 of the Act if 301(c) of the Act. such article or livestock: 331.3 States designated under paragraph (a) Is or has been prepared, sold, 301(c) of the Act; application of regula- transported, or otherwise distributed tions.
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331.4 Control and disposal of non-federally- EDITORIAL NOTE: For FEDERAL REGISTER ci- inspected products in States designated tations affecting § 331.2, see the List of CFR under paragraph 301(c) of the Act. Sections Affected in the Finding Aids sec- 331.5 Criteria and procedure for designating tion of this volume. establishments with operations which would clearly endanger the public health; § 331.3 States designated under para- disposition of products; application of graph 301(c) of the Act; application regulations. of regulations. 331.6 Designation of States under section 205 of the Act; application of sections of The provisions of the regulations in the Act and the regulations. this subchapter apply to operations and transactions wholly within each AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. State designated in § 331.2 under para- graph 301(c) of the Act, except as other- SOURCE: 35 FR 19667, Dec. 29, 1970, unless wise provided in this section. (The pro- otherwise noted. visions of the regulations apply in all § 331.1 Definition of ‘‘State’’. respects to operations and transactions in or for commerce.) For purposes of this part, the term ‘‘State’’ means any State (including (a) Each establishment located in the Commonwealth of Puerto Rico) or such a designated State shall be grant- organized Territory. ed inspection required under § 302.1(a)(2) of this subchapter only if it § 331.2 Designation of States under is found, upon a combined evaluation paragraph 301(c) of the Act. of its premises, facilities, and operat- Each of the following States has been ing procedures, to be capable of produc- designated, under paragraph 301(c) of ing products that are not adulterated the Act, as a State in which the provi- or misbranded. sions of Titles I and IV of the Act shall (b) Section 305.2 of this subchapter apply to operations and transactions will apply to establishments required wholly within such State. The Federal to have inspection under § 302.1(a)(2) of provisions apply, effective on the dates this subchapter, except that existing shown below: interconnections between official and unofficial establishments will be per- State Effective date of applica- mitted if it is determined in specific tion of Federal provisions cases that the interconnections are Arkansas ...... June 1, 1981. such that transfer of inedible product California ...... Apr. 1, 1976. into the official establishment would Colorado ...... July 1, 1975. be difficult or unusual, and any such Connecticut ...... Oct. 1, 1975. Florida ...... Dec. 2, 1997. transfers are strictly prohibited, except Guam ...... Jan. 21, 1972. as permitted under other provisions of Hawaii ...... Nov. 1, 1995. this subchapter. It is essential that Idaho ...... July 1, 1981. Kentucky ...... Jan. 14, 1972. separation of facilities be maintained Maine ...... May 12, 1980. to the extent necessary to assure that Maryland ...... March 31, 1991 inedible product does not enter the of- Massachusetts ...... Jan. 12, 1976. ficial establishment contrary to the Michigan ...... Oct. 3, 1981. Minnesota ...... May 16, 1972. regulations in this subchapter. Missouri ...... Aug. 18, 1972. (c) Section 308.4 of this subchapter Nebraska ...... Oct. 1, 1971. shall apply to such establishments, ex- Nevada ...... July 1, 1973. New Hampshire ...... Aug. 6, 1978. cept that separate facilities for men New Jersey ...... July 1, 1975. and women workers will not be re- New York ...... July 16, 1975. quired when the majority of the work- North Dakota ...... June 22, 1970. Northern Mariana Islands ...... Oct. 29, 1979. ers in the establishment are related by Oregon ...... July 1, 1972. blood or marriage, provided that this Pennsylvania ...... July 17, 1972. will not conflict with municipal or Puerto Rico ...... June 18, 1971. State requirements: and except that Rhode Island ...... Oct. 1, 1981. Tennessee ...... Oct. 1, 1975. separation of toilet soil lines from Virgin Islands of the U.S ...... Nov. 27, 1971. house drainage lines to a point outside Washington ...... June 1, 1973. the buildings will not be required in ex- isting construction when positive act- [35 FR 19667, Dec. 29, 1970] ing back-flow devices are installed.
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(d) Section 314.2 of this subchapter tion of each marking device for which shall apply to such establishments, ex- temporary approval has been granted cept that a separate room or compart- by the circuit supervisor (showing any ment need not be provided for inedible modifications required by the circuit products if they can be handled so that supervisor) to the Labels and Packag- they do not create insanitary condi- ing Staff, Meat and Poultry Inspection, tions in any room or compartment Food Safety and Inspection Service, used for edible products or otherwise USDA, Washington, DC 20250, accom- render any edible products adulterated panied by the formula and details of and do not interfere with the conduct preparation and packaging for each of inspection. For example, intestines, product. Within 90 days after inaugura- paunch contents, feet, and hides might tion of inspection, all labeling material be accumulated on the kill floor in and marking devices temporarily ap- clean, watertight drums with close fit- proved by the circuit supervisor must ting covers if there is sufficient space receive approval as required by §§ 316.7, to store them out of the way until the 317.3, and 317.4, of this subchapter or close of the day’s operation. their use must be discontinued. (e) Sections 316.7, 317.3, and 317.4 of (4) The circuit supervisor will also re- this subchapter shall apply to such es- view all shipping containers to insure tablishments, except as provided in that they do not have any false or mis- this paragraph (e). leading labeling and are otherwise not (1) The operator of each such estab- misbranded. Modifications of unaccept- lishment shall, prior to the inaugura- able information on labeling material tion of inspection, identify all labeling by the use of self-destructive pressure and marking devices in use, or pro- sensitive tape or by blocking out with posed for use (upon the date of inau- an ink stamp will be authorized on a guration of inspection) to the circuit temporary basis to permit the maxi- supervisor of the circuit in which the mum allowable use of all labeling ma- establishment is located. Temporary terials on hand. All unacceptable label- approval, pending formal approval ing material which is not modified to under §§ 316.7, 317.3, and 317.4 of this comply with the requirements of this subchapter, will be granted by the cir- subchapter must be destroyed or re- cuit supervisor for labeling and mark- moved from the official establishment. ing devices that he determines are nei- (f) Sections 320.1, 320.2, 320.3, 320.4, ther false nor misleading, provided the 320.5, 325.20, and 325.21 apply to oper- official inspection legend bearing the ations and transactions not in or for official establishment number is ap- commerce in a State designated under plied to the principal display panel of paragraph 301(c) only if the State is each label, either by a mechanical also designated under section 205 of the printing device or a self-destructive Act and if such provisions are applica- pressure sensitive sticker, and provided ble as shown in § 331.6. the label shows the true product name, (g) Section 321.1(a) of this subchapter an accurate ingredient statement, the will not apply to States designated name and address of the manufacturer, under paragraph 301(c) of the Act. packer, or distributor, and any other (h) Parts 322 and 327 and § 325.3 of this features required by paragraph 1(n) of subchapter relating to exports and im- the Act. ports do not apply to operations and (2) The circuit supervisor will for- transactions solely in or for intrastate ward one copy of each item of labeling commerce. and a description of each marking de- (i) Part 325 of this subchapter will vice for which he has granted tem- apply to establishments required to porary approval to the Washington, have inspection under § 302.1(a)(2) of DC, office of the Labeling and Packag- this subchapter and to operations and ing Staff and will retain one copy in a transactions solely in or for intrastate temporary approval file for the estab- commerce, except as provided in para- lishment. graphs (h) and (j) of this section. (3) The operator of the official estab- (j) Sections 325.4, 325.15, and 325.1(b) lishment shall promptly forward a copy of this subchapter will not apply to re- of each item of labeling and a descrip- quire a certificate, or evidence thereof,
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for the distribution solely within any § 331.5 Criteria and procedure for des- designated State of products that are ignating establishments with oper- U.S. inspected and passed and so ations which would clearly endan- marked. ger the public health; disposition of products; application of regula- [35 FR 19667, Dec. 29, 1970, as amended at 36 tions. FR 12004, June 24, 1971; 41 FR 18089, Apr. 30, (a) An establishment preparing prod- 1976; 62 FR 45026, Aug. 25, 1997] ucts solely for distribution within any State shall be designated as one pro- § 331.4 Control and disposal of non- federally-inspected products in ducing adulterated products which States designated under paragraph would clearly endanger the public 301(c) of the Act. health, if: (1) Any meat or meat food product Upon the effective date of designa- prepared at the establishment is adul- tion of a State under paragraph 301(c) terated in any of the following re- of the Act, no products can be prepared spects: within the State unless they are pre- (i) It bears or contains a pesticide pared under inspection pursuant to the chemical, food additive, or color addi- regulations in this subchapter or are tive, that is ‘‘unsafe’’ within the mean- exempted from the requirement of in- ing of sections 408, 409, or 706 of the spection under § 303.1 of this sub- Federal Food, Drug, and Cosmetic Act chapter, and no unexempted products or was intentionally subjected to radi- which were prepared without any in- ation in a manner not permitted under spection can lawfully be distributed section 409 of said Act; or if it bears or within the State. For a period of 90 contains any other added poisonous or days from the effective date of such added deleterious substance which may designation, products which were pre- render it injurious to health or make it pared and inspected and passed under unfit for human food; or the supervision of a responsible State (ii) It consists in whole or in part of or local inspection agency can be dis- any filthy, putrid, or decomposed sub- tributed solely within the State, pro- stance or is for any other reason un- vided they are not adulterated or mis- sound, unhealthful, or unwholesome or branded, except that the official in- otherwise unfit for human food (for ex- spection legend is not required. Within ample, it was prepared from meat or the 90-day period, products that have other ingredients exhibiting spoilage been inspected by the State or local in- characteristics; or it is, or was pre- spection agency may be further pre- pared from, a carcass affected with a pared and otherwise handled in official disease transmissible to humans and its condemnation would be required establishments required to have inspec- under part 309 or 310 of the Federal tion under § 302.1(a)(2) of this sub- Meat Inspection regulations (9 CFR chapter or at establishments exempted parts 309, 310) at federally inspected es- from the requirements of such inspec- tablishments; or it is a ready-to-eat tion under § 303.1 of this subchapter, pork product which has not been treat- and may be distributed as provided in ed to destroy trichinae as prescribed in this section but otherwise shall be han- § 318.10 of this subchapter for products dled in accordance with § 305.4 of this at federally inspected establishments); subchapter. Such products shall not or bear any [Federal] official inspection (iii) It has been prepared, packed or legends. After said 90–day period, only held under insanitary conditions federally inspected and passed products whereby it may have become contami- may be distributed within the des- nated with filth or may have been ren- ignated State, except as provided in dered injurious to health (for example § 303.1 of this subchapter. if insects or vermin are not effectively
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controlled at the establishments, or in- essary corrections, and notifying him sanitary water is used in preparing that failure to correct such deficiencies meat or meat food products for human may result in designation of the estab- food); or lishment and operator thereof as sub- (iv) It is, in whole or in part, the ject to the provisions of titles I and IV product of an animal that died other- of the Act as though engaged in com- wise than by slaughter; or merce. (v) Its container is composed, in (3) Thereafter the Program Inspector whole or in part, of any poisonous or shall survey the establishment and des- deleterious substance which may ignate it if he determines, in consulta- render the contents injurious to tion with the Regional Director, that it health; and is producing adulterated products, (2) Such adulterated articles are in- which would clearly endanger the pub- tended to be or are distributed from lic health, and formal notice of such the establishment while capable of use designation will be issued to the opera- as human food. tor of the establishment by the Re- (b) When any such establishment is gional Director. identified by a Program Inspector as (c) Products on hand at the time of one producing adulterated product, designation of an establishment under which would clearly endanger public this section are subject to detention, health under the criteria in paragraph seizure and condemnation in accord- (a) of this section, the following proce- ance with part 329 of this subchapter: dure will be followed: Provided, That products that have been (1) The Program Inspector will infor- federally inspected and so identified mally advise the operator of the estab- and that have not been further pre- lishment concerning the deficiencies pared at any nonfederally inspected es- found by him and report his findings to tablishment may be released for dis- the appropriate Regional Director for tribution if the products appear to be the Program. When it is determined by not adulterated or misbranded at the the Regional Director that any estab- time of such release. lishment preparing products solely for (d) No establishment designated distribution within any State is pro- under this section can lawfully prepare ducing adulterated products for dis- any products unless it first obtains in- tribution within such State which spection or qualifies for exemption would clearly endanger the public under § 303.1 of this subchapter. All of health, written notification thereof the provisions of the regulations shall will be issued to the appropriate State apply to establishments designated officials, including the Governor of the under this section, except that the ex- State and the appropriate Advisory ceptions provided for in § 331.3 of this Committee, for effective action under part shall apply to such establish- State or local law to prevent such en- ments. dangering of the public health. Such written notification shall clearly speci- § 331.6 Designation of States under fy the deficiencies deemed to result in section 205 of the Act; application the production of adulterated products of sections of the Act and the regu- and shall specify a reasonable time for lations. such action under State or local law. Each of the following States has been (2) If effective action is not taken designated, effective on the date shown under State or local law within the below, under section 205 of the Act, as specified time, written notification a State in which the provisions of the shall be issued by the Regional Direc- sections of the Act and regulations tor to the operator of the establish- specified below shall apply to operators ment, specifying the deficiencies in- engaged, other than in or for com- volved and allowing him ten days to merce, in the kinds of business indi- present his views or make the nec- cated below:
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Sections of act and regu- Effective date of lations Classes of operators State designation
Act, section 202; §§ Persons engaged (not in or for commerce) in (1) the busi- Arkansas ...... Mar. 29, 1982. 320.1, 320.2, 320.3, ness of slaughtering any livestock or preparing, freezing, California ...... Apr. 1, 1976. and 320.4. packaging or labeling any livestock carcasses or parts or Colorado ...... July 1, 1975. products thereof, for use as human food or animal food; Connecticut ...... Oct. 1, 1975. (2) the business of buying or selling (as a meat broker, Guam ...... Nov. 19, 1976. wholesaler, or otherwise), transporting or storing any live- Idaho ...... Mar. 29, 1982. stock carcasses or parts or products thereof; or (3) busi- Kentucky ...... Apr. 18, 1973. ness as a renderer, or in the business of buying, selling, or Maine ...... Feb. 9, 1981. transporting any dead, dying, disabled, or diseased live- Maryland ...... Mar. 31, 1991. stock or parts of carcasses of any livestock that died other- Massachusetts .. Jan. 12, 1976. wise than by slaughter. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975. North Dakota .... July 23, 1973. Northern Mari- Oct. 29, 1979. ana Islands. Oregon ...... Jan. 31, 1975. Pennsylvania .... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 203; § 320.5 ...... Persons engaged (not in or for commerce) in business as a Arkansas ...... Mar. 29, 1982. meat broker; renderer; animal food manufacturer; whole- California ...... Apr. 1, 1976. saler or public warehouseman of livestock carcasses, or Colorado ...... July 1, 1975. parts or products thereof; or buying, selling, or transporting Connecticut ...... Oct. 1, 1973. any dead, dying, disabled, or diseased livestock, or parts Guam ...... Nov. 19, 1976. of carcasses of any such livestock that dies otherwise than Idaho ...... Mar. 29, 1982. by slaughter. Kentucky ...... Apr. 18, 1976. Maine ...... Feb. 9, 1981. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1975. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1973. North Dakota .... July 23, 1975. Northern Mari- Oct. 29, 1979. ana Islands. Oregon ...... Jan. 31, 1974. Pennsylvania .... May 2, 1975. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 204; §§ 325.20 and Persons engaged (not in or for commerce) in the business of Arkansas ...... Mar. 29, 1982. 325.21. buying, selling or transporting any dead, dying, disabled or Connecticut ...... Oct. 1, 1975. diseased animals, or parts of carcasses of any animals Guam ...... Nov. 19, 1976. that died otherwise than by slaughter. Idaho ...... Mar. 29, 1982. Kentucky ...... Apr. 18, 1973. Maine ...... Feb. 9, 1981. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1976. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975. North Dakota .... July 23, 1973. Northern Mari- Oct. 29, 1979. ana Islands.
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Sections of act and regu- Effective date of lations Classes of operators State designation
Oregon ...... Jan. 31, 1975. Pennsylvania .... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975.
[35 FR 19667, Dec. 29, 1970]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 331.6, see the List of CFR Sec- tions Affected in the Finding Aids section of this volume.
PART 335—RULES OF PRACTICE 335.32 Procedure upon receipt of the estab- GOVERNING PROCEEDINGS lishment answer. UNDER THE FEDERAL MEAT IN- Subpart E—Criminal Violations SPECTION ACT 335.40 Opportunity for presentation of views before report of criminal violations. Subpart A—General AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, Sec. 2.55. 335.1 Scope and applicability of rules of SOURCE: 42 FR 10960, Feb. 25, 1977, unless practice. otherwise noted. Subpart B—Supplemental Rules of Practice Subpart A—General 335.10 Refusal or withdrawal of inspection service under section 401 of the Act. § 335.1 Scope and applicability of rules 335.11 Withdrawal of inspection service for of practice. failure of an establishment to destroy (a) The Uniform Rules of Practice for any condemned carcass or part thereof or any condemned meat or meat food prod- the Department of Agriculture promul- uct. gated in subpart H of part 1, subtitle A, 335.12 Withholding use of marking, labeling, title 7, Code of Federal Regulations, or containers from use under section 7 of are the Rules of Practice applicable to the Federal Meat Inspection Act. adjudicatory, administrative proceed- 335.13 Refusal or withdrawal of inspection ings under sections 4, 6, 7(e), 8, and 401 service under the Federal Meat Inspec- of the Federal Meat Inspection Act (21 tion Act for failure to maintain sanitary U.S.C. 604, 606, 607(e), 608 and 671). In conditions. addition, the Supplemental Rules of Practice set forth in subpart B of this Subpart C—Rules Applicable to Suspen- part shall be applicable to such pro- sion of Assignment of Inspectors for ceedings. Threats to Forcibly Assault or Forcible (b) The rules of practice set forth in Assault, Intimidation or Interference subpart C of this part shall be applica- With Any Inspection Service Employee ble to the suspension of assignment of 335.20 Notification to operator of establish- inspectors for threats to forcibly as- ment of incident. sault or forcible assault, intimidation 335.21 Procedure upon failure of operator of or interference with any inspection establishment to take action required by service employee pursuant to § 305.5(b) § 305.5(b) of the regulations. of the regulations (9 CFR 305.5(b)) under the Federal Meat Inspection Act. Subpart D—Rules Applicable to Suspension In addition, the definitions applicable of Assignment of Inspectors Under to proceedings under the Uniform Section 3(b) of the Federal Meat In- Rules of Practice (7 CFR 1.132) shall spection Act apply with equal force and effect to 335.30 Suspension of the assignment of in- proceedings under subpart C. spectors under section 3(b) of the Act. (c) The rules of practice set forth in 335.31 Written notification to operator of subpart D of this part shall be applica- establishment of incident. ble to the suspension of assignment of
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inspectors under section 3(b) of the Act tablishment. In the event of oral notifi- (21 U.S.C. 603(b)). In addition, the defi- cation, a written confirmation shall be nitions applicable to proceedings under given, as promptly as circumstances the Uniform Rules of Practice (7 CFR permit, to the operator of the estab- 1.132) shall apply with equal force and lishment of the intent to withdraw in- effect to proceedings under part 313. spection. The written notification or [42 FR 10960, Feb. 25, 1977, as amended at 44 confirmation shall be served upon the FR 68817, Nov. 30, 1979] operator of the establishment in the manner prescribed in § 1.147(b) of the Subpart B—Supplemental Rules of Uniform Rules of Practice (7 CFR 1.147(b)). Practice (b) If any establishment so notified § 335.10 Refusal or withdrawal of in- fails to destroy any condemned carcass spection service under section 401 or part thereof or any condemned meat of the Act. or meat food product as specified in the If the Administrator has reason to notice, the Administrator may issue believe that the applicant for or recipi- and file a complaint in accordance with ent of service under Title I of the Act the Uniform Rules of Practice. Effec- is unfit to engage in any business re- tive upon service of the complaint, in- quiring such inspection because of any spection service under the Act shall be of the reasons specified in section 401 of withdrawn from such establishment as the Act, he may institute a proceeding provided in sections 4, 6, and 401 of the by filing a complaint with the Hearing Federal Meat Inspection Act (21 U.S.C. Clerk, who shall promptly serve a true 604, 606 and 671), pending final deter- copy thereof upon each respondent, as mination in the proceeding. provided in § 1.147(b) of the Uniform Rules of Practice (9 CFR 1.147(b)). § 335.12 Withholding use of marking, labeling, or containers from use under section 7 of the Federal Meat § 335.11 Withdrawal of inspection serv- Inspection Act. ice for failure of an establishment to destroy any condemned carcass (a) In any situation in which the Ad- or part thereof or any condemned ministrator determines that any mark- meat or meat food product. ing or labeling or size or form of any (a) In any situation in which the Ad- container in use or proposed for use ministrator has reason to believe that with respect to any article subject to an establishment which receives in- Title I of the Federal Meat Inspection spection service under Title I of the Act is false or misleading in any par- Federal Meat Inspection Act has failed ticular, he shall notify, in writing, the to destroy any condemned carcass or person, firm, or corporation using or part thereof or any condemned meat or proposing to use such marking, label- meat food product, as required under ing, or container that such use shall be sections 4 and 6 of the Federal Meat In- withheld unless the marking, labeling, spection Act (21 U.S.C. 604 and 606) and or container is modified in such a man- the regulations in this subchapter, he ner as the Administrator may prescribe may notify the operator of the estab- so that it would not be false or mis- lishment, orally or in writing, of the leading. Administrator’s intent to withdraw (b) The written notification shall (for such period or indefinitely as the briefly set forth the reason for with- Administrator deems necessary to ef- holding the use of the marking, label- fectuate the purposes of the Act) in- ing, or container, and shall offer the re- spection service from the establish- spondent an opportunity to submit a ment, pursuant to sections 4, 6, and 401 written statement by way of answer to of the Act (21 U.S.C. 604, 606, and 671) the notification and a right to request and § 305.5(a) of the regulations (9 CFR a hearing with respect to the merits or 305.5(a)), if the establishment fails to validity of the withholding action. The destroy the condemned articles in- written notification shall be served in volved, as specified in the notification, the manner prescribed in § 1.147(b) of within three days of the receipt of the the Uniform Rules of Practice (7 CFR notification by the operator of the es- 1.147(b)).
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(c) Effective upon service of the noti- complaint, inspection service shall be fication, the use of the marking, label- refused or withdrawn from such estab- ing, or container shall be withheld, if lishment as provided in sections 8 and the Administrator so directs. 401 of the Act pending final determina- (d) If any person, firm, or corporation tion in the proceeding. so notified fails to accept the deter- mination of the Administrator and Subpart C—Rules Applicable to files an answer and requests a hearing, Suspension of Assignment of and the Administrator, after review of Inspectors for Threats to Forc- the answer, determines the initial de- ibly Assault or Forcible As- termination to be correct, he shall file with the Hearing Clerk the notifica- sault, Intimidation or Inter- tion, answer and request for hearing, ference With Any Inspection which shall constitute the complaint Service Employee and answer in the proceeding, which § 335.20 Notification to operator of es- shall thereafter be governed by the tablishment of incident. Uniform Rules of Practice. In any situation in which a super- § 335.13 Refusal or withdrawal of in- visor of an inspection service employee spection service under the Federal determines that the operator of any of- Meat Inspection Act for failure to ficial establishment or any subsidiary maintain sanitary conditions. therein, or any officer, employee, or (a) In any situation in which the Ad- agent of any such operator or any sub- ministrator determines that the sani- sidiary therein, acting within the scope tary conditions of an establishment of his office, employment, or agency, which is applying for inspection or re- has threatened to forcibly assault or ceiving inspection under Title I of the has forcibly assaulted, intimidated or Federal Meat Inspection Act are such interfered with any inspection service that any meat or meat food product employee, under his supervision, in or prepared therein are or would be ren- on account of the performance of the dered adulterated, he shall refuse to employee’s official duties under the allow said meat or meat food products Act, he shall notify the operator of the to be labeled, marked, stamped, or establishment, orally or in writing, of tagged as ‘‘inspected and passed,’’ pur- the incident in accordance with suant to section 8 of the Act (21 U.S.C. § 305.5(b) of the regulations in this sub- chapter (9 CFR 305.5(b)). 608). The Administrator shall notify the applicant or operator of the estab- § 335.21 Procedure upon failure of op- lishment, orally or in writing, as erator of establishment to take ac- promptly as circumstances permit, of tion required by § 305.5(b) of the such refusal to inspect and pass the regulations. meat or meat food products and the (a) If any operator of an establish- reasons therefor, and the action which ment notified pursuant to § 335.20 fails the Administrator deems necessary to to promply take any of the actions eliminate the insanitary conditions. In specified in § 305.5(b) of the regulations the event of oral notification, written (9 CFR 305.5(b)), the Administrator confirmation shall be given, as prompt- may suspend the assignment of inspec- ly as circumstances permit, to the ap- tors at that establishment, in whole or plicant or operator of the establish- in part, as the Administrator deter- ment in the manner prescribed in mines necessary to avoid impairment § 1.147(b) of the Uniform Rules of Prac- of the effective conduct of inspection tice (7 CFR 1.147(b)). service, by notifying the operator of (b) If any applicant or operator of an the establishment, orally or in writing, establishment so notified fails to take of such suspension. In the event of oral the necessary action to eliminate the notification, a written confirmation insanitary conditions within the period shall be given, as promptly as cir- specified in the notice, the Adminis- cumstances permit, to the operator of trator may issue a complaint in ac- the establishment. The written notifi- cordance with the Uniform Rules of cation or confirmation shall be served Practice. Effective upon service of the upon the operator of the establishment
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in the manner prescribed in § 1.147(b) of § 335.30 Suspension of the assignment the Uniform Rules of Practice (7 CFR of inspectors under section 3(b) of 1.147(b)). the Act. (b) The written notification or con- In any situation in which the Admin- firmation, specified in paragraph (a) of istrator has determined that livestock this section, which shall constitute the have been inhumanely slaughtered or complaint in the proceeding, shall handled in connection with slaughter briefly set forth the reason for the sus- at an official establishment, the Ad- pension of the assignment of inspec- ministrator may suspend the assign- tors, including allegations of fact ment of inspectors at that establish- which constitute a basis for the action. ment, in whole or in part, as the Ad- The complaint shall offer the respond- ministrator determines necessary to ent opportunity to submit a specific prevent inhumane treatment of live- written statement by way of answer stock. The Administrator shall notify and the right to request a hearing with the operator of an establishment orally respect to the merits or validity of the or in writing, of such suspension as suspension action, and shall state the soon as possible. In the event of oral time within which answer by the re- notification, a written confirmation spondent must be made, which shall shall be given as promptly as cir- not be less than 10 days after service of cumstances permit to the operator of the complaint. At any time prior to the the establishment. The written notifi- close of the hearing, the complaint cation or confirmation shall be served may be amended; but, in case of an upon the operator of the establishment amendment adding new provisions, the in a manner prescribed in § 1.147(b) of hearing shall, on the request of the re- the Uniform Rules of Practice (7 CFR spondent, be adjourned for a period not 1.147(b)). exceeding 15 days, if the judge deter- § 335.31 Written notification to opera- mines that such and adjournment is tor of establishment of incident. necessary to avoid prejudice to the re- spondent. The written notification or confirma- tion, specified in § 335.30, shall con- (c) A copy of the complaint served stitute the complaint in the proceeding upon the respondent shall be filed with and shall briefly set forth the reason the Hearing Clerk who shall assign the for the suspension of the assignment of matter a docket number. inspectors, including allegations of (d) After the complaint is served fact which constitute a basis for the upon the respondent, as provided in action. The complaint shall offer the paragraphs (a) and (b) of this section, establishment the opportunity to re- the proceeding shall thereafter be con- quest a hearing with respect to the ducted in accordance with rules of merits or validity of the suspension ac- practice which shall be adopted for the tion and shall give the establishment proceeding. the opportunity to furnish written as- surances satisfactory to the Secretary Subpart D—Rules Applicable to that all inhumane slaughtering and Suspension of Assignment of handling in connection with slaughter Inspectors Under Section 3(b) have stopped and will not recur. The complaint shall state the time within of the Federal Meat Inspec- which the respondent’s answer must be tion Act made, which shall not be less than 10 days after service of the complaint. AUTHORITY: Sec. 21, 34 Stat. 1260, as amend- ed, 21 U.S.C. 621; 92 Stat. 1069, 42 FR 35625, § 335.32 Procedure upon receipt of the 35626, 35631. establishment answer.
SOURCE: 44 FR 68817, Nov. 30, 1979, unless If any establishment notified in ac- otherwise noted. cordance with § 335.31:
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(a) Returns an answer and requests a pected violator that the Secretary in- hearing, the complaint, answer, and re- tends to report the violation for pros- quest for hearing shall be filed with the ecution and give the suspected violator Hearing Clerk, who shall assign the an opportunity to present the viola- matter a docket number. The proceed- tor’s views to the Secretary with re- ing shall thereafter be conducted in ac- spect to such proceeding. cordance with the rules of practice (1) Notice and opportunity need not which shall be adopted for the proceed- be provided if the Secretary has any ing; or reason to believe that providing such (b) Returns written assurances which notice and opportunity could result in the Secretary determines to be unsatis- the alteration or destruction of evi- factory, the establishment shall dence, or where disclosure could result promptly be informed of this deter- in injury to persons or property. mination in a written notification. (2) Notice and opportunity need not Said notification shall briefly set forth be provided if the Secretary has any the reason the assurances were deemed reason to believe that providing such unacceptable and shall offer the estab- notice and opportunity could result in lishment the right to file an answer to flight of a suspected violator to avoid the original complaint and to request a prosecution. hearing with respect to the merits or (3) Notice and opportunity need not validity of the suspension action. If be provided if the Secretary has any any establishment so notified files an reason to believe that providing such answer to the original complaint and notice and opportunity could result in requests a hearing, a copy of the com- compromising special investigative plaint, answer, and request for hearing techniques, such as undercover or shall be filed with the Hearing Clerk, other covert operations. who shall assign the matter a docket (4) Notice and opportunity need not number. The proceeding shall there- be provided when the impending crimi- after be conducted in accordance with nal referral involves suspicion of brib- the rules of practice which shall be ery and related offenses, or clandestine adopted for the proceeding. slaughtering and/or processing oper- (c) Returns written assurances which ations. the Secretary determines to be satis- (5) Notice and opportunity need not factory, the suspension shall be termi- be provided when the impending refer- nated and the establishment informed ral is part of an investigation involving of this action as soon as possible. non-Act violations, and the Act and non-Act violations are jointly referred Subpart E—Criminal Violations for prosecution. (b) A notice of opportunity to present views will be sent by registered or cer- AUTHORITY: Sec. 406, Pub. L. 99–641, 100 tified mail, summarize the violations Stat. 3571; 21 U.S.C. 606 note. that constitute the basis of the con- § 335.40 Opportunity for presentation templated prosecution, and describe of views before report of criminal the procedures for presentation of violations. views. Any information given by a re- (a) Except as provided in paragraphs spondent, orally or in writing, shall be- (a)(1) through (5) of this section, before come part of the Department’s official any violation of the Federal Meat In- record concerning the matter. The De- spection Act is reported to the Depart- partment is under no obligation to dis- ment of Justice by the Secretary for close evidence to the suspected viola- criminal prosecution the Secretary tor. must give reasonable notice to the sus- [52 FR 13828, Apr. 27, 1987]
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