FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

9 Animals and Animal Products 2 2009-01-01 2009-01-01 false FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE III CHAPTER III Animals and Animal Products 9 CFR Ch. III (1-1-09 Edition) Food Safety and Inspection Service, USDA CHAPTER III—FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE Editorial Note:

Nomenclature changes to chapter III appear at 69 FR 18803, Apr. 9 2004.

SUBCHAPTER A—AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION Part Page 300 Agency mission and organization 83 301 Terminology; Adulteration and misbranding standards 86 302 Application of inspection and other requirements 91 303 Exemptions 92 304 Application for inspection; grant of inspection 100 305 Official numbers; inauguration of inspection; withdrawal of inspection; reports of violation 101 306 Assignment and authorities of program employees 102 307 Facilities for inspection 103 308 [Reserved] 309 Ante-mortem inspection 108 310 Post-mortem inspection 116 311 Disposal of diseased or otherwise adulterated carcasses and parts 134 312 Official marks, devices and certificates 143 313 Humane slaughter of livestock 148 314 Handling and disposal of condemned or other inedible products at official establishments 154 315 Rendering or other disposal of carcasses and parts passed for cooking 157 316 Marking products and their containers 158 317 Labeling, marking devices, and containers 163 318 Entry into official establishments; reinspection and preparation of products 238 319 Definitions and standards of identity or composition 291 320 Records, registration, and reports 311 321 Cooperation with States and territories 313 322 Exports 314 325 Transportation 316 327 Imported products 327 329 Detention; seizure and condemnation; criminal offenses 345 331 Special provisions for designated States and Territories; and for designation of establishments which endanger public health and for such designated establishments 347 335 Rules of practice governing proceedings under the Federal Meat Inspection Act 352 350 Special services relating to meat and other products 353 351 Certification of technical animal fats for export 356 352 Exotic animals and horses; voluntary inspection 362 354 Voluntary inspection of rabbits and edible products thereof 370 355 Certified products for dogs, cats, and other carnivora; inspection, certification, and identification as to class, quality, quantity, and condition 395 362 Voluntary poultry inspection regulations 406 381 Poultry products inspection regulations 410 SUBCHAPTERS B-C [RESERVED] SUBCHAPTER D—FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS 390 Freedom of information and public information 596 391 Fees and charges for inspection services and laboratory accreditation 598 SUBCHAPTER E—REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT 416 Sanitation 600 417 Hazard Analysis and Critical Control Point (HACCP) Systems 604 424 Preparation and Processing Operations 608 430 Requirements for specific classes of product 634 439 Accreditation of non-Federal chemistry laboratories 637 441 Consumer Protection Standards: Raw Products 646 442 Quantity of contents labeling and procedures and requirements for accurate weights 648 500 Rules of Practice 650 SUBCHAPTER I—EGG PRODUCTS INSPECTION 590 Inspection of eggs and egg products (Egg Products Inspection Act) 653 592 Voluntary inspection of egg products 699 SUBCHAPTER A—AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION Pt. 300 PART 300—AGENCY MISSION AND ORGANIZATION Sec. 300.1 Purpose. 300.2 FSIS responsibilities. 300.3 FSIS organization. 300.4 Organizational terminology; personnel. 300.6 Access to establishments and other places of business. Authority:

21 U.S.C. 451-470, 601-695, 1031-1056; 7 U.S.C. 138-138i, 450, 1621-1627, 1901-1906; 7 CFR 2.7, 2.18, 2.53.

Source:

63 FR 72354, Dec. 31, 1998, unless otherwise noted.

§ 300.1 Purpose.

This part describes the duties and organization of the Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA). It also includes rules on the access of government employees to regulated places of business.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]

§ 300.2 FSIS responsibilities.

(a) Delegations of authority. The Secretary of Agriculture and Under Secretary for Food Safety have delegated to the Administrator of the Food Safety and Inspection Service the responsibility for exercising the functions of the Secretary of Agriculture under various statutes (see 7 CFR 2.7, 2.18, and 2.53).

(b) Implementing regulations. This chapter of title 9 of the Code of Federal Regulations (9 CFR chapter III) includes, in addition to administrative rules, rules and regulations that implement provisions of the following statutes:

(1) The Federal Meat Inspection Act, as amended (FMIA) (21 U.S.C. 601 et seq.), except provisions pertaining to the inspection and certification of the condition of animals for export, and related legislation;

(2) The Poultry Products Inspection Act, as amended (PPIA) (21 U.S.C. 451 et seq.);

(3) The Egg Products Inspection Act, as amended (EPIA) (21 U.S.C. 1031 et seq.), except for the shell egg surveillance program, voluntary laboratory analyses of egg products, and the voluntary grading program;

(4) The Humane Slaughter Act (7 U.S.C. 1901-1906);

(5) The Talmadge-Aiken Act (7 U.S.C. 450), with respect to cooperation with States in the administration of the Federal Meat Inspection Act and the Poultry Products Inspection Act;

(6) The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), relating to voluntary inspection of poultry and edible products thereof; voluntary inspection and certification of technical animal fat; certified products for dogs, cats, and other carnivora; voluntary inspection of rabbits and edible products thereof; and voluntary inspection and certification of edible meat and other products; and

(7) The National Laboratory Accreditation Program (7 U.S.C. 138-138i) with respect to laboratories accredited only for pesticide residue analysis in meat and poultry products.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]

§ 300.3 FSIS organization.

(a) General. The organization of FSIS reflects the agency's primary regulatory responsibilities: implementation of the FMIA, the PPIA, and the EPIA. FSIS implements the inspection provisions of the FMIA, the PPIA, and the EPIA through its field structure.

(b) Headquarters. FSIS has eight principal components or offices, each of which is under the direction of a Deputy Administrator. The Deputy Administrators, along with their staffs, and the Administrator, along with the Office of the Administrator and three staff offices that report to the Administrator, are located at U.S. Department of Agriculture headquarters in Washington, DC.

(1) Program Offices. FSIS's headquarters offices are the Office of Public Health and Science, which provides scientific analysis, advice, data, and recommendations on matters involving public health and science; the Office of Management, which provides centralized administrative and support services; the Office of Policy and Program Development, which develops and articulates the Agency's policies regarding food safety and other consumer protections; the Office of Field Operations, which manages regulatory oversight and inspection (see paragraph (c) of this section); the Office of Food Security and Emergency Preparedness, which works to prevent or, if necessary, coordinate a response to an intentional attack on the food supply; the Office of Program Evaluation, Enforcement, and Review, which acts to ensure that Agency programs are functioning in an efficient and effective manner; the Office of Public Affairs, Education, and Outreach, which is responsible for facilitating communications between FSIS and Congress, the Agency's constituents, and the media; and the Office of International Affairs, which is responsible for recommending and developing international policy activities.

(2) [Reserved]

(1) District offices. Each district office, under the direction of a District Manager, manages a farm-to-table food safety program of regulatory oversight and inspection in a district consisting of a State or several States and territories.

The locations of the district offices and the districts' geographic boundaries are as follows:

Alameda, CA California. Boulder, CO

Salem, OR (satellite office)

Arizona, Colorado, Nevada, New Mexico, Utah, Alaska, American Samoa, Guam, Hawaii, Idaho, Northern Mariana Islands, Oregon, and Washington. Minneapolis, MN Minnesota, Montana, North Dakota, South Dakota, and Wyoming. Des Moines, IA Iowa and Nebraska. Lawrence, KS Kansas and Missouri. Springdale, AR Arkansas, Louisiana, and Oklahoma. Dallas, TX Texas. Madison, WI Michigan and Wisconsin. Chicago, IL

Pickering, OH, (satellite office)

Illinois, Ohio, and Indiana. Philadelphia, PA Pennsylvania and New Jersey. Albany, NY Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. Beltsville, MD Delaware, District of Columbia, Maryland, Virginia, and West Virginia. Raleigh, NC North Carolina, South Carolina, and Kentucky. Atlanta, GA Florida, Georgia, Puerto Rico, and the Virgin Islands. Jackson, MS Alabama, Mississippi, and Tennessee.

(2) Technical Service Center. The Technical Service Center, which is located in Omaha, Nebraska, provides technical guidance, review, and training on the interpretation and application of regulatory requirements.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]

§ 300.4 Organizational terminology; personnel.

(a) Unless otherwise specifically provided or required in the context of a particular part of the regulations:

Administrator means the Administrator of the Food Safety and Inspection Service or any other officer or employee of the Department to whom authority has been or may in the future be delegated to act in his or her stead.

Circuit Supervisor means the official of the Inspection Service who is assigned responsibility for supervising the conduct of inspection at a specific group of official establishments.

Inspection program, inspection service, or program means the organizational unit within the Department with responsibility for carrying out the FMIA, the PPIA, and the EPIA.

Inspection program employee, inspection service employee, or program employee means an inspector or other government employee who is authorized to conduct any inspection or perform any other duty in connection with the inspection program, inspection service, or program.

Inspection service supervisor or Inspection program supervisor means an inspection program or service employee or program employee who is delegated authority to exercise supervision over one or more phases of the inspection program.

Inspector means an inspector of the inspection program, inspection service, and program. (“Inspector” includes an employee or official of the Federal government or the government of a State or territory or the District of Columbia who is authorized by the Administrator to inspect meat and meat products or poultry and poultry products under the authority of the FMIA or the PPIA, respectively, under an agreement entered into between the Administrator and the appropriate State or other agency.)

Inspector in charge or IIC means an inspection program employee, inspection service employee, or program employee who has primary responsibility for inspection program functions at a particular official establishment.

Secretary means the Secretary of Agriculture of the United States or his or her delegate.

(b) FSIS has replaced the regional office and import field office structure referenced in some parts of subchapter A of this chapter. Authority previously delegated to Regional Directors now is delegated to district managers; authority previously delegated to area supervisors and import supervisors now is delegated to inspection program supervisors in the successor district offices.

[69 FR 253, Jan. 5, 2004]

§ 300.6 Access to establishments and other places of business.

(a) General. Upon presentation of credentials—

(1) Persons subject to provisions of the FMIA or the PPIA must afford representatives of the Secretary access to establishments that slaughter or otherwise prepare livestock products or process poultry products and to other places of business subject to regulation thereunder; and

(2) Persons subject to provisions of the EPIA must afford representatives of the Secretary access as specified in part 590 of this chapter.

(b) Meat and poultry establishments and related industries. (1) At all times, by day or night, whether the establishment is being operated or not, inspection program employees must have access to the premises and to every part of an establishment that slaughters livestock or otherwise prepares meat products or slaughters poultry or otherwise processes poultry products that are subject to inspection for the purpose of conducting an inspection or performing any other inspection program duty. The numbered official badge of an inspection program employee is sufficient identification to entitle him or her to admittance to all parts of such an establishment and its premises.

(2) At all ordinary business hours, upon presentation of credentials by a representative of the Secretary, any person (including any firm or corporation or other business unit) subject to recordkeeping requirements under section 202 of the FMIA or section 11(b) of the PPIA must permit such representative to enter his or her place of business to examine the facilities and inventory and to examine and copy the records specified in § 320.1 and § 381.175, respectively, of this chapter and, upon payment of the fair market value therefor, take reasonable samples of the inventory.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 254, Jan. 5, 2004]

Pt. 301 PART 301—TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS Sec. 301.1 General. 301.2 Definitions. Authority:

21 U.S.C. 601-695; 7 U.S.C. 138-138i, 450, 1901-1906; 7 CFR 2.7, 2.18, 2.53.

§ 301.1 General.

For purposes of this chapter and unless otherwise specifically provided by regulation or required in the context of particular regulations:

(a) Terms have the meanings set forth in this part;

(b) The singular form also imports the plural, and the masculine form also imports the feminine and vice versa.

[69 FR 254, Jan. 5, 2004]

§ 301.2 Definitions.

As used in this subchapter, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:

The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., sec. 601 et seq.).

Adulterated. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) If it bears or contains any such poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

(2)(i) If it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is:

(A) A pesticide chemical in or on a raw agricultural commodity;

(B) A food additive; or

(ii) If it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;

(iii) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;

(iv) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, That an article which is not deemed adulterated under paragraphs (aa)(2) (ii), (iii), or (iv) of this section shall nevertheless be deemed adulterated if use of the pesticide chemical food additive, or color additive in or on such article is prohibited by the regulations in this subchapter in official establishments;

(3) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(5) If it is, in whole or in part, the product of an animal which has died otherwise than by slaughter;

(6) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(7) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act;

(8) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or,

(9) If it is margarine containing animal fat and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise adulterated.

Anesthesia. Loss of sensation or feeling.

Animal food. Any article intended for use as food for dogs, cats, or other animals derived wholly, or in part, from the carcass or parts or products of the carcass of any livestock, except that the term animal food as used herein does not include:

(1) Processed dry animal food or

(2) Livestock or poultry feeds manufactured from processed livestock byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and feed grade animal fat).

Animal food manufacturer. Any person engaged in the business of manufacturing or processing animal food.

Artificial coloring. A coloring containing any dye or pigment, which dye or pigment was manufactured by a process of synthesis or other similar artifice, or a coloring which was manufactured by extracting a natural dye or natural pigment from a plant or other material in which such dye or pigment was naturally produced.

Artificial flavoring. A flavoring containing any sapid or aromatic constituent, which constituent was manufactured by a process of synthesis or other similar artifice.

Biological residue. Any substance, including metabolites, remaining in livestock at time of slaughter or in any of its tissues after slaughter as the result of treatment or exposure of the livestock to a pesticide, organic or inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other therapeutic or prophylactic agent.

Capable of use as human food. This term applies to any carcass, or part or product of a carcass, of any livestock, unless it is denatured or otherwise identified as required by the applicable provisions of §§ 314.3, 314.10, 325.11, and 325.13 of this subchapter to deter its use as a human food, or it is naturally inedible by humans; e.g., hoofs or horns in their natural state.

Captive bolt. A stunning instrument which when activated drives a bolt out of a barrel for a limited distance.

Carbon dioxide. A gaseous form of the chemical formula CO2.

Carbon dioxide concentration. Ratio of carbon dioxide gas and atmospheric air.

Carcass. All parts, including viscera, of any slaughtered livestock.

Chemical preservative. Any chemical that, when added to a meat or meat food product, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices or substances added to meat and meat food products by exposure to wood smoke.

Other definitions, if any, that are applicable only for purposes of a specific part of the regulations in this subchapter, are set forth in such part.

Commerce. Commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.

Consciousness. Responsiveness of the brain to the impressions made by the senses.

Cutting up. Any division of any carcass or part thereof, except that the trimming of carcasses or parts thereof to remove surface contaminants is not considered as cutting up.

Dead livestock. The body (cadaver) of livestock which has died otherwise than by slaughter.

Dying, diseased, or disabled livestock. Livestock which has or displays symptoms of having any of the following:

(1) Central nervous system disorder;

(2) Abnormal temperature (high or low);

(3) Difficult breathing;

(4) Abnormal swellings;

(5) Lack of muscular coordination;

(6) Inability to walk normally or stand;

(7) Any of the conditions for which livestock is required to be condemned on ante-mortem inspection in accordance with the regulations in part 309 of this subchapter.

Edible. Intended for use as human food.

Experimental animal. Any animal used in any research investigation involving the feeding or other administration of, or subjection to, an experimental biological product, drug, or chemical or any nonexperimental biological product, drug, or chemical used in a manner for which it was not intended.

Exposure time. The period of time an animal is exposed to an anesthesia-producing carbon dioxide concentration.

Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.

Firm. Any partnership, association, or other unincorporated business organization.

Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments.

Immediate container. The receptacle or other covering in which any product is directly contained or wholly or partially enclosed.

Inedible. Adulterated, uninspected, or not intended for use as human food.

Inhumane slaughter or handling in connection with slaughter. Slaughter or handling in connection with slaughter not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 Stat. 1069) and part 313 of this subchapter.

“Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof). This term means that the product so identified has been inspected and passed under the regulations in this subchapter, and at the time it was inspected, passed, and identified, it was found to be not adulterated.

Label. A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.

Labeling. All labels and other written, printed, or graphic matter:

(1) Upon any article or any of its containers or wrappers, or

(2) Accompanying such article.

Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine.

Meat. (1) The part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing. As applied to products of equines, this term has a comparable meaning.

(i) Meat does not include the muscle found in the lips, snout, or ears.

(ii) Meat may not include significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).

(2) [Reserved]

Meat broker. Any person engaged in the business of buying or selling carcasses, parts of carcasses, meat or meat food products of livestock on commission, or otherwise negotiating purchases or sales of such articles other than for his/her own account or as an employee of another person.

Meat byproduct. Any part capable of use as human food, other than meat, which has been derived from one or more cattle, sheep, swine, or goats. This term, as applied to products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.

Meat food product. Any article capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, except those exempted from definition as a meat food product by the Administrator in specific cases or by the regulations in part 317 of this subchapter, upon a determination that they contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and provided that they comply with any requirements that are imposed in such cases or regulations as conditions of such exemptions to assure that the meat or other portions of such carcasses contained in such articles are not adulterated and that such articles are not represented as meat food products. This term, as applied to food products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.

Misbranded. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) If its labeling is false or misleading in any particular;

(2) If it is offered for sale under the name of another food;

(3) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated;

(4) If its container is so made, formed, or filled as to be misleading;

(5) If in a package or other container unless it bears a label showing:

(i) The name and place of business of the manufacturer, packer, or distributor; and

(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in part 317 of this subchapter with respect to the quantity of contents;

(6) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) If it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations in part 319 of this subchapter unless:

(i) It conforms to such definition and standard, and

(ii) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;

(8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(9) If it is not subject to the provisions of paragraph (vv)(7)(ii) of this section unless its label bears:

(i) The common or usual name of the food, if any there be, and

(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except as otherwise provided in part 317 of this subchapter;

(10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as is required by the regulations in part 317 of this subchapter.

(11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided by the regulations in part 317 of this subchapter; or

(12) If it fails to bear, directly thereon or on its containers, when required by the regulations in part 316 or 317 of this subchapter, the inspection legend and, unrestricted by any of the foregoing, such other information as the Administrator may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.

Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of meat food and meat products, excluding labeling and packaging materials as covered in part 317 of the subchapter.

Official certificate. Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act.

Official device. Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark.

Official establishment. Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter.

Official import inspection establishment. This term means any establishment, other than an official establishment as defined in paragraph (zz) of this section, where inspections are authorized to be conducted as prescribed in § 327.6 of this subchapter.

Official inspection legend. Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act.

Official mark. The official inspection legend or any other symbol prescribed by the regulations in this subchapter to identify the status of any article or animal under the Act.

Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for meat products.

Person. Any individual, firm, or corporation.

Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for purposes of the Act and the regulations in this subchapter as under the Federal Food, Drug, and Cosmetic Act.

Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.

Process authority. A person or organization with expert knowledge in meat production process control and relevant regulations. This definition does not apply to subpart G of part 318.

Process schedule. A written description of processing procedures, consisting of any number of specific, sequential operations directly under the control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. This definition does not apply to subpart G of part 318.

Product. Any carcass, meat, meat byproduct, or meat food product, capable of use as human food.

Renderer. Any person engaged in the business of rendering carcasses or parts or products of the carcasses of any livestock except rendering conducted under inspection or exemption under Title I of the Act.

Shipping container. The outside container (box, bag, barrel, crate, or other receptacle or covering) containing or wholly or partly enclosing any product packed in one or more immediate containers.

State. Any State of the United States or the Commonwealth of Puerto Rico.

Supervision. The controls, as prescribed in instructions to Program employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations in this subchapter.

Surgical anesthesia. A state of unconsciousness measured in conformity with accepted surgical practices.

Territory. Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.

U.S. Condemned. This term means that the livestock so identified has been inspected and found to be in a dying condition, or to be affected with any other condition or disease that would require condemnation of its carcass.

U.S. Inspected and Condemned (or any authorized abbreviation thereof). This term means that the carcass, viscera, other part of carcass, or other product so identified has been inspected, found to be adulterated, and condemned under the regulations in this subchapter.

U.S. Passed for Cooking. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be cooked or rendered as prescribed by the regulations in part 315 of this chapter.

U.S. Passed for Refrigeration. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be refrigerated or otherwise handled as prescribed by the regulations in part 311 of this subchapter.

U.S. Retained. This term means that the carcass, viscera, other part of carcass, or other product, or article so identified is held for further examination by an inspector to determine its disposal.

U.S. Suspect. This term means that the livestock so identified is suspected of being affected with a disease or condition which may require its condemnation, in whole or in part, when slaughtered, and is subject to further examination by an inspector to determine its disposal.

United States. The States, the District of Columbia, and the Territories of the United States.

[35 FR 15554, Oct. 3, 1970] Editorial Note:

For Federal Register citations affecting § 301.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

Pt. 302 PART 302—APPLICATION OF INSPECTION AND OTHER REQUIREMENTS Sec. 302.1 Establishments requiring inspection. 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public health. 302.3 Livestock and products entering official establishments. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

§ 302.1 Establishments requiring inspection.

(a) Inspection under the regulations in this subchapter is required at:

(1) Every establishment, except as provided in § 303.1 (a) and (b), or (c) of this subchapter, in which any livestock are slaughtered for transportation or sale as articles of commerce, or in which any products of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale as articles of commerce, which are intended for use as human food;

(2) Every establishment, except as provided in § 303.1 (a) and (b), or (d) of this subchapter, within any State or organized Territory which is designated pursuant to paragraph 301(c) of the Act, at which any livestock are slaughtered or any products of any livestock are prepared, for use as human food solely for distribution within such jurisdiction; and

(3) Every establishment, except as provided in § 303.1 (a) and (b) of this subchapter, that is designated by the Administrator pursuant to paragraph 301(c) of the Act as one producing adulterated products which would clearly endanger the public health.

[35 FR 15556, Oct. 3, 1970, as amended at 36 FR 12002, June 24, 1971]

§ 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public health.

Special provisions with respect to establishments and their operations and transactions by any persons in designated States and Territories and with respect to establishments designated as producing adulterated products which clearly endanger public health, and the operators thereof, in any State or Territory appear in part 331 of this subchapter, and apply to such establishments, operations and transactions in lieu of the regulations elsewhere in this subchapter except insofar as such regulations are made applicable by the provisions in part 331 of this subchapter.

[35 FR 15556, Oct. 3, 1970, as amended at 51 FR 29909, Aug. 21, 1986]

§ 302.3 Livestock and products entering official establishments.

All livestock and all products entering any official establishment and all products prepared, in whole or in part, therein, shall be inspected, handled, stored, prepared, packaged, marked, and labeled as required by the regulations in this subchapter.

[35 FR 15556, Oct. 3, 1970]

Pt. 303 PART 303—EXEMPTIONS Sec. 303.1 Exemptions. 303.2 Experimentation: Intensity of inspection coverage. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

§ 303.1 Exemptions.

(a) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to:

(1) The slaughtering by any individual of livestock of his own raising, and the preparation by him and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock exclusively for use by him and members of his household and his nonpaying guests and employees;

(2) The custom slaughter by any person of cattle, sheep, swine, or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat or meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That the following requirements are met by such custom operator;

(i) Establishments that conduct custom operations must be maintained and operated in accordance with the provisions of §§ 416.1 through 416.6, except for: § 416.2(g)(2) through (6) of this chapter, regarding water reuse and any provisions of part 416 of this chapter relating to inspection or supervision of specified activities or other action by a Program employee. If custom operations are conducted in an official establishment, however, all of the provisions of Part 416 of this chapter of shall apply to those operations.

(ii) If the custom operator prepares or handles any products for sale, they are kept separate and apart from the custom prepared products at all times while the latter are in his custody;

(iii) The custom prepared products are plainly marked “Not for Sale” as provided in § 316.16 of this subchapter, immediately after being prepared and are kept so identified until delivered to the owner; and

(iv) If exempted custom slaughtering or other preparation of products is conducted in an official establishment, all facilities and equipment in the official establishment used for such custom operations shall be thoroughly cleaned and sanitized before they are used for preparing any products for sale.

(b)(1) The exempted custom prepared products shall be prepared and handled in accordance with the provisions of §§ 318.5, 318.6, 318.7, 318.10, and 318.300 through 318.311 of this subchapter and shall not be adulterated as defined in paragraph 1(m) of the Act: Provided, That the provisions of §§ 318.5, 318.6, 318.10, and 318.300 through 318.311 relating to inspection or supervision of specified activities or other action by a Program inspector, and the provisions of § 318.6(b)(9) and (10), shall not apply to the preparation and handling of such exempted products.

(2) The exempted custom prepared products shall comply with the requirements of §§ 316.16 and 317.16 of this subchapter.

(3) The custom operators claiming exemption under paragraph (a)(2) of this section shall keep records, in addition to records otherwise required by part 320 of this subchapter, showing the numbers and kinds of livestock slaughtered on a custom basis, the quantities and types of products prepared on a custom basis, and the names and addresses of the owners of the livestock and products.

(4) Articles capable of use as human food, resulting from the exempted custom slaughter or other preparation of products shall be promptly denatured or otherwise identified in accordance with § 325.13 of this subchapter and not removed from the establishment where the custom operations are conducted until so identified, unless they are delivered to the owner of the articles for use in accordance with paragraph (a)(2) of this section.

(c) It has been determined that it is impracticable to provide inspection of the preparation of products at establishments in any unorganized Territory at which livestock are slaughtered or their products are prepared for distribution solely within such jurisdiction and that exempting such establishments from requirements of the Act for such inspections under the conditions stated in this section will otherwise facilitate enforcement of the Act. Therefore, such inspection requirements of the Act and of the regulations in this subchapter shall not apply at such establishments if they are operated in accordance with the regulations in part 416, §§ 416.1 through 416.5 of this chapter. However, the Administrator may refuse, withdraw, or modify any exemption under this paragraph when he determines in any specific case in accordance with the applicable rules of practice that such action is necessary to effectuate the purposes of this Act.

(d)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments.

(2) For purposes of paragraph (d)(1) of this section:

(i) Operations of types traditionally and usually conducted at retail stores and restaurants are the following:

(a) Cutting up, slicing, and trimming carcasses, halves, quarters, or wholesale cuts into retail cuts such as steaks, chops, and roasts, and freezing such cuts;

(b) Grinding and freezing products made from meat;

(c) Curing, cooking, smoking, rendering or refining of livestock fat, or other preparation of products, except slaughtering or the retort processing of canned products;

(d) Breaking bulk shipments of products;

(e) Wrapping or rewrapping products.

(ii) Any quantity or product purchased by a consumer from a particular retail supplier shall be deemed to be a normal retail quantity if the quantity so purchased does not in the aggregate exceed one-half carcass. The following amounts of product will be accepted as representing one-half carcass of the species identified:

One-half carcass pounds Cattle 300 Calves 37.5 Sheep 27.5 Swine 100 Goats 25

(iii) A retail store is any place of business where:

(a) The sales of product are made to consumers only;

(b) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Administrator. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $500. Notice of the adjusted dollar limitation will be published in the Federal Register. 1

1 The dollar limitation currently in effect may be obtained by contacting Director, Slaughter Inspection Standards and Procedures Division, Technical Services, Food and Safety Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 (202) 447-3219.

(c) Only federally or State inspected and passed product is handled or used in the preparation of any product, except that product resulting from the custom slaughter or custom preparation of product may be handled or used in accordance with paragraph (a)(2) and (b) of this section but not for sale;

(d) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section;

(e) The preparation of products for sale to household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section; and

(f) The preparation of products for sale to other than household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail store at which custom slaughtering or preparation of products is conducted is not thereby disqualified from exemption as a retail store under this paragraph (d).)

(iv) Restaurants. (a) A restaurant is any establishment where:

(1) Product is prepared only for sale or service in meals or as entrees directly to individual consumers at such establishments;

(2) Only federally or State inspected and passed product or such product prepared at a retail store exempted under paragraph (d)(2)(iii) of this section is handled or used in the preparation of any product;

(3) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and

(4) The preparation of product is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.

(b) The definition of a restaurant includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meets the requirements of this paragraph.

(c) For purposes of this paragraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirements of this paragraph: Provided, That the requirements of §§ 320.1 through 320.4 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary, if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator's determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.

(v) Similar retail-type establishment: Any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as prescribed in paragraphs (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.

(vi) Consumer: Any household consumer, hotel, restaurant, or similar institution as determined by the Administrator in specific cases.

(3) Whenever any complaint is received by the Administrator from any person alleging that any retail store claiming exemption under this paragraph (d), in any designated State or organized Territory that is identified under section 205 of the Act (as one that does not have or is not exercising adequate authority with respect to recordkeeping requirements) has been operated in violation of the conditions prescribed in this section for exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail store and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator still has reason to believe that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail store would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of total monthly purchases and of total monthly sales of meat, meat byproducts, and meat food products, in terms of dollar values of the products involved. Such records shall separately show total sales to household consumers and total sales to other consumers and shall be maintained for the period prescribed in § 320.3 of this subchapter. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this subparagraph.

(e)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to meat pizzas containing meat food product ingredients which were prepared, inspected, and passed in a cured or cooked form as ready-to-eat (i.e., no further cooking or other preparation is needed) in compliance with the requirements of the Act and these regulations; and the meat pizzas are to be served in public or private nonprofit institutions, provided that the meat pizzas are ready-to-eat (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to the receiving institution by employees of the preparing firm, receiving institution, or a food service management company contracted to conduct food service at the public or private nonprofit institution, without intervening transfer or storage.

(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-203, and 6-105, part IV, of the Food and Drug Administration's Food Service Sanitation Manual (1976 Recommendations), DHEW Publication No. (FDA) 78-2081, which is incorporated by reference, shall apply to the facilities and operations of businesses claiming this exemption. (These materials are incorporated as they exist on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Facilities and operations of businesses claiming this exemption shall also conform to the following requirements:

(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing and sanitizing of utensils and equipment, a sink with not fewer than three compartments shall be provided and used. Sink compartments shall be large enough to permit the accommodation of the equipment and utensils, and each compartment of the sink shall be supplied with hot and cold potable running water. Fixed equipment and utensils and equipment too large to be cleaned in sink compartments shall be washed manually or cleaned through pressure spray methods.

(B) Drain boards or easily movable dish tables of adequate size shall be provided for proper handling of soiled utensils prior to washing and for cleaned utensils following sanitizing and shall be located so as not to interfere with the proper use of the dishwashing facilities.

(C) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil.

(D) Except for fixed equipment and utensils too large to be cleaned in sink compartments, manual washing, rinsing and sanitizing shall be conducted in the following sequence:

(1) Sinks shall be cleaned prior to use.

(2) Equipment and utensils shall be thoroughly washed in the first compartment with a hot detergent solution that is kept clean.

(3) Equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment.

(4) Equipment and utensils shall be sanitized in the third compartment according to one of the methods prescribed in paragraph (e)(3)(i)(E) (1) through (4) of this section.

(E) The food-contact surfaces of all equipment and utensils shall be sanitized by:

(1) Immersion for at least 1/2 minute in clean, hot water at a temperature of at least 170 °F; or

(2) Immersion for at least 1 minute in a clean solution containing at least 50 parts per million of available chlorine as a hypochlorite and at a temperature of at least 75 °F; or

(3) Immersion for at least 1 minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and at a temperature of at least 75 °F; or

(4) Immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 that will provide the equivalent bactericidal effect of a solution containing at least 50 parts per million of available chlorine as a hypochlorite at a temperature of at least 75 °F for 1 minute; or

(5) Treatment with steam free from materials or additives other than those specified in 21 CFR 173.310 in the case of equipment too large to sanitize by immersion, but in which steam can be confined; or

(6) Rinsing, spraying, or swabbing with a chemical sanitizing solution of at least twice the strength required for that particular sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in the case of equipment too large to sanitize by immersion.

(F) When hot water is used for sanitizing, the following facilities shall be provided and used:

(1) An integral heating device or fixture installed in, on, or under the sanitizing compartment of the sink capable of maintaining the water at a temperature of at least 170 °F; and

(2) A numerically scaled indicating thermometer, accurate to ±3 °F, convenient to the sink for frequent checks of water temperature; and

(3) Dish baskets of such size and design to permit complete immersion of the tableware, kitchenware, and equipment in the hot water.

(G) When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted under 21 CFR 178.1010 and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.

(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils. These machines and devices shall be properly installed and maintained in good repair.

Machines and devices shall be operated in accordance with manufacturers' instructions, and utensils and equipment placed in the machine shall be exposed to all dishwashing cycles. Automatic detergent dispensers, wetting agent dispensers, and liquid sanitizer injectors, if any, shall be properly installed and maintained.

(B) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than 15 nor more than 25 pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A 1/4-inch IPS valve shall be provided immediately up stream from the final rinse control valve to permit checking the flow pressure of the final rinse water.

(C) Machine or water line mounted numerically scaled indicating thermometers, accurate to ±3 °F, shall be provided to indicate the temperature of the water in each tank of the machine and the temperature of the final rinse water as it enters the manifold.

(D) Rinse water tanks shall be protected by baffles, curtains, or other effective means to minimize the entry of wash water into the rinse water. Conveyors in dishwashing machines shall be accurately timed to assure proper exposure times in wash and rinse cycles in accordance with manufacturers' specifications attached to the machines.

(E) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of easily movable dishtables for the storage of clean utensils following sanitization.

(F) Equipment and utensils shall be flushed or scraped and, when necessary, soaked to remove gross food particles and soil prior to being washed in a dishwashing machine unless a prewashcycle is a part of the dishwashing machine operation. Equipment and utensils shall be placed in racks, trays, or baskets, or on conveyors, in a way that food-contact surfaces are exposed to the unobstructed application of detergent wash and clean rinse waters and that permits free draining.

(G) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washers) using chemicals for sanitization may be used: Provided, That,

(1) The temperature of the wash water shall not be less than 120 °F.

(2) The wash water shall be kept clean.

(3) Chemicals added for sanitization purposes shall be automatically dispensed.

(4) Utensils and equipment shall be exposed to the final chemical sanitizing rinse in accordance with manufacturers' specifications for time and concentration.

(5) The chemical sanitizing rinse water temperature shall be not less than 75 °F nor less than the temperature specified by the machine's manufacturer.

(6) Chemical sanitizers used shall meet the requirements of 21 CFR 178.1010.

(7) A test kit or other device that accurately measures the parts per million concentration of the solution shall be available and used.

(H) Machines using hot water for sanitizing may be used provided that wash water and pumped rinse water shall be kept clean and water shall be maintained at not less than the following temperatures:

(1) Single-tank, stationary-rack, dual-temperature machine:

Wash temperature

150 °F

Final rinse temperature

180 °F

(2) Single-tank, stationary-rack, single-temperature machine:

Wash temperature

165 °F

Final rinse temperature

165 °F

(3) Single-tank, conveyor machine:

Wash temperature

160 °F

Final rinse temperature

180 °F

(4) Multitank, conveyor machine:

Wash temperature

150 °F

Pumped rinse temperature

160 °F

Final rinse temperature

180 °F

(5) Single-tank, pot, pan, and utensil washer (either stationary or moving-rack):

Wash temperature

140 °F

Final rinse temperature

180 °F

(I) All dishwashing machines shall be thoroughly cleaned at least once a day or more often when necessary to maintain them in a satisfactory operating condition.

(iii) Steam. Steam used in contact with food or food-contact surfaces shall be free from any materials or additives other than those specified in 21 CFR 173.310.

(4) For purposes of this paragraph, the term “private nonprofit institution” means “a corporation, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals, no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation, and which does not participate in, or intervene in (including the publishing or distribution of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”

(5) The Administrator may withdraw or modify the exemption set forth in § 303.1(e)(1) for a particular establishment when he or she determines that such action is necessary to ensure food safety and public health. Before such action is taken, the owner or operator of the particular establishment shall be notified, in writing, of the reasons for the proposed action and shall be given an opportunity to respond, in writing, to the Administrator within 20 days after notification of the proposed action. The written notification shall be served on the owner or operator of the establishment in the manner prescribed in section 1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). In those instances where there is conflict of any material fact, the owner or operator of the establishment, upon request, shall be afforded an opportunity for a hearing with respect to the disputed fact, in accordance with rules of practice which shall be adopted for the proceeding. However, such withdrawal or modification shall become effective pending final determination in the proceeding when the Administrator determines that an imminent threat to food safety or public health exists, and that such action is, therefore, necessary to protect the public health, interest or safety. Such withdrawal or modification shall be effective upon oral or written notification, whichever is earlier, to the owner or operator of the particular establishment as promptly as circumstances permit. In the event of oral notification, written confirmation shall be given to the owner or operator of the establishment as promptly as circumstances permit. This withdrawal or modification shall continue in effect ending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.

(f) The adulteration and misbranding provisions of the Act and the regulations in this subchapter, other than the requirement of the official inspection legend, apply to articles which are exempted from inspection or not required to be inspected under this section. This includes the requirement that any pork and any product containing pork be prepared only in compliance with any applicable requirement for the destruction of trichina as provided in § 318.10 of this subchapter.

(g) The Administrator may extend the requirements of titles I and IV of the Act to any establishment in any State or organized Territory at which products are prepared for distribution solely within such jurisdiction, if he determines in accordance with the provisions of paragraph 301(c)(1) of the Act that it is producing adulterated products which would clearly endanger the public health.

(h) The Administrator may in specific classes of cases waive for limited periods any provisions of the regulations in this subchapter in order to permit appropriate and necessary action in the event of a public health emergency or to permit experimentation so that new procedures, equipment, and/or processing techniques may be tested to facilitate definite improvements: Provided, That such waivers of the provisions of such regulations are not in conflict with the purposes or provisions of the Act.

(Approved by the Office of Management and Budget under control number 0583-0015) [35 FR 15558, Oct. 3, 1970, as amended at 36 FR 12002, 12004, June 24, 1971; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 746, Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR 10032, Mar. 30, 1987; 52 FR 48091, Dec. 18, 1987; 53 FR 24679, June 30, 1988; 57 FR 34182, Aug. 3, 1992; 64 FR 56415, Oct. 20, 1999]

§ 303.2 Experimentation: Intensity of inspection coverage.

(a) Pursuant to the Processed Products Inspection Improvement Act of 1986, Title IV of the Futures Trading Act of 1986 (Pub. L. 99-641), in establishments preparing products at which inspection under the Act and regulations is required, the frequency with which and the manner in which meat food products made from livestock previously slaughtered in official establishments are examined and inspected by Program employees is to be based on considerations relevant to effective regulation of meat food products and protection of the health and welfare of consumers. In order to test procedures for use in making such determinations and, in particular, for determining whether and, is so, to what extent the intensity of inspection coverage exceeds that which should be considered necessary pursuant to section 6 of the Act, as amended by section 403(a) of the Futures Trading Act of 1986, the Administrator is initiating experimentation of a new system of inspection for reviewing the performance of establishments and for designing the supervision and other conditions and methods of inspection coverage. For the period of such experimentation, the Administrator shall identify establishments for review, and the frequency and the manner of inspection by Program employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.

(b) The determinations referred to in paragraph (a) of this section shall be made by the program and shall reflect evaluations of the performance and the characteristics and such establishments.

(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:

(i) The history of compliance with applicable regulatory requirements by the person conducting operations at such establishment or by anyone responsibly connected with the business conducting operations at such establishment, as “responsibly connected” is defined in section 401(g) of the Act,

(ii) The competence of the person conducting operations at such establishment, as indicated by:

(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,

(B) Demonstrated ability to apply such knowledge in a timely and consistent manner, and

(C) Commitment to correcting deficiencies noted by Program employees and otherwise assuring compliance with applicable regulatory requirements, and

(iii) The procedures used in such establishment to control the production process, environment, and resulting product in order to assure and monitor compliance with the requirements of the Act and the rules and regulations promulgated thereunder.

(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:

(i) The complexity of the processing operation(s) conducted at such establishment,

(ii) The frequency with which each such operation is conducted at such establishment,

(iii) The volume of product resulting from each such operation at such establishment,

(iv) Whether and to what extent slaughter operations also are conducted at such establishment,

(v) What, if any, food products not regulated under this Act or the Poultry Products Inspection Act also are prepared at such establishment, and

(vi) The size of such establishment.

(c)(1) For the period of experimentation described in paragraph (a) of this section, the frequency of inspection by Program employees of operations other than slaughter may be reduced in an establishment in which the procedures referred to therein are being tested if and only if the evaluation of the performance of such establishment described in paragraph (b)(1) indicates that there are:

(i) No instances, documented in records compiled no earlier than 10 years before, of substantial and recent noncompliance with applicable regulatory requirements (taking into account both the nature and frequency of any such noncompliance), and

(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.

(2)(i) The frequency of Federal inspection and other conditions and methods of inspection coverage in any establishment in which the frequency of Federal inspection is reduced shall be based on:

(A) The evaluation of the characteristics of such establishment described in paragraph (b)(2) of this section,1

1 These evaluations will be based upon guidelines developed by FSIS and the complexity categorization in FSIS Directive 1030.2 (Documentation of Processing and Combination Assignments, 4/22/85). The guidelines and Directive will be available for public inspection and copying in the Policy Office, Room 3168, South Agriculture Building, 14th Street and Independence Avenue, SW., Washington, DC.

(B) The significance of potential public health consequences of noncompliance, and

(ii) To the extent that such frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this subchapter, the Administrator will waive such provisions for the period of experimentation, in accordance with § 303.1(g) of this subchapter.

[52 FR 10032, Mar. 30, 1987 and 52 FR 48091, Dec. 18, 1987]

Pt. 304 PART 304—APPLICATION FOR INSPECTION; GRANT OF INSPECTION Sec. 304.1 Application for inspection. 304.2 Information to be furnished; grant or refusal of inspection. 304.3 Conditions for receiving inspection. Authority:

21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

§ 304.1 Application for inspection.

(a) Before the inspection is granted, each person conducting operations at an establishment subject to the Act, whether tenant, subsidiary, or landlord, shall make application therefor to the Administrator as provided for in this part.

(b) Every application under this section shall be made on an official form furnished by the Program, available from any Regional Director identified in § 301.2(kkk) of this subchapter, and shall be completed to include all information requested. Trade names of the applicant for labeling purposes, shall be inserted in the appropriate blank in the application. Each applicant for inspection will be held responsible for compliance with the Act and the regulations in this subchapter if inspection is granted. Preparation of product and other operations at the establishment for which inspection is granted may be conducted only by the applicant named in the application.

[40 FR 2575, Jan. 14, 1975, as amended at 53 FR 49848, Dec. 12, 1988]

§ 304.2 Information to be furnished; grant or refusal of inspection.

(a) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the establishment, including the limits of the establishment's premises, to which the grant pertains.

(b) The Administrator is authorized to grant inspection upon his determination that the applicant and the establishment are eligible therefor and to refuse to grant inspection at any establishment if he determines that it does not meet the requirements of this part or the regulations in parts 305, 307, and part 416, §§ 416.1 through 416.6 of this chapter or that the applicant has not received approval of labeling and containers to be used at the establishment as required by the regulations in parts 316 and 317. Any application for inspection may be refused in accordance with the rules of practice in part 500 of this chapter.

(c)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters in the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), to provide the Administrator with a certification as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless such certification has been obtained, or is waived because of failure or refusal of the State, interstate agency or the Secretary of the Interior to act on a request for certification within a reasonable period (which shall not exceed 1 year after receipt of such request).

(2) However, certification is not initially required in connection with an application for inspection granted after April 3, 1970, for facilities existing or under construction on April 3, 1970, although certification for such facilities is required to be obtained within the 3-year period immediately following April 3, 1970. Failure to obtain such certification and meet the other requirements of subsection 21(b) prior to April 3, 1973, will result in the termination of inspection at such facilities on that date.

Further, any application for inspection pending on April 3, 1970, and granted within 1 year thereafter shall not require certification for 1 year following the grant of inspection but such grant of inspection shall terminate at the end of 1 year after its issuance unless prior thereto such certification has been obtained and the other requirements of subsection 21(b) are met. [35 FR 15558, Oct. 3, 1970, as amended at 41 FR 4889, Feb. 3, 1976; 44 FR 68813, Nov. 30, 1979; 62 FR 45024, Aug. 25, 1997; 64 FR 56415, Oct. 20, 1999; 64 FR 66545, Nov. 29, 1999; 65 FR 2284, Jan. 14, 2000]

§ 304.3 Conditions for receiving inspection.

(a) Before being granted Federal inspection, an establishment shall have developed written sanitation Standard Operating Procedures, as required by part 416 of this chapter.

(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, as required by §§ 417.2 and 417.4 of this chapter. A conditional grant of inspection shall be issued for a period not to exceed 90 days, during which period the establishment must validate its HACCP plan.

(c) Before producing new product for distribution in commerce, an establishment shall have conducted a hazard analysis and developed a HACCP plan applicable to that product in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP plan, in accordance with § 417.4 of this chapter.

[61 FR 38864, July 25, 1996]

Pt. 305 PART 305—OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL OF INSPECTION; REPORTS OF VIOLATION Sec. 305.1 Official numbers; subsidiaries and tenants. 305.2 Separation of official establishments. 305.3 Sanitation and adequate facilities. 305.4 Inauguration of inspection. 305.6 Reports of violations. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15559, Oct. 3, 1970, unless otherwise noted.

§ 305.1 Official numbers; subsidiaries and tenants.

(a) An official number shall be assigned to each establishment granted inspection. Such number shall be used to identify all inspected and passed products prepared in the establishment. More than one number shall not be assigned to an establishment.

(b) Two or more official establishments under the same ownership or control may be granted the same official number, provided a serial letter is added in each case to identify each establishment and the products thereof.

(c) When inspection has been granted to any applicant at an establishment, it shall not be granted to any other person at the same establishment. However, persons operating as separate entities in the same building or structure may operate separate establishments therein only under their own grant of inspection. All such persons operating separate establishments in the same building or structure shall be responsible for compliance with the Act and regulations in their own establishments, which shall include common areas, e.g., hallways, stairways, and elevators.

[35 FR 15559, Oct. 3, 1970, as amended at 40 FR 2576, Jan. 14, 1975]

§ 305.2 Separation of official establishments.

(a) Each official establishment shall be separate and distinct from any unofficial establishment except a poultry products processing establishment operated under Federal inspection under the Poultry Products Inspection Act or under State inspection.

(b) The slaughter or other preparation of products of horses, mules, or other equines required to be conducted under inspection pursuant to the regulations in this subchapter shall be done in establishments separate from any establishment in which cattle, sheep, swine, or goats are slaughtered or their products are prepared.

(c) Inspection shall not be inaugurated in any building, any part of which is used as living quarters, unless the part for which inspection is requested is separated from such quarters by floors, walls, and ceilings of solid concrete, brick, wood, or similar material, and the floors, walls, and ceilings are without openings that directly or indirectly communicate with any part of the building used as living quarters.

§ 305.3 Sanitation and adequate facilities.

Inspection shall not be inaugurated if an establishment is not in a sanitary condition nor unless the establishment agrees to maintain a sanitary condition and provides adequate facilities for conducting such inspection.

§ 305.4 Inauguration of inspection.

When inspection is granted, the circuit supervisor shall, at or prior to the inauguration of inspection, inform the operator of the establishment of the requirements of the regulations in this subchapter. If the establishment, at the time inspection is inaugurated, contains any product which has not theretofore been inspected, passed, and marked in compliance with the regulations in this subchapter, the identity of the same shall be maintained, and it shall not be distributed in commerce, or otherwise subject to the requirements of such regulations, or dealt with as inspected and passed under the regulations. The establishment shall adopt and enforce all necessary measures and shall comply with all such directions as the circuit supervisor may prescribe, for carrying out the purposes of this section.

§ 305.6 Reports of violations.

Program employees shall report, in a manner prescribed by the Administrator, all violations of the Act or regulations in this subchapter of which they have information.

Pt. 306 PART 306—ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES Sec. 306.1 Designation of circuit supervisor and assistants. 306.2 Program employees to have access to establishments. 306.3 Badge as identification of inspectors. 306.4 Assignment of Program employees where members of family employed; soliciting employment; procuring product from official establishments. 306.5 Appeals. Authority:

21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.

Source:

35 FR 15559, Oct. 3, 1970, unless otherwise noted.

§ 306.1 Designation of circuit supervisor and assistants.

[See §§ 300.3 and 300.4 of this chapter regarding FSIS' organization and inspection program supervisors.]

[69 FR 254, Jan. 5, 2004]

§ 306.2 Program employees to have access to establishments.

[See § 300.6 of this chapter regarding access to establishments and other places of business.]

[69 FR 254, Jan. 5, 2004]

§ 306.3 Badge as identification of inspectors.

Each inspector will be furnished with a numbered official badge, which he shall not allow to leave his possession, and which he shall wear in such manner and at such times as the Administrator may prescribe.

[35 FR 15559, Oct. 3, 1970, as amended at 69 FR 254, Jan. 5, 2004]

§ 306.4 Assignment of Program employees where members of family employed; soliciting employment; procuring product from official establishments.

(a) Except as specifically authorized by the Administrator, no Program employee shall be detailed for duty at an establishment where any member of his family is employed by the operator of the establishment, or any tenant or subsidiary of such operator nor shall any circuit supervisor or other employee acting in a supervisory capacity be continued on duty at a circuit where any member of his family is so employed at any establishment under his jurisdiction. Program employees are forbidden to solicit, for any person, employment at any official establishment, or by any officer, manager, or employee thereof.

(b) Program employees shall not procure product from any official establishment or any other establishment if its operations or products are inspected or regulated under the Poultry Products Inspection Act or the Agricultural Marketing Act of 1946, as amended, or any other law administered by the Department unless the store or outlet from which the purchase is made is open to the general public and the price paid by such employee is the same as the price paid by the general public. Program employees must pay, and obtain receipts for money paid to such establishments for all such product and keep such receipts subject to inspection by supervisory employees or other authorized Department employees.

§ 306.5 Appeals.

Any appeal from a decision of any Program employee shall be made to his/her immediate supervisor having jurisdiction over the subject matter of the appeal, except as otherwise provided in the applicable rules of practice.

[48 FR 11418, Mar. 18, 1983, as amended at 60 FR 67454, Dec. 29, 1995]

Pt. 307 PART 307—FACILITIES FOR INSPECTION Sec. 307.1 Facilities for Program employees. 307.2 Other facilities and conditions to be provided by the establishment. 307.3 Inspectors to furnish and maintain implements in a sanitary condition. 307.4 Schedule of operations. 307.5 Overtime and holiday inspection service. 307.6 Basis of billing for overtime and holiday services. 307.7 Safety requirements for electrical stimulating (EST) equipment. Authority:

7 U.S.C. 394, 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15560, Oct. 3, 1970, unless otherwise noted.

§ 307.1 Facilities for Program employees.

Office space, including necessary furnishings, light, heat, and janitor service, shall be provided by official establishments, rent free, for the exclusive use for official purposes of the inspector and other Program employees assigned thereto. The space set aside for this purpose shall meet with approval of the circuit supervisor and shall be conveniently located, properly ventilated and provided with lockers suitable for the protection and storage of Program supplies and with facilities suitable for Program employees to change clothing if such clothes changing facilities are deemed necessary by the circuit supervisor. At the discretion of the Administrator, small plants requiring the services of less than one full time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Laundry service for inspectors' outer work clothing shall be provided by each establishment.

§ 307.2 Other facilities and conditions to be provided by the establishment.

When required by the circuit supervisor, the following facilities and conditions, and such others as may be found to be essential to efficient conduct of inspection and maintenance of sanitary conditions, shall be provided by each official establishment:

(a) Satisfactory pens, equipment, and assistants for conducting ante-mortem inspection and for separating, marking and holding apart from passed livestock those marked “U.S. suspect” and those marked “U.S. condemned” (pens, alleys, and runways shall be paved, drained, and supplied with adequate hose connections for cleanup purposes);

(b) Sufficient light to be adequate for proper conduct of inspection;

(c) Racks, receptacles, or other suitable devices for retaining such parts as the head, tongue, tail, thymus gland, and viscera, and all parts and blood to be used in the preparation of meat food products or medical products, until after the post-mortem examination is completed, in order that they may be identified in case of condemnation of the carcass; equipment, trucks, and receptacles for the handling of viscera of slaughtered animals so as to prevent contact with the floor; and trucks, racks, marked receptacles, tables, and other necessary equipment for the separate and sanitary handling of carcasses or parts passed for cooking;

(d) Tables, benches, and other equipment on which inspection is to be performed, of such design, material, and construction as to enable Program employees to conduct their inspection in a ready, efficient and clean manner;

(e) Watertight metal trucks or receptacles for holding and handling diseased carcasses and parts, so constructed as to be readily cleaned; such trucks or receptacles to be marked in a conspicuous manner with the phrase “U.S. condemned” in letters not less than 2 inches high, and, when required by the circuit supervisor, to be equipped with facilities for locking or sealing;

(f) Adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, for sterilizing all implements used in dressing diseased carcasses, floors, and such other articles and places as may be contaminated by diseased carcasses or otherwise;

(g) In establishments in which slaughtering is done, rooms, compartments, or specially prepared open places, to be known as “final inspection places,” at which the final inspection of retained carcasses may be conducted (competent assistants for handling retained carcasses and parts shall be provided by the establishment; final inspection places shall be adequate in size and their rail arrangement and other equipment shall be sufficient to prevent carcasses and parts passed for food or cooking, from being contaminated by contact with condemned carcasses or parts; they shall be equipped with hot water, lavatory, sterilizer, tables, and other equipment required for ready, efficient, and sanitary conduct of the inspection; the floors shall be of such construction as to facilitate the maintenance of sanitary conditions and shall have proper drainage connections, and when the final inspection place is part of a larger floor, it shall be separated from the rest of the floor by a curb, railing, or otherwise);

(h) Retention rooms, cages, or other compartments, and receptacles in which carcasses and product may be held for further inspection (these shall be in such number and in such locations as the needs of the inspection in the establishment may require; they shall be equipped for secure locking or sealing and shall be held under locks or official seals furnished by the Department; the keys of such locks shall not leave the custody of Program employees. Every such room, compartment, or receptacle shall be marked conspicuously with the phrase “U.S. retained” in letters not less than 2 inches high; rooms or compartments for these purposes shall be secure and susceptible of being kept clean, including a sanitary disposal of the floor liquids; establishment employees shall not enter any retention rooms or compartments or open any retention receptacles unless authorized by Program employees);

(i) Adequate facilities, including denaturing materials, for the proper disposal of condemned articles in accordance with the regulations in this subchapter (tanks or other rendering equipment which, under the regulations in this subchapter, must be sealed, shall be properly equipped for sealing as specified by the regulations in part 314 of this subchapter or by the circuit supervisor in specific cases);

(j) Docks and receiving rooms, to be designated by the operator of the official establishment, with the circuit supervisor, for the receipt and inspection of all products as provided in § 318.3 of this subchapter.

(k) Suitable lockers in which brands bearing the official inspection legend and other official devices (excluding labels) and official certificates shall be kept when not in use (all such lockers shall be equipped for sealing or locking with locks or seals to be supplied by the Department; the keys of such locks shall not leave the custody of Program employees);

(l) Sanitary facilities and accommodations as prescribed by § 416.2(c), (d), (e), (f), and (h) of this chapter.

(m) In addition to any facilities required to accomplish sanitary dressing procedures, the following inspection station facilities for cattle and swine slaughter lines described in § 310.1(b) of this subchapter are required:

(1) An inspection station consisting of 5 feet of unobstructed line space for each head or carcass inspector and, for viscera table kills, 8 feet for each viscera inspector on the inspector's side of the table.

(2) A minimum of 50 foot candles of shadow-free lighting at the inspection surfaces of the head, viscera, and carcass.

(3) A handwash lavatory (other than one which is hand operated), furnished with soap, towels, and hot and cold water, and located adjacent to the inspector's work area. In addition, for each head and viscera inspector on cattle slaughter lines, and each head inspector on swine slaughter lines, a sterilizer located adjacent to the inspector's work area.

(4) For mechanized operations, a line control switch located adjacent to each inspection station.

(5) Facilities to position tally sheets or other recording devices, such as digital counters, and facilities to contain condemned brands.

(6) For swine slaughter lines requiring three or more inspectors, and for those one- and two-inspector configurations where the establishment installs a mirror: At the carcass inspection station one glass or plastic, distortion-free mirror, at least 5 feet × 5 feet, mounted far enough away from the vertical axis of the moving line to allow the carcass to be turned, but not over 3 feet away, and so mounted that any inspector standing at the carcass inspection station can readily view the back of the carcass.

[35 FR 15560, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19902, May 13, 1985; 64 FR 56415, Oct. 20, 1999]

§ 307.3 Inspectors to furnish and maintain implements in a sanitary condition.

Inspectors shall furnish their own work clothing and implements, such as flashlights and triers, for conducting inspection and shall maintain their implements in sanitary condition as prescribed by § 416.3(a) of this chapter.

[64 FR 56415, Oct. 20, 1999]

§ 307.4 Schedule of operations.

(a) No operations requiring inspection shall be conducted except under the supervision of a Program employee. All slaughtering of animals and preparation of products shall be done with reasonable speed, considering the official establishment's facilities.

(b) A shift is a regularly scheduled operating period, exclusive of mealtime. One lunch period is the only official authorized interruption in the inspector's tour of duty once it begins. Lunch periods may be 30 minutes, 45 minutes, or in any case may not exceed one hour in duration. Once established, the lunch period must remain relatively constant as to time and duration. Lunch periods for inspectors shall not, except as provided herein, occur prior to 4 hours after the beginning of scheduled operations nor later than 5 hours after operations begin. In plants where a company rest break of not less than 30 minutes is regularly observed, approximately midpoint between start of work and the lunch period, and the inspector is allowed this time to meet his personal needs, the lunch period may be scheduled as long as 51/2 hours after the beginning of scheduled operations.

(c) Official establishments, importers, and exporters shall be provided inspection service, without charge, up to 8 consecutive hours per shift during the basic workweek subject to the provisions of § 307.5: Provided, That any additional shifts meet requirements as determined by the Administrator or his designee. The basic workweek shall consist of 5 consecutive 8-hour days within the administrative workweek Sunday through Saturday, excluding the lunch period; except that, when possible, the Department shall schedule the basic workweek so as to consist of 5 consecutive 8-hour days Monday through Friday, excluding lunch period. The Department may depart from the basic workweek in those cases where maintaining such a schedule would seriously handicap the Department in carrying out its function. These provisions are applicable to all official establishments except in certain cases as provided in § 318.4(h) of this subchapter.

(d)(1) Each official establishment shall submit a work schedule to the area supervisor for approval. In consideration of whether the approval of an establishment work schedule shall be given, the area supervisor shall take into account the efficient and effective use of inspection personnel. The work schedule must specify daily clock hours of operation and lunch periods for all departments of the establishment requiring inspection.

(2) Establishments shall maintain consistent work schedules. Any request by an establishment for a change in its work schedule involving an addition or elimination of shifts shall be submitted to the area supervisor at least 2 weeks in advance of the proposed change. Frequent requests for change shall not be approved: Provided, however, minor deviations from a daily operating schedule may be approved by the inspector in charge, if such request is received on the day preceding the day of change.

(3) Request for inspection service outside an approved work schedule shall be made as early in the day as possible for overtime work to be performed within that same workday; or made prior to the end of the day's operation when such a request will result in overtime service at the start of the following day: Provided, That an inspector may be recalled to his assignment after completion of his daily tour of duty under the provisions of § 307.6(b).

[40 FR 45799, Oct. 3, 1975, as amended at 40 FR 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, 1986]

§ 307.5 Overtime and holiday inspection service.

(a) The management of an official establishment, an importer, or an exporter shall reimburse the Program, at the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday as specified in paragraph (b) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.

(b) Holidays for Federal employees shall be New Year's Day, January 1; Birthday of Martin Luther King, Jr., the third Monday in January; Washington's Birthday, the third Monday in February; Memorial Day, the last Monday in May; Independence Day, July 4; Labor Day, the first Monday in September; Columbus Day, the second Monday in October; Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in November; Christmas Day, December 25. When any of the above-listed holidays falls outside the basic workweek, the nearest workday within that week shall become a holiday.

[40 FR 45800, Oct. 3, 1975, as amended at 43 FR 51754, Nov. 7, 1978; 50 FR 724, Jan. 7, 1985; 50 FR 51513, Dec. 18, 1985; 52 FR 4, Jan. 2, 1987; 53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, 1989]

§ 307.6 Basis of billing for overtime and holiday services.

(a) Each recipient of overtime or holiday inspection service, or both, shall be billed as provided for in § 307.5(a) and at the rates specified in § 391.3, in increments of quarter hours. For billing purposes, 8 or more minutes shall be considered a full quarter hour. Billing will be for each quarter hour of service rendered by each Program employee.

(b) Official establishments, importers, or exporters requesting and receiving the services of a Program employee after he has completed his day's assignment and left the premises, or called back to duty during any overtime or holiday period, shall be billed for a minimum of 2 hours overtime or holiday inspection service at the established rate.

(c) Bills are payable upon receipt and become delinquent 30 days from the date of the bill. Overtime or holiday inspection will not be performed for anyone having a delinquent account.

[40 FR 45800, Oct. 3, 1975, as amended at 54 FR 6389, Feb. 10, 1989]

§ 307.7 Safety requirements for electrical stimulating (EST) equipment.

(a) General. Electrical stimulating (EST) equipment is equipment that provides electric shock treatment to carcasses for the purpose of accelerating rigor mortis of facilitating blood removal. These provisions do not apply to electrical equipment used to stun and/or slaughter animals or to facilitate hide removal. Electrical stimulating equipment consists of two separate pieces—the control system and the applicator. The EST control system contains the circuitry to generate pulsed DC or AC voltage for stimulation and is separate from the equipment used to apply the voltage to the carcass. The voltage is applied by inserting a probe that penetrates the carcass or is inserted in the rectum, placing a clamp in the nose, a carcass rub-bar, a conveyor with energized surfaces traveling with the carcass, or any other acceptable method.

(b) Safety requirements—(1) Circuits, grounding. Either a bonded grounding conductor shall lead from each section of the carcass rail within the stimulating enclosure to the service ground, or the secondary voltage (stimulating circuit) shall be insulated from the service ground. If the stimulating section of the carcass rail and carcass drive mechanisms are insulated from the service ground then the stimulating rail or the return path shall be electrically bonded to the transformer secondary to isolate the stimulation voltage.

(2) Enclosure. Electrical stimulation shall occur in an area that will prevent persons from contacting an energized surface. If the area is surrounded by physical barriers, the enclosure shall be either electrically grounded or it shall be made of materials that do not conduct electricity. The interior of the stimulating area shall be visible from the start switch so the operator can be assured that there is no person, equipment or material present that should not be there prior to starting the stimulating sequence. If light or sound beam sensors form the enclosure, the stimulating equipment shall be automatically shut off when the sensor signals are broken.

(3) Mandatory Warning Devices and Signals. The following warning devices or signals shall be installed at each opening to the stimulating area through which a person would normally enter:

(i) A red light that flashes distinctly during the operating cycle of the stimulating equipment.

(ii) An ANSI Z53.1-Color Code sign reading (a) “Danger Electrical Hazard” for stimulating voltage below 50 or (b) “Danger High Voltage” for stimulating voltage above 50.

(iii) An emergency stop button.

(4) Optional Warning Device—Horn or Bell. If a warning horn or bell is installed, the signal shall be audible above background noises in the vicinity, and it shall sound for at least 1 second before each manual stimulation or before the carcass chain is started in an automatic system.

(1) Training. Only persons who have received safety instruction by the equipment manufacturer or designee may operate electrical stimulating equipment.

(2) Cleaning and Maintenance. To prevent an electrical shock to personnel, the electricity supplied to the stimulating surfaces shall be locked-off when cleaning, mechanical inspection, maintenance or testing are performed.

(3) Water. To prevent an electrical shock, personnel shall not spray streams of water on energized carcasses or on energized stimulating surfaces.

(d) Special provisions for manually operated equipment.

(1) Stimulating probes or clamps shall be stored in a sanitary container which is insulated with a material approved by the Administrator.1

1 A list of approved insulation materials is available upon request from the Facilities, Equipment and Sanitation Division, Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(2) The electric wires attached to a clamp or probe shall not allow for contact between the probe or clamp and an electrical ground and shall not extend outside the enclosure.

[53 FR 46432, Nov. 17, 1988, as amended at 64 FR 56415, Oct. 20, 1999]

PART 308 [RESERVED] Pt. 309 PART 309—ANTE-MORTEM INSPECTION Sec. 309.1 Ante-mortem inspection in pens of official establishments. 309.2 Livestock suspected of being diseased or affected with certain conditions; identifying suspects; disposition on post-mortem inspection or otherwise. 309.3 Dead, dying, disabled, or diseased and similar livestock. 309.4 Livestock showing symptoms of certain metabolic, toxic, nervous, or circulatory disturbances, nutritional imbalances, or infectious or parasitic diseases. 309.5 Swine; disposal because of hog cholera. 309.6 Epithelioma of the eye. 309.7 Livestock affected with anthrax; cleaning and disinfection of infected livestock pens and driveways. 309.8 Cattle affected with anasarca and generalized edema. 309.9 Swine erysipelas. 309.10 Onset of parturition. 309.11 Vaccine livestock. 309.12 Emergency slaughter; inspection prior to. 309.13 Disposition of condemned livestock. 309.14 Brucellosis-reactor goats. 309.15 Vesicular diseases. 309.16 Livestock suspected of having biological residues. 309.17 Livestock used for research. 309.18 Official marks and devices for purposes of ante-mortem inspection. Authority:

21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

Source:

35 FR 15563, Oct. 3, 1970, unless otherwise noted.

§ 309.1 Ante-mortem inspection in pens of official establishments.

(a) All livestock offered for slaughter in an official establishment shall be examined and inspected on the day of and before slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Administrator have been made in specific cases by the circuit supervisor for such examination and inspection to be made on a different day before slaughter.

(b) Such ante-mortem inspection shall be made in pens on the premises of the establishment at which the livestock are offered for slaughter before the livestock shall be allowed to enter into any department of the establishment where they are to be slaughtered or dressed or in which edible products are handled. When the holding pens of an official establishment are located in a public stockyard and are reserved for the exclusive use of the establishment, such pens shall be regarded as part of the premises of that establishment and the operator of the establishment shall be responsible for compliance with all requirements of the regulations in this subchapter with respect to such pens.

§ 309.2 Livestock suspected of being diseased or affected with certain conditions; identifying suspects; disposition on post-mortem inspection or otherwise.

(a) Any livestock which, on ante-mortem inspection, do not clearly show, but are suspected of being affected with any disease or condition that, under part 311 of this subchapter, may cause condemnation of the carcass on post-mortem inspection, and any livestock which show, on ante-mortem inspection, any disease or condition that, under part 311 of this subchapter would cause condemnation of only part of the carcass on post-mortem inspection, shall be so handled as to retain its identity as a suspect until it is given final post-mortem inspection, when the carcass shall be marked and disposed of as provided in parts 310 and 311 of this subchapter, or until it is disposed of as otherwise provided in this part.

(b) All seriously crippled animals and non-ambulatory disabled livestock shall be identified as U.S. Suspects and disposed of as provided in § 311.1 of this subchapter unless they are required to be classed as condemned under § 309.3. Non-ambulatory disabled livestock are livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.

(c) Livestock which have reacted to a test for leptospirosis, or anaplasmosis, but which show no symptoms of the disease, shall be identified as U.S. Suspects and disposed of as provided in § 311.10 of this subchapter.

(d) Livestock which are known to have reacted to the tuberculin test shall be identified as U.S. Suspects and disposed of as provided in § 311.2 of this subchapter, except that livestock bearing an official “USDA Reactor” or similar State reactor tag shall not be tagged as U.S. Suspects.

(e) Any cattle found on ante-mortem inspection to be affected with epithelioma of the eye or of the orbital region to a lesser extent than as described in § 309.6 shall be identified as a U.S. Suspect and disposed of as provided in § 311.12 of this subchapter.

(f) Cattle found on ante-mortem inspection to be affected with anasarca to a lesser extent than as described in § 309.8 shall be identified as U.S. Suspects and disposed of as provided in § 311.8 of this subchapter or paragraph (g) of this section.

(g) Any livestock suspected of being affected with anasarca may be set apart and held for treatment under Program or other responsible official supervision approved by the area supervisor. If at the expiration of the treatment period the livestock upon examination is found to be free from disease, it may be released for any purpose. Otherwise, it shall be identified as U.S. Suspect and disposed of as provided in § 311.8 of this subchapter or condemned and disposed of as provided in § 309.8, whichever is appropriate.

(h) All hogs suspected on ante-mortem inspection of being affected with swine erysipelas shall be identified as U.S. Suspects and disposed of as provided in § 311.5 of this subchapter or paragraph (i) of this section.

(i) A hog suspected of being affected with swine erysipelas may be set apart and held for treatment under Program or other responsible official supervision approved by the area supervisor. If at the expiration of the treatment period the animal upon examination is found to be free from disease, it may be released for any purpose. Otherwise, it shall be identified as U.S. Suspect and disposed of as provided in § 311.5 of this subchapter, or condemned and disposed of as provided in § 309.13, whichever is appropriate.

(j) Any livestock which is affected with vesicular exanthema or vesicular stomatitis, but which has recovered to the extent that the lesions are in process of healing, the temperature is within normal range, and the livestock shows a return to normal appetite and activity, shall be identified as U.S. Suspect and disposed of as provided in § 311.32 of this subchapter, except that if desired, such livestock may be set apart and held under supervision of a Program employee or other official designated by the area supervisor for treatment. If the livestock is set aside for treatment, the U.S. Suspect identification device will be removed by a Program employee, following such treatment, if the livestock is found to be free from any such disease. Such livestock found to be free from any such disease may be released for slaughter or for purposes other than slaughter, provided that in the latter instance, the operator of the official establishment or the owner of the animal shall first obtain permission from the local, State, or Federal livestock sanitary official having jurisdiction over the movement of such livestock.

(k) Livestock which are offered for ante-mortem inspection under this part, and which are regarded by the inspector as immature, shall be identified as U.S. Suspects and, if slaughtered, the disposition of their carcasses shall be determined by the post-mortem findings in connection with the ante-mortem conditions. If not slaughtered as suspects, such livestock shall be held under supervision of a Program employee or other official designated by the area supervisor, and after sufficient development may be released for slaughter or may be released for any other purpose, provided they have not been exposed to any infectious or contagious disease. If such exposure occurs, permission should be obtained from the nearest Veterinary Services unit of the Animal and Plant Health Inspection Service prior to release of such livestock.

(l) Livestock previously condemned for listeriosis, if released for slaughter under § 309.13(b) shall be identified as a U.S. Suspect in accordance with § 309.13(c).

(m) Each animal required by this part to be treated as a U.S. Suspect shall be identified as such by or under the supervision of a Program employee with an official device in accordance with § 309.18. No such device shall be removed except by a Program employee.

(n) Each animal identified as a U.S. Suspect on ante-mortem inspection shall be set apart and shall be slaughtered separately from other livestock at that establishment unless disposed of as otherwise provided in this part.

(o) Each animal identified as a U.S. Suspect on ante-mortem inspection, when presented for slaughter shall be accompanied with a form MP 402-2 on which the inspector at the establishment shall record the U.S. Suspect identification number and any other identifying tag numbers present and a brief description of the animal and of the disease or condition for which the animal was classed as a suspect, including its temperature when the temperature of such animal might have a bearing on the disposition of the carcass on post-mortem inspection.

(p) When any animal identified as a U.S. Suspect is released for any purpose or reason, as provided in this part, the official identification device shall be removed only by a Program employee and he shall report his action to the area supervisor. When a suspect is to be released under the provisions of this part for a purpose other than slaughter, the operator of the official establishment or the owner of the animal shall first obtain permission for the removal of such animal from the local, State or Federal livestock sanitary official having jurisdiction.

[35 FR 15563, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 FR 36000, Oct. 17, 1974; 69 FR 1873, Jan. 12, 2004]

§ 309.3 Dead, dying, disabled, or diseased and similar livestock.

(a) Livestock found to be dead or in a dying condition on the premises of an official establishment shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

(b) Livestock plainly showing on ante-mortem inspection any disease or condition that, under part 311 of this subchapter, would cause condemnation of their carcasses on post-mortem inspection shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

(c) Any swine having a temperature of 106 °F. or higher and any cattle, sheep, goats, horses, mules, or other equines having a temperature of 105 °F. or higher shall be identified as U.S. Condemned. In case of doubt as to the cause of the high temperature, or when for other reasons a Program employee deems such action warranted, any such livestock may be held for a reasonable time under the supervision of a Program employee for further observation and taking of temperature before final disposition of such livestock is determined. Any livestock so held shall be reinspected on the day it is slaughtered. If, upon such reinspection, or when not held for further observation and taking of temperature, then on the original inspection, the animal has a temperature of 106 °F. or higher in the case of swine, or 105 °F. or higher in the case of other livestock, it shall be condemned and disposed of in accordance with § 309.13.

(d) Any livestock found in a comatose or semicomatose condition or affected with any condition not otherwise covered in this part, which would preclude release of the animal for slaughter for human food, shall be identified “U.S. Condemned” and disposed of in accordance with § 309.13, except that such animal may be set apart and held for further observation or treatment under supervision of a Program employee or other official designated by the area supervisor and for final disposition in accordance with this part.

(e) Non-ambulatory disabled cattle that are offered for slaughter must be condemned and disposed of in accordance with § 309.13. FSIS inspection personnel will determine the disposition of cattle that become non-ambulatory after they have passed ante-mortem inspection on a case-by-case basis.

[35 FR 15563, Oct. 3, 1970, as amended at 69 FR 1873, Jan. 12, 2004; 72 FR 38729, July 13, 2007]

§ 309.4 Livestock showing symptoms of certain metabolic, toxic, nervous, or circulatory disturbances, nutritional imbalances, or infectious or parasitic diseases.

(a) All livestock showing, on ante-mortem inspection, symptoms of anaplasmosis, ketosis, leptospirosis, listeriosis, parturient paresis, pseudorabies, rabies, scrapie, tetanus, grass tetany, transport tetany, strangles, purpura hemorrhagica, azoturia, infectious equine encephalomyelitis, toxic encephalomyelitis (forage poisoning), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness or extensive fistula shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

(b) If any equine is suspected on ante-mortem inspection of being infected with glanders or dourine, the nearest Veterinary Services unit of the Animal and Plant Health Inspection Service shall be so informed by a Program employee. Tests shall be performed by said unit to determine whether the animal is, in fact, infected with such disease. If it is found on such tests to be infected, the animal shall be disposed of in accordance with paragraph (a) of this section. Otherwise, the animal shall be identified as a U.S. Suspect and disposed of as provided in § 311.10 of this subchapter.

[35 FR 15563, Oct. 3, 1970 as amended at 38 FR 29214, Oct. 23, 1973]

§ 309.5 Swine; disposal because of hog cholera.

(a) All swine found by an inspector to be affected with hog cholera shall be identified as U.S. Condemned and disposed of in accordance with § 309.13. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for the control of swine diseases in the State where the swine are located.

(b) All swine, even though not themselves identified as U.S. Suspects, which are of lots in which one or more animals have been condemned or identified as U.S. Suspect for hog cholera, shall, as far as possible, be slaughtered separately and apart from all other livestock passed on ante-mortem inspection.

[40 FR 27225, June 27, 1975]

§ 309.6 Epithelioma of the eye.

Any animal found on ante-mortem inspection to be affected with epithelioma of the eye and the orbital region in which the eye has been destroyed or obscured by neoplastic tissue and which shows extensive infection, suppuration, and necrosis, usually accompanied with foul odor, or any animal affected with epithelioma of the eye or of the orbital region which, regardless of extent, is accompanied with cachexia shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

§ 309.7 Livestock affected with anthrax; cleaning and disinfection of infected livestock pens and driveways.

(a) Any livestock found on ante-mortem inspection to be affected with anthrax shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

(b) No other livestock of a lot in which anthrax is found on ante-mortem inspection shall be slaughtered and presented for post-mortem inspection until it has been determined by a careful ante-mortem inspection that no anthrax infected livestock remains in the lot.

(c) Apparently healthy livestock (other than hogs) from a lot in which anthrax is detected, and any apparently healthy livestock which have been treated with anthrax biologicals which do not contain living anthrax organisms, may be slaughtered and presented for post-mortem inspection if they have been held not less than 21 days following the last treatment or the last death of any livestock in the lot. Alternatively, if desired, all apparently healthy livestock of the lot may be segregated and held for treatment by a State licensed veterinarian under supervision of a Program employee or other official designated by the area supervisor. No anthrax vaccine (live organisms) shall be used on the premises of an official establishment.

(d) Livestock which have been injected with anthrax vaccines (live organisms) within 6 weeks, and those bearing evidence of reaction to such treatment, such as inflammation, tumefaction, or edema at the site of the injection, shall be condemned on ante-mortem inspection, or such animals may be held under supervision of a Program employee or other official designated by the area supervisor until the expiration of the 6-week period and the disappearance of any evidence of reaction to the treatment.

(e) When livestock are found on ante-mortem inspection to be affected with anthrax, all exposed livestock pens and driveways of the official establishment shall be cleaned and disinfected by promptly and thoroughly removing and burning all straw, litter, and manure. This shall be followed immediately by a thorough disinfection of the exposed premises by soaking the ground, fences, gates, and all exposed material with a 5 percent solution of sodium hydroxide or commercial lye prepared as outlined in § 310.9(e)(1) of this subchapter, or other disinfectant that may be approved in specific cases by the Administrator specifically for this purpose.

§ 309.8 Cattle affected with anasarca and generalized edema.

All cattle found on ante-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive and generalized edema shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

§ 309.9 Swine erysipelas.

All hogs plainly showing on ante-mortem inspection that they are affected with acute swine erysipelas shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

§ 309.10 Onset of parturition.

Any livestock showing signs of the onset of parturition shall be withheld from slaughter until after parturition and passage of the placenta. Slaughter or other disposition may then be permitted if the animal is otherwise acceptable.

§ 309.11 Vaccine livestock.

Vaccine livestock with unhealed lesions of vaccinia, accompanied with fever, which have not been exposed to any other infectious or contagious disease, are not required to be slaughtered and may be released for removal from the premises.

§ 309.12 Emergency slaughter; inspection prior to.

In all cases of emergency slaughter, except as provided in § 311.27 of this subchapter, the animals shall be inspected immediately before slaughter, whether theretofore inspected or not. When the necessity for emergency slaughter exists, the establishment shall notify the inspector in charge so that such inspection may be made.

§ 309.13 Disposition of condemned livestock.

(a) Except as otherwise provided in this part, livestock identified as U.S. Condemned shall be killed by the official establishment, if not already dead. Such animals shall not be taken into the official establishment to be slaughtered or dressed; nor shall they be conveyed into any department of the establishment used for edible products; but they shall be disposed of in the manner provided for condemned carcasses in part 314 of this subchapter. The official U.S. Condemned tag shall not be removed from, but shall remain on the carcass until it goes into the tank, or is otherwise disposed of as prescribed in part 314 of this subchapter, at which time such tag may be removed by a Program employee only. The number of such tag shall be reported to the veterinary medical officer by the inspector who affixed it, and also by the inspector who supervised the tanking of the carcass.

(b) Any livestock condemned on account of ketosis, swine erysipelas, vesicular diseases, grass tetany, transport tetany, parturient paresis, anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory condition including pneumonia, enteritis, and peritonitis may be set apart and held for treatment under supervision of a Program employee or official designated by the area supervisor. Veal calves that are unable to rise from a recumbent position and walk because they are tired or cold may also be set apart and held as provided in this paragraph. The U.S. Condemned identification tag will be removed by a Program employee following treatment under such supervision if the animal is found to be free from any such disease.

(c) Livestock previously affected with listeriosis, including those released for slaughter after treatment under paragraph (b) of this section, shall be identified as U.S. Suspect.

(d) When livestock under the provisions of this section is to be released for a purpose other than slaughter, the operator of the official establishment or the owner of the livestock shall first obtain permission for the movement of such livestock from the local, State, or Federal livestock sanitary official having jurisdiction.

[35 FR 15563, Oct. 3, 1970, as amended at 72 FR 38729, July 13, 2007]

§ 309.14 Brucellosis-reactor goats.

Goats which have reacted to a test for brucellosis shall not be slaughtered in an official establishment.

§ 309.15 Vesicular diseases.

(a) Immediate notification shall be given by the inspector to the local, State, and Federal livestock sanitary officials having jurisdiction when any livestock is found to be affected with a vesicular disease.

(b) No livestock under quarantine by State or Federal livestock sanitary officials on account of a vesicular disease will be given ante-mortem inspection. If no quarantine is invoked, or if quarantine is invoked and later removed, upon ante-mortem inspection, any animal found to be affected with vesicular exanthema or vesicular stomatitis in the acute stages, as evidenced by acute and active lesions or an elevated temperature, shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.

§ 309.16 Livestock suspected of having biological residues.

(a) Except as provided by paragraph (d) of this section, livestock suspected of having been treated with or exposed to any substance that may impart a biological residue which would make the edible tissues unfit for human food or otherwise adulterated shall be handled in compliance with the provisions of this paragraph. They shall be identified at official establishments as “U.S. Condemned.” These livestock may be held under the custody of a Program employee, or other official designated by the Administrator, until metabolic processes have reduced the residue sufficiently to make the tissues fit for human food and otherwise not adulterated. When the required time has elapsed, the livestock, if returned for slaughter, must be re-examined on ante-mortem inspection. To aid in determining the amount of residue present in the tissues, officials of the Program may permit the slaughter of any such livestock for the purpose of collecting tissues for analysis for the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of livestock.

(b) All carcasses and edible organs and other parts thereof, in which are found any biological residues which render such articles adulterated, shall be marked as “U.S. Condemned” and disposed of in accordance with § 314.1 or § 314.3 of this chapter.

(d) Calves shall not be presented for ante-mortem inspection in an official establishment except under the provisions of this paragraph.

(1) Definitions. For purposes of this paragraph, the following definitions shall apply:

(i) Calf. A calf up to 3 weeks of age or up to 150 pounds.

(ii) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.

(iii) Healthy calf. A calf that an inspector determines shows no visual signs of disease or treatment of disease at ante-mortem inspection.

(iv) Producer. The owner of the calf at the time of its birth.

(v) Sick calf. A calf that an inspector on ante-mortem inspection determines has either signs of treatment or signs of disease.

(vi) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.

(2) General requirements. (i) The identity of the producer of each calf presented for ante-mortem inspection shall be made available by the official establishment to the inspection prior to the animal being presented for ante-mortem inspection.

(ii) The inspector shall segregate the calves presented for ante-mortem inspection at the establishment and identify each calf as one of the following: (a) Certified, (B) noncertified, or (C) previous residue condemnation.

(3) Certified group. (i) For a calf to be considered certified, the producer and all other subsequent custodians of the calf must certify in writing that while the calf was in his or her custody, the calf was not treated with animal drugs or was treated with one or more drugs in accordance with FDA approved label directions and was withheld from slaughter for the period(s) of time specified by those label directions. All prior certifications must be presented with the animal at the time of slaughter. The certifications shall contain a list of the calves with accompanying identification numbers, as required by paragraph (d)(3)(ii) of this section, followed by the following language:

I hereby certify that, while in my custody, from ____ to ____ (time period of custody), the above-listed calf or calves have not been treated with drugs, or have been treated with one or more drugs in accordance with FDA approved label directions and have been withheld from slaughter for the period(s) of time specified by those label directions. I certify that, to the best of my knowledge and belief, all information contained herein is true, that the information may be relied upon at the official establishment, and that I understand that any willful falsification of this certification is a felony and may result in a fine of up to $250,000 for an individual or up to $500,000 for an organization, or imprisonment for not more than 5 years, or both (21 U.S.C. 677, 18 U.S.C. 1001 and 3571).

Executed on (date of certification) (signature of certifier) (typed or printed name and address of certifier) (business of certifier)

(ii) Each calf must be identified by use of backtag, eartag, or other type of secure identification which displays a number which shall be recorded on all written certifications.

(iii) The inspector shall have segregated for veterinary medical officer examination any certified calf which he or she determines to show any sign of disease or which is not identified individually. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21 (c) and (d).

(iv) The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c) and (d).

(4) Noncertified group. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(c). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c).

(5) Calves from producers with previous residue condemnation. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(e). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(e).

(e) The name of each and all person(s) who sold or consigned each swine to the establishment shall be made available by the establishment to any Program employee or other authorized employee of the United States Department of Agriculture upon that employee's request and presentation of his or her official credentials. Swine identification, by means approved by the Animal and Plant Health Inspection Service, USDA, under part 71 of this title, must be maintained throughout post-mortem inspection, in accordance with § 310.23(a) of this subchapter.

(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0053) [36 FR 24928, Dec. 24, 1971, as amended at 44 FR 45606, Aug. 3, 1979; 44 FR 59499, Oct. 16, 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. 20, 1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, Dec. 30, 1985; 52 FR 2104, Jan. 20, 1987; 53 FR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990]

§ 309.17 Livestock used for research.

(a) No livestock used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless:

(1) The operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Program, or the Veterinary Services unit of the Animal and Plant Health Inspection Service of the Department of Agriculture or to the Environmental Protection Agency or to the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such livestock being adulterated, and a Program employee has approved such slaughter;

(2) Written approval by the Deputy Administrator, Meat and Poultry Inspection Field Operations is furnished the area supervisor prior to the time of slaughter;

(3) In the case of an animal administered any unlicensed, experimental veterinary biologic product regulated under the Virus-Serum Toxin Act (21 U.S.C. 151 et seq.), the product was prepared and distributed in compliance with Part 103 of the regulations issued under said Act (part 103 of this title), and used in accordance with the labeling approved under said regulations;

(4) In the case of an animal administered any investigational drug regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), the drug was prepared and distributed in compliance with the applicable provisions of part 135 of the regulations issued under said Act (21 CFR part 135), and used in accordance with the labeling approved under said regulations;

(5) In the case of an animal subjected to any experimental economic poison under section 2(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 135 et seq.), the product was prepared and distributed in accordance with § 362.17 of the regulations issued under said Act (7 CFR 362.17), and used in accordance with the labeling approved under said regulations.

(6) In the case of an animal administered or subjected to any substance that is a food additive or pesticide chemical under the Federal Food, Drug, and Cosmetic Act, supra, there has been compliance with all tolerance limitations established by said Act and the regulations promulgated thereunder (21 CFR 1.1 et seq.), and all other restrictions and requirements imposed by said Act and said regulations will be complied with at the time of slaughter.

(b) The inspector in charge may deny or withdraw the approval for slaughter of any livestock subject to the provision of this section when he deems it necessary to assure that all products prepared at the official establishment are free from adulteration.

§ 309.18 Official marks and devices for purposes of ante-mortem inspection.

(a) All livestock required by this part to be identified as U.S. Suspects shall be tagged with a serially numbered metal ear tag bearing the term “U.S. Suspect,” except as provided in § 309.2(d) and except that cattle affected with epithelioma of the eye, antinomycosis, or actinobacillosis to such an extent that the lesions would be readily detected on post-mortem inspection, need not be individually tagged on ante-mortem inspection with the U.S. Suspect tag, provided that such cattle are segregated and otherwise handled as U.S. Suspects.

(b) In addition, identification of U.S. Suspect swine must include the use of tattoos specified by the inspector to maintain the identity of the animals through the dehairing equipment when such equipment is used.

(c) All livestock required by this part to be identified as U.S. Condemned shall be tagged with a serially numbered metal ear tag bearing the term “U.S. Condemned.”

(d) The devices described in paragraphs (a), (b), and (c) of this section shall be the official devices for identification of livestock required to be identified as U.S. Suspect or U.S. Condemned as provided in this part.

Pt. 310 PART 310—POST-MORTEM INSPECTION Sec. 310.1 Extent and time of post-mortem inspection; post-mortem inspection staffing standards. 310.2 Identification of carcass with certain severed parts thereof and with animal from which derived. 310.3 Carcasses and parts in certain instances to be retained. 310.4 Identification of carcasses and parts; tagging. 310.5 Condemned carcasses and parts to be so marked; tanking; separation. 310.6 Carcasses and parts passed for cooking; marking. 310.7 Removal of spermatic cords, pizzles and preputial diverticuli. 310.8 Passing and marking of carcasses and parts. 310.9 Anthrax; carcasses not to be eviscerated; disposition of affected carcasses; hides, hoofs, horns, hair, viscera and contents, and fat; handling of blood and scalding vat water; general cleanup and disinfection. 310.10 Carcasses with skin or hide on; cleaning before evisceration; removal of larvae of Hypodermae, external parasites and other pathological skin conditions. 310.11 Cleaning of hog carcasses before incising. 310.12 Sternum to be split; abdominal and thoracic viscera to be removed. 310.13 Inflating carcasses or parts thereof; transferring caul or other fat. 310.14 Handling of bruised parts. 310.15 Disposition of thyroid glands and laryngeal muscle tissue. 310.16 Disposition of lungs. 310.17 Inspection of mammary glands. 310.18 Contamination of carcasses, organs, or other parts. 310.19 Inspection of kidneys. 310.20 Saving of blood from livestock as an edible product. 310.21 Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts. 310.22 Specified risk materials from cattle and their handling and disposition. 310.23 Identification of carcasses and parts of swine. 310.24 [Reserved] 310.25 Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards. Authority:

21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

Source:

35 FR 15567, Oct. 3, 1970, unless otherwise noted.

§ 310.1 Extent and time of post-mortem inspection; post-mortem inspection staffing standards.

(a) A careful post-mortem examination and inspection shall be made of the carcasses and parts thereof of all livestock slaughtered at official establishments. Such inspection and examination shall be made at the time of slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Administrator have been made in specific cases by the circuit supervisor for making such inspection and examination at a later time.

(b)(1) The staffing standards on the basis of the number of carcasses to be inspected per hour are outlined in the following tables. Standards for multiple inspector lines are based on inspectors rotating through the different types of inspection stations during each shift to equalize the workload. The inspector in charge shall have the authority to require the establishment to reduce slaughter line speeds where, in his judgment, the inspection procedure cannot be adequately performed at the current line speed because of particular deficiencies in carcass preparation and presentation by the plant at the higher speed, or because the health condition of the particular animals indicates a need for more extensive inspection.

(2) Cattle inspection. For all cattle staffing standards, an “a” in the “Number of Inspectors by Stations” column means that one inspector performs the entire inspection procedure and a “b” means that one inspector performs the head and lower carcass inspection and a second inspector performs the viscera and upper carcass inspection. 1

1 The “Maximum Slaughter Rates” figures listed in paragraph (b)(2)(i) of this section for one (a) and two (b) inspector kills are overstated because the time required to walk from one inspection station to another is not included. To determine the proper adjusted maximum slaughter line speed, paragraph (b)(2)(i)(A) of this section for one inspector kills or paragraph (b)(2)(i)(B) of this section for two inspector kills must be used along with their accompanying rules.

(i) Inspection Using the Viscera Truck.

Steers and Heifers Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 27 a a a 28 to 56 b b b 57 to 84 1 1 1 85 to 86 1 2 1 87 to 143 2 2 1 Cows and Bulls Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 27 a a a 28 to 55 b b b 56 to 77 1 1 1 78 to 81 1 2 1 82 to 134 2 2 1

(A) Rules for determining adjusted maximum slaughter rates for single-inspector kills considering walking distance according to the table in this subdivision: Determine the distances the inspector actually walks between the points shown in columns 2 through 14 of the following table. For each column, determine the deduction figure opposite the appropriate number of feet in column 1. Compute the total of the deduction figures for columns 2 through 14. The adjusted maximum rate is the maximum rate in paragraph (b)(2)(i) of this section minus total of the deduction figures. If the resultant number is not a whole number, it must be rounded off to the next lowest whole number.

One-Inspector Cattle Kill—Viscera Truck [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)] 1

Number of feet between points

Head rack and high rail

Strs. Hfrs. Cows Bulls 3

Viscera and low rail

Strs. Hfrs. Cows Bulls 4

Low rail and head rack

Strs. Hfrs. Cows Bulls 5

Head rack and carcass 2

Strs. Hfrs. Cows Bulls 6

Carcass 2 and washbasin

Strs. Hfrs. Cows Bulls 7

Tags—brands and low rail

Strs. Hfrs. Cows Bulls 8

Viscera and washbasin

Strs. Hfrs. Cows Bulls 9

Viscera and high rail

Strs. Hfrs. Cows Bulls 10

Low rail and high rail

Strs. Hfrs. Cows Bulls 11

Head rack and closest washbasin

Strs. Hfrs. Cows Bulls 12

Washbasin and high rail 1

Strs. Hfrs. Cows Bulls 13

Head rack and washbasin 1

Strs. Hfrs. Cows Bulls 14

Viscera and tags—brands

Strs. Hfrs. Cows Bulls 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.1 0 5 0 0 0.1 0 0 0 0 0 0 0 0 0 0 0.1 0.1 0.1 0 0 0 0 0 0 0 0 0.2 0.1 7 0 0 0.1 0.1 0.1 0.1 0 0 0 0 0.1 0.1 0.1 0.2 0.2 0.2 0.1 0.1 0 0 0 0 0 0 0.3 0.3 9 0 0 0.2 0.1 0.1 0.1 0 0 0 0 0.1 0.1 0.1 0.3 0.3 0.3 0.1 0.1 0 0 0.1 0.1 0.1 0.1 0.4 0.4 11 0.1 0.1 0.2 0.2 0.2 0.2 0 0 0 0 0.1 0.2 0.2 0.4 0.4 0.4 0.2 0.2 0 0 0.1 0.1 0.1 0.1 0.5 0.6 13 0.1 0.1 0.3 0.2 0.2 0.2 0 0 0 0 0.2 0.2 0.2 0.5 0.5 0.5 0.2 0.2 0 0 0.1 0.1 0.1 0.1 0.6 0.7 15 0.1 0.1 0.4 0.3 0.3 0.3 0 0 0 0 0.2 0.3 0.3 0.5 0.6 0.6 0.3 0.3 0 0 0.2 0.2 0.2 0.2 0.7 0.9 17 0.1 0.1 0.4 0.3 0.3 0.3 0 0 0 0 0.3 0.3 0.3 0.6 0.7 0.7 0.3 0.3 0 0.1 0.2 0.2 0.2 0.2 0.9 1.0 19 0.1 0.1 0.5 0.4 0.4 0.4 0 0 0 0 0.3 0.4 0.4 0.7 0.8 0.8 0.4 0.4 0 0.1 0.2 0.2 0.2 0.2 1.0 1.1 21 0.2 0.2 0.5 0.4 0.4 0.4 0 0 0 0 0.3 0.4 0.4 0.8 0.9 0.8 0.4 0.4 0 0.1 0.3 0.2 0.3 0.2 1.1 1.3 23 0.2 0.2 0.6 0.5 0.5 0.5 0 0 0 0 0.4 0.5 0.5 0.9 1.0 0.9 0.5 0.5 0 0.1 0.3 0.3 0.3 0.3 1.2 1.4 25 0.2 0.2 0.7 0.5 0.5 0.5 0 0 0 0 0.4 0.5 0.5 1.0 1.1 1.0 0.5 0.5 0 0.1 0.3 0.3 0.3 0.3 1.3 1.5 27 0.2 0.2 0.7 0.5 0.6 0.5 0 0 0 0 0.4 0.5 0.6 1.1 1.2 1.1 0.6 0.6 0 0.1 0.3 0.3 0.3 0.3 1.4 1.7 29 0.2 0.2 0.8 0.6 0.6 0.6 0 0 0 0 0.5 0.6 0.6 1.2 1.3 1.2 0.6 0.6 0 0.1 0.4 0.3 0.4 0.3 1.5 1.8 31 0.3 0.2 0.8 0.6 0.7 0.6 0 0 0 0 0.5 0.6 0.7 1.3 1.3 1.4 0.7 0.7 0 0.1 0.4 0.4 0.4 0.4 1.6 1.9 33 0.3 0.3 0.9 0.7 0.7 0.7 0 0 0 0 0.6 0.7 0.7 1.3 1.4 1.4 0.7 0.7 0 0.1 0.4 0.4 0.4 0.4 1.7 2.1 35 0.3 0.3 1.0 0.7 0.8 0.7 0 0 0 0 0.6 0.7 0.8 1.4 1.5 1.5 0.8 0.8 0 0.2 0.5 0.4 0.5 0.4 1.8 2.2 37 0.3 0.3 1.0 0.8 0.8 0.8 0 0 0 0 0.6 0.8 0.8 1.5 1.6 1.6 .0.8 0.8 0 0.2 0.5 0.5 0.5 0.5 1.9 2.3 39 0.3 0.3 1.1 0.8 0.9 0.8 0 0 0 0 0.7 0.8 0.9 1.6 1.7 1.7 0.9 0.9 0 0.2 0.5 0.5 0.5 0.5 2.0 2.4 41 0.4 0.3 1.1 0.9 0.9 0.9 0 0.1 0 0.1 0.7 0.9 0.9 1.7 1.7 1.8 0.9 0.9 0 0.2 0.6 0.5 0.6 0.5 2.1 2.6 43 0.4 0.4 1.2 0.9 1.0 0.9 0 0.1 0 0.1 0.7 0.9 1.0 1.8 1.8 1.9 1.0 1.0 0.1 0.2 0.6 0.5 0.6 0.5 2.2 2.7 45 0.4 0.4 1.2 0.9 1.0 0.9 0 0.1 0 0.1 0.8 0.9 1.0 1.8 1.9 2.0 1.0 1.0 0.1 0.2 0.6 0.6 0.6 0.6 2.3 2.8 47 0.4 0.4 1.3 1.0 1.1 1.0 0 0.1 0 0.1 0.8 1.0 1.1 1.9 2.0 2.1 1.1 1.1 0.1 0.2 0.6 0.6 0.6 0.6 2.4 2.9 49 0.4 0.4 1.4 1.0 1.1 1.0 0 0.1 0 0.1 0.8 1.0 1.1 2.0 2.1 2.2 1.1 1.1 0.1 0.2 0.7 0.6 0.7 0.6 2.5 3.1 51 0.5 0.5 1.4 1.1 1.2 1.1 0 0.1 0 0.1 0.9 1.1 1.2 2.1 2.2 2.2 1.2 1.2 0.1 0.3 0.7 0.7 0.7 0.7 2.6 3.2 53 0.5 0.5 1.5 1.1 1.2 1.1 0 0.1 0 0.1 0.9 1.1 1.2 2.2 2.3 2.3 1.2 1.2 0.1 0.3 0.7 0.7 0.7 0.7 2.7 3.3 55 0.5 0.5 1.5 1.2 1.2 1.2 0 0.1 0 0.1 1.0 1.2 1.2 2.3 2.3 2.4 1.3 1.3 0.1 0.3 0.8 0.7 0.8 0.7 2.8 3.4 57 0.5 0.5 1.6 1.2 1.3 1.2 0 0.1 0 0.1 1.0 1.2 1.3 2.3 2.4 2.5 1.3 1.3 0.1 0.3 0.8 0.7 0.8 0.7 2.9 3.5 59 0.5 0.5 1.6 1.3 1.3 1.3 0 0.1 0 0.1 1.0 1.3 1.3 2.4 2.5 2.6 1.4 1.4 0.1 0.3 0.8 0.8 0.8 0.8 3.0 3.6 1 The washbasin referred to here is the one the inspector uses while enroute from the head rack to high rail inspection. 2 This refers to the carcass in the bleeding area.

(B) Rules for determining adjusted maximum slaughter rates for two-inspector kills considering walking distance according to the table in this subdivision: Determine the distances the inspectors actually walk between the points shown in columns 2 through 9 of the following table. Column 9 is used only if the condemned brands and tags the viscera inspector uses are kept at a location other than at the washbasin-sterilizer. For each column, determine the deduction figure opposite the appropriate number of feet in column 1. Compute the total of the deduction figures for columns 2 through 9. Divide this total by 2. The adjusted maximum rate is the maximum rate in paragraph (b)(2)(i) of this section minus the number calculated above. If the resultant number is not a whole number, it must be rounded off to the next lowest whole number.

Two-Inspector Cattle Kill—Viscera Truck [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)] Heads and low rail inspection 1 Number of feet between points 2 Head rack and washbasin Strs. Hfrs. Cows Bulls 3 Head rack and carcasses 2 Strs. Hfrs. Cows Bulls 4 Washbasin and low rail Strs. Hfrs. Cows Bulls 5 Head rack and low rail Strs. Hfrs. Cows Bulls Viscera and high rail inspection 6 Viscera and brands tags (washbasin) Strs. Hfrs. Cows Bulls 7 Viscera and high rail Strs. Hfrs. Cows Bulls 8 High rail and washbasin Strs. Hfrs. Cows Bulls 9 1 Viscera and washbasin Strs. Hfrs. Cows Bulls 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0.1 0 0.1 0 0.1 0 0 0 0 0 0 0 0 0 0.1 0.2 5 0.1 0.1 0.1 0.1 0.1 0.1 0.8 0.7 0.4 0.5 0.5 0.5 0.1 0.2 0.2 0.3 7 0.1 0.2 0.1 0.1 0.1 0.1 1.5 1.4 0.7 0.9 1.0 0.9 0.3 0.3 0.3 0.4 9 0.2 0.2 0.1 0.2 0.1 0.2 2.2 2.0 1.1 1.3 1.5 1.3 0.4 0.5 0.4 0.5 11 0.2 0.3 0.1 0.2 0.2 0.2 2.8 2.7 1.4 1.7 1.9 1.8 0.5 0.6 0.4 0.6 13 0.2 0.4 0.1 0.3 0.2 0.2 3.5 3.3 1.7 2.1 2.4 2.2 0.6 0.7 0.5 0.8 15 0.3 0.4 0.1 0.3 0.2 0.3 4.1 3.9 2.0 2.5 2.9 2.6 0.7 0.9 0.6 0.9 17 0.3 0.5 0.1 0.4 0.2 0.3 4.8 4.5 2.4 2.9 3.3 3.0 0.8 1.0 0.7 1.0 19 0.3 0.6 0.2 0.4 0.3 0.4 5.4 5.1 2.7 3.3 3.7 3.4 0.9 1.2 0.7 1.2 21 0.3 0.6 0.2 0.4 0.3 0.4 6.0 5.7 3.0 3.7 4.2 3.7 1.0 1.3 0.8 1.3 23 0.4 0.7 0.2 0.5 0.3 0.5 6.6 6.3 3.3 4.0 4.6 4.1 1.2 1.4 0.9 1.4 25 0.4 0.7 0.2 0.5 0.3 0.5 7.2 6.8 3.6 4.4 5.0 4.5 1.3 1.6 1.0 1.6 27 0.4 0.8 0.2 0.6 0.4 0.5 7.8 7.4 3.9 4.7 5.4 4.9 1.4 1.7 1.0 1.7 29 0.5 0.9 0.2 0.6 0.4 0.6 8.3 7.9 4.2 5.1 5.8 5.2 1.5 1.8 1.1 1.8 31 0.5 0.9 0.2 0.7 0.4 0.6 8.9 8.5 4.5 5.4 6.2 5.6 1.6 2.0 1.2 2.0 33 0.5 1.0 0.2 0.7 0.4 0.7 9.4 9.0 4.8 5.8 6.5 5.9 1.7 2.1 1.3 2.1 35 0.6 1.1 0.3 0.8 0.5 0.7 10.0 9.5 5.0 6.1 6.9 6.3 1.8 2.2 1.3 2.3 37 0.6 1.1 0.3 0.8 0.5 0.7 10.5 10.0 5.3 6.4 7.3 6.6 1.9 2.4 1.4 2.4 39 0.6 1.2 0.3 0.9 0.5 0.8 11.0 10.5 5.6 6.8 7.6 6.9 2.0 2.5 1.5 2.5 41 0.7 1.2 0.3 0.9 0.6 0.8 11.5 11.0 5.9 7.1 8.0 7.2 2.1 2.6 1.5 2.6 43 0.7 1.3 0.3 0.9 0.6 0.9 12.0 11.4 6.1 7.4 8.3 7.6 2.2 2.8 1.6 2.8 45 0.7 1.4 0.3 1.0 0.6 0.9 12.5 11.9 6.4 7.7 8.7 7.9 2.4 2.9 1.7 2.9 47 0.8 1.4 0.3 1.0 0.6 1.0 13.0 12.4 6.7 8.0 9.0 8.2 2.5 3.0 1.8 3.0 49 0.8 1.5 0.3 1.1 0.7 1.0 13.4 12.8 6.9 8.3 9.4 8.5 2.6 3.2 1.8 3.1 51 0.8 1.6 0.3 1.1 0.7 1.0 13.9 13.3 7.2 8.6 9.7 8.8 2.7 3.3 1.9 3.3 53 0.9 1.6 0.4 1.2 0.7 1.1 14.4 13.7 7.4 8.9 10.0 9.1 2.8 3.4 2.0 3.4 55 0.9 1.7 0.4 1.2 0.7 1.1 14.8 14.1 7.7 9.2 10.3 9.4 2.9 3.5 2.0 3.5 57 0.9 1.7 0.4 1.3 0.8 1.2 15.2 14.6 7.9 9.5 10.6 9.7 3.0 3.7 2.1 3.6 59 0.9 1.8 0.4 1.3 0.8 1.2 15.7 15.0 8.2 9.7 10.9 9.9 3.1 3.8 2.2 3.8 1 This column to be used only if brands and tags are not located at the washbasin. 2 This refers to the carcasses in the bleeding area.

(ii) Inspection Using Viscera Table, Tongue-In Presentation of Heads.

Steers and Heifers Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 32 a a a 33 to 58 b b b 59 to 84 1 1 1 85 to 86 1 2 1 87 to 143 2 2 1 144 to 171 3 2 1 172 to 198 3 3 1 199 to 226 3 3 2 227 to 253 4 3 2 254 to 280 4 4 2 281 to 306 5 4 2 307 to 333 5 5 2 Cows and Bulls Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 29 a a a 30 to 56 b b b 57 to 77 1 1 1 78 to 81 1 2 1 82 to 134 2 2 1 135 to 159 2 3 1 160 to 187 3 3 1 188 to 213 3 4 1 214 to 234 3 4 2 235 to 264 4 4 2 265 to 289 5 4 2 290 to 314 5 5 2

(iii) Inspection Using Viscera Table, Tongue-Out Presentation of Heads.

Steers and Heifers Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 32 a a a 33 to 58 b b b 59 to 86 1 1 1 87 to 103 1 2 1 104 to 156 2 2 1 157 to 186 2 3 1 187 to 216 3 3 1 217 to 246 3 3 2 247 to 275 3 4 2 276 to 304 4 4 2 305 to 333 4 5 2 334 to 362 5 5 2 363 to 390 5 6 2 Cows and Bulls Maximum slaughter rates (head per hour) Number of inspectors by stations Head Viscera Carcass 1 to 29 a a a 30 to 56 b b b 57 to 79 1 1 1 80 to 98 1 2 1 99 to 147 2 2 1 148 to 174 2 3 1 175 to 205 3 3 1 206 to 233 3 4 1 234 to 256 3 4 2 257 to 288 4 4 2 289 to 316 5 4 2 317 to 343 5 5 2

(3) Swine Inspection. The following inspection staffing standards are applicable to swine slaughter configurations. The inspection standards for all slaughter lines are based upon the observation rather than palpation, at the viscera inspection station, of the spleen, liver, heart, lungs, and mediastinal lymph nodes. In addition, for one- and two-inspector lines, the standards are based upon the distance walked (in feet) by the inspector between work stations; and for three or more inspector slaughter lines, upon the use of a mirror, as described in § 307.2(m)(6), at the carcass inspection station. Although not required in a one- or two-inspector slaughter configuration, except in certain cases as determined by the inspection service, if a mirror is used, it must comply with the requirements of § 307.2(m)(6).

Table 1—One Inspector—Staffing Standards for Swine Distance walked 1 in feet is— Maximum inspection rates (head per hour) Market hogs (heads attached or detached) Without mirror With mirror Sows and boars (heads detached) Without mirror With mirror 0 to 5 140 150 131 143 6 to 10 134 144 126 137 11 to 15 129 137 122 132 16 to 20 124 132 117 127 21 to 35 120 127 113 122 26 to 30 116 122 110 118 31 to 35 112 118 106 114 36 to 40 108 114 103 110 41 to 45 105 110 100 106 46 to 50 101 107 97 103 51 to 55 98 103 94 100 56 to 60 96 100 91 97 61 to 65 93 97 89 94 66 to 70 90 95 87 92 71 to 75 88 92 85 89 76 to 80 86 89 82 87 81 to 85 84 87 80 85 86 to 90 82 85 79 83 91 to 95 80 83 77 81 96 to 100 78 81 75 79 1 Distance walked is the total distance that the inspector will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, head, and wash-basin). Table 2—Two Inspectors—Staffing Standards for Market Hogs Distance walked 1 in feet by inspector B is— Maximum inspection rates (head per hour with heads attached or detached) Line configuration Carcass,2 head viscera 3 Viscera,2 head carcass 3 Head,2 viscera carcass 3 Without Mirror 0 to 5 151-253 151-271 151-296 6 to 10 151-239 151-255 151-277 11 to 15 151-226 151-240 151-260 16 to 20 151-214 151-227 151-244 21 to 25 151-204 151-215 151-231 With Mirror 0 to 5 151-253 151-303 151-318 6 to 10 151-239 151-283 151-304 11 to 15 151-226 151-265 151-289 16 to 20 151-214 151-249 151-270 21 to 25 151-204 151-235 151-254 1 Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). 2 Inspector A. 3 Inspector B. Note:

In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload.

Table 3—Two Inspectors—Staffing Standards for Sows and Boars Distance walked 1 in feet by inspector B is— Maximum inspection rates (head per hour) Line Configuration Carcass,2 head viscera,3 heads detached Viscera,2 head carcass,3 heads detached Head,2 viscera carcass,3 heads detached Head,2 viscera carcass,3 heads attached Without Mirror 0 to 5 144-248 144-254 144-267 144-267 6 to 10 144-235 144-240 144-253 144-253 11 to 15 144-222 144-227 144-239 144-239 16 to 20 144-211 144-215 144-226 144-226 21 to 25 144-201 144-205 144-214 144-214 With Mirror 0 to 5 144-248 144-292 144-305 144-292 6 to 10 144-235 144-273 144-291 144-280 11 to 15 144-222 144-256 144-272 144-268 16 to 20 144-211 144-241 144-255 144-255 21 to 25 144-201 144-228 144-240 144-240 1 Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). 2 Inspector A. 3 Inspector B. Note:

In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload.

Table 4—Three Inspectors or More—Staffing Standards for Swine Maximum inspection rates (head per hour with heads attached) Number of inspectors by station Head Viscera Carcass Total Market hogs: 319 to 506 1 1 1 3 507 to 540 1 2 1 4 541 to 859 2 2 1 5 860 to 1,022 2 3 1 6 1,023 to 1,106 3 3 1 7 Sows and boars: 306 to 439 1 1 1 3 306 to 462 1 1 1 1 3 440 to 475 2 1 1 4 476 to 752 2 2 1 5 753 to 895 3 2 1 6 896 to 964 3 3 1 7 1 This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection. Note:

In multiple-inspector plants, the inspectors 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]

§ 310.2 Identification of carcass with certain severed parts thereof and with animal from which derived.

(a) The head, tail, tongue, thymus gland, and all viscera of each slaughtered animal, and all blood and other parts of such animal to be used in the preparation of meat food products or medical products, shall be handled in such a manner as to identify them with the rest of the carcass and as being derived from the particular animal involved, until the post-mortem examination of the carcass and parts thereof has been completed. Such handling shall include the retention of ear tags, backtags, implants, and other identifying devices affixed to the animal, in such a way to relate them to the carcass until the post-mortem examination has been completed.

(b) The official State-Federal Department backtag on any carcass shall:

(1)(i) Be removed from the hide of the animal by an establishment employee and placed in a clear plastic bag. The bag containing the tag shall be affixed to the corresponding carcass.

(ii) The bag containing the tag shall be removed from the carcass by an establishment employee and presented with the viscera to the Program inspector at the point where such inspector conducts the viscera inspection.

(2)(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales tags, ear bangles, and similar identification devices shall be removed from the animal's hide or ear by an establishment employee and shall be placed in a clear plastic bag and affixed to the corresponding carcass.

(3) In cases where both types of devices described in paragraphs (b)(1) and (2) of this section are present on the same animal, both types may be placed in the same plastic bag or in two separate bags.

(4) The circuit supervisor may allow the use of any alternate method proposed by the operator of an official establishment for handling the type of devices described in paragraph (b)(2) of this section if such alternate method would provide a ready means of identifying a specific carcass with the corresponding devices by a Program inspector during the post-mortem inspection.

(5) Disposition and use of identifying devices.

(i) The official State-Federal Department backtags will be collected by a Program inspector and used to obtain traceback information necessary for proper disposition of the animal or carcass and otherwise handled according to instructions issued to the inspectors.

(ii) The devices described in paragraph (b)(2) of this section shall be collected by the Program inspector when required to obtain traceback information necessary for proper disposition of the animal or carcass and for controlling the slaughter of reactor animals. Devices not collected for these purposes shall be discarded after the post-mortem examination is complete.

(6) Plastic bags used by the establishment for collecting identifying devices will be furnished by the Department.

[35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, 1971]

§ 310.3 Carcasses and parts in certain instances to be retained.

Each carcass, including all detached organs and other parts, in which any lesion or other condition is found that might render the meat or any part unfit for food purposes, or otherwise adulterated, and which for that reason would require a subsequent inspection, shall be retained by the Program employee at the time of inspection. The identity of every such retained carcass, detached organ, or other part shall be maintained until the final inspection has been completed. Retained carcasses shall not be washed or trimmed unless authorized by the Program employee.

§ 310.4 Identification of carcasses and parts; tagging.

Such devices and methods as may be approved by the Administrator may be used for the temporary identification of retained carcasses, organs, and other parts. In all cases, the identification shall be further established by affixing “U.S. Retained” tags as soon as practicable and before final inspection. These tags shall not be removed except by a Program employee.

§ 310.5 Condemned carcasses and parts to be so marked; tanking; separation.

Each carcass or part which is found on final inspection to be unsound, unhealthful, unwholesome, or otherwise adulterated shall be conspicuously marked, on the surface tissues thereof, by a Program employee at the time of inspection, as “U.S. Inspected and Condemned.” Condemned detached organs and other parts of such character that they cannot be so marked shall be placed immediately in trucks or receptacles which shall be kept plainly marked “U.S. Condemned,” in letters not less than 2 inches high. All condemned carcasses and parts shall remain in the custody of a Program employee and shall be disposed of as required in the regulations in part 314 of this subchapter at or before the close of the day on which they are condemned.

§ 310.6 Carcasses and parts passed for cooking; marking.

Carcasses and parts passed for cooking shall be marked conspicuously on the surface tissues thereof by a Program employee at the time of inspection, “U.S. Passed for Cooking.” All such carcasses and parts shall be cooked in accordance with part 315 of this subchapter, and until so cooked shall remain in the custody of a Program employee.

§ 310.7 Removal of spermatic cords, pizzles and preputial diverticuli.

Spermatic cords and pizzles shall be removed from all carcasses. Preputial diverticuli shall be removed from hog carcasses.

§ 310.8 Passing and marking of carcasses and parts.

Carcasses and parts found to be sound, healthful, wholesome, and otherwise not adulterated shall be passed and marked as provided in part 316 of this subchapter. In all cases where carcasses showing localized lesions are passed for food or for cooking and “U.S. Retained” tags are attached to the carcasses, the affected tissues shall be removed and condemned before the tags are removed. “U.S. Retained” tags shall be removed only by a Program employee.

§ 310.9 Anthrax; carcasses not to be eviscerated; disposition of affected carcasses; hides, hoofs, horns, hair, viscera and contents, and fat; handling of blood and scalding vat water; general cleanup and disinfection.

(a) Carcasses found before evisceration to be affected with anthrax shall not be eviscerated but shall be retained, condemned, and immediately tanked or otherwise disposed of as provided in part 314 of this subchapter.

(b) All carcasses and all parts, including hides, hoofs, horns, hair, viscera and contents, blood, and fat of any livestock found to be affected with anthrax shall be condemned and immediately disposed of as provided in part 314 of this subchapter, except that the blood may be handled through the usual blood cooking and drying equipment.

(c) Any part of any carcass that is contaminated with anthrax-infected material through contact with soiled instruments or otherwise shall be immediately condemned and disposed of as provided in part 314 of this subchapter.

(d) The scalding vat water through which hog carcasses affected with anthrax have passed shall be immediately drained into the sewer and all parts of the scalding vat shall be cleaned and disinfected as provided in paragraph (e) of this section.

(e)(1) That portion of the slaughtering department, including the bleeding area, scalding vat, gambrelling bench, floors, walls, posts, platforms, saws, cleavers, knives, and hooks, as well as employees' boots and aprons, contaminated through contact with anthrax-infected material, shall, except as provided in paragraph (e)(2) of this section be cleaned immediately and disinfected with one of the following disinfectants or other disinfectant 1 approved specifically for this purpose by the Administrator:

1 A list of disinfectants approved for this purpose is available upon request to the Scientific Services, Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(i) A 5 percent solution of sodium hydroxide or commercial lye containing at least 94 percent of sodium hydroxide. The solution shall be freshly prepared immediately before use by dissolving 21/2 pounds of sodium hydroxide or lye in 51/2 gallons of hot water and shall be applied as near scalding hot as possible to be most effective. (Owing to the extremely caustic nature of sodium hydroxide solution, precautionary measures such as the wearing of rubber gloves and boots to protect the hands and feet, and goggles to protect the eyes, should be taken by those engaged in the disinfection process. It is also advisable to have an acid solution, such as vinegar, in readiness in case any of the sodium hydroxide solution should come in contact with any part of the body.)

(ii) A solution of sodium hypochlorite containing approximately one-half of 1 percent (5,000 parts per million) of available chlorine. The solution shall be freshly prepared.

(iii) When a disinfectant solution has been applied to equipment which will afterwards contact product, the equipment shall be rinsed with clean water before such contact.

(2) In case anthrax infection is found in the hog slaughtering department, an immediate preliminary disinfection shall be made from the head-dropper's station to the point where the disease is detected and the affected carcasses shall be cut down from the rail and removed from the room. Upon completion of the slaughtering of the lot of hogs of which the anthrax-infected animals were a part, slaughtering operations shall cease, and a thorough cleanup and disinfection shall be made, as provided in paragraph (e)(1) of this section. If the slaughter of the lot has not been completed by the close of the day on which anthrax was detected, the cleanup and disinfection shall not be deferred beyond the close of that day.

(3) The first and indispensable precautionary step for persons who have handled anthrax material is thorough cleansing of the hands and arms with liquid soap and running hot water. It is important that this step be taken immediately after exposure, before vegetative anthrax organisms have had time to form spores. In the cleansing, a brush or other appropriate appliance shall be used to insure the removal of all contaminating material from under and about the fingernails. This process of cleansing is most effective when performed in repeated cycles of lathering and rinsing rather than in spending the same amount of time in scrubbing with a single lathering. After the hands have been cleansed thoroughly and rinsed free of soap, they may, if desired, be immersed for about 1 minute in a 1:1,000 solution of bichloride of mercury, followed by thorough rinsing in clean running water. Supplies of bichloride of mercury for the purpose must be held in the custody of the veterinary medical officer. (As a precautionary measure, all persons exposed to anthrax infection should report promptly any suspicious condition (sore or carbuncle) or symptom to a physician, in order that anti-anthrax serum or other treatment may be administered as indicated.)

[35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, 1971]

§ 310.10 Carcasses with skin or hide on; cleaning before evisceration; removal of larvae of Hypodermae, external parasites and other pathological skin conditions.

When a carcass is to be dressed with the skin or hide left on, the skin or hide shall be thoroughly washed and cleaned before any incision is made for the purpose of removing any part thereof or evisceration, except that where calves are slaughtered by the kosher method, the heads shall be removed from the carcasses, before washing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass infested with the larvae of the “oxwarble” fly (Hypoderma lineata and Hypoderma bovis), or external parasites, or affected with other pathological skin conditions.

§ 310.11 Cleaning of hog carcasses before incising.

All hair, scurf, dirt, hoofs and claws shall be removed from hog carcasses, and the carcasses shall be thoroughly washed and cleaned before any incision is made for inspection or evisceration.

§ 310.12 Sternum to be split; abdominal and thoracic viscera to be removed.

The sternum of each carcass shall be split and the abdominal and thoracic viscera shall be removed at the time of slaughter in order to allow proper inspection.

§ 310.13 Inflating carcasses or parts thereof; transferring caul or other fat.

(a)(1) Establishments shall not inflate carcasses or parts of carcasses with air, except as set forth in paragraph (a)(2) of this section.

(2)(i) Any establishment slaughtering livestock that wishes to inflate carcasses or parts thereof with air, using procedures other than the approved methods listed below, shall submit a request for approval for experimental testing to the Administrator. Such a request shall include the purpose of the use of air, a detailed description of the procedure for injecting the air and evidence that the procedure can be performed in a sanitary manner.

(ii) The Administrator shall evaluate newly submitted procedures for the use of air. If the Administrator determines that any such procedure will likely result in wholesome, unadulterated meat product, then the Administrator shall approve experimental testing of the new procedure. In any situation where the Administrator finds a submitted procedure to be unlikely to result in wholesome, unadulterated meat product, the Administrator shall send written notification to the establishment of the denial of such approval. The establishment may re-submit for evaluation a testing procedure that has been denied, provided that modifications have been made to address the original reason for denial. The establishment also shall be afforded an opportunity to submit a written statement in response to the notification of denial. In those instances where there is a conflict of facts, a hearing, under applicable rules of practice, will be held to resolve the conflict.

(iii) Final approval of an acceptable new proposed method shall be effectuated by modifying, through rulemaking procedures, the Federal regulations to include the new method.

(iv) Uses for which approval is granted are:

(A) Compressed air injection of cattle feet to facilitate removal of hair from feet intended for human consumption;

(B) Compressed air injection under the skin of cattle heads to facilitate head skinning;

(C) Compressed air injection into the skull of all livestock except cattle in conjunction with a captive bolt stunner to hold the animal still for dressing operations; or

(D) Compressed air injected into the abdominal cavity of swine to facilitate the skinning operation and to minimize the loss of body fat.

The method of compressed air injection shall be a sanitary procedure that includes air filtration and injection needle disinfection. Air filtration shall consist of not less than two stages. An initial stage of filtration shall occur at or near the use point and shall consist of an aerosol or coalescing filter, capable of filtration to not more than 0.75 micron, for the removal of oil and water. A subsequent stage of filtration shall occur at or near the point of needle hose attachment to the air line and shall be a particulate filter, capable of filtration to not more than 0.3 micron. The filters shall be maintained by inspecting regularly to assure they are working properly, and cleaned or replaced when necessary. The injection needle shall be disinfected by placement in water that is not less than 180 °F. for at least 10 seconds immediately prior to each injection.

(b) Transferring the caul or other fat from a fat to a lean carcass is prohibited.

(Approved by the Office of Management and Budget under control number 0583-0015) [54 FR 36756, Sept. 5, 1989, as amended at 55 FR 29565, July 20, 1990; 69 FR 1891, Jan. 12, 2004]

§ 310.14 Handling of bruised parts.

When only a portion of a carcass is to be condemned on account of slight bruises, either the bruised portion shall be removed immediately and disposed of in accordance with part 314 of this subchapter, or the carcass shall be promptly placed in a retaining room and kept until chilled and the bruised portion shall then be removed and disposed of as provided in part 314 of this subchapter.

§ 310.15 Disposition of thyroid glands and laryngeal muscle tissue.

(a) Livestock thyroid glands and laryngeal muscle tissue shall not be used for human food.

(b) Livestock thyroid glands and laryngeal muscle tissue may be distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with § 314.9 or § 325.19(c) of this subchapter, if they are labeled in accordance with § 316.13(f) of this subchapter. Otherwise, they shall be disposed of at the official establishment in accordance with § 314.1 or § 314.3 of this subchapter.

[53 FR 45890, Nov. 15, 1988]

§ 310.16 Disposition of lungs.

(a) Livestock lungs shall not be saved for use as human food.

(b) Lungs found to be affected with disease or pathology and lungs found to be adulterated with chemical or biological residue shall be condemned and identified as “U.S. Inspected and Condemned.” Condemned lungs may not be saved for pet food or other nonhuman food purposes. They shall be maintained under inspectional control and disposed of in accordance with §§ 314.1 and 314.3 of this subchapter.

(c) Lungs not condemned under paragraph (b) of this section may be used in the preparation of pet food or for other nonhuman food purposes at the official establishment, provided they are handled in the manner prescribed in § 318.12 of this subchapter, or they may be distributed from the establishment in commerce, or otherwise, in accordance with the conditions prescribed in § 325.8 of this subchapter for nonhuman food purposes or they may be so distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with §§ 314.9 and 325.19(b) of this subchapter, if they are labeled as “Inedible [SPECIES] Lungs—for Pharmaceutical Use Only.” Otherwise, they shall be disposed of at the official establishment, in accordance with §§ 314.1 and 314.3 of this subchapter.

[36 FR 11639, June 17, 1971]

§ 310.17 Inspection of mammary glands.

(a) Lactating mammary glands and diseased mammary glands of cattle, sheep, swine, and goats shall be removed without opening the milk ducts or sinuses. If pus or other objectionable material is permitted to come in contact with the carcass, the parts of the carcass thus contaminated shall be removed and condemned.

(b) Nonlactating cow udders may be saved for food purposes provided suitable facilities for handling and inspecting them are provided. Examination of udders by palpation shall be done by a Program employee. When necessary, in the judgment of the Program employee for adequate inspection, the official establishment employees shall incise udders in sections no greater than 2 inches in thickness. All udders showing disease lesions shall be condemned by a Program employee. Each udder shall be properly identified with its respective carcass and kept separate and apart from other udders until its disposal has been accomplished in accordance with the provisions of part 311 of this subchapter.

(d) The udders from cows officially designated as “Brucellosis reactors” or as “Mastitis elimination cows” shall be condemned.

§ 310.18 Contamination of carcasses, organs, or other parts.

(a) Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector.

(b) Brains, cheek meat, and head trimmings from animals stunned by lead, sponge iron, or frangible bullets shall not be saved for use as human food but shall be handled as described in § 314.1 or § 314.3 of this subchapter.

§ 310.19 Inspection of kidneys.

An employee of the establishment shall open the kidney capsule and expose the kidneys of all livestock at the time of slaughter for the purpose of examination by a Program employee.

§ 310.20 Saving of blood from livestock as an edible product.

Blood may be saved for edible purposes at official establishments provided it is derived from livestock, the carcasses of which are inspected and passed, and the blood is collected, defibrinated, and handled in a manner so as not to render it adulterated under the Federal Meat Inspection Act and regulations issued pursuant thereto. The defibrination of blood intended for human food purposes shall not be done with the hands. Anticoagulants may be used in accordance with 21 CFR Chapter I, Subchapter A and Subchapter B, or by regulation in 9 CFR Chapter III, Subchapter A or Subchapter E.

[64 FR 72174, Dec. 23, 1999]

§ 310.21 Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts.

(a) Calf carcasses from animals suspected of containing biological residues under § 309.16(d) of this subchapter shall, on post-mortem inspection, be handled in accordance with the provisions of this section.

(b) For purposes of this section, the following definitions shall apply:

(1) Calf. A calf up to 3 weeks of age or up to 150 pounds.

(2) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.

(3) Healthy carcass. A carcass that an inspector determines shows no lesions of disease or signs of disease treatment at post-mortem inspection

(4) Producer. The owner of the calf at the time of its birth.

(5) Sick calf carcass. A calf carcass that an inspector on post-mortem inspection determines has either signs of disease treatment or lesions of disease or was from an animal identified as sick on ante-mortem.

(6) Sign of treatment. Sign of treatment of a disease is indicated by leakage around jugular veins, subcutaneous, intramuscular or intraperitoneal injection lesions, or discoloration from particles or oral treatment in any part of the digestive tract.

(7) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.

1 The procedures for performing the swab bioassay test are set forth in one of two self-instructional guides: “Performing the CAST” or “Fast Antimicrobial Screen Test.” These guides are available for review in the office of the FSIS Docket Clerk, Room 4352 South, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(1) Any carcass from a calf tagged as “U.S. Suspect” at the time of ante-mortem inspection, except that calves whose carcasses are condemned for pathology shall not be tested for drug residues.

(2) Any carcass which he/she finds has either lesions of disease which is not condemned because of these lesions or a sign of treatment of disease at the time of post-mortem inspection,

(3) Any carcass of a calf from a producer whose calf or calves have previously been condemned for residues as prescribed in paragraph (e) of this section, and

(4) Carcasses from healthy-appearing certified and noncertified calves, as determined by the veterinary medical officer during ante-mortem inspection, will be selected for testing as set forth below:

Testing level Sampling Rate (percent of estimated day's slaughter) Certified Noncertified A 100 100 B 50 50 C 20 30 (Start) D 5 10 E 2 5 F 1 2

(d) Testing of carcasses:

(1) The inspector shall test all carcasses as prescribed in paragraph (c) of this section.

(2) Upon initiation of this program at an establishment, the inspector shall begin the testing rate for carcasses from healthy-appearing certified and noncertified calves at Level D as prescribed in paragraph (c)(4) of this section. The inspector shall increase the testing rate to the next higher level the following business day when three carcasses in 100 or less consecutively tested show a positive test result for a drug residue. The inspector shall decrease it to the next lower level when no more than two calves show a positive test result for a drug residue in either 500 calves consecutively tested or all calves tested over a 60 working day period.

(3) Test results shall be determined by the veterinary medical officer.

(4) The establishment may designate one or more of its employees to aid the inspector in performing the swab bioassay test under the supervision of the veterinary medical officer who shall interpret the results, maintain animal identification with the test unit, and ensure integrity of the testing program.

(5) All carcasses and parts thereof from calves selected for testing shall be retained until all test results are complete.

(6) The veterinary medical officer shall condemn all carcasses and parts thereof for which there are positive test results and release for human consumption all carcasses and parts thereof for which there are negative test results.

(7) If there is a positive test result, subsequent calves from the producer of the calf shall be tested in accordance with paragraph (e) of this section. These test results will not be included in computations to determine an establishment's compliance record.

(8) The veterinary medical officer may reduce inspection line rates when, in his/her judgment, the prescribed testing cannot be adequately performed within the time available because the establishment's compliance history dictates a need for extensive testing.

(e) Calves from producers with a previous residue condemnation. The inspector shall perform a swab bioassay test on all carcasses of all calves in the group. The veterinary medical officer shall determine the test results and shall condemn any carcass and parts thereof for which there is a positive test result and pass for human consumption any such carcass and parts thereof for which there is a negative test result. All subsequent calves from the same producer which has previously sold or delivered to official establishments any carcass that was condemned because of drug residues must be tested according to this paragraph until five consecutive animals test completely free of animal drug residues.

(f) If the owner or operator of an official establishment disagrees with the veterinary medical officer's disposition of carcasses and parts thereof, the owner or operator may appeal as provided in section 306.5 of this chapter.

[50 FR 32164, Aug. 9, 1985, as amended at 52 FR 2104, Jan. 20, 1987; 55 FR 7475, Mar. 2, 1990; 60 FR 66483, Dec. 22, 1995]

§ 310.22 Specified risk materials from cattle and their handling and disposition.

(a) The following materials from cattle are specified risk materials, except when they are from cattle from a country that can demonstrate that its bovine spongiform encephalopathy (BSE) risk status can reasonable be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States:

(1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from cattle 30 months of age and older and

(2) The distal ileum of the small intestine and the tonsils from all cattle.

(b) Specified risk materials are inedible and prohibited for use as human food.

(c) Specified risk materials must be removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with § 314.1 or § 314.3 of this subchapter. The spinal cord from cattle 30 months of age and older must be removed from the carcass at the establishment where the animal was slaughtered.

(d) Requirements for use of the small intestine for human food. (1) The small intestine from all cattle may be used for human food if:

(i) It is derived from cattle that were inspected and passed in an official establishment in the United States or in a certified foreign establishment in a country listed in 9 CFR 327.2(b) as eligible to export meat and meat products to the United States and it is otherwise eligible for importation under 9 CFR 327.1(b), and

(ii) The distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine as measured from the ceco-colic junction and progressing proximally towards the jejunum or by a procedure that the establishment demonstrates is effective in ensuring complete removal of the distal ileum.

(iii) If the conditions in paragraphs (d)(1)(i) or (ii) of this section are not met, the entire small intestine must be removed from the carcass, segregated from edible materials, and disposed of in accordance with §§ 314.1 or 314.3 of this subchapter.

(2) The requirements in paragraph (d)(1) of this section do not apply to materials from cattle from countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States.

(e) Procedures for the removal, segregation, and disposition of specified risk materials. (1) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials. These procedures must address potential contamination of edible materials with specified risk materials before, during, and after entry into the establishment. Establishments must incorporate their procedures for the removal, segregation, and disposition of specified risk materials into their HACCP plans or Sanitation SOPs or other prerequisite programs.

(2) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must take appropriate corrective action when either the establishment or FSIS determines that the establishment's procedures for the removal, segregation, and disposition of specified risk materials, or the implementation or maintenance of these procedures, have failed to ensure that specified risk materials are adequately and effectively removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with paragraph (c) of this section.

(3) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures as necessary whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.

(4) Recordkeeping requirements. (i) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must maintain daily records sufficient to document the implementation and monitoring of the procedures for the removal, segregation, and disposition of the materials listed in paragraph (a) of this section, and any corrective actions taken.

(ii) Records required by this section may be maintained on computers provided that the establishment implements appropriate controls to ensure the integrity of the electronic data.

(iii) Records required by this section must be retained for at least one year and must be accessible to FSIS. All such records must be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.

(f) Sanitation of equipment used to cut through specified risk materials. (1) If an establishment that slaughters cattle, or that processes the carcasses or parts from cattle, does not segregate the carcasses and parts from cattle 30 months of age and older from the carcasses and parts from cattle younger than 30 months during processing operations it must:

(i) Use dedicated equipment to cut through specified risk materials; or

(ii) Clean and sanitize equipment used to cut through specified risk materials before the equipment is used on carcasses or parts from cattle younger than 30 months of age.

(2) If an establishments that slaughters cattle, or that process the carcasses or parts from cattle, segregates the carcasses and parts of cattle 30 months of age and older from cattle younger than 30 months of age during processing operations, and processes the carcasses or parts from the cattle younger than 30 months first, it may use routine operational sanitation procedures on equipment used to cut through specified risk materials.

(g) Slaughter establishments may ship beef carcasses or parts that contain vertebral columns from cattle 30 months of age and older to another federally-inspected establishment for further processing if the establishment shipping these materials:

(1) Maintains control of the carcasses or parts while they are in transit or ensures that the carcasses or parts move under FSIS control;

(2) Ensures that the carcasses or parts are accompanied by documentation that clearly states that the carcasses or parts contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter;

(3) Maintains records that identify the official establishment that received the carcasses or parts;

(4) Maintains records that verify that the official establishment that received the carcasses or parts removed the portions of the vertebral column designated as specified risk materials in paragraph (a)(1) of this section and disposed of them in accordance with § 314.1 or § 314.3 of this subchapter.

(h) The materials listed in paragraph (a)(1) of this section will be deemed to be from cattle 30 months of age and older unless the establishment can demonstrate through documentation that the materials are from an animal that was younger than 30 months of age at the time of slaughter.

[72 FR 38729, July 13, 2007]

§ 310.23 Identification of carcasses and parts of swine.

(a) The identification of the carcasses and parts of swine identified in accordance with part 71 of this title shall be made available to the inspector upon the inspector's request throughout post-mortem inspection.

(b) If the establishment fails to provide required swine identification, the inspector shall order the retention of swine caracasses at the establishment until the completion of tests to confirm that the carcasses are not adulterated.

[53 FR 40387, Oct. 14, 1988]

§ 310.24 [Reserved]

§ 310.25 Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards.

(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters livestock must test for Escherichia coli Biotype 1 (E.coli) Establishments that slaughter more than one type of livestock or both livestock and poultry, shall test the type of livestock or poultry slaughtered in the greatest number. The establishment shall:

(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;

(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and

(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.

(2) Sampling requirements.

(i) Written procedures. Each establishment shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request.

(ii) Sample collection. The establishment must collect samples from all chilled livestock carcasses, except those boned before chilling (hot-boned), which must be sampled after the final wash. Samples must be collected in the following manner;

(A) For cattle, establishments must sponge or excise tissue from the flank, brisket and rump, except for hide-on calves, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.

(B) For sheep, goat, horse, mule, or other equine carcasses, establishments must sponge from the flank, brisket and rump, except for hide-on carcasses, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.

(iii) Sampling frequency. Slaughter establishments, except very low volume establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the volume of production at the following rates:

(A) Cattle, sheep, goats, horses, mules, and other equines: 1 test per 300 carcasses, but, a minimum of one sample during each week of operation.

Swine: 1 test per 1,000 carcasses, but a minimum of one sample during each week of operation.

(iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with § 417.2(b) of this chapter may substitute an alternative frequency for the frequency of sampling required under paragraph (a)(2)(iii) of this section if,

(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,

(B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls.

(v) Sampling in very low volume establishments. (A) Very low volume establishments annually slaughter no more than 6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules or other equines, 20,000 swine, or a combination of livestock not exceeding 6,000 cattle and 20,000 total of all livestock. Very low volume establishments that collect samples by sponging shall collect at least one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever comes first. Very low volume establishments collecting samples by excising tissue from carcasses shall collect one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until one series of 13 tests meets the criteria set forth in paragraph (a)(5)(i) of this section.

(B) Upon the establishment's meeting requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.

(3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) 2 or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the three tube Most Probable Number (MPN) method and agreeing with the 95 percent upper and lower confidence limit of the appropriate MPN index.

2 A copy of the current edition/revision of the “Official Methods of AOAC International,” 16th edition, 3rd revision, 1997, is on file with the Director, Office of the Federal Register, and may be purchased from the Association of Official Analytical Chemists International, Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417.

(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of CFU/cm2 of surface area sponged or excised. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results, by type of livestock slaughtered. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.

(5) Criteria for evaluation of test results. (i) An establishment excising samples from carcasses is operating within the criteria when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is three or fewer out of the most recent 13 samples (n) taken, as follows:

Table 1—Evaluation of E. Coli Test Results Type of livestock Lower limit of marginal range

(m)

Upper limit of marginal range

(M)

Number of sample tested

(n)

Maximum number permitted in marginal range

(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 carcasses shall evaluate E. coli test results using statistical process control techniques.

(6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.

(7) Failure to test and record. Inspection shall be suspended in accordance with rules of practice that will be adopted for such proceedings upon a finding by FSIS that one or more provisions of paragraphs (a) (1)-(4) of this section have not been complied with and written notice of same has been provided to the establishment.

(b) Pathogen reduction performance standard; Salmonella—(1) Raw meat product performance standards for Salmonella. An establishment's raw meat products, when sampled and tested by FSIS for Salmonella, as set forth in this section, may not test positive for Salmonella at a rate exceeding the applicable national pathogen reduction performance standard, as provided in Table 2:

Table 2—Salmonella Performance Standards Class of product Performance Standard (percent positive for Salmonella)a Number of samples tested

(n)

Maximum number of positives to achieve Standard

(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.

(2) Enforcement. FSIS will sample and test raw meat products in an individual establishment on an unannounced basis to determine prevalence of Salmonella in such products to determine compliance with the standard. The frequency and timing of such testing will be based on the establishment's previous test results and other information concerning the establishment's performance. In an establishment producing more than one class of product subject to the pathogen reduction standard, FSIS may sample any or all such classes of products.3

3 A copy of FSIS's “Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Meat and Poultry Products” is available for inspection in the FSIS Docket Room.

(3) Noncompliance and establishment response. When FSIS determines that an establishment has not met the performance standard:

(i) The establishment shall take immediate action to meet the standard.

(ii) If the establishment fails to meet the standard on the next series of compliance tests for that product, the establishment shall reassess its HACCP plan for that product and take appropriate corrective actions.

(iii) Failure by the establishment to act in accordance with paragraph (b)(3)(ii) of this section, or failure to meet the standard on the third consecutive series of FSIS-conducted tests for that product, constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan, in accordance with part 417 of this chapter, for that product, and will cause FSIS to suspend inspection services. Such suspension will remain in effect until the establishment submits to the FSIS Administrator or his/her designee satisfactory written assurances detailing the action taken to correct the HACCP system and, as appropriate, other measures taken by the establishment to reduce the prevalence of pathogens.

[61 FR 38864, July 25, 1996, as amended at 62 FR 26217, May 13, 1997; 63 FR 1735, Jan. 12, 1998;64 FR 66553, Nov. 29, 1999]

Pt. 311 PART 311—DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES AND PARTS Sec. 311.1 Disposal of diseased or otherwise adulterated carcasses and parts; general. 311.2 Tuberculosis. 311.3 Hog cholera. 311.5 Swine erysipelas. 311.6 Diamond-skin disease. 311.7 Arthritis. 311.8 Cattle carcasses affected with anasarca or generalized edema. 311.9 Actinomycosis and actinobacillosis. 311.10 Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in cattle, blackleg, bluetongue, hemorrhagic septicemia, icterohematuria in sheep, infectious bovine rhinotracheitis, leptospirosis, malignant epizootic catarrh, strangles, purpura hemorrhagica, azoturia, infectious equine encephalomyelitis, toxic encephalomyelitis (forage poisoning), infectious anemia (swamp fever), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness, extensive fistula, and unhealed vaccine lesions. 311.11 Neoplasms. 311.12 Epithelioma of the eye. 311.13 Pigmentary conditions; melanosis, xanthosis, ochronosis, etc. 311.14 Abrasions, bruises, abscesses, pus, etc. 311.15 Brucellosis. 311.16 Carcasses so infected that consumption of the meat may cause food poisoning. 311.17 Necrobacillosis, pyemia, and septicemia. 311.18 Caseous lymphadenitis. 311.19 Icterus. 311.20 Sexual odor of swine. 311.21 Mange or scab. 311.22 Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema. 311.23 Tapeworm cysts (cysticercus bovis) in cattle. 311.24 Hogs affected with tapeworm cysts. 311.25 Parasites not transmissible to man; tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms. 311.26 Emaciation. 311.27 Injured animals slaughtered at unusual hours. 311.28 Carcasses of young calves, pigs, kids, lambs, and foals. 311.29 Unborn and stillborn animals. 311.30 Livestock suffocated and hogs scalded alive. 311.31 Livers affected with carotenosis; livers designated as “telangiectatic,” “sawdust,” or “spotted.” 311.32 Vesicular diseases. 311.33 Listeriosis. 311.34 Anemia. 311.35 Muscular inflammation, degeneration, or infiltration. 311.36 Coccidioidal granuloma. 311.37 Odors, foreign and urine. 311.38 Meat and meat byproducts from livestock which have been exposed to radiation. 311.39 Biological residues. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15569, Oct. 3, 1970, unless otherwise noted.

§ 311.1 Disposal of diseased or otherwise adulterated carcasses and parts; general.

(a) The carcasses or parts of carcasses of all animals slaughtered at an official establishment and found at the time of slaughter or at any subsequent inspection to be affected with any of the diseases or conditions named in this part shall be disposed of according to the section pertaining to the disease or condition: Provided, That no product shall be passed for human food under any such section unless it is found to be otherwise not adulterated. Products passed for cooking or refrigeration under this part must be so handled at the official establishment where they are initially prepared unless they are moved to another official establishment for such handling or in the case of products passed for refrigeration are moved for such refrigeration to a freezing facility approved by the Administrator in specific cases: Provided, That when so moved the products are shipped in containers sealed in accordance with § 318.10(c) of this subchapter or in a sealed means of conveyance as provided in § 325.7 of this subchapter. Owning to the fact that it is impracticable to formulate rules covering every case and to designate at just what stage a disease process or a condition results in adulteration of a product, the decision as to the disposal of all carcasses, organs, or other parts not specifically covered in this part shall be left to the veterinary medical officer. The veterinary medical officer shall exercise his judgment regarding the disposition of all carcasses or parts of carcasses under this part in a manner which will insure that only wholesome, unadulterated product is passed for human food.

(b) In cases of doubt as to a condition, a disease, or the cause of a condition, or to confirm a diagnosis, representative specimens of the affected tissues, properly prepared and packaged, shall be sent for examination to one of the laboratories of the Biological Control Section of the Program.

§ 311.2 Tuberculosis.

The following principles shall apply to the disposition of carcasses of livestock based on the difference in the pathogenesis of tuberculosis in swine, cattle, sheep, goats, and equines.

(a) Carcasses condemned. The entire carcass of swine, cattle, sheep, goats, and equines shall be condemned if any of the following conditions occur:

(1) When the lesions of tuberculosis are generalized (tuberculosis is considered to be generalized when the lesions are distributed in a manner made possible only by entry of the bacilli into the systemic circulation);

(2) When on ante mortem inspection the animal is observed to have a fever found to be associated with an active tuberculosis lesion on post mortem inspection;

(3) When there is an associated cachexia;

(4) When a tuberculosis lesion is found in any muscle or intermuscular tissue, or bone, or joint, or abdominal organ (excluding the gastrointestinal tract) or in any lymph node as a result of draining a muscle, bone, joint, or abdominal organ (excluding the gastrointestinal tract);

(5) When the lesions are extensive in tissues of either the thoracic or the abdominal cavity;

(6) When the lesions are multiple, acute, and actively progressive; or

(7) When the character or extent of the lesions otherwise is not indicative of a localized condition.

(b) Organs or other parts condemned. An organ or other part of a swine, cattle, sheep, goat, or equine carcass affected by localized tuberculosis shall be condemned when it contains lesions of tuberculosis or when the corresponding lymph node contains lesions of tuberculosis.

(c) Carcasses of cattle passed without restriction for human food. Carcasses of cattle may be passed without restriction for human food only when the carcass of an animal not identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State, or accredited veterinarian 1 is found free of tuberculosis lesions during postmortem inspection.

1 Such testing is conducted in the tuberculosis eradication program of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture.

(d) Portions of carcasses and carcasses of cattle passed for cooking. (1) When a cattle carcass reveals a tuberculosis lesion or lesions not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(2) When the carcass of a cattle identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State or accredited veterinarian is found free of lesions of tuberculosis, the carcass may be passed for cooking in accordance with part 315 of this chapter.

(e) Portions of carcasses and carcasses of swine passed without restriction for human food. Swine carcasses found free of tuberculosis lesions during post mortem inspection may be passed for human food without restriction. When tuberculosis lesions in any swine carcass are localized and confined to one primary seat of infection, such as the cervical lymph nodes, the mesenteric lymph nodes, or the mediastinal lymph nodes, the unaffected portion of the carcass may be passed for human food without restriction after the affected organ or other part is condemned.

(f) Portions of carcasses of swine passed for cooking. When the carcass of any swine reveals lesions more severe or more numerous than those described in paragraph (e) of this section, but not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portions of such carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(g) Carcasses of sheep, goats, and equines passed without restriction for human food. Carcasses of sheep, goats, and equines may be passed without restriction for human food only if found free of tuberculosis lesions during post mortem inspection.

(h) Portions of carcasses of sheep, goats, and equines passed for cooking. If a carcass of any sheep, goat, or equine reveals a tuberculosis lesion or lesions that are not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

[37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, 1973]

§ 311.3 Hog cholera.

(a) The carcasses of all hogs affected with hog cholera shall be condemned.

(b) Inconclusive but suspicious symptoms of hog cholera observed during the ante-mortem inspection of a U.S. suspect shall be duly considered in connection with post-mortem findings and when the carcass of such a suspect shows lesions in the kidneys and the lymph nodes which resemble lesions of hog cholera, they shall be regarded as those of hog cholera and the carcass shall be condemned.

(c) When lesions resembling those of hog cholera occur in kidneys and lymph nodes of carcasses of hogs which appeared normal on ante-mortem inspection, further inspection of such carcasses shall be made for corroborative lesions. If on such further inspection, characteristic lesions of hog cholera are found in some organ or tissue in addition to those in the kidneys or in the lymph nodes or in both, then all lesions shall be regarded as those of hog cholera and the carcass shall be condemned. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for control of swine diseases in the State where the swine are located.

[35 FR 15569, Oct. 3, 1970, as amended at 40 FR 27225, June 27, 1975]

§ 311.5 Swine erysipelas.

Carcasses affected with swine erysipelas which is acute or generalized, or which show systemic change, shall be condemned.

§ 311.6 Diamond-skin disease.

Carcasses of hogs affected with diamond-skin disease when localized and not associated with systemic change may be passed for human food after removal and condemnation of the affected parts, provided such carcasses are otherwise healthy.

§ 311.7 Arthritis.

(a) Carcasses affected with arthritis which is localized and not associated with systemic change may be passed for human food after removal and condemnation of all affected parts. Affected joints with corresponding lymph nodes shall be removed and condemned. In order to avoid contamination of the meat which is passed, a joint capsule shall not be opened until after the affected joint is removed.

(b) Carcasses affected with arthritis shall be condemned when there is evidence of systemic involvement.

§ 311.8 Cattle carcasses affected with anasarca or generalized edema.

(a) Carcasses of cattle found on post-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive or well-marked generalized edema shall be condemned.

(b) Carcasses of cattle, including their detached organs and other parts, found on post-mortem inspection to be affected with anasarca to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the affected tissues, provided the lesion is localized.

§ 311.9 Actinomycosis and actinobacillosis.

(a) The definition of generalization as outlined for tuberculosis in § 311.2(a) shall apply for actinomycosis and actinobacillosis, and carcasses of livestock with generalized lesions of either such disease shall be condemned.

(b) Carcasses of livestock in a well-nourished condition showing uncomplicated localized lesions of actinomycosis or actinobacillosis may be passed for human food after the infected organs or other infected parts have been removed and condemned, except as provided in paragraphs (c) and (d) of this section.

(c) Heads affected with actinomycosis or actinobacillosis, including the tongue, shall be condemned, except that when the disease of the jaw is slight, strictly localized, and without suppuration, fistulous tracts, or lymph node involvement, the tongue, if free from disease, may be passed, or, when the disease is slight and confined to the lymph nodes, the head including the tongue, may be passed for human food after the affected nodes have been removed and condemned.

(d) When the disease is slight and confined to the tongue, with or without involvement of the corresponding lymph nodes, the head may be passed for human food after removal and condemnation of the tongue and corresponding lymph nodes.

§ 311.10 Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in cattle, blackleg, bluetongue, hemorrhagic septicemia, icterohematuria in sheep, infectious bovine rhinotracheitis, leptospirosis, malignant epizootic catarrh, strangles, purpura hemorrhagica, azoturia, infectious equine encephalomyelitis, toxic encephalomyelitis (forage poisoning), infectious anemia (swamp fever), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness, extensive fistula, and unhealed vaccine lesions.

(a) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned:

(1) Anthrax.

(2) Blackleg.

(3) Unhealed vaccine lesions (vaccinia).

(4) Strangles.

(5) Purpura hemorrhagica.

(6) Azoturia.

(7) Infectious equine encephalomye-litis.

(8) Toxic encephalomyelitis (forage poisoning).

(9) Infectious anemia (swamp fever).

(10) Dourine.

(11) Acute influenza.

(12) Generalized osteoporosis.

(13) Glanders (farcy).

(14) Acute inflammatory lameness.

(15) Extensive fistula.

(b) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned, except when recovery has occurred to the extent that only localized lesions persist, in which case the carcass may be passed for human food after removal and condemnation of the affected organs or other parts:

(1) Anaplasmosis.

(2) Bacillary hemoglobinuria in cattle.

(3) Babesiosis (piroplasmosis).

(4) Bluetongue.

(5) Hemorrhagic septicemia.

(6) Icterohematuria in sheep.

(7) Infectious bovine rhinotracheitis.

(8) Leptospirosis.

(9) Malignant epizootic catarrh.

[35 FR 15569, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971]

§ 311.11 Neoplasms.

(a) An individual organ or other part of a carcass affected with a neoplasm shall be condemned. If there is evidence of metastasis or that the general condition of the animal has been adversely affected by the size, position, or nature of the neoplasm, the entire carcass shall be condemned.

(b) Carcasses affected with malignant lymphoma shall be condemned.

§ 311.12 Epithelioma of the eye.

(a) Carcasses of animals affected with epithelioma of the eye, or the orbital region shall be condemned in their entirety if one of the following three conditions exists:

(1) The affection has involved the osseous structures of the head with extensive infection, suppuration, and necrosis;

(2) There is metastasis from the eye, or the orbital region, to any lymph node including the parotid lymph node, internal organs, muscles, skeleton, or other structures, regardless of the extent of the primary tumor; or

(3) The affection, regardless of extent, is associated with cachexia or evidence of absorption or secondary changes.

(b) Carcasses of animals affected with epithelioma of the eye, or the orbital region, to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the head, including the tongue, provided the carcass is otherwise normal.

§ 311.13 Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.

(a) Except as provided in § 311.19, carcasses of livestock showing generalized pigmentary deposits shall be condemned.

(b) The affected parts of carcasses showing localized pigmentary deposits of such character as to be unwholesome or otherwise adulterated shall be removed and condemned.

§ 311.14 Abrasions, bruises, abscesses, pus, etc.

All slight, well-limited abrasions on the tongue and inner surface of the lips and mouth, when without lymph node involvement, shall be carefully excised, leaving only sound, normal tissue, which may be passed for human food. Any organ or other part of a carcass which is badly bruised or which is affected by an abscess, or a suppurating sore shall be condemned; and when the lesions are of such character or extent as to affect the whole carcass, the whole carcass shall be condemned. Portions of carcasses which are contaminated by pus or other diseased material shall be condemned.

§ 311.15 Brucellosis.

Carcasses affected with localized lesions of brucellosis may be passed for human food after the affected parts are removed and condemned.

§ 311.16 Carcasses so infected that consumption of the meat may cause food poisoning.

(a) All carcasses of animals so infected that consumption of the products thereof may give rise to food poisoning shall be condemned. This includes all carcasses showing signs of:

(1) Acute inflammation of the lungs, pleura, pericardium, peritoneum, or meninges.

(2) Septicemia or pyemia, whether puerperal, traumatic, or without any evident cause.

(3) Gangrenous or severe hemorrhagic enteritis or gastritis.

(4) Acute diffuse metritis or mammitis.

(5) Phlebitis of the umbilical veins.

(6) Septic or purulent traumatic pericarditis.

(7) Any acute inflammation, abscess, or suppurating sore, if associated with acute nephritis, fatty and degenerated liver, swollen soft spleen, marked pulmonary hyperemia, general swelling of lymph nodes, diffuse redness of the skin, cachexia, icteric discoloration of the carcass or similar condition, either singly or in combination.

(8) Salmonellosis.

(b) Implements contaminated by contact with carcasses affected with any of the disease conditions mentioned in this section shall be thoroughly cleaned and sanitized as prescribed in part 308 of this subchapter. The equipment used in the dressing of such carcasses, such as viscera trucks or inspection tables, shall be sanitized with hot water having a minimum temperature of 180 °F. Carcasses or parts of carcasses contaminated by contact with such diseased carcasses shall be condemned unless all contaminated tissues are removed within 2 hours.

§ 311.17 Necrobacillosis, pyemia, and septicemia.

From the standpoint of meat inspection, necrobacillosis may be regarded as a local infection at the beginning, and carcasses in which the lesions are localized may be passed for human food if in a good state of nutrition, after those portions affected with necrotic lesions are removed and condemned. However, when emaciation, cloudy swelling of the parenchymatous tissue of organs or enlargement of the lymph nodes is associated with the infection, it is evident that the disease has progressed beyond the condition of localization to a state of toxemia, and the entire carcass shall therefore be condemned as both unwholesome and noxious. Pyemia or septicemia may intervene as a complication of the local necrosis, and when present the carcass shall be condemned in accordance with § 311.16.

§ 311.18 Caseous lymphadenitis.

(a) A thin carcass showing well-marked lesions in the viscera and the skeletal lymph nodes, or a thin carcass showing extensive lesions in any part shall be condemned.

(b) A thin carcass showing well-marked lesions in the viscera with only slight lesions elsewhere or showing well-marked lesions in the skeletal lymph nodes with only slight lesions elsewhere may be passed for cooking.

(c) A thin carcass showing only slight lesions in the skeletal lymph nodes and in the viscera may be passed for human food without restriction.

(d) A well-nourished carcass showing well-marked lesions in the viscera and with only slight lesions elsewhere or showing well-marked lesions confined to the skeletal lymph nodes with only slight lesions elsewhere may be passed for human food without restriction.

(e) A well-nourished carcass showing well-marked lesions in the viscera and the skeletal lymph nodes may be passed for cooking; but where the lesions in a well-nourished carcass are both numerous and extensive, it shall be condemned.

(f) All affected organs and nodes of carcasses passed for human food without restriction or passed for cooking shall be removed and condemned.

(g) As used in this section, the term “thin” does not apply to a carcass which is anemic or emaciated; and the term “lesions” refers to lesions of caseous lymphadenitis.

§ 311.19 Icterus.

Carcasses showing any degree of icterus shall be condemned. Yellow fat conditions caused by nutritional factors or characteristic of certain breeds of livestock and yellow fat sometimes seen in sheep shall not be confused with icterus. Such carcasses should be passed for human food, if otherwise normal.

§ 311.20 Sexual odor of swine.

(a) Carcasses of swine which give off a pronounced sexual odor shall be condemned.

(b) The meat of swine carcasses which give off a sexual odor less than pronounced may be passed for use in comminuted cooked meat food product or for rendering. Otherwise it shall be condemned.

§ 311.21 Mange or scab.

Carcasses of livestock affected with mange or scab in advanced stages, showing cachexia or extensive inflammation of the flesh, shall be condemned. When the disease is slight, the carcass may be passed after removal of the affected portion.

§ 311.22 Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

Carcasses of hogs affected with urticaria (nettle rash), tinea tonsurans, demodex folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the carcass is otherwise not adulterated.

§ 311.23 Tapeworm cysts (cysticercus bovis) in cattle.

(a) Except as provided in paragraph (b) of this section, carcasses of cattle affected with lesions of cysticercus bovis shall be disposed of as follows:

(1) Carcasses of cattle displaying lesions of cysticercus bovis shall be condemned if the infestation is extensive or if the musculature is edematous or discolored. Carcasses shall be considered extensively infested if in addition to finding lesions in at least two of the usual inspection sites, namely the heart, diaphragm and its pillars, muscles of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, they are found in at least two of the sites exposed by (i) an incision made into each round exposing the musculature in cross section, and (ii) a transverse incision into each forelimb commencing 2 or 3 inches above the point of the olecranon and extending to the humerus.

(2) Carcasses of cattle showing one or more tapeworm lesions of cysticercus bovis but not so extensive as indicated in paragraph (a)(1) of this section, as determined by a careful examination, including examination of, but not limited to, the heart, diaphragm and its pillars, muscles of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, may be passed for human food after removal and condemnation of the lesions with surrounding tissues: Provided, That the carcasses, appropriately identified by retained tags, are held in cold storage under positive control of a USDA Food Inspector at a temperature not higher than 15 °F. continuously for a period of not less than 10 days, or in the case of boned meat derived from such carcasses, the meat, when in boxes, tierces, or other containers, appropriately identified by retained tags, is held under positive control of a Program Inspector at a temperature of not higher than 15 °F. continuously for a period of not less than 20 days. As an alternative to retention in cold storage as provided in this subparagraph, such carcasses and meat may be heated throughout to a temperature of at least 140 °F. under positive control of a Program Inspector.

(b) Edible viscera and offal shall be disposed of in the same manner as the rest of the carcass from which they were derived unless any lesion of cysticercus bovis is found in these byproducts, in which case they shall be condemned.

[36 FR 4591, Mar. 10, 1971]

§ 311.24 Hogs affected with tapeworm cysts.

Carcasses of hogs affected with tapeworm cysts (Cysticercus cellulosae) may be passed for cooking, unless the infestation is excessive, in which case the carcass shall be condemned.

§ 311.25 Parasites not transmissible to man; tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms.

(a) In the disposal of carcasses, edible organs, and other parts of carcasses showing evidence of infestation with parasites not transmissible to man, the following general rules shall govern except as otherwise provided in this section: If the lesions are localized in such manner and are of such character that the parasites and the lesions caused by them can be completely removed, the nonaffected portion of the carcass, organ, or other part of the carcass may be passed for human food after the removal and condemnation of the affected portions. If an organ or other part of a carcass shows numerous lesions caused by parasites, or if the character of the infestation is such that complete extirpation of the parasitic infestation or invasion renders the part in any way unfit for human food, the affected part shall be condemned. If parasites are found to be distributed in a carcass in such a manner or to be of such character that their removal and the removal of the lesions caused by them is impracticable, no part of the carcass shall be passed for human food. If the infestation is excessive, the carcass shall be condemned. If the infestation is moderate, the carcass may be passed for cooking, but in case such carcass is not cooked as required by part 315 of this subchapter, it shall be condemned.

(b) In the case of sheep carcasses affected with tapeworm cysts (Cysticercus ovis, so-called sheep measles, not transmissible to man), such carcasses may be passed for human food after the removal and condemnation of the affected portions: Provided, however, That if, upon the final inspection of sheep carcasses retained on account of measles, the total number of cysts found embedded in muscular tissue, or in immediate relation with muscular tissue, excluding the heart, exceeds five, the entire carcass shall be condemned, or such carcass shall be heated throughout to a temperature of at least 140 °F. After removal and condemnation of all affected portions.

(c) Carcasses found infested with gid bladder-worms (Coenurus cerebralis, Multiceps multiceps) may be passed for human food after condemnation of the affected organ (brain or spinal cord).

(d) Organs or other parts of carcasses infested with hydatid cysts (echinococus) shall be condemned.

(e) Livers infested with flukes or fringed tapeworms shall be condemned.

§ 311.26 Emaciation.

Carcasses of livestock too emaciated to produce wholesome meat, and carcasses which show a serous infiltration of muscle tissues, or a serous or mucoid degeneration of the fatty tissue, shall be condemned. A gelatinous change of the fat of the heart and kidneys of well-nourished carcasses and mere leanness shall not be classed as emaciation.

[35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, 1971]

§ 311.27 Injured animals slaughtered at unusual hours.

When it is necessary for humane reasons to slaughter an injured animal at night or on Sunday or a holiday when the inspector cannot be obtained, the carcass and all parts of all livestock except for cattle shall be kept for inspection, with the head and all viscera except the stomach, bladder, and intestines held by the natural attachments. If all parts are not so kept for inspection, the carcass shall be condemned. If, on inspection of a carcass slaughtered in the absence of an inspector, any lesion or other evidence is found indicating that the animal was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante-mortem inspection, or if there is lacking evidence of the condition which rendered emergency slaughter necessary, the carcass shall be condemned. The parts and carcasses of cattle slaughtered in the absence of an inspector shall not be used for human food.

[35 FR 15569, Oct. 3, 1970, as amended at 69 FR 1874, Jan. 12, 2004]

§ 311.28 Carcasses of young calves, pigs, kids, lambs, and foals.

Carcasses of young calves, pigs, kids, lambs, and foals are unwholesome and shall be condemned if (a) the meat has the appearance of being water-soaked, is loose, flabby, tears easily, and can be perforated with the fingers; or (b) its color is grayish-red; or (c) good muscular development as a whole is lacking, especially noticeable on the upper shank of the leg, where small amounts of serous infiltrates or small edematous patches are sometimes present between the muscles; or (d) the tissue which later develops as the fat capsule of the kidneys is edematous, dirty yellow, or grayish-red, tough, and intermixed with islands of fat.

§ 311.29 Unborn and stillborn animals.

All unborn and stillborn animals shall be condemned and no hide or skin thereof shall be removed from the carcass within a room in which edible products are handled.

§ 311.30 Livestock suffocated and hogs scalded alive.

All livestock which have been suffocated in any way and hogs which have entered the scalding vat alive shall be condemned.

§ 311.31 Livers affected with carotenosis; livers designated as “telangiectatic,” “sawdust,” or “spotted.”

(a) Livers affected with carotenosis shall be condemned.

(b) Cattle livers and calf livers showing the conditions sometimes designated as “telangiectatic,” “sawdust,” or “spotted” shall be disposed of as follows:

(1) When any or all of the conditions are slight in the organ, the whole organ shall be passed for human food without restriction.

(2) When any or all of the conditions are more severe than slight and involve less than one-half of the organ, while in the remainder of the organ the conditions are slight or nonexistent, the remainder shall be passed for human food without restriction and the other portion shall be condemned.

(3) When any or all of the conditions are more severe than slight and involve one-half or more of the organ, the whole organ shall be condemned.

(4) The divisions of an organ into two parts as contemplated in this paragraph for disposition, shall be accomplished by one cut through the organ. This, of course, does not prohibit incisions which are necessary for inspection.

(c) “Telangiectatic,” “sawdust,” or “spotted” livers and parts of livers which are condemned for human food may be shipped from an official establishment for purposes other than human food in accordance with § 314.10 of this subchapter.

§ 311.32 Vesicular diseases.

(a) Any carcass affected with vesicular disease shall be condemned if the condition is acute and if the extent of the condition is such that it affects the entire carcass or there is evidence of absorption or secondary change.

(b) Any carcass affected with vesicular disease to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the affected parts, if the carcass is otherwise healthy.

§ 311.33 Listeriosis.

Carcasses of livestock identified as U.S. Suspects because of a history of listeriosis shall be passed for human food after condemnation of the head if the carcass is otherwise normal.

§ 311.34 Anemia.

Carcasses of livestock too anemic to produce wholesome meat shall be condemned.

§ 311.35 Muscular inflammation, degeneration, or infiltration.

(a) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is impractical, the carcass shall be condemned.

(b) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is practical, the following rules shall govern the disposal of the carcasses, edible organs, and other parts of carcasses showing such muscular lesions. If the lesions are localized in such a manner and are of such a character that the affected tissues can be removed, the nonaffected parts of the carcass may be passed for human food after the removal and condemnation of the affected portion. If a part of the carcass shows numerous lesions, or if the character of the lesion is such that complete extirpation is difficult and uncertainly accomplished, or if the lesion renders the part in any way unfit for human food, the part shall be condemned.

(c) If the lesions are slight or of such character as to be insignificant from a standpoint of wholesomeness, the carcass or parts may be passed for use in the manufacture of comminuted cooked product, after removal and condemnation of the visibly affected portions.

§ 311.36 Coccidioidal granuloma.

(a) Carcasses which are affected with generalized coccidioidal granuloma or which show systemic changes because of such disease shall be condemned.

(b) Carcasses affected with localized lesions of this disease may be passed for human food after the affected parts are removed and condemned.

§ 311.37 Odors, foreign and urine.

(a) Carcasses which give off a pronounced odor of medicinal, chemical, or other foreign substance shall be condemned.

(b) Carcasses which give off a pronounced urine odor shall be condemned.

(c) Carcasses, organs, or parts affected by odor to a lesser degree than as described in paragraphs (a) and (b) of this section and in which the odor can be removed by trimming or chilling may be passed for human food, after removal of affected parts or dissipation of the condition.

§ 311.38 Meat and meat byproducts from livestock which have been exposed to radiation.

Meat and meat byproducts from livestock which have been administered radioactive material shall be condemned unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act.

§ 311.39 Biological residues.

Carcasses, organs, or other parts of carcasses of livestock shall be condemned if it is determined that they are adulterated because of the presence of any biological residues.

Pt. 312 PART 312—OFFICIAL MARKS, DEVICES AND CERTIFICATES Sec. 312.1 General. 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 connection with post-mortem inspection and identification of adulterated products and insanitary equipment and facilities. 312.7 [Reserved] 312.8 Official export inspection marks, devices, and certificates. 312.9 Official detention marks and devices. 312.10 Official mark for maintaining the identity and integrity of samples. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15573, Oct. 3, 1970, unless otherwise noted.

§ 312.1 General.

The marks, devices, and certificates prescribed or referenced in this part shall be official marks, devices, and certificates for purposes of the Act, and shall be used in accordance with the provisions of this part and the regulations cited therein.

§ 312.2 Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats.

(a) The official inspection legend required by part 316 of this subchapter to be applied to inspected and passed carcasses and parts of carcasses of cattle, sheep, swine and goats, meat food products in animal casings, and other products as approved by the Administrator, shall be in the appropriate form as hereinafter specified: 1

1 The number “38” is given as an example only. The establishment number of the official establishment where the product is prepared shall be used in lieu thereof.

EC11SE91.000

For application to sheep carcasses, the loins and ribs of pork, beef tails, and the smaller varieties of sausage and meat food products in animal casings.

EC11SE91.001

For application to calf and goat carcasses and on the larger varieties of sausage and meat food products in animal casings.

EC11SE91.002

For application to beef and hog carcasses primal parts and cuts therefrom, beef livers, beef tongues, beef hearts, and smoked meats not in casings.

EC11SE91.003

For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.

(b)(1) The official inspection legend required by part 317 of this subchapter to be shown on all labels for inspected and passed products of cattle, sheep, swine, and goats shall be in the following form 1 except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated:

EC11SE91.004

(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.

(3) The official inspection legend described in paragraph (b)(1) of this section may also be used for purposes of part 316 of this subchapter on shipping containers, band labels, artificial casings, and other articles with the approval of the Administrator.

(c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark prescribed 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]

§ 312.3 Official marks and devices to identify inspected and passed equine products.

(a) The official inspection legend required by § 316.12 or § 317.2 of this subchapter to identify inspected and passed horse carcasses and parts of carcasses, or horse meat food products shall be in the appropriate form as hereinafter specified: 1

EC11SE91.005 EC11SE91.055

(b) The official inspection legend required by § 316.12 or § 317.2 of this subchapter to identify inspected and passed mule and other (nonhorse) equine carcasses and parts of carcasses, or equine meat food products shall be in whichever of the following form, is appropriate:1

1 The number “38” is given as an example only. The establishment number of the official establishment where the product is prepared shall be used in lieu thereof.

EC11SE91.006 EC11SE91.007

§ 312.4 Official ante-mortem inspection marks and devices.

The official marks and devices used in connection with ante-mortem inspection 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 conveyance as prescribed in part 325 of this subchapter shall be the inscription and a serial number as hereinafter shown 2 and any seal approved by the Administrator for applying such mark shall be an official device for purposes of the Act. This seal shall be attached to the means of conveyance only by a Program employee and he shall also affix thereto a “Warning Tag” (Form MP-408-3).

2 The number “2135202” is given as an example only. The serial number of the specific seal will be shown in lieu thereof.

EC11SE91.008 [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 inspection and identification of adulterated products and insanitary equipment and facilities.

(a) The official marks required by parts 310 and 416 of this chapter for use in post-mortem inspection and identification of adulterated products and insanitary equipment and facilities are:

(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 legend “U.S. Retained.”

(2) The “U.S. Retained” mark which is applied to products and articles as prescribed in part 310 of this subchapter by means of a paper tag (Form MP-35) bearing the legend “U.S. Retained.”

(3) The “U.S. Rejected” mark which is used to identify insanitary buildings, rooms, or equipment as prescribed in part 416, section 6, of this chapter and is applied by means of a paper tag (Form MP-35) bearing the legend “U.S. Rejected.”

(4) The “U.S. Passed for Cooking” mark is applied on products passed for cooking as prescribed in part 310 of this subchapter by means of a brand and is in the following form:

EC11SE91.009

(5) The “U.S. Inspected and Condemned” mark shall be applied to products condemned as prescribed in part 310 by means of a brand and is in the following form:

EC11SE91.010

(b) The “U.S. Retained” and “U.S. Rejected” tags, and all other brands, stamps, labels, and other devices approved by the Administrator and bearing any official mark prescribed in paragraph (a) of this section, shall be official devices for purposes of the Act.

[35 FR 15573, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 FR 36000; Oct. 7, 1974; 43 FR 29268, July 7, 1978; 64 FR 36415, Oct. 20, 1999; 65 FR 2284, Jan. 14, 2000]

§ 312.7 [Reserved]

§ 312.8 Official export inspection marks, devices, and certificates.

(a) The official export meat inspection mark required by part 322 of this subchapter shall be in the following form as hereinafter specified: 1

1 The number “529893” is given as an example only. The number of the official export certificate will be shown in lieu thereof.

EC11SE91.012 Any rubber stamp approved by the Administrator, in the manner provided for in part 317 of this subchapter, and bearing the official mark prescribed in this paragraph shall be an official device for the purposes of the Act.

(b) The official export certificate required by part 322 of this subchapter is a paper certificate form for signature by a Program employee, bearing a letterhead 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 is sound and wholesome. The certificate also bears a serial number such as “No. 184432.”

[35 FR 15573, Oct. 3, 1970, as amended at 42 FR 11825, Mar. 1, 1977; 47 FR 29823, July 9, 1982]

§ 312.9 Official detention marks and devices.

The official mark for articles and livestock detained under part 329 of this subchapter shall be the designation “U.S. Detained” and the official device for applying such mark shall be the official “U.S. Detained” tag (FSIS Form 8400-2) as prescribed in § 329.2 of this subchapter.

[55 FR 47842, Nov. 16, 1990]

§ 312.10 Official mark for maintaining the identity and integrity of samples.

The official mark for use in sealing containers of samples submitted under any requirements in this subchapter and section 202 of the Federal Meat Inspection Act shall bear the designation “Sample Seal” accompanied by the official 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. Such device shall be supplied to inspectors, compliance officers, and other designated Agency officials by the United States Department of Agriculture.

EC11SE91.011 [52 FR 41958, Nov. 2, 1987]

Pt. 313 PART 313—HUMANE SLAUGHTER OF LIVESTOCK Sec. 313.1 Livestock pens, driveways and ramps. 313.2 Handling of livestock. 313.5 Chemical; carbon dioxide 313.15 Mechanical; captive bolt. 313.16 Mechanical; gunshot. 313.30 Electrical; stunning or slaughtering with electric current. 313.50 Tagging of equipment, alleyways, pens or compartments to prevent inhumane slaughter or handling in connection with slaughter. 313.90 [Reserved] Authority:

7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

44 FR 68813, Nov. 30, 1979, unless otherwise noted.

§ 313.1 Livestock pens, driveways and ramps.

(a) Livestock pens, driveways and ramps shall be maintained in good repair. They shall be free from sharp or protruding objects which may, in the opinion of the inspector, cause injury or pain to the animals. Loose boards, splintered or broken planking, and unnecessary openings where the head, feet, or legs of an animal may be injured shall be repaired.

(b) Floors of livestock pens, ramps, and driveways shall be constructed and maintained so as to provide good footing for livestock. Slip resistant or waffled floor surfaces, cleated ramps and the use of sand, as appropriate, during winter months are examples of acceptable construction and maintenance.

(c) U.S. Suspects (as defined in § 301.2(xxx)) and dying, diseased, and disabled livestock (as defined in § 301.2(y)) shall be provided with a covered pen sufficient, in the opinion of the inspector, to protect them from the adverse climatic conditions of the locale while awaiting disposition by the inspector.

(d) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized.

[44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]

§ 313.2 Handling of livestock.

(a) Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.

(b) Electric prods, canvas slappers, or other implements employed to drive animals shall be used as little as possible in order to minimize excitement and injury. Any use of such implements which, in the opinion of the inspector, is excessive, is prohibited. Electrical prods attached to AC house current shall be reduced by a transformer to the lowest effective voltage not to exceed 50 volts AC.

(c) Pipes, sharp or pointed objects, and other items which, in the opinion of the inspector, would cause injury or unnecessary pain to the animal shall not be used to drive livestock.

(d) Disabled livestock and other animals unable to move.

(1) Disabled animals and other animals unable to move shall be separated from normal ambulatory animals and placed in the covered pen provided for in § 313.1(c).

(2) The dragging of disabled animals and other animals unable to move, while conscious, is prohibited. Stunned animals may, however, be dragged.

(3) Disabled animals and other animals unable to move may be moved, while conscious, on equipment suitable for such purposes; e.g., stone boats.

(e) Animals shall have access to water in all holding pens and, if held longer than 24 hours, access to feed. There shall be sufficient room in the holding pen for animals held overnight to lie down.

(f) Stunning methods approved in § 313.30 shall be effectively applied to animals prior to their being shackled, hoisted, thrown, cast, or cut.

§ 313.5 Chemical; carbon dioxide.

The slaughtering of sheep, calves and swine with the use of carbon dioxide gas and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(a) Administration of gas, required effect; handling. (1) The carbon dioxide gas shall be administered in a chamber in accordance with this section so as to produce surgical anesthesia in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be exposed to the carbon dioxide gas in a way that will accomplish the anesthesia quickly and calmly, with a minimum of excitement and discomfort to the animals. In swine, carbon dioxide may be administered to induce death in the animals before they are shackled, hoisted, thrown, cast, or cut.

(2) The driving or conveying of the animals to the carbon dioxide chamber shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the anesthesia chamber is essential since the induction, or early phase, of anesthesia is less violent with docile animals. Among other things this requires that, in driving animals to the anesthesia chamber, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) On emerging from the carbon dioxide tunnel, the animals shall be in a state of surgical anesthesia and shall remain in this condition throughout shackling, sticking, and bleeding, except for swine in which death has been induced by the administration of carbon dioxide. Asphyxia or death from any cause shall not be produced in animals before bleeding, except for swine in which death has been induced by the administration of carbon dioxide.

(b) Facilities and procedures—(1) General requirements for gas chambers and auxiliary equipment; operator. (i) The carbon dioxide gas shall be administered in a tunnel which is designed to permit the effective exposure of the animal. Two types of tunnels, based on the same principle, are in common use for carbon dioxide anesthesia. They are the “U” type tunnel and the “Straight Line” type tunnel, and are based on the principle that carbon dioxide gas has a higher specific gravity than air. The tunnels are open at both ends for entry and exit of animals and have a depressed central section. Anesthetizing, or, in the case of swine, death-inducing, carbon dioxide concentrations are maintained in the central sections of the tunnels. Effective anaesthetization is produced in these central sections. Animals are driven from holding pens through pathways constructed of large-diameter pipe or smooth metal and onto continuous conveyor devices that move the animals through the tunnels. The animals are either compartmentalized on the conveyors by mechanical impellers synchronized with the conveyor or they are otherwise prevented from crowding. While impellers are used to compartmentalize the animals, mechanically or manually operated gates are used to move the animals onto the conveyors. Surgically anaesthetized animals, or killed swine, are moved out of the tunnels by the same continuous conveyors that moved them into and through the carbon dioxide gas.

(ii) Flow of animals into and through the carbon dioxide chamber is dependent on one operator. The operation or stoppage of the conveyor is entirely dependent upon this operator. It is necessary that he be skilled, attentive, and aware of his responsibility. Overdosages and death of animals can be brought about by carelessness of this individual.

(2) Special requirements for gas chamber and auxiliary equipment. The ability of anesthetizing equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, gas chambers, and all other equipment used must be designed to accommodate properly the species of animals being anesthetized. They shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces or openings where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or well padded rigid material. Power activated gates designed for constant flow of animals to anesthetizing equipment shall be so fabricated that they will not cause injury. All equipment involved in anesthetizing animals shall be maintained in good repair.

(3) Gas. Maintenance of a uniform carbon dioxide concentration and distribution in the anesthesia chamber is a vital aspect of producing surgical anesthesia. This may be assured by reasonably accurate instruments which sample and analyze carbon dioxide gas concentration within the chamber throughout anesthetizing operations. Gas concentration shall be maintained uniform so that the degree of anesthesia in exposed animals will be constant. Carbon dioxide gas supplied to anesthesia chambers may be from controlled reduction of solid carbon dioxide or from a controlled liquid source. In either case the carbon dioxide shall be supplied at a rate sufficient to anesthetize adequately and uniformly the number of animals passing through the chamber. Sampling of gas for analysis shall be made from a representative place or places within the chamber and on a continuing basis. Gas concentrations and exposure time shall be graphically recorded throughout each day's operation. Neither carbon dioxide nor atmospheric air used in the anesthesia chambers shall contain noxious or irritating gases. Each day before equipment is used for anesthetizing animals, proper care shall be taken to mix adequately the gas and air within the chamber. All gas producing and control equipment shall be maintained in good repair and all indicators, instruments, and measuring devices must be available for inspection by Program inspectors during anesthetizing operations and at other times. An exhaust system must be provided so that, in case of equipment failure, non-uniform carbon dioxide concentrations in the gas tunnel or contamination of the ambient air of the establishment will be prevented.

[44 FR 68813, Nov. 30, 1979, as amended at 59 FR 21640, Apr. 26, 1994]

§ 313.15 Mechanical; captive bolt.

The slaughtering of sheep, swine, goats, calves, cattle, horses, mules, and other equines by using captive bolt stunners and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(a) Application of stunners, required effect; handling. (1) The captive bolt stunners shall be applied to the livestock in accordance with this section so as to produce immediate unconsciousness in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be stunned in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.

(2) The driving of the animals to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the stunning areas is essential since accurate placement of stunning equipment is difficult on nervous or injured animals. Among other things, this requires that, in driving animals to the stunning areas, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) Immediately after the stunning blow is delivered the animals shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.

(b) Facilities and procedures—(1) General requirements for stunning facilities; operator. (i) Acceptable captive bolt stunning instruments may be either skull penetrating or nonpenetrating. The latter type is also described as a concussion or mushroom type stunner. Penetrating instruments on detonation deliver bolts of varying diameters and lengths through the skull and into the brain. Unconsciousness is produced immediately by physical brain destruction and a combination of changes in intracranial pressure and acceleration concussion. Nonpenetrating or mushroom stunners on detonation deliver a bolt with a flattened circular head against the external surface of the animal's head over the brain. Diameter of the striking surface of the stunner may vary as conditions require. Unconsciousness is produced immediately by a combination of acceleration concussion and changes in intracranial pressures. A combination instrument utilizing both penetrating and nonpenetrating principles is acceptable. Energizing of instruments may be accomplished by detonation of measured charges of gunpowder or accurately controlled compressed air. Captive bolts shall be of such size and design that, when properly positioned and activated, immediate unconsciousness is produced.

(ii) To assure uniform unconsciousness with every blow, compressed air devices must be equipped to deliver the necessary constant air pressure and must have accurate, constantly operating air pressure gauges. Gauges must be easily read and conveniently located for use by the stunning operator and the inspector. For purposes of protecting employees, inspectors, and others, it is desirable that any stunning device be equipped with safety features to prevent injuries from accidental discharge. Stunning instruments must be maintained in good repair.

(iii) The stunning area shall be so designed and constructed as to limit the free movements of animals sufficiently to allow the operator to locate the stunning blow with a high degree of accuracy. All chutes, alleys, gates and restraining mechanisms between and including holding pens and stunning areas shall be free from pain-producing features such as exposed bolt ends, loose boards, splintered or broken planking, and protruding sharp metal of any kind. There shall be no unnecessary holes or other openings where feet or legs of animals may be injured. Overhead drop gates shall be suitably covered on the bottom edge to prevent injury on contact with animals. Roughened or cleated cement shall be used as flooring in chutes leading to stunning areas to reduce falls of animals. Chutes, alleys, and stunning areas shall be so designed that they will comfortably accommodate the kinds of animals to be stunned.

(iv) The stunning operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately place the stunning instrument to produce immediate unconsciousness. He must use the correct detonating charge with regard to kind, breed, size, age, and sex of the animal to produce the desired results.

(2) Special requirements and prohibitions. (i) Choice of instrument and force required to produce immediate unconsciousness varies, depending on kind, breed, size, age, and sex of the animal. Young swine, lambs, and calves usually require less stunning force than mature animals of the same kind. Bulls, rams, and boars usually require skull penetration to produce immediate unconsciousness. Charges suitable for smaller kinds of livestock such as swine or for young animals are not acceptably interchanged for use on larger kinds or older livestock, respectively.

(ii) Captive bolt stunners that deliberately inject compressed air into the cranium at the end of the penetration cycle shall not be used to stun cattle.

[44 FR 68813, Nov. 30, 1979, as amended at 69 FR 1891, Jan. 12, 2004]

§ 313.16 Mechanical; gunshot.

The slaughtering of cattle, calves, sheep, swine, goats, horses, mules, and other equines by shooting with firearms and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(a) Utilization of firearms, required effect; handling. (1) The firearms shall be employed in the delivery of a bullet or projectile into the animal in accordance with this section so as to produce immediate unconsciousness in the animal by a single shot before it is shackled, hoisted, thrown, cast, or cut. The animal shall be shot in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.

(2) The driving of the animals to the shooting areas shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the shooting area is essential since accurate placement of the bullet is difficult in case of nervous or injured animals. Among other things, this requires that, in driving animals to the shooting areas, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) Immediately after the firearm is discharged and the projectile is delivered, the animal shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.

(b) Facilities and procedure—(1) General requirements for shooting facilities; operator. (i) On discharge, acceptable firearms dispatch free projectiles or bullets of varying sizes and diameters through the skull and into the brain. Unconsciousness is produced immediately by a combination of physical brain destruction and changes in intracranial pressure. Caliber of firearms shall be such that when properly aimed and discharged, the projectile produces immediate unconsciousness.

(ii) To assure uniform unconsciousness of the animal with every discharge where small-bore firearms are employed, it is necessary to use one of the following type projectiles: Hollow pointed bullets; frangible iron plastic composition bullets; or powdered iron missiles. When powdered iron missiles are used, the firearms shall be in close proximity with the skull of the animal when fired. Firearms must be maintained in good repair. For purposes of protecting employees, inspectors and others, it is desirable that all firearms be equipped with safety devices to prevent injuries from accidental discharge. Aiming and discharging of firearms should be directed away from operating areas.

(iii) The provisions contained in § 313.15(b)(1)(iii) with respect to the stunning area also apply to the shooting area.

(iv) The shooting operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately direct the projectile to produce immediate unconsciousness. He must use the correct caliber firearm, powder charge and type of ammunition to produce the desired results.

(2) Special requirements. Choice of firearms and ammunition with respect to caliber and choice of powder charge required to produce immediate unconsciousness of the animal may vary depending on age and sex of the animal. In the case of bulls, rams, and boars, small bore firearms may be used provided they are able to produce immediate unconsciousness of the animals. Small bore firearms are usually effective for stunning other cattle, sheep, swine, and goats, and calves, horses, and mules.

§ 313.30 Electrical; stunning or slaughtering with electric current.

The slaughtering of swine, sheep, calves, cattle, and goats with the use of electric current and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(a) Administration of electric current, required effect; handling. (1) The electric current shall be administered so as to produce, at a minimum, surgical anesthesia, i.e., a state where the animal feels no painful sensation. The animals shall be either stunned or killed before they are shackled, hoisted, thrown, cast, or cut. They shall be exposed to the electric current in a way that will accomplish the desired result quickly and effectively, with a minimum of excitement and discomfort.

(2) The driving or conveying of the animals to the place of application of electric current shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the place of application is essential to ensure rapid and effective insensibility. Among other things, this requires that, in driving animals to the place of application, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) The quality and location of the electrical shock shall be such as to produce immediate insensibility to pain in the exposed animal.

(4) The stunned animal shall remain in a state of surgical anesthesia through shackling, sticking, and bleeding.

(b) Facilities and procedures; operator—(1) General requirements for operator. It is necessary that the operator of electric current application equipment be skilled, attentive, and aware of his or her responsibility.

(2) Special requirements for electric current application equipment. The ability of electric current equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, current applicators, and all other equipment used must be designed to properly accommodate the species of animals being anesthetized. Animals shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces or openings where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or padded material. Power activated gates designed for constant flow of animals shall be so fabricated that they will not cause injury. All equipment used to apply and control the electrical current shall be maintained in good repair, and all indicators, instruments, and measuring devices shall be available for inspection by Program inspectors during the operation and at other times.

(3) Electric current. Each animal shall be given a sufficient application of electric current to ensure surgical anesthesia throughout the bleeding operation. Suitable timing, voltage and current control devices shall be used to ensure that each animal receives the necessary electrical charge to produce immediate unconsciousness. The current shall be applied so as to avoid the production of hemorrhages or other tissue changes which could interfere with inspection procedures.

[44 FR 68813, Nov. 30, 1979, as amended at 50 FR 25202, June 18, 1985]

§ 313.50 Tagging of equipment, alleyways, pens, or compartments to prevent inhumane slaughter or handling in connection with slaughter.

When an inspector observes an incident of inhumane slaughter or handling in connection with slaughter, he/she shall inform the establishment operator of the incident and request that the operator take the necessary steps to prevent a recurrence. If the establishment operator fails to take such action or fails to promptly provide the inspector with satisfactory assurances that such action will be taken, the inspector shall follow the procedures specified in paragraph (a), (b), or (c) of this section, as appropriate.

(a) If the cause of inhumane treatment is the result of facility deficiencies, disrepair, or equipment breakdown, the inspector shall attach a “U.S. Rejected” tag thereto. No equipment, alleyway, pen or compartment so tagged shall be used until made acceptable to the inspector. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.

(b) If the cause of inhumane treatment is the result of establishment employee actions in the handling or moving of livestock, the inspector shall attach a “U.S. Rejected” tag to the alleyways leading to the stunning area. After the tagging of the alleyway, no more livestock shall be moved to the stunning area until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to the tagging may be dressed, processed, or prepared under inspection.

(c) If the cause of inhumane treatment is the result of improper stunning, the inspector shall attach a “U.S. Rejected” tag to the stunning area. Stunning procedures shall not be resumed until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.

§ 313.90 [Reserved]

Pt. 314 PART 314—HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE PRODUCTS AT OFFICIAL ESTABLISHMENTS Sec. 314.1 Disposition of condemned products at official establishments having tanking facilities; sealing of tanks. 314.2 Tanking and other facilities for inedible products to be separate from edible product facilities. 314.3 Disposition of condemned products at official establishments having no tanking facilities. 314.4 Suppression of odors in preparing inedible products. 314.5 Inedible rendered fats prepared at official establishments. 314.6 Inedible fats from outside official establishments. 314.7 Carcasses of livestock condemned on ante-mortem inspection not to pass through edible product areas. 314.8 Dead animal carcasses. 314.9 Specimens for educational, research, and other nonfood purposes; permits for, required. 314.10 Livers condemned because of parasitic infestation and for other causes; conditions for disposal for purposes other than human food. 314.11 Handling of certain condemned products for purposes other than human food. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15575, Oct. 3, 1970, unless otherwise noted.

§ 314.1 Disposition of condemned products at official establishments having tanking facilities; sealing of tanks.

(a) Carcasses, parts of carcasses, and other products condemned at official establishments having facilities for tanking shall, except as provided in paragraph (c) of this section or elsewhere in this part, be disposed of by tanking as follows:

(1) The lower opening of the tank shall first be sealed securely by a Program employee, except when permanently connected with a blow line; then the condemned products shall be placed in the tank in his presence, after which the upper opening shall also be sealed securely by such employee, who shall then see that the contents of the tank are subjected to sufficient heating for sufficient time to effectively destroy the contents for human food purposes.

(2) The use of equipment such as crushers or hashers for pretanking preparation of condemned products in the inedible products department has been found to give inedible character and appearance to the material. Accordingly, if condemned products are so crushed or hashed, conveying systems, rendering tanks, and other equipment used in the further handling of crushed or hashed material need not be locked or sealed during the tanking operations. If the rendering tanks or other equipment contain condemned material not so crushed or hashed, the equipment shall be sealed as prescribed in paragraph (a)(1) of this section. If the crushed or hashed material is not rendered in the establishment where produced, it shall be denatured as provided for in § 314.3 before leaving such establishment.

(b) The seals of tanks shall be broken only by a Program employee and only after the contents of the tanks have been treated as provided in paragraph (a) of this section. The rendered fat derived from condemned material shall be held until a Program employee shall have had an opportunity to determine whether it conforms with the requirements of this section. Samples shall be taken by Program employees as often as is necessary to determine whether the rendered fat is effectually denatured.

(c) Carcasses of animals condemned under § 309.3 of this subchapter may be disposed of as provided in § 314.3, in lieu of tanking, with the approval of the inspector.

§ 314.2 Tanking and other facilities for inedible products to be separate from edible product facilities.

All tanks and equipment used for rendering, otherwise preparing, or storing inedible products must be in rooms or compartments separate from those used for preparing or storing edible products. There may be a connection between rooms or compartments containing inedible products and those containing edible products as long as it does not cause the adulteration of edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]

§ 314.3 Disposition of condemned products at official establishments having no tanking facilities.

(a) Carcasses, parts of carcasses, and other products condemned at an official establishment which has no facilities for tanking shall, except as provided in paragraph (b) of this section or elsewhere in this part, be destroyed in the presence of an inspector by incineration, or denatured with crude carbolic acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella or any other proprietary material approved by the Administrator in specific cases. When such product is to be denatured, it shall be freely slashed before the denaturing agent is applied, except that, in the case of dead animals that have not been dressed, the denaturant may be applied by injection. The denaturant must be deposited in all portions of the carcass or product to the extent necessary to preclude its use for food purposes.

(b) All carcasses and parts condemned on account of anthrax, as identified in § 310.9(b) of this subchapter, at official establishments which are not equipped with tanking facilities shall be disposed of by (1) complete incineration, or (2) by thorough denaturing with crude carbolic acid, or cresylic disinfectant, and then disposed of in accordance with the requirements of the particular State or municipal authorities, who shall be notified immediately by the area supervisor.

§ 314.4 Suppression of odors in preparing inedible products.

Tanks, fertilizer driers, and other equipment used in the preparation of inedible product must be operated in a manner that will suppress odors incident to such preparation which could adulterate edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]

§ 314.5 Inedible rendered fats prepared at official establishments.

Except as provided in § 325.11(b) of this subchapter, rendered animal fat derived from condemned or other inedible materials at official establishments shall be denatured to effectually distinguish it from an edible product, either with low grade offal during the rendering or by adding to, and mixing thoroughly with, such fat, denaturing oil, No. 2 fuel oil, or brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, and may be shipped in commerce in accordance with § 325.11(c) of this subchapter.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]

§ 314.6 Inedible fats from outside official establishments.

Except as provided in § 325.11(b) of this subchapter, inedible fats from outside the premises of any official establishment shall not be received into an official establishment except into the tank room provided for inedible products, and then only when they have been denatured in accordance with § 314.5 and are marked in accordance with § 316.15 of this subchapter, and when their receipt into the tank room produces no insanitary condition on the premises; nor shall such fats be received in such volume as interferes with prompt disposal of condemned or other inedible material produced at the establishment. When received, they shall not enter any room or compartment used for edible products.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]

§ 314.7 Carcasses of livestock condemned on ante-mortem inspection not to pass through edible product areas.

Carcasses of livestock which have been condemned on ante-mortem inspection shall not be taken through rooms or compartments in which an edible product is prepared, handled, or stored.

§ 314.8 Dead animal carcasses.

(a) With the exception of dead livestock which have died en route and are received with livestock for slaughter at an official establishment, no dead animal or part of the carcass of any livestock that died otherwise than by slaughter may be brought on the premises of an official establishment unless advance permission therefore is obtained from the circuit supervisor.

(b) Under no circumstances shall the carcasses of any animal which has died otherwise than by slaughter, or any part thereof, be brought into any room or compartment in which any edible product is prepared, handled, or stored.

§ 314.9 Specimens for educational, research, and other nonfood purposes; permits for, required.

(a) Specimens of condemned or other inedible materials, including embryos and specimens of animal parasites, may be released for educational, research, or other nonfood purposes under permit issued by the inspector in charge: Provided, That the person desiring such specimens makes a written application to the inspector in charge for such permit on Form MP-403-10 and arranges with and receives permission from the official establishment to obtain the specimens. Permits shall be issued for a period not longer than 1 year. The permit may be revoked by the inspector in charge if the specimens are not used as stated in the application, or if the collection or handling of the specimens interferes with inspection or the maintenance of sanitary conditions in the establishment.

(b) The specimens referred to in paragraph (a) of this section shall be collected and handled only at such time and place and in such manner as not to interfere with the inspection or to cause any objectionable condition and shall be identified as inedible when they leave the establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 38 FR 18665, July 13, 1973; 39 FR 36000, Oct. 7, 1974]

§ 314.10 Livers condemned because of parasitic infestation and for other causes; conditions for disposal for purposes other than human food.

(a) Livers condemned on account of hydatid cysts shall be disposed of by tanking pursuant to the provisions of § 314.1 of this subchapter if condemned at official establishments having facilities for tanking; otherwise they shall be destroyed pursuant to the provisions of § 314.3 of this subchapter.

(b) Livers condemned because of parasites other than hydatid cysts; and livers condemned because of telangiectasis, angioma, “sawdust” condition, cirrhosis, carotenosis, or other nonmalignant change, benign abscesses, or contamination, when these conditions are not associated with infectious diseases in the carcasses, may be shipped from an official establishment only for purposes other than human food, and only if all tissue affected with abscesses is removed and destroyed within the establishment, and all livers are processed and denatured, with any agent prescribed in § 325.13(a)(1) or (2) or (5), and in accordance with § 325.13(a)(6) of this subchapter. This provision for movement from an official establishment is made solely under the Federal Meat Inspection Act and is not intended to relieve or modify any other applicable requirements under any other law regarding the movement of such articles, for purposes other than use as human food.

(c) Livers condemned because of conditions described in paragraph (b) of this section shall be in containers plainly marked “inedible”.

[41 FR 23701, June 11, 1976]

§ 314.11 Handling of certain condemned products for purposes other than human food.

Condemned carcasses of animals affected with one or more of the following conditions may be shipped from an official establishment only for purposes other than human food and only if permission therefor is obtained from the circuit supervisor: Anasarca, Ocular Squamous Cell Carcinoma (after removal of neoplastic tissue), emaciation, eosinophilic myositis, immaturity, nonseptic bruises and injuries, and sarcosporidiosis. This provision also applies to unborn calves and to products such as paunches and udders when they have not been handled as required under this subchapter for products for human food purposes; provided, such articles have not been condemned for other pathological reasons. Such permission will be granted only if all parts to be so used will be promptly handled, freely slashed and adequately identified as required by § 325.13(a)(2) of this subchapter. The slashing, identification and packing of the product shall be accomplished in an inedible product area under the supervision of an inspector. Facilities must be adequate so that the carcasses or parts saved under these provisions are not contaminated with pus, manure, septic, or toxic materials, or similar substances. The operation must not result in unsanitary conditions within the establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 36 FR 11903, June 23, 1971]

Pt. 315 PART 315—RENDERING OR OTHER DISPOSAL OF CARCASSES AND PARTS PASSED FOR COOKING Sec. 315.1 Carcasses and parts passed for cooking; rendering into lard or tallow. 315.2 Carcasses and parts passed for cooking; utilization for food purposes after cooking. 315.3 Disposal of products passed for cooking if not handled according to this part. Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

§ 315.1 Carcasses and parts passed for cooking; rendering into lard or tallow.

Carcasses and parts passed for cooking may be rendered into lard in accordance with § 319.702 of this subchapter or rendered into tallow, provided such rendering is done in the following manner:

(a) When closed rendering equipment is used, the lower opening, except when permanently connected with a blowline, shall first be sealed securely by a Program employee; then the carcasses or parts shall be placed in such equipment in his presence, after which the upper opening shall be securely sealed by such employee. When the product passed for cooking in the tank does not consist of a carcass or whole primal part, the requirements for sealing shall be at the discretion of the circuit supervisor. Such carcasses and parts shall be cooked for a time sufficient to render them effectually into lard or tallow, provided all parts of the products are heated to a temperature not lower than 170 °F. for a period of not less than 30 minutes.

(b) At establishments not equipped with closed rendering equipment for rendering carcasses and parts passed for cooking into lard and tallow, such carcasses or parts may be rendered in open kettles under the direct supervision of a Program employee. Such rendering shall be done during regular hours of work and in compliance with the requirements as to temperature and time specified in paragraph (a) of this section.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 25420, June 13, 1978]

§ 315.2 Carcasses and parts passed for cooking; utilization for food purposes after cooking.

Carcasses and parts passed for cooking may be used for the preparation of meat food products, provided all such carcasses or parts are heated to a temperature not lower than 170 °F. for a period of not less than 30 minutes either before being used in or during the preparation of the finished product.

[37 FR 2661, Feb. 4, 1972]

§ 315.3 Disposal of products passed for cooking if not handled according to this part.

Products passed for cooking if not handled and processed in accordance with the provisions of this part, shall be disposed of in accordance with § 314.1 or § 314.3 of this subchapter.

[35 FR 15577, Oct. 3, 1970. Redesignated at 37 FR 2661, Feb. 4, 1972]

Pt. 316 PART 316—MARKING PRODUCTS AND THEIR CONTAINERS Sec. 316.1 Authorization required to make devices bearing official marks. 316.2 Approval required for official marks. 316.3 Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required. 316.4 Marking devices; to be furnished by official establishments; control of. 316.5 Branding ink; to be furnished by official establishments; approval by Program; color. 316.6 Products not to be removed from official establishments unless marked in accordance with the regulations. 316.7 Marking devices not to be false or misleading; style and size of lettering; approval required. 316.8 Unmarked inspected products; moved between official establishments; moved in commerce. 316.9 Products to be marked with official marks. 316.10 Marking of meat food products with official inspection legend and ingredient statement. 316.11 Special markings for certain meat food products. 316.12 Marking of equine carcasses and parts thereof. 316.13 Marking of outside containers. 316.14 Marking tank cars and tank trucks used in transportation of edible products. 316.15 Marking outside containers of inedible grease, etc. 316.16 Custom prepared products to be marked “Not for Sale.” Authority:

21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Source:

35 FR 15577, Oct. 3, 1970, unless otherwise noted.

§ 316.1 Authorization required to make devices bearing official marks.

No brand manufacturer, printer or other person shall cast, print, lithograph, or otherwise make or cause to be made any device containing any official mark or simulation thereof without prior written authority therefor from the Administrator as provided for in part 317 of this subchapter.

§ 316.2 Approval required for official marks.

No device containing any official mark shall be made or caused to be made for use on any product until it has been approved by the Administrator as provided for in part 317 of this subchapter.

§ 316.3 Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required.

(a) No person shall affix or place, or cause to be affixed or placed, the official inspection legend or any other official mark, or any abbreviation or simulation of any official mark, to or on any product, or container thereof, except under the supervision of a Program employee, or as authorized by part 317 of this subchapter in connection with the manufacture of containers.

(b) No person shall fill, or cause to be filled, in whole or in part, with any product, any container bearing or intended to bear any official mark, or any abbreviation or simulation of any official mark, except under the supervision of a Program employee.

(c) Product bearing any official mark shall not be canned, cooked, cured, smoked, salted, packed, rendered, or otherwise prepared by any person for commercial purposes unless:

(1) Such preparation is performed at an official establishment; or

(2) Such preparation is conducted under State or other governmental inspection and the prepared product is marked to show that fact; or

(3) The official marks are removed, defaced, or otherwise destroyed before or during such preparation; or

(4) The preparation of the product consists solely of cutting up operations at any establishment exempted from inspection under paragraph 301(c)(2) of the Act or equal provisions of a law of a State or organized Territory or at any establishment in an unorganized Territory exempted under paragraph 23(b) of the Act.

§ 316.4 Marking devices; to be furnished by official establishments; control of.

(a) The operator of each official establishment or official import inspection establishment shall furnish such ink brands, burning brands, and any other device for marking products with official marks as the Administrator may determine is necessary for marking products at such establishment. The official inspection legend on such a device shall be as prescribed in part 312 of this subchapter.

(b) All official devices for marking products with the official inspection legend, or other official inspection marks, including self-locking seals, shall be used only under supervision of a Program employee, and, when not in use for marking shall be kept locked in properly equipped locks or compartments, the keys of which shall not leave the possession of a Program employee, or the locker or compartment shall be sealed with an official seal of the Department as prescribed in part 312 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 46 FR 38072, July 24, 1981]

§ 316.5 Branding ink; to be furnished by official establishments; approval by Program; color.

(a) The operator of each official establishment shall furnish all ink for marking products with the official marks at such establishment. Such ink must be made with harmless ingredients that are approved for the purpose by the Administrator. Samples of inks shall be submitted to the Program laboratory from time to time as may be deemed necessary by the inspector in charge.

(b) Only ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses of cattle, sheep, swine, or goats and fresh meat cuts derived therefrom. Any ink containing F.D. & C. Violet No. 1 shall not be considered an approved ink within the meaning of this paragraph.

(c) Green ink shall not be used to apply marks to carcasses of cattle, sheep, swine, or goats or fresh meat cuts derived therefrom.

(d) Except as provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose by the Administrator in specific cases, may be used to apply ink brands, bearing official marks, to processed meat cuts derived from cattle, sheep, swine, or goats.

(e) Only green ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses and parts of carcasses and meat cuts derived from horses, mules, and other equines.

(f) Ink used must assure legibility and permanence of the markings and the color of ink shall provide acceptable contrast with the color of the product to which it is applied.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 9088, Apr. 10, 1973]

§ 316.6 Products not to be removed from official establishments unless marked in accordance with the regulations.

No person shall remove or cause to be removed from an official establishment any products which the regulations in this subchapter require to be marked in any way unless they are clearly and legibly marked in compliance with such regulations.

§ 316.7 Marking devices not to be false or misleading; style and size of lettering; approval required.

No brand or other marking device shall be false or misleading. The letters and figures thereon shall be of such style and type as will make a clear and legible impression. All markings to be applied to products in an official establishment shall be approved prior to use by the Administrator as provided for in § 317.3 of this subchapter, except that official markings prescribed by the Federal meat grading regulations (7 CFR 53.19) need not be submitted to the Administrator for approval.

§ 316.8 Unmarked inspected products; moved between official establishments; moved in commerce.

(a) Unmarked products which have been inspected and passed but do not bear the official inspection legend may be transported in compliance with part 325 of this subchapter from one official establishment to another official establishment, for further processing, in a railroad car, truck, or other closed container, if the railroad car, truck, or container is sealed with an official seal of the Department (as prescribed in part 312 of this subchapter) bearing the official inspection legend.

(b) Products which have been inspected and passed but do not bear the official inspection legend may be removed from an official establishment in closed containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: Provided, That upon removal from such closed container the product may not be further transported in commerce unless such removal is made under the supervision of a Program employee and such product is reinspected by a Program employee and packed under his supervision in containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: And provided further, That unmarked product shall not be brought into an official establishment in an open container.

§ 316.9 Products to be marked with official marks.

(a) Each carcass which has been inspected and passed in an official establishment shall be marked at the time of inspection with the official inspection legend containing the number of the official establishment.

(b) Except as provided otherwise in § 316.8, each primal part of a carcass and each liver, beef tongue, and beef heart which has been inspected and passed shall be marked with the official inspection legend containing the number of the official establishment before it leaves the establishment in which it is first inspected and passed, and each such inspected and passed product shall be marked with the official inspection legend containing the number of the official establishment where it was last prepared. Additional official marks of inspection may be applied to products as desired to meet local conditions. Primal parts are the wholesale cuts of carcasses as customarily distributed to retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank are primal parts of beef carcasses. Veal, mutton, and goat primal parts are the leg; flank, loin, rack, breast, and shoulder. The ham, belly, loin, shoulder, and jowl are pork primal parts. Equine primal parts are the round, flank, loin, rib, plate, brisket, chuck, and shank.

(c) Beef livers shall be marked with the official inspection legend containing the number of the official establishment, at which the cattle involved were slaughtered, on the convex surface of the thickest portion of the organ.

(d) Inspected and passed parts of carcasses which are not marked with the official inspection legend under this section shall not enter any official establishment or be sold, transported, or offered for sale or transportation, in commerce, except as provided in § 316.8.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 23720, Dec. 14, 1971]

§ 316.10 Marking of meat food products with official inspection legend and ingredient statement.

(a) Inspected and passed sausages and other products in casings or in link form, of the ordinary “ring” variety or larger shall be marked with the official inspection legend and list of ingredients in accordance with part 317 of this subchapter. The official marks required by this section shall be branded near each end of the sausage or similar product prepared in casings when the product is of a size larger than that customarily sold at retail intact.

(b) Inspected and passed sausage and other products, in casings or in link form, of the smaller varieties, shall bear one or more official inspection legends and one or more lists of ingredients in accordance with part 317 of this subchapter on each kilogram (2.205 lbs.) of product, except where such products leave the official establishment completely enclosed in properly labeled immediate containers having a capacity of 5 kilograms (11.025 lbs.) or less and containing a single kind of product: Provided, That such products in properly labeled closed containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to another official establishment for further processing or to a governmental agency, need only have the official inspection legend and list of ingredients shown twice throughout the contents of the container. When such products are shipped to another official establishment for further processing, the inspector in charge at the point of origin shall identify the shipment to the inspector in charge at destination by means of Form MP 408-1.

(c) The list of ingredients may be applied by stamping, printing, using paper bands, tags, or tissue strips, or other means approved by the Administrator in specific cases.

(d) All cured products shall be marked with the list of ingredients in accordance with part 317 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 37 FR 16863, Aug. 22, 1972; 38 FR 4385, Feb. 14, 1973; 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, 1979]

§ 316.11 Special markings for certain meat food products.

(a) Meat food products prepared in casing or link form (whether or not thereafter subdivided), other than sausage, which possess the characteristics of or resemble sausage, shall bear on each link or piece the word “imitation” prominently displayed: Provided, That the following need not be so marked if they bear on each link or piece the name of the product in accordance with § 317.2 of this subchapter: Such products as coppa, capocollo, lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts of meat which are prepared without added substance other than curing materials or condiments; meat rolls, bockwurst, and similar products which do not contain cereal or vegetables; headcheese, souse, sulze, scrapple, blood pudding, and liver pudding; and other products such as loaves, chili con carne, and meat and cheese products when prepared with sufficient cheese to give definite characteristics to the finished products: And provided further, That imitation sausage packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact, need not bear the word “imitation” on each link or piece if no other marking or labeling is applied directly to the product.

(b) When cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, or calcium reduced dried skim milk is added to sausage in casing or in link form within the limits prescribed in part 319 of this subchapter, the products shall be marked with the name of each added ingredient, as for example “cereal added,” “potato flour added,” “cereal and potato flour added,” “soy flour added,” “isolated soy protein added,” “nonfat dry milk added,” “calcium reduced dried skim milk added,” or “cereal and nonfat dry milk added,” as the case may be.

(c)(1) When product is placed in a casing to which artificial coloring is thereafter applied, as permitted in part 318 of this subchapter, the product shall be legibly and conspicuously marked by stamping or printing on the casing the words “artificially colored.”

(2) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, the product from which the casing has been removed shall be marked by stamping directly thereon the words “artificially colored.”

(3) The casing containing product need not be marked to show that it is colored if it is colored prior to its use as a covering for the product, and the coloring is of a kind and so applied as not to be transferable to the product and not to be misleading or deceptive in any respect.

(d) When an approved artificial smoke flavoring or an approved smoke flavoring is added to the formula of any meat food product as permitted in part 318 of this subchapter, the product shall be legibly and conspicuously marked with the words “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” whichever may be applicable.

(e) Subject to the provisions in paragraph (a) of this section, in the case of sausage of the smaller varieties, the markings prescribed in this section may be limited to links bearing the official inspection legend, and such markings shall not be required if the sausages are packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact. Further, all markings otherwise required by this section (except those required by paragraph (a) of this section) may be omitted from the casings of sausage and other meat food products when these products are to be processed in sealed metal containers properly labeled in accordance with the requirements in part 317 of this subchapter.

(f) When an approved antioxidant is added to any meat food product as permitted in parts 318 and 319 of this subchapter, the products shall be legibly and conspicuously marked in an approved manner identifying the specific antioxidant used by its common name or approved abbreviation and the purpose for which it is added, such as, “BHA, BHT, and Propylgallate added to help protect flavor.”

(g) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of this subchapter shall be marked as prescribed in § 317.8(b)(28) of this subchapter).

§ 316.12 Marking of equine carcasses and parts thereof.

(a) All inspected and passed equine carcasses and parts thereof prepared at any establishment shall be conspicuously marked at the time of inspection with the official inspection legend as prescribed in § 312.3 of this subchapter and with other information prescribed for marking products in this part.

(b) All equine carcasses and meat and other parts thereof shall be marked to show the kinds of animals from which they were derived, before the products are sold, transported, offered for sale or transportation, or received for transportation in commerce.

§ 316.13 Marking of outside containers.

(a) Except as otherwise provided in part 325 of this subchapter, when any inspected and passed product for domestic commerce is moved from an official establishment, the outside container shall bear an official inspection legend as prescribed in part 312 of this subchapter.

(b) When any product prepared in an official establishment for domestic commerce has been inspected and passed and is enclosed in a cloth or other wrapping, such wrapping shall bear the official inspection legend and official establishment number applied by the approved 21/2-inch rubber brand in the form prescribed in part 312 of this subchapter: Provided, That the rubber brand may be omitted if the official inspection legend and official establishment number on the product itself are clearly legible through the wrapping or the wrapping is labeled in accordance with part 317 of this subchapter: Provided further, That plain unprinted wrappings, such as stockinettes, cheesecloth, paper, and crinkled paper bags, for properly marked products, which are used solely to protect the product against soiling or excessive drying during transportation or storage, need not bear the official inspection legend.

(c) The outside containers of products for export shall be marked in compliance with part 322 of this subchapter as well as this part.

(d) Slack barrels used as outside containers of products shall have a cloth or paper top covering bearing the official inspection legend containing the official establishment number. At the time of removal of the covering, the official inspection legend shall be destroyed.

(e) The outside containers of any product which has been inspected and passed for cooking, pork which has been refrigerated as provided in § 318.10(c) of this subchapter, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in § 325.7(b) of this subchapter.

(f) The outside containers of glands and organs which are not used for human food purposes, such as those described in § 325.19 of this subchapter, shall be plainly marked with the phrase “For pharmaceutical purposes,” “For organotherapeutic purposes” or “For technical purposes,” as appropriate, with no reference to inspection, and need not bear other markings otherwise required under the regulations in this subchapter.

(g) Stencils, box dies, labels, and brands may be used on shipping containers of properly labeled products and on such immediate containers, of properly marked products, as tierces, barrels, drums, boxes, crates, and large-size fiber-board containers, without approval as provided for in § 317.3 of this subchapter: Provided, That the stencils, box dies, labels, and brands are not false or misleading and are approved by the inspector in charge. The official inspection legend for use with such markings shall be approved by the Administrator as provided for in part 317 of this subchapter.

(h) The outside containers of livers prepared as described in § 314.10(b), shall be marked as prescribed in § 314.10(c) of this subchapter.

(i) The outside containers of any equine product shall be marked to show the kinds of animals from which derived, when the products are sold, transported, offered for sale or transported, or received for transportation in commerce.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978]

§ 316.14 Marking tank cars and tank trucks used in transportation of edible products.

Each tank car and each tank truck carrying inspected and passed product from an official establishment shall bear a label containing the name of the product in accordance with § 317.2 of this subchapter, the official inspection legend containing the number of the official establishment and the words “date of loading,” followed by a suitable space in which the date the tank car or tank truck is loaded shall be inserted. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label.

[53 FR 28634, July 29, 1988]

§ 316.15 Marking outside containers of inedible grease, etc.

(a) Outside containers of inedible grease, inedible tallow, or other inedible animal fat, or mixture of any such articles, resulting from operations at any official establishment shall be marked conspicuously with the word “inedible” prior to removal from the point of filling. Containers, such as tierces, barrels, and half barrels shall have both ends painted white with durable paint, if necessary, to provide a contrasting background, and the word “inedible” shall be marked thereon in letters not less than 2 inches high, while on tank cars and tank trucks the letters shall be not less than 4 inches high.

(b) Inspected rendered animal fat which is intended not to be used for human food may also be marked “inedible” if handled as provided in paragraph (a) of this section and part 314 of this subchapter.

§ 316.16 Custom prepared products to be marked “Not for Sale.”

Carcasses and parts therefrom that are prepared on a custom basis under § 303.1(a)(2) of this subchapter shall be marked at the time of preparation with the term “Not for Sale” in letters at least three-eighths inch in height, except that such products need not be so marked if in immediate containers properly labeled in accordance with the regulations in § 317.16 of this subchapter. Ink used for marking such products must comply with the requirements of § 316.5.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973]

Pt. 317 PART 317—LABELING, MARKING DEVICES, AND CONTAINERS Subpart A—General Sec. 317.1 Labels required; supervision by Program employee. 317.2 Labels: definition; required features. 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception. 317.4 Labeling approval. 317.5 Generically approved labeling. 317.6 Approved labels to be used only on products to which they are applicable. 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers. 317.9 Labeling of equine products. 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc. 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations. 317.12 Relabeling products; requirements. 317.13 Storage and distribution of labels and containers bearing official marks. 317.14-317.15 [Reserved] 317.16 Labeling and containers of custom prepared products. 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.18-317.23 [Reserved] 317.24 Packaging materials. Subpart B—Nutrition Labeling 317.300 Nutrition labeling of meat or meat food products. 317.301 [Reserved] 317.302 Location of nutrition information. 317.303-317.307 [Reserved] 317.308 Labeling of meat or meat food products with number of servings. 317.309 Nutrition label content. 317.310-317.311 [Reserved] 317.312 Reference amounts customarily consumed per eating occasion. 317.313 Nutrient content claims; general principles. 317.314-317.342 [Reserved] 317.343 Significant participation for voluntary nutrition labeling. 317.344 Identification of major cuts of meat products. 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. 317.346-317.353 [Reserved] 317.354 Nutrient content claims for “good source,” “high,” and “more”. 317.355 [Reserved] 317.356 Nutrient content claims for “light” or “lite”. 317.357-317.359 [Reserved] 317.360 Nutrient content claims for calorie content. 317.361 Nutrient content claims for the sodium content. 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. 317.363 Nutrient content claims for “healthy”. 317.364-317.368 [Reserved] 317.369 Labeling applications for nutrient content claims. 317.370-317.379 [Reserved] 317.380 Label statements relating to usefulness in reducing or maintaining body weight. 317.381-317.399 [Reserved] 317.400 Exemption from nutrition labeling. Authority:

21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

Source:

35 FR 15580, Oct. 3, 1970, unless otherwise noted.

Subpart A—General

§ 317.1 Labels required; supervision by Program employee.

(a) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in § 317.2 except that the following do not have to bear such a label.

(1) Wrappings of dressed carcasses and primal parts in an unprocessed state, bearing the official inspection legend, if such wrappings are intended solely to protect the product against soiling or excessive drying during transportation or storage, and the wrappings bear no information except company brand names, trade marks, or code numbers which do not include any information required by § 317.2;

(2) Uncolored transparent coverings, such as cellophane, which bear no written, printed, or graphic matter and which enclose any unpackaged or packaged product bearing all markings required by part 316 of this subchapter which are clearly legible through such coverings;

(3) Animal and transparent artificial casings bearing only the markings required by part 316 of this subchapter;

(4) Stockinettes used as “operative devices”, such as those applied to cured meats in preparation for smoking, whether or not such stockinettes are removed following completion of the operations for which they were applied;

(5) Containers such as boil-in bags, trays of frozen dinners, and pie pans which bear no information except company brand names, trademarks, code numbers, directions for preparation and serving suggestions, and which are enclosed in a consumer size container that bears a label as described in § 317.2;

(6) Containers of products passed for cooking or refrigeration and moved from an official establishment under § 311.1 of this subchapter.

(b) Folders and similar coverings made of paper or similar materials, whether or not they completely enclose the product and which bear any written, printed, or graphic matter, shall bear all features required on a label for an immediate container.

(c) No covering or other container which bears or is to bear a label shall be filled, in whole or in part, except with product which has been inspected and passed in compliance with the regulations in this subchapter, which is not adulterated and which is strictly in accordance with the statements on the label. No such container shall be filled, in whole or in part, and no label shall be affixed thereto, except under supervision of a Program employee.

§ 317.2 Labels: definition; required features.

(a) A label within the meaning of this part shall mean a display of any printing, lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the immediate container (not including package liners) of any product.

(b) Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this part. Except as provided in § 317.7, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend.

(c) Labels of all products shall show the following information on the principal display panel (except as otherwise permitted in this part), in accordance with the requirements of this part or, if applicable, part 319 of this subchapter:

(1) The name of the product, which in the case of a product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in part 319 of this subchapter, shall be the name of the food specified in the standard, and in the case of any other product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation, as prescribed in paragraph (e) of this section;

(2) If the product is fabricated from two or more ingredients, the word “ingredients” followed by a list of the ingredients as prescribed in paragraph (f) of this section;

(3) The name and place of business of the manufacturer, packer, or distributor for whom the product is prepared, as prescribed in paragraph (g) of this section;

(4) An accurate statement of the net quantity of contents, as prescribed in paragraph (h) of this section;

(5) An official inspection legend and, except as otherwise provided in paragraph (i) of this section, the number of the official establishment, in the form required by part 312 of this subchapter;

(6) Any other information required by the regulations in this part or part 319 of this subchapter.

(d) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part and part 319 of this subchapter with clarity and conspicuousness and without obscuring of such information by designs or vignettes or crowding. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. The principal display panel shall be:

(1) In the case of a rectangular package, one entire side, the area of which is at least the product of the height times the width of that side.

(2) In the case of a cylindrical or nearly cylindrical container:

(i) An area that is 40 percent of the product of the height of the container times the circumference of the container, or

(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, That if there is immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in paragraphs (c) (2), (3), and (5), such panel shall be known as the “20 percent panel” and such information may be shown on that panel in lieu of showing it on the principal display panel.

(3) In the case of a container of any other shape, 40 percent of the total surface of the container.

(e) Any descriptive designation used as a product name for a product which has no common or usual name shall clearly and completely identify the product. Product which has been prepared by salting, smoking, drying, cooking, chopping, or otherwise shall be so described on the label unless the name of the product implies, or the manner of packaging shows that the product was subjected to such preparation. The unqualified terms “meat,” “meat byproduct,” “meat food product,” and terms common to the meat industry but not common to consumers such as “picnic,” “butt,” “cala,” “square,” “loaf,” “spread,” “delight,” “roll,” “plate,” “luncheon,” and “daisy” shall not be used as names of a product unless accompanied with terms descriptive of the product or with a list of ingredients, as deemed necessary in any specific case by the Administrator in order to assure that the label will not be false or misleading.

(f)(1) The list of ingredients shall show the common or usual names of the ingredients arranged in the descending order of predominance, except as otherwise provided in this paragraph.

(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner:

(A) The term “spice” means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10, and 184.

(B) The term “natural flavor,” “natural flavoring,” “flavor” or “flavoring” means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product or roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portion of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 172.510. The term natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powered onion, powdered garlic, and powdered celery.

(ii) The term “corn syrup” may be used to designate either corn syrup or corn syrup solids.

(iii) The term “animal and vegetable fats” or “vegetable and animal fats” may be used to designate the ingredients of mixtures of such edible fats in product designated “compound” or “shortening.” “Animal fats” as used herein means fat derived from inspected and passed cattle, sheep, swine, or goats.

(iv) When a product is coated with pork fat, gelatin, or other approved substance and a specific declaration of such coating appears contiguous to the name of the product, the ingredient statement need not make reference to the ingredients of such coating.

(v) When two meat ingredients comprise at least 70 percent of the meat and meat byproduct ingredients of a formula and when neither of the two meat ingredients is less than 30 percent by weight of the total meat and meat byproducts used, such meat ingredients may be interchanged in the formula without a change being made in the ingredients statement on labeling materials: Provided, That the word “and” in lieu of a comma shall be shown between the declaration of such meat ingredients in the statement of ingredients.

(vi)(A) Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as “Contains _____ percent of _____ ,” “Less than _____percent of _____ .” The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may also be utilized when an ingredients statement contains a listing of ingredients by individual components. Each component listing may utilize the required quantifying statement at the end of each component ingredients listing.

(B) Such ingredients may be adjusted in the product formulation without a change being made in the ingredients statement on the labeling, provided that the adjusted amount complies with § 318.7(c)(4) and part 319 of this subchapter, and does not exceed the amount shown in the quantifying statement. Any such adjustments to the formulation shall be provided to the inspector-in-charge.

(2) On containers of frozen dinners, entrees, pizzas, and similar consumer packaged products in cartons the ingredient statement may be placed on the front riser panel: Provided, That the words “see ingredients” followed immediately by an arrow is placed on the principal display panel immediately above the location of such statement without intervening print or designs.

(3) The ingredient statement may be placed on the 20 percent panel adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container.

(4) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter.

(g)(1) The name or trade name of the person that prepared the product may appear as the name of the manufacturer or packer without qualification on the label. Otherwise the name of the distributor of the product shall be shown with a phrase such as “Prepared for * * *”. The place of business of the manufacturer, packer, or distributor shall be shown on the label by city, State, and postal ZIP code when such business is listed in a telephone or city directory, and if not listed in such directory, then the place of business shall be shown by street address, city, State, and postal ZIP code.

(2) The name and place of business of the manufacturer, packer, or distributor may be shown:

(i) On the principal display panel, or

(ii) On the 20 percent panel adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container, or

(iii) On the front riser panel of frozen food cartons, or

(iv) On the information panel.

(h)(1) The statement of net quantity of contents shall appear on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph.

(2) The statement as it is shown on a label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall be as provided in § 317.19. The statement shall not include any term qualifying a unit of weight, measure, or count such as “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “minimum,” or words of similar importance.

(3) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel in lines generally parallel to the base: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph (h). In any case, the statement may appear in more than one line. The terms “net weight” or “net wt.” shall be used when stating the net quantity of contents in terms of weight, and the term “net contents” or “content” when stating the net quantity of contents in terms of fluid measure.

(4) Except as provided in § 317.7, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semisolid viscous or a mixture of solid and liquid. For example, a declaration of 3/4-pound avoirdupois weight shall be expressed as “Net Wt. 12 oz.” except as provided for in paragraph (h)(5) of this section for random weight packages; a declaration of 11/2 pounds avoirdupois weight shall be expressed as “Net Wt. 24 oz. (1 lb. 8 oz.),” “Net Wt. 24 oz. (11/2 lb.),” or “Net Wt. 24 oz. (1.5 lbs.).”

(5) On packages containing 1 pound or 1 pint and less than 4 pounds or 1 gallon, the statement shall be expressed as a dual declaration both in ounces and (immediately thereafter in parentheses) in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart, except that on random weight packages the statement shall be expressed in terms of pounds and decimal fractions of the pound, for packages over 1 pound, and for packages which do not exceed 1 pound the statement may be in decimal fractions of the pound in lieu of ounces. Paragraph (h)(9) of this section permits certain exceptions from the provisions of this paragraph for margarine packages, random weight consumer size packages, and packages of less than 1/2 ounce net weight. Pargraph (h)(12) of this section permits certain exceptions from the provision of this paragraph for multi-unit packages.

(6) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform of all packages of substantially the same size by complying with the following type specifications:

(i) Not less than one-sixteenth inch in height on packages, the principal display panel of which has an area of 5 square inches or less;

(ii) Not less than one-eighth inch in height on packages, the principal display panel of which has an area of more than 5 but not more than 25 square inches;

(iii) Not less than three-sixteenths inch in height on packages, the principal display panel of which has an area of more than 25 but not more than 100 square inches;

(iv) Not less than one-quarter inch in height on packages, the principal display panel of which has an area of more than 100 but not more than 400 square inches.

(v) Not less than one-half inch in height on packages, the principal display panel of which has an area of more than 400 square inches.

(7) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). Heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards.

(8) The statement shall appear as a distinct item on the principal display panel and shall be separated by a space at least equal to the height of the lettering used in the statement from other printed label information appearing above or below the statement and by a space at least equal to twice the width of the letter “N” of the style of type used in the quantity of contents statement from other printed label information appearing to the left or right of the statement. It shall not include any term qualifying a unit of weight, measure, or count such as, “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “Minimum” or words of similar import.

(9) The following exemptions from the requirements contained in this paragraph (h) are hereby established:

(i) Individually wrapped, random weight consumer size packages shipped in bulk containers (as specified in paragraph (h)(11) of this section) and meat products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined under § 317.19 need not bear a net weight statement when shipped from an official establishment, provided that a net weight shipping statement which meets the requirements of paragraph (h)(2) of this section is applied to their shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size, dual declaration, and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement on random weight consumer size packages for retail sale shall be exempt from the type size, dual declaration, and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.

(ii) Individually wrapped and labeled packages of less than 1/2 ounce net weight and random weight consumer size packages shall be exempt from the requirements of this paragraph if they are in a shipping container and the statement of net quantity of contents on the shipping container meets the requirements of paragraph (h)(2) of this section;

(iii) Individually wrapped and labeled packages of less than 1/2 ounce net weight bearing labels declaring net weight, price per pound, and total price, shall be exempt from the type size, dual declaration, and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.

(iv) Margarine in 1 pound rectangular packages (except packages containing whipped or soft margarine or packages that contain more than four sticks) is exempt from the requirements of paragraphs (h) (3) and (5) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds, if the statement appears as “1 pound” or “one pound” in a conspicuous manner on the principal display panel.

(v) Sliced shingle packed bacon in rectangular packages is exempt from the requirements of paragraphs (h)(3) and (h)(5) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel, and that the statement be expressed both in ounces and in pounds, if the statement appears in a conspicuous manner on the principal display panel.

(10) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of the net quantity of each such serving.

(11) As used in this section, a “random weight consumer size package” is one which is one of a lot, shipment or delivery of packages of the same product with varying weights and with no fixed weight pattern.

(12) On a multiunit retail package, a statement of the net quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and in parentheses, the total net quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces, except that such declaration of total quantity need not be followed by an additional parenthetical declaration in terms of the largest whole units and subdivisions thereof, as required by paragraph (h)(5) of this section. For the purposes of this section, “multiunit retail package” means a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multiunit retail package but capable of being individually sold in full compliance with all requirements of the regulations in this part. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph if the labeling of each individual unit complies with the requirements of paragraphs (h) (2), (3), (6), and (8) of this section.

(i) The official establishment number of the official establishment in which the product was processed under inspection shall be placed as follows:

(1) Within the official inspection legend in the form required by part 312 of this subchapter; or

(2) Outside the official inspection legend elsewhere on the exterior of the container or its labeling, e.g., the lid of a can, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition and accompanied by the prefix “EST”; or

(3) Off the exterior of the container, e.g., on a metal clip used to close casings or bags, or on the back of a paper label of a canned product, or on other packaging or labeling material in the container, e.g., on aluminum pans and trays placed within containers, when a statement of its location is printed contiguous to the official inspection legend, such as “EST. No. on Metal Clip” or “Est. No. on Pan”, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition; or

(4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix “EST”.

(j) Labels of any product within any of the following paragraphs shall show the information required by such paragraph for such product:

(1) A label for product which is an imitation of another food shall bear the word “imitation” immediately preceding the name of the food imitated and in the same size and style of lettering as in that name and immediately thereafter the word “ingredients:” and the names of the ingredients arranged in the order of their predominance.

(2) If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations (21 CFR part 125) established pursuant to sections 403, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).

(3) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of a meat food product, as permitted in part 318 of this subchapter, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as may be applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring so added as an ingredient in the formula of the meat food product.

(4) When any other artificial flavoring is permitted under part 318 of this subchapter to be added to a product, the ingredient statement shall identify it as “Artificial Flavoring.”

(5) When artificial coloring is added to edible fats as permitted under part 318 of this subchapter such substance shall be declared on the label in a prominent manner and contiguous to the name of the product by the words “Artificially colored” or “Artificial coloring added” or “With added artificial coloring.” When natural coloring such as annatto is added to edible fats as permitted under part 318 of this subchapter, such substance shall be declared on the label in the same manner by a phrase such as “Colored with annatto.”

(6) When product is placed in a casing to which artificial coloring is applied as permitted under part 318 of this subchapter, there shall appear on the label, in a prominent manner and contiguous to the name of the product, the words, “Artificially colored.”

(7) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, there shall appear on the label, in a prominent manner and contiguous to the name of product, the words “Artificially colored.”

(8) When a casing is colored prior to its use as a covering for product and the color is not transferred to the product enclosed in the casing, no reference to color need appear on the label but no such casing may be used if it is misleading or deceptive with respect to color, quality, or kind of product, or otherwise.

(9) Product which bears or contains any other artificial coloring, as permitted under part 318 of this subchapter, shall bear a label stating that fact on the immediate container or if there is none, on the product.

(10) When an antioxidant is added to product as permitted under part 318 of this subchapter, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement identifying the officially approved specific antioxidant by its common name or abbreviation thereof and the purpose for which it is added, such as, “BHA, BHT, and Propylgallate added to help protect flavor.”

(11) Containers of meat packed in borax or other preservative for export to a foreign country which permits the use of such preservative shall, at the time of packing, be marked “for export,” followed on the next line by the words “packed in preservative,” or such equivalent statement as may be approved for this purpose by the Administrator and directly beneath this there shall appear the word “establishment” or abbreviation thereof, followed by the number of the establishment at which the product is packed. The complete statement shall be applied in a conspicuous location and in letters not less than 1 inch in height.

(12) Containers of other product packed in, bearing, or containing any chemical preservative shall bear a label stating that fact.

(13)(i) On the label of any “Mechanically Separated (Species)” described in § 319.5(a) of this subchapter, the name of such product shall be followed immediately by the phrase “for processing” unless such product has a protein content of not less than 14 percent and a fat content of not more than 30 percent.

(ii) When any “Mechanically Separated (Species)” described in § 319.5 of this subchapter is used as an ingredient in the preparation of a meat food product and such “Mechanically Separated (Species)” contributes 20 mg or more of calcium to a serving of such meat food product, the label of such meat food product shall state the calcium content of such meat food product, determined and expressed as the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and (e), as part of any nutrition information included on such label, or if such meat food product does not bear nutrition labeling information, as part of a prominent statement in immediate conjunction with the list of ingredients, as follows: “A ___ serving contains __% of the U.S. RDA of calcium”, with the blanks to be filled in, respectively, with the quantity of such product that constitutes a serving and the amount of calcium provided by such serving: Provided, That, calcium content need not be stated where (a) the percent of the U.S. RDA of calcium to be declared would not differ from the percent of the U.S. RDA that would be declared if the meat food product contained only hand deboned ingredients or (b) the calcium content of a serving of the meat food product would be 20 percent of the U.S. RDA or more if the meat food product contained only hand deboned ingredients.

(k) Packaged products which require special handling to maintain their wholesome condition shall have prominently displayed on the principal display panel of the label the statement: “Keep Refrigerated,” “Keep Frozen,” “Perishable Keep Under Refrigeration,” or such similar statement as the Administrator may approve in specific cases. Products that are distributed frozen during distribution and thawed prior to or during display for sale at retail shall bear the statement on the shipping container: “Keep Frozen.” The consumer-size containers for such products shall bear the statement “Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated.” For all perishable canned products the statement shall be shown in upper case letters one-fourth inch in height for containers having a net weight of 3 pounds or less, and for containers having a net weight over 3 pounds, the statement shall be in upper case letters at least one-half inch in height.

(l) Safe handling instructions shall be provided for: All meat and meat products of cattle, swine, sheep, goat, horse, other equine that do not meet the requirements contained in § 318.17, or that have not undergone other processing that would render them ready-to-eat; and all comminuted meat patties not heat processed in a manner that conforms to the time and temperature combinations in the Table for Permitted Heat-Processing Temperature/Time Combinations For Fully-Cooked Patties in § 318.23, except as exempted under paragraph (l)(4) of this section.

(1)(i) Safe handling instructions shall accompany every meat or meat product, specified in this paragraph (l) destined for household consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall be in lettering no smaller than one-sixteenth of an inch in size and shall be prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(ii) The safe handling information shall be presented on the label under the heading “Safe Handling Instructions” which shall be set in type size larger than the print size of the rationale statement and handling statements as discussed in paragraphs (l)(2) and (l)(3) of this section. The safe handling information shall be set off by a border and shall be one color type printed on a single color contrasting background whenever practical.

(2) The labels of the meat and meat products specified in this paragraph (l) shall include the following rationale statement as part of the safe handling instructions, “This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements.

(3) Meat and meat products, specified in this paragraph (l), shall bear the labeling statements:

(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. (Any portion of this statement that is in conflict with the product's specific handling instructions, may be omitted, e.g., instructions to cook without thawing.) (A graphic illustration of a refrigerator shall be displayed next to the statement.);

(ii) Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry. (A graphic illustration of soapy hands under a faucet shall be displayed next to the statement.);

(iii) Cook thoroughly. (A graphic illustration of a skillet shall be displayed next to the statement.); and

(iv) Keep hot foods hot. Refrigerate leftovers immediately or discard. (A graphic illustration of a thermometer shall be displayed next to the statement.)

(4) Meat or meat products intended for further processing at another official establishment are exempt from the requirements prescribed in paragraphs (l)(1) through (l)(3) of this section.

(m)(1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions:

(i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used.

(ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel.

(iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.

(2) (i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel.

(ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes.

[35 FR 15580, Oct. 3, 1970] Editorial Note:

For Federal Register citations affecting § 317.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception.

(a) The Administrator may approve and authorize the use of abbreviations of marks of inspection under the regulations in this subchapter. Such abbreviations shall have the same force and effect as the respective marks for which they are authorized abbreviations.

(b) Except for the purposes of preparing and submitting a sample or samples of the same to the Administrator for approval, no brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any marking device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, without the written authority therefor of the Administrator. However, when any such sample label, or other marking device, is approved by the Administrator, additional supplies of the approved label, or marking device, may be made for use in accordance with the regulations in this subchapter, without further approval by the Administrator. The provisions of this paragraph apply only to labels, or other marking devices, bearing or containing an official inspection legend shown in § 312.2(b), § 312.3(a) (only the legend appropriate for horse meat food products) or § 312.3(b) (only the legend appropriate for other (nonhorse) equine meat food products), or any abbreviations, copy or representation thereof.

(c) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a brand or other marking device containing an official inspection legend, or simulation thereof, shown in § 312.2(a), § 312.3(a) (only the legend appropriate for horse carcasses and parts of horse carcasses), § 312.3(b) (only the legend appropriate for other equine (nonhorse) carcasses and parts of other (nonhorse) equine carcasses) or § 312.7(a).

(1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the brand or other marking device, bearing a certificate serial number and a letterhead and the seal of the United States Department of Agriculture. The certificate authorizes the making of only the brands or other marking devices of the type and quantity listed on the certificate.

(2) After signing the certificate, the Program employee and the establishment shall each keep a copy, and the remaining two copies shall be given to the brand or other marking device manufacturer.

(3) The manufacturer of the brands or other marking devices shall engrave or otherwise mark each brand or other marking device with a permanent identifying serial number unique to it. The manufacturer shall list on each of the two copies of the certificate given to the manufacturer the number of each brand or other marking device authorized by the certificate. The manufacturer shall retain one copy of the certificate for the manufacturer's records and return the remaining copy with the brands or other marking devices to the Program employee whose name and address are given on the certificate as the recipient.

(4) In order that all such brands or other marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such brand or other marking device which does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such brand or other marking device with a permanent identifying number.

(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0015) [35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]

§ 317.4 Labeling approval.

(a) No final labeling shall be used on any product unless the sketch labeling of such final labeling has been submitted for approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and approved by such division, accompanied by FSIS form, Application for Approval of Labels, Marking, and Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the official establishment or establishment certified under a foreign inspection system, in accordance with part 327 of this subchapter, must maintain a copy of all labeling used, along with the product formulation and processing procedure, in accordance with part 320 of this subchapter. Such records shall be made available to any duly authorized representative of the Secretary upon request.

(b) The Food Labeling Division shall permit submission for approval of only sketch labeling, as defined in § 317.4(d), for all products, except as provided in § 317.5(b) (2)-(9) and except for temporary use of final labeling as prescribed in paragraph (f) of this section.

(c) All labeling required to be submitted for approval as set forth in § 317.4(a) shall be submitted in duplicate to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. A parent company for a corporation may submit only one labeling application (in duplicate form) for a product produced in other establishments that are owned by the corporation.

(d) “Sketch” labeling is a printer's proof or equivalent which clearly shows all labeling features, size, location, and indication of final color, as specified in § 317.2. FSIS will accept sketches that are hand drawn, computer generated or other reasonable facsimiles that clearly reflect and project the final version of the labeling. Indication of final color may be met by: submission of a color sketch, submission of a sketch which indicates by descriptive language the final colors, or submission with the sketch of previously approved final labeling that indicates the final colors.

(e) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed within, containers and coverings of product shall be submitted for approval in the same manner as provided for labeling in § 317.4(a), except that such devices which contain no reference to product and bear no misleading feature shall be used without submission for approval as prescribed in § 317.5(b)(7).

(f)(1) Consistent with the requirements of this section, temporary approval for the use of a final label or other final labeling that may otherwise be deemed deficient in some particular may be granted by the Food Labeling Division. Temporary approvals may be granted for a period not to exceed 180 calendar days, under the following conditions:

(i) The proposed labeling would not misrepresent the product;

(ii) The use of the labeling would not present any potential health, safety, or dietary problems to the consumer;

(iii) Denial of the request would create undue economic hardship; and

(iv) An unfair competitive advantage would not result from the granting of the temporary approval.

(2) Extensions of temporary approvals may also be granted by the Food Labeling Division provided that the applicant demonstrates that new circumstances, meeting the above criteria, have developed since the original temporary approval was granted.

(g) The inspector-in-charge shall approve meat carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316 of this subchapter.

[60 FR 67454, Dec. 29, 1995]

§ 317.5 Generically approved labeling.

(a)(1) An official establishment or an establishment certified under a foreign inspection system, in accordance with part 327 of this subchapter, is authorized to use generically approved labeling, as defined in paragraph (b) of this section, without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington or the field, provided the labeling is in accordance with this section and shows all mandatory features in a prominent manner as required in § 317.2, and is not otherwise false or misleading in any particular.

(2) The Food Safety and Inspection Service shall select samples of generically approved labeling from the records maintained by official establishments and establishments certified under foreign inspection systems, in accordance with part 327 of this subchapter, as required in § 317.4, to determine compliance with labeling requirements. Any finding of false or misleading labeling shall institute the proceedings prescribed in § 335.12.

(b) Generically approved labeling is labeling which complies with the following:

(1) Labeling for a product which has a product standard as specified in part 319 of this subchapter or the Standards and Labeling Policy Book and which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9)(xxv) of this section), or guarantees, or which is not a domestic product labeled in a foreign language;

(2) Labeling for single-ingredient products (such as beef steak or lamb chops) which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9)(xxv) of this section), or guarantees, or which is not a domestic product labeled with a foreign language;

(3) Labeling for containers of products sold under contract specifications to Federal Government agencies, when such product is not offered for sale to the general public, provided that the contract specifications include specific requirements with respect to labeling, and are made available to the inspector-in-charge;

(4) Labeling for shipping containers which contain fully labeled immediate containers, provided such labeling complies with § 316.13;

(5) Labeling for products not intended for human food, provided they comply with part 325 of this subchapter;

(6) Meat inspection legends, which comply with parts 312 and 316 of this subchapter;

(7) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed within containers, and coverings of products, provided such devices contain no reference to product and bear no misleading feature;

(8) Labeling for consumer test products not intended for sale; and

(9) Labeling which was previously approved by the Food Labeling Division as sketch labeling, and the final labeling was prepared without modification or with the following modifications:

(i) All features of the labeling are proportionately enlarged or reduced, provided that all minimum size requirements specified in applicable regulations are met and the labeling is legible;

(ii) The substitution of any unit of measurement with its abbreviation or the substitution of any abbreviation with its unit of measurement, e.g., “lb.” for “pound,” or “oz.” for “ounce,” or of the word “pound” for “lb.” or “ounce” for “oz.”;

(iii) A master or stock label has been approved from which the name and address of the distributor are omitted and such name and address are applied before being used (in such case, the words “prepared for” or similar statement must be shown together with the blank space reserved for the insertion of the name and address when such labels are offered for approval);

(iv) Wrappers or other covers bearing pictorial designs, emblematic designs or illustrations, e.g., floral arrangements, illustrations of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make necessary the application of labeling not otherwise required);

(v) A change in the language or the arrangement of directions pertaining to the opening of containers or the serving of the product;

(vi) The addition, deletion, or amendment of a dated or undated coupon, a cents-off statement, cooking instructions, packer product code information, or UPC product code information;

(vii) Any change in the name or address of the packer, manufacturer or distributor that appears in the signature line;

(viii) Any change in the net weight, provided the size of the net weight statement complies with § 317.2;

(ix) The addition, deletion, or amendment of recipe suggestions for the product;

(x) Any change in punctuation;

(xi) Newly assigned or revised establishment numbers for a particular establishment for which use of the labeling has been approved by the Food Labeling Division, Regulatory Programs;

(xii) The addition or deletion of open dating information;

(xiii) A change in the type of packaging material on which the label is printed;

(xiv) Brand name changes, provided that there are no design changes, the brand name does not use a term that connotes quality or other product characteristics, the brand name has no geographic significance, and the brand name does not affect the name of the product;

(xv) The deletion of the word “new” on new product labeling;

(xvi) The addition, deletion, or amendment of special handling statements, provided that the change is consistent with § 317.2(k);

(xvii) The addition of safe handling instructions as required by § 317.2(l);

(xviii) Changes reflecting a change in the quantity of an ingredient shown in the formula without a change in the order of predominance shown on the label, provided that the change in quantity of ingredients complies with any minimum or maximum limits for the use of such ingredients prescribed in parts 318 and 319 of this subchapter;

(xix) Changes in the color of the labeling, provided that sufficient contrast and legibility remain;

(xx) A change in the product vignette, provided that the change does not affect mandatory labeling information or misrepresent the content of the package;

(xxi) A change in the establishment number by a corporation or parent company for an establishment under its ownership;

(xxii) Changes in nutrition labeling that only involve quantitative adjustments to the nutrition labeling information, except for serving sizes, provided the nutrition labeling information maintains its accuracy and consistency;

(xxiii) Deletion of any claim, and the deletion of non-mandatory features or non-mandatory information; and

(xxiv) The addition or deletion of a direct translation of the English language into a foreign language for products marked “for export only.”

(xxv) A country of origin statement on any product label described in § 317.8(b)(40) that complies with the requirements in that paragraph.

[60 FR 67455, Dec. 29, 1995, as amended at 73 FR 50703, Aug. 28, 2008]

§ 317.6 Approved labels to be used only on products to which they are applicable.

Labels shall be used only on products for which they are approved, and only if they have been approved for such products in accordance with § 317.3: Provided, That existing stocks of labels approved prior to the effective date of this section and the quantity of which has been identified to the circuit supervisor as being in storage on said date at the official establishment or other identified warehouse for the account of the operator of the official establishment may be used until such stocks are exhausted, but not later than 1 year after the effective date of this section unless such labels conform to all the requirements of this part and part 319 of this subchapter. The Administrator may upon the show of good cause grant individual extension of time as he deems necessary.

§ 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations.

Labels to be affixed to packages of products for foreign commerce may be printed in a foreign language and may show the statement of the quantity of contents in accordance with the usage of the country to which exported and other deviations from the form of labeling required under this part may be approved for such product by the Administrator in specific cases: Provided,

(a) That the proposed labeling accords to the specifications of the foreign purchaser,

(b) That it is not in conflict with the laws of the country to which the product is intended for export, and

(c) That the outside container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of this subchapter apply. The inspection legend and the establishment number shall in all cases appear in English but in addition, may appear literally translated in a foreign language.

§ 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.

(a) No product or any of its wrappers, packaging, or other containers shall bear any false or misleading marking, label, or other labeling and no statement, word, picture, design, or device which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling. No product shall be wholly or partly enclosed in any wrapper, packaging, or other container that is so made, formed, or filled as to be misleading.

(b) The labels and containers of product shall comply with the following provisions, as applicable:

(1) Terms having geographical significance with reference to a locality other than that in which the product is prepared may appear on the label only when qualified by the word “style,” “type,” or “brand,” as the case may be, in the same size and style of lettering as in the geographical term, and accompanied with a prominent qualifying statement identifying the country, State, Territory, or locality in which the product is prepared, using terms appropriate to effect the qualification. When the word “style” or “type” is used, there must be a recognized style or type of product identified with and peculiar to the area represented by the geographical term and the product must possess the characteristics of such style or type, and the word “brand” shall not be used in such a way as to be false or misleading: Provided, That a geographical term which has come into general usage as a trade name and which has been approved by the Administrator as being a generic term may be used without the qualifications provided for in this paragraph. The terms “frankfurter,” “vienna,” “bologna,” “lebanon bologna,” “braunschweiger,” “thuringer,” “genoa,” “leona,” “berliner,” “holstein,” “goteborg,” “milan,” “polish,” “italian,” and their modifications, as applied to sausages, the terms “brunswick” and “irish” as applied to stews and the term “boston” as applied to pork shoulder butts need not be accompanied with the word “style,” “type,” or “brand,” or a statement identifying the locality in which the product is prepared.

(2) Such terms as “farm” or “country” shall not be used on labels in connection with products unless such products are actually prepared on the farm or in the country: Provided, That if the product is prepared in the same way as on the farm or in the country these terms, if qualified by the word “style” in the same size and style of lettering, may be used: Provided further, That the term “farm” may be used as part of a brand designation when qualified by the word “brand” in the same size and style of lettering, and followed with a statement identifying the locality in which the product is prepared: And Provided further, That the provisions of this paragraph shall not apply to products prepared in accordance with § 319.106 of this subchapter. Sausage containing cereal shall not be labeled “farm style” or “country style,” and lard not rendered in an open kettle shall not be designated as “farm style” or “country style.”

(3) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not relieve any establishment from the requirement that its label shall not be misleading in any particular.

(4) The term “spring lamb” or “genuine spring lamb” is applicable only to carcasses of new-crop lambs slaughtered during the period beginning in March and terminating not beyond the close of the week containing the first Monday in October.

(5)(i) Coverings shall not be of such color, design, or kind as to be misleading with respect to color, quality, or kind of product to which they are applied. For example, transparent or semitransparent coverings for such articles as sliced bacon or fresh (uncooked) meat and meat food products shall not bear lines or other designs of red or other color which give a false impression of leanness of the product. Transparent or semitransparent wrappers, casings, or coverings for use in packaging cured, cured and smoked, or cured and cooked sausage products, and sliced ready-to-eat meat food products may be color tinted or bear red designs on 50 percent of such wrapper or covering: Provided, That the transparent or semitransparent portion of the principal display panel is free of color tinting and red designs: And provided further, That the principal display panel provides at least 20 percent unobstructed clear space, consolidated in one area so that the true nature and color of the product is visible to the consumer.

(ii) Packages for sliced bacon that have a transparent opening shall be designed to expose, for viewing, the cut surface of a representative slice. Packages for sliced bacon which meet the following specifications will be accepted as meeting the requirements of this subparagraph provided the enclosed bacon is positioned so that the cut surface of the representative slice can be visually examined:

(a) For shingle-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice, and this window shall be at least 11/2 inches wide. The transparent window shall be located not more than five-eighths inch from the top or bottom edge of a 1-pound or smaller package and not more than three-fourths inch from either the top or bottom edge of a package larger than 1 pound.

(b) For stack-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice and be at least 11/2 inches wide.

(6) The word “fresh” shall not be used on labels to designate product which contains any sodium nitrate, sodium nitrite, potassium nitrate, or potassium nitrite, or which has been salted for preservation.

(7)(i) No ingredient shall be designated on the label as a spice, flavoring, or coloring unless it is a spice, flavoring, or coloring, as the case may be. An ingredient that is both a spice and a coloring, or both a flavoring and a coloring, shall be designated as “spice and coloring”, or “flavoring and coloring”, as the case may be, unless such ingredient is designated by its common or usual name.

(ii) Any ingredient not designated in § 317.2(f)(1)(i) of this part whose function is flavoring, either in whole or in part, must be designated by its common or usual name. Those ingredients which are of livestock and poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived.

(8) As used on labels of product, the term “gelatin” shall mean (i) the jelly prepared in official establishments by cooking pork skins, tendons, or connective tissue from inspected and passed product, and (ii) dry commercial gelatin or the jelly resulting from its use.

(9) Product (other than canned product) labeled with the term “loaf” as part of its name:

(i) If distributed from the official establishment in consumer size containers may be in any shape;

(ii) If distributed in a container of a size larger than that sold intact at retail the product shall be prepared in rectangular form, or as in paragraph (b)(9)(iii) of this section;

(iii) If labeled as an “Old Fashioned Loaf” shall be prepared in a traditional form, such as rectangular with rounded top or circular with flat bottom and rounded top.

(10) The term “baked” shall apply only to product which has been cooked by the direct action of dry heat and for a sufficient time to permit the product to assume the characteristics of a baked article, such as the formation of a brown crust on the surface, rendering out of surface fat, and the caramelization of the sugar if applied. Baked loaves shall be heated to a temperature of at least 160 °F. and baked pork cuts shall be heated to an internal temperature of at least 170 °F.

(11) When products such as loaves are browned by dipping in hot edible oil or by a flame, the label shall state such fact, e.g., by the words “Browned in Hot Cottonseed Oil” or “Browned by a Flame,” as the case may be, appearing as part of the product name.

(12) The term “meat” and the names of particular kinds of meat, such as beef, veal, mutton, lamb, and pork, shall not be used in such manner as to be false or misleading.

(13) The word “ham,” without any prefix indicating the species of animal from which derived, shall be used in labeling only in connection with the hind legs of swine. Ham shanks as such or ham shank meat as such or the trimmings accruing in the trimming and shaping of hams shall not be labeled “ham” or “ham meat” without qualification. When used in connection with a chopped product the term “ham” or “ham meat” shall not include the skin.

(14) The terms “shankless” and “hockless” shall apply only to hams and pork shoulders from which the shank or hock has been completely removed, thus eliminating the entire tibia and fibula, or radius and ulna, respectively, together with the overlying muscle, skin, and other tissue.

(15) Such terms as “meat extract” or “extract of beef” without qualification shall not be used on labels in connection with products prepared from organs or other parts of the carcass, other than fresh meat. Extracts prepared from any parts of the carcass other than fresh meat may be properly labeled as extracts with the true name of the parts from which prepared. In the case of extract in fluid form, the word “fluid” shall also appear on the label, as, for example, “fluid extract of beef.”

(16) [Reserved]

(17) When any product is enclosed in a container along with a packing substance such as brine, vinegar, or agar jelly, a declaration of the packing substance shall be printed prominently on the label as part of the name of the product, as for example, “frankfurts packed in brine,” “lamb tongue packed in vinegar,” or “beef tongue packed in agar jelly,” as the case may be. The packing substance shall not be used in such a manner as will result in the container being so filled as to be misleading.

(18) “Leaf lard” is lard prepared from fresh leaf fat.

(19) When lard or hardened lard is mixed with rendered pork fat or hardened rendered pork fat, the mixture shall be designated as “rendered pork fat” or “hardened rendered pork fat,” as the case may be.

(20) Oil, stearin, or stock obtained from beef or mutton fats rendered at a temperature above 170 °F. shall not be designated as “oleo oil,” “oleo stearin,” or “oleo stock,” respectively.

(21) When not more than 20 percent of beef fat, mutton fat, oleo stearin, vegetable stearin, or hardened vegetable fat is mixed with lard or with rendered pork fat, there shall appear on the label, contiguous to and in the same size and style of lettering as the name of the product, the words “beef fat added,” “mutton fat added,” “oleo stearin added,” “vegetable stearin added,” or “hardened vegetable fat added,” as the case may be. If more than 20 percent is added, the product name shall refer to the particular animal fat or fats used, such as, “Lard and Beef Fat.” The designation “vegetable fat” is applicable to vegetable oil, vegetable stearin, or a combination of such oil and stearin, whereas the designations “vegetable oil” and “vegetable stearin” shall be applicable only to the oil and the stearin respectively, when used in meat food products.

(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar products, shall be labeled to show that the bones remain in the product, if such is the case. The designation “semi-boneless” shall not be used if less than 50 percent of the total weight of bones has been removed.

(23) When monoglycerides, diglycerides, and/or polyglycerol esters of fatty acids are added to rendered animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and contiguous to the name of the product a statement such as “With Monoglycerides and Diglycerides Added,” or “With Diglycerides and Monoglycerides,” or “With Polyglycerol Esters of Fatty Acids” as the case may be.

(24) Section 407 of the Federal Food, Drug, and Cosmetic Act contains provisions with respect to colored margarine or colored oleomargarine (21 U.S.C. 347) which are set forth herein as footnote. 1

1 “Sec. 407(a) Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this Act as if it had been introduced in interstate commerce.

(b) No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—

(1) Such oleomargarine or margarine is packaged,

(2) The net weight of the contents of any package sold in a retail establishment is one pound or less,

(3) There appears on the label of the package (A) The word ‘oleomargarine’ or ‘margarine’ in type or lettering at least as large as any other type or lettering on such label, and (B) A full and accurate statement of all the ingredients contained in such oleomargarine, or margarine, and

(4) Each part of the contents of the package is contained in a wrapper which bears the word ‘oleomargarine’ or ‘margarine’ in type or lettering not smaller than 20-point type.

The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this Act.

(c) No person shall possess in a form ready for serving colored oleomargarine or colored margarine at a public eating place unless a notice that oleomargarine or margarine is served is displayed prominently and conspicuously in such place and in such manner as to render it likely to be read and understood by the ordinary individual being served in such eating place or is printed or is otherwise set forth on the menu in type or lettering not smaller than that normally used to designate the serving of other food items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made therefor, unless (1) each separate serving bears or is accompanied by labeling identifying it as oleomargarine or margarine, or (2) each separate serving thereof is triangular in shape.

(d) Colored oleomargarine or colored margarine when served with meals at a public eating place shall at the time of such service be exempt from the labeling requirements of section 343 of this Act (except subsection (a) and (f) of section 343 of this title) if it complies with the requirements of subsection (b) of this section.

(e) For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade containing more than one and six tenths degrees of yellow or of yellow and red collectively, but with an excess of yellow over red, measured in terms of Lovibond tintometer scale or its equivalent” (21 U.S.C. 347).

(25) When approved proteolytic enzymes as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with [approved enzyme],” to indicate the use of such enzymes. Any other approved substance which may be used in the solution shall also be included in the statement.

When approved inorganic chlorides as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts there shall appear on the label in a prominent manner, contiguous to the product name, the statement, “Tenderized with (names of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be in the solution shall also be included in the statement.

(26) When dimethylpolysiloxan is added as an antifoaming agent to rendered fats, its presence shall be declared on the label contiguous to the name of the product. Such declaration shall read “Dimethylpolysiloxan Added.”

(27) When pizzas are formulated with crust containing calcium propionate or sodium propionate, there shall appear on the label contiguous to the name of the product the statement “____ added to retard spoilage of crust” preceded by the name of the preservative.

(28) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of this subchapter, shall be marked or labeled with a statement disclosing such treatment and the purpose thereof, such as “dipped in a potassium sorbate solution to retard mold growth.”

(29) Meat of goats shall be identified as goat meat or chevon.

(30) The term “Chitterlings” shall apply to the large intestines of swine, or young bovine animals when preceded with the word “Calf” or “Veal.” Meat food products that contain chitterlings or calf or veal chitterlings, in accordance with § 318.6(b)(8) of this subchapter shall be identified with product names that refer to such ingredients, as for instance, “Chitterling Loaf,” “Chitterling Pie,” or “Calf Chitterlings and Gravy,” and shall be packed in containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact and bearing such other information as is required by this part.

(31) Products that contain blood from livestock as permitted by part 318 of this subchapter shall be labeled with a name that includes the term “blood,” and the specific kind of blood shall be declared in the ingredient statement, e.g., “Swine blood,” in the manner required by this part.

(32) A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:

(i) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading.

(ii) Immediately adjacent to the calendar date shall be a phrase explaining the meaning of such date, in terms of “packing” date, “sell by” date, or “use before” date, with or without a further qualifying phrase, e.g., “For Maximum Freshness” or “For Best Quality”, and such phrases shall be approved by the Administrator as prescribed in § 317.4.

(33) [Reserved]

(34) The terms “All,” “Pure,” “100%,” and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient.

(35) When agar-agar is used in canned jellied meat food products, as permitted in part 318 of this subchapter, there shall appear on the label in a prominent manner, contiguous to the product name, a statement to indicate the use of agar-agar.

(36) When sodium alginate, calcium carbonate, and lactic acid and calcium carbonate (or glucono delta-lactone) are used together in a dry binding matrix in restructured, formed meat food products, as permitted in part 318 of this subchapter, there shall appear on the label contiguous to the product name, a statement to indicate the use of sodium alginate, calcium carbonate and lactic acid and calcium carbonate (or glucono delta-lactone).

(37) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with part 320 of this chapter.

(38) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement.

(39) When transglutaminase enzyme is used to bind pieces of meat to form a cut of meat, or to reform a piece of meat from a multiple cuts, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Beef Tenderloin” or “Reformed and Shaped Beef Tenderloin.”

(40) A country of origin statement on the label of any meat “covered commodity” as defined in 7 CFR Part 65, Subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400.

[35 FR 15580, Oct. 3, 1970] Editorial Note:

For Federal Register citations affecting § 317.8, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 317.9 Labeling of equine products.

The immediate containers of any equine products shall be labeled to show the kinds of animals from which derived when the products are sold, transported, offered for sale or transportation or received for transportation in commerce.

§ 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.

(a) No official inspection legend or other official mark which has been previously used shall be used again for the identification of any product, except as provided for in paragraph (b) of this section.

(b) All stencils, marks, labels, or other labeling on previously used containers, whether relating to any product or otherwise, shall be removed or obliterated before such containers are used for any product, unless such labeling correctly indicates the product to be packed therein and such containers are refilled under the supervision of a Program employee.

§ 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.

(a) No person shall in any official establishment apply or affix, or cause to be applied or affixed, any label to any product prepared or received in such establishment, or to any container thereof, or fill any container at such an establishment, except in compliance with the regulations in this subchapter.

(b) No covering or other container shall be filled, in whole or in part, at any official establishment with any product unless it has been inspected and passed in compliance with the regulations in this subchapter, is not adulterated, and is strictly in accordance with the statements on the label, and such filling is done under the supervision of a Program employee.

(c) No person shall remove, or cause to be removed from an official establishment any product bearing a label unless such label is in compliance with the regulations in this subchapter, or any product not bearing a label required by such regulations.

§ 317.12 Relabeling products; requirements.

When it is claimed by an official establishment that any of its products which bore labels bearing official marks has been transported to a location other than an official establishment, and it is desired to relabel the product because the labels have become mutilated or otherwise damaged, a request for relabeling the product shall be sent to the Administrator, accompanied with a statement of the reasons therefor. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with labels bearing any official marks shall be done under the supervision of a Program inspector. The official establishment shall reimburse the Program, in accordance with the regulations of the Department, for any cost involved in supervising the relabeling of such product.

§ 317.13 Storage and distribution of labels and containers bearing official marks.

Labels, wrappers, and containers bearing any official marks, with or without the establishment number, may be transported from one official establishment to any other official establishment provided such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subchapter.

§§ 317.14-317.15 [Reserved]

§ 317.16 Labeling and containers of custom prepared products.

Products that are custom prepared under § 303.1(a)(2) of this subchapter must be packaged immediately after preparation and must be labeled (in lieu of information otherwise required by this part 317) with the words “Not For Sale” in lettering not less than three-eighth inch in height. Such exempted custom prepared products or their containers may bear additional labeling provided such labeling is not false or misleading.

[37 FR 4071, Feb. 26, 1972]

§ 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.

(a) With respect to sections 1(n) (7), (9), and (12) of the Act and § 317.2, any substance mixed with another substance to cure a product must be identified in the ingredients statement on the label of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any product, must be identified on the label of the product by listing each such ingredient in accordance with the provisions of § 317.2.

(b) Any product, such as bacon and pepperoni, which is required to be labeled by a common or usual name or descriptive name in accordance with § 317.2(c)(1) and to which nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and labeled with such common or usual name or descriptive name when immediately preceded with the term “Uncured” as part of the product name in the same size and style of lettering as the product name, provided that the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate or nitrite, or both.

(c)(1) Products described in paragraph (b) of this section or § 319.2 of this subchapter, which contain no nitrate or nitrite shall bear the statement “No Nitrate or Nitrite Added.” This statement shall be adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name.

(2) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall bear, adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name, the statement “Not Preserved—Keep Refrigerated Below 40 °F. At All Times” unless they have been thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have been dried to a water activity of 0.92 or less.

(3) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall not be subject to the labeling requirements of paragraphs (b) and (c) of this section if they contain an amount of salt sufficient to achieve a brine concentration of 10 percent or more.

[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]

§§ 317.18-317.23 [Reserved]

§ 317.24 Packaging materials.

(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for their intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).

(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.

(c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.

(d) The Department will monitor the use of packaging material in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information tm designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective, and approval to continue using the specified packaging material in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.

(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health.

(f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing.

(g) Nothing in this section shall affect the authority of Program inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health.

[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]

Subpart B—Nutrition Labeling Source:

58 FR 664, Jan. 6, 1993, unless otherwise noted.

§ 317.300 Nutrition labeling of meat or meat food products.

(a) Nutrition labeling shall be provided for all meat or meat food products intended for human consumption and offered for sale, except single-ingredient, raw products, in accordance with the requirements of § 317.309; except as exempted under § 317.400 of this subpart.

(b) Nutrition labeling may be provided for single-ingredient, raw meat or meat food products in accordance with the requirements of §§ 317.309 and 317.345. Significant participation in voluntary nutrition labeling shall be measured by the Agency in accordance with §§ 317.343 and 317.344 of this subpart.

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]

§ 317.301 [Reserved]

§ 317.302 Location of nutrition information.

(a) Nutrition information on a label of a packaged meat or meat food product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section.

(b) Nutrition information for gift packs may be shown at a location other than on the product label, provided that the labels for these products bear no nutrition claim. In lieu of on the product label, nutrition information may be provided by alternate means such as product label inserts.

(c) Meat or meat food products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995]

§§ 317.303-317.307 [Reserved]

§ 317.308 Labeling of meat or meat food products with number of servings.

The label of any package of a meat or meat food product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 317.2(h)(10).

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]

§ 317.309 Nutrition label content.

(a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section.

(b)(1) The term “serving” or “serving size” means an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the product. When the product is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.

(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply” (Reference Amount(s)) that appear in § 317.312(b) using the procedures described in this paragraph (b). For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ___ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the Reference Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims.

(3) The declaration of nutrient and food component content shall be on the basis of the product “as packaged” for all products, except that single-ingredient, raw products may be declared on the basis of the product “as consumed” as set forth in § 317.345(a)(1). In addition to the required declaration on the basis of “as packaged” for products other than single-ingredient, raw products, the declaration may also be made on the basis of “as consumed,” provided that preparation and cooking instructions are clearly stated.

(4) For products in discrete units (e.g., hot dogs, and individually packaged products within a multi-serving package), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size shall be declared as follows:

(i) If a unit weighs 50 percent or less of the Reference Amount, the serving size shall be the number of whole units that most closely approximates the Reference Amount for the product category.

(ii) If a unit weighs more than 50 percent but less than 67 percent of the Reference Amount, the manufacturer may declare one unit or two units as the serving size.

(iii) If a unit weighs 67 percent or more but less than 200 percent of the Reference Amount, the serving size shall be one unit.

(iv) If a unit weighs 200 percent or more of the Reference Amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single eating occasion.

(v) For products that have Reference Amounts of 100 grams (or milliliter) or larger and are individual units within a multi-serving package, if a unit contains more than 150 percent but less than 200 percent of the Reference Amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings.

(vi) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product as determined in § 317.312(c).

(vii) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit.

(5) For products in large discrete units that are usually divided for consumption (e.g., pizza), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g. pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption, the serving size shall be the fractional slice of the ready-to-eat product (e.g., 1/8 quiche, 1/4 pizza) that most closely approximates the Reference Amount for the product category. The serving size may be the fraction of the package used to make the Reference Amount for the unprepared product determined in § 317.312(d) or the fraction of the large discrete unit represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount of the combined product determined in § 317.312(c). In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3.

(6) For nondiscrete bulk products (e.g., whole roast beef, marinated beef tenderloin, large can of chili), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., roast beef and gravy), the serving size shall be the amount in household measure that most closely approximates the Reference Amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product determined in § 317.312(c).

(7) For labeling purposes, the term “common household measure” or “common household unit” means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), or other common household equipment used to package food products (e.g., jar or tray). In expressing serving size in household measures, except as specified in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following rules shall be used:

(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate. Cups shall be expressed in 1/4- or 1/3-cup increments, tablespoons in whole number of tablespoons for quantities less than 1/4 cup but greater than or equal to 2 tablespoons (tbsp), 1, 11/3, 11/2, or 1 2/3 tbsp for quantities less than 2 tbsp but greater than or equal to 1 tbsp, and teaspoons in whole number of teaspoons for quantities less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in 1/4-tsp increments for quantities less than 1 tsp.

(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.

(iii) If cups, tablespoons and teaspoons, or units such as piece, slice, tray, jar, or fraction are not applicable, ounces may be used. Ounce measurements shall be expressed in 0.5-ounce increments most closely approximating the Reference Amount with rounding indicated by the use of the term “about” (e.g., about 2.5 ounces).

(iv) A description of the individual container or package shall be used for single-serving containers and for individually packaged products within multi-serving containers (e.g., can, box, package, meal, or dinner). A description of the individual unit shall be used for other products in discrete units (e.g., chop, slice, link, or patty).

(v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., pizza kit), the fraction or portion of the package may be used.

(vi) For products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g., ham with a glaze packet), the nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) of this section.

(vii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz in weight means 28 grams (g).

(viii) When a serving size, determined from the Reference Amount in § 317.312(b) and the procedures described in this section, falls exactly half way between two serving sizes (e.g., 2.5 tbsp), manufacturers shall round the serving size up to the next incremental size.

(8) A product that is packaged and sold individually and that contains less than 200 percent of the applicable Reference Amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving, except for products that have Reference Amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the Reference Amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable Reference Amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.

(9) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(8) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams), except for single-serving containers.

(i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to paragraph (b)(11) of this section. However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single-servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement.

(ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments.

(iii) In addition, serving size may be declared in ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity equivalent to the metric quantity should be expressed in 0.1-oz increments.

(iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, and oz for ounce.

(10) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section.

(i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term “about” (e.g., about 2 servings; about 3.5 servings).

(ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size (e.g., pickled pigs feet), the manufacturer may state the typical number of servings per container (e.g., usually 5 servings).

(iii) For random weight products, a manufacturer may declare “varied” for the number of servings per container provided the nutrition information is based on the Reference Amount expressed in ounces. The manufacturer may provide the typical number of servings in parenthesis following the “varied” statement (e.g., varied (approximately 8 servings per pound)).

(iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package.

(v) For packages containing several individually packaged multi-serving units, the number of servings shall be determined by multiplying the number of individual multi-serving units in the total package by the number of servings in each individual unit.

(11) The declaration of nutrient and food component content shall be on the basis of product as packaged or purchased with the exception of products that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed. Declaration of the nutrient and food component content of products that are packed in liquid which is not customarily consumed shall be based on the drained solids.

(12) The serving size for meal-type products and main-dish products as defined in § 317.313(l) and § 317.313(m) in single-serving containers will be the entire edible content of the package. Serving size for meal-type products and main-dish products in multi-serve containers will be based on the reference amount applicable to the product in § 317.312(b) if the product is listed in § 317.312(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 317.312(b) will be based on the reference amount according to § 317.312(c), (d), and (e).

(13) Another column of figures may be used to declare the nutrient and food component information in the same format as required by § 317.309(e),

(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as packaged or purchased.

(ii) Per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit.

(14) If a product consists of assortments of meat or meat food products (e.g., variety packs) in the same package, nutrient content shall be expressed on the entire package contents or on each individual product.

(15) If a product is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare the nutrient contents on the basis of the product as consumed for the product alone (e.g., a cream soup mix may be labeled with one set of Daily Values for the dry mix (per serving), and another set for the serving of the final soup when prepared (e.g., per serving of cream soup mix and 1 cup of vitamin D fortified whole milk)): Provided, That the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.

(c) The declaration of nutrition information on the label or in labeling of a meat or meat food product shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraph (f) or (g) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraph (d) or (e) of this section.

(1) “Calories, total,” “Total calories,” or “Calories”: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parenthesis immediately following the statement of the caloric content.

(i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving.

(A) Using specific Atwater factors (i.e., the Atwater method) given in Table 13, page 25, “Energy Value of Foods—Basis and Derivation,” by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), which is incorporated by reference. Table 13 of the “Energy Value of Foods—Basis and Derivation,” Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700;

(B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.);

(C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.); or

(D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of 21 CFR, or by other means, as appropriate.

(ii) “Calories from fat”: A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section per serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving and amounts less than 5 calories may be expressed as zero. This statement shall be declared as provided in paragraph (d)(5) of this section.

(iii) “Calories from saturated fat” or “Calories from saturated” (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section per serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories from fat as provided in paragraph (d)(5) of this section.

(2) “Fat, total” or “Total fat”: A statement of the number of grams of total fat per serving defined as total lipid fatty acids and expressed as triglycerides. Amounts shall be expressed to the nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(i) “Saturated fat” or “Saturated”: A statement of the number of grams of saturated fat per serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat per serving if no claims are made about fat or cholesterol content, and if “calories from saturated fat” is not declared. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(A) “Stearic Acid” (VOLUNTARY): A statement of the number of grams of stearic acid per serving may be declared voluntarily, except that when a claim is made about stearic acid, label declaration shall be required. Stearic acid content shall be indented under saturated fat and expressed to the nearest 0.5 (1/2)-gram increment below 5 grams and the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(B) [Reserved]

(ii) “Polyunsaturated fat” or “Polyunsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat per serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(iii) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat per serving defined as cis-monounsaturated fatty acids may be declared voluntarily, except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(3) “Cholesterol”: A statement of the cholesterol content per serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams of cholesterol per serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. If the product contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as “less than 5 milligrams.”

(4) “Sodium”: A statement of the number of milligrams of sodium per serving expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.

(5) “Potassium” (VOLUNTARY): A statement of the number of milligrams of potassium per serving may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.

(6) “Carbohydrate, total” or “Total carbohydrate”: A statement of the number of grams of total carbohydrate per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, or, if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the product. This calculation method is described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 2 and 3, which is incorporated by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.)

(i) “Dietary fiber”: A statement of the number of grams of total dietary fiber per serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required, or, alternatively, the statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(A) “Soluble fiber” (VOLUNTARY): A statement of the number of grams of soluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(ii) “Sugars”: A statement of the number of grams of sugars per serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars per serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(iii) “Sugar alcohol” (VOLUNTARY): A statement of the number of grams of sugar alcohols per serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the product, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term “sugar alcohol,” the name of the specific sugar alcohol (e.g., “xylitol”) present in the product may be used in the nutrition label, provided that only one sugar alcohol is present in the product. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less then 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(iv) “Other carbohydrate” (VOLUNTARY): A statement of the number of grams of other carbohydrate per serving may be declared voluntarily. Other carbohydrate shall be defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(7) “Protein”: A statement of the number of grams of protein per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in products represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a product represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as percent of Daily Value. When the protein quality in a product as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a product represented or purported to be for infants, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by appropriate methods of analysis in accordance with § 317.309(h), except when the procedure for a specific food requires another factor.

(i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be for infants or children under 4 years of age. When such a declaration is provided, it shall be placed on the label adjacent to the statement of grams of protein and aligned under the column headed “Percent Daily Value,” and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the product is represented or purported to be for infants and the protein quality value is less than 40 percent of the reference standard.

(ii) The corrected amount of protein (grams) per serving for products represented or purported to be for adults and children 1 or more years of age is equal to the actual amount of protein (grams) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8 in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990, which is incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” as published by the Food and Agriculture Organization of the United Nations/World Health Organization, is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700. For products represented or purported to be for infants, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject product's protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.

(iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively.

(8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as percent of Daily Value.

(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d) through (g) of this section, products represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For products represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on products represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other products shall use the RDI for adults and children 4 or more years of age.

(ii) The declaration of vitamins and minerals as a percent of the RDI shall include vitamin A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and the vitamins and minerals are:

(A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another product; or

(B) Included in a product solely for technological purposes and declared only in the ingredients statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section.

(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Amounts of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).” Alternatively, if vitamin A, vitamin C, calcium, or iron is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a significant source of ___ (listing the vitamins or minerals omitted)” is placed at the bottom of the table of nutrient values.

(iv) The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units Vitamin C, 60 milligrams Calcium, 1.0 gram Iron, 18 milligrams Vitamin D, 400 International Units Vitamin E, 30 International Units Thiamin, 1.5 milligrams Riboflavin, 1.7 milligrams Niacin, 20 milligrams Vitamin B6, 2.0 milligrams Folate, 0.4 milligram Vitamin B12, 6 micrograms Biotin, 0.3 milligram Pantothenic acid, 10 milligrams Phosphorus, 1.0 gram Iodine, 150 micrograms Magnesium, 400 milligrams Zinc, 15 milligrams Copper, 2.0 milligrams

(v) The following synonyms may be added in parenthesis immediately following the name of the nutrient or dietary component:

Vitamin C—Ascorbic acid Thiamin—Vitamin B1 Riboflavin—Vitamin B2 Folate—Folacin Calories—Energy

(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent of Daily Value of vitamin A in the product (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)”). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section.

(9) For the purpose of labeling with a percent of the DRV, the following DRV's are established for the following food components based on the reference caloric intake of 2,000 calories:

Food component Unit of measurement DRV Fat grams (g) 65 Saturated fatty acids do 20 Cholesterol milligrams (mg) 300 Total carbohydrate grams (g) 300 Fiber do 25 Sodium milligrams (mg) 2,400 Potassium do 3,500 Protein grams (g) 50

(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on products in the following format, except on products on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those products on which the simplified format is permitted to be used as provided for in paragraph (f) of this section, on products for infants and children less than 4 years of age as provided for in § 317.400(c), and on products in packages that have a total surface area available to bear labeling of 40 or less square inches as provided for in paragraph (g) of this section.

(i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.

(ii) All information within the nutrition label shall utilize:

(A) A single easy-to-read type style,

(B) Upper and lower case letters,

(C) At least one point leading (i.e., space between two lines of text) except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section, and

(D) Letters should never touch.

(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and (d)(8) of this section shall be in type size no smaller than 8 point. Except for the heading “Nutrition Facts,” the information required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other information contained within the nutrition label shall be in type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall also be in type no smaller than 6 point.

(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) of this section (i.e., “Nutrition Facts,” “Amount per Serving,” and “% Daily Value*”), the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, and Protein), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted by bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. No other information shall be highlighted.

(v) A hairline rule that is centered between the lines of text shall separate “Amount Per Serving” from the calorie statements required in paragraph (d)(5) of this section and shall separate each nutrient and its corresponding percent of Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent of Daily Value above and below it.

(2) The information shall be presented under the identifying heading of “Nutrition Facts” which shall be set in a type size larger than all other print size in the nutrition label and, except for labels presented according to the format provided for in paragraph (d)(11) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section.

(3) Information on serving size shall immediately follow the heading. Such information shall include:

(i) “Serving Size”: A statement of the serving size as specified in paragraph (b)(9) of this section.

(ii) “Servings Per Container”: The number of servings per container, except that this statement is not required on single-serving containers as defined in paragraph (b)(8) of this section.

(4) A subheading “Amount Per Serving” shall be separated from serving size information by a bar.

(5) Information on calories shall immediately follow the heading “Amount Per Serving” and shall be declared in one line, leaving sufficient space between the declaration of “Calories” and “Calories from fat” to allow clear differentiation, or, if “Calories from saturated fat” is declared, in a column with total “Calories” at the top, followed by “Calories from fat” (indented), and “Calories from saturated fat” (indented).

(6) The column heading “% Daily Value,” followed by an asterisk (e.g., “% Daily Value*”), shall be separated from information on calories by a bar. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the left of, and below, this column heading. The column headings “Percent Daily Value,” “Percent DV,” or “% DV” may be substituted for “% Daily Value.”

(7) Except as provided for in paragraph (g) of this section, and except as permitted by § 317.400(d)(2), nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label, except vitamins and minerals, shall be declared as follows:

(i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a “g” for grams or “mg” for milligrams.

(ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading “% Daily Value” established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %).

(8) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, Iron 4%) or may be listed in two columns, except that when more than four vitamins and minerals are declared, they may be declared vertically with percentages listed under the column headed “% Daily Value.”

(9) A footnote, preceded by an asterisk, shall be placed beneath the list of vitamins and minerals and shall be separated from that list by a hairline.

(i) The footnote shall state: Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.

Calories: 2,000 2,500 Total fat Less than 65 g 80 g Saturated fat Less than 20 g 25 g Cholesterol Less than 300 mg 300 mg Sodium Less than 2,400 mg 2,400 mg Total carbohydrate 300 g 375 g Dietary fiber 25 g 30 g

(ii) If the percent of Daily Value is given for protein in the Percent of Daily Value column as provided in paragraph (d)(7)(ii) of this section, protein shall be listed under dietary fiber, and a value of 50 g shall be inserted on the same line in the column headed “2,000” and value of 65 g in the column headed “2,500.”

(iii) If potassium is declared in the column described in paragraph (d)(7)(i) of this section, potassium shall be listed under sodium and the DRV established in paragraph (c)(9) of this section shall be inserted on the same line in the numeric columns.

(iv) The abbreviations established in paragraph (g)(2) of this section may be used within the footnote.

(10) Caloric conversion information on a per-gram basis for fat, carbohydrate, and protein may be presented beneath the information required in paragraph (d)(9), separated from that information by a hairline. This information may be presented horizontally (i.e., “Calories per gram: Fat 9, Carbohydrate 4, Protein 4”) or vertically in columns.

(11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in paragraph (d)(9) of this section, the information required in paragraph (d)(9) may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.

(ii) If the space beneath the mandatory declaration of iron is not adequate to accommodate any remaining vitamins and minerals to be declared or the information required in paragraph (d)(9) of this section, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.

(iii) If there is not sufficient continuous vertical space (i.e., approximately 3 inches) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron, the nutrition label may be presented in a tabular display in which the footnote required by paragraph (d)(9) of the section is given to the far right of the label, and additional vitamins and minerals beyond the four that are required (i.e., vitamin A, vitamin C, calcium, and iron) are arrayed horizontally following declarations of the required vitamins and minerals.

(12) The following sample label illustrates the provisions of paragraph (d) of this section:

EC11SE91.013

(13)(i) Nutrition labeling on the outer label of packages of meat or meat food products that contain two or more products in the same packages (e.g., variety packs) or of packages that are used interchangeably for the same type of food (e.g., meat salad containers) may use an aggregate display.

(ii) Aggregate displays shall comply with format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified to the right of the “Nutrition Facts” title, and both the quantitative amount by weight (i.e., g/mg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food.

(14) When nutrition labeling appears in a second language, the nutrition information may be presented in a separate nutrition label for each language or in one nutrition label with the information in the second language following that in English. Numeric characters that are identical in both languages need not be repeated (e.g., “Protein/Proteinas 2 g”). All required information must be included in both languages.

(e) Nutrition information may be presented for two or more forms of the same product (e.g., both “raw” and “cooked”) or for common combinations of foods as provided for in paragraph (b) of this section, or for different units (e.g., per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDI's are established (e.g., both infants and children less than 4 years of age) as provided for in paragraph (c)(8)(i) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that:

(1) Following the subheading of “Amount Per Serving,” there shall be two or more column headings accurately describing the forms of the same product (e.g., “raw” and “roasted”), the combinations of foods, the units, or the RDI groups that are being declared. The column representing the product as packaged and according to the label serving size based on the Reference Amount in § 317.312(b) shall be to the left of the numeric columns.

(2) When the dual labeling is presented for two or more forms of the same product, for combinations of foods, or for different units, total calories and calories from fat (and calories from saturated fat, when declared) shall be listed in a column and indented as specified in paragraph (d)(5) of this section with quantitative amounts declared in columns aligned under the column headings set forth in paragraph (e)(1) of this section.

(3) Quantitative information by weight required in paragraph (d)(7)(i) of this section shall be specified for the form of the product as packaged and according to the label serving size based on the Reference Amount in § 317.312(b).

(i) Quantitative information by weight may be included for other forms of the product represented by the additional column(s) either immediately adjacent to the required quantitative information by weight for the product as packaged and according to the label serving size based on the Reference Amount in § 317.312(b) or as a footnote.

(A) If such additional quantitative information is given immediately adjacent to the required quantitative information, it shall be declared for all nutrients listed and placed immediately following and differentiated from the required quantitative information (e.g., separated by a comma). Such information shall not be put in a separate column.

(B) If such additional quantitative information is given in a footnote, it shall be declared in the same order as the nutrients are listed in the nutrition label. The additional quantitative information may state the total nutrient content of the product identified in the second column or the nutrient amounts added to the product as packaged for only those nutrients that are present in different amounts than the amounts declared in the required quantitative information. The footnote shall clearly identify which amounts are declared. Any subcomponents declared shall be listed parenthetically after principal components (e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).

(ii) Total fat and its quantitative amount by weight shall be followed by an asterisk (or other symbol) (e.g., “Total fat (2 g)*”) referring to another asterisk (or symbol) at the bottom of the nutrition label identifying the form(s) of the product for which quantitative information is presented.

(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this section shall be presented under the subheading “% DAILY VALUE” and in columns directly under the column headings set forth in paragraph (e)(1) of this section.

(5) The following sample label illustrates the provisions of paragraph (e) of this section:

EC11SE91.014

(f)(1) Nutrition information may be presented in a simplified format as set forth herein when any required nutrients, other than the core nutrients (i.e., calories, total fat, sodium, total carbohydrate, and protein), are present in insignificant amounts. An insignificant amount shall be defined as that amount that may be rounded to zero in nutrition labeling, except that for total carbohydrate, dietary fiber, sugars and protein, it shall be an amount less than 1 gram.

(2) The simplified format shall include information on the following nutrients:

(i) Total calories, total fat, total carbohydrate, sodium, and protein;

(ii) Any of the following that are present in more than insignificant amounts: Calories from fat, saturated fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and

(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added in fortified or fabricated foods.

(3) Other nutrients that are naturally present in the product in more than insignificant amounts may be voluntarily declared as part of the simplified format.

(4) Any required nutrient, other than a core nutrient, that is present in an insignificant amount may be omitted from the tabular listing, provided that the following statement is included at the bottom of the nutrition label, “Not a significant source of ____.” The blank shall be filled in with the appropriate nutrient or food component. Alternatively, amounts of vitamins and minerals present in insignificant amounts may be declared by the use of an asterisk (or symbol) that is placed at the bottom of the table of nutrient values and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).”

(5) Except as provided for in paragraph (g) of this section and in § 317.400(c) and (d), nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section, except that the footnote required in paragraph (d)(9) of this section is not required. When the footnote is omitted, an asterisk shall be placed at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”

(g) Foods in packages that have a total surface area available to bear labeling of 40 or less square inches may modify the requirements of paragraphs (c) through (f) of this section and § 317.302(a) by one or more of the following means:

(1)(i) Presenting the required nutrition information in a tabular or linear (i.e., string) fashion, rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Nutrition information may be given in a linear fashion only if the package shape or size will not accommodate a tabular display.

(ii) When nutrition information is given in a linear display, the nutrition information shall be set off in a box by the use of a hairline. The percent Daily Value is separated from the quantitative amount declaration by the use of parenthesis, and all nutrients, both principal components and subcomponents, are treated similarly. Bolding is required only on the title “Nutrition Facts” and is allowed for nutrient names for “Calories,” “Total fat,” “Cholesterol,” “Sodium,” “Total carbohydrate,” and “Protein.”

(2) Using any of the following abbreviations:

Serving size—Serv size Servings per container—Servings Calories from fat—Fat cal Calories from saturated fat—Sat fat cal Saturated fat—Sat fat Monounsaturated fat—Monounsat fat Polyunsaturated fat—Polyunsat fat Cholesterol—Cholest Total carbohydrate—Total carb Dietary fiber—Fiber Soluble fiber—Sol fiber Insoluble fiber—Insol fiber Sugar alcohol—Sugar alc Other carbohydrate—Other carb

(3) Omitting the footnote required in paragraph (d)(9) of this section and placing another asterisk at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”

(4) Presenting the required nutrition information on any other label panel.

(h) Compliance with this section shall be determined as follows:

(1) A production lot is a set of food production consumer units that are from one production shift. Alternatively, a collection of consumer units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, constitutes a production lot.

(2) The sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each from a production lot. Alternatively, the sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each randomly chosen to be representative of a production lot. In each case, the units may be individually analyzed and the results of the analyses averaged, or the units would be composited and the composite analyzed. In both cases, the results, whether an average or a single result from a composite, will be considered by the Agency to be the nutrient content of a composite. All analyses shall be performed by appropriate methods and procedures used by the Department for each nutrient in accordance with the “Chemistry Laboratory Guidebook,” or, if no USDA method is available and appropriate for the nutrient, by appropriate methods for the nutrient in accordance with the 1990 edition of the “Official Methods of Analysis” of the AOAC International, formerly Association of Official Analytical Chemists, 15th ed., which is incorporated by reference, unless a particular method of analysis is specified in § 317.309(c), or, if no USDA, AOAC, or specified method is available and appropriate, by other reliable and appropriate analytical procedures as so determined by the Agency. The “Official Methods of Analysis” is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Two classes of nutrients are defined for purposes of compliance:

(i) Class I. Added nutrients in fortified or fabricated foods; and

(ii) Class II. Naturally occurring (indigenous) nutrients. If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added, which would make the total amount of such nutrient subject to Class I requirements.

(4) A product with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) unless it meets the following requirements:

(i) Class I vitamin, mineral, protein, dietary fiber, or potassium. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.

(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.

(5) A product with a label declaration of calories, sugars, total fat, saturated fat, cholesterol, or sodium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls above this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.

(6) The amount of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium may vary over labeled amounts within good manufacturing practice. The amount of calories, sugars, total fat, saturated fat, cholesterol, or sodium may vary under labeled amounts within good manufacturing practice.

(7) Compliance will be based on the metric measure specified in the label statement of serving size.

(8) The management of the establishment must maintain records to support the validity of nutrient declarations contained on product labels. Such records shall be made available to the inspector or any duly authorized representative of the Agency upon request.

(9) The compliance provisions set forth in paragraph (h) (1) through (8) of this section shall not apply to single-ingredient, raw meat (including ground beef) products, including those that have been previously frozen, when nutrition labeling is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or its published form, the Agriculture Handbook No. 8 series available from the Government Printing Office.

(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088) [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004]

§§ 317.310-317.311 [Reserved]

§ 317.312 Reference amounts customarily consumed per eating occasion.

(a) The general principles followed in arriving at the reference amounts customarily consumed per eating occasion (Reference Amount(s)), as set forth in paragraph (b) of this section, are:

(1) The Reference Amounts are calculated for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These Reference Amounts are based on data set forth in appropriate national food consumption surveys.

(2) The Reference Amounts are calculated for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. Such Reference Amounts are to be used only when the product is specially formulated or processed for use by an infant or by a child under 4 years of age.

(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.

(4) To determine the amount of food customarily consumed per eating occasion, the mean, median, and mode of the consumed amount per eating occasion were considered.

(5) When survey data were insufficient, FSIS took various other sources of information on serving sizes of food into consideration. These other sources of information included:

(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;

(ii) Serving sizes recommended in comments;

(iii) Serving sizes used by manufacturers and grocers; and

(iv) Serving sizes used by other countries.

(6) Because they reflect the amount customarily consumed, the Reference Amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.

(7) The Reference Amount is based on the major intended use of the product (e.g., a mixed dish measurable with a cup as a main dish and not as a side dish).

(8) The Reference Amounts for products that are consumed as an ingredient of other products, but that may also be consumed in the form in which they are purchased (e.g., ground beef), are based on use in the form purchased.

(9) FSIS sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform Reference Amount.

(b) The following Product Categories and Reference Amounts shall be used as the basis for determining serving sizes for specific products:

Table 1—Reference Amounts Customarily Consumed per Eating Occasion—Infant and Toddler Foods 1,2,3 Product category Reference amount Infant & Toddler Foods: Dinner Dry Mix 15 g Dinner, ready-to-serve, strained type 60 g Dinner, soups, ready-to-serve junior type 110 g Dinner, stew or soup ready-to-serve toddlers 170 g Plain meats and meat sticks, ready-to-serve 55 g 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost ready-to-serve form of the product (i.e., heat and serve). If not listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form. 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. Table 2—Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply 1,2,3,4,5 Product category Reference amount Ready-to-serve Reference amount 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 of less than 2:1; e.g., pepperoni 30 g n/a. Snacks; e.g., meat snack food sticks 30 g n/a. Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crumbles, 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 55 g n/a. Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet 55 g n/a. 75 g=uncooked sausage. Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pureed adult foods 85 g 114 g. 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, pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada 140 g (plus 55 g for products with sauce toppings) n/a. Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with 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 1 cup n/a. Salads—pasta or potato, potato salad with bacon, macaroni and meat salad 140 g n/a. Salads—all other meat, salads, ham salad 100 g n/a. Soups—all varieties 245 g n/a. Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with meatballs 125 g n/a. 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. 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 appropriate 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 Reference Amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., lunch meat with cheese and crackers), the Reference Amount for the combined product shall be determined using the following rules:

(1) For bulk products, the Reference Amount for the combined product shall be the Reference Amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients.

(2) For products where the ingredient represented as the main ingredient is one or more discrete units, the Reference Amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the Reference Amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients.

(3) If the Reference Amounts are in compatible units, they shall be summed (e.g., ingredients in equal volumes such as tablespoons). If the Reference Amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., grams of one ingredient plus gram weight of tablespoons of a second ingredient).

(d) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a Reference Amount for the product in the prepared form, then the Reference Amount for the unprepared product shall be determined using the following rules:

(1) Except as provided for in paragraph (d)(2) of this section, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the Reference Amount for the prepared product as established in paragraph (b) of this section.

(2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the Reference Amount for the prepared product as established in paragraph (b) of this section.

(e) The Reference Amount for an imitation or substitute product or altered product as defined in § 317.313(d), such as a “low calorie” version, shall be the same as for the product for which it is offered as a substitute.

(f) The Reference Amounts set forth in paragraphs (b) through (e) of this section shall be used in determining whether a product meets the criteria for nutritional claims. If the serving size declared on the product label differs from the Reference Amount, and the product meets the criteria for the claim only on the basis of the Reference Amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the Reference Amount as it appears in paragraph (b) of this section followed, in parentheses, by the amount in common household measure if the Reference Amount is expressed in measures other than common household measures.

(g) The Administrator, on his or her own initiative or on behalf of any interested person who has submitted a labeling application, may issue a proposal to establish or amend a Product Category or Reference Amount identified in paragraph (b) of this section.

(1) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.

(2) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(3) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.

(4) Data accompanying the labeling application, such as food consumption data, shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.

(5) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.

(6) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.

(7) Labeling applications for a new Reference Amount and/or Product Category shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:

(Date)

The undersigned, ______ submits this labeling application pursuant to 9 CFR 317.312 with respect to Reference Amount and/or Product Category.

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement of the objective of the labeling application;

(ii) A description of the product;

(iii) A complete sample product label including nutrition label, using the format established by regulation;

(iv) A description of the form in which the product will be marketed;

(v) The intended dietary uses of the product with the major use identified (e.g., ham as a luncheon meat);

(vi) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;

(vii) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);

(viii) The names of the most closely-related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);

(ix) The suggested Reference Amount (the amount of edible portion of food as consumed, excluding bone, skin or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested Reference Amount. In determining the Reference Amount, general principles and factors in paragraph (a) of this section should be followed.

(x) The suggested Reference Amount shall be expressed in metric units. Reference Amounts for foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density such as mixed dishes measurable with a cup.

(A) In expressing the Reference Amount in grams, the following general rules shall be followed:

(1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment.

(2) For quantities less than 10 grams, exact gram weights shall be used.

(B) [Reserved]

(xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information:

(A) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the Reference Amount for the parent category to warrant a separate Reference Amount. Data must include sample size, and the mean, standard deviation, median, and modal consumed amount per eating occasion for the product identified in the labeling application and for other products in the category. All data must be derived from the same survey data.

(B) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the product identified in the labeling application from the rest of the products in the category.

(xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed.

(A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.

(B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.

(C) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.

(D) The methodology used to collect or process data including study design, sampling procedures, materials used (e.g., questionnaire, interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse, should be fully documented.

(xiii) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule.

Yours very truly, Applicant By (Indicate authority)

(8) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.

(9) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.

(10) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed Reference Amount and/or Product Category is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.

(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.

(11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the Federal Register a proposed rule to amend the regulations to authorize the use of the Reference Amount and/or Product Category. The proposal shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's proposed rule shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the proposed Reference Amount and/or Product Category. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the proposed Reference Amount and/or Product Category shall be approved for use on the labeling of meat food products.

(i) If the Reference Amount and/or Product Category is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the Reference Amount and/or Product Category on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.

(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of an answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.

(ii) If the Reference Amount and/or Product Category is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a final rule amending the regulations to authorize the use of the Reference Amount and/or Product Category.

(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088) [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 1995]

§ 317.313 Nutrient content claims; general principles.

(a) This section applies to meat or meat food products that are intended for human consumption and that are offered for sale.

(b) A claim which, expressly or by implication, characterizes the level of a nutrient (nutrient content claim) of the type required in nutrition labeling pursuant to § 317.309, may not be made on a label or in labeling of that product unless the claim is made in accordance with the applicable provisions in this subpart.

(1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the product, e.g., “low sodium” or “contains 100 calories.”

(2) An implied nutrient content claim is any claim that:

(i) Describes the product or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or

(ii) Suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”).

(3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on products intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in subpart B of this part.

(4) Reasonable variations in the spelling of the terms defined in applicable provisions in this subpart and their synonyms are permitted provided these variations are not misleading (e.g., “hi” or “lo”).

(c) Information that is required or permitted by § 317.309 to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims.

(d) A “substitute” product is one that may be used interchangeably with another product that it resembles, i.e., that it is organoleptically, physically, and functionally (including shelf life) similar to, and that it is not nutritionally inferior to unless it is labeled as an “imitation.”

(1) If there is a difference in performance characteristics that materially limits the use of the product, the product may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim as defined in paragraph (j)(2)(iii) of this section, informing the consumer of such difference (e.g., “not recommended for frying”).

(2) This disclaimer shall be in easily legible print or type and in a size no less than that required by § 317.2(h) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than 1/16-inch minimum height, except as permitted by § 317.400(d)(2).

(e)(1) Because the use of a “free” or “low” claim before the name of a product implies that the product differs from other products of the same type by virtue of its having a lower amount of the nutrient, only products that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the product, remove the nutrient from the product, or not include the nutrient in the product, may bear such a claim (e.g., “low sodium beef noodle soup”).

(2) Any claim for the absence of a nutrient in a product, or that a product is low in a nutrient when the product has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the product inherently meets the criteria and shall clearly refer to all products of that type and not merely to the particular brand to which the labeling attaches (e.g., “lard, a sodium free food”).

(f) A nutrient content claim shall be in type size and style no larger than two times that of the statement of identity and shall not be unduly prominent in type style compared to the statement of identity.

(g) Labeling information required in §§ 317.313, 317.354, 317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not otherwise specified, is required to be in letters and/or numbers no less than 1/16 inch in height, except as permitted by § 317.400(d)(2).

(h) [Reserved]

(i) Except as provided in § 317.309 or in paragraph (q)(3) of this section, the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if:

(1) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is consistent with a definition for a claim, as provided in subpart B of this part, for the nutrient that the label addresses. Such a claim might be, “less than 10 g of fat per serving;”

(2) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is not consistent with such a definition, but the label carries a disclaimer adjacent to the statement that the product is not “low” in or a “good source” of the nutrient, such as “only 200 milligrams (mg) sodium per serving, not a low sodium product.” The disclaimer must be in easily legible print or type and in a size no less than required by § 317.2(h) for the net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than 1/16-inch minimum height, except as permitted by § 317.400(d)(2);

(3) The statement does not in any way implicitly characterize the level of the nutrient in the product and it is not false or misleading in any respect (e.g., “100 calories” or “5 grams of fat”), in which case no disclaimer is required.

(4) “Percent fat free” claims are not authorized by this paragraph. Such claims shall comply with § 317.362(b)(6).

(j) A product may bear a statement that compares the level of a nutrient in the product with the level of a nutrient in a reference product. These statements shall be known as “relative claims” and include “light,” “reduced,” “less” (or “fewer”), and “more” claims.

(1) To bear a relative claim about the level of a nutrient, the amount of that nutrient in the product must be compared to an amount of nutrient in an appropriate reference product as specified in this paragraph (j).

(i)(A) For “less” (or “fewer”) and “more” claims, the reference product may be a dissimilar product within a product category that can generally be substituted for one another in the diet or a similar product.

(B) For “light,” “reduced,” and “added” claims, the reference product shall be a similar product, and

(ii)(A) For “light” claims, the reference product shall be representative of the type of product that includes the product that bears the claim. The nutrient value for the reference product shall be representative of a broad base of products of that type; e.g., a value in a representative, valid data base; an average value determined from the top three national (or regional) brands, a market basket norm; or, where its nutrient value is representative of the product type, a market leader. Firms using such a reference nutrient value as a basis for a claim, are required to provide specific information upon which the nutrient value was derived, on request, to consumers and appropriate regulatory officials.

(B) For relative claims other than “light,” including “less” and “more” claims, the reference product may be the same as that provided for “light” in paragraph (j)(1)(ii)(A) of this section or it may be the manufacturer's regular product, or that of another manufacturer, that has been offered for sale to the public on a regular basis for a substantial period of time in the same geographic area by the same business entity or by one entitled to use its trade name, provided the name of the competitor is not used on the labeling of the product. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting labeling is internally consistent (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information, and the declaration of the percentage of nutrient by which the product has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.

(2) For products bearing relative claims:

(i) The label or labeling must state the identity of the reference product and the percent (or fraction) of the amount of the nutrient in the reference product by which the nutrient has been modified, (e.g., “50 percent less fat than ‘reference product’ ” or “1/3 fewer calories than ‘reference product’ ”); and

(ii) This information shall be immediately adjacent to the most prominent claim in easily legible boldface print or type, in distinct contrast to other printed or graphic matter, that is no less than that required by § 317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the referral statement shall be no less than one-half the size of the claim, but no smaller than 1/16-inch minimum height, except as permitted by § 317.400(d)(2).

(iii) The determination of which use of the claim is in the most prominent location on the label or labeling will be made based on the following factors, considered in order:

(A) A claim on the principal display panel adjacent to the statement of identity;

(B) A claim elsewhere on the principal display panel;

(D) A claim elsewhere on the label or labeling.

(iv) The label or labeling must also bear:

(A) Clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving size with that in the reference product; and

(B) This statement shall appear adjacent to the most prominent claim or to the nutrition information.

(3) A relative claim for decreased levels of a nutrient may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the requirement for a “low” claim for that nutrient.

(k) The term “modified” may be used in the statement of identity of a product that bears a relative claim that complies with the requirements of this part, followed immediately by the name of the nutrient whose content has been altered (e.g., “modified fat ‘product’ ”). This statement of identity must be immediately followed by the comparative statement such as “contains 35 percent less fat than ‘reference product’ ” The label or labeling must also bear the information required by paragraph (j)(2) of this section in the manner prescribed.

(l) For purposes of making a claim, a “meal-type” product will be defined as a product that:

(1) Makes a major contribution to the diet by:

(i) Weighing at least 10 ounces per labeled serving; and

(ii) Containing not less than three 40 gram portions of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (l)(1)(ii)(E) of this section:

(A) Bread, cereal, rice, and pasta;

(B) Fruits and vegetables;

(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:

(E) These foods will not be sauces (except for foods in the four food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and

(2) Is represented as, or is in the form commonly understood to be, a breakfast, lunch, dinner, meal, or entre. Such representations may be made by statements, photographs, or vignettes.

(m) For purposes of making a claim, a main-dish product will be defined as a food that:

(1) Makes a major contribution to the meal by:

(i) Weighing at least 6 ounces per labeled serving; and

(ii) Containing not less than 40 grams of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (m)(1)(ii)(E) of this section.

(A) Bread, cereal, rice, and pasta;

(B) Fruits and vegetables;

(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:

(E) These foods will not be sauces (except for foods in the four food groups in paragraph (m)(l)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and

(3) Is represented as, or is in a form commonly understood to be, a main dish (e.g., not a beverage or dessert). Such representations may be made by statements, photographs, or vignettes.

(n) Nutrition labeling in accordance with § 317.309, shall be provided for any food for which a nutrient content claim is made.

(o) Compliance with requirements for nutrient content claims shall be in accordance with § 317.309(h).

(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in § 317.312(b) through (e) shall be used in determining whether a product meets the criteria for a nutrient content claim. If the serving size declared on the product label differs from the reference amount customarily consumed, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by § 317.312(f) (e.g., “very low sodium, 35 mg or less per 55 grams”).

(2) The criteria for the claim shall be immediately adjacent to the most prominent claim in easily legible print or type and in a size that is no less than that required by § 317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the criteria statement shall be no less than one-half the size of the claim but no smaller than 1/16-inch minimum height, except as permitted by § 317.400(d)(2).

(q) The following exemptions apply:

(1) Nutrient content claims that have not been defined by regulation and that appear as part of a brand name that was in use prior to November 27, 1991, may continue to be used as part of that brand name, provided they are not false or misleading under section 1(n) of the Act (21 U.S.C. 601(n)(1)).

(2) [Reserved]

(3) A statement that describes the percentage of a vitamin or mineral in the food, including foods intended specifically for use by infants and children less than 2 years of age, in relation to a Reference Daily Intake (RDI) as defined in § 317.309 may be made on the label or in the labeling of a food without a regulation authorizing such a claim for a specific vitamin or mineral.

(4) The requirements of this section do not apply to infant formulas and medical foods, as described in 21 CFR 101.13(q)(4).

(5) [Reserved]

(6) Nutrient content claims that were part of the name of a product that was subject to a standard of identity as of November 27, 1991, are not subject to the requirements of paragraph (b) of this section whether or not they meet the definition of the descriptive term.

(7) Implied nutrient content claims may be used as part of a brand name, provided that the use of the claim has been authorized by FSIS. Labeling applications requesting approval of such a claim may be submitted pursuant to § 317.369.

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 1, 1994; 60 FR 187, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004]

§§ 317.314-317.342 [Reserved]

§ 317.343 Significant participation for voluntary nutrition labeling.

(a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw meat products, as identified in § 317.344, including those that have been previously frozen.

(b) FSIS will judge a food retailer to be participating at a significant level if the retailer provides nutrition labeling information for at least 90 percent of the major cuts of single-ingredient, raw meat products, listed in § 317.344, that it sells, and if the nutrition label is consistent in content and format with the mandatory program, or nutrition information is displayed at point-of-purchase in an approriate manner.

(c) To determine whether there is significant participation by retailers under the voluntary nutrition labeling guidelines, FSIS will select a representative sample of companies allocated by type and size.

(d) FSIS will find that significant participation by food retailers exists if at least 60 percent of all companies that are evaluated are participating in accordance with the guidelines.

(e) FSIS will evaluate significant participation of the voluntary program every 2 years beginning in May 1995.

(1) If significant participation is found, the voluntary nutrition labeling guidelines shall remain in effect.

(2) If significant participation is not found, FSIS shall initiate rulemaking to require nutrition labeling on those products under the voluntary program.

§ 317.344 Identification of major cuts of meat products.

The major cuts of single-ingredient, raw meat products are: Beef chuck blade roast, beef loin top loin steak, beef rib roast large end, beef round eye round steak, beef round top round steak, beef round tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef round bottom round steak, beef brisket (whole, flat half, or point half), beef rib steak small end, beef loin tenderloin steak, ground beef regular without added seasonings, ground beef about 17% fat, pork loin chop, pork loin country style ribs, pork loin top loin chop boneless, pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin roast, pork shoulder blade steak, pork loin top roast boneless, ground pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, veal shoulder blade steak, veal rib roast, veal loin chop, and veal cutlets.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994]

§ 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

(a) Nutrition information on the cuts of single-ingredient, raw meat products, including those that have been previously frozen, shall be provided in the following manner:

(1) If a retailer or manufacturer chooses to provide nutrition information on the label of these products, these products shall be subject to all requirements of the mandatory nutrition labeling program, except that nutrition labeling may be declared on the basis of either “as consumed” or “as packaged.” In addition, the declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen.

(2) A retailer may choose to provide nutrition information at the point-of-purchase, such as by posting a sign, or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. If a nutrition claim is made on point-of-purchase materials all of the requirements of the mandatory nutrition labeling program apply. However, if only nutrition information—and not a nutrition claim—is supplied on point-of-purchase materials:

(i) The requirements of the mandatory nutrition labeling program apply, but the nutrition information may be supplied on an “as packaged” or “as consumed,” basis;

(ii) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in § 317.309(c)(8)) and footnote required by § 317.309(d)(9) may be omitted; and

(iii) The point-of-purchase materials are not subject to any of the format requirements.

(b) [Reserved]

(c) The declaration of nutrition information may be presented in a simplified format as specified in § 317.309(f) for the mandatory nutrition labeling program.

(d) The nutrition label data should be based on either the raw or cooked edible portions of meat cuts with external cover fat at trim levels reflecting current marketing practices. If data are based on cooked portions, the methods used to cook the products must be specified and should be those which do not add nutrients from other ingredients such as flour, breading, and salt. Additional nutritional data may be presented on an optional basis for the raw or cooked edible portions of the separable lean of meat cuts.

(e) Nutrient data that are the most current representative data base values contained in USDA's National Nutrient Data Bank or its published form, the Agriculture Handbook No. 8 series, may be used for nutrition labeling of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen. These data may be composite data that reflect different quality grades of beef or other variables affecting nutrient content. Alternatively, data that reflect specific grades or other variables may be used, except that if data are used on labels attached to a product which is labeled as to grade of meat or other variables, the data must represent the product in the package when such data are contained in the representative data base. When data are used on labels attached to a product, the data must represent the edible meat tissues present in the package.

(f) If the nutrition information is in accordance with paragraph (e) of this section, a nutrition label or labeling will not be subject to the Agency compliance review under § 317.309(h), unless a nutrition claim is made on the basis of the representative data base values.

(g) Retailers may use data bases that they believe reflect the nutrient content of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen; however, such labeling shall be subject to the compliance procedures of paragraph (e) of this section and the requirements specified in this subpart for the mandatory nutrition labeling program.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995]

§§ 317.346-317.353 [Reserved]

§ 317.354 Nutrient content claims for “good source,” “high,” and “more.”

(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a product in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV) established for that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (b)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § 317.313(m) provided that:

(i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of broccoli in this meal is high in vitamin C”).

(c) “Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label or in labeling of products, except meal-type products as described in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § 317.313(m) provided that:

(i) The product contains a food that meets the definition of “good source” in paragraph (c)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of sweet potatoes in this meal is a good source of fiber”).

(d) Fiber claims. (1) If a nutrient content claim is made with respect to the level of dietary fiber, i.e., that the product is high in fiber, a good source of fiber, or that the product contains “more” fiber, and the product is not “low” in total fat as defined in § 317.362(b)(2) or, in the case of a meal-type product or a main-dish product, is not “low” in total fat as defined in § 317.362(b)(3), then the labeling shall disclose the level of total fat per labeled serving size (e.g., “contains 12 grams (g) of fat per serving”); and

(2) The disclosure shall appear in immediate proximity to such claim and be in a type size no less than one-half the size of the claim.

(e) “More” claims. (1) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in a product, except meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that:

(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber than ‘reference product’ ”); and

(B) Quantitative information comparing the level of the nutrient in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 1 g per serving; ‘this product’ contains 4 g per serving”).

(2) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that:

(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(B) Quantitative information comparing the level of the nutrient in the meal-type product or a main-dish product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 2 g per 3 oz; ‘this product’ contains 5 g per 3 oz”).

[60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

§ 317.355 [Reserved]

§ 317.356 Nutrient content claims for “light” or “lite.”

(a) General requirements. A claim using the terms “light” or “lite” to describe a product may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) “Light” claims. The terms “light” or “lite” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), without further qualification, provided that:

(1) If the product derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or

(2) If the product derives less than 50 percent of its calories from fat:

(i) The number of calories is reduced by at least one-third (331/3 percent) per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or

(ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the appropriate reference product as described in § 317.313(j)(1); and

(3) As required in § 317.313(j)(2) for relative claims:

(i) The identity of the reference product and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim (e.g., “1/3 fewer calories and 50 percent less fat than the market leader”); and

(ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—200 calories, 4 grams (g) fat; regular ‘reference product’—300 calories, 8 g fat per serving”); and

(iii) If the labeled product contains less than 40 calories or less than 3 g fat per reference amount customarily consumed, the percentage reduction for that nutrient need not be declared.

(4) A “light” claim may not be made on a product for which the reference product meets the definition of “low fat” and “low calorie.”

(c)(1)(i) A product for which the reference product contains 40 calories or less and 3 g fat or less per reference amount customarily consumed may use the terms “light” or “lite” without further qualification if it is reduced by 50 percent or more in sodium content compared to the reference product; and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim (e.g., “50 percent less sodium than the market leader”); and

(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—500 milligrams (mg) sodium per serving; regular ‘reference product’—1,000 mg sodium per serving”).

(2)(i) A product for which the reference product contains more than 40 calories or more than 3 g fat per reference amount customarily consumed may use the terms “light in sodium” or “lite in sodium” if it is reduced by 50 percent or more in sodium content compared to the reference product, provided that “light” or “lite” is presented in immediate proximity with “in sodium” and the entire term is presented in uniform type size, style, color, and prominence; and

(ii) As required in § 317.313(j)(2) for relative claims:

(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., or “lite ‘this product’—170 mg sodium per serving; regular ‘reference product’—350 mg per serving”).

(3) Except for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), a “light in sodium” claim may not be made on a product for which the reference product meets the definition of “low in sodium.”

(d)(1) The terms “light” or “lite” may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product meets the definition of:

(A) “Low in calories” as defined in § 317.360(b)(3); or

(B) “Low in fat” as defined in § 317.362(b)(3); and

(ii)(A) A statement appears on the principal display panel that explains whether “light” is used to mean “low fat,” “low calories,” or both (e.g., “Light Delight, a low fat meal”); and

(B) The accompanying statement is no less than one-half the type size of the “light” or “lite” claim.

(2)(i) The terms “light in sodium” or “lite in sodium” may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that the product meets the definition of “low in sodium” as defined in § 317.361(b)(5)(i); and

(ii) “Light” or “lite” and “in sodium” are presented in uniform type size, style, color, and prominence.

(3) The term “light” or “lite” may be used in the brand name of a product to describe the sodium content, provided that:

(i) The product is reduced by 50 percent or more in sodium content compared to the reference product;

(ii) A statement specifically stating that the product is “light in sodium” or “lite in sodium” appears:

(A) Contiguous to the brand name; and

(B) In uniform type size, style, color, and prominence as the product name; and

(iii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim; and

(e) Except as provided in paragraphs (b) through (d) of this section, the terms “light” or “lite” may not be used to refer to a product that is not reduced in fat by 50 percent, or, if applicable, in calories by 1/3 or, when properly qualified, in sodium by 50 percent unless:

(1) It describes some physical or organoleptic attribute of the product such as texture or color and the information (e.g., “light in color” or “light in texture”) so stated, clearly conveys the nature of the product; and

(2) The attribute (e.g., “color” or “texture”) is in the same style, color, and at least one-half the type size as the word “light” and in immediate proximity thereto.

(f) If a manufacturer can demonstrate that the word “light” has been associated, through common use, with a particular product to reflect a physical or organoleptic attribute to the point where it has become part of the statement of identity, such use of the term “light” shall not be considered a nutrient content claim subject to the requirements in this part.

(g) The term “lightly salted” may be used on a product to which has been added 50 percent less sodium than is normally added to the reference product as described in § 317.313(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not “low in sodium” as defined in § 317.361(b)(4), the statement “not a low sodium food,” shall appear adjacent to the nutrition information and the information required to accompany a relative claim shall appear on the label or labeling as specified in § 317.313(j)(2).

[60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

§§ 317.357-317.359 [Reserved]

§ 317.360 Nutrient content claims for calorie content.

(a) General requirements. A claim about the calorie or sugar content of a product may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in labeling of products, provided that:

(i) The product contains less than 5 calories per reference amount customarily consumed and per labeled serving size; and

(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does not provide more than 40 calories per reference amount customarily consumed; or

(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and does not provide more than 40 calories per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains 120 calories or less per 100 g of product; and

(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the calorie content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches.

(4) The terms “reduced calorie,” “reduced in calories,” “calorie reduced,” “fewer calories,” “lower calorie,” or “lower in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., lower calorie ‘product’—“331/3 percent fewer calories than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of calories in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 150 to 100 calories per serving”).

(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”

(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent fewer calories per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “calorie reduced ‘product’, 25% less calories per ounce (oz) (or 3 oz) than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of calories in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 110 calories per 3 oz to 80 calories per 3 oz”).

(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”

(c) Sugar content claims. (1) Terms such as “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” or “dietarily insignificant source of sugar” may reasonably be expected to be regarded by consumers as terms that represent that the product contains no sugars or sweeteners, e.g., “sugar free,” or “no sugar,” as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (c)(2) of this section, a product may not be labeled with such terms unless:

(i) The product contains less than 0.5 g of sugars, as defined in § 317.309(c)(6)(ii), per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of sugars per labeled serving size;

(ii) The product contains no ingredient that is a sugar or that is generally understood by consumers to contain sugars unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietarily insignificant amount of sugar;” and

(iii)(A) It is labeled “low calorie” or “reduced calorie” or bears a relative claim of special dietary usefulness labeled in compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this section; or

(B) Such term is immediately accompanied, each time it is used, by either the statement “not a reduced calorie product,” “not a low calorie product,” or “not for weight control.”

(2) The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if:

(i) No amount of sugars, as defined in § 317.309(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging;

(ii) The product does not contain an ingredient containing added sugars such as jam, jelly, or concentrated fruit juice;

(iii) The sugars content has not been increased above the amount present in the ingredients by some means such as the use of enzymes, except where the intended functional effect of the process is not to increase the sugars content of a product, and a functionally insignificant increase in sugars results;

(iv) The product that it resembles and for which it substitutes normally contains added sugars; and

(v) The product bears a statement that the product is not “low calorie” or “calorie reduced” (unless the product meets the requirements for a “low” or “reduced calorie” product) and that directs consumers' attention to the nutrition panel for further information on sugar and calorie content.

(3) Paragraph (c)(1) of this section shall not apply to a factual statement that a product, including products intended specifically for infants and children less than 2 years of age, is unsweetened or contains no added sweeteners in the case of a product that contains apparent substantial inherent sugar content, e.g., juices.

(4) The terms “reduced sugar,” “reduced in sugar,” “sugar reduced,” “less sugar,” “lower sugar,” or “lower in sugar” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less sugars per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “this product contains 25 percent less sugar than our regular product”); and

(B) Quantitative information comparing the level of the sugar in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been lowered from 8 g to 6 g per serving”).

(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less sugars per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sugar ‘product’—25% less sugar than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz”).

[60 FR 191, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

§ 317.361 Nutrient content claims for the sodium content.

(a) General requirements. A claim about the level of sodium in a product may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) Sodium content claims. (1) The terms “sodium free,” “free of sodium,” “no sodium,” “zero sodium,” “without sodium,” “trivial source of sodium,” “negligible source of sodium,” or “dietarily insignificant source of sodium” may be used on the label or in labeling of products, provided that:

(i) The product contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 5 mg of sodium per labeled serving size;

(ii) The product contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium”; and

(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(2) The terms “very low sodium” or “very low in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and contains 35 mg or less sodium per reference amount customarily consumed; or

(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 35 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(i) The product contains 35 mg or less of sodium per 100 g of product; and

(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(4) The terms “low sodium,” “low in sodium,” “little sodium,” “contains a small amount of sodium,” or “low source of sodium” may be used on the label and in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp and contains 140 mg or less sodium per reference amount customarily consumed; or

(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 140 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and

(i) The product contains 140 mg or less sodium per 100 g of product; and

(6) The terms “reduced sodium,” “reduced in sodium,” “sodium reduced,” “less sodium,” “lower sodium,” or “lower in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less sodium per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’, 50 percent less sodium than regular ‘product’ ”); and

(B) Quantitative information comparing the level of sodium in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been lowered from 300 to 150 mg per serving”).

(iii) Claims described in paragraph (b)(6) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low sodium.”

(7) The terms defined in paragraph (b)(6) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less sodium per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’—30% less sodium per 3 oz than our ‘regular product’ ”); and

(B) Quantitative information comparing the level of sodium in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been reduced from 220 mg per 3 oz to 150 mg per 3 oz”).

(iii) Claims described in paragraph (b)(7) of this section may not be made on the label or in labeling of products if the nutrient content of the reference product meets the definition for “low sodium.”

(c) The term “salt” is not synonymous with “sodium.” Salt refers to sodium chloride. However, references to salt content such as “unsalted,” “no salt,” “no salt added” are potentially misleading.

(1) The term “salt free” may be used on the label or in labeling of products only if the product is “sodium free” as defined in paragraph (b)(1) of this section.

(2) The terms “unsalted,” “without added salt,” and “no salt added” may be used on the label or in labeling of products only if:

(i) No salt is added during processing;

(ii) The product that it resembles and for which it substitutes is normally processed with salt; and

(iii) If the product is not sodium free, the statement, “not a sodium free product” or “not for control of sodium in the diet” appears adjacent to the nutrition information of the product bearing the claim.

(3) Paragraph (c)(2) of this section shall not apply to a factual statement that a product intended specifically for infants and children less than 2 years of age is unsalted, provided such statement refers to the taste of the product and is not false or otherwise misleading.

[60 FR 192, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

§ 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content.

(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of products if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “nonfat,” “trivial source of fat,” “negligible source of fat,” or “dietarily insignificant source of fat” may be used on the label or in labeling of products, provided that:

(i) The product contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of fat per labeled serving size;

(ii) The product contains no added ingredient that is a fat or is generally understood by consumers to contain fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat”; and

(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label and in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g or less of fat per reference amount customarily consumed; or

(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 3 g or less of fat per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(i) The product contains 3 g or less of total fat per 100 g of product and not more than 30 percent of calories from fat; and

(4) The terms “reduced fat,” “reduced in fat,” “fat reduced,” “less fat,” “lower fat,” or “lower in fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less fat per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat—50 percent less fat than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fat content has been reduced from 8 g to 4 g per serving”).

(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”

(i) The product contains at least 25 percent less fat per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat ‘product’, 33 percent less fat per 3 oz than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent such claim or to the nutrition information (e.g., “fat content has been reduced from 8 g per 3 oz to 5 g per 3 oz”).

(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”

(6) The term “___ percent fat free” may be used on the label or in labeling of products, provided that:

(i) The product meets the criteria for “low fat” in paragraph (b)(2) or (b)(3) of this section;

(ii) The percent declared and the words “fat free” are in uniform type size; and

(iii) A “100 percent fat free” claim may be made only on products that meet the criteria for “fat free” in paragraph (b)(1) of this section, that contain less than 0.5 g of fat per 100 g, and that contain no added fat.

(iv) A synonym for “___ percent fat free” is “___ percent lean.”

(c) Fatty acid content claims. (1) The terms “saturated fat free,” “free of saturated fat,” “no saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of saturated fat,” “negligible source of saturated fat,” or “dietarily insignificant source of saturated fat” may be used on the label or in labeling of products, provided that:

(i) The product contains less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per labeled serving size;

(ii) The product contains no ingredient that is generally understood by consumers to contain saturated fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of saturated fat,” “adds a negligible amount of saturated fat,” or “adds a dietarily insignificant amount of saturated fat;” and

(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(2) The terms “low in saturated fat,” “low saturated fat,” “contains a small amount of saturated fat,” “low source of saturated fat,” or “a little saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains 1 g or less of saturated fat per reference amount customarily consumed and not more than 15 percent of calories from saturated fat; and

(ii) If the product meets these conditions without benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(3) The terms defined in paragraph (c)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains 1 g or less of saturated fat per 100 g and less than 10 percent calories from saturated fat; and

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(4) The terms “reduced saturated fat,” “reduced in saturated fat,” “saturated fat reduced,” “less saturated fat,” “lower saturated fat,” or “lower in saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product contains at least 25 percent less saturated fat per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’, contains 50 percent less saturated fat than the national average for ‘product’ ”); and

(B) Quantitative information comparing the level of saturated fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat reduced from 3 g to 1.5 g per serving”).

(iii) Claims described in paragraph (c)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”

(i) The product contains at least 25 percent less saturated fat per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’,” “50 percent less saturated fat than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of saturated fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz”).

(iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”

(d) Cholesterol content claims. (1) The terms “cholesterol free,” “free of cholesterol,” “zero cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of cholesterol,” “negligible source of cholesterol,” or “dietarily insignificant source of cholesterol” may be used on the label or in labeling of products, provided that:

(i) The product contains less than 2 milligrams (mg) of cholesterol per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), less than 2 mg of cholesterol per labeled serving size;

(ii) The product contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of cholesterol,” “adds a negligible amount of cholesterol,” or “adds a dietarily insignificant amount of cholesterol”;

(iii) The product contains 2 g or less of saturated fat per reference amount customarily consumed or, in the case of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), 2 g or less of saturated fat per labeled serving size; and

(iv) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches; or

(v) If the product meets these conditions only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol was reduced are declared in immediate proximity to the most prominent such claim (e.g., “cholesterol free ‘product’, contains 100 percent less cholesterol than ‘reference product’ ”); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “contains no cholesterol compared with 30 mg in one serving of ‘reference product’ ”).

(2) The terms “low in cholesterol,” “low cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” or “little cholesterol” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i)(A) If the product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp:

(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed; and

(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed; or

(B) If the product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less:

(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and

(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed.

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches; or

(iii) If the product contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “low cholesterol ‘product’, contains 85 percent less cholesterol than our regular ‘product’ ”); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 30 mg to 5 mg per serving”).

(3) The terms defined in paragraph (d)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(i) The product contains 20 mg or less of cholesterol per 100 g of product;

(ii) The product contains 2 g or less of saturated fat per 100 g of product; and

(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(4) The terms “reduced cholesterol,” “reduced in cholesterol,” “cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in cholesterol” may be used on the label or in labeling of products or products that substitute for those products as specified in § 317.313(d), excluding meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:

(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;

(ii) The product contains 2 g or less of saturated fat per reference amount customarily consumed; and

(iii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25 percent less cholesterol than ‘reference product’ ”); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 55 mg to 30 mg per serving”).

(iv) Claims described in paragraph (d)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”

(5) The terms defined in paragraph (d)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:

(ii) The product contains 2 g or less of saturated fat per 100 g of product; and

(iii) As required in § 317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25% less cholesterol than ‘reference product’ ”); and

(B) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz).

(iv) Claims described in paragraph (d)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”

(e) “Lean” and “Extra Lean” claims. (1) The term “lean” may be used on the label or in labeling of a product, provided that the product contains less than 10 g of fat, 4.5 g or less of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m).

(2) The term “extra lean” may be used on the label or in labeling of a product, provided that the product contains less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m).

[60 FR 193, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

§ 317.363 Nutrient content claims for “healthy.”

(a) The term “healthy,” or any other derivative of the term “health,” may be used on the labeling of any meat or meat food product, provided that the product is labeled in accordance with § 317.309 and § 317.313.

(b)(1) The product shall meet the requirements for “low fat” and “low saturated fat,” as defined in § 317.362, except that single-ingredient, raw products may meet the total fat and saturated fat criteria for “extra lean” in § 317.362.

(2) The product shall not contain more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:

(i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and

(ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean”in § 317.362.

(3) The product shall not contain more than 480 mg of sodium per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:

(i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 oz per serving (container), shall not contain more than 600 mg of sodium per labeled serving size;1 and

1 This regulation previously provided that, after January 1, 2006, individual meat products bearing the claim “healthy” (or any derivative of the term “health”) must contain no more than 360 mg of sodium and that meal-type products bearing the claim “healthy” (or any other derivative of the term “health”) must contain no more than 600 mg of sodium. Implementation of these sodium level requirements for products bearing the claim “healthy” (or any derivative of the term “health”) has been deferred indefinitely due to technological barriers and consumer preferences.

(ii) The requirements of this paragraph (b)(3) do not apply to single-ingredient, raw products.

(4) The product shall contain 10 percent or more of the Reference Daily Intake or Daily Reference Value as defined in § 317.309 for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition, except that:

(i) A main-dish product, as defined in § 317.313(m), and including main-dish products that weigh less than 10 oz per serving (container), shall meet the level for two of the nutrients per labeled serving size; and

(ii) A meal-type product, as defined in § 317.313(l), shall meet the level for three of the nutrients per labeled serving size.

[59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 2003; 69 FR 58802, Oct. 1, 2004; 71 FR 1686, Jan. 11, 2006]

§§ 317.364-317.368 [Reserved]

§ 317.369 Labeling applications for nutrient content claims.

(a) This section pertains to labeling applications for claims, express or implied, that characterize the level of any nutrient required to be on the label or in labeling of product by this subpart.

(b) Labeling applications included in this section are:

(1) Labeling applications for a new (heretofore unauthorized) nutrient content claim,

(2) Labeling applications for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient, and

(3) Labeling applications for the use of an implied claim in a brand name.

(c) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.

(d) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(e) If nonclinical laboratory studies accompany a labeling application, the applicant shall include, with respect to each nonclinical study included with the application, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(f) If clinical investigations accompany a labeling application, the applicant shall include, with respect to each clinical investigation included with the application, either a statement that the investigation was conducted in compliance with the requirements for institutional review set forth in part 56 of chapter 1, title 21, or was not subject to such requirements in accordance with § 56.194 or § 56.105, and that it was conducted in compliance with the requirements for informed consents set forth in part 50 of chapter 1, title 21.

(g) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.

(h) The data specified under this section to accompany a labeling application shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.

(i) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.

(j) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.

(k)(1) Labeling applications for a new nutrient content claim shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250.

(Date)

The undersigned, _____, submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the claim and its proposed use).

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement identifying the nutrient content claim and the nutrient that the term is intended to characterize with respect to the level of such nutrient. The statement shall address why the use of the term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify the level at which the nutrient must be present or what other conditions concerning the product must be met for the appropriate use of the term in labels or labeling, as well as any factors that would make the use of the term inappropriate.

(ii) A detailed explanation supported by any necessary data of why use of the food component characterized by the claim is of importance in human nutrition by virtue of its presence or absence at the levels that such claim would describe. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, and scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.

(iii) Analytical data that demonstrates the amount of the nutrient that is present in the products for which the claim is intended. The assays should be performed on representative samples in accordance with 317.309(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular food. The validation data shall include a statistical analysis of the analytical and product variability.

(iv) A detailed analysis of the potential effect of the use of the proposed claim on food consumption, and any corresponding changes in nutrient intake. The analysis shall specifically address the intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is intended for a specific group within the population, the analysis shall specifically address the dietary practices of such group, and shall include data sufficient to demonstrate that the dietary analysis is representative of such group.

Yours very truly, Applicant By (Indicate authority)

(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.

(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.

(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.

(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the Federal Register a proposed rule to amend the regulations to authorize the use of the nutrient content claim. The proposal shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's proposed rule shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the proposed nutrient content claim. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the proposed nutrient content claim shall be approved for use on the labeling of meat and meat food products.

(i) If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.

(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.

(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a final rule amending the regulations to authorize the use of the claim.

(l)(1) Labeling applications for a synonymous term shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:

(Date)

The undersigned, ______ submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the synonymous term and its proposed use in a nutrient content claim that is consistent with an existing term that has been defined under subpart B of part 317).

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement identifying the synonymous term, the existing term defined by a regulation with which the synonymous term is claimed to be consistent, and the nutrient that the term is intended to characterize the level of. The statement shall address why the use of the synonymous term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify whether any limitations not applicable to the use of the defined term are intended to apply to the use of the synonymous term.

(ii) A detailed explanation supported by any necessary data of why use of the proposed term is requested, including whether the existing defined term is inadequate for the purpose of effectively characterizing the level of a nutrient. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed, and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.

Yours very truly, Applicant By (Indicate authority)

(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed synonymous term is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed synonymous term.

(5) If the claim is approved, the Agency shall notify the applicant, in writing, and shall publish in the Federal Register a notice informing the public that the synonymous term has been approved for use.

(m)(1) Labeling applications for the use of an implied nutrient content claim in a brand name shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:

(Date)

The undersigned, ______ submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the implied nutrient content claim and its proposed use in a brand name).

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement identifying the implied nutrient content claim, the nutrient the claim is intended to characterize, the corresponding term for characterizing the level of such nutrient as defined by a regulation, and the brand name of which the implied claim is intended to be a part. The statement shall address why the use of the brand-name as proposed will not be misleading. The statement shall provide examples of the types of products on which the brand name will appear. It shall also include data showing that the actual level of the nutrient in the food would qualify the label of the product to bear the corresponding term defined by regulation. Assay methods used to determine the level of a nutrient shall meet the requirements stated under labeling application format in paragraph (k)(1)(iii) of this section.

(ii) A detailed explanation supported by any necessary data of why use of the proposed brand name is requested. This explanation shall also state what nutritional benefit to the public will derive from use of the brand name as proposed. If the branded product is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group and scientific data sufficient for such purpose.

Yours very truly, Applicant By

(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed implied nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.

(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish a notice of the labeling application in the Federal Register seeking comment on the use of the implied nutrient content claim. The notice shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's notice shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the implied nutrient content claim. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the implied nutrient content claim shall be approved for use on the labeling of meat food products.

(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a notice informing the public that the implied nutrient content claim has been approved for use.

(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088) [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]

§§ 317.370-317.379 [Reserved]

§ 317.380 Label statements relating to usefulness in reducing or maintaining body weight.

(a) General requirements. Any product that purports to be or is represented for special dietary use because of usefulness in reducing body weight shall bear:

(1) Nutrition labeling in conformity with § 317.309 of this subpart, unless exempt under that section, and

(2) A conspicuous statement of the basis upon which the product claims to be of special dietary usefulness.

(b) Nonnutritive ingredients. (1) Any product subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.

(2) A special dietary product may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the product under the applicable law and regulations of this chapter. Any product that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener; e.g., “Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).”

(c) “Low calorie” foods. A product purporting to be “low calorie” must comply with the criteria set forth for such foods in § 317.360.

(d) “Reduced calorie” foods and other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such foods in § 317.360(b) (4) and (5).

(e) “Label terms suggesting usefulness as low calorie or reduced calorie foods”. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if the claim is not false or misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative calorie claim in compliance with the applicable provisions in this subpart.

(2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term “diet” that clearly shows that the product is offered solely for a dietary use other than regulating body weight, e.g., “for low sodium diets.”

(3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement or other product that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on foods.

(f) “Sugar free” and “no added sugar”. Criteria for the use of the terms “sugar free” and “no added sugar” are provided for in § 317.360(c).

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. 3, 1995]

§§ 317.381-317.399 [Reserved]

§ 317.400 Exemption from nutrition labeling.

(a) The following meat or meat food products are exempt from nutrition labeling:

(1) Food products produced by small businesses provided that the labels for these products bear no nutrition claims or nutrition information,

(i) A food product, for the purposes of the small business exemption, is defined as a formulation, not including distinct flavors which do not significantly alter the nutritional profile, sold in any size package in commerce.

(ii) For purposes of this paragraph, a small business is any single-plant facility or multi-plant company/firm that employs 500 or fewer people and produces no more than the following amounts of pounds of the product qualifying the firm for exemption from this subpart:

(A) During the first year of implementation of nutrition labeling, from July 1994 to July 1995, 250,000 pounds or less,

(B) During the second year of implementation of nutrition labeling, from July 1995 to July 1996, 175,000 pounds or less, and

(iii) For purposes of this paragraph, calculation of the amount of pounds shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years or where products have been produced for less than 2 years, reasonable estimates must indicate that the annual pounds produced will not exceed the amounts specified.

(2) Products intended for further processing, provided that the labels for these products bear no nutrition claim or nutrition information,

(3) Products that are not for sale to consumers, provided that the labels for these products bear no nutrition claims or nutrition information,

(4) Products in small packages that are individually wrapped packages of less than 1/2 ounce net weight, provided that the labels for these products bear no nutrition claims or nutrition information,

(5) Products custom slaughtered or prepared,

(6) Products intended for export, and

(7) The following products prepared and served or sold at retail provided that the labels or the labeling of these products bear no nutrition claims or nutrition information:

(i) Ready-to-eat products that are packaged or portioned at a retail store or similar retail-type establishment; and

(ii) Multi-ingredient products (e.g., sausage) processed at a retail store or similar retail-type establishment.

(b) Restaurant menus generally do not constitute labeling or fall within the scope of these regulations.

(c)(1) Foods represented to be specifically for infants and children less than 2 years of age shall bear nutrition labeling as provided in paragraph (c)(2) of this section, except such labeling shall not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, and cholesterol.

(2) Foods represented or purported to be specifically for infants and children less than 4 years of age shall bear nutrition labeling except that:

(i) Such labeling shall not include declarations of percent of Daily Value for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber;

(ii) Nutrient names and quantitative amounts by weight shall be presented in two separate columns;

(iii) The heading “Percent Daily Value” required in § 317.309(d)(6) shall be placed immediately below the quantitative information by weight for protein;

(iv) The percent of the Daily Value for protein, vitamins, and minerals shall be listed immediately below the heading “Percent Daily Value”; and

(v) Such labeling shall not include the footnote specified in § 317.309(d)(9).

(d)(1) Products in packages that have a total surface area available to bear labeling of less than 12 square inches are exempt from nutrition labeling, provided that the labeling for these products bear no nutrition claims or other nutrition information. The manufacturer, packer, or distributor shall provide, on the label of packages that qualify for and use this exemption, an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., “For nutrition information call 1-800-123-4567”).

(2) When such products bear nutrition labeling, either voluntarily or because nutrition claims or other nutrition information is provided, all required information shall be in a type size no smaller than 6 point or all upper case type of 1/16-inch minimum height, except that individual serving-size packages of meat products that have a total area available to bear labeling of 3 square inches or less may provide all required information in a type size no smaller than 1/32-inch minimum height.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]

Pt. 318 PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS Subpart A—General Sec. 318.1 Products and other articles entering official establishments. 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments. 318.3 Designation of places of receipt of products and other articles for reinspection. 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control. 318.5 Requirements concerning procedures. 318.6 Requirements concerning ingredients and other articles used in preparation of products. 318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes. 318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination. 318.10 Prescribed treatment of pork and products containing pork to destroy trichinae. 318.11 [Reserved] 318.12 Manufacture of dog food or similar uninspected article at official establishments. 318.13 Mixtures containing product but not amendable to the Act. 318.14 Adulteration of product by polluted water; procedure for handling. 318.15 Tagging chemicals, preservatives, cereals, spices, etc., “U.S. retained.” 318.16 Pesticide chemicals and other residues in products. 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products. 318.18 Handling of certain material for mechanical processing. 318.19 Compliance procedure for cured pork products. 318.20 Use of animal drugs. 318.21 [Reserved] 318.22 Determination of added water in cooked sausages. 318.23 Heat-processing and stabilization requirements for uncured meat patties. 318.24 Product prepared using advanced meat/bone separation machinery; process control. Subparts B-F [Reserved] Subpart G—Canning and Canned Products 318.300 Definitions. 318.301 Containers and closures. 318.302 Thermal processing. 318.303 Critical factors and the application of the process schedule. 318.304 Operations in the thermal processing area. 318.305 Equipment and procedures for heat processing systems. 318.306 Processing and production records. 318.307 Record review and maintenance. 318.308 Deviations in processing. 318.309 Finished product inspection. 318.310 Personnel and training. 318.311 Recall procedure. Authority:

7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

Subpart A—General Source:

35 FR 15586, Oct. 3, 1970, unless otherwise noted.

§ 318.1 Products and other articles entering official establishments.

(a) Except as otherwise provided in paragraphs (g) and (h) of this section or § 318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with § 318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under § 318.3, until it has been reinspected by the inspector.

(b) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been (1) previously inspected and passed and is identified as such in accordance with the requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the regulations thereunder, and has not been prepared other than in an establishment inspected under said Act, or (2) has been inspected and passed and is identified as such in accordance with the requirements of a State law.

(c) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this part or part 317 of this subchapter, and a list of ingredients in the article if composed of two or more ingredients: Provided, That in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper.

(d) To ensure the safe use of preparations used in hog scalding water or in the denuding of tripe, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.

(e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.

(f) [Reserved]

(g) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in § 318.12(a).

(h)(1) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of paragraph 23(a) of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of § 303.1(a)(2) of this subchapter.

(2) Meat, meat byproducts, and meat food products bearing official marks showing that they were inspected and passed under State inspection in any State not designated in § 331.2 of this subchapter may be received by official establishments for storage and distribution solely in intrastate commerce. The presence of such State inspected products must not create any unsanitary condition or otherwise result in adulteration of any products at the official establishment or interfere with the conduct of inspection under this subchapter. In addition, such State inspected products must be stored separately and apart from the federally inspected products in the official establishment.

(i) The operator of the official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question.

(j) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Administrator to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of this regulation. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 1984; 64 FR 72174, Dec. 23, 1999]

§ 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.

(a) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a Program employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in this subchapter.

(b) All products, whether fresh, cured, or otherwise prepared, even though previously inspected and passed, shall be reinspected by Program employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of the regulations in this subchapter are complied with.

(c) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The circuit supervisor shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator. 1

1 Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisors of Program circuits. These sampling plans are developed for individual products by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved, such as liver, oxtails, etc.

(d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the area supervisor.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]

§ 318.3 Designation of places of receipt of products and other articles for reinspection.

Every official establishment shall designate, with the approval of the circuit supervisor, a dock or place at which products and other articles subject to reinspection under § 318.2 shall be received, and such products and articles shall be received only at such dock or place.

§ 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.

(a) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by Program employees unless such preparation is conducted as a custom operation exempted from inspection under § 303.1(a)(2) of this subchapter in any official establishment or consists of operations that are exempted from inspection under § 303.1(d) of this subchapter and are conducted in a retail store in an establishment subject to inspection only because the State or Territory in which the establishment is located is designated under paragraph 301(c) of the Act. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.

(b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to assure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter. The effectiveness of such measures will be subject to review by the Department.

(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:

(1) A letter to the Administrator from the establishment owner of operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control system requires it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.

(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be responsible for the quality control system.

(3) A list identifying those parts and sections of the Federal meat inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the quality control system will serve to maintain compliance with the applicable regulations.

(4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters or limits which will be used, and the points at which corrective action will occur and the nature of such corrective action—ranging from least to most severe: Provided, That, subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator.

(d) [Reserved]

(e) Evaluation and Approval of Total Plant Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system will be approved and plans will be made for implementation under departmental supervision.

(2) In any situation where the system is found by the Administrator to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Administrator, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding.

(3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control system to assure compliance with the requirements of the Act and regulations thereunder. The Secretary shall continue to provide the Federal inspection necessary to carry out his responsibilities under the Act.

(f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section, may only use, as a part of any labeling, the following logo. Any labeling bearing the logo and any wording of explanation with respect to this logo shall be approved as required by parts 316 and 317 of this subchapter.

EC11SE91.015

(g) Termination of Total Plant Quality Control. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator.

(2) The approval of a total plant quality control system may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:

(i) If adulterated or misbranded meat food product is found by the Administrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. In those instances where there is 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 approval shall remain in effect pending the final determination of the proceeding.

(ii) If the establishment fails to comply with the quality control system or program to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of the letter. In those instances where 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 establishment quality control system has been terminated in accordance with the provisions 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 Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permission will be granted provided that:

(i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year.

(ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection.

(iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector.

(2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in § 318.4(h)(1) have been or will be met.

(3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspection services at the discretion of the circuit supervisor and charged for such services.

(Reporting requirements were approved by the Office of Management and Budget under control number 0583-0015) [35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000]

§ 318.5 Requirements concerning procedures.

(a)(1) Care shall be taken to assure that product is not adulterated when placed in freezers. If there is doubt as to the soundness of any frozen product, the inspector will require the defrosting and reinspection of a sufficient quantity thereof to determine its actual condition.

(2) Frozen product may be defrosted in water or pickle in a manner and with the use of facilities which are acceptable to the inspector. Before such product is defrosted, a careful examination shall be made to determine its condition. If necessary, this examination shall include defrosting of representative samples by means other than in water or pickle.

(b) Product, such as pork tenderloins, brains, sweetbreads, stew, or chop suey, shall not be packed in hermetically sealed metal or glass containers, unless subsequently heat processed or otherwise treated to preserve the product in a manner approved by the Administrator in specific cases.

(d) Heads for use in the preparation of meat food products shall be split and the bodies of the teeth, the turbinated and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.

(e) Kidneys for use in the preparation of meat food products shall first be freely sectioned and then thoroughly soaked and washed. All detached kidneys, including beef kidneys with detached kidney fat, shall be inspected before being used in or shipped from the official establishment.

(f) Cattle paunches and hog stomachs for use in the preparation of meat food products shall be thoroughly cleaned on all surfaces and parts immediately after being emptied of their contents, which shall follow promptly their removal from the carcasses.

(g) Clotted blood shall be removed from hog hearts before they are shipped from the official establishment or used in the preparation of meat food products.

(h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog bungs, hog middles, and hog stomachs which are to be used as containers of any meat food product shall be presented for inspection, turned with the fat surface exposed.

(i) Portions of casings which show infection with Oesophagostomum or other nodule-producing parasite, and weasands infected with the larvae of Hypoderma lineatum, shall be rejected, except that when the infestation is slight and the nodules and larvae are removed, the casing or weasand may be passed.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]

§ 318.6 Requirements concerning ingredients and other articles used in preparation of products.

(a) All ingredients and other articles used in the preparation of any product shall be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated. Official establishments shall furnish inspectors accurate information on all procedures involved in product preparation including product composition and any changes in such procedures essential for inspectional control of the product.

(b)(1) The only animal casings that may be used as containers of product are those from sheep, swine, or goats. Casings from cattle may be used as containers of products. However, if casings from cattle are derived from the small intestine, the small intestine must comply with the requirements in 9 CFR 310.22(d). Establishments that use casings derived from the small intestine of cattle as containers for products must demonstrate, through documentation, that the small intestine from which the casing was derived complies with the requirements in 9 CFR 310.22(d).

(2) Casings for products shall be carefully inspected by Program employees. Only those casings which have been carefully washed and thoroughly flushed with clean water immediately before stuffing and are suitable for containers, are clean, and are passed on such inspection shall be used, except that preflushed animal casings packed in salt or salt and glycerine solution or other approved medium may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed before use.

(3) Hog and sheep casings intended for use as containers of product may be treated by soaking in or applying thereto sound, fresh pineapple juice or papain or bromelin or pancreatic extract to permit the enzymes contained in these substances to act on the casings to make them less resistant. The casings shall be handled in a clean and sanitary manner throughout and the treatment shall be followed by washing and flushing the casings with water sufficiently to effectively remove the substance used and terminate the enzymatic action.

(4) On account of the invariable presence of bone splinters, detached spinal cords shall not be used in the preparation of edible product other than for rendering where they constitute a suitable raw material. Detached spinal cords from cattle 30 months of age and older shall not be used as raw materials for edible rendering.

(5) Testicles if handled as an edible product may be shipped from the official establishment as such, but they shall not be used as an ingredient of a meat food product.

(6) Tonsils shall be removed and shall not be used as ingredients of meat food products.

(7) Blood from livestock prepared in accordance with § 310.20 of this subchapter may be used as an ingredient of a meat food product for which a standard is prescribed in part 319 of this subchapter, if permitted by such standard, and may be used in any meat food product for which no such standard is prescribed in part 319 of this subchapter if it is a common and usual ingredient of such product.

(8) Intestines shall not be used as ingredients in any meat food product for which a standard is prescribed in part 319 of this subchapter and shall not be used in other products unless the products are labeled in accordance with § 317.8(b)(3) of this subchapter. When small intestine from cattle is used in a meat food product or for edible rendering, it must comply with the requirements in 9 CFR 310.22(d).

(9) Poultry products and egg products (other than shell eggs) which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when identified as having been inspected and passed for wholesomeness by the Department under the regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to be sound and otherwise acceptable when presented for use. Poultry products and egg products (other than shell eggs) which have not been so inspected and passed for wholesomeness shall not be used in the preparation of such meat food products.

(10) Dry milk products which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when produced in a plant approved by the Department under the regulations in 7 CFR part 58, and when found to be sound and otherwise acceptable when presented for use. Dry milk products prepared in a plant not so approved shall not be used in the preparation of such meat food products.

(11) [Reserved]

(12) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of level permitted in § 318.16.

(13) Use of “Mechanically Separated (Kind of Poultry),” as defined in § 381.173 of this chapter, in the preparation of meat food products shall accord with § 381.174 and all other applicable provisions of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, Nov. 3, 1995; 69 FR 1874, Jan. 12, 2004; 70 FR 53050, Sept. 7, 2005; 72 FR 38730, July 13, 2007]

§ 318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes.

(a) Preservatives and other substances not permitted in domestic product under the regulations in this subchapter may be used in the preparation and packing of product intended for export provided the product (1) accords to the specifications or directions of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; and (3) is labeled on the outside container to show that it is intended for export, and is otherwise labeled as required by this subchapter for such export product.

(b) The preparation and packing of export product as provided for in paragraph (a) of this section shall be done in a manner acceptable to the inspector in charge so that the identity of the export product is maintained conclusively and the preparation of domestic product is adequately protected. The preservatives and other substances not permitted in domestic product shall be stored in a room or compartment separate from areas used to store other supplies and shall be held under Program lock. Use of the preservatives or other substances shall be under the direct supervision of a Program employee.

(c) The packing of all articles under paragraph (a) of this section shall be conducted under the direct supervision of a Program employee.

(d) No article prepared or packed for export under paragraph (a) of this section shall be sold or offered for sale for domestic use or consumption, but unless exported shall be destroyed for food purposes under the direct supervision of a Program employee.

(e) The contents of the container of any article prepared or packed for export under paragraph (a) of this section shall not be removed, in whole or in part, from such container prior to exportation, except under the supervision of a Program employee. If such contents are removed prior to exportation, then the article shall be either repacked, in accordance with the provisions of paragraphs (b) and (c) of this section, or destroyed for food purposes under the direct supervision of a Program employee.

(f) Permission must be obtained from the Administrator before meats packed in borax are shipped from one official establishment to another or to an unofficial establishment for storage, except such meat prepared for the account of Federal agencies.

(g) At all times, the identity of meat to which borax has been added shall be effectively maintained. In no case shall such meat, nor any trimmings or fat derived from such meat, whether unwashed or washed, or otherwise treated, be diverted to domestic use.

(h) Salt used for bulking meat previously packed in borax may not again be used in an edible products department other than in connection with the packing of meat in borax. Only metal equipment should be used for handling such meat. Particularly effective cleansing will be required if wooden equipment such as trucks, washing vats, etc., is used. Boxes from which boraxed meat has been removed may be used for repacking meat in borax, but their use as containers for other meat will be dependent upon the effective removal of all traces of borax.

(i) The following instructions pertain to export cured pork packed in borax for the account of Federal agencies. The meat may be packed in borax in a room in which there is borax-free meat, provided proper care is taken to see that the borax-free meat is not affected by the borax. Under the same condition, meat packed in borax may be received, unpacked, defrosted, soaked, washed, smoked, and repacked in a room where there is other meat. However, meat originally packed in borax shall at all times be subject to the restrictions of meat so packed, even though repacked without borax. After packing or repacking, borax packed meat may be stored in a room with meat not packed in borax, provided a reasonable degree of separation is maintained between the two classes of product.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38 FR 29214, Oct. 23, 1973]

§ 318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.

Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Program, for examination, as often as may be deemed necessary for the efficient conduct of the inspection.

§ 318.10 Prescribed treatment of pork and products containing pork to destroy trichinae.

(a)(1) All forms of fresh pork, including fresh unsmoked sausage containing pork muscle tissue, and pork such as bacon and jowls, other than those covered by paragraph (b) of this section, are classed as products that are customarily well cooked in the home or elsewhere before being served to the consumer. Therefore, the treatment of such products for the destruction of trichinae is not required.

(2) Pork from carcasses or carcass parts that have been found free of trichinae as described under paragraph (e) or (f) of this section is not required to be treated for the destruction of trichinae.

(b) Products named in this paragraph, and products of the character hereof, containing pork muscle tissue (not including pork hearts, pork stomachs, and pork livers), or the pork muscle tissue which forms an ingredient of such products, shall be effectively heated, refrigerated, or cured to destroy any possible live trichinae, as prescribed in this section at the official establishment where such products are prepared: Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage; knoblauch sausage; mortadella; all forms of summer or dried sausage, including mettwurst; flavored pork sausages such as those containing wine or similar flavoring materials; cured pork sausage; sausage containing cured and/or smoked pork; cooked loaves; roasted, baked, boiled, or cooked hams, pork shoulders, or pork shoulder picnics; Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or cured boneless pork shoulder butts, hams, loins, shoulders, shoulder picnics, and similar pork cuts, in casings or other containers in which ready-to-eat delicatessen articles are customarily enclosed (excepting Scotch-style hams); breaded pork products; cured boneless pork loins; boneless back bacon; bacon used for wrapping around patties, steaks and similar products; and smoked pork cuts such as hams, shoulders, loins, and pork shoulder picnics (excepting smoked hams, and smoked pork shoulder picnics which are specially prepared for distribution in tropical climates or smoked hams delivered to the Armed Services); ground meat mixtures containing pork and beef, veal, lamb, mutton, or goat meat and other product consisting of mixtures of pork and other ingredients, which the Administrator determines at the time the labeling for the product is submitted for approval in accordance with part 317 of the regulations in this subchapter or upon subsequent reevaluation of the product, would be prepared in such a manner that the product might be eaten rare or without thorough cooking because of the appearance of the finished product or otherwise. Cured boneless pork loins shall be subjected to prescribed treatment for destruction of trichinae prior to being shipped from the establishment where cured.

(1) Heating. (i) All parts of the pork muscle tissue shall be heated according to one of the time and temperature combinations in the following table:

Minimum internal temperature Degrees fahrenheit Degrees centigrade Minimum time 120 49.0 21 hours. 122 50.0 9.5 hours. 124 51.1 4.5 hours. 126 52.2 2 hours. 128 53.4 1 hour. 130 54.5 30 minutes. 132 55.6 15 minutes. 134 56.7 6 minutes. 136 57.8 3 minutes. 138 58.9 2 minutes. 140 60.0 1 minute. 142 61.1 1 minute. 144 62.2 Instant.

(ii) Time and temperature shall be monitored by a calibrated recording instrument that meets the requirements of paragraph (d) of this section, except for paragraph (c)(1)(iv).

(iii) The time to raise product temperature from 60 °F. to 120 °F shall not exceed 2 hours unless the product is cured or fermented.

(iv) Time, in combination with temperatures of 138 °F to 143 °F, need not be monitored if the product's minimum thickness exceeds 2 inches (5.1 cm) and refrigeration of the product does not begin within 5 minutes of attaining 138 °F (58.9 °C).

(v) The establishment shall use procedures which insure the proper heating of all parts of the product. It is important that each piece of sausage, each ham, and other product treated by heating in water be kept entirely submerged throughout the heating period; and that the largest pieces in a lot, the innermost links of bunched sausage or other massed articles, and pieces placed in the coolest part of a heating cabinet or compartment or vat be included in the temperature tests.

(2) Refrigerating. At any stage of preparation and after preparatory chilling to a temperature of not above 40 °F. or preparatory freezing, all parts of the muscle tissue of pork or product containing such tissue shall be subjected continuously to a temperature not higher than one of those specified in table 1, the duration of such refrigeration at the specified temperature being dependent on the thickness of the meat or inside dimensions of the container.

Table 1—Required Period of Freezing at Temperature Indicated Temperature °F. Group 1 (Days) Group 2 (Days) 5 20 30 −10 10 20 −20 6 12

(i) Group 1 comprises product in separate pieces not exceeding 6 inches in thickness, or arranged on separate racks with the layers not exceeding 6 inches in depth, or stored in crates or boxes not exceeding 6 inches in depth, or stored as solidly frozen blocks not exceeding 6 inches in thickness.

(ii) Group 2 comprises product in pieces, layers, or within containers, the thickness of which exceeds 6 inches but not 27 inches, and product in containers including tierces, barrels, kegs, and cartons having a thickness not exceeding 27 inches.

(iii) The product undergoing such refrigeration or the containers thereof shall be so spaced while in the freezer as will insure a free circulation of air between the pieces of meat, layers, blocks, boxes, barrels, and tierces in order that the temperature of the meat throughout will be promptly reduced to not higher than 5 °F., −10 °F., or −20 °F., as the case may be.

(iv) In lieu of the methods prescribed in Table 1, the treatment may consist of commercial freeze drying or controlled freezing, at the center of the meat pieces, in accordance with the times and temperatures specified in Table 2.

Table 2—Alternate Periods of Freezing at Temperatures Indicated Maximum internal temperature Degrees Fahrenheit Degrees centigrade Minimum Time 0 −17.8 106 hours. −5 −20.6 82 hours. −10 −23.3 63 hours. −15 −26.1 48 hours. −20 −28.9 35 hours. −25 −31.7 22 hours. −30 −34.5 8 hours. −35 −37.2 1/2 hour.

(v) During the period of refrigeration the product shall be kept separate from other products and in the custody of the Program in rooms or compartments equipped and made secure with an official Program lock or seal. The rooms or compartments containing product undergoing freezing shall be equipped with accurate thermometers placed at or above the highest level at which the product undergoing treatment is stored and away from refrigerating coils. After completion of the prescribed freezing of pork to be used in the preparation of product covered by paragraph (b) of this section the pork shall be kept under close supervision of an inspector until it is prepared in finished form as one of the products enumerated in paragraph (b) of this section or until it is transferred under Program control to another official establishment for preparation in such finished form.

(vi) Pork which has been refrigerated as specified in this subparagraph may be transferred in sealed railroad cars, sealed motortrucks, sealed trailers, or sealed closed containers to another official establishment at the same or another location, for use in the preparation of product covered by paragraph (b) of this section. Such vehicles and containers shall be sealed and transported between official establishments in accordance with § 325.7 of this subchapter.

(3) Curing—(i) Sausage. The sausage may be stuffed in animal casings, hydrocellulose casings, or cloth bags. During any stage of treating the sausage for the destruction of live trichinae, except as provided in Method 5, these coverings shall not be coated with paraffin or like substance, nor shall any sausage be washed during any prescribed period of drying. In the preparation of sausage, one of the following methods may be used:

Method No. 1. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 31/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, sausage having a diameter not exceeding 31/2 inches, measured at the time of stuffing, shall be held in a drying room not less than 20 days at a temperature not lower than 45 °F., except that in sausage of the variety known as pepperoni, if in casings not exceeding 13/8 inches in diameter measured at the time of stuffing, the period of drying may be reduced to 15 days. In no case, however, shall the sausage be released from the drying room in less than 25 days from the time the curing materials are added, except that sausage of the variety known as pepperoni, if in casings not exceeding the size specified, may be released at the expiration of 20 days from the time the curing materials are added. Sausage in casings exceeding 31/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing, shall be held in a drying room not less than 35 days at a temperature not lower than 45 °F., and in no case shall the sausage be released from the drying room in less than 40 days from the time the curing materials are added to the meat.

Method No. 2. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 31/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, sausage having a diameter not exceeding 31/2 inches, measured at the time of stuffing, shall be smoked not less than 40 hours at a temperature not lower than 80 °F., and finally held in a drying room not less than 10 days at a temperature not lower than 45 °F. In no case, however, shall the sausage be released from the drying room in less than 18 days from the time the curing materials are added to the meat. Sausage exceeding 31/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing, shall be held in a drying room, following smoking as above indicated, not less than 25 days at a temperature not lower than 45 °F., but in no case shall the sausage be released from the drying room in less than 33 days from the time the curing materials are added to the meat.

Method No. 3. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 31/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After admixture with the salt and other curing materials and before stuffing, the ground or chopped meat shall be held at a temperature not lower than 34 °F. for not less than 36 hours. After being stuffed, the sausage shall be held at a temperature not lower than 34 °F. for an additional period of time sufficient to make a total of not less than 144 hours from the time the curing materials are added to the meat, or the sausage shall be held for the time specified in a pickle-curing medium of not less than 50° strength (salometer reading) at a temperature not lower than 44 °F. Finally, sausage having a diameter not exceeding 31/2 inches, measured at the time of stuffing, shall be smoked for not less than 12 hours. The temperature of the smokehouse during this period at no time shall be lower than 90 °F.; and for 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 °F. Sausage exceeding 31/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing shall be smoked, following the prescribed curing, for not less than 15 hours. The temperature of the smokehouse during the 15-hour period shall at no time be lower than 90 °F., and for 7 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 °F. In regulating the temperature of the smokehouse for the treatment of sausage under this method, the temperature of 128 °F. shall be attained gradually during a period of not less than 4 hours.

Method No. 4. The meat shall be ground or chopped into pieces not exceeding one-fourth of an inch in diameter. A dry-curing mixture containing not less than 21/2 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After admixture with the salt and other curing materials and before stuffing, the ground or chopped sausage shall be held as a compact mass, not more than 6 inches in depth, at a temperature not lower than 36 °F. for not less than 10 days. At the termination of the holding period, the sausage shall be stuffed in casings or cloth bags not exceeding 31/3 inches in diameter, measured at the time of stuffing. After being stuffed, the sausage shall be held in a drying room at a temperature not lower than 45 °F. for the remainder of a 35-day period, measured from the time the curing materials are added to the meat. At any time after stuffing, if the establishment operator deems it 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 subjected to smoking at a temperature not lower than 80 °F., or the product may be both heated and smoked as specified. The time consumed in heating and smoking, however, shall be in addition to the 35-day holding period specified.

Method No. 5. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 31/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, the sausage shall be held for not less than 65 days at a temperature not lower than 45 °F. The coverings for sausage prepared according to this method may be coated at any stage of the preparation before or during the holding period with paraffin or other substance approved by the Administrator.

Method No. 6. (A) Basic requirements. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3.33 pounds of salt to each hundredweight of the unstuffed sausage, excluding the weight of dry ingredients, shall be thoroughly mixed with the ground or chopped meat. After the curing mixture has been added, the sausage shall be held for two time periods, a holding period and a drying period. The holding period will be for a minimum of 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 the drying period. During the drying period, the sausage shall be held in a drying room at a temperature not lower than 50 (10.0 °F. (10.0 °C) for a period of time determined by Tables 3A, 3B, and 4. The length of the drying period, established in (c)(3)(i)(A), may be modified as provided in paragraphs (c)(3)(i)(B) and (c)(3)(i)(C) of this section.

Table 3A—Sausage Drying Room Times by Method No. 6 Diameter of casing at time of stuffing1 Days in drying room2 Up to: 1 inches 14 11/2 inches 15 2 inches 16 21/2 inches 18 3 inches 20 31/2 inches 23 4 inches 25 41/2 inches 30 5 inches 35 51/2 inches 43 6 inches 50 1 The drying room times for flattened or oval sausages shall use a diameter derived by measuring the circumference and dividing by 3.14 (pi). 2 Drying room time may be modified as set forth in Tables 3B and 4.

(B) Reduction in Drying Room Time. During the holding period, the sausage may be smoked or fermented. If the temperature is increased to 70 °F. (21.1 °C) or higher, while the sausage is being held after adding curing materials but before the drying period, the subsequent drying room times prescribed for this method may be reduced according to the schedule in Table 3B. No interpolation of values is permissible.

Table 3B—Percentage Reduction in Drying Room Time (Table 3A) Permitted by Holding Times and Temperatures Prior to Drying 1 Minimum Time Minimum Temperature 2 70 °F 21.1 °C 75 °F 23.9 °C 80 °F 26.7 °C 85 °F 29.5 °C 90 °F 32.2 °C 95 °F 35.0 °C 100 °F 37.9 °C 105 °F 40.6 °C 110 °F 43.3 °C 120 °F 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. 2 Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-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 drying room period is required for products so treated.

(C) Reduced Salt Content—Drying Room Times. Salt content of less than 3.33 pounds for each hundredweight of sausage formulation, excluding dry ingredients, (such as salts, sugars, and spices), may be permitted provided the drying time is increased according to the schedule contained in Table 4.

Trichina Treatment of Sausage by Method No. 6; Table 4—Reduced Salt Content—Drying Room Times [Required percentage increase in drying room time (table 3A) for added salt of less than 3.33 pounds per hundredweight of sausage] Minimum pounds of salt added to sausage 1 Increase in drying room time 2 3.3 1 3.2 4 3.1 7 3.0 10 2.9 13 2.8 16 2.7 19 2.6 22 2.5 25 2.4 28 2.3 31 2.2 34 2.1 37 2.0 40 1 Calculate the salt content for column 1 as follows: Multiply the pounds of salt in the sausage formulation by 100. Then divide this number by the total weight of sausage formulation minus the weight of dry ingredients and round down to the next lowest 0.1%. Percents may be substituted for pounds. Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1 lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium nitrite total weight is 127.872 lbs. (3.56×100)/(127.872−3.56−2−.8−.012)=356/121.5=2.93 Therefore, the sausage drying time must be increased by 13 percent. 2 In computing the days to be added to the required total drying time, fractions shall be rounded to the next higher whole number and added to the required total drying time. Example: Sausage stuffed in 31/2 inch diameter casing requires 23 days in the drying room (from Drying Room Times). If the 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 Room Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to the 23 days to equal 33 days. The total drying time required in the drying room, therefore, will be 33 days.

Method No. 7, Dry Sausages. (A) General Requirements. The establishment shall use meat particles reduced in size to no more than 1/4 inch in diameter. The establishment shall add a curing mixture containing no less than 2.7 pounds of salt per hundred pounds of meat and mix it uniformly throughout the product. The establishment shall hold, heat, and dry the product according to paragraph (B) or (C) below.

(B) Holding, Heating, and Drying Treatment, Large Sausages. Except as permitted in (C) below, the establishment shall subject sausages in casings not exceeding 105 mm in diameter, at the time of stuffing, to all of the following minimum chamber temperatures and time periods.

Treatment Schedule for Sausages 105 Millimeters (41/8 Inches) or Less in Diameter Minimum chamber temperature (°F) (°C) Minimum time (hours) 50 10 12 90 32.2 1 100 37.8 1 110 43.3 1 120 48.9 1 125 51.7 7 Following the preceding treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °C) for not less than 7 days.

(C) Heating and Drying Treatment, Small Sausages. Alternatively, the establishment may subject sausages in casings not exceeding 55 mm in diameter, at the time of stuffing, to all of the following minimum chamber temperatures and time periods.

Treatment Schedule for Sausages 55 Millimeters (21/8 Inches) or Less in Diameter Minimum chamber temperature (°F) (°C) Minimum time (hours) 50 10 12 100 37.8 1 125 51.7 6 Following the preceding heat treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °C) for not less than 4 days.

(ii) Capocollo (capicola, capacola). Boneless pork butts for capocollo shall be cured in a dry-curing mixture containing not less than 41/2 pounds of salt per hundredweight of meat for a period of not less than 25 days at a temperature not lower than 36 °F. If the curing materials are applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be smoked for a period of not less than 30 hours at a temperature not lower than 80 °F., and shall finally be held in a drying room not less than 20 days at a temperature not lower than 45 °F.

(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-curing mixture containing not less than 41/2 pounds of salt per hundredweight of meat for a period of not less than 18 days at a temperature not lower than 36 °F. If the curing mixture is applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be held in a drying room not less than 35 days at a temperature not lower than 45 °F.

(iv) Hams and pork shoulder picnics. In the curing of hams and pork shoulder picnics, one of the methods below shall be used. For calculating days per pound, the establishment shall use the weight of the heaviest ham or picnic in the lot.

Method No. 1. The hams and pork shoulder picnics shall be cured by a dry-salt curing process not less than 40 days at a temperature no lower than 36 °F. The products shall be laid down in salt, not less than 4 pounds to each hundredweight of product, the salt being applied in a thorough manner to the lean meat of each item. When placed in cure, the products may be pumped with pickle if desired. At least once during the curing process, the products shall be overhauled (turned over for the application of additional cure) and additional salt applied, if necessary, so that the lean meat of each item is thoroughly covered. After removal from cure, the products may be soaked in water at a temperature not higher than 70 °F for not more than 15 hours, during which time the water may be changed once, but they shall not be subjected to any other treatment designed to remove salt from the meat except that superficial washing may be allowed. The products shall finally be dried or smoked at a time and temperature not less than a combination prescribed in Table 5 of Method No. 3.

Method No. 2. [Reserved]

Method No. 3. (A) Curing. (Other than bag curing): Establishments shall cure hams and shoulders by using a cure mixture containing not less than 70 percent salt by weight to cover all exposed muscle tissue and to pack the hock region. Total curing time consists of a mandatory cure contact time and an optional equalization time.

(B) Cure Contact Time. This is the cure contact period, during which the establishment shall keep exposed muscle tissue coated with the cure mixture at least 28 days but for no less than 1.5 days per pound of ham or shoulder. Overhaul is optional so long as the exposed muscle tissue remains coated with curing mixture.

(C) Equalization. The establishment may provide an equalization period after the minimum cure contact period in (B) above to permit the absorbed salt to permeate the product's inner tissues. Equalization is the time after the excess cure has been removed from the product at the end of the cure contact period until the product is placed in the drying room and the drying period begins. The total curing time (equalization plus cure contact) shall be at least 40 days and in no case less than 2 days per pound of an uncured ham or shoulder.

(D) Removing Excess Cure. After the required cure contact period, the establishment may remove excess cure mixture from the product's surface mechanically or by rinsing up to 1 minute with water, but not by soaking.

(E) Bag Curing. Bag curing is a traditional ham curing technique in which the manufacturer wraps the ham and all of the cure mixture together in kraft paper then hangs them individually. The paper keeps the extra cure mixture in close contact with the product making reapplication of salt unnecessary, and it protects the product from mites and insects. Establishments may employ the bag curing method as an alternative to (A) through (D) above. An establishment which elects to use the bag curing method shall apply a cure mixture containing at least 6 pounds of salt per 100 pounds of uncured product. The establishment shall rub the curing mixture into the exposed muscle tissue, pack the hock region with the curing mixture, and use uncoated wrapping paper to wrap the product together with any remaining curing mixture. The bag cured product shall remain wrapped throughout the curing period and may or may not remain wrapped during the drying period. In any case, the curing period shall be at least 40 days but not less than 2 days per pound of an uncured ham or shoulder. After curing, the cured product shall be exposed to a drying time and temperature prescribed in Table 5.

(F) Curing Temperature. During the curing period the establishment shall use one of the following procedures:

(1) The establishment shall control the room temperature at not less than 35 °F (1.7 °C) nor greater than 45 °F (7.2 °C) for the first 1.5 days per pound of an uncured ham or shoulder, and not less than 35 °F (1.7 °C) nor greater than 60 °F (15.6 °C) for the remainder of the curing period.

(2) The establishment shall monitor and record daily product temperature. The room temperature need not be controlled but days on which the product temperature drops below 35 °F (1.7 °C) shall not be counted as curing time. If the product temperature exceeds 45 °F (7.2 °C) within the first period of 1.5 days per pound of an uncured ham or shoulder or if it exceeds 60 °F (15.6 °C) for the remainder of the curing period, the establishment shall cool the product back to the 45 °F (7.2 °C) maximum during the first period or 55 °F (12.8 °C) maximum during the remainder of the period.

(3) The establishment shall begin curing product only between the dates of December 1 and February 13. The room temperature need not be controlled, but the establishment shall monitor and record daily room temperatures, and days in which the room temperature drops below 35 °F (1.7 °C) shall not be counted as curing time.

(G) Drying. After the curing period, establishments shall use one of three procedures for drying:

(1) The establishment shall subject the product to a controlled room temperature for a minimum time and minimum temperature combination prescribed in Table 5 or for a set of such combinations in which the total of the fractional periods (in column 4 of Table 5) exceeds 1.5.

(2) Establishments using uncontrolled room temperatures shall monitor and record the internal product temperature. The drying period shall be complete when, from the days which can be counted as curing time, one of the time/temperature combinations of Table 5 is satisfied or when the total of the fractional values for the combinations exceeds 1.5.

(3) Establishments using uncontrolled room temperatures shall dry the product for a minimum of 160 days including the entire months of June, July, and August. This procedure is obviously dependent on local climatic conditions and no problem exists with respect to current producers who use this procedure. Future applicants shall demonstrate that their local monthly average temperatures and the local monthly minimum temperatures are equal to or warmer than the normal average temperatures and normal minimum temperatures compiled by the National Oceanic and Atmospheric Administration for Boone, North Carolina, station 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 Trichina Inactivation in Hams and Shoulders Table 5—Minimum Drying Days at a Minimum Temperature* Minimum Drying Temperature Degrees fahrenheit Degrees centigrade Minimum days at drying temperature Fractional period for one day of drying 130 54.4 1.5 .67 125 51.7 2 .50 120 48.9 3 .33 115 46.1 4 .25 110 43.3 5 .20 105 40.6 6 .17 100 37.8 7 .14 95 35.0 9 .11 90 32.2 11 .091 85 29.4 18 .056 80 26.7 25 .040 75 23.9 35 .029 * Interpolation of these times or temperatures is not acceptable; establishments wishing to use temperatures or times not in this Table shall first validate their efficacy as provided by 318.10(c)(4) of this section.

Method No. 4. (A) Cure: Establishments shall cure hams and shoulders by using a cure mixture containing not less than 71.5 percent salt by weight to cover all exposed muscle tissue and to pack the hock region. Establishments may substitute potassium chloride (KCl) for up to half of the required salt on an equal weight basis.

(B) Curing. Establishments shall apply the cure at a rate not less than 5.72 pounds of salt and KCl per hundred pounds of fresh meat. The cure shall be applied in either three or four approximately equal amounts (two or three overhauls) at separate times during the first 14 days of curing.

(C) Cure Contact Time. Establishments shall keep the product in contact with the cure mixture for no less than 2 days per pound of an uncured ham or shoulder but for at least 30 days. Establishments shall maintain the curing temperature at no less than 35 °F (1.7 °C) during the cure contact time.

(D) Equalization. After the cure contact period, establishments shall provide an added equalization period of no less than 1 day per pound of an uncured ham or shoulder but at least 14 days. Equalization is the time after the excess cure has been removed from the product, the end of the cure contact period, and before the drying period begins. Establishments may substitute additional cure contact days for an equal number of equalization days.

(E) Removing Excess Cure. After the required cure contact period, the establishment may remove excess cure mixture from the product's surface mechanically or by rinsing up to 1 minute with water, but not by soaking.

(F) Drying. After the curing period, establishments shall use one of the controlled temperature methods for drying listed in Method No. 3 of this subparagraph.

Method No. 5 (A) Curing. The establishment shall cure the ham to a minimum brine concentration of 6 percent by the end of the drying period. Brine concentration is calculated as 100 times the salt concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 × [salt] / ([salt] + [water])

The Agency will accept the brine concentration in the biceps femoris as a reasonable estimate of the minimum brine concentration in the ham.

(B) Drying and Total Process Times. The establishment shall dry the cured ham at a minimum temperature of 55 °F (13 °C) for at least 150 days. The total time of drying plus curing shall be at least 206 days.

(C) Ensuring an Acceptable Internal Brine Concentration. (1) To establish compliance, the establishment shall take product samples from the first 12 lots of production as follows: From each lot,

(i) One sample shall be taken from each of 5 or more hams;

(ii) Each sample shall be taken from the biceps femoris. As an alternative to the use of the biceps femoris, the Agency shall consider other method(s) of sampling the dry-cured hams to determine the minimum internal brine concentration, as long as the establishment proposes it and submits data and other information to establish its sufficiency to the Director of the Processed Products Inspection Division;

(iii) Each sample shall weigh no less than 100 grams;

(iv) The samples shall be combined as one composite sample and sealed in a water vapor proof container;

(v) The composite sample shall be submitted to a laboratory accredited under the provisions of § 318.21 to be analyzed for salt and water content using methods from the “Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC),” 15th Edition, 1990, Section 983.18 (page 931) and Section 971.19 (page 933) which are incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If the time between sampling and submittal of the composite sample to the accredited laboratory will exceed 8 hours, then the establishment shall freeze the composite sample immediately after the samples are combined;

(vi) Once the laboratory results for the composite sample are received, the manufacturer shall calculate the internal brine concentration by multiplying the salt concentration by 100 and then dividing that figure by the sum of the salt and water concentrations;

(vii) Compliance is established when the samples from the first 12 lots of production have a minimum internal brine concentration of 6 percent. Lots being tested to establish compliance shall be held until the internal brine concentration has been determined and found to be at least 6 percent. If the minimum internal brine concentration is less than 6 percent, the lot being tested shall be held until the establishment brings the lot into compliance by further processing.

(2) To maintain compliance, the establishment shall take samples, have the samples analyzed, and perform the brine calculations as set forth above from one lot every 13 weeks. Lots being tested to maintain compliance shall not be held. If the minimum internal brine concentration is less than 6 percent in a lot being tested to maintain compliance, the establishment shall develop and propose steps acceptable to FSIS to ensure that the process is corrected.

(3) Accredited laboratory results and the brine calculations shall be placed on file at the establishment and available to Program employees for review.

Method No. 6 (A) Curing. The establishment shall cure the ham to a minimum brine concentration of 6 percent by the end of the drying period. Brine concentration is calculated as 100 times the salt concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 × [salt] / ([salt] + [water])

The Agency will accept the brine concentration in the biceps femoris as a reasonable estimate of the minimum brine concentration.

(B) Drying and Total Process Times. The establishment shall dry the cured ham at a minimum temperature of 110 °F (43 °C) for at least 4 days. The total time of drying plus curing shall be at least 34 days.

(c) Ensuring an Acceptable Internal Brine Concentration. (1) To establish compliance the establishment shall take product samples from the first 12 lots of production as follows: From each lot,

(i) One sample shall be taken from each of 5 or more hams;

(ii) Each sample shall be taken from the biceps femoris. As an alternative to the use of the biceps femoris, the Agency will consider other methods of sampling the dry-cured hams to determine internal brine concentration, as long as the establishment proposes it and submits data and other information to establish its sufficiency to the Director of the Processed Products Inspection Division;

(iii) Each sample shall weigh no less than 100 grams;

(iv) The samples shall be combined as one composite sample and sealed in a water vapor proof container;

(v) The composite sample shall be submitted to a laboratory accredited under the provisions of § 318.21 to be analyzed for salt and water content using methods from the “Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC),” 15th Edition, 1990, section 983.18 (page 931) and section 971.19 (page 933) which are incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If the time between sampling and submittal of the composite sample to the accredited laboratory will exceed 8 hours, then the establishment shall freeze the composite sample immediately after the samples are combined;

(vi) Compliance is established when the samples from the first 12 lots of production have a minimum internal brine concentration of 6 percent. Lots being tested to establish compliance shall be held until the internal brine concentration has been determined and found to be at least 6 percent. If the minimum internal brine concentration is less than 6 percent, the lot being tested shall be held until the establishment brings the lot into compliance by further processing.

(3) Accredited laboratory results and the brine calculations shall be placed on file in the establishment and available to Program employees for review.

(v) Boneless pork loins and loin ends. In lieu of heating or refrigerating to destroy possible live trichinae in boneless loins, the loins may be cured for a period of not less than 25 days at a temperature not lower than 36 °F. by the use of one of the following methods:

Method No. 1. Application of a dry-salt curing mixture containing not less than 5 pounds of salt to each hundredweight of meats.

Method No. 2. Application of a pickle solution of not less than 80° strength (salometer) on the basis of not less than 60 pounds of pickle to each hundredweight of meat.

Method No. 3. Application of a pickle solution added to the dry-salt cure prescribed as Method No. 1 in this subdivision (v) provided the pickle solution is not less than 80° strength (salometer).

After removal from cure, the loins may be soaked in water for not more than 1 hour at a temperature not higher than 70 °F. or washed under a spray but shall not be subjected, during or after the curing process, to any other treatment designed to remove salt.

Following curing, the loins shall be smoked for not less than 12 hours. The minimum temperature of the smokehouse during this period at no time shall be lower than 100 °F., and for 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 125 °F.

Finally, the product shall be held in a drying room for a period of not less than 12 days at a temperature not lower than 45 °F.

(4) The Administrator shall consider additional processing methods upon petition by manufacturers, and shall approve any such method upon his/her determination that it can be properly monitored by an inspector and that the safety of such methods is adequately documented by data which has been developed by following an experimental protocol previously reviewed and accepted by the Department.

(d) General instructions: When necessary to comply with the requirements of this section, the smokehouses, drying rooms, and other compartments used in the treatment of pork to destroy possible live trichinae shall be suitably equipped, by the operator of the official establishment, with accurate automatic recording thermometers. Circuit supervisors are authorized to approve for use in sausage smokehouses, drying rooms, and other compartments, such automatic recording thermometers as are found to give satisfactory service and to disapprove and require discontinuance of use, for purposes of the regulations in this subchapter, any thermometers (including any automatic recording thermometers) of the establishment that are found to be inaccurate or unreliable.

(e) The requirements for using the pooled sample digestion technique to analyze pork for the presence of trichina cysts are:

(1) The establishment shall submit for the approval of the Regional Director its proposed procedure for identifying and pooling carcasses, collecting and pooling samples, testing samples (including the name and address of the laboratory), communicating test results, retesting individual carcasses, and maintaining positive identification and clear separation of pork found to be trichina-free from untested pork or trichina-positive pork.

(2) The establishment shall use the services of a laboratory approved by the Administrator for all required testing. Such approval shall be based on adequacy of facilities, reagents, and equipment, and on demonstration of continuing competency and reliability in performing the pooled sample digestion technique for trichinae.

(3) The establishment shall sample no less than 5 grams of diaphragm muscle or tongue tissue from each carcass or no less than 10 grams of other muscle tissue. Samples may be pooled but a pool shall not consist of more than 100 grams of sample. Sampling and sample preparation are subject to inspection supervision.

(4) Pork or products made from tested pork shall not be released as trichina free from the official establishment without treatment until the inspector in charge receives a laboratory report that the tested pork is free of trichina cysts.

(f) Approval of other tests for trichinosis in pork. The Administrator shall consider any additional analytical method for trichinosis upon petition by a manufacturer, and may approve that method upon the determination that it will detect at least 98 percent of swine bearing cysts present at a tissue density equal to or less than one cyst per gram of muscle from the diaphragm pillars at a 95 percent confidence level. Any such petitions shall be supported by any data and other information that the Administrator finds necessary. Notice of any approval shall be given in the Federal Register, and the approved method will be incorporated into this section.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39 FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, 1985; 50 FR 48075, Nov. 21, 1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR 33633, July 30, 1992; 57 FR 56440, Nov. 30, 1992]

§ 318.11 [Reserved]

§ 318.12 Manufacture of dog food or similar uninspected article at official establishments.

(a) When dog food, or similar uninspected article is manufactured in an edible product department, there shall be sufficient space allotted and adequate equipment provided so that the manufacture of the uninspected article in no way interferes with the handling or preparation of edible products. Where necessary to avoid adulteration of edible products, separate equipment shall be provided for the uninspected article. To assure the maintenance of sanitary conditions in the edible product departments, the operations incident to the manufacture of the uninspected article will be subject to the same sanitary requirements that apply to all operations in edible product departments. The manufacture of the uninspected article shall be limited to those hours during which the establishment operates under inspectional supervision; and there shall be no handling, other than receiving at the official establishment, of any of the product ingredient of the uninspected article, other than during the regular hours of inspection. The materials used in the manufacture of the uninspected article shall not be used so as to interfere with the inspection of edible product or the maintenance of sanitary conditions in the department or render any edible product adulterated. The meat, meat byproducts, and meat food product ingredients of the uninspected article may be admitted into any edible products department of an official establishment only if they are U.S. Inspected and Passed. Products within § 314.11 of this subchapter or parts of carcasses of kinds not permitted under the regulations in this subchapter to be prepared for human food (e.g., lungs or intestines), which are produced at any official establishment, may be brought into the inedible products department of any official establishment for use in uninspected articles under this section. The uninspected article may be stored in, and distributed from, edible product departments: Provided, That adequate facilities are furnished, there is no interference with the maintenance of sanitary conditions, and such article is properly identified.

(b) When dog food or similar uninspected article is manufactured in a part of an official establishment other than an edible product department, the area in which the article is manufactured shall be separated from edible product departments in the manner required for separation between edible product departments and inedible product departments. Sufficient space must be allotted and adequate equipment provided so that the manufacture of the uninspected article does not interfere with the proper functioning of the other operations at the establishment. Except as provided in § 314.11 of this subchapter, nothing in this paragraph shall be construed as permitting any deviation from the requirement that dead animals, condemned products, and similar materials of whatever origin, must be placed in the inedible product rendering equipment, and without undue delay. The manufacture of the uninspected article must be such as not to interfere with the maintenance of general sanitary conditions on the premises, and it shall be subject to inspectional supervision similar to that exercised over other inedible product departments. There shall be no movement of any product from an inedible product department to any edible product department. Trucks, barrels, and other equipment shall be cleaned before being returned to edible product departments from inedible product departments. Unoffensive material prepared outside edible product departments may be stored in, and distributed from, edible product departments only if packaged in clean, properly identified, sealed containers.

(c) Animal food shall be distinguished from articles of human food, so as to avoid distribution of such animal food as human food. To accomplish this, such animal food shall be labeled or otherwise identified in accordance with § 325.11(d) of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53 FR 24679, June 30, 1988]

§ 318.13 Mixtures containing product but not amendable to the Act.

Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of § 318.1.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]

§ 318.14 Adulteration of product by polluted water; procedure for handling.

(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.

(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator 1 shall be applied to the surface of the rooms and equipment and rinsed with potable water before use.

(c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:

(1) Separate and condemn all product in damaged or extensively rusted containers.

(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:

(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator, 1 rinse in potable water, and dry thoroughly; or

1 A list of approved disinfectants is available upon request to Scientific Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly.

(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.

(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]

§ 318.15 Tagging chemicals, preservatives, cereals, spices, etc., “U.S. retained.”

When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a “U.S. retained” tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.

§ 318.16 Pesticide chemicals and other residues in products.

(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act.

(b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.

(c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator.

§ 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.

(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards:

(1) Lethality. A 6.5-log10 reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency.

(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log10 multiplication of Clostridium perfringens within the product.

(b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule.

(c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.

[64 FR 744, Jan. 6, 1999]

§ 318.18 Handling of certain material for mechanical processing.

Material to be processed into “Mechanically Separated (Species)” shall be so processed within 1 hour from the time it is cut or separated from carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 °F. (4 °C.) or less, or held indefinitely at 0 °F. (−18 °C.) or less. “Mechanically Separated (Species)” shall, directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 °F. (4 °C.) or less or indefinitely at 0 °F. (−18 °C.) or less.

[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]

§ 318.19 Compliance procedure for cured pork products.

(a) Definitions. For the purposes of this section:

(1) A product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in § 319.104 or the chart in § 319.105.

(2) A Product Group or a Group means one of the following:

Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations.

Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations.

Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III.

Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit into Group I, Group II, or Group III shall be placed in this Group.

(3) A lot is that product from one production shift.

(4) A production rate is frequency of production, expressed in days per week.

(5) Protein fat free percentage, protein fat free content, PFF percentage, PFF content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.

(b) Normal Compliance Procedures. The Department shall collect samples of cured pork products and analyze them for their PFF content. Analyses shall be conducted in accordance with the “Official Methods of Analysis of the Association of Official Analytical Chemists §§ 950.46, and 928.08 (Chapter 39).1 The “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is incorporated by reference with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Each analytical result shall be recorded and evaluated to determine whether future sampling of product Groups within an official establishment shall be periodic or daily under the provisions of paragraph (b)(1) of this section, and if the affected lot and subsequent production of like product shall be U.S. retained, or administratively detained, as appropriate, as provided in paragraph (b)(2) of this section.2

1 A copy of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is on file with the Director, Office of the Federal Register, and may be purchased from the Association of Official Analytical Chemists, Inc., 2200 Wilson Boulevard, Suite 400, Arlington, Virginia 22201.

2 Rules for Rounding:

1. Laboratory results for percent meat protein and fat will be reported to the second decimal place (hundredths).

2. PFF and Sample Values for charting purposes will be calculated from the reported laboratory results to the second decimal place. Rounding of calculations to reach two decimal places will be done by the following rule:

All values of five-thousandths (0.005) or more will be rounded up to the next highest hundredth. All values of less than five-thousandths (0.005) will be dropped.

3. For compliance with the Absolute Minimum PFF requirements, the PFF will be rounded to the first decimal place (tenths). Rounding of calculations to reach one decimal place will be done by the following rule:

All PFF values of five-hundredths (0.05) or more will be rounded up to the next highest tenth. All PFF values of less than five-hundredths (0.05) will be dropped.

4. For product disposition (pass-fail of a minimum PFF standard for retained product) the average PFF calculation will be rounded to the first decimal place. Individual PFF Values will be calculated to the nearest hundredth as in (2) above. The average, however, will be rounded to the nearest tenth as in (3) above.

(1) Criteria to determine sampling frequency of Product Groups. For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows:

(i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91.

(iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference.

(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value.

(v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values.

(vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than −1.40 (e.g., −1.39, −1.14, 0, 0.50, etc.) and shall be daily when the Group Value is −1.40 or less (e.g., −1.40, −1.45, −1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is −1.65 or greater (e.g., −1.63, −1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c).

(2) Criteria for U.S. retention or administrative detention of cured pork products for further analysis. Cured prok products shall be U.S. retained, or administratively detained, as appropriate, when prescribed by paragraphs (b)(2) (i) or (ii) of this section as follows:

(i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of § 319.104 or § 319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be U.S. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there U.S. retained. Any subsequently produced lots of like product and any lots of like product for which production dates cannot be established shall be U.S. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such U.S. retained product shall be in accordance with paragraph (c) of this section.

(ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be U.S. retained shall be as follows:

(A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of § 319.104 and § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of this section by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section to find the standardized difference.

(D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be ignored in determining future Product Values.

(E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is −1.65 or less (e.g., −1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be U.S. retained and further evaluated under paragraph (c) of this section. Except for release of individual lot pursuant to paragraph (c)(1), subsequently produced lots of like product shall continue to be U.S. retained until discontinued pursuant to paragraph (c)(2) of this section.

(c) Compliance procedure during product retention. When a product lot is U.S. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section.3

3 If the processor does not wish to have the product evaluated in this manner, alternate sampling plans may be used provided such plans have been formulated by the processor and approved by the Administrator prior to evaluation by the three-sample criteria, and provided the analyses specified in such plans are performed at the expense of the processor.

(1) A product lot which is U.S. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met:

(i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by § 319.104 or § 319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain.

(ii) The lot of the product is relabeled to conform to the provisions of § 319.104 or § 319.105, under the supervision of a program employee.

(iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of U.S. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section.

(2) The PFF content of three randomly selected samples from each U.S. retained lot shall be used to maintain the Product Value described in paragraph (c)(2)(ii). The manner and effect of such maintenance shall be as follows: (i) Find the average PFF content of the three samples.

(ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirements.

(iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference.

(iv) Use the lesser of 1.30 and the standardized difference as the Sample Value.

(v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (c)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values.

(vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a U.S. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section. Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew.

(vii) When U.S. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section.

(3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing a product from its Product Group, provided product lots are being U.S. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first U.S. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being U.S. retained, the product shall again be considered with its Group.

(d) Adulterated and misbranded products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)).

(e) Quality control. Cured pork products bearing on their labeling the statement “X% of Weight is Added Ingredients” shall be prepared only under a quality control system or program in accordance with § 318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under § 318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided in plant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect.

[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, Aug. 25, 1997]

§ 318.20 Use of animal drugs.

Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein.

[50 FR 32165, Aug. 9, 1985]

§ 318.21 [Reserved]

§ 318.22 Determination of added water in cooked sausages.

(a) For purposes of this section, the following definitions apply.

(1) Cooked sausage. Cooked sausage is any product described in § 319.140 and §§ 319.180-319.182 of this chapter.

(2) Group 1 Protein-Contributing Ingredients. Ingredients of livestock or poultry origin from muscle tissue which is skeletal or which is found in the edible organs, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing; meat byproducts; mechanically separated (species); and poultry products; except those ingredients processed by hydrolysis, extraction, concentrating or drying.

(3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup 1 protein-contributing ingredients processed by hydrolysis, extraction, concentrating, or drying, or any other ingredient which contributes protein.

(b) The amount of added water in cooked sausage is calculated by:

(1) Determining by laboratory analysis the total percentage of water contained in the cooked sausage; and

(2) Determining by laboratory analysis the total percentage of protein contained in the cooked sausage; and

(3) Calculating the percentage of protein in the cooked sausage contributed by the Group 2 protein-contributing ingredients; and

(4) Subtracting one pecent from the total percentage of protein calculated in (b)(3)); and

(5) Subtracting the remaining percentage of protein calculated in (b)(3) from the total protein content determined in (b)(2); and

(6) Calculating the percentage of indigenous water in the cooked sausage by multiplying the percentage of protein determined in (b)(5) by 4, (This amount is the percentage of water attributable to Group 1 protein-contributing ingredients and one percent of Group 2 protein-contributing ingredients in a cooked sausage.); and

(7) Subtracting the percentage of water calculated in (b)(6) from the total percentage of water determined in (b)(1). (This amount is the percentage of added water in a cooked sausage.) 1

1 The equation for the narrative description of the calculation for added water is as follows: AW=TW-(TP-(P-1.0))4, Where AW=Added Water, TW-Total Water Determined by Laboratory Analysis, TP=Total Protein Determined by Laboratory Analysis, P=Protein Contributed by Group 2 Protein-Contributing Ingredients, 1.0=Percent Allowance for Group 2 Protein-Contributing Ingredients, 4=Moisture-Protein Ratio for Cooked Sausage.

[55 FR 7299, Mar. 1, 1990]

§ 318.23 Heat-processing and stabilization requirements for uncured meat patties.

(a) Definitions. For purposes of this section, the following definitions shall apply:

(1) Patty. A shaped and formed, comminuted, flattened cake of meat food product.

(2) Comminuted. A processing term describing the reduction in size of pieces of meat, including chopping, flaking, grinding, or mincing, but not including chunking or sectioning.

(3) Partially-cooked patties. Meat patties that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.

(4) Char-marked patties. Meat patties that have been marked by a heat source and that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.

(b) Heat-processing procedures for fully-cooked patties. (1) Official establishments which manufacture fully-cooked patties shall use one of the following heat-processing procedures:

Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties Minimum internal temperature at the center of each patty

(Degrees)

Fahrenheit Or centigrade Minimum holding time after required internal temperature is reached

(Time)

Minutes Or seconds 151 66.1 .68 41 152 66.7 .54 32 153 67.2 .43 26 154 67.8 .34 20 155 68.3 .27 16 156 68.9 .22 13 157 (and up) 69.4 (and up) .17 10

(2) The official establishment shall measure the holding time and temperature of at least one fully-cooked patty from each production line each hour of production to assure control of the heat process. The temperature measuring device shall be accurate within 1 degree F.

(3) Requirements for handling heating deviations. (i) If for any reason a heating deviation has occurred, the official establishment shall investigate and identify the cause; take steps to assure that the deviation will not recur; and place on file in the official establishment, available to any duly authorized FSIS program employee, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence.

(ii) In addition, in the case of a heating deviation, the official establishment may reprocess the affected product, using one of the methods in paragraph (b)(1) in this section; use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics; or relabel the affected product as a partially-cooked patty product, if it meets the stabilization requirements in paragraph (c) of this section.

(c) Stabilization. (1) Fully cooked, partially cooked, and char-marked meat patties must be produced using processes ensuring no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log10 multiplication of Clostridium perfringens, within the product.

(2) For each meat patty product produced using a stabilization process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule.

(3) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.

(4) Partially cooked patties must bear the labeling statement “Partially cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement must be adjacent to the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(5) Char-marked patties must bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement shall be adjacent to the product name, at least one-half the size of the largest letter in the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

[64 FR 744, Jan. 6, 1999]

§ 318.24 Product prepared using advanced meat/bone separation machinery; process control.

(a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in § 310.22 of this subchapter, using advances in mechanical meat/bone separation machinery (i.e., AMR systems) that, in accordance with this section, recover meat—

(1) Without significant incorporation of bone solids or bone marrow as measured by the presence of calcium and iron in excess of the requirements in this section, and

(2) Without the presence of any brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).

(b) Process control. As a prerequisite to labeling or using product as meat derived by the mechanical separation of skeletal muscle tissue from livestock bones, the operator of an establishment must develop, implement, and maintain procedures that ensure that the establishment's production process is in control.

(1) The production process is not in control if the skulls entering the AMR system contain any brain or trigeminal ganglia tissue, if the vertebral column bones entering the AMR system contain any spinal cord, if the recovered product fails otherwise under any provision of paragraph (c)(1), if the product is not properly labeled under the provisions of paragraph (c)(2), or if the spent bone materials are not properly handled under the provisions of paragraph (c)(3) of this section.

(2) The establishment must document its production process controls in writing. The program must be designed to ensure the on-going effectiveness of the process controls. If the establishment processes cattle, the program must be in its HACCP plan, its Sanitation SOP, or other prerequisite program. The program shall describe the on-going verification activities that will be performed, including the observation of the bones entering the AMR system for brain, trigeminal ganglia, and spinal cord; the testing of the product exiting the AMR system for bone solids, bone marrow, spinal cord, and DRG as prescribed in paragraph (c)(1) of this section; the use of the product and spent bone materials exiting the AMR system; and the frequency with which these activities will be performed.

(3) The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process.

(4) The establishment shall make available to inspection program personnel the documentation described in paragraphs (b)(2) and (b)(3) of this section and any other data generated using these procedures.

(c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances:

(i) Bone solids. The product's calcium content, measured by individual samples and rounded to the nearest 10th, is more than 130.0 mg per 100 g.

(ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g.1

1 The excessive iron (ExcFe) measurement for an analyzed sample is equal to the obtained iron (Fe) result expressed in mg/100 g measured and rounded to the nearest 100th or more for that sample, minus the product of three factors: (1) The iron to protein ratio (IPR) factor associated with corresponding hand-deboned product; (2) the obtained protein (P) result (%) for that sample; and (3) a constant factor of 1.10. In formula, this can be written as: ExcFe = mFe − IPR × Protein × 1.10, where ExcFe represents the excess iron, expressed in units of mg/100 g; mFe represents the measured level of iron (Fe, mg/100 g), IPR is the iron to protein ratio for the appropriate hand-deboned product, and “Protein” is the measured level of protein rounded to the nearest 100th and expressed as a percentage of the total weight of the sample. In lieu of data demonstrating otherwise, the values of IPR to be used in the above formula are as follows: For beef products the value of IPR is equal to 0.104, except for any combination of bones that include any beef neckbone product, for which the value of 0.138 is to be used; for pork product, the IPR value is 0.052. Other IPR values can be used provided that the operator of an establishment has verified and documented the ratio of iron content to protein content in the skeletal muscle tissue attached to bones prior to their entering the AMR system, based on analyses of hand-deboned samples, and the documented value is to be substituted for the IPR value (as applicable) in the above formula with respect to product that the establishment mechanically separates from those bones.

(iii) Brain or trigeminal ganglia. Skulls that enter the AMR system have tissues of brain or trigeminal ganglia.

(iv) Spinal cord. Vertebral column bones that enter the AMR system have tissues of spinal cord, or the product that exits the AMR system contains spinal cord.

(v) DRG. The product that exits the AMR system contains DRG.

(2) If product that may not be labeled or used as “meat” under this section meets the requirements of § 319.5 of this subchapter, it may bear the name “Mechanically Separated (Species)” except as follows:

(i) If skulls or vertebral column bones of cattle younger than 30 months of age that enter the AMR system have tissues of brain, trigeminal ganglia, or spinal cord, the product that exits the AMR system shall not be used as an ingredient of a meat food product.

(ii) If product that exits the AMR system contains spinal cord or DRG from bones of cattle younger than 30 months of age, it shall not be used as an ingredient of a meat food product.

(iii) If product derived from any bones of cattle of any age does not comply with (c)(1)(i) or (ii), it may bear a common or usual name that is not false or misleading, except that the product may not bear the name “Mechanically Separated (Beef).”

(3) Spent skulls or vertebral column bone materials from cattle younger than 30 months of age that exit the AMR system shall not be used as an ingredient of a meat food product.

[69 FR 1884, Jan. 12, 2004]

Subparts B-F [Reserved] Subpart G—Canning and Canned Products Source:

51 FR 45619, Dec. 19, 1986, unless otherwise noted.

§ 318.300 Definitions.

(a) Abnormal container. A container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled.

(b) Acidified low acid product. A canned product which has been formulated or treated so that every component of the finished product has a pH of 4.6 or lower within 24 hours after the completion of the thermal process unless data are available from the establishment's processing authority demonstrating that a longer time period is safe.

(c) Bleeders. Small orifices on a retort through which steam, other gasses, and condensate are emitted from the retort throughout the entire thermal process.

(d) Canned product. A meat food product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Unless otherwise specified, the term “product” as used in this subpart G shall mean “canned product.”

(e) Closure technician. The individual(s) identified by the establishment as being trained to perform specific container integrity examinations as required by this subpart and designated by the establishment to perform such examinations.

(f) Code lot. All production of a particular product in a specific size container marked with a specific container code.

(g) Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heating medium into a closed retort and the start of process timing.

(h) Critical factor. Any characteristic, condition or aspect of a product, container, or procedure that affects the adequacy of the process schedule. Critical factors are established by processing authorities.

(i) Headspace. That portion of a container not occupied by the product.

(1) Gross headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (i.e., the flange of an unsealed can, the top of the double seam on a sealed can, or the top edge of an unsealed jar).

(2) Net headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the inside surface of the lid.

(j) Hermetically sealed containers. Air-tight containers which are designed and intended to protect the contents against the entry of microorganisms during and after thermal processing.

(1) Rigid container. A container, the shape or contour of which, when filled and sealed, is neither affected by the enclosed product nor deformed by external mechanical pressure of up to 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(2) Semirigid container. A container, the shape or contour of which, when filled and sealed, is not significantly affected by the enclosed product under normal atmospheric temperature and pressure, but can be deformed by external mechanical pressure of less than 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(3) Flexible container. A container, the shape or contour of which, when filled and sealed, is significantly affected by the enclosed product.

(k) Incubation tests. Tests in which the thermally processed product is kept at a specific temperature for a specified period of time in order to determine if outgrowth of microorganisms occurs.

(l) Initial temperature. The temperature, determined at the initiation of a thermal process cycle, of the contents of the coldest container to be processed.

(m) Low acid product. A canned product in which any component has a pH value above 4.6.

(n) Process schedule. The thermal process and any specified critical factors for a given canned product required to achieve shelf stability.

(o) Process temperature. The minimum temperature(s) of the heating medium to be maintained as specified in the process schedule.

(p) Process time. The intended time(s) a container is to be exposed to the heating medium while the heating medium is at or above the process temperature(s).

(q) Processing authority. The person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart.

(r) Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program (see § 301.2(f)).

(s) Retort. A pressure vessel designed for thermal processing of product packed in hermetically sealed containers.

(t) Seals. Those parts of a semirigid container and lid or of a flexible container that are fused together in order to hermetically close the container.

(u) Shelf stability. The condition achieved by application of heat, sufficient, alone or in combination with other ingredients and/or treatments, to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50 °F or 10 °C) at which the product is intended to be held during distribution and storage. Shelf stability and shelf stable are synonymous with commercial sterility and commercially sterile, respectively.

(v) Thermal process. The heat treatment necessary to achieve shelf stability as determined by the establishment's processing authority. It is quantified in terms of:

(1) Time(s) and temperature(s); or

(2) Minimum product temperature.

(w) Venting. The removal of air from a retort before the start of process timing.

(x) Water activity. The ratio of the water vapor pressure of the product to the vapor pressure of pure water at the same temperature.

§ 318.301 Containers and closures.

(a) Examination and cleaning of empty containers. (1) Empty containers, closures, and flexible pouch roll stock shall be evaluated by the establishment to ensure that they are clean and free of structural defects and damage that may affect product or container integrity. Such an examination should be based upon a statistical sampling plan.

(2) All empty containers, closures, and flexible pouch roll stock shall be stored, handled, and conveyed in such a manner that will prevent soiling and damage that could affect the hermetic condition of the sealed container.

(3) Just before filling, rigid containers shall be cleaned to prevent incorporation of foreign matter into the finished product. Closures, semirigid containers, preformed flexible pouches, and flexible pouch roll stock contained in original wrappings do not need to be cleaned before use.

(b) Closure examinations for rigid containers (cans)—(1) Visual examinations. A closure technician shall visually examine the double seams formed by each closing machine head. When seam defects (e.g., cutovers, sharpness, knocked down flanges, false seams, droops) are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken. In addition to the double seams, the entire container shall be examined for product leakage or obvious defects. A visual examination shall be performed on at least one container from each closing machine head, and the observations, along with any corrective actions, shall be recorded. Visual examinations shall be conducted with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for changes in container size).

(2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing head shall be examined on the packer's end during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have container specification guidelines for double seam integrity on file and available for review by Program employees. A teardown examination of the can maker's end shall be performed on at least one container selected from each closing machine during each examination period except when teardown examinations are made on incoming empty containers or when, in the case of self-manufactured containers, the containers are made in the vicinity of the establishment and the container plant records are made available to Program employees. Additional teardown examinations on the packer's end should be made at the beginning of production, immediately following every jam in a closing machine and after closing machine adjustment (including adjustment for a change in container size). The following procedures shall be used in teardown examinations of double seams:

(i) One of the following two methods shall be employed for dimensional measurements of the double seam.

(a) Micrometer measurement. For cylindrical containers, measure the following dimensions (Figure 1) at three points approximately 120 degrees apart on the double seam excluding and at least one-half inch from the side seam juncture:

(1) Double seam length—W;

(2) Double seam thickness—S;

(3) Body hook length—BH; and

(4) Cover hook length—CH.

Maximum and minimum values for each dimensional measurement shall be recorded by the closure technician. EC11SE91.016

(b) Seamscope or seam projector. Required measurements of the seam include thickness, body hook, and overlap. Seam thickness shall be obtained by micrometer. For cylindrical containers, at least two locations, excluding the side seam juncture, shall be used to obtain the required measurements.

(ii) Seam tightness. Regardless of the dimensional measurement method used to measure seam dimensions, at a minimum, the seam(s) examined shall be stripped to assess the degree of wrinkling.

(iii) Side seam juncture rating. Regardless of the dimensional measurement method used to measure seam dimensions, the cover hook shall be stripped to examine the cover hook droop at the juncture for containers having side seams.

(iv) Examination of noncylindrical containers. Examination of noncylindrical containers (e.g., square, rectangular, “D”-shaped, and irregularly-shaped) shall be conducted as described in paragraphs (b)(2) (i), (ii), and (iii) of this section except that the required dimensional measurements shall be made on the double seam at the points listed in the establishment's container specification guidelines.

(c) Closure examinations for glass containers—(1) Visual examinations. A closure technician shall visually assess the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine shall be taken and recorded. In addition to the closures, the entire container shall be examined for defects. Visual examinations shall be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).

(2) Closure examinations and tests. Depending upon the container and closure, tests shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made either before or after thermal processing and at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing machine shall be examined during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have specification guidelines for closure integrity on file and available for review by Program employees. Additional closure examinations should be made at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).

(d) Closure examinations for semirigid and flexible containers—(1) Heat seals—(i) Visual examinations. A closure technician shall visually examine the seals formed by each sealing machine. When sealing defects are observed, necessary corrective actions, such as adjusting or repairing the sealing machine, shall be taken and recorded. In addition to examining the heat seals, the entire container shall be examined for product leakage or obvious defects. Visual examinations shall be performed before and after the thermal processing operation and with sufficient frequency to ensure proper closure. These examinations should be conducted at least in accordance with a statistical sampling plan. All defects noted and corrective actions taken shall be promptly recorded.

(ii) Physical tests. Tests determined by the establishment as necessary to assess container integrity shall be conducted by the closure technician at a frequency sufficient to ensure proper closure. These tests shall be performed after the thermal processing operation and should be made at least every 2 hours of continuous production. The establishment's acceptance guidelines for each test procedure shall be on file and available for review by Program employees. Test results along with any necessary corrective actions, such as adjusting or repairing the sealing machine, shall be recorded.

(2) Double seams on semirigid or flexible containers shall be examined and the results recorded as provided in paragraph (b) of this section. Any additional measurements specified by the container manufacturer shall also be made and recorded.

(e) Container coding. Each container shall be marked with a permanent, legible, identifying code mark. The mark shall, at a minimum, identify in code the product (unless the product name lithographed or printed elsewhere on the container) and the day and year the product was packed.

(f) Handling of containers after closure. (1) Containers and closures shall be protected from damage which may cause defects that are likely to affect the hermetic condition of the containers. The accumulation of stationary containers on moving conveyors should be minimized to avoid damage to the containers.

(2) The maximum time lapse between closing and initiation of thermal processing shall be 2 hours. However, the Administrator may specify a shorter period of time when considered necessary to ensure product safety and stability. A longer period of time between closing and the initiation of thermal processing may be permitted by the Administrator.

(Approved by the Office of Management and Budget under control number 0583-0015)

§ 318.302 Thermal processing.

(a) Process schedules. Prior to the processing of canned product for distribution in commerce, an establishment shall have a process schedule (as defined in § 318.300(n) of this subpart) for each canned meat product to be packed by the establishment.

(b) Source of process schedules. (1) Process schedules used by an establishment shall be developed or determined by a processing authority.

(2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements shall be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority shall amend the process schedule accordingly.

(3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, shall be made available by the establishment to the Program employee upon request.

(c) Submittal of process information. (1) Prior to the processing of canned product for distribution in commerce, the establishment shall provide the inspector at the establishment with a list of the process schedules (including alternate schedules) along with any additional applicable information, such as the retort come-up operating procedures and critical factors.

(2) Letters or other written communications from a processing authority recommending all process schedules shall be maintained on file by the establishment. Upon request by Program employees, the establishment shall make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment shall provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to establish the process schedule. Once submitted, the process schedules and associated critical factors and the procedures for measuring (including the frequency), controlling, and recording of critical factors shall not be changed without the prior written submittal of the revised procedures (including supporting documentation) to the inspector at the establishment.

(Approved by the Office of Management and Budget under control number 0583-0015)

§ 318.303 Critical factors and the application of the process schedule.

Critical factors specified in the process schedule shall be measured, controlled and recorded by the establishment to ensure that these factors remain within the limits used to establish the process schedule. Examples of factors that are often critical to process schedule adequacy may include:

(a) General. (1) Maximum fill-in weight or drained weight;

(2) Arrangement of pieces in the container;

(3) Container orientation during thermal processing;

(4) Product formulation;

(5) Particle size;

(6) Maximum thickness for flexible, and to some extent semirigid containers during thermal processing;

(7) Maximum pH;

(8) Percent salt;

(9) Ingoing (or formulated) nitrite level (ppm);

(10) Maximum water activity; and

(11) Product consistency or viscosity.

(b) Continuous rotary and batch agitating retorts. (1) Minimum headspace; and

(2) Retort reel speed.

(d) Steam/air retorts. (1) Steam/air ratio; and

(2) Heating medium flow rate.

§ 318.304 Operations in the thermal processing area.

(a) Posting of processes. Process schedules (or operating process schedules) for daily production, including minimum initial temperatures and operating procedures for thermal processing equipment, shall be posted in a conspicuous place near the thermal processing equipment. Alternatively, such information shall be available to the thermal processing system operator and the inspector.

(b) Process indicators and retort traffic control. A system for product traffic control shall be established to prevent product from bypassing the thermal processing operation. Each basket, crate or similar vehicle containing unprocessed product, or at least one visible container in each vehicle, shall be plainly and conspicuously marked with a heat sensitive indicator that will visually indicate whether such unit has been thermally processed. Exposed heat sensitive indicators attached to container vehicles shall be removed before such vehicles are refilled with unprocessed product. Container loading systems for crateless retorts shall be designed to prevent unprocessed product from bypassing the thermal processing operation.

(c) Initial temperature. The initial temperature of the contents of the coldest container to be processed shall be determined and recorded by the establishment at the time the processing cycle begins to assure that the temperature of the contents of every container to be processed is not lower than the minimum initial temperature specified in the process schedule. Thermal processing systems which subject the filled and sealed containers to water at any time before process timing begins shall be operated to assure that such water will not lower the temperature of the product below the minimum initial temperature specified in the process schedule.

(d) Timing devices. Devices used to time applicable thermal processing operation functions or events, such as process schedule time, come-up time and retort venting, shall be accurate to assure that all such functions or events are achieved. Pocket watches and wrist watches are not considered acceptable timing devices. Analog and digital clocks are considered acceptable. If such clocks do not display seconds, all required timed functions or events shall have at least a 1-minute safety factor over the specified thermal processing operation times. Temperature/time recording devices shall correspond within 15 minutes to the time of the day recorded on written records required by § 318.306.

(e) Measurement of pH. Unless other methods are approved by the Administrator, potentiometric methods using electronic instruments (pH meters) shall be used for making pH determinations when a maximum pH value is specified as a critical factor in a process schedule.

(Approved by Office of Management and Budget under control number 0583-0015)

§ 318.305 Equipment and procedures for heat processing systems.

(a) Instruments and controls common to different thermal processing systems—(1) Indicating temperature devices. Each retort shall be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, shall be used as the reference instrument for indicating the process temperature.

(i) Mercury-in-glass thermometers. A mercury-in-glass thermometer shall have divisions that are readable to 1F °(or 0.5C°) and whose scale contains not more than 17F°/inch (or 4.0C°/cm) of graduated scale. Each mercury-in-glass thermometer shall be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test shall be maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard shall be repaired and tested for accuracy before further use, or replaced.

(ii) Other devices. Temperature-indicating devices, such as resistance temperature detectors, used in lieu of mercury-in-glass thermometers, shall meet known, accurate standards for such devices when tested for accuracy. The records of such testing shall be available to FSIS program employees.

(2) Temperature/time recording devices. Each thermal processing system shall be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy shall be equal to or better than 1F °(or 0.5C°) at the process temperature. The temperature recording chart should be adjusted to agree with, but shall never be higher than, the known accurate indicating temperature device. A means of preventing unauthorized changes in the adjustment shall be provided. For example, a lock or a notice from management posted at or near the recording device warning that only authorized persons are permitted to make adjustments, are satisfactory means for preventing unauthorized changes. Air-operated temperature controllers shall have adequate filter systems to ensure a supply of clean, dry air. The recorder timing mechanism shall be accurate.

(i) Chart-type devices. Devices using charts shall be used only with the correct chart. Each chart shall have a working scale of not more than 55F°/inch (or 12C°/cm) within a range of 20F °(or 11C°) of the process temperature. Chart graduations shall not exceed 2F degrees (or 1C degree) within a range of 10F degrees (or 5C degrees) of the process temperature. Multipoint plotting chart-type devices shall print temperature readings at intervals that will assure that the parameters of the process time and process temperature have been met. The frequency of recording should not exceed 1-minute intervals.

(ii) Other devices. Temperature/time recording devices or procedures used in lieu of chart-type devices must meet known accurate standards for such devices or procedures when tested for accuracy. Such a device must be accurate enough for ensuring that process time and temperature parameters have been met.

(3) Steam controllers. Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recording/controlling instrument when combined with a temperature/time recording device.

(4) Air valves. All air lines connected to retorts designed for pressure processing in steam shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of air into the retort during the process cycle.

(5) Water valves. All retort water lines that are intended to be closed during a process cycle shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of water into the retort during the process cycle.

(b) Pressure processing in steam—(1) Batch still retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 3/4 inch (1.9 cm) diameter opening and equipped with a 1/16 inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulb or probe. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described under paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point to facilitate air removal during venting.

(iv) Crate supports. Vertical still retorts with bottom steam entry shall employ bottom retort crate supports. Baffle plates shall not be used in the bottom of retorts.

(v) Steam spreader. Perforated steam spreaders, if used, shall be maintained to ensure they are not blocked or otherwise inoperative. Horizontal still retorts shall be equipped with perforated steam spreaders that extend the full length of the retort unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority. Such information shall be maintained on file by the establishment and made available to Program employees for review.

(vi) Bleeders and condensate removal. Bleeders, except those for external wells of temperature devices, shall have 1/8 inch (or 3 mm) or larger openings and shall be wide open during the entire process, including the come-up time. For horizontal still retorts, bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost locations of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly. Vertical retorts shall have at least one bleeder opening located in the portion of the retort opposite the steam inlet. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly. In retorts having a steam inlet above the level of the lowest container, a bleeder shall be installed in the bottom of the retort to remove condensate. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vii) Stacking equipment—(a) Equipment for holding or stacking containers in retorts. Crates, trays, gondolas, carts, and other vehicles for holding or stacking product containers in the retort shall be so constructed to ensure steam circulation during the venting, come-up, and process times. The bottom of each vehicle shall have perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) centers or the equivalent unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority and such information is maintained on file by the establishment and made available to Program employees for review.

(b) Divider plates. Whenever one or more divider plates are used between any two layers of containers or placed on the bottom of a retort vehicle, the establishment shall have on file documentation that the venting procedure allows the air to be removed from the retort before timing of the thermal process is started. Such documentation shall be in the form of heat distribution data or documentation from a processing authority. This information shall be made available to Program employees for review.

(viii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have on file documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be made available to Program employees for review.

(ix) Vents—(a) Vents shall be located in that portion of the retort opposite the steam inlet and shall be designed, installed, and operated in such a way that air is removed from the retort before timing of the thermal process is started. Vents shall be controlled by a gate, plug cock, or other full-flow valve which shall be fully opened to permit rapid removal of air from retorts during the venting period.

(b) Vents shall not be connected to a closed drain system without an atmospheric 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 line. A manifold header connecting vents or manifolds from several still retorts shall lead to the atmosphere. The manifold header shall not be controlled by a valve and shall be of a size such that the cross-sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from the maximum number of retorts to be vented simultaneously.

(c) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(d) For crateless retort installations, the establishment shall have heat distribution data or other documentation from the equipment manufacturer or from a processing authority that demonstrates that the venting procedure used accomplishes the removal of air and condensate. This information shall be maintained on file by the establishment and made available to Program employees for review.

(e) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows:

(1) Venting horizontal retorts.

(i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.

EC11SE91.017

Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other full-flow valve and discharging to atmosphere. The end vents shall not be more than 21/2 feet (or 75 cm) from ends of retort. Venting method (Figure 1): Vent valves shall be wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or at least 7 minutes and to at least 220 °F (or 104.5 °C).

(ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.

EC11SE91.018

Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length; vents not over 21/2 feet (or 75 cm) from ends of retort; size of manifold for retorts less than 15 feet (4.6 m) in length, 21/2 inches (6.4 cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 cm).

Venting method (Figure 2): The manifold 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.

EC11SE91.019

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-sectional area is equal to the cross-sectional area of the vent pipe inlet.

Venting method (Figure 3): The gate, plug cock, or other full-flow valve on the water spreader vent shall be wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or for at least 7 minutes and to at least 220 °F (or 104.5 °C).

(iv) Venting through a single 21/2 inch (6.4 cm) top vent for retorts not exceeding 15 feet (4.6 m) in length.

EC11SE91.020

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 located within 2 feet (61 cm) of the center of the retort.

Venting method (Figure 4): The vent valve shall be wide open for at least 4 minutes and to at least 220 °F (or 104.5 °C).

(2) Venting vertical retorts.

(i) Venting through a 11/2 inch (3.8 cm) overflow.

EC11SE91.021 Figure 5

Specifications (Figure 5): A 11/2 inch (3.8 cm) overflow pipe equipped with a 11/2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11/2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header.

Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C).

(ii) Venting through a single 1 inch (2.5 cm) side or top vent.

EC11SE91.022

Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top side, equipped with a gate, plug cock, or other full-flow valve and discharging directly into the atmosphere or to a manifold header.

Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 minutes and to at least 230 °F (110 °C), or for at least 7 minutes and to at least 220 °F (or 104.5 °C).

(2) Batch agitating retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 3/4 inch (1.9 cm) diameter opening and equipped with a 1/16 (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort and shall enter at a point(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 1/8 inch (or 3 mm) or larger and shall be wide open during the entire process including the come-up time. Bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers, at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the retort to remove condensate during retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vi) Retort or reel speed timing. The retort or reel speed shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(3) Continuous rotary retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 3/4 inch (1.9 cm) diameter opening and equipped with a 1/16 inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 1/8 inch (3.2 mm) or larger and shall be wide open during the entire process, including the come-up time. B!eeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top of the retort. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who deve!oped the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the shell to remove condensate during the retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vi) Retort speed timing. The rotational speed of the retort shall be specified in the process schedule. The speed shall be adjusted as specified, and recorded by the establishment when the retort is started, and checked and recorded at intervals not to exceed 4 hours to ensure that the correct retort speed is maintained. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. If a recording tachometer is used, the speed shall be manually checked against an accurate stopwatch at least once per shift and the results recorded. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(4) Hydrostatic retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, indicating temperature devices shall be located in the steam dome near the steam/water interface. Where the process schedule specifies maintenance of particular water temperatures in the hydrostatic water legs, at least one indicating temperature device shall be located in each hydrostatic water leg so that it can accurately measure water temperature and be easily read. The temperature/time recorder probe shall be installed either within the steam dome or in a well attached to the dome. Each probe shall have a 1/16 inch (1.6 mm) or larger bleeder opening which emits steam continuously during the processing period. Additional temperature/time recorder probes shall be installed in the hydrostatic water legs if the process schedule specifies maintenance of particular temperatures in these water legs.

(ii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlets shall be large enough to provide steam for proper operation of the retort.

(iv) Bleeders. Bleeder openings 1/4 inch (or 6 mm) or larger shall be located in the steam chamber(s) opposite the point of steam entry. Bleeders shall be wide open and shall emit steam continuously during the entire process, including the come-up time. All bleeders shall be arranged in such a way that the operator can observe that they are functioning properly.

(v) Venting. Before the start of processing operations, the retort steam chamber(s) shall be vented to ensure removal of air. Heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the air is removed from the retort prior to processing shall be kept on file at the establishment and made available to Program employees for review.

(vi) Conveyor speed. The conveyor speed shall be calculated to obtain the required process time and recorded by the establishment when the retort is started. The speed shall be checked and recorded at intervals not to exceed 4 hours to ensure that the correct conveyor speed is maintained. A recording device may be used to provide a continuous record of the conveyor speed. When a recording device is used, the speed shall be manually checked against an accurate stopwatch at least once per shift by the establishment. A means of preventing unauthorized speed changes of the conveyor shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the muffler do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(c) Pressure processing in water—(1) Batch still retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulbs or probes of indicating temperature devices shall be located in such a position that they are beneath the surface of the water throughout the process. On horizontal retorts, the indicating temperature device bulb or probe shall be inserted directly into the retort shell. In both vertical and horizontal retorts, the indicating temperature device bulb or probe shall extend directly into the water a minimum of 2 inches (or 5 cm) without a separable well or sleeve. In vertical retorts equipped with a recorder/controller, the controller probe shall be located at the bottom of the retort below the lowest crate rest in such a position that the steam does not strike it directly. In horizontal retorts so equipped, the controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for direct steam impingement on the controller probe. Air-operated temperature controllers shall have filter systems to ensure a supply of clean, dry air.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority demonstrating uniform heat distribution within the retort shall be kept on file at the establishment and made available to Program employees for review.

(v) Crate supports. A bottom crate support shall be used in vertical retorts. Baffle plates shall not be used in the bottom of the retort.

(vi) Stacking equipment. For filled flexible containers and, where applicable, semirigid containers, stacking equipment shall be designed to ensure that the thickness of the filled containers does not exceed that specified in the process schedule and that the containers do not become displaced and overlap or rest on one another during the thermal process.

(vii) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(viii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). For retorts requiring complete immersion of containers, water shall cover the top layer of containers during the entire come-up time and thermal processing periods and should cover the top layer of containers during cooling. For retorts using cascading water or water sprays, the water level shall be maintained within the range specified by the retort manufacturer or processing authority during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the water level at intervals to ensure it meets the specified processing parameters.

(ix) Air supply and controls. In both horizontal and vertical still retorts, a means shall be provided for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(x) Water recirculation. When a water recirculation system is used for heat distribution, the water shall be drawn from the bottom of the retort through a suction manifold and discharged through a spreader that extends the length or circumference of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running, and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution or other documentation from a processing authority and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used, provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(2) Batch agitating retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, the indicating temperature device bulb or probe shall extend directly into the water without a separable well or sleeve. The recorder/controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for steam to directly strike the controller bulb or probe.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority shall be kept on file by the establishment and made available to Program employees for review.

(v) Stacking equipment. All devices used for holding product containers (e.g., crates, trays, divider plates) shall be so constructed to allow the water to circulate around the containers during the come-up and thermal process periods.

(vi) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(vii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). Water shall completely cover all containers during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the adequacy of the water level with sufficient frequency to ensure it meets the specified processing parameters.

(viii) Air supply and controls. Retorts shall be provided with a means for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(ix) Retort or reel speed timing. The retort or reel speed timing shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by the establishment by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(x) Water recirculation. If a water recirculation system is used for heat distribution, it shall be installed in such a manner that water will be drawn from the bottom of the retort through a suction manifold and discharged through a spreader which extends the length of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(d) Pressure processing with steam/air mixtures in batch retorts. (1) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes for indicating temperature devices and temperature/time recording devices or controller probes shall be inserted directly into the retort shell in such a position that steam does not strike them directly.

(2) Steam controllers are required as described in paragraph (a)(3) of this section.

(3) Recording pressure controller. A recording pressure controller shall be used to control the air inlet and the steam/air mixture outlet.

(4) Circulation of steam/air mixtures. A means shall be provided for the circulation of the steam/air mixture to prevent formation of low-temperature pockets. The efficiency of the circulation system shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. The circulation system shall be checked to ensure its proper functioning and shall be equipped with a pilot light or a similar device to warn the operator when it is not functioning. Because of the variety of existing designs, reference shall be made to the equipment manufacturer for details of installation, operation, and control.

(e) Atmospheric cookers—(1) Temperature/time recording device. Each atmospheric cooker (e.g., hot water bath) shall be equipped with at least one temperature/time recording device in accordance with the basic requirements described in paragraph (a)(2) of this section.

(2) Heat distribution. Each atmospheric cooker shall be equipped and operated to ensure uniform heat distribution throughout the processing system during the thermal process. Heat distribution data or other documentation from the manufacturer or a processing authority demonstrating uniform heat distribution within the cooker shall be kept on file by the establishment and made available to Program employees for review.

(f) Other systems. All other systems not specifically delineated in this section and used for the thermal processing of canned product shall be adequate to produce shelf-stable products consistently and uniformly.

(g) Equipment maintenance. (1) Upon installation, all instrumentation and controls shall be checked by the establishment for proper functioning and accuracy and, thereafter, at any time their functioning or accuracy is suspect.

(2) At least once a year each thermal processing system shall be examined by an individual not directly involved in daily operations to ensure the proper functioning of the system as well as all auxiliary equipment and instrumentation. In addition, each thermal processing system should be examined before the resumption of operation following an extended shutdown.

(3) Air and water valves that are intended to be closed during thermal processing shall be checked by the establishment for leaks. Defective valves shall be repaired or replaced as needed.

(4) Vent and bleeder mufflers shall be checked and maintained or replaced by the establishment to prevent any reduction in vent or bleeder efficiency.

(5) When water spreaders are used for venting, a maintenance schedule shall be developed and implemented to assure that the holes are maintained at their original size.

(6) Records shall be kept on all maintenance items that could affect the adequacy of the thermal process. Records shall include the date and type of maintenance performed and the person conducting the maintenance.

(h) Container cooling and cooling water. (1) Potable water shall be used for cooling except as provided for in paragraphs (h) (2) and (3) of this section.

(2) Cooling canal water shall be chlorinated or treated with a chemical approved by the Administrator as having a bactericidal effect equivalent to chlorination. There shall be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals shall be cleaned and replenished with potable water to prevent the buildup of organic matter and other materials.

(3) Container cooling waters that are recycled or reused shall be handled in systems that are so designed, operated, and maintained so there is no buildup of microorganisms, organic matter, and other materials in the systems and in the waters. System equipment, such as pipelines, holding tanks and cooling towers, shall be constructed and installed so that they can be cleaned and inspected. In addition, the establishment shall maintain, and make available to Program employees for review, information on at least the following:

(i) System design and construction;

(ii) System operation including the rates of renewal with fresh, potable water and the means for treating the water so that there is a measurable residual of an acceptable sanitizer, per paragraph (h)(2) of this section, in the water at the point where the water exits the container cooling vessel;

(iii) System maintenance including procedures for the periodic cleaning and sanitizing of the entire system; and

(iv) Water quality standards, such as microbiological, chemical and physical, monitoring procedures including the frequency and site(s) of sampling, and the corrective actions taken when water quality standards are not met.

(i) Post-process handling of containers Containers shall be handled in a manner that will prevent damage to the hermetic seal area. All worn and frayed belting, can retarders, cushions, and the like shall be replaced with nonporous materials. To minimize container abrasions, particularly in the seal area, containers should not remain stationary on moving conveyors. All post-process container handling equipment should be kept clean so there is no buildup of microorganisms on surfaces in contact with the containers.

(Approved by the Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]

§ 318.306 Processing and production records.

At least the following processing and production information shall be recorded by the establishment: date of production; product name and style; container code; container size and type; and the process schedule, including the minimum initial temperature. Measurements made to satisfy the requirements of § 318.303 regarding the control of critical factors shall be recorded. In addition, where applicable, the following information and data shall also be recorded:

(a) Processing in steam—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or the number of retort crates per retort load, product initial temperature, time steam on, the time and temperature vent closed, the start of process timing, time steam off, and the actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required for batch, still steam retorts in paragraph (a)(1) of this section, record the functioning of the condensate bleeder(s) and the retort or reel speed.

(3) Continuous rotary retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent closed, time process temperature reached, the time the first can enters and the time the last can exits the retort. The retort or reel speed shall be determined and recorded at intervals not to exceed 4 hours. Readings of the indicating temperature device(s) and temperature recorder(s) shall be made and recorded at the time the first container enters the retort and thereafter with sufficient frequency to ensure compliance with the process schedule. These observations should be made and recorded at intervals not exceeding 30 minutes of continuous retort operation. Functioning of the condensate bleeder(s) shall be observed and recorded at the time the first container enters the retort and thereafter as specified in § 318.305(b)(3)(v).

(4) Hydrostatic retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent(s) closed, time process temperature reached, time first containers enter the retort, time last containers exit the retort, and, if specified in the process schedule, measurements of temperatures in the hydrostatic water legs. Readings of the temperature indicating device, which is located in the steam/water interface, and the temperature recording device shall be observed and the temperatures recorded at the time the first containers enter the steam dome. Thereafter, these instruments shall be read and the temperatures recorded with sufficient frequency to ensure compliance with the temperature specified in the process schedule and should be made at least every hour of continuous retort operation. Container conveyor speed, and for agitating hydrostatic retorts, the rotative chain speed, shall be determined and recorded at intervals of sufficient frequency to ensure compliance with the process schedule and should be performed at least every 4 hours.

(b) Processing in water—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, the start of process timing, water level, water recirculation rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required in paragraph (b)(1) of this section, record the retort or reel speed.

(c) Processing in steam/air mixtures. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, venting procedure, if applicable, the start of process timing, maintenance of circulation of the steam/air mixture, air flow rate or forced recirculation flow rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(d) Atmospheric cookers—(1) Batch-type systems. For each cooker batch, record the cooker number or other designation and the approximate number of containers. In addition, record all critical factors of the process schedule such as cooker temperature, initial temperature, the time the thermal process cycle begins and ends, hold time, and the final internal product temperature.

(2) Continuous-type systems. Record the cooker number or other designation, the time the first containers enter and the last containers exit a cooker, and the approximate total number of containers processed. In addition, record all critical factors of the process schedule such as the initial temperature, cooker speed, and final internal product temperature.

(Approved by the Office of Management and Budget under control number 0583-0015)

§ 318.307 Record review and maintenance.

(a) Process records. Charts from temperature/time recording devices shall be identified by production date, container code, processing vessel number or other designation, and other data as necessary to enable correlation with the records required in § 318.306. Each entry on a record shall be made at the time the specific event occurs, and the recording individual shall sign or initial each record form. No later than 1 working day after the actual process, the establishment shall review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, shall be signed or initialed and dated by the person conducting the review. All processing and production records required in this subpart shall be made available to Program employees for review.

(b) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems shall be designed and operated in a manner that will ensure compliance with the applicable requirements of § 318.306.

(c) Container closure records. Written records of all container closure examinations shall specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records shall be signed or initialed by the container closure technician and shall be reviewed and signed by the establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart shall be made available to Program employees for review.

(d) Distribution of product. Records shall be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended use.

(e) Retention of records. Copies of all processing and production records required in § 318.306 shall be retained for no less than 1 year at the establishment, and for an additional 2 years at the establishment or other location from which the records can be made available to Program employees within 3 working days.

(Approved by the Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]

§ 318.308 Deviations in processing.

(a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it shall be considered a deviation in processing.

(b) Deviations in processing (or process deviations) must be handled according to:

(1)(i) A HACCP plan for canned product that addresses hazards associated with microbial contamination, or,

(ii) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(iii) Paragraph (d) of this section.

(d) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.

(1) Deviations identified in-process. If a deviation is noted at any time before the completion of the intended process schedule, the establishment shall:

(i) Immediately reprocess the product using the full process schedule; or

(ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 318.302 (a) and (b) and is filed with the inspector in accordance with § 318.302(c); or

(iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment shall provide the inspector the following:

(a) A complete description of the deviation along with all necessary supporting documentation;

(b) A copy of the evaluation report; and

(iv) Product handled in accordance with paragraph (d)(1)(iii) of this section shall not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product disposition actions.

(v) If an alternate process schedule is used that is not on file with the inspector or if an alternate process schedule is immediately calculated and used, the product shall be set aside for further evaluation in accordance with paragraphs (d)(1)(iii) and (iv) of this section.

(vi) When a deviation occurs in a continuous rotary retort, the product shall be handled in accordance with paragraphs (d)(1)(iii) and (iv) of this section or in accordance with the following procedures:

(a) Emergency stops.

(1) When retort jams or breakdowns occur during the processing operations, all containers shall be given an emergency still process (developed per § 318.302(b)) before the retort is cooled or the retort shall be cooled promptly and all containers removed and either reprocessed, repacked and reprocessed, or destroyed. Regardless of the procedure used, containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or breakdown shall be removed and either reprocessed, repacked and reprocessed and or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 301.2(ttt) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) The time the retort reel stopped and the time the retort is used for an emergency still retort process shall be noted on the temperature/time recording device and entered on the other production records required in § 318.306.

(b) Temperature drops. When the retort temperature drops below the temperature specified in the process schedule, the reel shall be stopped and the following actions shall be taken:

(1) For temperature drops of less than 10 °F (or 5.5 °C) either, (i) all containers in the retort shall be given an emergency still process (developed per § 318.302(b)) before the reel is restarted; (ii) container entry to the retort shall be prevented and an emergency agitating process (developed per § 318.302(b)) shall be used before container entry to the retort is restarted; or (iii) container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 318.2(ee) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) For temperature drops of 10 °F (or 5.5 °C) or more, all containers in the retort shall be given an emergency still process (developed per § 318.302(b)). The time the reel was stopped and the time the retort was used for a still retort process shall be marked on the temperature/time recording device by the establishment and entered on the other production records required in § 318.306. Alternatively, container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 301.2(ee) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) Deviations identified through record review. Whenever a deviation is noted during review of the processing and production records required by § 318.307 (a) and (b), the establishment shall hold the product involved and the deviation shall be handled in accordance with paragraphs (d)(1) (iii) and (iv) of this section.

(e) Process deviation file. The establishment shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description of the corrective actions taken, the evaluation procedures and results, and the disposition of the affected product. Such records shall be maintained in a separate file or in a log that contains the appropriate information. The file or log shall be retained in accordance with § 318.307(e) and shall be made available to Program employees upon request.

(Approved by the Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended at 53 FR 49848, Dec. 12, 1988; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, Sept. 5, 2000]

§ 318.309 Finished product inspection.

(a) Finished product inspections must be handled according to:

(1) A HACCP plan for canned product that addresses hazards associated with microbiological contamination;

(2) An FSIS-approved total quality control system;

(3) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(4) Paragraph (d) of this section.

(b)-(c) [Reserved]

(d) Procedures for handling finished product inspections where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.

(1) Incubation of shelf stable canned product—(i) Incubator. The establishment shall provide incubation facilities which include an accurate temperature/time recording device, an indicating temperature device, a means for the circulation of the air inside the incubator to prevent temperature variations, and a means to prevent unauthorized entry into the facility. The Program is responsible for the security of the incubator.

(ii) Incubation temperature. The incubation temperature shall be maintained at 95±5 °F (35±2.8 °C). If the incubation temperature falls below 90 °F (or 32 °C) or exceeds 100 °F (or 38 °C) but does not reach 103 °F (or 39.5 °C), the incubation temperature shall be adjusted within the required range and the incubation time extended for the time the sample containers were held at the deviant temperature. If the incubation temperature is at or above 103 °F (or 39.5 °C) for more than 2 hours, the incubation test(s) shall be terminated, the temperature lowered to within the required range, and new sample containers incubated for the required time.

(iii) Product requiring incubation. Shelf stable product requiring incubation includes:

(a) Low acid products as defined in § 318.300(m); and

(b) Acidified low acid products as defined in § 318.300(b).

(iv) Incubation samples. (a) From each load of product processed in a batch-type thermal processing system (still or agitation), the establishment shall select at least one container for incubation.

(b) For continuous rotary retorts, hydrostatic retorts, or other continuous-type thermal processing systems, the establishment shall select at least one container per 1,000 for incubation.

(v) Incubation time. Canned product requiring incubation shall be incubated for not less than 10 days (240 hours) under the conditions specified in paragraph (d)(1)(ii) of this section.

(vi) Incubation checks and record maintenance. Designated establishment employees shall visually check all containers under incubation each working day and the inspector shall be notified when abnormal containers are detected. All abnormal containers should be allowed to cool before a final decision on their condition is made. For each incubation test the establishment shall record at least the product name, container size, container code, number of containers incubated, in and out dates, and incubation results. The establishment shall retain such records, along with copies of the temperature/time recording charts, in accordance with § 318.307(e).

(vii) Abnormal containers. The finding of abnormal containers (as defined in § 318.300(a)) among incubation samples is cause to officially retain at least the code lot involved.

(viii) Shipping. No product shall be shipped from the establishment before the end of the required incubation period except as provided in this paragraph or paragraph (b) or (c) of this section. An establishment wishing to ship product prior to the completion of the required incubation period shall submit a written proposal to the area supervisor. Such a proposal shall include provisions that will assure that shipped product will not reach the retail level of distribution before sample incubation is completed and that product can be returned promptly to the establishment should such action be deemed necessary by the incubation test results. Upon receipt of written approval from the area supervisor, product may be routinely shipped provided the establishment continues to comply with all requirements of this subpart.

(2) Container condition—(i) Normal containers. Only normal-appearing containers shall be shipped from an establishment as determined by an appropriate sampling plan or other means acceptable to Program employees.

(ii) Abnormal containers. When abnormal containers are detected by any means other than incubation, the establishment shall inform the inspector, and the affected code lot(s) shall not be shipped until the Program has determined that the product is safe and stable. Such a determination will take into account the cause and level of abnormals in the affected lot(s) as well as any product disposition actions either taken or proposed by the establishment.

(Approved by the Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, Sept. 5, 2000]

§ 318.310 Personnel and training.

All operators of thermal processing systems specified in § 318.305 and container closure technicians shall be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for properly training supervisors of canning operations.

[51 FR 45619, Dec. 19, 1986]

§ 318.311 Recall procedure.

Establishments shall prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure shall be made available to Program employees for review.

(Approved by the Office of Management and Budget under control number 0583-0015)

Pt. 319 PART 319—DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION Subpart A—General Sec. 319.1 Labeling and preparation of standardized products. 319.2 Products and nitrates and nitrites. 319.5 Mechanically Separated (Species). 319.6 Limitations with respect to use of Mechanically Separated (Species). 319.10 Requirements for substitute standardized meat food products named by use of an expressed nutrient content claim and a standardized term. Subpart B—Raw Meat Products 319.15 Miscellaneous beef products. 319.29 Miscellaneous pork products. Subpart C—Cooked Meats 319.80 Barbecued meats. 319.81 Roast beef parboiled and steam roasted. Subpart D—Cured Meats, Unsmoked and Smoked 319.100 Corned beef. 319.101 Corned beef brisket. 319.102 Corned beef round and other corned beef cuts. 319.103 Cured beef tongue. 319.104 Cured pork products. 319.105 “Ham patties,” “Chopped ham,” “Pressed ham,” “Spiced ham,” and similar products. 319.106 “Country Ham,” “Country Style Ham,” “Dry Cured Ham,” “Country Pork Shoulder,” “Country Style Pork Shoulder,” and “Dry Cured Pork Shoulder.” 319.107 Bacon. Subpart E—Sausage Generally: Fresh Sausage 319.140 Sausage. 319.141 Fresh pork sausage. 319.142 Fresh beef sausage. 319.143 Breakfast sausage. 319.144 Whole hog sausage. 319.145 Italian sausage products. Subpart F—Uncooked, Smoked Sausage 319.160 Smoked pork sausage. Subpart G—Cooked Sausage 319.180 Frankfurter, frank, furter, hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and similar products. 319.181 Cheesefurters and similar products. 319.182 Braunschweiger and liver sausage or liverwurst. Subpart H [Reserved] Subpart I—Semi-Dry Fermented Sausage [Reserved] Subpart J—Dry Fermented Sausage [Reserved] Subpart K—Luncheon Meat, Loaves and Jellied Products 319.260 Luncheon meat. 319.261 Meat loaf. Subpart L—Meat Specialties, Puddings and Nonspecific Loaves 319.280 Scrapple. 319.281 Bockwurst. Subpart M—Canned, Frozen, or Dehydrated Meat Food Products 319.300 Chili con carne. 319.301 Chili con carne with beans. 319.302 Hash. 319.303 Corned beef hash. 319.304 Meat stews. 319.305 Tamales. 319.306 Spaghetti with meatballs and sauce, spaghetti with meat and sauce, and similar products. 319.307 Spaghetti sauce with meat. 319.308